View Information Collection Request (ICR) Package
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Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.
Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
3150-0010
ICR Reference No:
199002-3150-001
Status:
Historical Active
Previous ICR Reference No:
198910-3150-002
Agency/Subagency:
NRC
Agency Tracking No:
Title:
MEDICAL USE OF BYPRODUCT MATERIAL - 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:
Approved without change
Conclusion Date:
03/30/1990
Retrieve Notice of Action (NOA)
Date Received in OIRA:
02/01/1990
Terms of Clearance:
In accordance with the Paperwork Reduction Act and 5 CFR 1320, this collection is approved through January 31, 1993. However, if EPA implements information collection requirements related to the National Emission Standards for Hazardous Air Pollutant for Radionuclides, the NRC, after consulting with EPA, is required to report to OMB in writing, within two months of EPA's action, whether or not there is any duplication of information collections. If there is, the NRC must describe the steps it is taking to reduce th duplicative burden.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
01/31/1993
01/31/1993
01/31/1992
Responses
8,422,955
0
8,422,955
Time Burden (Hours)
302,944
0
302,944
Cost Burden (Dollars)
0
0
0
Abstract:
THIS AMENDMENT TO 10 CFR 35 WOULD REQUIRE MEDICAL USE OF LICENSEES TO DEVELOP AND IMPLEMENT A BASIC QUALITY ASSURANCE PROGRAM TO PREVENT ERRORS IN THE ADMINISTRATION OF BYPRODUCT MATERIAL TO PATIENTS. THIS AMENDMENT ALSO CONTAINS MODIFICATIONS TO THE EXISTING REPORTING AND RECORDKEEPING REQUIREMENTS OF CERTAIN THERAPY OR DIAGNOSTIC EVENTS.
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
MEDICAL USE OF BYPRODUCT MATERIAL - 10 CFR PART 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
8,422,955
8,422,955
0
0
0
0
Annual Time Burden (Hours)
302,944
302,944
0
0
0
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:
02/01/1990
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