Medical Use of Byproduct Material -- 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
33147	Medical Use of Byproduct Material -- 10 CFR 35	Migrated

ICR Details

OMB Control No: 3150-0010	ICR Reference No: 199610-3150-004
Status: Historical Active	Previous ICR Reference No: 199607-3150-001
Agency/Subagency: NRC	Agency Tracking No:
Title: Medical Use of Byproduct Material -- 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: 01/06/1997
	Date Received in OIRA: 10/31/1996
Terms of Clearance: This ICR is approved for 3 years under 5 CFR 1320. Consistent with the PRA provisions of 1320.5(d)(2)(viii), NRC shall assure that the information required by Paragraph(c) is collected in a way that assures that confidential patient information is not traceable or attributable to specific patients. Further, NRC shall assure that licensee recordkeeping is conducted in a manner that assures patients' confidentiality, such as by retaining data in a central file without a record or cross-reference to specific patient files. These information collection and recordkeeping requirements are approved solely for the purpose of verifying that licensees have proper procedures in place for assessing potential third-party exposure associated with and arising from exposure to patients administered radioactive material. Further, these new requirements are approved only to the extent that they do not interfere with or contradict the best medical judgment of physicians. Specifically, the requirement that licensees provide written instructions to lactating patients shall not be used to specify the content of instructions and recommendations in a way that interferes with the discretion and judgment of the physician. OMB expects that NRC will provide it with the relevant regulatory guidance before it is made public (potentially Spring 1997) so that OMB can ensure that the guidance is consistent with the PRA and with the terms of this approval.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2000	01/31/2000	09/30/1999
Responses	6,678,285	0	6,587,935
Time Burden (Hours)	1,336,353	0	1,319,277
Cost Burden (Dollars)	0	0	0

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Abstract: The NRC is amending the criteria for the release of patients administered radioactive material under 10 CFR 35. The final rule requires licensees to provide the patient with instructions on how to maintain doses to others as low as reasonably achievable and requires licensees to maintain records pertaining to the patient.

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Authorizing Statute(s): None

Citations for New Statutory Requirements: None

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

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

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

IC Title	Form No.	Form Name
Medical Use of Byproduct Material -- 10 CFR 35

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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	6,678,285	6,587,935	0	90,350	0	0
Annual Time Burden (Hours)	1,336,353	1,319,277	0	17,076	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to:

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

Burden Reduction Due to:

Short Statement:

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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

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Common Form ICR:  No

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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: 10/31/1996

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