[Federal Register Volume 72, Number 31 (Thursday, February 15, 2007)]
[Notices]
[Pages 7438-7440]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-2578]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0381]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 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 March 
19, 2007.

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: 202-395-6974.

FOR FURTHER INFORMATION CONTACT:  Denver Presley, Jr., Office of the 
Chief Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1472.

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

    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 ensure 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-

[[Page 7439]]

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.
    In the Federal Register of September 22, 2006 (71 FR 55488), FDA 
published a 60-day notice soliciting public comments on the information 
collection requirements of the proposed collection. In response to that 
notice, no comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                                       Table 1.--Estimated Annual Reporting Burden
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                                                                 Annual                                                      Total
          21 CFR Section/ FDA Form               No. of       Frequency per   Total Annual      Hours per    Total Hours    Capital    Total Operating &
                                               Respondents      Response        Responses       Response                     Costs     Maintenance Costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
900.3(b)(1)                                            0.33               1            0.33               1         0.33  ...........  .................
900.3(b)(3) full\1\                                    0.33               1            0.33             320          106      $10,000  .................
900.3(b)(3) limited\2\                                    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  ...........                $36
900.4(c) facility\3\                                  2,947               1           2,947            1.54        4,538  ...........  .................
900.4(c) AB\4\                                            6               1               6             378        2,268  ...........           $117,867
900.4(d) facility\3\                                  2,947               1           2,947            0.77        2,269  ...........  .................
900.4(d) AB\4\                                            6               1               6             189        1,134  ...........  .................
900.4(e) facility\3\                                  8,840               1           8,840               1        8,840  ...........             $8,840
900.4(e) AB\4\                                            6               1               6           1,473        8,838  ...........  .................
900.4(f)                                                336               1             336               7        2,352  ...........            $77,840
900.4(h) facility\3\                                  8,840               1           8,840               1        8,840  ...........             $3,536
900.4(h) AB\4\                                            6               1               6              10           60  ...........  .................
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             0.5          2.5  ...........  .................
900.11(c)                                               270               1             270               5        1,350  ...........  .................
900.12(c)(2)                                          8,840           4,072      36,000,000           0.083    3,000,000  ...........     $14,400,000\5\
900.12(c)(2) patient refusal\5\                          89               1              89             0.5         44.5  ...........  .................
900.12(h)(4)                                              5               1               5               1            5  ...........  .................
900.12(j)(1) facility\3\                                 25               1              25             200        5,000  ...........               $250
900.12(j)(1) AB\4\                                       25               1              25           1,000       25,000  ...........               $750
900.12(j)(2)                                              3               1               3             100          300  ...........             $3,604
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)                                                 1               1               1             320          320      $30,000                $71
900.21(c)(2)                                            0.3               1            0.33              30           10  ...........  .................
900.22(h)                                                 6             200           1,200           0.083          100  ...........  .................
900.22(i)                                                 2               1               2              30           60  ...........  .................
900.23                                                    6               1               6              20          120  ...........  .................
900.24(a)                                               0.3               1             0.3             200           60  ...........                $26
900.24(a)(2)                                           0.15               1            0.15             100           15  ...........                $13
900.24(b)                                               1.2               1             1.2              30           36
900.24(b)(1)                                            0.3               1             0.3             200           60  ...........                $26
900.24(b)(3)                                           0.15               1            0.15             100           15  ...........                $13
900.25(a)                                               0.2               1             0.2              16          3.2  ...........  .................
FDA Form 3422                                           700               1             700            0.25          175  ...........  .................
TOTAL                                        ..............  ..............  ..............  ..............    3,072,138      $40,000        $14,612,872
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\1\ Refers to entities that are applying for the first time.
\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.


                                                    Table 2. --Estimated Annual Recordkeeping Burden
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                                                                                                                                                Total
                                             Number of        Annual       Total Annual      Hours per                      Total Capital    Operating &
             21 CFR Section                Recordkeepers   Frequency of       Records         Record        Total Hours         Costs        Maintenance
                                                           Recordkeeping                                                                        Costs
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900.4(g)                                               6               1               6               1               6  .................  ...........
900.12(a)(1)(i)(B)(2)                                 89               1              89               8             712  .................  ...........
900.12(a)(4)                                       8,840               4          35,360               1          35,360  .................  ...........
900.12(c)(4)                                       8,840               1           8,840               1           8,840            $25,000  ...........
900.12(e)(13)                                      8,840              52         459,680           0.083          38,154  .................  ...........
900.12(f)                                          8,840               1           8,840              16         141,440  .................  ...........
900.12(h)(2)                                       8,840               2          17,680               1          17,680  .................  ...........

[[Page 7440]]

 
900.22(a)                                              6               1               6               1               6  .................  ...........
900.22(d)                                              6               1               6               1               6  .................  ...........
900.22(e)                                              6               1               6               1               6  .................  ...........
900.22(f)                                              3               1               3               1               3  .................  ...........
900.22(g)                                              6               1               6               1               6  .................          $60
900.25(b)                                              6               1               6               1               6  .................  ...........
Total                                     ..............  ..............  ..............  ..............         242,225            $25,000          $60
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    This request for OMB approval now serves to consolidate previously 
issued information collection, OMB control number 0910-0580 into 0910-
0309. The hourly burden as well as the associated operating costs were 
increased to better represent the actual burden and costs on facilities 
and accreditation bodies.
    The following regulations were not included in the above 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 Sec.  
900.3(f)(1) (21 CFR 900.3(f)(1)).
    The following regulations were not included in the above burden 
tables because they were not considered applicable during the 
information collection period or their burdens were reported under 
other regulatory requirements. Therefore, they resulted in no 
additional reporting or recordkeeping burden: Sec.  900.3(c), 21 CFR 
900.11(b)(1) and (b)(2), and 900.24(c).

    Dated: February 8, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-2578 Filed 2-14-07; 8:45 am]
BILLING CODE 4160-01-S