Mammography Facilities, Standards, and Lay Summaries for Patients

Forms and Documents

Document Name	Status
Form FDA 3422 Mammography Facilities, Standards, and Lay Summaries for Patients Form and Instruction	Unchanged
0309_Supporting Statement_Proposed Rule.doc Supporting Statement A	2019-03-29

IC Document Collections

IC ID	Document Title	Status
5881	Mammography Facilities, Standards, and Lay Summaries for Patients Form and Instruction	Unchanged
235527	New Burden from Rulemaking (Third-Party Disclosure) - Patient notification of significant risk (by State certification agency)--900.12(j)(2)	New
235526	New Burden from Rulemaking (Third-Party Disclosure) - Facility closure; notification and records access-900.12(c)(4)(v)	New
235524	New Burden from Rulemaking (Third-Party Disclosure) - Transfer/provision of copies of mammograms and records upon patient's request-900.12(c)(4)(ii) and (c)(4)(iii)	New
235522	New Burden from Rulemaking (Third-Party Disclosure) - Breast density reporting in lay summary (one-time burden)-900.12(c)(2)	New
235521	New Burden from Rulemaking (Third-Party Disclosure) - New assessment categories and breast density reporting in mammography report (one-time burden)-900.12(c)(1)(iv)-(c)(1)(vi)	New
235520	New Burden from Rulemaking (Third-Party Disclosure) - Transfer of personnel records by closing facilities-900.12(a)(4)	New
235519	New Burden from Rulemaking (Third-Party Disclosure) - Provision of personnel records --900.12(a)(4)	New

ICR Details

OMB Control No: 0910-0309	ICR Reference No: 201903-0910-026
Status: Historical Inactive	Previous ICR Reference No: 201608-0910-006
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
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: Comment filed on proposed rule and continue	Conclusion Date: 04/01/2019
	Date Received in OIRA: 03/30/2019
Terms of Clearance: Prior to publication of the final rule, the agency should provide to OMB a summary of all comments received on the proposed information collection and identify any changes made in response to these comments.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2019	36 Months From Approved	10/31/2019
Responses	35,208,523	0	35,208,523
Time Burden (Hours)	3,940,842	0	3,940,842
Cost Burden (Dollars)	24,410,106	0	24,410,106

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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.

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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:
0910-AH04	Proposed rulemaking	84 FR 11669	03/28/2019

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 8

IC Title	Form No.	Form Name
New Burden from Rulemaking (Third-Party Disclosure) - Transfer of personnel records by closing facilities-900.12(a)(4)
New Burden from Rulemaking (Third-Party Disclosure) - Provision of personnel records --900.12(a)(4)
New Burden from Rulemaking (Third-Party Disclosure) - New assessment categories and breast density reporting in mammography report (one-time burden)-900.12(c)(1)(iv)-(c)(1)(vi)
New Burden from Rulemaking (Third-Party Disclosure) - Transfer/provision of copies of mammograms and records upon patient's request-900.12(c)(4)(ii) and (c)(4)(iii)
New Burden from Rulemaking (Third-Party Disclosure) - Breast density reporting in lay summary (one-time burden)-900.12(c)(2)
New Burden from Rulemaking (Third-Party Disclosure) - Facility closure; notification and records access-900.12(c)(4)(v)
Mammography Facilities, Standards, and Lay Summaries for Patients	FDA 3422	GOVERNMENTAL ENTITY DECLARATION
New Burden from Rulemaking (Third-Party Disclosure) - Patient notification of significant risk (by State certification agency)--900.12(j)(2)

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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: No

Burden Reduction Due to:

Short Statement: In its proposed rule “Mammography Quality Standards Act; Amendments to Part 900 Regulations” (84 FR 11669) FDA is proposing to amend its mammography reporting requirements. The proposed revisions to the third-party disclosure burden described in section 12a of this ICR, would result in an increase of 1,347,744 hours to the estimated burden.

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Annual Cost to Federal Government: $11,906,454

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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

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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: 03/30/2019

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