ML20198H907
Text
e April 1, 1997 RF70-1 MEMORANDUM 10:
Brenda Jo Shelton, Chief Information and Records Management Branch Q){
Office of Information Resources Management FROM:
Cheryl A. Trottier, Acting Chief
/s/
Radiation Protection and Health Effects Branch Division of Regulatory Applications Office of Nuclear Regulatory Research
SUBJECT:
OMB PACKAGE FOR A PROPOSED ROLE:
EXEMPT DISTRIBUTION OF A RADI0 ACTIVE DRUG CONTAINING ONE MICR0 CURIE OF CARBON-14 UREA (PARTS 30 AND 32)
Attached for your action are the FR n'otice and the supporting statement to be submitted to OMB for approval. Appropriate comments on the OMB package contained in your memorandum dated March 20, 1997 have been incorporated.
Comments on the proposed rule and Commission paper will be incorporated along with comments from other offices.
The following 2 comments on the supporting statement have not been incorporated:
1.
Comment: Address section 30.21 under, " Description of information Collection," and in paragraph A., " JUSTIFICATION." The Supporting Statement as written only addresses Part 32.
Response
We did not incorporate this comment because 5 30.21 would not contain any information collection requirements, thus, this section should not be discussed in " Description of information collection." Paragraph 30.21(c) is merely a reminder that a license, as required by 32.21, would be required if any person intends to manufacture or commercially distribute the capsules.
2.
Comment:
In section 32.21a, include the retention period that you establish for the rule as requested above.
Response
We did not add a retention period because this requirement would impose a one-time burde.. However, we added a discussion of "one-time burden."
Please let Sam Jones or me know if you have any questions.
Attachment:
OMB clearance package cc: M._Lesar, ADM Distribution: CTrottier/RPHEB rf; File Center; ATse; EJordan, DED0 DOCUMENT'NAME: g:\\tseic14pr.omb
- See previous concurrence T2 eseelve 0 copy of this document,4ndacete in the ben:
- C' = Copy without ettechment/ enclosure
- E' = Copy with attachment / enclosure
- N* = No copy l 0FFICE DRA/RES l
DRA/RES 1.c-'
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tNAME SJones*
CTrottie M l0 ATE 03/31/97 04/i /97 0FFICIAL RECORD COPY RES File Code No. 3A 3 l
9901130422 900109 PDR PR l
30 62FR32552 PDR 01 7
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9 ga a'c q o
0 UNITED STATES 4g' j
NUCLEAR REGULATORY COMMISSION C
g WASHINGTON. D.C. 20555 4001 k9*****
,o April 1, 1997 MEMORANDUM TO:
Brenda Jo Shelton, Chief i
Information and Records Management Branch Offi:0 of Information Resources Management
~
t RUMi -
Cheryl A. Trottier, Acting Chie Radiation Protection and Health Effects Branch Division of Regulatory Applications Office of Nuclear Regulatory Research
SUBJECT:
OMB PACKAGE FOR A PROPOSED RULE: EXEMPT DISTRIBUTION OF A RADI0 ACTIVE DRUG CONTAINING ONE MICR0CURIL Or CARBON-14 UREA (PARTS 30 AND 32)
Attached for your action are the FR notice and the supporting statement to be j
submitted to OMB for approval. Appropriate comments on the OMB package i
contained in your memorandum dated March 20, 1997 have been incorporated.
Comments on the proposed rule and Commission paper will be incorporated along with comments from other offices.
The following 2 comments on the supporting statement have not been incorporated:
1.
Cc rent:
Address section 30.21 under, " Description of information Collection," and in paragraph A., " JUSTIFICATION." The Supporting Statement as written only addresses Part 32.
Response: We did not incorporate this comment because 5 30.21 would not contain any information collection requirements, Sus, this section should not be discussed in " Description of information collection." Paragraph 30.21(c) is merely a reminder that a license, as required by 32.21, would be required if any person intends to manufacture or commercially distribute the capsules.
2.
Comment:
In section 32.21a, include the retention period that you establish for the rule as requested above.
Response: We did not add a retention period because this requirement would impose a one-time burden. However, we added a discussion of "one-time burden."
Please let Sam Jones or me know if you have any questions.
Attachment:
OMB clearance package cc:
M. Lesar, ADM
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[7590-01-P) t U. S; NUCLEAR REGULATORY COMMISSION '
Documents Containing Reporting or Recordkeeping Requirements: Office of Management and Budget (OMB) Review e
AGENCY:
- U. S. Nuclear Regulatory Commission (NRC)
ACTION:
Notice of the OMB review of information collection and
. solicitation of public comment.
SUMMARY
- The NRC has recently submitted to OMB for review the
- following proposal for the collection of information under the provisions of the Paperwork Reduction Act' of 1995 (44 U.S.C. Chapter 35).
I 1.
Type of submission, now, revision, or extension:
. Revision.
I'
- 2.
The title of the information collection: Proposed rule,10 CFR' Parts 30 and Exempt Distribution of a Radioactive Drug Containing j;
One Microcurie of Carbon-14 Urea.
o
i 3.
The form number if applicable: NRC Form 313.
4 4.
How often the collection is reouired: On occasion.
5.
Who will be required or asked to report: Manufacturers and distributors of the radioactive drug containing Carbon-14 urea.
- 6. < An estimate of the n:!mber of responses: 3.
7.
The estimated number of annual respondents: 3.
8.
An estimate of the total number of hours needed annually to completo the requirement or request: 54 hour6.25e-4 days <br />0.015 hours <br />8.928571e-5 weeks <br />2.0547e-5 months <br />s: 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> reporting and a one-time 6 hours6.944444e-5 days <br />0.00167 hours <br />9.920635e-6 weeks <br />2.283e-6 months <br /> recordkeeping burden (18 hours2.083333e-4 days <br />0.005 hours <br />2.97619e-5 weeks <br />6.849e-6 months <br /> per respondent).
9.
An indication of whether Section 3507(d). Pub. L.104-13 applies:
Applicable.
- 10. Abstract: In response to a petition for rulemaking submitted by Tri-Med Specialties, Inc., the NRC is proposing to amend its regulations to allow NRC licensees to distribute a radioactive drug containing one microcurie of carbon-14 urea to any person for "in vivo" diagnostic use, if 2
adopted, this amendment would make the drug more widely_ available, thus reducing costs to patients.
Submit, by (insert date 30 days after publication in the Federal Reoister), comments that address the following questions:
- 1.,is the proposed collection of information necessary for the NHC to properly perform its functions? Does the information have practical utility?
2.
Is the burden estimate accurate?
3.
Is there a way to enhance the quality, utility, and clarity of tha information to be collected?
4.
How can the burden of the information collection be minimized, including the use of automated collection techniques or other forms of information technology?
A copy of the submittal may be viewed free of charge at the NRC Public Document Room, 2120 L Street NW, (lower level), Washington, DC. The proposed rule indicated
- in "The title of the information collection" is or has been published in the Federal B9sinat within several days of the publication date of this Federal Register Notice.
3
OMB SUPPORTING STATEMENT FOR PROPOSED RULE 10 CFR PARTS 30 Afg J2,
" Exempt Distribution of a Radioactive Drug Containing One Microcurie of Carbon-14 Urea" (3150-0001)
Descriotion of information Collection This clearance package covers certain recordkeeping and reporting requirements in 10 CFR Part 32, " Specific Domestic Licenses to Manufacture or Transfer Certain items Containing Byproduct Material." Two new sections would be added to Part 32: 5 32.21, "Radioactivo drug: iflanufacture, distribution, and transfer of carbon-14 urea capsules not exceeding one microcurie each for "in vivo" diagnostic use: Requirements for a license" and 5 32.21a, "Same: Conditions of license." Both sections would contain information collection requirements as described below. Because the distribution of items exempt from licensing and regulatory controlis reserved under NRC's jurisdiction, Agreement State licensees would not be affected under the proposed amendments.
A.
JUSTlFICATION The regulations in 10 CFR Part 32 would t e amended to add two new sections, 55 32.21 and 32.21a, to provide reauirements for a specific license to manufacture, process, produce, package, repackage, or transfer capsules containing one microcurie of carbon 14 urea, as a radioactive drug, to be distributed to any person for "in vivo" diagnostic use. A person who intends to manufacture or commercially distribute the capsules should submit a license application to describe how the person would meet applicable NRC requirements pertaining to the radioactive drug.
1.
Need for and Pract cal Utility of the Collection of Information i
The information collection requirements of the amendments to 10 CFR Part 32 are described below.
9 30.21 Radioactivodrua: Caosules containina one microcurie of carbon-14 urea for "in vivo" diannostic use.
This section would allow any person to receive, possess, use, transfer, own, or acquire capsules containing one microcurie carbon 14 urea for "in vivo" diagnostic testing without having a license from the NRC or an Agreement State. However, this section would not contain information collection requirements.
1]L21 Radioactive druo: Manufar ? *tribution, and transfer of carbon-14 urea caosules not exceedino one micioct ne each for "in vivo" diaonostic use:
Roouirements for a license.
Paragraph (a) of this section would require an applicant to submit an application fcr a specific license to manufacture, process, produce, package, repackage, or transfer for commercial distribution carbon-14 urea capsules not exceeding one
1 microcurie each for "in vivo" diagnostic use, to persons exempt from licensing. The application should contain information sufficient for the NRC to make c decision that the applicant would meet NRC requirement 1.1Section 32.21(a)(6) would require the applicant to submit copies of prototype labels s'nd brochures with the-j application for NRC approval.
j Paragraph (b) of this section would ptovide a reminder that nothing in this section,
would relieve the licensees from complying with applicable FDA, other Federal, and State requirements governing drugs. However, this section would not contain information collection requirements.
132.21s Same: Conditions of license.
Paragraph (afof this section would require that the container holding the capsules bear a label that specifies the radioisotope, its physical and chemical form, the quantity of radioactivity of each capsule at a specific date, ar.d the words
" Radioactive Material." This requirement would impose a one-time burden because the applicant would need to reprogram its computer to print additional words on the label or-the brochure.
Paragraph (b) of this section would require that the labcl or an accompanying brochure include the following statements: "the contents are exempt from NRC or Agreement State licensing requirements" and " Radioactive Material-For "In Vivo" D; agnostic Use Only - Not for Research involving Human Subjects. Introduction inu Foods, Beverages, Cosmetics, Other Drugs or Medicinals, or into Products Manufactured for Commercial Distribution is Prohibited."
-2.
Anency Use of Information The information to be submitted under 5 32.21 is necessary so that NRC can review the information to ensure that the capsules are manufactured or distributed in accordance with NRC regulations. The labeling requirements under 5 32.21a are necessary to inform users that the capsules contain radioactive material, the name of the radioisotope, its radioectivity, and intended use.
31
- Reduction of Burden Throuah Information Technoloov There are no known legal obstacles to reducing the burden associated with this information collection through information technology. Moreover, NRC encourages its uSo.
4.
Effort to identify Duolication and Use Similar Information The information requested in the proposed rule does not duplicate information
' currently submitted to the NRC. The Information Requirements Control Automated System (IRCAS) was searched for duplication, and none was found.
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5.
Effort to Reduce Small Business Burden The NRC believes that there is no way to reduce the burden on small businesses by less frequent or less complete records while m'intaining the required level of safety.
a 6.
Consecuences of Federal Prooram or Policy Activities if the Collection is Not Conducted or is Conducted Less Frecuentiv The consequences of not collecting the information or collecting less frequently would be that there would be no basis for demonstrating compliance with the required level of safety through the NRC licensing program.
7.
Circumstances That Justifv Varia' ion from OMB Guidelines e
There are norvariations from OMB guidelines.
8.
Consultation Outside the NRC The NRC published in the Federal Reoister on December 2,1994 (59 FR 61831) a notice of receipt of the petition for rulemaking for public comment. A total of 315 public comment letters,313 supporting (mostly form letters) and 2 opposing lotters, were received. The NRC consulted with its Advisory Committee on the Medical Uses of isotopes (ACMUI) at the October 1995 meeting. A draft rulemaking plan was forwarded to 29 Agreement States for comments. In addition, the proposed rule will be published in the Federal Reoister for public comment.
9.
Pavment or Gift to Resoondents Not applicable.
10.
Confidentiality of Information NRC providos ne pledge of confidentiality for this collection of information.
11.
Justification for Sensitive Questions No sensitive questions would be involved under the proposed amendments 12.
Estimated Burden and Burden Hour Cost The burden for applicants can be estimated as follows:
(a) Burden for Rooortino Reouirements The application requirements of 5 32.21(a)(1) and (6) are covered by the NRC Form 313 (OMB Clearance 3150-0120). The increase in burden for the NRC Form 313 is
' estimated to be 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> for 3 forms por year. At a cost of $125 per hour, the cost to licensees would be about $6,000 por year.
3
I i
(b) Burden for Recordkeenino Reouirements For !i 32.21a, assuming each of the 3 applicants in a year would need 2 hours2.314815e-5 days <br />5.555556e-4 hours <br />3.306878e-6 weeks <br />7.61e-7 months <br /> to reprogram it9 computer to print additionra words on the label or the brochure, the one-time bu den would be about 6 hours6.944444e-5 days <br />0.00167 hours <br />9.920635e-6 weeks <br />2.283e-6 months <br />. At a cost of $125 per hour, the cost to applicants would be about $750 per year.
(c) Total Burden
~
The total burden to affected appNants would be 54 hours6.25e-4 days <br />0.015 hours <br />8.928571e-5 weeks <br />2.0547e-5 months <br /> per year. At a cost rf
$125 per hour, the total cost would be about $6,750 per yesir.
13.
Estimate of Other Additional Costs None.
14.
Estimated Annualized Cost to the Federal Government The estimated burden on tne NRC to review applications is estimatJd to be 8 hours9.259259e-5 days <br />0.00222 hours <br />1.322751e-5 weeks <br />3.044e-6 months <br /> per application, or 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> for estimated 3 applicants per year. At a cost of $125 por hour, the estimated cost to NRC is about $3,000 per year. This cost is fully recovered throegh fee assessments to NRC licensees pursuant to 10 CFR Parts 170, or 171, or both.
15.
Reasons for Chanoes in Burden or Cost The existing regulations in 10 CFR Part 35, " Medical Use of Byproduct Material,"
require physicians who meet the training and experience requirements (i.e.,
authorized users) to administer radioactive drugs, including the capsules containing one.nicrocurie of carbon 14. Thus, under the current.ule, physicians who are not authorized users must refer patients to authorized users to undergo the diagnostic test.
The proposed amendments would allow the capsules to be distributed to and used by any person who is permitted to receive and use the drug under an appropriate Federal or State law governing the distribution and use of the drug. The amendments, if adopted, would make the capsules more widely svailable, would avoid unnecessary referrals, thus, would reduce costs to patients. The information collection requirements would be needed to ensure that the applicant would meet NRC requirements and that the users would be informed of the radioactive drug's intended use.
16.
Publication for Statistical Usc There is no application to statistics in the information collected. There is no l
publication of this information.
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- 17.. flaasons for Not Disol'avino the Exoiration Date-'
' The expiration date is; displayed on the NRC Form 313.-
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- 18.3 ;Exceotions to the Certification Statement There are no ' exceptions.
B. -
COLLECTIONS OF INFORMATION EMPLOYING STATISTICAL METHODS -
' Not' applicable.
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NIC FORM 620 u.S. NUCLEAR REGULATORY COMMISSION M O-95)
PROGRAM OFHCIAL CERTIFICATION FOR PROPOSED COLLECTION OF INFORMATION TITLE OF COLLECTION Proposed Rute,10 CFR Parts 30 and 32. Emempt Distributson of a Radioactive Drug Containing One Microcurie of Carbon-14 Urea n
I certify that the proposed collection of information -
Program Ofricial should answer the fonowing questions and certify responses by signing below:
YES NO N/A 1.
Reduces to the extent practicable the burden, including with respect to small entities,
@y using techniques such as: (1) establishing differing timetables or reporting requirements W$F to account for avalletfle resources, (2) clarifying, consolidating, or simplifying reporting X
iss@
requirements, and (4) exempting en'.; ties from all or part of the information collection M!$0M requirement.
2.
Is written using plain, coherent, and unambiguous terminology and is understandable t X
respondents.
4
- 3. Will be implemented in ways consistent and compatible, to the maxir'um extent Y N' X
practicable, with respondents' exirlg reporting and recordkeeping practices.
M; 4
i 4.
Has baen developed by an office that has planned and allocated resources for the yg efficient and effective manageme.t arid use of the information, including processing the X
l information in a manne to enhance, where appropriate, the information's utility to agencies and the public.
?@k
- 5. Uses effective, efficient, and appropriate statistical survey methodology.
X
- 6. To the maximum extent practicable, uses information technology to reduce burden and Wg improve data quality, agency efficiency and responsiveness to the public.
- M 7.
Is necessary for NRC to properly perform its functions, and that the information has X
Nb practical utility.
Td 8.
Is not unnecessarily duplicative of information otherwise reasonably accessible to the WM agency.
%d 9.
Indicates for each recordkeeping requirement the record retention.
X
- 10. - Informs potential respondants why the information is being collected; its necessRy to
?@
the agency's performance; provides an estimate of and request for comment on the
[y f;h burden; indicates whether responses are mandatory, voluntary, or required to obtain a benefit (citing authority); confidentiailty (citing authority); and the fact that an agency 7$3 may not conduct or sponsor, and a' person is not required to respond to, a collection of information unless it displays a currently valid control number.
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Date J.7 /- f 7 Program Office Official
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(Signature)
Cheryl A. Trottier (Type or print name)
NRc FOfw S20 (toes)
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. Instructions for accessing the electronic OMB clearance package for the rulemaking have been appende'd to the electronic rulemaking. Members of the public may access
~
.the electronic OMB clearance package by following the directions for electronic access provided iri,the preamble to the titled rulemaking.
Comments and questions should be directed to the OMB reviewer by finsert date 30 days after publication in the federal Reaister):
Edward Michlovich Office of information and Regulatory Affairs (3150-0001)
- NEOB 10202 Office of Management and Budget Washington DC 20503 Comments can also be submitted by telephone at (202) 395-3084, The NRC Clearance Officer is Brenda Jo. Shelton, (301) 415-7233.
I Dated at Rockville, Maryland, this day of
,1997.
For the Nuclear Regulatory Commission.
Gerald F. Cranford, Designated Senior.
Official for Information Resources Managerncnt
s 9
Ir structions for accessing the electronic OMB clearance packago for the rulemaking hsve bpen appended to the electronic rulemaking. Members of the public may access rae electronic OMB clearance package by following the directions for electronic access provided in the preamble to the titled rulemaking.
Comments and questions should be directed to the OMB reviewer by (insert date 30 days af ter publication in the Federal Reoister):
Edward Michlovich Office of information and Regulatory Affairs (3150-0001)
NEOB-10202 Office of Management and Budget Washington DC 20503 Comments can also be submitted by telephone at (202) 395 3084.
The NRC Clearance Officer is Brenda Jo Shelton, (301) 415-7;133.
Dated at Rockville, Maryland, this day of
,1997.
For the Nuclear Regulatory Commission.
Gerald F. Cranford, Designated Senior Official for information Resources Man:,gement Distribution:
CTrottier/RPHEB rf Filo Center ATse EJordan, DEDO
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OFF6CUa, RECORD COPY
Comments and questions should be directed to the OMB reviewer by (insert date 30 days after publication in the Federal Rooister):
Edward Michlovich Office of information and Regul tory Affairs (3150-0001)
NEOB 10202 Office of Management and Bu g W' Washington DC 20503. -.
/
Comments can also be sub tted by telephone at (202) 395-3084.
The NRC Clearance,<Off cer is Brenda
. Shelton, (301) 415-7233.
Dated at Rockville, Maryl nd, this.
da of 1997.
/
For the Nuclear Regulatory Commission.
Gerald F. Cranford, Designated Senior Official for Information Resources Management Distribution:
- CTrottier/RPHEB rf File Center ATse EJordan, DEDO DOCUMENT NAME: g:\\tse\\c14pr.omb r.
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