ML20237A197
| ML20237A197 | |
| Person / Time | |
|---|---|
| Issue date: | 08/05/1998 |
| From: | Shelton B NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM) |
| To: | |
| Shared Package | |
| ML20237A200 | List: |
| References | |
| NUDOCS 9808130169 | |
| Download: ML20237A197 (6) | |
Text
________-_-__ - ___
[7590-01-P]
U. S. NUCLEAR REGULATORY COMMISSION Agency information Collection Activities: Submission for OMB Review; Comment Request AGENCY: U. S. Nuclear Regulatory Commission (NRC)
ACTION: Notice of the OMB review ofinformation 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). The NRC hereby informs potential respondents that an agency may not conduct or sponsor, and that a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.
- 1. Type of submission: Revision
- 2. The title of the information collection:
10 CFR 35.32 and 35.33 " Quality Management Program and Misadministration" /
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9808130169 980805 PDR ORG EUSOMB ,-
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- 3. The form number if applicable: Not Applicable.
- 4. How often the collection is required:
For quality management program (QMP):
Reoorting: New applicants for medical use licenses, who plan to use byproduct material in limited diagnostic and therapy quantities under Part 35, must develop a written QMP and submit a copy of it to NRC. When a new modality involving therapeutic quantities of byproduct material is added to an existing license, current I
i licensees must submit OMP modifications.
This ICR burden estimate is inflated by the one-time cost for the development and submission of QMPs for approximately 2000 Agreement States licensees in the ten Agreement States who have not adopted the rule and are not required to.
l Recordkeeoina: Records of written directives, administered dose or dosage, annual review, and recordable events, for 3 years.
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l For Misadministration:
r-Reoortina: Whenever a misadministration occurs.
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f Recordkeeoina: Records of misadministration for 5 years.
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- 5. Who will be required or asked to report:
NRC Part 35 licensees who use byproduct material in limited diagnostic and therapeutic ranges and similar type of licensees regulated by Agreement States.
- 6. An estimate of the number of responses: 3,194
- 7. The estimated number of annual respondents:
6300 (for both reporting and recordkeeping)
- 8. An estimate of the total number of hours needed annually to I complete the requirement or request:
34,743 hours0.0086 days <br />0.206 hours <br />0.00123 weeks <br />2.827115e-4 months <br /> for applicable licensees (Reporting: 24,400 Hrs /yr, 1 I
and Recordkeeping: 10,343 Hrs /yr, or an average of 5.5 hrs per I licensee). j l
- 9. An indication of whether Section 3507(d), Pub. L.104-13 applies. ,
1 Not Applicable l
- 10. Abstract: In the medical use of byproduct material, there have l been instances where byproduct material was not administeld as
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intended or was administered to a wrong individual, which resulted in unnecessary exposures or inadequate diagnostic or therapeutic procedures. The most frequent causes of these incidents were:
insufficient supervision, deficient procedures, failure to follow procedures, and inattention to detail. In an effort to reduce the
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freqtancy of such events, the NRC requires licensees to implement a quality management program ( 35.32) to provide high I l
confidence that byproduct material or radiation from byproduct l material will ba administered as directed by an authorized user physician.
Collection of this information enables the NRC to ascertain whether misadministration are investigated by the licensee and that corrective action is taken. Additionally, NRC has a responsibility to inform the medical community of generic issues identified in the NRC review of misadministration.
On May 6,1998, an invitation to comment on the information collection requirements for 10 CFR 35.32 and 35.33 was published in the Federal Reaister (63 FR 25098). NRC received two l
l responses. The NRC is evaluating the reporting and recordkeeping requirements associated with this clearance as part of NRC's efforts to revise 10 CFR Part 35," Medical Use of l
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i-Byproduc' Material,"in its entirety, The proposed rule is expected to be published for comment in August 1998. The comments received in response to the May 1998 Federal Reoister notice will be considered during development of the final rule.
A copy of the final supporting statement may be viewed free of charge at the NRC Public Document Room,2120 L Street, NW (lower level), Washington, DC. OMB clearance requests are available at the NRC worldwide web site (http://www.nrc. gov) '
under the FedWorld collection link on the home page tool bar. The document will be ,
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available on the NRC home page site for 60 days after the signature date of this notice.
Comments and questions should be directed to the OMB reviewer by (insert date 30 days after publication in the Federal Reoister):
Erik Godwin Office of Information and Regulatory Affairs (3150-0171)
NEOB-10202 Office of Management and Budget l Washington, DC 20503 l
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-g Comments can also be submitted by telephone at (202) 395-3084.
The NRC Clearance Officer is Brenda Jo. Shelton,301-415-7233.
Dated at Rockville, Maryland, this 6 day d 1998.
For the Nuclear Regulatory Commission.
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Brenda o. Shelton, NRC Clearance Officer Office of the Chief Information Officer i
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