ML20140D677

Notice of OMB Review of Info Collection & Solicitation of Public Comment.Listed Proposal Was Submitted for OMB Review, Under Provisions of Paperwork Reduction Act of 1995 (44 Usc Chapter 35)

ML20140D677
Person / Time
Issue date:	06/05/1997
From:	Levin A NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM)
To:
References
FRN-62FR32552 AF70-1-005, AF70-1-5, NUDOCS 9706110041
Download: ML20140D677 (16)

Text

e .

l

[7 590-01-P] l U. S. NUCLEAK REGULATORY COMMISSION l i

l Agency Information Collection Activities: Submission for OMB Review; Comment Request i

AGENCY: U. S. Nuclear Regulatory Commission (NRC) l I

ACTION: Notice of the OMB review of infc mation collection and solicitation of public l comment.

I i

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).

1. Type of submission, new, revision, or extension: Revision.

2. The title of the information collection: Proposed rule, 10 CFR Parts 30 and 32 - Exempt Distribution of a Radioactive Drug Containing One Microcurie of Carbon-14 Urea.

3. The form number if applicable: NRC Form 313.

C$rL4 y /MF- jfr

. , jya1 n .L

!!l.lilll.lllll.lill.lHll.lllil.lllll.llIl.ll - ,

~~

\

9706110041 970605 <

PDR ORG EUSOMB

[) f PDR

4 .

4. How often the collection is required: 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 nu.aber of responses: 3.

7. The estimated number of annual respondents: 3.

8. An estimate of the total number of hours needed annually to 1

complete the requirement or request: 54 hours6.25e-4 days <br />0.015 hours <br />8.928571e-5 weeks <br />2.0547e-5 months <br /> initially; thereafter 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> annually - 16 hours1.851852e-4 days <br />0.00444 hours <br />2.645503e-5 weeks <br />6.088e-6 months <br /> for each of 3 respondents (48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> per year reporting burden and a one-time 6-hour recordkeeping burden, 2 hours2.314815e-5 days <br />5.555556e-4 hours <br />3.306878e-6 weeks <br />7.61e-7 months <br /> for each of 3 respondents)

9. An indication of whether Section 3507(d). Pub. L.10413 applies:

Applicable.

10. Abstract: In response to a petition for rulemaking submitted by Tri-Med Spe::ialties, 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

j. vivo" diagnostic use. The adoption of this amendment would make 4

the drug more widely available, thus reducing costs to patients.

4 4

2

_ _ __ m . __ _ _ ... .. _ _ __ _._ _ _ - . _ - _ _ _ . _ _ . -. _ ..

Submit, by (insert date 30 days after publication in the Epjpral Reaister), comrnents that address the following questions:

1. Is the proposed collection of information necessary for the NRC to properly perform its functions? Does the information have practical utility?

2. Is the burden estimate accurate?

l 1

3. Is there a way to enhar - 'e quality, utility, and clarity of the l information to be collected?

l

4. How can the burden of the information collection be minimized,

including the use of automated collection techniques or other forms l .

i

of information technology? l l

l 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 Reaister within several days of the publication date of this Federal Register Notice. Instructions for accessing the electronic OMB clearance package for the rulemaking have been appended l l

to the electronic rulemaking. Members of the public may access the electronic OMB f vance package by following the directions for electronic access provided in the preamble to the titled rulemaking.

3 l

i ,

4 -

I l

\

l Comments and questions should be directed to the OMB reviewer by (insert date 30 days after publication in the Federal Reaister)-

l 4

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. I The NRC Clearance Officer is Brenda Jo. Shelton, (301) 415-7233.

Dated at Rockville, Maryland, this I day of El n( ,1997.

For the Nuclear Regulatory Commission.

i  : J/

/_ n AITiold E. Levin," Acting' designated Senior Official for Information Resources Management i

l l

4 a

s .

PAPERWORK REDUCTION ACT SUBMISSION Please read the instructons before completng this form. For additonal forms or assistance in completng this form, contact your agency's Paperwork Clearance Officer. Send two copies of thid form, the collection instrument to be feviewed, the CJpportng Statement, and any additonal documentaton to: Office of information and Regulatory Affairs, Office of Management and Budget, Docket Library, Room 10102,72517th Street NW, Washington, DC 20503

1. Agency / Subagency originatng request __2. OMB control number U.S. Nuclear Regulatory Commission X a. 3150 - 0120 b. None 3 Type of information collectx>n (check one) 4 Type of review requested (check one)

a. New crJiection V a Regular submission c. Delege5d X b. Revision of a currently approved collection b, Emergency - Approval requested by (date)-

c. Extension of a currently approved coller . tin 5. Will this information collection have a ,, y,,

significant economic Irrpact on a

d. Reinstatement, without change, of a previously approved substantial numbe/ of small entibes? b.No collection for which approval has expired lX

e. Reinstatement, with change, of a previously approved conection for which approval has expired X a. Three years from approval date

_ Requested ---

6 expiration date

f. Existing collection in use without an OMB control number b. Other(Specify):

7 Title Application for Material License

8. A2ency form number (s) (if app 4 cable) ,

NRC Form 313

9. keyworc's Byoroduct material, Nuclear material

10. Abstract

' Exempt Distribution of a Radioactive Drug Containing One Microcurie of Carbon 14-urea," will The amend proposed Parts 30 an rule,d 32 to permit the exempt distribution and use of Carbon-14 capsules for in vivo diagnosis l

2 Affacted pubie (Mark onmary we Ven_d of others met appy we T) 12. Obibgatton to respond (Mark pnmary we Vand eIIothers met apply we xi i

a. Voluntary I

s. Individuals or households d. Farms P b. casiness or other for-profit X e. FederalGovernment b. Requiredy obtain or retain benefits

c. Not-for-profit institutions X f. State, Local, or Tribal Government c. Mandatory X _P i.a. Annual reportmg ano recordkeepmg hour burden 14. Annual reporting and recordkeepmg cost burden on mousands or dottars)

a. Number of respondents a Total annuattred capraal/startup costs 0 18.600 ~

b, Total annual responses 11.841 b. Total annual costs (C4V) 0

1. Percentage of these responses c. Total annualized cost requested 0 collected electroncally o  % d. Current OMB Inventory 0

c. Total annual hours requested 72.987 e. Difference 0

d. Current OMB inventory f. Explanation of difference 72.987

e. Derference 0 1. Program change

f. Explanation of difrerence 2. Adjustment

1. Program ctange

2. Adjustment .

I i

15. Purpose of informaton collection 16 Frequency of recordkeeping or reporting Check all mat apply)

(Mark prfmary wlm P"and sti omers that apply wfm T) a. Recordkeepmg b Third-party disclosure

a. Appication for benefits o. Program plannmg or manageme it X c. Reportmg l

""~ ~~

b. Program evaluation f. Research X 1. On occasion 2.Weekty l3. Monthly

c. General purpose statistes p g. Regulatory or cunpliance 4 Quarterty 5. Sambannually l6 Annually

d. Audit 8. Other (desenbe) 5 yr renewal

17. Statisical methods t 8. Agency contact (person who can best answer quesfjona regardng ife content of mts suomesskm)

Does this information collection employ statistcal methods?

Name Anthony N. Tse Yes h No Pnone (301)415-6233 OMBB31 10/95

19. Certification for Paperwork Reduction Act Submiasiona 4

On behalf of this Federal agency,I certify that the collection ofinforraation encompassed by this request complies with 5 CFR 1320.9.

NOTE: The 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.

l I The following is a summary of the topics, regarding the proposed collection ofinformation, that the certificadon covers:

(a) It is necessary for the proper performance of agency functions; (b) It avoids unnecessary duplication; (c) It reduces burden on small entities; (d) It uses plain, coherent, and unambiguous termmology that is mderstandable to supukets; (e) Its implementation will be consistet and compatible with current reportmg and recordkeeping practices; (f) It indicates the retention periods for recordkeeping requirements; (g) It informs respondents of the infonnation 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 and extent of confidentiality; and (vi) Need to display currently valid OMB control number, l

I (h) It was developed by an office that has planned and allocated resources for the efIicient and etrective management and use o the information to be collected (see note in Item 19 of the instructions).

(i) It uses efrective and efficient statistical survey me*hodology; and l

f (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.

i I

I l

a noe Date Signature Senior Official or d I ~ ' ' ;6u ouirk:

a OMB SUPPORTING STATEMENT FOR PROPOSED RULE 10 CFR PARTS 30 AND 32, 4 l

l

" Exempt Distribution of a Radioactive Drug {

{ Containing One Microcurie of Carbon-14 Urea"  !

i (3150-0001, 3150-0017, 3150-0120) s i

Descriotion of Information Collection J

This clearanco 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: 6 32.21,  !

" Radioactive drug: Manufacture, distribution, and transfer of carbon-14 urea capsules not exceeding one microcurie each for "in vivo" diagnostic use: Requirements for a license" l

1 and i 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 control is reserved under NRC's jurisdiction, Agreement State licensees would not be affected under the proposed amendments.

A. JUSTIFICATION The regulations in 10 CFR Part 32 would be amended to add two new sections, il 32.21 '

and 32.21a, to provide requirements for a specific license to manufacture, process, produce, package, repackage, or transfer capsules contrining 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

)

l

. pertaining to the radioactive drug. All burdens associated with application requirements are covered under NRC Form 313, " Application for Material License" (OMB Clearance No.

3150-0120).

1

1. Need for and Practical Utility of the Collection of Information 1

I 30.21 Radioactive drua

Caosules containina one microcurie of carbon-14 urea j

s for "in vivo" diaanostic use for humans i

l i

Paragraph (a) of 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 to apply for and receive a license from the NRC or an Agreement State. There are no information collection requirements.

j i

Paragraph (b) of this section would provide a reminder that any person who desires 1 to use the capsules for research involving human subjects needs to apply for and receive a specific license pursuant to Part 35 of this chapter. The burden associated with application requirements is covered under NRC Form 313,

" Application for Material License" (OMB Clearance No. 3150-0120).

Paragraph (c) of this section would provide a reminder that an NRC specific license would be required for any person who desired to manufacture, prepare, process, produce, package, repackage, or transfer for commercial distribution carbon-14 capsules for in vivo diagnostic testing. The burden associated with application 2

. . - - - - . ~ - - . . . ..~.- _ . -. - . - .

. . ... ... . . - - . _ - . - - _ ~ . -

1 .

l requirements is covered under NRC Form 313, " Application for Material License"  ;

(OMB Clearance No. 3150-0120). ,

l  !

i The information collection requirements of the arnendments to 10 CFR Part 32 are  !

s t

l

! described below.  :

i j' i 32.21 Radioactive drua: Manufacture, orecaration, or transfer for commercial l

distribution of carbon-14 orea caosules not exceedina one microcurie each for "in i i

vivo" diaanostic use for humans to oersons exemot from licensina: Reauirements  !

for a license.

i

! J I

Paragraph (a) of this section would require an applicant to submit an application for  !

a specific license to manufacture, prepare, process, produce, package, repackage, l l

or transfer for commercial distribution carbon-14 urea capsules not exceeding one microcurie each for "in vivo" diagnostic use, to persons exempt from licensing. The application should contain information sufficient for the NRC to make a decision

! that the applicant would meet NRC requirements. The burden associated with e

application requirements is covered under NRC Form 313, " Application for Material License" (OMB Clearance No. 3150-0120). Section 32.21(a)(6) would require the-applicant to submit copies of prototype labels and brochures with the application '

i t

' for NRC approval. .

l i

i

! Paragraph (b) of this section would provide a reminder that nothing in this section would relieve the licensees from complying with applicable FDA, other Federal, and I i

! 3 1

a i i I ,

s

. . i h

' l l State requirements governing drugs. However, this section would not contain  :

4 information collection requirements. l 1

l 32.21a Same: Conditions of license. ,

.i 5

Paragraph (a) of 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, and the words

.i :

" Radioactive Material " The assumptions are that: (1) this requirement would l.. impose a one-time burden because the Part 32 a. plicant generates labels using ,

f  !

computers and would need to reprogram its computer to print additional words on the label or the brochure; and (2) the label will remain on the container until it no longer contains radioactive material.

Paragraph (b) of this section would require that the label or an accompanying brochure must state that the contents are exempt from NRC or Agreement State licensing requirements; bear the words " Radioactive Material. For "in Vivo" Diagnostic Use Only. This Materialis Not to be Used for Research involving Human '

Subjects and Must Not be Introduced into Foods, Beverages, Cosmetics, or Other Drugs or Medicinals, or into Products Manufactured for Commercial Distribution."

4

1

]

2. Aaency Use of Information I

l i

The NRC would review the information submitted in order to determine whether the 1 capsules are manufactured with appropriate quantities of carbon-14 and without j l

contamination of other radioactive material. Also, the NRC would review prototype ,

I l

labels and brochures to ensure that they contain necessary information such as the  :

identity of the radioisotope, the physical and chemical form, and the dosage. The NRC considers that this information is necessary to inform any individual that the capsules contain radioactive material, the name of the radioisotope, its  !

I radioactivity, and intended use.

I I

3. Reduction of Burden Throuah information Technoloov i There are no known legal obstacles to reducing the burden associated with this i

information collection through information technology. Moreover, NRC encourages' its use.

4. Effort to identifv Duolication and Use Similar Ir. formation 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, anc none was found.

l 5

J

5. Effort to Reduce Small Business Burden l

The NRC believes that there is no way to reduce the burden on small businesses by less frequent or less complete records while maintaining the required level of safety.

)

6. Consecuences of Federal Procram or Policy Activities if the Co!!ection is Not Conducted or is Conducted Less Freauentiv 1

There would be no basis for demonstrating compliance with the required level of l safety through the NRC licensing program.

j l

7. Circumstances That Justifv Variation from OMB Guidelines l l

There are no variations from OMB guidelines, i

8. Consultation Outside the NRC l 1

The NRC published in the Federal Reniggr 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 letters, were received. The NRC consulted with its Advisory Committee on the i

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 Reaister for public comment.

6

1

9. Pavment or Gift to Resoondents Not applicable.

10. Confidentiality of Information  ;

NRC provides no pledge of confidentiality for this collection of information.

11. Justification for Sensitive Questions No sensitive questions would be involved under the proposed amendments.

l

12. Estimated Burden and Burden Hour Cost The burden for applicants can be estimated as follows:

1 (a) Burden for Reportina Reauirements l l

l l

Whereas a new applicant (non-licensee) who mcnufactures and distributes the capsule would be required to have two licenses, one to manufacture and one to distribute to persons exempt from NRC regulations, we do not anticipate any new applications for manufacturing only carbon-14 capsules. Therefore, the burden only addresses the licensees who already have licenses to manufacture radioactive drugs but require a new license to distribute the capsules to persons exempt from NRC regulations.

7

l

. l The application requirements of 9 32.21(a) are covered by the NRC Form 313

. l (OMB Clearance No. 3150-0120). The annualincrease 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 />, or 3 responses at 16 hours1.851852e-4 days <br />0.00444 hours <br />2.645503e-5 weeks <br />6.088e-6 months <br /> per response. At a l cost of $125 per hour, the cost to licensees would be about $6,000 per year.

There is no information collection burden for i 32.21(b).

I l

l (b) Burden for Recordkeeoina Recuirements l

For 6 32.21a(a) and (b), assuming annually each of 3 applicants 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 their computers to print adc"Snal words on the label or the 1

4 brochure, the one-time burden would be 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 4

I annual cost to applicants would be $750.  ;

I l

(c) Total Burden I i

The annual burden to affected applicants would be 18 hours2.083333e-4 days <br />0.005 hours <br />2.97619e-5 weeks <br />6.849e-6 months <br /> per applicant: 16 hours1.851852e-4 days <br />0.00444 hours <br />2.645503e-5 weeks <br />6.088e-6 months <br /> reporting and 2 hours2.314815e-5 days <br />5.555556e-4 hours <br />3.306878e-6 weeks <br />7.61e-7 months <br /> recordkeeping, or 54 hours6.25e-4 days <br />0.015 hours <br />8.928571e-5 weeks <br />2.0547e-5 months <br /> total. At a cost of $125 per hour, the total cost would be $6,750 per year.

13. Estimate of Other Additional Costs  ;

i None. j i

8 I

I

=

l

, 14. Estimated Annualized Cost to the Federal Govemment j r

The estimated burden on the_NRC to review applications is estimated to be 8 hours9.259259e-5 days <br />0.00222 hours <br />1.322751e-5 weeks <br />3.044e-6 months <br /> f

per application, or 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> for an estimated 3 applicants per year. At a cost i of $125 per hour, the estimated ccst to NRC is $3,000 per year. This cost is fully  ;

recovered through fee assessments to NRC licensees pursuant to 10 CFR l Parts 170, or 171, or both.

[

15. Reasons for Chanaes 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 l

-one microcurie of carbon-14. Thus, under the cunent rule, physicians who are not j authorized users must refer patients to authorized users to undergo the diagnostic l test.

The proposed amendments would allow the capsules to be distributed and used by any person (e.g., gastrointestinal specialist) who is permitted to receive and use the drug under an appropriate Federal or State law governing the drug. If the proposed amendments were adopted, there would be a slight increase in information collection burden for the manufacturers or distributors (estimated to be an annual cost of $6,750). However, the estimated annual savings to patients, insurers, and the health care industry could be as high as $20 million.

9

J

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

17. Reasons for Not Disclavino the Exoiration Date The expiration date is displayed on the NRC Form 313.

1 1

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

B. COLLECTIONS OF INFORMATION EMPLOYING STATISTICAL METHODS I i

Not applicable. )

4 10