ML20198H672
| ML20198H672 | |
| Person / Time | |
|---|---|
| Issue date: | 06/05/1997 |
| From: | Tse A NRC |
| To: | |
| Shared Package | |
| ML20013E023 | List:
|
| References | |
| FRN-62FR32552, RULE-PR-30, RULE-PR-32 AF70-1-004, AF70-1-4, OMB-3150-0120, OMB-3150-120, NUDOCS 9801130364 | |
| Download: ML20198H672 (12) | |
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PAPERWORK REDLICTION ACT SUBMISSION Please read the instructions before completing thts form For addmonal forms or assstance in completing thrs form, contact your agency's Paperwork Clearance Officer. Send two copies of thrs form, the collectJn instrument to be reviewed, the Supporting Statement, and any add $onal documentation 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 onginating request _ 2. OMB control number U.S. Nuclear Regulatory Commission X a. 3150 - 0120 b. None J Type ofinformation collecton (check one) 21ype of review requested (check one) _
a New collecton ir a. Regular submisson c. Delegr*:d X b. Revson of a currently approved conection b Errergency. Approvalrequested by(date)-
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- c. Eutenson of a currently approved cohecten 5. We this informaton conecton have a , ' y,,
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- d. conect.un Reensta% ment, without cha%,experedof a previously approved substantiai number of sman ent.1 s? X b.No for wn.ch approval
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' $* g,*,Nc"n s'pprova e
6~ '"P'rsten Requesteddate
- s. Three years from approval date
- f. Exoting conecten in use wnhout an oMe controi number , 0,n , { p,c,,yy
- 7. THis Application for Material License
- 6. Agancy form number (s) (if app 6 cane)
NRC Form 313 9 Keywords Byproduct material, Nuclear material 10 Abstract
" Exempt Distribution of a Radioactive Drug Containing One Microcurie of Carbon 14-urea," will The amend proposed Parts 30 an rule,d 32 to permit the exempt distribution and use of Carbon-14 capsules for in vivo diagn 12 Obhpehon to respond (Het pnmary we 'P'eruf e# cmarp Mer opp & we x7 2 Mocted pubho (Hers rwney e em Fe=,,,#,e,,#cours smetesp& we 'x?
- a. Inder6 duals or households d. Forms e. Voluntary
- b. Business or other for-proht K e. Federal" b. Required to obtain or retain beneras P
- e. Not-for prord instRduons X P c. Mendelary X f. ,$lete Local. or T*iel t'w'[a , ,
- 13. Annual reportmg and reoordheepm0 hour burden 14 Annual reportmo end , , g cost burden (m emuse,ws orsauere
- e. Number or respondents t 8.000
- e. Total annuskred capnel/startup coste 0
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b, Total ennuei rosponses 11,641 b. Total ennual costs (O&M) o 1 Percentage of theme responses c. Total annuskred cost requested 0 collected electronicalsy 0 g d. Current OMB inventory o
- s. Tosal annuel hours requested T2.967 e omerence o
- f. Explanehan of deerence
- d. Current OMil trwentory 72.967 o 1. Pmgreen cha ige
- e. omerence
- f. Esplenatsun of deerence 2. Adeushnerd
- 1. Program change _
- 2. Adjustment
- 15. Purpose of information collection 2 Frequency or recordkeepmg or reportmg Checa a# malapoty)
(Mark 1 enery wrth F and s# omers har sappfy weh "4 e. Recordheeping b. Third-party dmclosure
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a Apedicatsun for benerns o. Program plannmg or management T c. Reportmg
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2.Weekty 3. Monthly
- b. Program evaluation f. Research X 1. On occasion
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- c. Generet purpose statshen p g. Regulatory or erwnplance 4 Quarterly $. Semi-annualsy 6. Annuany d Audd 7 8 Other(desenbe)
$ yr renewal 17, statet cal methode 18 Agency gact g who can best answer gueshons reganang me ooes t,,,s .,o,ma,mn co. , mn e,n, , st.imt.cai rnethods, Name Anthony N. Tse Yes X No Pho,,- (301)415-6233 g11g364990109 ,
<ne 30 62Fft32SS2 PDft COL /
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- 19. Certification for Paperwork Reduction Act Submissions t {
I On behalf ar this Federal agency, I certify that the collection of information encompassed by thislrequest 1320 9.
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The text of 5 CFR 13209, and the related provisions of 5 CFR l320.8(b)(3), appear at the end of the' n,.er.
NOTE:
cert (fication is to be made with erference to those regulatt provisions as setforth in Ik instruc'. e :
l The following is a summary of the topics, regarding the proposed collection ofinformation, that the certificatw (a) It is necessary for the proper performance of agency functions, (b) It avoids wmecessary duplication; (c) It reduces burden on small entities; (d) It uses plain, coherent, and unambiguous terminology that is understandat'e to respondents; (c) Its implementation will be consistent and compatible with current ieportmg and recordkeeping
. It indicaH the retention penoda for recordkeeping requirements;
. (f)
(g) It informs respondents of the informatim called for under 5 CFR 1320.8(b)(3):
(i) Why the information is being collected, (ii)Use ofinformation; (iii) Durden estimate; Nature of response (voluntary, required for a benefit, or mandatory);
(iv)
(v) Nature and extent of confidentiality; and Need to display currently valid OMB control number; (vi)
(b) It was developed by an office that has planned and allocated resources for the e the information to be collected (see note in item 19 of the instructions).
It uses effective and eflicient statistical survey methodology; and (i)
- (j) It makes appropriate use of information technology.
If you are unable to certify compliance with any of these risovisions, identify the item b Supporting Statement.
Date Sgnature 4 Saner Ofretal or
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OMB SUPPORTING STATEMENT FOR PROPOSED RULE 10 CFR PARTS 30 AND 32, l l
- Exempt Distribution of a Radioactive Drug -j Containing One Microcurie of Carbon 14 Urea" .
(3150 0001, 3150-0017, 3150 0120) !
Descriotion of information Collection i
This clearance package covers certain recordkeeping and reporting requirements in 10 CFR Part 32, " Specific Domestic Licenses to Mar.ufacture or Transfer Certain items Containing Byproduct Material." Two new sec f...a would be added to Part 32: i 32.21,
" Radioactive drug: Manufacture, distribution, and transfer of carbon 14 urea capsules not ,
a exceeding one microcurie each for "in vivo" diagnostic use: Requirements for a license" i and i 32.21a, *Same: Conditions of license." Both sections would contain information i collection requirements as described below. Because the distribution of items exempt i
from licensing and regulatory controlis reserved under NRC's jurisdiction, Agreernent State licensees would not be affected under the proposed amendments.
A. JUSTlFICATION
- 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 rnanufuture, process, produce, package, repackage, or transfer capsules containing one microcurie of carbon 14
- utes, as a radioactive drug, to be distributed to any person for "in vivo" diagnostic use. A
. person who int' ends to manufacture or commercially distribute the capsules should submit a license application to describe how the person would meet applicable NRC requirements A
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pertaining to the radioactive drug. All burdens associated with application requirements are covered under NRC Form 313,_" Application for Material License * (OM8 Clearance No.
3150 0120).
- 1. Nged for and Practical Utility of the Collection of Information i 30,21 Radioactive drua: Caosules containino one microcurie of carbon 14 ures for "in vivo" diaanostic use for humans Paragraph (a) of this section would allow any peru.. 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 en Agreement State. There are no information collection requirements.
Paragraph (b) of this section would provide a reminder that any person who desires 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 dasired to manufacture, prep. stocess, produce, package, repackage, or transfer for commercial distribution carbon 14 capsules for in vivo diagnostic testing. The burden associated with application 2
requirements is covered under NRC Form 313, " Application for Material License" (OMB Clearance No. 3150-0120).
The information collection requirements of the amendments to 10 CFR Part 32 are d6 scribed below.
6 32.21 Radioactivo drua: Manufacture, orecaration. or transfer for comme [glaj distribution of carbon 14 urea caosules not exceedino one microcurie each for "in yivo" disanostic use for humans to Dersons exemot from licensina: Reauirements for a licana Paragraph (a) of this section would require an applicant to submit an application for a specific license to manufacture, prepote, process, produce, package, repackage, 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 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 for NRC approval.
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 3
State requirements governing drugs. However, this section would not contain
- information collection requirements, i 32.21a Same Conditions of license.
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
" Radioactive Material." The assumptions are that: (1) this requirement would impose a one time burden because the Part 32 applicant generates labels using ,
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 stato 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."
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- 2. Ananev Use of Information The NRC would review the information submitted in order to determine whether the capsules are manufactured with appropriate quantities of carbon 14 and without contamination of other radioactive material. Also, the NRC would review prototype 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 colsiders that this information is necessary to inform any individual that the capsules contain radioactive rnaterial, the name of the radioisotope, its radioactivity, and intended use.
- 3. Reduction of Burden Throuah information Technoloav There are no known legal obstacles to reducing the burden associated with this information collection through information technology. Moreover, NRC encourages its use.
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 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.
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- 6. Conseauences of Federal Proaram or Policy Activities if the Collection in Not Conducted or is Conducted Less Freauentiv There would be no basis for demonstrating .:ompliance with the required level of- l safety through the NRC licensing program.
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- 7. i Circumstances That Justifv Variation from OMB Guidelines t
i There are no variations from OMB guidelines.
- b. Consultation Outside the NRC ;
The NRC published in the Federal Reaister on December 2,1994 (59 FR 61831), a i
notice of receipt of the petition for rulemaking for public comment. A_ total of 315 i public comment letters,313 supporting (mostly form letters) and 2 opposing letters, were received. The NRC' consulted with its Advisory Committee on the Medical Uses of Isotopes (ACMUI) at the October 1995 meeting. A draft 3 rulemaking plan was forwarded'to 29 Agreement States for comments, in addition, e
the proposed rule will be published in the Federal Reaister for public comment.
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- 9. Pavmant or Gift to Resoonderits i
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Not applicable.
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- 10. Confidentiality of information ;
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NRC provides no pledge of confidentiality for this collection of information, j 21 1. Justification for Sensitive Questions- !
No sensitive questions would be involved under the proposed amendments.
- 12. Estimated Burden and Burden Hour Cost ,
li The burden for applicants can be estimated as follows:
(a) Surden for Reoortino Reouirements Whereas a new applicant (non-licensee) who rnanufactures and distributes the-I capsule would be required to have two licenses, one to manufacture und one to distribute to persons exempt from NRC regulations, we do not anticipate any new - 1 applications for manufacturing only carbon 14 capsules. Therefore, the burden only
-addresses the licenseen who already have licenses to manufacture radioactive drugs ~
but require e new license to distribute the capsules to persons exempt from NRC regulations.
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The application toonirements of i 32.21(a) are covered by the NRC Form 313 (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 ,
cost of $125 per hour, the cost to licensees would be about $6,000 per year. j There is no information co!!ection burden for i 32.21(b).
t (b) Burden for Recordkeeoina Reauirements .
I For i 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 additional words on the label or the ,
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 rir hour, the annual cost to applicants would be 6750. 4 4 (c) Total Burden 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.
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- 13. Estimate of Other Additional Costs None.
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14, Estimated Annualized Cost to the Federal Government The eotimated 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 /> 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 of $125 per hour, the estimated cost to NRC is $3,000 per year. This cost is fully recovered through fee assessments to NRC licensees pursuant to 10 CFR Parts 170, or 171, or both.
- 15. Beasons for Chanoes in Burden or Crit 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 microcurie of carbon 14. Thus, under the current rule, physicians who are not authorized users must refer patients to authorized users to undergo the diagnostic test.
The proposed amcodments 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 fr .m manufacturers or distributors (estimated to be an annual cost of $6,750). ' wever, the estimated annual savings to patients, insurers, and the health care industry could be as high as $20 million.
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- 16. Publication for statistical Use .
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- . 'f There is no apdication to statistier. in the information collected.L There is no ,
publication of this information.
- 17. Reasons for Not Disolavino the Exoiration Date . l t
5 i The expiration date is displayed on the NRC Form 313. ~
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Excentions to the Certification Statement .
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There are no exceptions. !
B. COLLECTIONS OF INFORMATION EMPLOYING STATISTICAL METHODS Not applicable. .
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i 17590 01 P) l U. S. NUCLEAR REGULATORY COMMISSION l
Agency Information Collection Activities: Subrnission for OMB Review: Comment Request AGENCY: U. S. Nuclear Regulatory Comrnission (NRC)
ACTION: Notice of the OMB review of information collection and solicitation of public comment.
SUMMARY
- The NRC has recontly 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 inforrnation 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.
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- 4. How often the collection is sequired: On occasion, t
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- 5. Who will be required 0: asked to report: Manufacturers and j distributors of the radioactive drug containing Carbon 14 urea. !
- 3. - An estimate of the number of respenses: 3.- !
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- 7. - The estimated number of annual respondents: ' 3. ,
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- 8. An estimate of the total number of hours needed annually to [
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 /> tvinually 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 hour6.944444e-5 days <br />0.00167 hours <br />9.920635e-6 weeks <br />2.283e-6 months <br /> 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.
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- 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 -
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~ vivo" diagnostic use.- The adoption of this amendment would make.
the drug more widely available, thus reducing costs to patients.
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Submit, by (insert date 30 days after publication in the Federal Reaisterb comments 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 j utility?
- 2. Is the burden estimate accurate?
- 3. Is there a way to enhar .he quality, utitity, and clarity of the information to be cellected?
- 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 iriformation 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 to the electronic rulemaking. Members of the public may access the electronic OMB clearance package by following the directions for elcctronic access provided in the preamble to the titled rulemaking, 3
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~ Comments and questions should be directed to the OMB reviewer by (insert date 30 days
- l after publication in the Federal Renists): >
Edward Micitiovich - .
Office of Information and Regulatory Affairs (3150 0001)
NEOC 10202 ., .
Office of Management and Budget >
- Washington DC 20503
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6 Comments can also be submitted by telephone at (202) 395 3084.-
The NRC Clearance Officer is Brenda Jo. Shelton, (301) 415 7233, 3 Dated at Rockville, Maryland, this I day of [v1 >W ,1997. .;
For_the Nuclear Regulatory Commission, i 1
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. Ahfold i. Levin,' Acting'delingnated Senior
- Of ficial for information Resources '
Management i
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