Skip to main content
An official website of the United States government
The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.
Search:
Agenda
Reg Review
ICR
This script is used to control the display of information in this page.
Display additional information by clicking on the following:
All
Brief and OIRA conclusion
Abstract/Justification
Legal Statutes
Rulemaking
FR Notices/Comments
IC List
Burden
Misc.
Common Form Info.
Certification
View Information Collection (IC) List
View Supporting Statement and Other Documents
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:
0910-0309
ICR Reference No:
200703-0910-014
Status:
Historical Active
Previous ICR Reference No:
200402-0910-003
Agency/Subagency:
HHS/FDA
Agency Tracking No:
Title:
Mammography Facilities, Standards, and Lay Summaries for Patients
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:
06/08/2007
Retrieve Notice of Action (NOA)
Date Received in OIRA:
03/23/2007
Terms of Clearance:
OMB notes that the information collection requirements from 0910-0580 have been consolidated into this package. For 0910-0580, FDA will submit either an 83-D to discontinue or an 83-C to reduce the burden by the amount transferred into this collection (whichever is appropriate.)
Inventory as of this Action
Requested
Previously Approved
Expiration Date
06/30/2010
36 Months From Approved
06/30/2007
Responses
36,026,285
0
36,000,000
Time Burden (Hours)
3,314,363
0
3,219,936
Cost Burden (Dollars)
14,637,321
0
19,491,000
Abstract:
The Mammography Quality Standards Act Final Regulations establishes quality standards for mammography facilities, accreditation bodies and State certification agencies (21 CFR 900).
Authorizing Statute(s):
US Code:
42 USC 263
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
71 FR 55488
09/22/2006
30-day Notice:
Federal Register Citation:
Citation Date:
72 FR 7438
02/15/2007
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
Mammography Facilities, Standards, and Lay Summaries for Patients
3422
Governmental Entity Declaration
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
36,026,285
36,000,000
0
26,285
0
0
Annual Time Burden (Hours)
3,314,363
3,219,936
0
94,427
0
0
Annual Cost Burden (Dollars)
14,637,321
19,491,000
0
-4,853,679
0
0
Burden increases because of Program Change due to Agency Discretion:
Yes
Burden Increase Due to:
Miscellaneous Actions
Burden decreases because of Program Change due to Agency Discretion:
Yes
Burden Reduction Due to:
Miscellaneous Actions
Short Statement:
This renewal request for the collection 0910-0309 also serves to consolidate the information collection requirements for 0910-0580. As a result of this consolidation, due to Agency discretion, there has been an increase in total burden estimate. The collection for 0910-0580 will be discontinued upon OMB approval of this collection. In addition a number of other factors contributed to the change in the number of hours among which were, the average number of mammography units per facility increased; the hours for performing additional mammography reviews and patient/physicians notifications as well as the associated operating cost were increased to better represent the actual burden on facilities and accreditation bodies.
Annual Cost to Federal Government:
$6,428,000
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
Agency Contact:
Saleda Perryman
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:
03/23/2007
An official website of the United States government
The .gov means it's official.
The site is secure.
