ML20249A708

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Submits Comments on 10CFR32.14(d)(1), License Applications for Certain Items Containing Byproduct Matl. Determined That Rule Does Not Modify Regulatory Requirements & OMB Clearance Package,Required
ML20249A708
Person / Time
Issue date: 06/17/1997
From: Shelton B
NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM)
To: Trottier C
NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES)
Shared Package
ML20013K439 List:
References
FRN-58FR53670, RULE-PR-32 AF76-1-011, AF76-1-11, NUDOCS 9806180130
Download: ML20249A708 (3)


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'C NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555 4001

% 4! June 17, 1997 MEMORANDUM T0: Cheryl Trottier, Chief Radiation Protection and Health Effects Branch Division of Regulatory Applications Office of N clear Regulatory Research FROM: Brenda . ef on h Information and Recor agement Branch Office of Information Resources Management

SUBJECT:

10 CFR 32.14(d)(1), LICENSE APPLICATIONS FOR CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL We have again reviewed the subject proposed rule for compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.) and have the following comments:

The rule removes the specific arototype testing requirements from 10 CFR 32.14(d) and moves them to NUREG-1562, " Standard Review Plan for Applications for Licenses to Distribute Byproduct Material to Persons Exempt from the Requirements for an NRC License." The rule still does not clearly explain the purpose for this change. When we reviewed the supporting statement, it indicated that to obtain a license under the provisions of section 32.22, the applicant must submit information sufficient to obtain a registration certificate, while those under 32.14 do not require such certification. We again contacted NHSS to seek a better understanding of the objective of the rule. Based on NHSS' explanation of the rule's purpose, we suggest that you clarify the intent of the rule by including wording in the rule's preamble similar to the following:

"GTL licensees, who currently must meet the requirements specified in section 32.22, would only be required to meet the requirements of section 32.14 because staff has determined that this licensee group does not need to be regulated at the level that section 32.22 imposes. Licenses issued under the provisions of section 32.22 require that information on prototym testing, dose assessment, and other safety information a submitted to NRC for review to obtain a registration certificate as required by section 32.210, while licenses issued under the provisions of section 32.14 require only that the licensee state that such requirements have been met. This recategorization for GTL licenses will result iii a marginal reduction in the application burden for these licensees.

"The specific prototype testing requirements in section 32.14(d) are also being moved to the guidance document, NUREG-1562, so that reviewers can evaluate safety data for ntw technologies or alternatives without being tied to the prescriptive requirements contained in section 32.14(d)."

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C. Trottier In addition, on page 5, under " Proposed Amendments" the rule uses the words " changes" and " modifies" as t'augh they have different meanings, which they do not. We suggest that you reword this passage as follows:

"Further, the pro)osed rule would modify the regulatory text but would not alter t1e intent of the existing general performance standard."

We have determined that because this rulemaking-doesinot modify regulatory requirements, but;only.movesia-category of section~32.22 licenses:toisection? :-

32.14,;no 0 5 clearance package is required at this time.- However, we will-need to review ~lutEGe1562 before its issuance.to determine:1f any of =the~

rocuirements.are.different from those: contained in'the current regulation? We uncerstand that the NUREG will not be developed until the final rule is published. 'If the..NUREG changes' the information collections, 0MB' clearance .

for:the revised requirements must be obtained.s Because an 0 2 clearance is-

> not required. at- this time : please- re>1 ace.the Paperwork. Reduction Act:

Statement with Attachment 1.c Note tiat the burden reduction per response should be changed to 21 hours2.430556e-4 days <br />0.00583 hours <br />3.472222e-5 weeks <br />7.9905e-6 months <br /> to conform with the NMSS estimate of the burden for requesting an evaluation to obtain a registration certificate.

Should you require assistance or have any questions, please contact Beth St.

Mary on 415 5878 or e mail BCS. .

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Attachment:

As stated cc: M. Thomas,4RES.-

l ATShepard,~ADM" R. O'Connell, NMSS I

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A."

d PAPERWORK REDUCTION ACT STATEENT .

This proposed rule would reduce the burden' licensees for gaseous tritium light sources by allowing them to file an application under the provisions of section 32.14 rather than under those of section 32.22, which also requires that the applicant obtain a registration certificate. The reduction in burden is' estimated to be 21 hours2.430556e-4 days <br />0.00583 hours <br />3.472222e-5 weeks <br />7.9905e-6 months <br /> per response. Because the a> plication requirements contained in sections 32.14 and 32.22 are not >eing substantively changed, no 02 clearance is required. 10 CFR Part 32 requirements are approved by the Office of Management and Budget approval number 3150 0001.

i Public Protection I: ratification The NRC may not conduct or sponsor, and a person is not requirc.1 to respond to, an information collection unless it displays a currently valid 02 control number.

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Attachment 1 i

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