ML18073A109

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Management Directive 3.17, NRC Information Quality Program.
ML18073A109
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Issue date: 06/28/2016
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DT-17-114 MD 3.17
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U.S. NUCLEAR REGULATORY COMMISSION MANAGEMENT DIRECTIVE (MD)

MD 3.17 NRC INFORMATION QUALITY PROGRAM DT-17-114 Volume 3, Information Management Part 1: Publications, Mail, and Information Disclosure Approved By: Victor M. McCree Executive Director for Operations Date Approved: June 28, 2016 Cert. Date: N/A, for the latest version of any NRC directive or handbook, see the online MD Catalog.

Issuing Office: Office of the Chief Information Officer Customer Service Division Contact Name: Margie Janney Kimyata MorganButler Fajr Majeed 301-415-7245 301-415-0733 301-415-6736 EXECUTIVE

SUMMARY

Management Directive (MD) 3.17, NRC Information Quality Program, is revised to

  • Incorporate current policy, standards, and procedures, including the Office of Management and Budget (OMB) Memoranda M-10-22, Guidance for Online Use of Web Measurement and Customization Technologies, and M-10-23, Guidance for Agency Use of Third-Party Websites and Applications.
  • Incorporate the recommendations from the Office of the Inspector General Record, Audit of NRCs Process for Ensuring Integrity in Scientific Research (OIG-15-A-08).
  • Reflect the April 2013 reorganization of the Office of Information Services and the subsequent retitling of the office to the Office of the Chief Information Officer in November 2015.
  • Reflect changes resulting from the merger of the Office of Nuclear Material Safety and Safeguards and the Office of Federal and State Materials and Environmental Management Programs.
  • Reflect changes to the tables. The tables formerly in Exhibit 1 have been moved to Exhibit 2: Table 1, NRC Information Products - Information Subject to NRC Information Quality Guidelines and to the Public Seeking Correction, and Table 2, Information Exempt from NRC Information Quality Guidelines and from the Public Seeking Correction. The information in the previous Exhibit 2 has been eliminated.

The current version of the Final Information Quality Bulletin for Peer Review has been incorporated by reference (70 FR 2664, January 14, 2005).

For updates or revisions to policies contained in this MD that were issued after the MD was signed, please see the Yellow Announcement to Management Directive index (YA-to-MD index).

MD 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 06/28/2016 EXECUTIVE

SUMMARY

  • Incorporate Exhibit 4, contents of Memorandum to Office Director Responsible for Creation of Product That May Qualify as Influential Scientific Information or Highly Influential Scientific Assessment.
  • Introduce the internal NRC Information Quality Web site. The Web site also includes a variety of resources and aids to assist employees engaging in the Information Quality Program, including guidelines, exhibits, a template for the Annual Surveys of ISI and HISA, and Information Quality reports.

TABLE OF CONTENTS I. POLICY..............................................................................................................................3 II. OBJECTIVES ....................................................................................................................3 III. ORGANIZATIONAL RESPONSIBILITIES AND DELEGATIONS OF AUTHORITY ........... 3 A. Executive Director for Operations (EDO) ......................................................................3 B. Inspector General (IG) ..................................................................................................4 C. Chief Information Officer (CIO) .....................................................................................4 D. Office of the General Counsel (OGC) and Regional Counsels ......................................4 E. Director, Office of Administration (ADM) .......................................................................4 F. Office Directors and Regional Administrators ...............................................................4 G. Directors of Offices in Possession of Scientific Information Products (Office of Nuclear Regulatory Research (RES), Office of Nuclear Reactor Regulation (NRR), Office of New Reactors (NRO), Office of Nuclear Material and Safety and Safeguards (NMSS), Office of Nuclear Security and Incident Response (NSIR), and Regional Administrators with Program Responsibilities)......................................................................................4 H. Information Quality Coordinator (IQC) ..........................................................................5 I. Information Office Coordinator (IOC) ............................................................................5 J. Peer Review Coordinator (PRC) ...................................................................................6 IV. APPLICABILITY ................................................................................................................6 V. DIRECTIVE HANDBOOK ..................................................................................................6 VI. REFERENCES ...................................................................................................................6 For the latest version of any NRC directive or handbook, see the online MD Catalog. 2

MD 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 06/28/2016 I. POLICY It is the policy of the U.S. Nuclear Regulatory Commission to ensure the quality of all information it relies on for making decisions or disseminates to the public. NRCs policies and practices are designed to ensure that the appropriate level of quality commensurate with the nature of the information is established and maintained. Thus, the most influential scientific, financial, and statistical data are subject to the most rigorous quality standards.

NRC will correct information that does not meet its standards and the Office of Management and Budgets (OMBs) guidelines on the basis of the significance and the impact of the correction. The NRC also ensures that all influential scientific information (ISI) and highly influential scientific assessments (HISA) that the agency intends to disseminate are subject to appropriate peer review, consistent with OMB guidelines.

II. OBJECTIVES Conform to the NRC Information Quality Guidelines (67 Federal Register (FR) 61695),

October 1, 2002, and OMBs Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by Federal Agencies (67 FR 8452).

Ensure disseminated information meets the information quality criteria for utility, integrity, and objectivity as described in the information quality standards found in this handbook.

Impose the highest level of quality on influential scientific, financial, or statistical information.

Ensure Information Correction Requests (ICRs) from the public receive appropriate consideration.

Ensure that peer review is conducted on all influential scientific information and highly influential scientific assessment that the agency intends to disseminate, as defined and described in the peer review guidelines found in this handbook.

III. ORGANIZATIONAL RESPONSIBILITIES AND DELEGATIONS OF AUTHORITY A. Executive Director for Operations (EDO)

1. Provides oversight of the NRC Information Quality Program.
2. Performs functions assigned to the head of agency by the OMB Final Information Quality Bulletin for Peer Review (70 FR 2664).
3. Approves offices designation of information as ISI or as a HISA that must be peer reviewed in accordance with the OMB Final Information Quality Bulletin for Peer Review and directs the most appropriate office to conduct the peer review.

For the latest version of any NRC directive or handbook, see the online MD Catalog. 3

MD 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 06/28/2016 B. Inspector General (IG)

Conducts audits and investigations as warranted concerning the Information Quality Program.

C. Chief Information Officer (CIO)

1. Oversees NRC information management programs.
2. Ensures that the NRC Information Quality Program is consistent with Federal statutes and OMB guidance.
3. Ensures that a program to address ICRs is effectively implemented throughout NRC.
4. Appoints the NRC Information Quality Coordinator (IQC).
5. Provides automated data processing assistance, including continuing development, enhancement, and modification of a tracking system to monitor correction requests.
6. Directs the agencys program to comply with the OMB Final Information Quality Bulletin for Peer Review.

D. Office of the General Counsel (OGC) and Regional Counsels

1. Provide legal opinions and advice related to the NRC Information Quality Program.
2. Review substantive ICR denials to ensure there is no legal objection to the denial.

E. Director, Office of Administration (ADM)

Forwards allegations of research misconduct concerning NRC grantees or contractors conducting research using Federal funds to the Office of the Inspector General.

F. Office Directors and Regional Administrators

1. Ensure employees are aware of and follow the NRCs policies in the NRC Information Quality Program.
2. Appoint an Information Office Coordinator (IOC) to facilitate the review of requests for correction and be responsible for the management of the program within the office or region.

G. Directors of Offices in Possession of Scientific Information Products (Office of Nuclear Regulatory Research (RES), Office of Nuclear Reactor Regulation (NRR),

Office of New Reactors (NRO), Office of Nuclear Material and Safety and Safeguards (NMSS), Office of Nuclear Security and Incident Response (NSIR), and Regional Administrators with Program Responsibilities)

1. Appoint a Peer Review Coordinator and ensure office has guidance on peer review that aligns with MD 3.17.

For the latest version of any NRC directive or handbook, see the online MD Catalog. 4

MD 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 06/28/2016

2. Review scientific information products generated by the individual office intended to be disseminated to the public to determine if they could potentially qualify as ISI or as a HISA.
3. Inform other NRC office directors and regional administrators when they receive scientific information products that the information could possibly qualify as ISI or as a HISA that would have to be peer reviewed in accordance with the OMB Final Information Quality Bulletin for Peer Review.
4. Evaluate the scientific information products to determine if the information qualifies as ISI or as a HISA per MD 3.17 that should be peer reviewed.
5. Provide the list of information products reviewed in the offices response to the annual survey of products that may qualify for peer review to OCIO. Identify those information products that the office determines qualify for peer review, provide information to document how the information product qualifies, and identify the most appropriate office to conduct the peer review.
6. Conduct peer review of scientific information products that constitute ISI or a HISA.
7. Assist other offices conducting peer reviews with preparing the peer review plan and conducting the peer review, as appropriate.

H. Information Quality Coordinator (IQC)

1. Manages the ICR review and appeal process of the NRC Information Quality Program.
2. Maintains the official ICR files and public Web sites for ICRs and peer reviews.
3. Prepares the annual report to OMB and other necessary reports to keep management abreast of the status and issues relating to ICR reviews.
4. Assesses the consistency of decisions to correct or not to correct information.
5. Independently assesses each decision to correct information for its impact on other agency processes and activities.
6. Coordinates the agencys efforts to comply with OMBs Final Information Quality Bulletin for Peer Review.
7. Identifies the number and nature of ICRs received and their resolution, including an explanation of decisions to deny or limit corrective actions, and provides the information to OMB in the NRCs annual fiscal year report.

I. Information Office Coordinator (IOC)

1. Facilitates and evaluates ICR requests for correction and appeals with the support of knowledgeable management and staff in the office or region where the IOC is assigned.
2. Forwards initial review documents with findings and appeals from the ICR to the IQC.

For the latest version of any NRC directive or handbook, see the online MD Catalog. 5

MD 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 06/28/2016 J. Peer Review Coordinator (PRC)

1. Serves as the office contact for responding to the annual survey to identify information products that may qualify for peer review in accordance with OMBs Final Information Quality Bulletin for Peer Review.
2. Serves as the principal contact for the semi-annual update to the Peer Review Agenda.
3. Serves as the principal contact for updates to a Peer Review Plan.

IV. APPLICABILITY The provisions of this directive and handbook apply to and must be followed by all NRC employees and NRC contractors.

V. DIRECTIVE HANDBOOK Handbook 3.17 contains detailed procedures on the NRC Information Quality Program.

VI. REFERENCES Code of Federal Regulations Federal Acquisition Regulation (FAR) 48 CFR Part 1, Federal Acquisition Regulations System.

48 CFR, Chapter 20, NRC Acquisition Regulations System.

Office of the Federal Register Federal Policy on Research Misconduct (65 FR 76260), December 6, 2000, at http://www.gpo.gov/fdsys/pkg/FR-2000-12-06/pdf/00-30852.pdf.

NRC Information Quality Guidelines (67 FR 61968), October 1, 2002, at http://www.gpo.gov/fdsys/pkg/FR-2002-10-01/html/02-24944.html.

Office of Management and Budget Final Information Quality Bulletin for Peer Review (70 FR 2664), January 14, 2005, at http://www.gpo.gov/fdsys/pkg/FR-2005-01-14/pdf/05-769.pdf.

Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by Federal Agencies (67 FR 8452), February 22, 2002, at https://www.gpo.gov/fdsys/.

For the latest version of any NRC directive or handbook, see the online MD Catalog. 6

MD 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 06/28/2016 Office of Management and Budget Memoranda M-10-22, Guidance for Online Use of Web Measurement and Customization Technologies, June 25, 2010, at http://www.whitehouse.gov/sites/default/files/omb/assets/memoranda_2010/m10-22.pdf.

M-10-23, Guidance for Agency Use of Third-Party Websites and Applications, June 25, 2010, at http://www.whitehouse.gov/sites/default/files/omb/assets/memoranda_2010/m10-23.pdf.

Nuclear Regulatory Commission Documents NRC Information Notice No. 89-39, List of Parties Excluded from Federal Procurement or Non-Procurement Programs, April 5, 1989 (ML031180796).

NRC Management Directives 3.4, Release of Information to the Public.

12.5, NRC Cybersecurity Program.

NRC Policy for Handling, Marking, and Protecting Sensitive Unclassified Non-Safeguards Information (ML052990146).

NUREG-Series Publications NUREG/BR-0058, Rev. 4, Regulatory Analysis Guidelines of the U.S. Nuclear Regulatory Commission (ML042820192).

NUREG/BR-0184, Regulatory Analysis Technical Evaluation Handbook (ML050190193).

United States Code Congressional Review Act of 1996 (5 U.S.C. 804 et seq.).

Federal Advisory Committee Act (5 U.S.C. App. 2).

Freedom of Information Act of 1966, as amended (5 U.S.C. 552).

Paperwork Reduction Act of 1995, (44 U.S.C. 3502(1)).

Privacy Act of 1974, as amended (5 U.S.C. 552a).

Treasury and General Government Appropriations Act for FY 2001 (Pub. L. 106-554, Section 515(a)).

For the latest version of any NRC directive or handbook, see the online MD Catalog. 7

MD 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 06/28/2016 Web Sites, Other NRC Information Quality Guidelines:

http://www.nrc.gov/public-involve/info-quality.html.

Submit a Request for an Appeal:

http://www.nrc.gov/public-involve/info-quality/submit-appeal.html.

NRC Customer Service Catalog:

http://www.internal.nrc.gov/ois/CScatalog/catalog.html.

NRC Information Quality Internal Web Site:

http://www.internal.nrc.gov/ois/CScatalog/customerservicecatalogs/information-management/quality/information-quality.html.

The National Academies Policy on Committee Composition and Balance and Conflicts of Interest:

http://www.nationalacademies.org/coi/bi-coi_form-0.pdf.

The NRCs Plain Language Action Plan, Reports, and News:

http://www.nrc.gov/public-involve/open/plain-writing/nrc-plan-rpts-news.html.

For the latest version of any NRC directive or handbook, see the online MD Catalog. 8

U.S. NUCLEAR REGULATORY COMMISSION DIRECTIVE HANDBOOK (DH)

DH 3.17 NRC INFORMATION QUALITY PROGRAM DT-17-114 Volume 3, Information Management Part 1: Publications, Mail, and Information Disclosure Approved By: Victor M. McCree Executive Director for Operations Date Approved: June 28, 2016 Cert. Date: N/A, for the latest version of any NRC directive or handbook, see the online MD Catalog.

Issuing Office: Office of the Chief Information Officer Customer Service Division Contact Name: Margie Janney Kimyata MorganButler Fajr Majeed 301-415-7245 301-415-0733 301-415-6736 EXECUTIVE

SUMMARY

Management Directive (MD) 3.17, NRC Information Quality Program, is revised to

  • Incorporate current policy, standards, and procedures, including the Office of Management and Budget (OMB) Memoranda M-10-22, Guidance for Online Use of Web Measurement and Customization Technologies, and M-10-23, Guidance for Agency Use of Third-Party Websites and Applications.
  • Incorporate the recommendations from the Office of the Inspector General Record, Audit of NRCs Process for Ensuring Integrity in Scientific Research (OIG-15-A-08).
  • Reflect the April 2013 reorganization of the Office of Information Services and the subsequent retitling of the office to the Office of the Chief Information Officer in November 2015.
  • Reflect changes resulting from the merger of the Office of Nuclear Material Safety and Safeguards and the Office of Federal and State Materials and Environmental Management Programs.
  • Reflect changes to the tables. The tables formerly in Exhibit 1 have been moved to Exhibit 2: Table 1, NRC Information Products - Information Subject to NRC Information Quality Guidelines and to the Public Seeking Correction, and Table 2, Information Exempt from NRC Information Quality Guidelines and from the Public Seeking Correction. The information in the previous Exhibit 2 has been eliminated.

The current version of the Final Information Quality Bulletin for Peer Review has been incorporated by reference (70 FR 2664, January 14, 2005).

For updates or revisions to policies contained in this MD that were issued after the MD was signed, please see the Yellow Announcement to Management Directive index (YA-to-MD index).

DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 06/28/2016 EXECUTIVE

SUMMARY

  • Incorporate Exhibit 4, contents of Memorandum to Office Director Responsible for Creation of Product That May Qualify as Influential Scientific Information or Highly Influential Scientific Assessment.
  • Introduce the internal NRC Information Quality Web site. The Web site also includes a variety of resources and aids to assist employees engaging in the Information Quality Program, including guidelines, exhibits, a template for the Annual Surveys of ISI and HISA, and Information Quality reports.

TABLE OF CONTENTS I. NRC INFORMATION QUALITY GUIDELINES ..................................................................3 A. Introduction...................................................................................................................3 B. NRC Information Quality Guidelines .............................................................................3 C. Scope of Information Subject to These Guidelines .......................................................4 D. NRC Quality Standards ................................................................................................5 E. NRC Policy on Research Misconduct ...........................................................................9 II. NRC ADMINISTRATIVE PROCESS FOR THE PUBLIC TO SUBMIT A REQUEST FOR CORRECTION OF INFORMATION .........................................................................12 A. Correction Process .....................................................................................................12 B. Information Quality Coordinator (IQC) Actions ............................................................13 C. Office Processing Actions ...........................................................................................14 D. NRC Receipt and Review of Appeals to ICR Decisions .............................................. 14 E. Responding to the Requester .....................................................................................15 F. Follow-up Actions .......................................................................................................15 G. Annual Reporting Requirement...................................................................................15 III. NRC GUIDELINES FOR APPLYING THE OMB FINAL INFORMATION QUALITY BULLETIN FOR PEER REVIEW .....................................................................................16 A. Identification of Scientific Information Subject to Office of Management and Budget Peer Review Guidelines ..........................................................................16 B. Peer Review Plan .......................................................................................................20 C. Conduct of Peer Reviews ...........................................................................................21 D. Administrative Record Certification .............................................................................25 E. Alternative Procedures To Comply With Peer Review Requirements in the OMB Final Information Quality Bulletin for Peer Review ....................................... 26 F. Waivers and Deferrals of Certain Requirements .........................................................26 G. Exemptions.................................................................................................................26 For the latest version of any NRC directive or handbook, see the online MD Catalog. 2

DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 06/28/2016 H. Annual Report ............................................................................................................27 IV. ACRONYMS ....................................................................................................................28 EXHIBITS Exhibit 1 Overview of the Quality Products .......................................................................30 Exhibit 2 NRC Information Products: Information Subject to or Exempt from the Guidelines to the Public Seeking Correction ................................................ 33 Exhibit 3 NRC Flowchart: Peer Review Identification Process .......................................... 49 Exhibit 4 Contents of Memorandum to the Office Director Responsible for Creation of a Product That May Qualify as Influential Scientific Information or Highly Influential Scientific Assessment ...................................... 50 I. NRC INFORMATION QUALITY GUIDELINES A. Introduction On February 22, 2002, the Office of Management and Budget (OMB) published Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by Federal Agencies (67 Federal Register (FR) 8452)

(OMB Information Quality Guidelines), in accordance with Section 515 of the Treasury and General Government Appropriations Act for Fiscal Year 2001 (Public Law 106-554; H.R. 5658). The OMB Information Quality Guidelines require that Federal agencies develop procedures for reviewing and substantiating the quality of information before it is disseminated by the agency to the public. The NRC originally published its Information Quality Guidelines on October 1, 2002 (67 FR 61965) (NRC Information Quality Guidelines). The scope of information covered by the guidelines includes the applicability of the guidelines to proposed rulemaking and other public comment processes, procedures for the waiver of standards in urgent conditions, NRC quality standards, and NRCs administrative process for the public to seek correction of information. A discussion of the NRC Information Quality Guidelines follows.

B. NRC Information Quality Guidelines NRC is committed to ensuring the quality of all information that it relies on or disseminates. For purposes of these guidelines, Dissemination refers to NRC-initiated or sponsored distribution of information to the public. Consistent with OMB guidance, NRC-sponsored information includes information disseminated to the public by a third-party (e.g., a contractor) either at the direction of the NRC, or where the NRC has the authority to review and approve the information before its dissemination. It does not For the latest version of any NRC directive or handbook, see the online MD Catalog. 3

DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 06/28/2016 include information that is solely funded by the NRC and disseminated at the discretion of the third-party. NRCs policies and practices are designed to ensure that the agency establishes and maintains an appropriate level of quality commensurate with the nature of the information. Thus, the most influential scientific, financial, and statistical data are subject to the most rigorous quality standards. NRC will correct information that does not meet its guidelines or the OMB Information Quality Guidelines based on the significance and impact of the correction. The NRC Information Quality Guidelines are general statements of agency policy and are not legally binding on the agency or on affected persons.

C. Scope of Information Subject to These Guidelines

1. The agencys information quality reviews will apply to NRC information that is publicly disseminated for the first time on or after October 1, 2002. The fact that an information product is already on NRCs Web site or in the Public Document Room before October 1, 2002, and is still maintained by NRC (e.g., in NRCs files, in publications that NRC continues to distribute on its Web site) does not make the information subject to these guidelines or to the request for correction process because it falls within the archival records" exemption identified in Exhibit 1 of this handbook. This information would be subject to the correction and appeal process discussed in Section II of this handbook should the information be challenged and the complainant can demonstrate that the challenged data, which is publicly available through agency Web sites or other means, serves agency program responsibilities and is relied upon by the public as official Government data.

Additionally, if specific information has previously been disseminated and is not covered by these guidelines, that information may still be subject to the NRC Information Quality Guidelines during a post October 1, 2002, dissemination of the information in which NRC either adopts, endorses, or uses the information to formulate or support a regulation, guidance, or other agency decision or position.

2. Because of the importance of openness and transparency, NRC routinely makes available to the public the majority of its regulatory documents, information about its decisionmaking processes, and the standards used to analyze information submitted by the regulated community. The OMB Information Quality Guidelines require NRC to apply information quality standards only to a subset of this information; however, NRC is committed to ensuring the quality of all of the information it disseminates, whether or not it is specifically covered by these guidelines. In addition, NRC has many existing processes by which the public may comment on agency information.

The agency will continue to use these processes to respond to comments and requests, regardless of whether they are specifically covered by these guidelines.

(a) Information Subject to NRC Information Quality Guidelines These guidelines apply to print and electronic versions of agency information. For a comprehensive listing of the types of NRC information covered by the guidelines, see Exhibit 2, NRC Information Products, Table 1, Information For the latest version of any NRC directive or handbook, see the online MD Catalog. 4

DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 06/28/2016 Subject to NRC Information Quality Guidelines and to the Public Seeking Correction, of this handbook.

(b) Information Exempt from NRC Information Quality Guidelines On the basis of the OMB guidelines, a comprehensive listing of the types of NRC information exempt from the guidelines can be found in Exhibit 2, NRC Information Products, Table 2, Information Exempt from NRC Information Quality Guidelines and from the Public Seeking Correction, of this handbook.

(c) Applicability to Proposed Rulemaking and Other Public Comment Processes The correction and appeal process that will address data quality challenges does not apply to information disseminated by NRC through a comprehensive public comment process; for example, proposed rules, regulatory analyses, requests for comments on information collections subject to the Paperwork Reduction Act, environmental impact statements, and other documents for which NRC solicits public comment by publishing a notice in the Federal Register. Persons questioning the quality of information disseminated in those documents, or documents referenced or relied upon in those documents, must submit comments as directed in the notice requesting public comment on the given document. NRC will use its existing processes for responding to public comments to address a request for correction and will describe the actions it has taken with regard to the request in the final agency rule, regulatory analysis, or other final action. An additional complaint and appeal process for information that is already subject to a public comment process would be inappropriate and unfair to other public commenters who submit timely comments.

(d) Waiver of Standards Under Urgent Conditions The NRCs information quality standards may be temporarily waived for information that is disseminated in urgent situations. NRC will consider urgent situations to include emergency conditions at licensed facilities, as well as imminent or credible threats to the public health and safety, the common defense and security, including homeland security, the environment, and other situations deemed to be urgent conditions on a case-by-case basis. The quality of this information should be reviewed as soon as practicable once the urgent conditions necessitating the waiver have ended.

D. NRC Quality Standards

1. Information that NRC relies on or disseminates must meet both the NRC Information Quality Standards and OMB Information Quality Guidelines, in order to ensure and maximize information quality. These information quality standards also apply to the creation, collection, acquisition, and maintenance of information by NRC. NRC will ensure that its draft information collection packages submitted for OMB approval will result in the information being collected, maintained, and used in a manner that is For the latest version of any NRC directive or handbook, see the online MD Catalog. 5

DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 06/28/2016 consistent with NRC and OMB Information Quality Guidelines. Agency policies and procedures will ensure that NRC meets and maintains these standards.

2. NRC has set information quality as a measure of agency performance. NRC will meet the information quality criteria for utility, integrity, and objectivity, as defined in the OMB and NRC Information Quality Guidelines, available at the internal NRC Information Quality Web site. The standards in this section expound on how NRC will apply the OMB criteria in its regulatory environment. The degree of rigor of the pre-dissemination reviews will be commensurate with the nature and significance of the information. NRC Information Quality Web site is available at http://www.internal.nrc.gov/ois/CScatalog/customerservicecatalogs/information-management/quality/information-quality.html.
3. NRC will impose the highest level of quality on influential scientific, financial, or statistical information, which the agency defines as information that forms the technical basis for a substantive rulemaking that has substantial impact on an industry. The NRC may also deem other types of information as influential as authorized by OMB guidelines on a case-by-case basis. In determining what constitutes influential scientific, financial, or statistical information, NRC considers two principal factors:

(a) The information must have a clear and substantial impact that has a high probability of occurring.

(b) The information must impact regulatory decisions affecting a broad class of applicants or licensees. Although information contained in a regulatory decision for an individual applicant or licensee may have substantial impact, it is limited in its breadth, therefore will not be deemed influential for the purposes of these guidelines.

4. NRC applies the most rigorous procedures to ensure the quality of influential information. The reproducibility of original and supporting data for influential scientific, financial, or statistical information will be consistent with commonly accepted scientific, financial, or statistical standards. When reproducibility is not achievable through public access because of confidentiality protection or compelling interests, analytical results will receive especially rigorous reviews. NRC will describe the specific reviews, as well as the specific data sources, quantitative methods, and assumptions used.
5. The following provides a definition of the elements of information quality (utility, integrity, and objectivity) and a description of how NRC ensures information quality.

(a) Utility is the usefulness of the information to its intended users. To ensure information utility, NRC will (i) Adhere to NRC policy on the dissemination of information to the public, which clearly specifies what is to be made available to the public and when it should be available for public release. See Management Directive (MD) 3.4, Release of Information to the Public.

For the latest version of any NRC directive or handbook, see the online MD Catalog. 6

DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 06/28/2016 (ii) Make information associated with the agency regulatory processes and decisions public unless release is restricted. Examples where public release of information may be restricted include regulatory processes or decisions that contain classified national security information, Safeguards Information, sensitive unclassified non-Safeguards Information, proprietary information, sensitive homeland security information, or other information that is protected from disclosure in accordance with the Freedom of Information Act (FOIA).

(iii) Use feedback mechanisms on the NRCs Web site to request public comments on what information NRC disseminates and how it is disseminated.

(iv) Request public comments on individual documents and hold public meetings, as appropriate, to solicit public comments.

(v) Assist the public in quickly and conveniently locating the information they are seeking through the NRCs Public Document Room, or Web site.

(b) Integrity is the security of information from unauthorized access or revision to ensure that the information is not compromised through corruption or falsification.

To ensure information integrity, NRC will adhere to agency policies for personnel security, computer security, information security, and records management, which include the following key components:

(i) NRC electronic systems are required to protect information integrity to prevent inadvertent or deliberate alteration and ensure appropriate access controls in accordance with MD 12.5, NRC Cybersecurity Program.

(ii) Computer and personnel security policies ensure that employees and contractors who have access to electronic information and associated computer systems are screened for trustworthiness and assigned the appropriate level of access.

(iii) Records management policies require that agency records be properly maintained and protected. In particular, the NRCs electronic records management system (i.e., the Agencywide Documents Access and Management System (ADAMS)) is designed to ensure that documents that are disseminated to the public are protected from alteration or falsification.

(c) Objectivity involves two distinct elements, including presentation and substance.

Information must be presented in a manner that is accurate, clear, complete, and unbiased. In addition, the substance of the information presented must be accurate, reliable, and unbiased. To ensure information objectivity, NRC will (i) Achieve accuracy and completeness in the following ways:

  • Provide formal review of and concurrence with all information disseminated, including rulemaking documents, inspection reports, technical reports, generic communications, and all other agency documents covered by these guidelines.

For the latest version of any NRC directive or handbook, see the online MD Catalog. 7

DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 06/28/2016

  • Adhere to Quality Management Control standards before disseminating information on the NRCs public Web site.

(ii) Ensure that information is reliable and unbiased in the following ways:

  • Apply sound statistical and research methods to generate data and analytical results for scientific and statistical information.
  • Use peer reviews for agency-sponsored or -developed influential scientific information. In accordance with OMB guidance, one acceptable method of peer review is the review of agency information by independent advisory committees, including ACRS and ACMUI, as appropriate. Where information has been subjected to formal, independent, external peer review, the information may generally be presumed to be of acceptable objectivity. However, this presumption is rebuttable based on a persuasive showing in a particular instance.

as appropriate, for information and related analyses with generic implications.

  • Use reviews by Agreement States, as appropriate, for matters pertaining to the regulation of nuclear materials.
  • Provide opportunities for the public and States to comment on rulemakings, Commission policy statements, regulatory guides, and other information products, as appropriate.
  • Hold public meetings to seek public views and solicit public comments through the NRCs public Web site and FRNs, as appropriate.
  • Comply with internal policy to ensure unbiased incident investigation team investigations.
  • Use reviews of proposed policy decisions by the Commission.

(iii) Achieve transparency in the following ways:

  • Include in relevant agency information products descriptions of the data and methods used to develop the information product in a way that would make it possible for an independent, qualified individual or organization to reproduce the results.

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DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 06/28/2016

  • Adhere to NRC policy and guidance overseeing the performance of regulatory analyses as provided in publicly available NUREG/BR-0058, Rev. 4, Regulatory Analysis Guidelines of the U.S. Nuclear Regulatory Commission, (Agencywide Documents Access and Management System (ADAMS) Accession Number ML042820192), and NUREG/BR-0184, Regulatory Analysis Technical Evaluation Handbook (ADAMS Accession Number ML050190193). NRC will perform regulatory analyses that assess uncertainty, in the context of quantifying risk, and communicate those findings to the public in a manner that meets the intent of the OMB referenced information quality standards.

(iv) Achieve clarity in the following ways:

  • Ensure that the analysis of technical information receives editorial review.
  • Respond to stakeholder comments on the clarity of proposed actions.
  • The Information Quality Coordinator (IQC) will identify the number and nature of information correction requests received and their resolution, including an explanation of decisions to deny or limit corrective actions in its annual fiscal year reports to OMB.

E. NRC Policy on Research Misconduct This section implements the NRCs policy on research misconduct relating to the conduct and reporting of research results by research institutions to the NRC.

Research institution includes any and all organizations using Federal funds for research (e.g., Intergovernmental Agency Agreement, DOE laboratory agreements, commercial contracts with universities and private companies, and financial assistance awards). This policy is adopted in accordance with the Office of Science and Technology Policys (OSTP) Federal Policy on Research Misconduct (65 FR 76260, December 6, 2000). OSTP requires all allegations of research misconduct are forwarded to the NRC and are investigated and adjudicated in a fair and timely manner either by the research institution or the agency. This policy does not supersede any other Government or institutional policies or procedures for addressing misconduct, nor does it limit or supersede any applicable criminal or civil law.

1. Research Misconduct Defined Research misconduct is defined as fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. It does not include honest error or differences of opinion.

(a) Fabrication is making up data or results and recording or reporting them.

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DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 06/28/2016 (b) Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results so that the research is not accurately represented in the research record.

(c) Plagiarism is the appropriation of another person's ideas, processes, results, or words without giving appropriate credit.

2. Findings of Research Misconduct A finding of research misconduct requires that (a) There is a significant departure from accepted practices of the relevant research community.

(b) The misconduct is committed intentionally, knowingly, or recklessly.

(c) The allegation is proven by a preponderance of evidence.

3. Responsibilities of the NRC and Research Institutions (a) While Federal agencies have ultimate oversight authority for federally funded research, research institutions bear primary responsibility under the OSTP policy statement for prevention and detection of research misconduct and for the inquiry, investigation, and adjudication of research misconduct alleged to have occurred in association with their own institution. At the NRC, the expectation is that research institutions will self-report allegations or findings of research misconduct by individuals performing research associated with its grant or contract. If substantiated, the NRC may take any applicable administrative action authorized by law, taking into consideration the factors listed in Section I.E.4 of this handbook.

(b) Notwithstanding this expectation placing primary reporting responsibility upon the research institution, the NRC may also compel the investigation and resolution of an allegation of research misconduct through the following means:

(i) Grants

  • The terms and conditions of NRC grants require that any allegation of research misconduct be submitted to the grants officer identified within the grant. These terms and conditions place the primary responsibility to investigate these allegations with the research institution which submits its findings to the grants officer. The NRC should ensure that this submission includes the investigative report, a copy of the evidentiary record upon which the report was based, the research institutions adjudicatory decision, and any corrective actions or recommendations taken or planned by the research institution.
  • The grants officer also must notify the OIG of such an allegation. The NRC may accept the research institutions findings or proceed with its own investigation, conducted by the OIG under its authority to investigate fraud, waste, and abuse within NRC programs and activities.

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DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 06/28/2016 (ii) Contracts An allegation of research misconduct may be considered evidence of fraud or an offense indicating a lack of business integrity or business honesty, constituting a cause for suspension under the Federal Acquisition Regulations (FAR) in Chapter 1 of Title 48 of the CFR. The NRC Acquisition Regulations in Chapter 20 of Title 48 of the CFR provide procedures for contracting officers who receive information which may be sufficient cause for suspension. Contracting officers should follow such procedures when handling allegations of research misconduct, which include submitting a statement of facts and recommended action to the appropriate director and, where warranted, possible referral to the OIG for investigation. Where an allegation of research misconduct is substantiated but does not result in a formal suspension or debarment under the FAR, the agency may still take any appropriate lawful administrative action listed below in Section I.E.4(c) of this handbook based on the seriousness of the misconduct.

4. Agency Administrative Actions (a) While the NRC may choose to accept and rely on the findings of a research institution that self-reports research misconduct, nothing precludes the NRC from proceeding with its own inquiry or investigation if the circumstances warrant, including when the NRC determines that the research institution is not prepared or is not capable of investigating the allegation in a manner that is fair, impartial, or timely, or where the NRC determines that its own involvement is needed to protect the public interest or public health and safety.

(b) Upon a substantiated finding of research misconduct, the NRC will determine an appropriate and lawful administrative action by considering the seriousness of the misconduct. Factors when making this determination include but are not limited to (i) The degree to which the misconduct was knowing, intentional, or reckless; (ii) Whether the misconduct was an isolated event or part of a pattern; and (iii) The degree to which the misconduct had significant impact on the research record, research subjects, other researchers, institutions, or the public welfare.

(c) Administrative actions authorized by law may include, but are not limited to (i) Letters of reprimand; (ii) Imposition of a special certification or assurance requirement to ensure compliance with applicable regulations or terms of an award; (iii) Suspension or termination of an active award, for which the research institution may be liable for repayment; For the latest version of any NRC directive or handbook, see the online MD Catalog. 11

DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 06/28/2016 (iv) Suspension and debarment in accordance with applicable NRC and Governmentwide rules on suspension and debarment as described in Chapter 1 and Chapter 20 of Title 48 of the CFR, Federal Acquisition Regulations System; or (v) Any other appropriate steps necessary to correct the research record.

(d) Any administrative actions imposed upon Government employees must comply with all relevant Federal personnel policies and laws.

5. Criminal or Civil Fraud Violations Anyone who receives information that a criminal or civil fraud violation may have occurred must promptly refer the matter to the OIG.

II. NRC ADMINISTRATIVE PROCESS FOR THE PUBLIC TO SUBMIT A REQUEST FOR CORRECTION OF INFORMATION The OMB Information Quality Guidelines require that Federal agencies establish administrative mechanisms allowing affected persons to seek and obtain correction of information maintained and disseminated by the agency that does not comply with OMB or agency information quality guidelines. The NRC published its guidelines for the public to request correction of information in 67 FR 61698 on October 1, 2002. This part implements the NRC staffs procedures for reviewing and responding to requests for correction of information that are received by the IQC as described on the public NRC Information Quality Web site, available at http://www.nrc.gov/public-involve/info-quality.html, and administrative appeal procedures when a requestor disagrees with the agencys decision or corrective action.

A. Correction Process

1. The correction process is designed to address the genuine and valid needs of affected persons without disrupting agency operations. In determining whether to correct information, NRC may reject claims made in bad faith or without justification.

NRC is required to undertake only the degree of correction that it concludes is appropriate for the nature and timeliness of the information involved.

2. Subject to applicable laws, NRCs corrective measures may include, without limitation, personal contacts via letter or telephone, form letters, press releases, postings on the NRCs Web site, correction in the next version of a document, or other appropriate methods that would give affected persons reasonable notice of any corrective actions made.
3. It is NRCs intent to make corrections within a reasonable time after the agency has made the determination that a correction is appropriate.

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DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 06/28/2016

4. NRC will continue to process any decision or document that has had a related information collection request (ICR) unless NRC decides that the information requires correction before the process may continue.
5. NRCs information correction process will be open to the public as a commitment to transparency and request responses will be made public through ADAMS, excluding the requesters personal privacy information.

B. Information Quality Coordinator (IQC) Actions

1. When the IQC receives an ICR, the ICR will be marked with the date of receipt and assigned a sequential case number to be used as the reference in all matters about the ICR.

(a) The IQC will perform an initial review to determine if the issue requires immediate action, particularly if it concerns an allegation or physical security.

(b) If immediate action is required, the IQC refers the ICR to the appropriate regulatory office (e.g., the Office of Enforcement or NSIR).

2. The IQC will perform an acceptance review within 5 calendar days that will include (a) Determining if the submitter of the ICR is an affected party; (b) Determining if all the necessary information on which the correction review will be performed was included with the ICR; and (c) Determining whether the ICR is more appropriately addressed through some other NRC administrative mechanism, such as the allegations program.
3. If the IQC determines that the ICR does meet the acceptance criteria, the requester will be informed that the ICR has been accepted and given the anticipated completion date.
4. If the IQC determines that the ICR does not meet the acceptance criteria, the requester will be informed why the ICR was not accepted and how to appeal this decision.
5. If the ICR is accepted, the IQC will assign the ICR to the Information Office Coordinator (IOC) in the office that is knowledgeable about the information in question.
6. The IQC will respond to the requester within 45 calendar days of receipt by letter or e-mail, and the response will explain the findings of the review and any actions that NRC will take.
7. The response will contain information on how the requester can appeal the agencys decision. If the request requires more than 45 calendar days to resolve, the ICQ will inform the requester that more time is required, state the reason why, and include an estimated decision date. See appeal guidance, How To Submit a Request for an Appeal, available at http://www.nrc.gov/public-involve/info-quality/submit-appeal.html.

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DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 06/28/2016 C. Office Processing Actions

1. The Information Office Coordinator (IOC) should ensure that the appropriate management official at the branch chief or deputy division director level reviews the ICR for correctness.
2. The assigned management official will review the ICR and make a determination whether there is an error that warrants correction. If so, the management official will determine appropriate action. The management official may consult with other Federal agencies or staff in making this determination.
3. The assigned management official will consider, at a minimum, the following in making the determination:

(a) The significance of the asserted error, (b) The benefits that are likely to be derived from such a correction, (c) The costs of the correction and its impact on other agency processes and activities, and (d) The agencys more pressing priorities and obligations.

4. The assigned management official will provide a written determination (typically a memorandum) of whether there is an error to the IOC. This determination will include the following:

(a) The justification for making a correction or not making a correction; (b) The corrective action already taken or to be taken, if any; (c) The schedule for future corrective actions, if any; and (d) The management officials name, title, office, and date of determination.

5. The IOC will provide the written determination to the IQC within 30 calendar days after the offices receipt of the action from the IQC.

D. NRC Receipt and Review of Appeals to ICR Decisions

1. Any NRC employee who receives an appeal to an ICR will forward it immediately to the IQC.
2. When the IQC receives an appeal, the IQC will mark the appeal with the date of receipt and assign a sequential case number to be used as the reference in all matters about the appeal ICR.
3. The IQC will perform an acceptance review within 5 calendar days that will include (a) Determining if the submitter of the appeal is the original requester.

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DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 06/28/2016 (b) Determining if all the necessary information on which the appeal review will be performed was included with the ICR.

4. If the IQC determines that the appeal does meet the acceptance criteria, the requester will be informed that the appeal has been accepted and the anticipated completion date.
5. If the IQC determines that the appeal does not meet the acceptance criteria, the requester will be informed why the appeal was not accepted and given the anticipated completion date.
6. If the appeal is accepted, the IQC will assign the appeal to the office that is knowledgeable of the information in question, typically the office that made the determination on the initial ICR.
7. The IOC will assign the appeal for evaluation to a management official, typically at the division director level, who is a member of the Senior Executive Service and who, in most cases, does not supervise the management official who was responsible for the initial response to the ICR.
8. The management official will limit the appeal review to the basis of the appeal and may consult with other Federal agencies or NRC employees in responding to the appeal, as appropriate.
9. The management official will determine whether a correction is warranted and, if so, what action will be taken and will provide that response to the IOC.

E. Responding to the Requester

1. The IQC will provide the response to the requester through a letter or e-mail within 30 calendar days. The response will contain the management officials determination. If the appeal requires more than 30 calendar days to resolve, the IQC will inform the requester that more time is required, state the reason why, and include an estimated decision date.
2. If the decision on the initial ICR was overturned, the IQC will independently assess the decision to correct information for its impact on other agency processes and activities.

F. Follow-up Actions If corrective actions are not completed at the time the response is sent to the requester, the IQC will track any necessary follow-up actions.

G. Annual Reporting Requirement NRC will identify the number and nature of ICRs received and their resolution, including an explanation of decisions to deny or limit corrective actions in its annual fiscal year reports to OMB by December 15 of each year.

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DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 06/28/2016 III. NRC GUIDELINES FOR APPLYING THE OMB FINAL INFORMATION QUALITY BULLETIN FOR PEER REVIEW A. Identification of Scientific Information Subject to Office of Management and Budget Peer Review Guidelines

1. Introduction (a) On January 14, 2005, the OMB issued the Final Information Quality Bulletin for Peer Review (70 FR 2664), hereafter referred to as the (OMB bulletin). The OMB bulletin requires that all agencies conduct a peer review of information that qualifies as influential scientific information (ISI) or as a highly influential scientific assessment (HISA) that the NRC intends to disseminate publicly.

(b) The OMB bulletin is designed to realize the benefits of meaningful peer review of the most important science disseminated by the Federal Government and applies only to information that meets the threshold of ISI or HISA, as defined in Section III.A.2, Definitions, of this handbook. The annual number of NRC products that could likely contain ISI or HISA is anticipated to be very low. As the OMB guidance is applied to the NRC, ISI or HISA likely would be associated with documents that form the technical basis for major guidance changes or rule changes, where there is a potential for policy changes that have a significant impact to the public or industry as described in Section III.A.2, Definitions, of this handbook. Because of the potential need to perform a peer review, it is important for staff that are involved in work that supports substantial changes to NRC guidance or rules to be aware of the OMB guidelines for quality peer review of scientific information so that such reviews can be accounted for in the schedules for those products.

(c) Existing NRC peer review mechanisms, including review by the ACRS and ACMUI, satisfy the requirements of the OMB bulletin. In addition, because the peer review requirements in the OMB bulletin apply only to information that the NRC disseminates, NRC products listed in Exhibit 2, Table 2, as exempt from the NRCs Information Quality Guidelines also are exempt from these peer review guidelines.

(d) NRC will post to its public Web site (http://www.nrc.gov/public-involve/info-quality.html) an agenda of Peer Review Plans describing all planned and ongoing peer reviews of information products in development qualifying as ISI and as an HISA and that are expected to be disseminated to the public in draft or final form in the next 3 years. The agenda is to be updated at least semiannually. For each relevant peer review, NRC will prepare a Peer Review Plan and post the plan to its public Web site. The NRC will provide an annual report to OMB, due by December 15 of each year or on the date that OMB requests the annual report. The report will contain a summary of the peer reviews conducted during the fiscal year.

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DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 06/28/2016

2. Definitions (a) Scientific information means factual inputs, data, models, analyses, technical information, or scientific assessments related to such disciplines as the behavioral and social sciences, public health and medical sciences, life and earth sciences, engineering, or physical sciences. This definition includes any communication or representation of knowledge (e.g., facts or data, in any medium or form, including textual, numerical, graphic, cartographic, narrative, or audiovisual forms). This definition includes information that NRC disseminates from its Web page but does not include the provision of hyperlinks on a Web page to information that others disseminate. This definition excludes opinions where NRCs presentation makes clear that an individuals opinion, rather than a statement of fact or of the agencys findings and conclusions, is being offered.

(b) Influential scientific information (ISI) means scientific information for which the NRC reasonably can determine will have or does have a clear and substantial impact on important public policies or private sector decisions.

(i) NRC interprets influential information, in accordance with the internal NRC Information Quality Guidelines and OMB bulletin as information that forms the technical basis for a substantive rulemaking that has substantial impact on an industry.

(ii) Scientific information forming the technical basis for regulatory action deemed to be a major rule under the Congressional Review Act (5 U.S.C. 801 et seq.) presumptively constitutes ISI, unless noted as exempt in Exhibit 2. Examples of this information could be NUREGs or other supporting NRC scientific reports that support these rules.

(iii) On a case-by-case, NRC may deem other scientific information to be influential, based on the following factors:

  • The scientific information is contained in a product that is not exempt from the Information Quality Guidelines (i.e., it is not in a product listed in Exhibit 2, Table 2).
  • The information must have a clear and substantial impact that has a high probability of occurring.
  • The information must impact regulatory decisions affecting a broad class of applicants or licensees or the public. (Although information contained in a regulatory decision for an individual applicant or licensee, and the local population, may have substantial impact, it is limited in its breadth, therefore will not be deemed influential for the purposes of these guidelines.)
  • Technical basis documents for generic communications, rulemakings, or other regulatory actions that could be considered significant are For the latest version of any NRC directive or handbook, see the online MD Catalog. 17

DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 06/28/2016 considered within the scope of NRC scientific products that would be subject to OMB guidance on peer review.

(c) A scientific assessment is one type of scientific information and means an evaluation of a body of scientific or technical knowledge, which typically synthesizes multiple factual inputs, data, models, assumptions, and/or applies best professional judgment to bridge uncertainties in the available information.

These assessments include, but are not limited to, state-of-science reports; technology assessments; weight-of-evidence analyses; meta-analyses; health, safety, or ecological risk assessments; toxicological characterizations of substances; integrated assessment models; hazard determinations; or exposure assessments. These assessments are often communicated by NRC through NUREGs, generic communications, and other means. NRC may sponsor or develop scientific assessments to support rulemakings, policy statements, or other regulatory decisions.

(d) NRC defines a highly influential scientific assessment (HISA) as follows:

(i) A scientific assessment used as the basis of a rulemaking or regulatory action that NRC determines could have a potential impact of more than $500 million in any single year on either the public or private sector.

(ii) In accordance with OMB guidelines, in cases where the NRC determines the potential impact of the rulemaking or regulatory action is less than $500 million, an assessment still can be considered HISA if it represents a novel, controversial, or precedent-setting approach, or has significant interagency interest, either because of the information in the assessment or the way the assessment was performed. At the NRC, only scientific assessments of the utmost significance are expected to constitute HISA under this alternative approach.

3. Initiation of the Annual Survey (a) Before the initiation of each annual survey, the IQC will ensure involved NRC staff (typically the offices Peer Review Coordinators) and management discuss the requirements and responsibilities associated with the identification and reporting of ISI and HISA.

(b) The Chief Information Officer (CIO), on or before September 1 of each year, will survey NRC offices to determine if those offices are working on projects that will likely disseminate scientific information within the next 3 years that could qualify as ISI or as an HISA.

(c) A flow chart, Peer Review Identification Process, summarizing the annual process for identifying scientific information that may qualify for peer review through the OMB bulletin is shown in Exhibit 3 and on the internal NRC Information Quality Web Site.

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DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 06/28/2016

4. Office Actions in Response to the Annual Survey (a) Identification of Potential Information Products The Offices of Nuclear Regulatory Research (RES), Nuclear Reactor Regulation (NRR), Nuclear Material Safety and Safeguards (NMSS), New Reactors (NRO),

Nuclear Security and Incident Response (NSIR), or any other office involved in the development of scientific information will review their activities to determine if any of those activities could result in information products that potentially qualify as ISI or as an HISA. For NRC offices, this typically includes only major NRC activities such as substantive rulemakings and Generic Communications. If necessary, the information products produced by RES are referred to the lead office that sponsored or requested the products.

(b) Evaluation of Impact RES, NRR, NMSS, NRO, or NSIR will evaluate the potential impact of information products identified as potentially qualifying as ISI or as a HISA and thus necessitating a peer review of the product.

5. Office Coordination If RES, NRR, NMSS, NRO, or NSIR identifies an information product that the office believes may qualify as ISI or as an HISA, the office director will inform the office responsible for creation of the information product and will provide to that office director the explanatory information listed in Exhibit 4 for each product.
6. Office Response RES, NRR, NMSS, NRO, and NSIR will provide the CIO the results of their annual survey, using a template provided by OCIO, listing the products reviewed for potential ISI or HISA information. The response will include a determination, for each listed product, whether the office judged the product likely to be ISI or HISA. For templates, exhibits, and other information, see the internal NRC Information Quality Web Site.
7. OCIO Evaluation of the Adequacy of an Office Response The CIO will review each offices response to the survey for completeness and clarity to ensure that the Agency standards for proper identification of ISI and HISA are being met. In addition, for any information product recommended for designation as either ISI or as an HISA, the OCIO will review the information provided, as required in Section III.A.6 of this handbook, to determine if it provides an adequate basis for the Executive Director for Operations (EDO) to determine if a peer review is required.
8. Formal Designation as Influential Scientific Information or as a Highly Influential Scientific Assessment (a) The CIO, on the basis of an office response to the survey, will submit a report to the EDO before November 1 of each year listing the date of the annual meeting For the latest version of any NRC directive or handbook, see the online MD Catalog. 19

DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 06/28/2016 with staff and management on the program (discussed in Section III.A.3(a) of this handbook), listing all products reviewed for potential ISI or HISA information, and recommending those information products that the agency identified that qualify as ISI or as a HISA. This report will be coordinated with the offices responsible for the information products.

(b) The EDO will approve or disapprove the recommendation and provide the decision to the CIO before December 1 of each year.

9. Posting Peer Review on the NRC Public Web Site On the basis of the EDO action, the IQC will prepare and post an agenda (i.e., a list) of planned and ongoing peer reviews, if any, to the NRC public Web site. Where no peer reviews have been identified, a notice will be made on the public Web site. The IQC will include contact information to allow interested members of the public to provide comments on the adequacy of individual peer review plans.
10. Semi-annual Update of the Peer Review Agenda The CIO contacts offices semiannually to update the status of the peer review agenda. If any information products are added, dropped, or changed from influential to highly influential or vice versa, OCIO will obtain the EDOs approval before changing the Web site.

B. Peer Review Plan The Peer Review Plan will include the following:

1. Responsibility Once the EDO provides a decision, the CIO will request each office responsible for a qualifying information product to prepare a Peer Review Plan. The office assigned responsibility for conducting the peer review will, within 120 days of the approval by the EDO of an information product as either ISI or as a HISA, prepare a Peer Review Plan, and provide it to the IQC for posting on the public Peer Review Web site.
2. Contents of a Peer Review Plan (a) Include a beginning paragraph containing the title, subject, and purpose of the planned report, as well as an agency contact to whom inquiries may be directed to learn the specifics of the plan.

(b) Indicate the type of information product (ISI or a HISA).

(c) Describe the timing of the review (including deferrals).

(d) Describe whether the review will be conducted through a panel or individual letters (or whether an alternative procedure will be employed).

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DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 06/28/2016 (e) Describe whether there will be opportunities for the public to comment on the work product to be peer reviewed and, if so, how and when these opportunities will be provided.

(f) Describe whether the agency will provide significant and relevant public comments to the peer reviewers before they conduct their review.

(g) Describe the anticipated number of reviewers (e.g., 3 or fewer, 4 to 10, or more than 10).

(h) Give a succinct description of the primary disciplines or expertise needed in the review.

(i) Describe whether reviewers will be selected by a designated outside organization.

(j) Describe whether the public, including scientific or professional societies, will be asked to nominate potential peer reviewers.

(k) Provide other information that OMB may request be included in a particular years annual report, as communicated by OCIO in the annual survey.

C. Conduct of Peer Reviews Peer reviews of ISI must meet the requirements in Section III.C.1 of this handbook. Peer reviews of HISA must meet the requirements in Section III.C.1 and the additional requirements in Section III.C.2 of this handbook. For most products, an ACRS or ACMUI review constitutes a peer review for information quality purposes.

1. Influential Scientific Information For scientific information the EDO approves as ISI, the office director responsible for that information will ensure a peer review is conducted in accordance with requirements set forth in Section II of the OMB bulletin, which is summarized in this section of the handbook. Agencies are given broad discretion in determining what type of peer review is appropriate and what procedures should be employed to select appropriate reviewers. Any peer review for ISI must adhere to the guidance found in Section II of the OMB bulletin and specific NRC guidance that is set forth below.

(a) Peer Review Mechanisms (OMB Bulletin Section II.4)

(i) Can range from a review from one or more subject matter experts to panels such as ACRS or ACMUI.

(ii) Considerations in selecting a peer review mechanism:

  • Novelty and complexity of the information to be reviewed,
  • Importance of the information to the decisionmaking,
  • The extent of prior peer reviews, For the latest version of any NRC directive or handbook, see the online MD Catalog. 21

DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 06/28/2016

  • Expected benefits and costs of review, and
  • Transparency.

(b) Scope of Peer Reviewer Charge: The review will be solely of scientific and technical matters; policy determinations are left for the agency (OMB Bulletin Section II.1).

(c) Informing Peer Reviewers of Applicable Federal Information Quality Standards:

Access, objectivity, reproducibility, and other quality standards in accordance with Federal laws governing information access and quality (OMB Bulletin Section II.1).

(d) Adequacy of Prior Peer Reviews (OMB Bulletin Section II.2).

(i) No further peer review is required if prior peer reviews are adequate.

Publication in a referenced scientific journal may mean that adequate peer review has been performed. The agency must determine if a peer review is adequate.

(ii) In determining whether further peer review is required, consider

  • Novelty and complexity of the information to be reviewed.
  • Importance of the information to the decisionmaking.
  • The extent of prior peer reviews.
  • Expected benefits and costs of the review.

(iii) National Academy of Sciences (NAS) principal findings, conclusions, and recommendations are generally presumed to be adequately peer reviewed.

(e) Selection of Reviewers (OMB Bulletin Section II.3 and Supplementary Information)

(i) Expertise (OMB Bulletin Section II.3.a and Supplementary Information)

  • Reviewers must represent a necessary spectrum of knowledge where information spans a variety of scientific disciplines.
  • Consider requesting that the public, including scientific and professional societies, nominate potential reviewers.

(ii) Balance (OMB Bulletin Section II.3.a and Supplementary Information)

  • Represent diversity of scientific perspectives relevant to the information.

(iii) Independence (OMB Bulletin Section II.3.c)

  • The reviewer should not be involved in producing the scientific information.

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DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 06/28/2016

  • Careful evaluation is required for Government-funded scientists and may differ for grantees vs. contractors. (Grantees are considered more independent than contractors unless the contractor is used only to perform a peer review).

(iv) Repeated use of the same reviewers on multiple assessments needs to be avoided unless it is essential and reviewers cannot be obtained elsewhere.

(v) Conflict of Interest (OMB Bulletin Section II.3.b)

  • Ensure that financial arrangements and organizational relationships do not impair the individuals objectivity or create an unfair competitive advantage for a person or an organization.
  • Federal employees who serve as peer reviewers must comply with Federal ethics requirements.
  • Adapt NAS policy for committee selection with respect to evaluating conflicts for potential non-Federal Government peer reviewers.

(f) Public Participation (See OMB bulletin discussion on public participation.)

(i) Public comment is encouraged but not required for the peer review of ISI.

(ii) Public comment can be obtained through a variety of means.

(iii) Clearly specify the time period allowed for public comment.

(g) Transparency (OMB Bulletin Section II.5, Peer Review Report)

(i) Peer reviewers will prepare a report that describes the nature of their review, findings, and conclusions and will include

  • A verbatim copy of each reviewers comments (either with or without attribution) or represent the views of the group as a whole, including any disparate and dissenting views; and
  • The names of reviewers and their organizational affiliations. Reviewers will be notified in advance about the extent of disclosure and attribution planned by the agency. Public attribution of specific reviewer comments is not mandated. Before public disclosure of this information, consult with the NRC FOIA/Privacy Act Officer.

(ii) The peer review report should be

  • Posted to the agency public Web site, and
  • Discussed in the statement of consideration of any related rulemaking and included in the administrative record of the agency.

For the latest version of any NRC directive or handbook, see the online MD Catalog. 23

DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 06/28/2016 (h) Release of Proprietary and Other Sensitive Information to Peer Reviewers.

Consult the Office of the General Counsel (OGC) if there is a need to disclose proprietary confidential commercial or financial information or intellectual property, or other sensitive unclassified information, to the peer reviewers. The specific arrangements will depend on whether the peer reviewers are NRC employees, NRC consultants, other Federal employees, or NRC contractors.

(i) Outside Management of Peer Review.

NRC may commission independent entities to manage the peer review process, including selection of peer reviewers, in accordance with the OMB bulletin.

2. Highly Influential Scientific Assessment For that scientific information that the EDO has approved as HISA, the office director responsible for that information will conduct a peer review in accordance with requirements set forth in Section III of the OMB bulletin.Section III of the OMB bulletin states that all the guidelines in Section II related to ISI (described in the preceding Subsection C.1) will be met for a peer review of a HISA, in addition to the guidelines set forth in Section III.Section III should be consulted regarding additional guidelines, the highlights of which are set forth below.

(a) Selection of Peer Reviewers - Independence (i) NRC employees are not permitted to serve as peer reviewers for HISA.

However, this prohibition does not preclude Special Government Employees, including members of the ACRS or ACMUI, from serving as peer reviewers.

Additionally, as discussed in Section III.C of the OMB bulletin, the NAS criteria for evaluating use of employees of sponsors serves as an additional exception to this prohibition.

(ii) Refer to Section III.C of the OMB bulletin for more information on this exception.

(b) Peer Review Access to Information Agencies are to provide peer reviewers access to sufficient information, including background information about key studies and models, to enable them to understand the data, analytic procedures, and assumptions used to support the key findings or conclusions of the draft scientific assessment. Consult OGC if there is a need to disclose proprietary confidential commercial or financial information or intellectual property, or other sensitive unclassified information to the peer reviewers.

(c) Public Participation (i) Where feasible and appropriate, the draft scientific assessment being peer reviewed will be made available to the public for comment at the same time it For the latest version of any NRC directive or handbook, see the online MD Catalog. 24

DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 06/28/2016 is submitted to the peer reviewers, or during the time the peer review is being conducted.

(ii) Public comment can be made by oral presentation or in writing before the peer reviewers.

(iii) Peer reviewers, whenever practicable, are to be provided access to public comments on the draft scientific assessment.

(iv) Time limits on public participation will be clearly specified.

(d) Transparency: Peer Review Report A Peer Review Report will be prepared and include (i) Information required in Section III.C.1(g) of this handbook (these requirements are derived from OMB Bulletin Section II.5),

(ii) The charge (i.e., instructions) given the peer reviewers, and (iii) Short paragraph on both the credentials and relevant experiences of each peer reviewer. Before public disclosure of this information, consult with the NRC FOIA/Privacy Act Officer.

(iv) NRC written response to the peer review explaining

  • NRC agreement or disagreement with the views expressed in the report,
  • The actions NRC has undertaken or will undertake in response to the report, and
  • The reasons NRC believes those actions satisfy the key concerns stated in the report.

(v) The Peer Review Report will be disseminated on the NRCs Web site with the related material specified in OMB Bulletin Section II.5.

(e) Independent Management of the Peer Review Process (Optional)

NRC has the option to commission independent entities to manage the peer review process, including the selection of peer reviewers.

D. Administrative Record Certification When NRC relies on ISI or a HISA to support a regulatory action, the NRC IQC will maintain an administrative record for that action, including a certification. The IQC will include a statement that explains how the agency has complied with the requirements of the OMB bulletin and the applicable information quality guidelines, along with relevant materials.

This certification also will be maintained in the administrative record for the action.

For the latest version of any NRC directive or handbook, see the online MD Catalog. 25

DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 06/28/2016 E. Alternative Procedures To Comply With Peer Review Requirements in the OMB Final Information Quality Bulletin for Peer Review In accordance with Section IV of the OMB Bulletin, the following alternatives are available:

1. Rely on the principal findings, conclusions, and recommendations of a report produced by NAS.
2. Commission NAS to peer review an agencys draft scientific information.
3. Employ an alternative scientific procedure or process that ensures the agencys scientific information satisfies applicable information quality standards. The alternative procedure(s) may be applied to a designated report or group of reports.

F. Waivers and Deferrals of Certain Requirements The OMB bulletin provides for waivers and deferrals of the requirements in Sections II and III of the bulletin as follows:

1. Deferral of peer review is allowed usually because of the need to comply with legal deadlines.
2. Waiver of the requirements is allowed in some instances (see OMB Bulletin Section VIII).
3. Deferrals and waivers must have a compelling rationale and be made by the agency head.
4. OMB bulletin notes deferrals and waivers should seldom be warranted.

G. Exemptions NRC does not need to have a peer review conducted on an information product that is exempt from the application of Sections II and III of the OMB bulletin. To be exempt, an information product should qualify by one of the exemptions set forth in OMB Bulletin Section IX summarized below:

1. Related to certain national security, foreign affairs, or negotiations involving international treaties and trade where compliance with the OMB bulletin would interfere with the need for secrecy or promptness.
2. Information disseminated in the course of an individual agency adjudication or permit proceeding unless the agency determines that peer review is practical and appropriate and that the influential dissemination is scientifically or technically novel or likely to have precedent-setting influence on future adjudications and/or permit proceedings.

(a) A health or safety dissemination where NRC determines that the dissemination is time-sensitive.

For the latest version of any NRC directive or handbook, see the online MD Catalog. 26

DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 06/28/2016 (b) An agency regulatory impact analysis or regulatory flexibility analysis, except for underlying data and analytical models.

(c) Routine statistical information released by Federal statistical agencies and analyses of these data to compute standard indicators and trends.

(d) Accounting, budget, actuarial, and financial information, including that which is generated or used by agencies that focus on interest rates, banking, currency, securities, commodities, futures, or taxes.

(e) Information disseminated in connection with routine rules that materially alter entitlements, grants, user fees, or loan programs, or the rights and obligations of recipients thereof.

(f) Information products exempted by the NRC Information Quality Guidelines.

H. Annual Report

1. Responsibility for Preparing the Annual Report The CIO will prepare the NRC Annual Report required by Section VI of the guidelines.
2. Contents of the Annual Report The report will consist of a summary of the peer reviews conducted by the agency during the fiscal year, including the following:

(a) The number of peer reviews conducted subject to the OMB bulletin (i.e., for ISI and HISAs);

(b) The number of times alternative procedures were invoked; (c) The number of times waivers or deferrals were invoked (and in the case of deferrals, the length of time elapsed between the deferral and the peer review);

(d) Any decision to appoint a reviewer based on any exception to the applicable independence or conflict-of-interest standards of the OMB bulletin, including determinations by the Executive Director for Operations based on OMB Bulletin,Section III(3)(c);

(e) The number of peer review panels that were conducted in public (e.g., advisory committee meetings open to the public) and the number that allowed public comment; (f) The number of public comments provided on the agencys Peer Review Plans; and (g) The numbers of peer reviewers that the agency used that were recommended by professional societies.

For the latest version of any NRC directive or handbook, see the online MD Catalog. 27

DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 06/28/2016

3. Submission of the Annual Report The CIO will submit the NRC Annual Report to the Administrator of the Office of Information and Regulatory Affairs, OMB, by December 15 of each year or the date that OMB requests the annual report.

IV. ACRONYMS ACMUI Advisory Committee on the Medical Uses of Isotopes ACRS Advisory Committee on Reactor Safeguards ADAMS Agencywide Documents Access and Management System CIO Chief Information Officer CRGR Committee to Review Generic Requirements EA environmental assessment EDO Executive Director for Operations EIS environmental impact statement FOIA Freedom of Information Act FRN Federal Register notice HQ headquarters HISA highly influential scientific assessment ICR information collection request IOC Information Office Coordinator IQC Information Quality Coordinator ISI influential scientific information MC manual chapter MD management directive MOU memorandum of understanding NMED Nuclear Materials Event Database NMSS Office of Nuclear Material Safety and Safeguards NOED notice of enforcement discretion NRO Office of New Reactors NRR Office of Nuclear Reactor Regulation For the latest version of any NRC directive or handbook, see the online MD Catalog. 28

DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 06/28/2016 OMB Office of Management and Budget OPA Office of Public Affairs PM project manager QC quality control RES Office of Nuclear Regulatory Research RIS regulatory issue summary ROP reactor oversight process SDLCM systems development and life cycle management SER safety evaluation report For the latest version of any NRC directive or handbook, see the online MD Catalog. 29

DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 06/28/2016 Exhibit 1 Overview of the Quality Products NRC has long been committed to ensuring the quality of the information that it makes publicly available. Existing policies and practices ensure that NRCs publicly available information reflects a level of quality commensurate with the nature of the information. The NRC uses a graduated approach to ensuring information quality the more influential the information, the more robust the quality standards used with the most influential scientific, financial, and statistical data being subject to the most rigorous quality standards.

For example, NRC quality control practices include

1. The appropriate level of management review and approval as part of the concurrence process,
2. Internal peer review groups like the Committee to Review Generic Requirements,
3. Public comment on NRC policy before it is finalized,
4. Participation of the public and affected parties in meetings, both with the employees and the Commission,
5. Early and substantial feedback from the Agreement States,
6. Independent peer review of research products,
7. Independent review by the Advisory Committee on Reactor Safeguards (ACRS), and the Advisory Committee on the Medical Uses of Isotopes (ACMUI), and
8. Review by the Commission.

(a) NRC information subject to these Information Quality Guidelines includes, but is not limited to, documents pertaining to rulemakings, inspections of regulated facilities, regulatory guides, findings of the reactor oversight process (ROP),

generic communications, and technical reports (e.g., NUREGs). Table 1 lists information that is subject to the guidelines and NRC quality processes that currently exist for ensuring quality.

(b) There are several types of NRC-initiated or -sponsored information that are not subject to the Office of Management and Budget's (OMBs) or the NRCs Information Quality Guidelines. The guidelines apply only to information disseminated to the public, and OMB says that dissemination does not include (i) Adjudicative process, public filings, or subpoenas; (ii) Distribution limited to Government employees or agency contractors or grantees; (iii) Intra- or interagency use or sharing of Government information; For the latest version of any NRC directive or handbook, see the online MD Catalog. 30

DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 06/28/2016 (iv) Responses to requests for agency records in accordance with the Freedom of Information Act (FOIA), the Privacy Act, the Federal Advisory Committee Act, or similar law; (v) Correspondence with individuals or persons; (vi) Press release; and (vii) Archival records.

In addition, the information quality standards may be waived temporarily for information disseminated in urgent situations. NRC will consider the following as urgent situations: emergency conditions at licensed facilities and imminent or credible threats to the public health and safety, the environment, and the common defense and security, including homeland security.

It should be recognized that just because OMB and NRC do not apply their guidelines to a particular NRC information product does not mean that NRC is any less committed to the quality of its information, whether disseminated or not. Indeed, NRC will ensure the level of quality appropriate to each kind of information it generates. Therefore, in effect, the primary difference is that information subject to the guidelines will also be subject to correction through the special administrative mechanism called for by OMBs guidelines and the NRCs conforming guidelines, whereas information not subject to the guidelines will not be subject to correction through this special administrative mechanism.

Consistent with OMBs definition of dissemination and the types of agency-initiated or agency-sponsored information considered exempt from these guidelines, the NRC has made the following determinations:

1. The adjudication exemption will encompass only actions actually being adjudicated.
2. Intra-agency use includes all Office of the Secretary (SECY) papers since these documents are primarily for the use of agency decisionmakers and in many cases are made public as a matter of Commission policy.
3. NRC information products that contain trade secrets, intellectual property, unclassified Safeguards Information, classified national security information, proprietary information, restricted data, sensitive homeland security information or other information withholdable under a statue or an executive order.
4. NRC information products that are nonscientific/nonstatistical general, procedural, or organizational information are not covered by the guidelines (e.g., 10 CFR Part 2 and the fee rule).
5. NRC correspondence with individuals or persons, including correspondence to members of Congress are not covered by the guidelines.

For the latest version of any NRC directive or handbook, see the online MD Catalog. 31

DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 06/28/2016 Table 2 lists information that is not subject to the guidelines, the reasons why it is not, and the NRC quality processes that currently exist. Because this information is not disseminated, the information products in Table 2 are also exempt from the peer review requirements in Section III of this handbook. It should be understood that while the table indicates a class of information that is not covered by the guidelines, there may be limited circumstances where information within that class would be subject to these guidelines.

OMB guidelines require that agencies review information to assure its quality before being disseminated. The current NRC quality practices and processes are considered to meet this pre-dissemination review. These NRC quality reviews would apply to agency information publicly disseminated for the first time on or after October 1, 2002. Information that was already on NRC's Web site or in the Public Document Room need not go through a special NRC quality review. All information subject to these guidelines and disseminated on or after October 1, 2002, is subject to the administrative process for correction regardless of when the information was first disseminated.

For the latest version of any NRC directive or handbook, see the online MD Catalog. 32

DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 06/28/2016 Exhibit 2 NRC Information Products: Information Subject to or Exempt from the Guidelines to the Public Seeking Correction Table 1: Information Subject to NRC Information Quality Guidelines and to the Public Seeking Correction The Way the Existing Guidance Public Can Documents/Processes that Existing Required Data Request a Information Product Pertain to Quality of Data Quality Reviews Correction Rulemaking-Published Management Directive (MD) Office Concurrence Public proposed and final 6.3, "The Rulemaking comment on rules and final policy Process" Executive Director for all Proposed statements, including Operations (EDO) Rules and supporting documents NUREG/BR-0053, Rev. 6, Concurrence Advance (except those of a "US NRC Regulations Notice of nonscientific/ Handbook" Reactor: Advisory Committee Proposed nonstatistical, general, on Reactor Safeguards Rulemaking procedural, or NUREG/BR-0058, Rev. 4, (ACRS)/Committee to Review organizational nature) "Regulatory Analysis Generic Requirements Guidelines of the U.S. NRC" (CRGR)

MD 3.54, "NRC Collections Waste/ Decommissioning of Information and Reports Management" Medical: Advisory Committee on the Medical uses of Paperwork Reduction Act of Isotopes (ACMUI) 1995 (44 U.S.C. 3501 et seq.). Materials: Agreement State Coordination NRR Office Instructions ACRS/ACMUI/ CRGR Charter EDO/ACRS Memorandum of Understanding (MOU)

Generic ACRS/ACGR Charters Division Concurrence NRC Communications, Information including Bulletins, EDO/ACRS MOU Reactor: ACRS/CRGR Change Generic Letters, Request Information Notices, Licensing Assistant Waste/Decommissioning Public Web Regulatory Issue Handbook page Summaries (RISs) Medical: ACMUI Inspection Manual Materials: Agreement States For the latest version of any NRC directive or handbook, see the online MD Catalog. 33

DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 06/28/2016 Table 1: Information Subject to NRC Information Quality Guidelines and to the Public Seeking Correction The Way the Existing Guidance Public Can Documents/Processes that Existing Required Data Request a Information Product Pertain to Quality of Data Quality Reviews Correction Regulatory Actions not Enforcement Manual Division or Branch NRC Subject to Concurrence Information Adjudication (notice of Project Manager (PM) Change enforcement discretion Handbook Request (NOEDs), Exemptions, Public Web and Reliefs) page Safety Evaluation PM Handbook Division or Branch Public Report (Licensing and Concurrence comment for Non-Licensing) NRR and NRO Office EIS and (e.g., approves a Instructions certification topical report) and Licensing Assistant of generic environmental Handbook compliance assessment SERs for (EA)/environmental Standard Review Plans spent fuel impact statement (EIS) casks Licenses and NRR and NRO Office Branch/Division/Office NRC Certificates, Instruction Concurrence Information Amendments, Change Renewals, Transfers, PM Handbook Request Exemptions Public Web Licensing Assistant Site Handbook NUREG-1556, Consolidated Guidance About Materials Licenses Licensing EIS and NUREGs for EAs/EISs Branch/Division/Office EAs Concurrence PM Handbook Public comment on Licensing Assistant all proposed Handbook EISs and EAs For the latest version of any NRC directive or handbook, see the online MD Catalog. 34

DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 06/28/2016 Table 1: Information Subject to NRC Information Quality Guidelines and to the Public Seeking Correction The Way the Existing Guidance Public Can Documents/Processes that Existing Required Data Request a Information Product Pertain to Quality of Data Quality Reviews Correction Generic MD 3.7, NUREG-Series Publications Review Public Environmental Impact Publications comment Statements ACRS ACRS Charter Office/Division Review EDO/ACRS MOU 10 CFR Part 51, Environmental Protection Regulations for Domestic Licensing and Related Regulatory Functions Guidance for ACRS/ACMUI/ Reactor: Office Concurrence, Public licensees including ACRS, CRGR comment Regulatory Guides, CRGR Charters Standard Format and Waste/ Decommissioning:

Content Guides, EDO/ACRS MOU Office or Division Branch Technical concurrence Positions NUREG on Standard Format and Content for Regulatory Medical: ACMUI Guides.

Materials: Division MD 6.6, Regulatory Guides concurrence Reactor Oversight NRC Inspection Manual, Regional Concurrence Licensee Process Findings Manual Chapter 0609, comment Significance Determination Process Risk Significance Determination Inspection Reports Inspection Manual Regional Branch or HQ Licensee exit and Technical Reports Branch Concurrence meeting Publicly Accessible Compliance with SDLCM Sponsor QC NRC Databases Information (e.g., Daily Plant Data Entry Quality change Status) Assurance Request Public Webpage For the latest version of any NRC directive or handbook, see the online MD Catalog. 35

DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 06/28/2016 Table 1: Information Subject to NRC Information Quality Guidelines and to the Public Seeking Correction The Way the Existing Guidance Public Can Documents/Processes that Existing Required Data Request a Information Product Pertain to Quality of Data Quality Reviews Correction NUREGs/CRs MD 3.7, NUREG-Series Publications Review Varies with (Employees Technical Publications importance of and Contractor) ACRS topic and end ACRS Charter use CRGR EDO/ACRS MOU Office or Division review RES Office Instructions Peer Review (some)

NUREGs intended for MD 3.7, NUREG-Series Publications Review NRC the general public Publications Information OPA Office Change Request Office/Division Review Public Web site Communications with MD 6.5, "NRC Participation NRC standard-setting in the Development and Use Information organizations of Consensus Standards" Change Request Public Web site Web page content Web Management Controls Review by Sponsor Contact page other than documents owner as Web Liaison noted on Web site Sensitivity Reviews Publications Employees (Web, Editors, Graphics)

For the latest version of any NRC directive or handbook, see the online MD Catalog. 36

DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 06/28/2016 Table 1: Information Subject to NRC Information Quality Guidelines and to the Public Seeking Correction The Way the Existing Guidance Public Can Documents/Processes that Existing Required Data Request a Information Product Pertain to Quality of Data Quality Reviews Correction Legend ACMUI - Advisory Committee on the Medical ISI - Influential Scientific Information Uses of Isotopes MD - Management Directive ACRS - Advisory Committee on Reactor Safeguards MOU - Memorandum of Understanding ADAMS - Agencywide Documents Access and NMED - Nuclear Materials Event Database Management System NMSS - Office of Nuclear Material Safety and CFR - Code of Federal Regulations Safeguards CIO - Chief Information Officer NOED - Notice of Enforcement Discretion CRGR - Committee to Review Generic NRO - Office of New Reactors Requirements NRR - Office of Nuclear Reactor Regulation EA - Environmental Assessment OMB - Office of Management and Budget EDO - Executive Director for Operations OPA - Office of Public Affairs EIS - Environmental Impact Statement PM - project manager FOIA - Freedom of Information Act RES - Office of Nuclear Regulatory Research FRN - Federal Register notice RIS - Regulatory Issue Summary HISA - Highly Influential Scientific Assessment ROP - Reactor Oversight Process ICR - Information Collection Request SDLCM - systems development and life cycle IOC - Information Office Coordinator management IQC - Information Quality Coordinator SER - Safety Evaluation Report For the latest version of any NRC directive or handbook, see the online MD Catalog. 37

DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 06/28/2016 Table 2: Information Exempt from NRC Information Quality Guidelines and from the Public Seeking Correction Existing Existing Way Guidance Documents, Required Pre- Public Can Information Processes dissemination Request Product Exemption (Name/number) Reviews Correction Correspondence:

Correspondence Correspondence MD 3.57, Branch/Division/ No to licensees, with individuals Correspondence Office/EDO/

public, individual or persons Management Commission members of Concurrence Congress, States, petitioners, ADAMS contractors Internal Commission Procedures Project Manager Handbook Licensing Assistant Handbook Confirmatory Correspondence Inspection Manual Division/Office No Action Letters concurrence Licensing Assistant Handbook Preliminary Nonroutine Inspection Manual Office No Notifications safety related concurrence information For the latest version of any NRC directive or handbook, see the online MD Catalog. 38

DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 06/28/2016 Table 2: Information Exempt from NRC Information Quality Guidelines and from the Public Seeking Correction Existing Existing Way Guidance Documents, Required Pre- Public Can Information Processes dissemination Request Product Exemption (Name/number) Reviews Correction Non-scientific and/or Non-statistical Procedures:

Reports to Correspondence MD 3.57, Office/EDO/ No Congress or with individuals Correspondence Commission letters to or persons Management Concurrence Congressional Committees (includes ADAMS Presidents Nonscientific/

Budget to nonstatistical Congress, general, Performance and Internal Commission procedural, or Procedures Accountability organizational Report, Strategic Plan, Information Digest)

Published Nonscientific/ MD 6.3,"The Office Yes nonscientific/ nonstatistical Rulemaking Process" Concurrence nonstatistical, general, Public comment general, or procedural, or on all proposed procedural organizational rules NUREG/BR-0053, Rev. EDO proposed and 6, "US NRC Concurrence final rules and Regulations Handbook" final Parts 2, 170, and 171) NUREG/BR-0058, Rev.

4, "Regulatory Analysis Guidelines of the U.S.

NRC" MD 3.54, "NRC Collections of Information and Reports Management" Paperwork Reduction Act of 1995 (44 U.S.C.

3501 et seq.)

For the latest version of any NRC directive or handbook, see the online MD Catalog. 39

DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 06/28/2016 Table 2: Information Exempt from NRC Information Quality Guidelines and from the Public Seeking Correction Existing Existing Way Guidance Documents, Required Pre- Public Can Information Processes dissemination Request Product Exemption (Name/number) Reviews Correction E-gov Nonscientific/ MD 3.55, Forms Branch/Division/ No applications, nonstatistical Management Program Office including forms, general, Concurrence how to file, fee procedural, or information organizational Federal Register Nonscientific/ Project Manager Project Manager/ Yes Notices nonstatistical Handbook Branch/Division/

(themselves), general, NRC contact including FONSIs procedural, or Office/EDO/ listed in the and General organizational Commission Federal Licensing Assistant concurrence Register notice Notices Handbook Organizational Nonscientific/ MD Volume 9, NRC Branch/Division/ No information, nonstatistical Organization and including general, Functions Office organization procedural, or Concurrence charts, organizational descriptions of MD Volume 10, laws and Personnel regulations that Management underpin agency activities, biographies, phone directories Federal employee Nonscientific/ OPM Regulations EDO No pay, benefits, nonstatistical Concurrence for employment general, Management opportunities and procedural, or MD Volume 9, NRC Directives the like organizational Organization and Functions MD Volume 10, Personnel Management For the latest version of any NRC directive or handbook, see the online MD Catalog. 40

DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 06/28/2016 Table 2: Information Exempt from NRC Information Quality Guidelines and from the Public Seeking Correction Existing Existing Way Guidance Documents, Required Pre- Public Can Information Processes dissemination Request Product Exemption (Name/number) Reviews Correction Public Meeting Nonscientific/ MD 3.5, "Attendance at Project Manager No Notices nonstatistical NRC Staff-Sponsored general, Meetings" procedural, or organizational Project Manager Handbook Licensing Assistant Handbook CRGR Meeting Nonscientific/ CRGR Charter CRGR No Notices and nonstatistical Minutes general, procedural, or organizational Full Written Nonscientific/ Government in the OGC No Explanation and nonstatistical Sunshine Act, 5 U.S.C.

Certification of general, 552b Closed procedural, or Commission organizational Meetings Speeches, Nonscientific/ Internal Commission Division/ No Testimony, nonstatistical Procedures Office/EDO/

Q & A, and general, Presentations procedural, or Commission organizational concurrence For the latest version of any NRC directive or handbook, see the online MD Catalog. 41

DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 06/28/2016 Table 2: Information Exempt from NRC Information Quality Guidelines and from the Public Seeking Correction Existing Existing Way Guidance Documents, Required Pre- Public Can Information Processes dissemination Request Product Exemption (Name/number) Reviews Correction Interagency Use and Shared Government Information:

Interagency Interagency use MD 11.1, NRC Office/ No agreements and Acquisition of Supplies Commission interagency and Services Concurrence MOUs MD 11.7, NRC Procedures for Placement and Monitoring of Work With the U.S.

Department of Energy (DOE)

MD 11.8, NRC Procedures for Placement and Monitoring of Work With Other Federal Agencies Other Than the U.S. Department of Energy (DOE)

Reports to other Interagency use NUREG/BR-0053, Branch/Division/ No agencies, Rev. 6, "U.S. NRC Office including e.g., Regulations Handbook" Concurrence Small Business Regulatory Enforcement MD 3.54, NRC Fairness Act Information Collections Report to OMB, Program Report on Information Collection Budget to OMB Internal Intra-agency use MD 3.57, Branch/Division/ No Memoranda Correspondence Office Management Concurrence ADAMS For the latest version of any NRC directive or handbook, see the online MD Catalog. 42

DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 06/28/2016 Table 2: Information Exempt from NRC Information Quality Guidelines and from the Public Seeking Correction Existing Existing Way Guidance Documents, Required Pre- Public Can Information Processes dissemination Request Product Exemption (Name/number) Reviews Correction Internal NRC Intra-agency use MD 1.1, NRC Division Director No Policy and Management Directives or Office Director Procedures, System Concurrence including e.g.,

Management MD review Directives, process Internal Commission Procedures, Office Instructions and Procedures, Inspection Procedures, Enforcement Manual, PM Handbook, Decommissioning PM Handbook Research Intra-agency use RES Office Instruction Office No Information Concurrence Letters (RILs)

SECY Papers Intra-agency use Internal Commission EDO No Procedures Concurrence MD 3.57 Correspondence Management NRR Office Instructions Staff Intra-agency use Internal Commission Commission No Requirements Procedures concurrence Memoranda (SRMs)

Commission Intra-agency use Internal Commission Commission No Voting Records Procedures concurrence (CVRs)

For the latest version of any NRC directive or handbook, see the online MD Catalog. 43

DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 06/28/2016 Table 2: Information Exempt from NRC Information Quality Guidelines and from the Public Seeking Correction Existing Existing Way Guidance Documents, Required Pre- Public Can Information Processes dissemination Request Product Exemption (Name/number) Reviews Correction Commission Intra-agency use Internal Commission Commission No Action Procedures concurrence Memoranda (COMs)

Individual Intra-agency use Internal Commission Commissioner No Commissioner Procedures concurrence Vote Sheets on SECY Papers, COMs International Interagency MD 5.13, NRC Office/ No Agreements and (with State International Activities Commission supporting Department) Practices and Concurrence An international information Procedures agreement is a legally binding (bilateral and document that multilateral) cannot be changed unless and technical agreed to and information authorized by supplied to others both parties.

as part of international agreements Integrated Interagency use MD 5.6, Integrated IMPEP Board States may Materials (with States) Materials Performance comment, but Performance Evaluation Program not public Evaluation (IMPEP) Office/

Program (IMPEP) Commission and Review of concurrence New Agreement New Agreement MD 5.10, Formal Requests Requests Qualifications for published for IMPEP Team public comment Members MD 9.15, Organization and Functions of State and Tribal Programs For the latest version of any NRC directive or handbook, see the online MD Catalog. 44

DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 06/28/2016 Table 2: Information Exempt from NRC Information Quality Guidelines and from the Public Seeking Correction Existing Existing Way Guidance Documents, Required Pre- Public Can Information Processes dissemination Request Product Exemption (Name/number) Reviews Correction Standard Review Intra-agency use Generally become Branch/Division/ Some are Plan NUREGs Office published for concurrence public comment NUREGs Intra-agency MD 3.7, NUREG- Branch/Division/ No intended for use, frequently Series Publications Office internal use, e.g., procedural concurrence NUREG/

BR-0053, Rev. 6, "US NRC Regulations Handbook" FOIA or Privacy Act Requests:

Response to Responses to 10 CFR Part 9, Public Division/Office No FOIA or Privacy requests made Records Concurrence Act Requests by FOIA, Privacy Act, FACA or similar MD 3.1, Freedom of laws Information Act MD 3.2, Privacy Act Grantees or Contractors:

Procurement Distribution MD 11.1, NRC Contract Officer Yes solicitations limited to Acquisition of Supplies agency and Services contractors or grantees FAR 5.201 Records:

Commission Archival External Peer No History (Books) Review Publisher Review For the latest version of any NRC directive or handbook, see the online MD Catalog. 45

DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 06/28/2016 Table 2: Information Exempt from NRC Information Quality Guidelines and from the Public Seeking Correction Existing Existing Way Guidance Documents, Required Pre- Public Can Information Processes dissemination Request Product Exemption (Name/number) Reviews Correction Agency Press Releases:

Press Releases Press Release MD 5.5, "Public Affairs OPA/Chairman No Program" NMSS Licensee Press Release NUREG/Staff Report Section No Newsletter, MOX concurrence Newsletter, etc.

Opinions:

Papers, Journal Opinions MD 3.9, NRC Staff and Branch/Division/ No Articles Contractor Speeches, Office/EDO Presentations, Papers, concurrence and Journal Articles on Regulatory and Technical Subjects NRR Office Instructions Project Manager Handbook Adjudicative and Allegations Process:

Orders Adjudicative 10 CFR Part 2, Agency Office/EDO/ Opportunity for Rules of Practice and Commission hearing; Procedure concurrence emergency public safety information exemption Demand or Adjudicative 10 CFR Part 2, Agency Division/Office/ Yes Request for Rules of Practice and EDO Information Procedure concurrence Licensee can correct information in response CRGR Notice of Violation Adjudicative Enforcement Manual Branch/Division Licensee concurrence response can correct and exit meeting For the latest version of any NRC directive or handbook, see the online MD Catalog. 46

DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 06/28/2016 Table 2: Information Exempt from NRC Information Quality Guidelines and from the Public Seeking Correction Existing Existing Way Guidance Documents, Required Pre- Public Can Information Processes dissemination Request Product Exemption (Name/number) Reviews Correction Adjudicatory Adjudicative Licensing Assistant Division No Documents, Handbook concurrence including Licensing Board Notifications ASLBP/SECY review 2.206 Director Adjudicative MD 8.11, Review Office No Decision and Process for 10 CFR concurrence Petition Status 2.206 Petitions MD now Reports provides for issuance of proposed NRR Office Instructions decision Licensing Assistant Handbook Information neither Initiated nor Sponsored by NRC:

Petitions (2.206 Correspondence 10 CFR Part 2, Agency (none) Rulemaking petitions and with individuals Rules of Practice and petitions are rulemaking or persons not Procedure published for petitions) originated or comment sponsored by the agency License Correspondence 10 CFR Part 2, Agency (none) Public can Applications or with individuals Rules of Practice and request hearing other information or persons not Procedure on application provided by originated or licensees sponsored by (includes Topical the agency Reports and Event Reports)

Comments, Correspondence 10 CFR Part 2, Agency (none) Further including with individuals Rules of Practice and comments from rulemaking or persons not Procedure public comments and all originated or other comments sponsored by the agency For the latest version of any NRC directive or handbook, see the online MD Catalog. 47

DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 06/28/2016 Table 2: Information Exempt from NRC Information Quality Guidelines and from the Public Seeking Correction Existing Existing Way Guidance Documents, Required Pre- Public Can Information Processes dissemination Request Product Exemption (Name/number) Reviews Correction Compilation:

NRC portion of Compilation Public Law 96-354, Branch Yes the Unified Regulatory Flexibility concurrence Agenda of Act, 5 U.S.C. 601 et Issued for Federal seq. public comment Regulatory and Deregulatory Actions Executive Order 12866, Regulatory Planning and Review NRC Rules and Compilation MD 6.3, The Concurrence No Regulations Rulemaking Process (based on public documents; this is a compilation of Administrative all rules) Procedure Act (5 U.S.C. 551 et seq.)

Legend ACMUI - Advisory Committee on the Medical NMSS - Office of Nuclear Material Safety and Uses of Isotopes Safeguards ACRS - Advisory Committee on Reactor NOED - notice of enforcement discretion Safeguards NRR - Office of Nuclear Reactor Regulation MOX - mixed oxide ADAMS - Agencywide Documents Access and OGC - Office of the General Counsel Management System OMB - Office of Management and Budget ASLBP - Atomic Safety and Licensing Board OPA - Office of Public Affairs Panel OPM - Office of Personnel Management CFR - Code of Federal Regulations PM - project manager Q&A - questions and answers COM - Commission action memorandum CRGR - Committee to Review Generic Requirements CVR - Commission voting record NMED - Nuclear Materials Event Database For the latest version of any NRC directive or handbook, see the online MD Catalog. 48

DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 06/28/2016 Exhibit 3 NRC Flowchart: Peer Review Identification Process For the latest version of any NRC directive or handbook, see the online MD Catalog. 49

DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 06/28/2016 Exhibit 4 Contents of Memorandum to the Office Director Responsible for Creation of a Product That May Qualify as Influential Scientific Information or Highly Influential Scientific Assessment If RES, NRR, NMSS, NRO, or NSIR identifies an information product that the office believes may qualify as ISI or as an HISA, the office director will inform the office responsible for creation of the information product and will provide that office director with the explanatory information listed below for each product:

1. A description of the scientific information product (e.g., NUREG or other research reports, other NRC report or product).
2. The date when the scientific information is expected to be disseminated.
3. The anticipated guidance, rulemaking or other regulatory action for which the scientific information will form the technical basis.
4. The projected timeframe during which the proposed guidance, rulemaking, or other regulatory action will be issued.
5. The industry or class of licensees or applicants that will be affected.
6. A description of the nature of the impact on the affected industry or class of applicants or licensees, as follows:

(c) The anticipated increase in costs or reduction in costs (e.g., benefits) to the affected industry, applicants, or licensees, (d) The anticipated increase in costs or reduction in costs (e.g., benefits) to other private sector activities and the general public.

(e) The highest financial costs or benefits that may occur in a single year, and (f) A brief paragraph which describes why the impact meets above definition of ISI or HISA.

7. The type of peer review, if any, that was already performed on the scientific information products,
8. If the scientific information only qualifies as ISI, the response to the office director should state why the information does not also qualify as an HISA.
9. If the scientific information product constitutes as an HISA, provide the following additional information:

(a) Whether there could be a financial impact that would exceed $500 million in any single year on either the public or private sector, or (b) Whether the guidance, rulemaking, or other regulatory action is based on an assessment that represents or does not represent a novel, controversial, or precedent-setting approach, or has significant interagency interest, either For the latest version of any NRC directive or handbook, see the online MD Catalog. 50

DH 3.17 NRC INFORMATION QUALITY PROGRAM Date Approved: 06/28/2016 because of the information in the assessment or the way the assessment was performed.

10. The NRC office that will be responsible for the peer review.
11. An estimate of the resources required to conduct the peer review, including NRC employees resources and contractor resources.
12. Special circumstances, if any, the agency should consider that may merit deferral of the peer review or waiver of the requirement for a peer review. (See Section IV.A.4(f) of this handbook and OMB Bulletin,Section VIII.)
13. Scientific information products that may qualify for peer review but are exempt by the OMB Bulletin or the NRC Information Quality Guidelines. (See Section IV.A.4(g) of this handbook and OMB Bulletin,Section IX.)

For the latest version of any NRC directive or handbook, see the online MD Catalog. 51

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