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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
	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

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	35,208,523	35,391,604	-183,081
Annual Time Burden (Hours)	3,940,842	3,858,703	82,139
Annual Cost Burden (Dollars)	24,410,106	19,768,411	4,641,695

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

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