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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:
201307-0910-001
Status:
Historical Active
Previous ICR Reference No:
201006-0910-002
Agency/Subagency:
HHS/FDA
Agency Tracking No:
19938
Title:
Mammography Facilities, Standards, and Lay Summaries for Patients
Type of Information Collection:
Extension without change of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
08/16/2013
Retrieve Notice of Action (NOA)
Date Received in OIRA:
07/03/2013
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
08/31/2016
36 Months From Approved
10/31/2013
Responses
35,208,523
0
35,391,604
Time Burden (Hours)
3,940,842
0
3,858,703
Cost Burden (Dollars)
24,410,106
0
19,768,411
Abstract:
Under the regulations, as a first step in becoming certified, mammography facilities must become accredited by an FDA approved accreditation body (AB). This requires undergoing a review of their clinical images and providing the AB with information showing that they meet the equipment, personnel, quality assurance and quality control standards, and have a medical reporting and recordkeeping program, a medical outcomes audit program, and a consumer compliant mechanism. On the basis of this accreditation, facilities are then certified by FDA or an FDA-approved State certification agency and must prominently display their certificate. These actions are taken to ensure safe, accurate, and reliable mammography on a nationwide basis.
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:
78 FR 13681
02/28/2013
30-day Notice:
Federal Register Citation:
Citation Date:
78 FR 39731
07/02/2013
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
FDA 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
35,208,523
35,391,604
0
0
-183,081
0
Annual Time Burden (Hours)
3,940,842
3,858,703
0
0
82,139
0
Annual Cost Burden (Dollars)
24,410,106
19,768,411
0
0
4,641,695
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:
After a review under the PRA, we have determined that it is more appropriate to categorize several of the information collections as third-party disclosure because respondents send information to third-parties such as accreditation bodies, facilities, patients, or physicians, rather than directly to FDA. We have therefore moved these ICs to a newly added third-party disclosure burden table above. To increase the ease with which one may cross-reference the burden table items with the narrative descriptions of the requirements, we have re-ordered the descriptions in section 1 of this supporting statement to appear by 21 CFR citation, rather than by IC burden type. The hour burden tables have been corrected to reflect that the information collected under 21 CFR 900.23 (evaluation of certification agency) is maintained by the certification agency for FDA's annual evaluation, but not sent to FDA and is, therefore, a recordkeeping burden rather than a reporting burden. The figures in the "Total Hours" column in all three burden tables have been rounded. (Where the number was a portion of one hour, it has been rounded to 1 hour. All other numbers have been rounded to the nearest whole number.) FDA previously estimated the annual burden for reporting and recordkeeping requirements under information collection 0910-0309 to be 3,858,703 hours. The current total burden estimate is 3,940,842 hours; an increase of 82,139 total burden hours. The annualized cost burden estimate formerly associated with these requirements was $58,598,274. The updated estimate is $64,168,727; an increase of $5,570,453. The total capital cost listed in the previous extension as $65,000, was incorrect due to a mathematical or typographical error. Additionally, in error the $65,000 was mistakenly left out of the ROCIS system. We have corrected the total capital cost to read $68,000 and added it to the total Capital and O&M costs in ROCIS. The capital costs have not changed since the previous approval. The total operating and maintenance cost formerly associated with these requirements was $19,768,411. The updated estimate of operating and maintenance costs is $24,410,106; an increase of $4,641,695. A number of factors contributed to the adjustment of the number of hours and monetary costs in the current estimates. The most significant factors are: Change in the number of mammography facilities, which resulted in adjustments to the number of respondents and a decrease of annual responses by 183,081. The number of mammography examinations has increased and is projected to be 40,000,000 per year, an increase of 1,000,000 from the previous estimate. The cost of materials and postage for mailing lay summaries has increased. Personnel salaries have increased.
Annual Cost to Federal Government:
$5,360,000
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]?
No
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
No
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
No
Is this ICR related to the Pandemic Response?
Uncollected
Agency Contact:
Daniel Gitteson 3017965156 daniel.gitteson@fda.hhs.gov
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:
07/03/2013