ML20207A189

Request for OMB Review & Supporting Statement Re 10CFR33, Specific Domestic Licenses Broad Scope for Byproduct Matl. Estimated Respondent Burden of 1 Hour

ML20207A189
Person / Time
Issue date:	05/21/1999
From:	Shelton B NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM)
To:
Shared Package
ML20207A186	List: ML20207A183 ML20207A189
References
OMB-3150-0015, OMB-3150-15, NUDOCS 9905260199
Download: ML20207A189 (7)

Text

I"Mr*CMWWUMn MCUUb ilVM Mb a buDivilbblVN yf Ple se r:ad th3 instructions befora compi;. ting this form. For cdditionIl forms or sesistrnce in "

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't f ntact yoer egIncy's Paperwork Cistranca Offictr. Sind two copiss of this form, the coll 2ction ins le zd, tha Supporting Stitiment, and tny tdditionil documint tion to: Offics cf Inf rmitien and Rigult Afftirs, Offica et Management and Budget, Docket Library, Room 10102, 72517th Street NW, Washington, DC 2050

1. Agency / Subagency onginating request g/lp 3 OMB control number yVs U.S. Nuclear Regulatory Commission g a. 3150- 0015 b.None

3. Type of informaton collection (check one) 4. Type of revew requested (check one)

a. New collection y a. Regular c. Delegated

b. Revision of a currently approved collection b. Emergency Approval requested by (date) g c. Extension of a currently approved collection 5. Will this information collection have a a,Yes

~ significant economic impact on a -

d. Reinstatement, without change, of a previously approved substantial number of sma:I ontites?

collection for which approval has expired d D. N0 e.colgj9 R'i s atgn th h ,agfs New usly approved g g ,/ a Three years from approval date

f. Existing collection in use without an OMB control number '**P**" #'

b. Other (Specify):

7, Title 10 CFR 33, Specific Domestic Licenses of Bmad Scope for Byproduct Material

8. Agency form number (s) (if appleatWe)

NA

9. Keywords Byproduct Material, Reporting and Recordkeeping Requirements

10. Abstract 10 CFR 33 contains requirements for the issuance of a broad scope license authorizing the use of byproduct material and specific requirements for obtaining a broad scope beense. The requirements include equipment, facilities, personnel, and procedures to protect health and minimize danger to hfe or property.

11. Atfected g ublic ruers onmary mm P'and aR cthers that apply wth *)G 12. ODlngation to re$ pond (Muk pnmary mth "P'and aM cthers wat apply wth 'X*)

a. Individuals or households d. Farms a. Voluntary T b. Busineas or other for-profit T e. Federal Government

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b Required to obtain or retain benefits T c. Not-for-profit institutions T f. State Local or Tribal GovemmentT c. Mandatory

13. Annual reporting and recordkeeping hour burden 14. Annual reporting and recordkeeping cost burden (m thousanos r do2#

a. Number of respondents 1 a. Total annuahred capital /startup costs

b. Totalannualresponses I b. Total annual costs (O&M)

1. Percentage of these responses c. Total annualized cost requested collected electronically 0.0  % d. current OMB inventory

c. Total annual hours requested l e. Difference

d. Current OMB inventory I

f. Explanation of difference

e. Difference 0 f, Explanation of difference 1. gram mange

1. Program change 2. Adjustment

2. Adjustment

15. Purpose of information collection 16. Frequency of recordkeeping or reporting (chack allthat apply)

(Mark pnmary w4h *P* and all others that apply with *X*)

a. Recordkeeping b. Third-party disclosure

a. Application for benefits e. Program planning or management 7

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c. Reporting

b. Program evaluation f. Research 71. On occasion 2. Weekly 3. Monthly

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c. General purpose stabstics T g. Regulatory or compliance 4. Quarterly 5. Semi-annually 6. Annually ud. Audit '

7. Biennially 7 8. Other (describe) 5 year renewal

17. Statistcal methods 18. Agency contact (person who can oest answerquestens regarding the Does this informahon collecton employ statistical methods?

Name: .layne McCausland Yes Tj No Phone. 301-415-6219 OMB831 inn form *= ouv*o ano inr arms 10/95 9905260199 990521 PDR 7

ORO EUSOPIB PDR

19. C2rtificctinn far Pap:rw:rk RIduction Act Submis2 ions On behalf of this Federal agency, I certify that the collection ofinformation encompassed by this request complies with 5 CFR 1320.9.

NOTE: De text of 5 CFR 1320.9, and the related provisions of 5 CFR 1320.8 (b)(3), appear at the end of the instructions. The certification is to be made with reference to those regulatory provisions as setforth in the instructions.

De following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions; (b) It at Wds unnecessary duplication; (c) It reduces burden on small entities; (d) It uses plain, coherent, and unambiguous terminology that is understandable to respondents; (e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices; (f) It indicates the retention periods.for recordkeeping requirements; (g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3):

(i) Why the information is being collected; (ii) Use ofinformation; (iii) Burden estimate; (iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature of extent of confidentiality; and (vi) Need to display currently valid OMB control number; (h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected (see note in item 19 of the instructions);

(i) It uses effective and efficient statistical survey methodology; and (j) It makes appropriate use ofinformation technology.

If you are unable to certify compliance with any of these provisions, identify the item below and explain the reason in item 18 of the Supporting Statement.

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Signature of Authonzed Agency Ofhcial Date

(

)

-. nature Senior Ofhcial or desigmte ,

Date (

BNpee- Iton _ _ _ cer. Jce Ithe Chef Information Officer J .M 9 0M8 834 N 10/95 i 1

FINAL SUPPORTING STATEMENT FOR 10 CFR PART 33 SPECIFIC DOMESTIC LICENSES OF BROAD SCOPE FOR BYPRODUCT MATERIAL (3150-0015)

CLEARANCE EXTENSION Descriotion of the Information Collection The NRC regulations in 10 CFR Part 33 specify requirements for applying for and being granted licenses authorizing broad scope use of byproduct material. Three types of licenses may be issued: Type A, Type B, or Type C, with Type A being the largest program. The types of licenses are defined by Section 33.11. Applicants and licensees are primarily medical institutions, colleges, universities, government agencies, and large private companies engaged in broad educational, research, and development activities.

A. J_ustification

1. Need for and Practical Utility of the Collection of information Section 33.12 specifies that an applicant for a broad license must complete NRC Form 313, " Application for Material License." The NRC Form 313 has previously been cleared under OMB Clearance No. 3150-0120; which should be referred to for additional supporting information, burden, and cost data.

Sections 33.13, 33.14, and 33.15 specify the information which must be included in an application in order for the NRC to issue a license based on a finding that the public health and safety will be adequately protected.

, Section 33.13 specifies the requirements for a Typ A broad license. It requires that an applicant have equipment and facilities adequate to proteci health and minimize danger to life or property, have personnel with adequate training and experience, and have adequate administrative controls and procedures, including a radi; tion safety committee and radiation safety officer. The applicant must describe the prograra for meeting these requirements when the applicarrt ut, mite c !!cente cppl; cation, in order to establish that radioactive material can be used safely.

Section 33.14 specifies the requirements for a Type B broad license. The requirements are similar to those specified in Section 33.13, except that the applicant need not demonstrate as extensive experience in use of radioactive materials as is required for a Type A broad license, and need not have a radiation safety committee.

The application submitted by the applicant must demonstrate that he can meet these requirements.

Section 33.15 specifies the requirements for a Type C broad license. It requires that an applicant have equipment and facilities adequate

to protect health and minimize danger to life or property, have personnel meeting certain training and experience requirements, supervise use of radioactive material, and have adequate adTiinistrative controls and procedures to assure safe use of radioactive material. The application submitted by the applicant must demonstrate that he can meet these requirements.

2. Aaency Use of Information l

I The NRC reviews the information submitted in order to determine whether the applicant's training, personnel experience, equipment, facilities, and procedures for i the use of byproduct material are adequate to protect the public health and safety as l required by the Atomic Energy Act, as amended, and the Energy Reorganization Act of 1974, as amended, so that the Commission may determine whether to issue, amend, or renew a broad scope license.

3. Reduction of Burden throuoh Information Technoloav There are no legal obstacles to reducing the burden associated with this information collection with the use of information technology. However, there are no current information technology applications that would reduce the burden of these information collection requirements. The NRC encourages applicants and licensees to use new automated information technology when it would be beneficial to them. However, because of the types of information and the infrequency of submission, the applications may not lend themselves readily to the use of automated information technology for their submission. Consequently, the current percentage of electronic submission is zero.

4. Effort to identify Duplication and Use Similar Information The Information Requirements Control Automated System was searched to determine duplication. None was found. The information is not a duplication of other information the affected licensee must submit for other purposes. The nature of the information being requested is unique to licensed activities at the facilities, and is necessary so that the Commission may determine whether to issue, amend, or renew a broad license.

5. Effort to Reduce Small Business Burden While a number of the licensees are considered small businesses, under the NRC's current definitions, the health and safety consequences of improper use of radioactive material are the same for large and small entities. There is a minimum amount of information that must be provided in order for the Commission to determine if an applicant's facilities, equipment, and procedures are adequate to protect the public health and safety. Therefore, it is not possible to reduce the burden on small businesses by less frequent submission or less complete applications.

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6. Conseauences to Federal Proaram or Policy Activities if the Collection is Not Conducted or is Conducted Less Freauentiv Applications for a new license are submitted only once, while applications for renewal of a license are submitted every 5 years. Amendments are submitted as needed by the licensee. This is the minimum frequency necessary to assure that licensees will continue to conduct programs in a manner that will assure adequate protection of the public health and safety. If the information is not collected, the NRC will have no way to determine the adequacy of licensees' programs to protect the public health and safeiy.

7. Circumstances which Justify Variation from OMB Guidelines There are no variations from OMB guidelines.

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8. Consultations Outside the NRC  !

l An opportunity to comment on the information collection req > irements in 10 CFR Part 33 was provided in a Federal Register notice published on February 26,1999 (at 64 FR 9455). No comments were received.

9. Payment or Gift to Respondents Not applicable.

10. Confidentiality of the Information l

This information is usually not confidential. If it were, the information would be handled as proprietary in accordance with 10 CFR 2.790 of the NRC regulations. ,

11. dpstification for Sensitive Questions No sensitive information is requested under these regulations.

12. Estimated Industry Burden and Costs Reporting Requirements (Sections 33.12,33.13,33.14, and 33.15 combined)

NRC Licensee Burden:

Anrual Responses Staff Hours Annual Licensee Burden 177 25 4,425 This burden data is provided for information only. The burden for this information collection is attributable to and is reported for inventory purposes under NRC Form 313, OMB control number 3150-0120.

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a Estimated annual cost to the industry to respond to the collection requirement is

$535,425 (4,425 hrs x $121/hr].

Aareement State Licensees:

The compatibility level for 10 CFR Part 33 is Division 3. However, most, if not all, Agreement States have provisions for broad scope licenses. The Agreement State licensees are also required to submit very similar information in order to receive a license. Agreement States are estimated to have twice the number of licensees as does the NRC. The NRC has assumed that the amount of licensee staff hours for a licensing action and the staff hour cost for Agreement State staff will be the same as for NRC licensees and NRC staff.

Annual Responses Staff Hours Annual Licensee Burden l

354 25 8,850 l l

Estimated annual cost to the industry in Agreement States to respond to the collection requirement is $1,070,850 [8,850 hrs x $121/hr]. l 1

13. Estimate of Other Additional Cost None.

14. Estimated Annualized Cost to the Federal Government Professional: 177 responses x 15 hrs / response x $121/hr = $321,255 This cost is fully recovered through fee assessments to NRC licensees pursuant to 10 CFR Parts 170 and 171.

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15. Reasons for Chanaes in Burden or Cost There is no change in burden. There is a small change in costs to account for the difference in per hour rate.

16. Publication for Statistical Use There is no application to statistics in the information collected. There are no plans for publication of this information.

17. Reason for Not Displayino the Expiration Date The requirement is contained in a regulation. Amending the Code of Federal Regulations to display information that, in an annual publication, could become out of date, would confuse the public.

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18. Exceptions to the Certification Statement There are no exceptions.

B' COLLECTIONS OF INFORMATION EMPLOYING STATISTICAL METHODS Not applicable.

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