Medical Byproduct Licensing -- 10 CFR Part 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
33148	Medical Byproduct Licensing -- 10 CFR Part 35	Migrated

ICR Details

OMB Control No: 3150-0010	ICR Reference No: 199808-3150-005
Status: Historical Inactive	Previous ICR Reference No: 199701-3150-004
Agency/Subagency: NRC	Agency Tracking No:
Title: Medical Byproduct Licensing -- 10 CFR Part 35
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Comment filed on proposed rule and continue	Conclusion Date: 11/16/1998
	Date Received in OIRA: 08/13/1998
Terms of Clearance: Because of the likelihood of public comment and the possibility of subsequent changes in the information collection, NRC should resubmit the information collection request when it takes final action. The resubmittal should, in particular, discuss the following areas of interest: 1). The specific need for sections 35.40 and 35.41. 2). The justification for the training and experience requirements for Authorized Users. 3). A discussion of the reasons behind requiring that the licensee or individual keep a record stating that the individual has successfully passed a certifying examination given by an organization or entity approved by the Commission.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/1999	11/30/2001	10/31/1999
Responses	6,678,285	0	6,678,285
Time Burden (Hours)	1,336,353	0	0
Cost Burden (Dollars)	0	0	0

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

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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 Byproduct Licensing -- 10 CFR Part 35

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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:

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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: 08/13/1998

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