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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0381]

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; 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 March 19, 2007.

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: 202-395-6974.

FOR FURTHER INFORMATION CONTACT:

Denver Presley, Jr., Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1472.

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

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 ensure 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.

In the

Federal Register

of September 22, 2006 (71 FR 55488), FDA published a 60-day notice soliciting public comments on the information collection requirements of the proposed collection. In response to that notice, no comments were received.

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

Table 1.—Estimated Annual Reporting Burden

21 CFR Section/ FDA Form

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) full

1

0.33

1

0.33

320

106

$10,000

900.3(b)(3) limited

2

5

1

5

30

150

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

$36

900.4(c) facility

3

2,947

1

2,947

1.54

4,538

900.4(c) AB

4

6

1

6

378

2,268

$117,867

900.4(d) facility

3

2,947

1

2,947

0.77

2,269

900.4(d) AB

4

6

1

6

189

1,134

900.4(e) facility

3

8,840

1

8,840

1

8,840

$8,840

900.4(e) AB

4

6

1

6

1,473

8,838

900.4(f)

336

1

336

7

2,352

$77,840

900.4(h) facility

3

8,840

1

8,840

1

8,840

$3,536

900.4(h) AB

4

6

1

6

10

60

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

0.5

2.5

900.11(c)

270

1

270

5

1,350

900.12(c)(2)

8,840

4,072

36,000,000

0.083

3,000,000

$14,400,000

5

900.12(c)(2) patient refusal

5

89

1

89

0.5

44.5

900.12(h)(4)

5

1

5

1

5

900.12(j)(1) facility

3

25

1

25

200

5,000

$250

900.12(j)(1) AB

4

25

1

25

1,000

25,000

$750

900.12(j)(2)

3

1

3

100

300

$3,604

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)

1

1

1

320

320

$30,000

$71

900.21(c)(2)

0.3

1

0.33

30

10

900.22(h)

6

200

1,200

0.083

100

900.22(i)

2

1

2

30

60

900.23

6

1

6

20

120

900.24(a)

0.3

1

0.3

200

60

$26

900.24(a)(2)

0.15

1

0.15

100

15

$13

900.24(b)

1.2

1

1.2

30

36

900.24(b)(1)

0.3

1

0.3

200

60

$26

900.24(b)(3)

0.15

1

0.15

100

15

$13

900.25(a)

0.2

1

0.2

16

3.2

FDA Form 3422

700

1

700

0.25

175

TOTAL

3,072,138

$40,000

$14,612,872

1

Refers to entities that are applying for the first time.

2

Refers to accreditation bodies applying to accredit specific Full Field Digital Mammography units.

3

Refers to the facility component of the burden for this requirement.

4

Refers to the accreditation body component of the burden for this requirement.

5

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

Number of Recordkeepers

Annual Frequency of Recordkeeping

Total Annual Records

Hours per Record

Total Hours

Total Capital Costs

Total Operating & Maintenance Costs

900.4(g)

6

1

6

1

6

900.12(a)(1)(i)(B)(2)

89

1

89

8

712

900.12(a)(4)

8,840

4

35,360

1

35,360

900.12(c)(4)

8,840

1

8,840

1

8,840

$25,000

900.12(e)(13)

8,840

52

459,680

0.083

38,154

900.12(f)

8,840

1

8,840

16

141,440

900.12(h)(2)

8,840

2

17,680

1

17,680

900.22(a)

6

1

6

1

6

900.22(d)

6

1

6

1

6

900.22(e)

6

1

6

1

6

900.22(f)

3

1

3

1

3

900.22(g)

6

1

6

1

6

$60

900.25(b)

6

1

6

1

6

Total

242,225

$25,000

$60

This request for OMB approval now serves to consolidate previously issued information collection, OMB control number 0910-0580 into 0910-0309. The hourly burden as well as the associated operating costs were increased to better represent the actual burden and costs on facilities and accreditation bodies.

The following regulations were not included in the above 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 § 900.3(f)(1) (21 CFR 900.3(f)(1)).

The following regulations were not included in the above burden tables because they were not considered applicable during the information collection period or their burdens were reported under other regulatory requirements. Therefore, they resulted in no additional reporting or recordkeeping burden: § 900.3(c), 21 CFR 900.11(b)(1) and (b)(2), and 900.24(c).

Dated: February 8, 2007.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. E7-2578 Filed 2-14-07; 8:45 am]

BILLING CODE 4160-01-S