Thursday, March 11, 2010
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0121] Agency Information Collection Activities; Proposed Collection; Comment Request; Mammography Quality Standards Act Requirements
AGENCY: Food and Drug Administration, HHS.
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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 theFederal Registerconcerning 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 and recordkeeping burden associated with the Mammography Quality Standards Act requirements.
DATES: Submit written or electronic comments on the collection of information by May 10, 2010.
ADDRESSES: Submit electronic comments on the collection of information tohttp://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 theFederal Registerconcerning 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.
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.
FDA estimates the burden of this collection of information as follows:
| 21 CFRSection | No.of Respondents | AnnualFrequency per Response | Total AnnualResponses | Hours perResponse | Total Hours | TotalCapital Costs | Total OperatingMaintenance 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(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) | 2,894 | 1 | 2,894 | 1.5 | 4,341 | ||
| 900.11(b)(1) | |||||||
| 900.11(b)(2)facility3 | |||||||
| 900.4(c)AB4 | 5 | 1 | 5 | 421 | 2,105 | $173,620 | |
| 900.4(d) | 2,894 | 1 | 2,894 | .75 | 2,171 | ||
| 900.11(b)(1) | |||||||
| 900.11(b)(2)facility3 | |||||||
| 900.4(d)AB4 | 5 | 1 | 5 | 211 | 1,055 | ||
| 900.4(e) | 8,681 | 1 | 8,681 | 1 | 8,681 | $8,681 | |
| 900.11(b)(1) | |||||||
| 900.11(b)(2)facility3 | |||||||
| 900.4(e)AB4 | 5 | 1 | 5 | 1,736 | 8,680 | ||
| 900.4(f) | 331 | 1 | 331 | 7 | 2,317 | $77,640 | |
| 900.4(h)facility3 | 8,681 | 1 | 8,681 | 1 | 8,681 | $3,820 | |
| 900.4(h)AB4 | 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 refusal5 | 87 | 1 | 87 | .5 | 43.5 | ||
| 900.12(h)(4) | 7 | 1 | 7 | 1 | 7 | ||
| 900.12(j)(1)facility3 | 8 | 1 | 8 | 200 | 1,600 | $120 | |
| 900.12(j)(1)AB4 | 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 | 20 | |
| 900.22(i) | 2 | 1 | 2 | 30 | 60 | ||
| 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 | 3,620,673 | $40,000 | $19,768,361 | ||||
| 1One-time burden. | |||||||
| 2Refers to accreditation bodies applying to accredit specific Full Field Digital Mammographyunits. | |||||||
| 3Refers to the facility component of the burden for this requirement. | |||||||
| 4Refers to the accreditation body component of the burden for this requirement. | |||||||
| 5Refers to the situation where a patient specifically does not want to receive the lay summary of her exam. |
| 21 CFR Section | No. ofRecordkeepers | AnnualFrequency per Recordkeeping | Total AnnualRecords | Hours perRecord | Total Hours | TotalCapital Costs | Total OperatingMaintenance 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 |
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.
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