Document ID: FDA-2010-N-0121-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Mammography Quality Standards Act Requirements
Posted Date: 2010-03-11T05:00Z

[Federal Register: March 11, 2010 (Volume 75, Number 47)]
[Notices]               
[Page 11542-11545]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11mr10-59]                         

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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.

-----------------------------------------------------------------------

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, 
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

[[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
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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  ...............
full\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
900.3(b)(3)                                           5                  1           5           30                  150     ..........  ...............
limited\2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
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)                                ..............  ..............  .............  ................  ..............  ..........
facility\3\
--------------------------------------------------------------------------------------------------------------------------------------------------------
900.4(c)                                              5                  1           5          421                2,105     ..........         $173,620
AB\4\
--------------------------------------------------------------------------------------------------------------------------------------------------------
900.4(d)                                          2,894                  1       2,894             .75             2,171     ..........  ...............
--------------------------------------------------------------------------------------------------------------------------------------------------------
900.11(b)(1)                                ..............  ..............  .............  ................  ..............  ..........  ...............
--------------------------------------------------------------------------------------------------------------------------------------------------------
900.11(b)(2)                                ..............  ..............  .............  ................  ..............  ..........  ...............
facility\3\
--------------------------------------------------------------------------------------------------------------------------------------------------------
900.4(d)                                              5                  1           5          211                1,055     ..........  ...............
AB\4\
--------------------------------------------------------------------------------------------------------------------------------------------------------
900.4(e)                                          8,681                  1       8,681            1                8,681     ..........           $8,681
--------------------------------------------------------------------------------------------------------------------------------------------------------
900.11(b)(1)                                ..............  ..............  .............  ................  ..............  ..........  ...............
--------------------------------------------------------------------------------------------------------------------------------------------------------
900.11(b)(2)                                ..............  ..............  .............  ................  ..............  ..........  ...............
facility\3\
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 11544]]

900.4(e)                                              5                  1           5        1,736                8,680     ..........  ...............
AB\4\
--------------------------------------------------------------------------------------------------------------------------------------------------------
900.4(f)                                            331                  1         331            7                2,317     ..........          $77,640
--------------------------------------------------------------------------------------------------------------------------------------------------------
900.4(h)                                          8,681                  1       8,681            1                8,681     ..........           $3,820
facility\3\
--------------------------------------------------------------------------------------------------------------------------------------------------------
900.4(h)                                              5                  1           5           10                   50     ..........  ...............
AB\4\
--------------------------------------------------------------------------------------------------------------------------------------------------------
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   ..........  ...............
patient refusal\5\
--------------------------------------------------------------------------------------------------------------------------------------------------------
900.12(h)(4)                                          7                  1           7            1                    7     ..........  ...............
--------------------------------------------------------------------------------------------------------------------------------------------------------
900.12(j)(1)                                          8                  1           8          200                1,600     ..........             $120
facility\3\
--------------------------------------------------------------------------------------------------------------------------------------------------------
900.12(j)(1)                                          8                  1           8          320                2,560     ..........             $240
AB\4\
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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.

    Dated: March 8, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-5230 Filed 3-11-10; 8:45 am]
BILLING CODE 4160-01-S