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Notice

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; The Mammography Quality Standards Act Requirements

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Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

DATES:

Fax written comments on the collection of information by July 15, 2010.

ADDRESSES:

To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or e-mailed to oira_submission@omb.eop.gov. All comments should be identified with the OMB control number 0910-0309. Also include the FDA docket number found in brackets in the heading of this document.

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FOR FURTHER INFORMATION CONTACT:

Daniel Gittleson, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, 301-796-5156, Daniel.Gittleson@fda.hhs.gov.

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SUPPLEMENTARY INFORMATION:

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

The Mammography Quality Standards Act Requirements—21 CFR Part 900 (OMB Control Number 0910-0309)—Extension

The Mammography Quality Standards Act requires the establishment of a Federal certification and inspection program for mammography facilities; Start Printed Page 33812regulations and standards for accreditation and certification bodies for mammography facilities; and standards for mammography equipment, personnel, and practices, including quality assurance. The intent of these regulations is to assure safe, reliable, and accurate mammography on a nationwide level. Under the regulations, as a first step in becoming certified, mammography facilities must become accredited by an FDA-approved accreditation body. This requires undergoing a review of their clinical images and providing the accreditation body 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. The following sections of title 21 of the Code of Federal Regulations (CFR) were not included in the previously mentioned burden tables because they were considered usual and customary practice and were part of the standard of care prior to the implementation of the regulations. Therefore, they resulted in no additional reporting or recordkeeping burden: 21 CFR 900.12(c)(1) and (c)(3) and 21 CFR 900.3(f)(1). Section 900.3(c) was not included in the previously mentioned burden tables because all four existing accreditation bodies are approved until late in 2013; so, no applicants will reapply during the requested information collection period. Section 900.24(c) was also not included in the previously mentioned burden tables because if a certifying state had its approval withdrawn, FDA would take over certifying authority for the affected facilities. Because FDA already has all the certifying state's electronic records, there wouldn't be an additional reporting burden.

In the Federal Register of March 11, 2010 (75 FR 11542), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.

FDA estimates the burden of this collection of information as follows:

Table 1—Estimated Annual Reporting Burden

21 CFR SectionNo. of RespondentsAnnual Frequency per ResponseTotal Annual ResponsesHours per ResponseTotal HoursTotal Capital CostsTotal Operating & Maintenance Costs
900.3(b)(1)0.3310.3310.33
900.3(b)(3) full10.3310.33320106$10,000
900.3(b)(3) limited251530150
900.3(c)31.3311.331520
900.3(d)(2)0.110.1303
900.3(d)(5)0.110.1303
900.3(e)0.110.110.1
900.3(f)(2)0.110.120020$45
900.4(c), 900.11(b)(1), and 900.11(b)(2) facility42,89412,8941.54,341
900.4(c) AB55154212,105$173,620
900.4(d), 900.11(b)(1), and 900.11(b)(2) facility42,89412,894.752,171
900.4(d) AB55152111,055
900.4(e), 900.11(b)(1), and 900.11(b)(2) facility48,68118,68118,681$8,681
900.4(e) AB55151,7368,680
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900.4(f)331133172,317$77,640
900.4(h) facility48,68118,68118,681$3,820
900.4(h) AB55151050
900.4(i)(2)1111616
900.6(c)(1)0.110.1606
900.11(b)(3)515.52.5
900.11(c)400140052,000
900.12(c)(2)8,6814,94242,901,502.08333333,575,124$19,500,000
900.12(c)(2) patient refusal687187.543.5
900.12(h)(4)71717
900.12(j)(1) facility48182001,600$120
900.12(j)(1) AB58183202,560$240
900.12(j)(2)212100200$3,875
900.15(c)515210
900.15(d)(3)(ii)11122
900.18(c)21224
900.18(e)21212
900.21(b)0.3310.33320106$30,000$174
900.21(c)(2)0.110.1303
900.22(h)52001,000.08383
900.22(i)2123060$20
900.2351520100
900.24(a)0.410.420080$42
900.24(a)(2)0.1510.1510015$21
900.24(b)1113030
900.24(b)(1)0.310.320060$42
900.24(b)(3)0.1510.1510015$21
900.25(a)0.210.2163.2
FDA Form 34227001700.25175
Total3,620,692$40,000$19,768,361
1 One-time burden.
2 Refers to accreditation bodies applying to accredit specific Full Field Digital Mammography units.
3 While not included in the 60-day notice, all 4 accreditation bodies are expected to reapply to continue to be accreditation bodies during the information collection period.
4 Refers to the facility component of the burden for this requirement.
5 Refers to the accreditation body component of the burden for this requirement.
6 Refers to the situation where a patient specifically does not want to receive the lay summary of her exam.
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Table 2—Estimated Annual Recordkeeping Burden

21 CFR SectionNo. of RecordkeepersAnnual Frequency per RecordkeepingTotal Annual RecordsHours per RecordTotal HoursTotal Capital CostsTotal Operating & Maintenance Costs
900.3(f)(1)0.110.100
900.4(g)51515
900.12(a)(1)(i)(B)(2)871878696
900.12(a)(4)8,681434,724134,724
900.12(c)(4)8,68118,68118,681$28,000
900.12(e)(13)8,68152451,412.08333337,618
900.12(f)8,68118,68116138,896
900.12(h)(2)8,681217,362117,362
900.22(a)51515
900.22(d)51515
900.22(e)51515
900.22(f)31313
900.22(g)51515$50
900.25(b)51515
Total238,010$28,000$50
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Dated: May 27, 2010.

Leslie Kux,

Acting Assistant Commissioner for Policy.

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[FR Doc. 2010-14317 Filed 6-14-10; 8:45 am]

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