2010-14317. Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; The Mammography Quality Standards Act Requirements

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: [phone], or e-mailed to [e-mail]. 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.

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, [e-mail].

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; regulations 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 Section	No. of Respondents	Annual Frequency per Response	Total Annual Responses	Hours per Response	Total Hours	Total Capital Costs	Total Operating & Maintenance Costs
900.3(b)(1)	0.33	1	0.33	1	0.33
900.3(b)(3) full1	0.33	1	0.33	320	106	$10,000
900.3(b)(3) limited2	5	1	5	30	150
900.3(c)3	1.33	1	1.33	15	20
900.3(d)(2)	0.1	1	0.1	30	3
900.3(d)(5)	0.1	1	0.1	30	3
900.3(e)	0.1	1	0.1	1	0.1
900.3(f)(2)	0.1	1	0.1	200	20		$45
900.4(c), 900.11(b)(1), and 900.11(b)(2) facility4	2,894	1	2,894	1.5	4,341
900.4(c) AB5	5	1	5	421	2,105		$173,620
900.4(d), 900.11(b)(1), and 900.11(b)(2) facility4	2,894	1	2,894	.75	2,171
900.4(d) AB5	5	1	5	211	1,055
900.4(e), 900.11(b)(1), and 900.11(b)(2) facility4	8,681	1	8,681	1	8,681		$8,681
900.4(e) AB5	5	1	5	1,736	8,680
900.4(f)	331	1	331	7	2,317		$77,640
900.4(h) facility4	8,681	1	8,681	1	8,681		$3,820
900.4(h) AB5	5	1	5	10	50
900.4(i)(2)	1	1	1	16	16
900.6(c)(1)	0.1	1	0.1	60	6
900.11(b)(3)	5	1	5	.5	2.5
900.11(c)	400	1	400	5	2,000
900.12(c)(2)	8,681	4,942	42,901,502	.0833333	3,575,124		$19,500,000
900.12(c)(2) patient refusal6	87	1	87	.5	43.5
900.12(h)(4)	7	1	7	1	7
900.12(j)(1) facility4	8	1	8	200	1,600		$120
900.12(j)(1) AB5	8	1	8	320	2,560		$240
900.12(j)(2)	2	1	2	100	200		$3,875
900.15(c)	5	1	5	2	10
900.15(d)(3)(ii)	1	1	1	2	2
900.18(c)	2	1	2	2	4
900.18(e)	2	1	2	1	2
900.21(b)	0.33	1	0.33	320	106	$30,000	$174
900.21(c)(2)	0.1	1	0.1	30	3
900.22(h)	5	200	1,000	.083	83
900.22(i)	2	1	2	30	60		$20
900.23	5	1	5	20	100
900.24(a)	0.4	1	0.4	200	80		$42
900.24(a)(2)	0.15	1	0.15	100	15		$21
900.24(b)	1	1	1	30	30
900.24(b)(1)	0.3	1	0.3	200	60		$42
900.24(b)(3)	0.15	1	0.15	100	15		$21
900.25(a)	0.2	1	0.2	16	3.2
FDA Form 3422	700	1	700	.25	175
Total					3,620,692	$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.

Table 2—Estimated Annual Recordkeeping Burden

21 CFR Section	No. of Recordkeepers	Annual Frequency per Recordkeeping	Total Annual Records	Hours per Record	Total Hours	Total Capital Costs	Total Operating & Maintenance Costs
900.3(f)(1)	0.1	1	0.1	0	0
900.4(g)	5	1	5	1	5
900.12(a)(1)(i)(B)(2)	87	1	87	8	696
900.12(a)(4)	8,681	4	34,724	1	34,724
900.12(c)(4)	8,681	1	8,681	1	8,681	$28,000
900.12(e)(13)	8,681	52	451,412	.083333	37,618
900.12(f)	8,681	1	8,681	16	138,896
900.12(h)(2)	8,681	2	17,362	1	17,362
900.22(a)	5	1	5	1	5
900.22(d)	5	1	5	1	5
900.22(e)	5	1	5	1	5
900.22(f)	3	1	3	1	3
900.22(g)	5	1	5	1	5		$50
900.25(b)	5	1	5	1	5
Total					238,010	$28,000	$50

Dated: May 27, 2010.

Leslie Kux,

Acting Assistant Commissioner for Policy.