[Federal Register Volume 75, Number 47 (Thursday, March 11, 2010)]
[Notices]
[Pages 11542-11545]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-5230]
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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.
ACTION: Notice.
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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 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
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,
[email protected].
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
[[Page 11543]]
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.
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:
Table 1.--Estimated Annual Reporting Burden
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Annual Total Total Operating
21 CFR Section No. of Frequency per Total Annual Hours per Total Hours Capital & Maintenance
Respondents Response Responses Response Costs Costs
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900.3(b)(1) 0.33 1 0.33 1 0.33 .......... ...............
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900.3(b)(3) 0.33 1 0.33 320 106 10,000 ...............
full\1\
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900.3(b)(3) 5 1 5 30 150 .......... ...............
limited\2\
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900.3(d)(2) 0.1 1 0.1 30 3 .......... ...............
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900.3(d)(5) 0.1 1 0.1 30 3 .......... ...............
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900.3(e) 0.1 1 0.1 1 0.1 .......... ...............
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900.3(f)(2) 0.1 1 0.1 200 20 .......... $45
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900.4(c) 2,894 1 2,894 1.5 4,341 .......... ...............
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900.11(b)(1) .............. .............. ............. ................ .............. .......... ...............
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900.11(b)(2) .............. .............. ............. ................ .............. ..........
facility\3\
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900.4(c) 5 1 5 421 2,105 .......... $173,620
AB\4\
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900.4(d) 2,894 1 2,894 .75 2,171 .......... ...............
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900.11(b)(1) .............. .............. ............. ................ .............. .......... ...............
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900.11(b)(2) .............. .............. ............. ................ .............. .......... ...............
facility\3\
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900.4(d) 5 1 5 211 1,055 .......... ...............
AB\4\
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900.4(e) 8,681 1 8,681 1 8,681 .......... $8,681
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900.11(b)(1) .............. .............. ............. ................ .............. .......... ...............
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900.11(b)(2) .............. .............. ............. ................ .............. .......... ...............
facility\3\
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[[Page 11544]]
900.4(e) 5 1 5 1,736 8,680 .......... ...............
AB\4\
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900.4(f) 331 1 331 7 2,317 .......... $77,640
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900.4(h) 8,681 1 8,681 1 8,681 .......... $3,820
facility\3\
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900.4(h) 5 1 5 10 50 .......... ...............
AB\4\
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900.4(i)(2) 1 1 1 16 16 .......... ...............
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900.6(c)(1) 0.1 1 0.1 60 6 .......... ...............
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900.11(b)(3) 5 1 5 .5 2.5 .......... ...............
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900.11(c) 400 1 400 5 2,000 .......... ...............
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900.12(c)(2) 8,681 4,942 42,901,502 .0833333 3,575,124 .......... $19,500,000
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900.12(c)(2) 87 1 87 .5 43.5 .......... ...............
patient refusal\5\
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900.12(h)(4) 7 1 7 1 7 .......... ...............
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900.12(j)(1) 8 1 8 200 1,600 .......... $120
facility\3\
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900.12(j)(1) 8 1 8 320 2,560 .......... $240
AB\4\
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900.12(j)(2) 2 1 2 100 200 .......... $3,875
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900.15(c) 5 1 5 2 10 .......... ...............
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900.15(d)(3)(ii) 1 1 1 2 2 .......... ...............
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900.18(c) 2 1 2 2 4 .......... ...............
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900.18(e) 2 1 2 1 2 .......... ...............
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900.21(b) 0.33 1 0.33 320 106 $30,000 $174
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900.21(c)(2) 0.1 1 0.1 30 3 .......... ...............
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900.22(h) 5 200 1,000 .083 83 .......... 20
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900.22(i) 2 1 2 30 60 .......... ...............
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900.23 5 1 5 20 100 .......... ...............
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900.24(a) 0.4 1 0.4 200 80 .......... $42
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900.24(a)(2) 0.15 1 0.15 100 15 .......... $21
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900.24(b) 1 1 1 30 30 .......... ...............
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900.24(b)(1) 0.3 1 0.3 200 60 .......... $42
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900.24(b)(3) 0.15 1 0.15 100 15 .......... $21
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900.25(a) 0.2 1 0.2 16 3.2 .......... ...............
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FDA Form 3422 700 1 700 .25 175 .......... ...............
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Total .............. .............. ............. ................ 3,620,673 $40,000 $19,768,361
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\1\ One-time burden.
\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.
[[Page 11545]]
Table 2.--Estimated Annual Recordkeeping Burden\1\
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Annual Total Total Operating
21 CFR Section No. of Frequency per Total Annual Hours per Total Hours Capital & Maintenance
Recordkeepers Recordkeeping Records Record Costs Costs
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900.3(f)(1) 0.1 1 0.1 0 0 .......... ...............
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900.4(g) 5 1 5 1 5 .......... ...............
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900.12(a)(1)(i)(B)(2) 87 1 87 8 696 .......... ...............
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900.12(a)(4) 8,681 4 34,724 1 34,724 .......... ...............
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900.12(c)(4) 8,681 1 8,681 1 8,681 $28,000 ...............
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900.12(e)(13) 8,681 52 451,412 .083333 37,618 .......... ...............
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900.12(f) 8,681 1 8,681 16 138,896 .......... ...............
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900.12(h)(2) 8,681 2 17,362 1 17,362 .......... ...............
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900.22(a) 5 1 5 1 5 .......... ...............
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900.22(d) 5 1 5 1 5 .......... ...............
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900.22(e) 5 1 5 1 5 .......... ...............
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900.22(f) 3 1 3 1 3 .......... ...............
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900.22(g) 5 1 5 1 5 .......... $50
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900.25(b) 5 1 5 1 5 .......... ...............
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Total .............. .............. ............. ................ 238,010 $28,000 $50
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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.
Dated: March 8, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-5230 Filed 3-11-10; 8:45 am]
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