ML20236Y608

Request for OMB Review & Supporting Statement Re 10CFR35, Medical Byproduct Licensing. Estimated Respondent Burden Will Be 1,336,353 H

ML20236Y608
Person / Time
Issue date:	08/11/1998
From:	Shelton B NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM)
To:
Shared Package
ML20236Y609	List: ML20236Y608 ML20236Y611 ML20236Y616
References
OMB-3150-0010, OMB-3150-10, NUDOCS 9808120348
Download: ML20236Y608 (2)

Text

) PAPERWORK REDUCTION ACT SUBMISSION

//

u Ple se r id th3 instructions befors completing this form. For additional forms or assistance in completing this form, contact

• your eg:ncy's Pap rwork Clitrence Offic:r. S:nd two copies of this form, ths collection instrument to be reviewed, ths Supporting Statement, and any additional documentation to: Office of Information and Regulatory Affairs, Office of Management and Budget Docket Library, Room 10102,72517th Street NW, Washington, DC 20503.

1. Agenc// Subagency onginating request 2. OMB control number U.S. Nuclear Regulatory Commission g a. 3150-0010 b.None 3 Type of information collection (check one) 4. Type of review requested (check one)

a. New collection g a. Regular c. Delegated g b. Revision of a currently approved collection b. Emergency - Approval requested by (date):

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 small entities ?

callection for which approval has expired g b.No col o or h a ov s ekp r 6 Requested -

J a. Three years from approval date exp ration date 4

f. Existing collection in use without an OMB control number g

7. Title 10 CFR Part 35, Medical Byproduct Licensing

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

9. Keywords Byproduct Material, Reporting and Recordkeeping Requirements, Medical Devices, Nuclear Materials

~

10. Abstract 10 CFR Part 35 contains mandatory recordkeeping and reporting requirements for licensees authorized to cdminister byproduct material or radiation therefrom to humans for medical use to ensure that public health crd safety is protected and that possession and use of byproduct material is in compliance with the license and regulatory requirements.

$ Attected pubhc tuern onmary em v and an orners that appoy em x's 12. Oohgation to respond cuare pr. mary em v ams an ornas war aopoy mm x=>

e. Individuals or households d. Farms a Voluntary T b. Business or other for-profit T e. Federal Government 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 recordkeepmg hour burden 14. Annual reporting and recordkeeping cost burden (m thousanos orawars)

a. Number of respondents 6,696 a. Total annuahzed capitat/startup costs 0

h. Totalannualresponses 93,966 b. Total annual costs (O&M) 0

1. Percentage of these responses c. Total annualized cost requested 0 collected electronically 0.0  % d. Current OMB inventory 0

c. Total annual hours requested 1,336,353 e. o,fference o

d. Current OMB inventory 1,336,353

f. Explanation of diffeince

e. Difference O

f. Explanation of difference gram ange

1. Program change 2. Adjustment

2. Adjustment g 15. Purpose of information collection (Mark pnmary with 'P* and all others that apply with *X*)

16. Frequency of recordkeepirig or reporting (cheCA allthat apply)

.Q -

] a. Recordkeeping b. Third-party disclosure

a. Application for benefits e. Program planning or management 7 c. Reporting - -

b. Program evaluation f. Research -7 1. On occasion 2. Weekly 3. Monthly

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c. General purpose statistics T g. Regulatory or comphance 4. Quarterly 5. Semiannually 6. Annually

! d. Audit 7. Biennially 7 8. Other (describe) tvery 5 years

17. Statistical metnods 18. Agency contact tverson wrio con best answer questions regardnng the b Does this information collection employ statistical methods?

Name: Cathy llaney ltE Yes No ,O

~ ~ 301-415-6825 Phone:

OMB 83-1 in earm . ooyms umno inronns 10/95 GV /Q) y; mpO {'

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19.C:rtific ti:n far Pcp;rwork R: duction Act Submi::iana

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On behah of this Federal agency, I certify that the collection of information 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.

The following is a summary of the topics, regarding the proposed collection ofinformation, that the certification 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 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 .

1 (vi) Need to display currently valid OMB control number; j 1

(h) It was developed by an office that has planned and allocated resources for the eflicient and effective manage-

" t i ftMnstrucdons);

(i) Eiises""eYtEfne$# dei"kicNSfatfsh8afSu'EMy nNTfddfogy!,t a I"d (j) It makes appropriate use of information 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.

l l

Sgnature of Authonzed Agency Official Date Sgnature of

• nior Ohixp ' ee Date

, Bre . Shelton. N Cie nce Offigd , i f the Chief information Officer b lI

! OMB 83-4 V " 10/95 t i