[Federal Register Volume 71, Number 184 (Friday, September 22, 2006)]
[Notices]
[Pages 55488-55490]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-8027]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0381]


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 November 21, 2006.

ADDRESSES: Submit electronic comments on the collection of information 
to: http://www.fda.gov/dockets/ecomments. 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: Denver Presley, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1472.

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 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\1\
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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        Records      Response                    Costs      Maintenance 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) full\1\                                      0.33                1          0.33          320          106       $10,000  ..................
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[[Page 55489]]

 
900.3(b)(3) limited\2\                                      5                1             5           30          150
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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  ............                 $36
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900.4(c) facility\3\                                    2,947                1         2,947        10.54        4,538  ............  ..................
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900.4(c) AB\4\                                              6                1             6          378        2,268  ............            $117,867
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900.4(d) facility\3\                                    2,947                1         2,947         0.77        2,947  ............  ..................
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900.4(d) AB\4\                                              6                1             6          189        1,134  ............  ..................
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900.4(e) facility\3\                                    8,840                1         8,840            1        8,840  ............              $8,840
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900.4(e) AB\4\                                              6                1             6        1,473        8,838  ............  ..................
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900.4(f)                                                  336                1           336            7        2,352  ............             $77,840
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900.4(h) facility\3\                                    8,840                1         8,840            1        8,840  ............              $3,536
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900.4(h) AB\4\                                              6                1             6           10           60  ............  ..................
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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          0.5          2.5  ............  ..................
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900.11(c)                                                 270                1           270            5        1,350  ............  ..................
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900.12(c)(2)                                            8,840            4,072    36,000,000        0.083    3,000,000  ............      $14,400,000\5\
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900.12(c)(2) patient refusal\5\                            89                1            89          0.5         44.5  ............  ..................
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900.12(h)(4)                                                5                1             5            1            5  ............  ..................
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900.12(j)(1) facility\3\                                   25                1            25          200        5,000  ............                $250
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900.12(j)(1) AB\4\                                         25                1            25        1,000       25,000  ............                $750
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900.12(j)(2)                                                3                1             3          100          300  ............              $3,604
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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)                                                   1                1           320          320            2       $30,000                 $71
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900.21(c)(2)                                             0.33                1          0.33           30           10  ............  ..................
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900.22(h)                                                   6              200         1,200        0.083          100  ............  ..................
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900.22(i)                                                   2                1             2           30           60  ............  ..................
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900.23                                                      6                1             6           20          120  ............  ..................
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900.24(a)                                                 0.3                1           0.3          200           60  ............                 $26
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900.24(a)(2)                                             0.15                1          0.15          100           15  ............                 $13
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[[Page 55490]]

 
900.24(b)                                                 1.2                1           1.2           30           36  ............  ..................
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900.24(b)(1)                                              0.3                1           0.3          200           60  ............                 $26
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900.24(b)(3)                                             0.15                1          0.15          100           15  ............                 $13
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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         0.25          175  ............  ..................
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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\1\
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                                                                                                                                                Total
                                                    Number of            Annual      Total Annual    Hours per      Total         Total      Operating &
                 CFR Section                      Recordkeepers       Frequency of      Records    Recordkeeper     Hours        Capital     Maintenance
                                                                     Recordkeeping                                                Costs         Costs
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900.4(g)                                                         6                1             6             1            6  ............  ............
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900.12(a)(1)(i)(B)(2)                                           89                1            89             8          712  ............  ............
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900.12(a)(4)                                                 8,840                4        35,360             1       35,360  ............  ............
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900.12(c)(4)                                                 8,840                1         8,840             1        8,840       $25,000  ............
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900.12(e)(13)                                                8,840               52       459,680         0.083       38,154  ............  ............
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900.12(f)                                                    8,840                1         8,840            16      141,440  ............  ............
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900.12(h)(2)                                                 8,840                2        17,680             1       17,680  ............  ............
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900.22(a)                                                        6                1             6             1            6  ............  ............
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900.22(d)                                                        6                1             6             1            6  ............  ............
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900.22(e)                                                        6                1             6             1            6  ............  ............
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900.22(f)                                                        3                1             3             1            3  ............  ............
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900.22(g)                                                        6                1             6             1            6  ............           $60
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900.25(b)                                                        6                1             6             1            6  ............  ............
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Total                                         ....................  ...............  ............  ............      242,225       $25,000           $60
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    This request for OMB approval now serves to consolidate previously 
approved 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), 900.12(c)(3), and 
900.3(f)(1).
    The following regulations were not included in the previously 
mentioned 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: 21 CFR 900.3(c), 
900.11(b)(1), 900.11(b)(2), and 900.24(c).

    Dated: September 15, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 06-8027 Filed 9-21-06; 8:45 am]
BILLING CODE 4160-01-S