Document ID: FDA-2010-N-0121-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Mammography Quality Standards Act Requirements
Posted Date: 2010-06-15T04:00Z

[Federal Register: June 15, 2010 (Volume 75, Number 114)]
[Notices]               
[Page 33811-33814]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15jn10-85]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0121]

 
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.

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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 oira_submission@omb.eop.gov. 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, 
Daniel.Gittleson@fda.hhs.gov.

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;

[[Page 33812]]

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:

                                                       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(c)\3\                                           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)          2,894                  1       2,894            1.5              4,341     ..........  ...............
 facility\4\
--------------------------------------------------------------------------------------------------------------------------------------------------------
900.4(c)                                              5                  1           5          421                2,105     ..........         $173,620
AB\5\
--------------------------------------------------------------------------------------------------------------------------------------------------------
900.4(d), 900.11(b)(1), and 900.11(b)(2)          2,894                  1       2,894             .75             2,171     ..........  ...............
 facility\4\
--------------------------------------------------------------------------------------------------------------------------------------------------------
900.4(d)                                              5                  1           5          211                1,055     ..........  ...............
AB\5\
--------------------------------------------------------------------------------------------------------------------------------------------------------
900.4(e), 900.11(b)(1), and 900.11(b)(2)          8,681                  1       8,681            1                8,681     ..........           $8,681
 facility\4\
--------------------------------------------------------------------------------------------------------------------------------------------------------
900.4(e)                                              5                  1           5        1,736                8,680     ..........  ...............
AB\5\
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 33813]]

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\4\
--------------------------------------------------------------------------------------------------------------------------------------------------------
900.4(h)                                              5                  1           5           10                   50     ..........  ...............
AB\5\
--------------------------------------------------------------------------------------------------------------------------------------------------------
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\6\
--------------------------------------------------------------------------------------------------------------------------------------------------------
900.12(h)(4)                                          7                  1           7            1                    7     ..........  ...............
--------------------------------------------------------------------------------------------------------------------------------------------------------
900.12(j)(1)                                          8                  1           8          200                1,600     ..........             $120
facility\4\
--------------------------------------------------------------------------------------------------------------------------------------------------------
900.12(j)(1)                                          8                  1           8          320                2,560     ..........             $240
AB\5\
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ One-time burden.
\2\ Refers to accreditation bodies applying to accredit specific Full Field Digital Mammography units.
\3\ While not included in the 60-day notice, all 4 accreditation bodies are expected to reapply to continue to be accreditation bodies during the
  information collection period.
\4\ Refers to the facility component of the burden for this requirement.
\5\ Refers to the accreditation body component of the burden for this requirement.
\6\ Refers to the situation where a patient specifically does not want to receive the lay summary of her exam.

[[Page 33814]]

                                                     Table 2--Estimated Annual Recordkeeping Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  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
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Dated: May 27, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-14317 Filed 6-14-10; 8:45 am]
BILLING CODE 4160-01-S