Agency Information Collection Activities; Proposed Collection; Comment Request; Mammography Quality Standards Act Requirements

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0134]

Agency Information Collection Activities; Proposed Collection; Comment Request; Mammography Quality Standards Act Requirements

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the

Federal Register

concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on

the estimated reporting, recordkeeping, and third-party disclosure burden associated with the Mammography Quality Standards Act requirements.

DATES:

Submit either electronic or written comments on the collection of information by April 29, 2013.

ADDRESSES:

Submit electronic comments on the collection of information to

http://www.regulations.gov.

Submit written comments on the collection of information to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the 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,

Daniel.Gittleson@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the

Federal Register

concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

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 (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 complaint 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) are not included in the burden tables because they are 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 burden: 21 CFR 900.12(c)(1) and (c)(3) and 21 CFR 900.3(f)(1). Section 900.24(c) was also not included in the 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.

We have rounded numbers in the “Total Hours” column in all three burden tables. (Where the number was a portion of one hour, it has been rounded to 1 hour. All other “Total Hours” have been rounded to the nearest whole number.)

We do not expect any respondents for § 900.3(c) because all four ABs are approved until April 2020.

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

Table 1—Estimated Annual Reporting Burden

Activity/21 CFR Section/FDA Form No.

Number of respondents

Number of responses per respondent

Total annual responses

Average burden per response

Total hours

1

Total capital costs

Total operating & maintenance costs

Notification of intent to become an AB—900.3(b)(1)

0.33

1

0.33

1

1

Application for approval as an AB; full

2

—900.3(b)(3)

0.33

1

0.33

320

106

$10,000

Application for approval as an AB; limited

3

—900.3(b)(3)

5

1

5

30

150

AB renewal of approval—900.3(c)

0

1

0

15

1

AB application deficiencies—900.3(d)(2)

0.1

1

0.1

30

3

AB resubmission of denied applications—900.3(d)(5)

0.1

1

0.1

30

3

Letter of intent to relinquish accreditation authority—900.3(e)

0.1

1

0.1

1

1

Summary report describing all facility assessments—900.4(f)

330

1

330

7

2,310

$77,600

AB reporting to FDA; facility

4

—900.4(h)

8,654

1

8,654

1

8,654

4,327

AB reporting to FDA; AB

5

—900.4(h)

5

1

5

10

50

AB financial records—900.4(i)(2)

1

1

1

16

16

Former AB new application—900.6(c)(1)

0.1

1

0.1

60

6

Reconsideration of accreditation following appeal—900.15(d)(3)(ii)

1

1

1

2

2

Application for alternative standard—900.18(c)

2

1

2

2

4

Alternative standard amendment—900.18(e)

10

1

10

1

10

Certification agency application—900.21(b)

0.33

1

0.33

320

106

$208

Certification agency application deficiencies—900.21(c)(2)

0.1

1

0.1

30

3

Certification electronic data transmission—900.22(h)

5

200

1000

0.083

83

$30,000

Changes to standards—900.22(i)

2

1

2

30

60

$20

Certification agency minor deficiencies—900.24(b)

1

1

1

30

30

Appeal of adverse action taken by FDA—900.25(a)

0.2

1

0.2

16

3

Inspection fee exemption—FDA Form 3422

700

1

700

0.25

175

Total

11,777

40,000

82,155

1

Total hours have been rounded.

2

One time burden.

3

Refers to accreditation bodies applying to accredit specific full-field digital mammography units.

4

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

5

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

Table 2—Estimated Annual Recordkeeping Burden

Activity/21 CFR Section

No. of recordkeepers

No. of records per recordkeeper

Total

annual records

Average burden per recordkeeping

Total hours

1

Total capital costs

Total operating and maintenance costs

AB transfer of facility records—900.3(f)(1)

0.1

1

0.1

0

1

Consumer complaints system; AB—900.4(g)

5

1

5

1

5

Documentation of interpreting physician initial requirements—900.12(a)(1)(i)(B)(

2

)

87

1

87

8

696

Documentation of interpreting physician personnel requirements—900.12(a)(4)

8,654

4

34,616

1

34,616

Permanent medical record—900.12(c)(4)

8,654

1

8,654

1

8,654

$28,000

Procedures for cleaning equipment—900.12(e)(13)

8,654

52

450,008

0.083

37,351

Audit program—900.12(f)

8,654

1

8,654

16

138,464

Consumer complaints system; facility—900.12(h)(2)

8,654

2

17,308

1

17,308

Certification agency conflict of interest—900.22(a)

5

1

5

1

5

Processes for suspension and revocation of certificates—900.22(d)

5

1

5

1

5

Processes for appeals—900.22(e)

5

1

5

1

5

Processes for additional mammography review—900.22(f)

5

1

5

1

5

Processes for patient notifications—900.22(g)

3

1

3

1

3

$30

Evaluation of certification agency—900.23

5

1

5

20

100

Appeals—900.25(b)

5

1

5

1

5

Total

237,223

28,000

30

1

Total hours have been rounded.

Table 3—Estimated Annual Third-Party Disclosures

1

Activity/21 CFR Section

Number of respondents

Number of disclosures per respondent

Total annual disclosures

Average burden per disclosure

Total hours

2

Total operating and maintenance costs

Notification of facilities that AB relinquishes its accreditation—900.3(f)(2)

0.1

1

0.1

200

20

$50

Clinical images; facility

2

—900.4(c), 900.11(b)(1), and 900.11(b)(2)

2,885

1

2,885

1.44

4,154

Clinical images; AB

3

—900.4(c)

5

1

5

416

2,080

230,773

Phantom images; facility

2

—900.4(d), 900.11(b)(1), and 900.11(b)(2)

2,885

1

2,885

0.72

2,077

Phantom images; AB

3

—900.4(d)

5

1

5

208

1,040

Annual equipment evaluation and survey; facility

2

—900.4(e), 900.11(b)(1), and 900.11(b)(2)

8,654

1

8,654

1

8,654

8,654

Annual equipment evaluation and survey; AB

3

—900.4(e)

5

1

5

1,730

8,650

Provisional mammography facility certificate extension application—900.11(b)(3)

0

1

0

0.5

1

Mammography facility certificate reinstatement application—900.11(c)

312

1

312

5

1,560

24,000,000

Lay summary of examination—900.12(c)(2)

8,654

5,085

44,005,590

0.083

3,652,464

Lay summary of examination; patient refusal

4

—900.12(c)(2)

87

1

87

0.5

44

Report of unresolved serious complaints—900.12(h)(4)

20

1

20

1

20

Information regarding compromised quality; facility

2

—900.12(j)(1)

20

1

20

200

4,000

300

Information regarding compromised quality; AB

3

—900.12(j)(1)

20

1

20

320

6,400

600

Patient notification of serious risk—900.12(j)(2)

5

1

5

100

500

19,375

Reconsideration of accreditation—900.15(c)

5

1

5

2

10

Notification of requirement to correct major deficiencies—900.24(a)

0.4

1

0.4

200

80

68

Notification of loss of approval; major deficiencies—900.24(a)(2)

0.15

1

0.15

100

15

25.50

Notification of probationary status—900.24(b)(1)

0.3

1

0.3

200

60

51

Notification of loss of approval; minor deficiencies—900.24(b)(3)

0.15

1

0.15

100

15

25.50

Total

3,691,842

24,259,921

1

There are no capital costs associated with this collection of information.

2

Total hours have been rounded.

Dated: February 22, 2013.

Leslie Kux,

Assistant Commissioner for Policy.

[FR Doc. 2013-04677 Filed 2-27-13; 8:45 am]

BILLING CODE 4160-01-P