Quality Management Program and Misadministrations -- 10 CFR 35

Forms and Documents

Document Name	Status

No forms / supporting documents in this ICR. Check IC Document Collections.

IC Document Collections

IC ID	Document Title	Status
33461	Quality Management Program and Misadministrations -- 10 CFR 35	Migrated

ICR Details

OMB Control No: 3150-0171	ICR Reference No: 199512-3150-002
Status: Historical Active	Previous ICR Reference No: 199510-3150-001
Agency/Subagency: NRC	Agency Tracking No:
Title: Quality Management Program and Misadministrations -- 10 CFR 35
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 02/27/1996
	Date Received in OIRA: 12/29/1995
Terms of Clearance: OMB continues to have concerns with the practical utility of this collection of information. We also understand that the NRC is undertaking its own review of the Part 35 rules to address concerns raised by the National Academy of Sciences, Congressional appropriations committee, and other interested parties. Therefore, we are approving this ICR for one year pending the outcome of the NRC review. Although the NRC is unlikely to complete revisions to its regulations in that time, it may have some suggestions for interim measures to reduce the burden of this program at that time. In particular, the NRC should examine whether data obtainable from other sources (e.g. The Food and Drug Administration) can be used to meet the NRC's objectives. The NRC should also include in future submissions of this ICR an estimate of the burden associated with the inspection of licensee facilities (to the extent such inspections continue to be a part of the program). Note: The change in burden estimate for this ICR reflects an increase in NRC's estimate of burden of 31,912 hours and a correction of an OMB clerical error.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/1997	02/28/1997	02/29/1996
Responses	6,388	0	2,553
Time Burden (Hours)	51,778	0	310,699
Cost Burden (Dollars)	0	0	0

---

Abstract: NRC requires licensees to implement a quality management program to provide high confidence that byproduct material or radiation from byproduct material will be administered as directed by an authorized use physician. Records and reports are required for certain errors in the administration of limited diagnostic and therapeutic quantities of byproduct material by medical use licensees.

---

Authorizing Statute(s): None

Citations for New Statutory Requirements: None

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:

---

Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

---

Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Quality Management Program and Misadministrations -- 10 CFR 35

---

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	6,388	2,553	0	0	3,835	0
Annual Time Burden (Hours)	51,778	310,699	0	0	-258,921	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement:

---

Annual Cost to Federal Government: $0

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

Is this ICR related to the Pandemic Response? Uncollected

---

Common Form ICR:  No

---

On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, 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 language 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) about:

(i) Why the information is being collected;

(ii) Use of information;

(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;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 12/29/1995

---