[Federal Register Volume 78, Number 40 (Thursday, February 28, 2013)]
[Notices]
[Pages 13681-13684]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-04677]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0134]


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

[[Page 13682]]

the estimated reporting, recordkeeping, and third-party disclosure 
burden associated with the Mammography Quality Standards Act 
requirements.

DATES: Submit either electronic or written comments on the collection 
of information by April 29, 2013.

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 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.

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 (AB). This 
requires undergoing a review of their clinical images and providing the 
AB 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 complaint 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) are not included in the burden tables because they 
are 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 burden: 21 CFR 900.12(c)(1) 
and (c)(3) and 21 CFR 900.3(f)(1). Section 900.24(c) was also not 
included in the 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.
    We have rounded numbers in the ``Total Hours'' column in all three 
burden tables. (Where the number was a portion of one hour, it has been 
rounded to 1 hour. All other ``Total Hours'' have been rounded to the 
nearest whole number.)
    We do not expect any respondents for Sec.  900.3(c) because all 
four ABs are approved until April 2020.
    FDA estimates the burden of this collection of information as 
follows:

                                                       Table 1--Estimated Annual Reporting Burden
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                                                                             Number of                                                          Total
                                                                Number of    responses      Total       Average    Total hours     Total     operating &
            Activity/21 CFR Section/FDA Form No.               respondents      per         annual     burden per      \1\        capital    maintenance
                                                                             respondent   responses     response                   costs        costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Notification of intent to become an AB--900.3(b)(1).........          0.33            1         0.33        1                1  ...........  ...........
Application for approval as an AB; full \2\--900.3(b)(3)....          0.33            1         0.33      320              106      $10,000  ...........
Application for approval as an AB; limited \3\--900.3(b)(3).          5               1         5          30              150  ...........  ...........
AB renewal of approval--900.3(c)............................          0               1         0          15                1  ...........  ...........
AB application deficiencies--900.3(d)(2)....................          0.1             1         0.1        30                3  ...........  ...........
AB resubmission of denied applications--900.3(d)(5).........          0.1             1         0.1        30                3  ...........  ...........
Letter of intent to relinquish accreditation authority--              0.1             1         0.1         1                1  ...........  ...........
 900.3(e)...................................................
Summary report describing all facility assessments--900.4(f)        330               1       330           7            2,310  ...........      $77,600
AB reporting to FDA; facility \4\--900.4(h).................      8,654               1     8,654           1            8,654  ...........        4,327
AB reporting to FDA; AB \5\--900.4(h).......................          5               1         5          10               50  ...........  ...........
AB financial records--900.4(i)(2)...........................          1               1         1          16               16  ...........  ...........

[[Page 13683]]

 
Former AB new application--900.6(c)(1)......................          0.1             1         0.1        60                6  ...........  ...........
Reconsideration of accreditation following appeal--                   1               1         1           2                2  ...........  ...........
 900.15(d)(3)(ii)...........................................
Application for alternative standard--900.18(c).............          2               1         2           2                4  ...........  ...........
Alternative standard amendment--900.18(e)...................         10               1        10           1               10  ...........  ...........
Certification agency application--900.21(b).................          0.33            1         0.33      320              106  ...........         $208
Certification agency application deficiencies--900.21(c)(2).          0.1             1         0.1        30                3  ...........  ...........
Certification electronic data transmission--900.22(h).......          5             200      1000           0.083           83      $30,000  ...........
Changes to standards--900.22(i).............................          2               1         2          30               60  ...........          $20
Certification agency minor deficiencies--900.24(b)..........          1               1         1          30               30  ...........  ...........
Appeal of adverse action taken by FDA--900.25(a)............          0.2             1         0.2        16                3  ...........  ...........
Inspection fee exemption--FDA Form 3422.....................        700               1       700           0.25           175  ...........  ...........
                                                             -------------------------------------------------------------------------------------------
    Total...................................................  ............  ...........  ...........  ...........       11,777       40,000       82,155
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\1\ Total hours have been rounded.
\2\ One time burden.
\3\ Refers to accreditation bodies applying to accredit specific full-field digital mammography units.
\4\ Refers to the facility component of the burden for this requirement.
\5\ Refers to the AB component of the burden for this requirement.


                                                     Table 2--Estimated Annual Recordkeeping Burden
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                                                                                                                                                Total
                                                                             No. of        Total       Average                     Total      operating
                 Activity/21 CFR Section                       No. of      records per    annual      burden per   Total hours    capital        and
                                                           recordkeepers  recordkeeper    records   recordkeeping      \1\         costs     maintenance
                                                                                                                                                costs
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AB transfer of facility records--900.3(f)(1).............            0.1             1         0.1         0                 1  ...........  ...........
Consumer complaints system; AB--900.4(g).................            5               1         5           1                 5  ...........  ...........
Documentation of interpreting physician initial                     87               1        87           8               696  ...........  ...........
 requirements--900.12(a)(1)(i)(B)(2).....................
Documentation of interpreting physician personnel                8,654               4    34,616           1            34,616  ...........  ...........
 requirements--900.12(a)(4)..............................
Permanent medical record--900.12(c)(4)...................        8,654               1     8,654           1             8,654      $28,000  ...........
Procedures for cleaning equipment--900.12(e)(13).........        8,654              52   450,008           0.083        37,351  ...........  ...........
Audit program--900.12(f).................................        8,654               1     8,654          16           138,464  ...........  ...........
Consumer complaints system; facility--900.12(h)(2).......        8,654               2    17,308           1            17,308  ...........  ...........
Certification agency conflict of interest--900.22(a).....            5               1         5           1                 5  ...........  ...........
Processes for suspension and revocation of certificates--            5               1         5           1                 5  ...........  ...........
 900.22(d)...............................................
Processes for appeals--900.22(e).........................            5               1         5           1                 5  ...........  ...........
Processes for additional mammography review--900.22(f)...            5               1         5           1                 5  ...........  ...........
Processes for patient notifications--900.22(g)...........            3               1         3           1                 3  ...........          $30
Evaluation of certification agency--900.23...............            5               1         5          20               100  ...........  ...........
Appeals--900.25(b).......................................            5               1         5           1                 5  ...........  ...........
                                                          ----------------------------------------------------------------------------------------------
    Total................................................  .............  ............  ..........  .............      237,223       28,000           30
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\1\ Total hours have been rounded.


[[Page 13684]]


                                                  Table 3--Estimated Annual Third-Party Disclosures \1\
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                                                                                    Number of                                                  Total
                                                                       Number of   disclosures   Total annual     Average    Total hours   operating and
                      Activity/21 CFR Section                         respondents      per        disclosures    burden per      \2\        maintenance
                                                                                    respondent                   disclosure                    costs
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Notification of facilities that AB relinquishes its accreditation--          0.1             1            0.1       200               20             $50
 900.3(f)(2).......................................................
Clinical images; facility \2\--900.4(c), 900.11(b)(1), and               2,885               1        2,885           1.44         4,154  ..............
 900.11(b)(2)......................................................
Clinical images; AB \3\--900.4(c)..................................          5               1            5         416            2,080         230,773
Phantom images; facility \2\--900.4(d), 900.11(b)(1), and                2,885               1        2,885           0.72         2,077  ..............
 900.11(b)(2)......................................................
Phantom images; AB \3\--900.4(d)...................................          5               1            5         208            1,040  ..............
Annual equipment evaluation and survey; facility \2\--900.4(e),          8,654               1        8,654           1            8,654           8,654
 900.11(b)(1), and 900.11(b)(2)....................................
Annual equipment evaluation and survey; AB \3\--900.4(e)...........          5               1            5       1,730            8,650  ..............
Provisional mammography facility certificate extension application--         0               1            0           0.5              1  ..............
 900.11(b)(3)......................................................
Mammography facility certificate reinstatement application--               312               1          312           5            1,560      24,000,000
 900.11(c).........................................................
Lay summary of examination--900.12(c)(2)...........................      8,654           5,085   44,005,590           0.083    3,652,464  ..............
Lay summary of examination; patient refusal \4\--900.12(c)(2)......         87               1           87           0.5             44  ..............
Report of unresolved serious complaints--900.12(h)(4)..............         20               1           20           1               20  ..............
Information regarding compromised quality; facility \2\--                   20               1           20         200            4,000             300
 900.12(j)(1)......................................................
Information regarding compromised quality; AB \3\--900.12(j)(1)....         20               1           20         320            6,400             600
Patient notification of serious risk--900.12(j)(2).................          5               1            5         100              500          19,375
Reconsideration of accreditation--900.15(c)........................          5               1            5           2               10  ..............
Notification of requirement to correct major deficiencies--                  0.4             1            0.4       200               80              68
 900.24(a).........................................................
Notification of loss of approval; major deficiencies--900.24(a)(2).          0.15            1            0.15      100               15           25.50
Notification of probationary status--900.24(b)(1)..................          0.3             1            0.3       200               60              51
Notification of loss of approval; minor deficiencies--900.24(b)(3).          0.15            1            0.15      100               15           25.50
                                                                    ------------------------------------------------------------------------------------
    Total..........................................................  ............  ...........  ..............  ...........    3,691,842      24,259,921
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\1\ There are no capital costs associated with this collection of information.
\2\ Total hours have been rounded.


    Dated: February 22, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-04677 Filed 2-27-13; 8:45 am]
BILLING CODE 4160-01-P