Mammography Facilities, Standards, and Lay Summaries for Patients

Forms and Documents

Document Name	Status
Form 3422 Mammography Facilities, Standards, and Lay Summaries for Patients Form and Instruction	Modified
SS- 0910-0309.DOC Supporting Statement A	0000-00-00

IC Document Collections

IC ID	Document Title	Status
5881	Mammography Facilities, Standards, and Lay Summaries for Patients Form and Instruction	Modified

ICR Details

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
	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

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Abstract: The Mammography Quality Standards Act Final Regulations establishes quality standards for mammography facilities, accreditation bodies and State certification agencies (21 CFR 900).

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Authorizing Statute(s): US Code: 42 USC 263 Name of Law: null
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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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

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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

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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.

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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

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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: 03/23/2007

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