# 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: 202-395-7285, or e-mailed to *[email protected]* . 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, *[email protected]* .
**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:
| 21 CFR | No. | Annual | Total Annual | Hours per | Total Hours | Total | Total Operating |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 900.3(b)(1) | 0.33 | 1 | 0.33 | 1 | 0.33 | | |
| 900.3(b)(3) | 0.33 | 1 | 0.33 | 320 | 106 | $10,000 | |
| 900.3(b)(3) | 5 | 1 | 5 | 30 | 150 | | |
| 900.3(c) | 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) facility | 2,894 | 1 | 2,894 | 1.5 | 4,341 | | |
| 900.4(c) | 5 | 1 | 5 | 421 | 2,105 | | $173,620 |
| 900.4(d), 900.11(b)(1), and 900.11(b)(2) facility | 2,894 | 1 | 2,894 | .75 | 2,171 | | |
| 900.4(d) | 5 | 1 | 5 | 211 | 1,055 | | |
| 900.4(e), 900.11(b)(1), and 900.11(b)(2) facility | 8,681 | 1 | 8,681 | 1 | 8,681 | | $8,681 |
| 900.4(e) | 5 | 1 | 5 | 1,736 | 8,680 | | |
| 900.4(f) | 331 | 1 | 331 | 7 | 2,317 | | $77,640 |
| 900.4(h) | 8,681 | 1 | 8,681 | 1 | 8,681 | | $3,820 |
| 900.4(h) | 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) | 87 | 1 | 87 | .5 | 43.5 | | |
| 900.12(h)(4) | 7 | 1 | 7 | 1 | 7 | | |
| 900.12(j)(1) | 8 | 1 | 8 | 200 | 1,600 | | $120 |
| 900.12(j)(1) | 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 | | | | |
| 21 CFR | No. of | Annual | Total Annual | Hours per | Total Hours | Total | Total Operating |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 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.