[Federal Register Volume 81, Number 161 (Friday, August 19, 2016)]
[Notices]
[Pages 55463-55466]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-19808]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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 
September 19, 2016.

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 emailed to [email protected]. 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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, Three White Flint North,10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, [email protected].

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.

Mammography Quality Standards Act Requirements--21 CFR Part 900, OMB 
Control Number 0910-0309--Extension

    The Mammography Quality Standards Act (Pub. L. 102-539) 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 (3) and 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 1 hour, it has been 
rounded to 1 hour. All other ``Total Hours'' have been rounded to the 
nearest whole number.)

[[Page 55464]]

    We do not expect any respondents for Sec.  900.3(c) because all 
four ABs are approved until April 2020.
    In the Federal Register of June 8, 2016 (81 FR 36924), 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
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                                                                                                                                               Total
                                                                       Number of                    Average                     Total      operating and
         Activity/21 CFR Section/Form FDA No.            Number of     responses   Total annual    burden per   Total hours    capital      maintenance
                                                        respondents       per        responses      response        \1\       costs (in     costs  (in
                                                                      respondent                                               dollars)      dollars)
--------------------------------------------------------------------------------------------------------------------------------------------------------
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\--                  0.33             1          0.33        320              106       10,000  ..............
 900.3(b)(3).........................................
Application for approval as an AB; limited \3\--               5                1          5            30              150  ...........  ..............
 900.3(b)(3).........................................
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                   0.1              1          0.1           1                1  ...........  ..............
 authority--900.3(e).................................
Summary report describing all facility assessments--         330                1        330             7            2,310  ...........          77,600
 900.4(f)............................................
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  ...........  ..............
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--                0.1              1          0.1          30                3  ...........  ..............
 900.21(c)(2)........................................
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--Form FDA 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
                                                               Number of                      Average                      Total capital   operating and
          Activity/21 CFR Section              Number of      records per    Total annual    burden per     Total hours      costs (in      maintenance
                                             recordkeepers   recordkeeper      records     recordkeeping        \1\          dollars)       costs  (in
                                                                                                                                             dollars)
--------------------------------------------------------------------------------------------------------------------------------------------------------
AB transfer of facility records--                      0.1               1            0.1          0                   1  ..............  ..............
 900.3(f)(1)...............................

[[Page 55465]]

 
Consumer complaints system; AB--900.4(g)...            5                 1            5            1                   5  ..............  ..............
Documentation of interpreting physician               87                 1           87            8                 696  ..............  ..............
 initial requirements--
 900.12(a)(1)(i)(B)(2).....................
Documentation of interpreting physician            8,654                 4       34,616            1              34,616  ..............  ..............
 personnel 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--                8,654                52      450,008            0.083          37,351  ..............  ..............
 900.12(e)(13).............................
Audit program--900.12(f)...................        8,654                 1        8,654           16             138,464  ..............  ..............
Consumer complaints system; facility--             8,654                 2       17,308            1              17,308  ..............  ..............
 900.12(h)(2)..............................
Certification agency conflict of interest--            5                 1            5            1                   5  ..............  ..............
 900.22(a).................................
Processes for suspension and revocation of             5                 1            5            1                   5  ..............  ..............
 certificates--900.22(d)...................
Processes for appeals--900.22(e)...........            5                 1            5            1                   5  ..............  ..............
Processes for additional mammography                   5                 1            5            1                   5  ..............  ..............
 review--900.22(f).........................
Processes for patient notifications--                  3                 1            3            1                   3  ..............              30
 900.22(g).................................
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.


                                               Table 3--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                               Total
                                                                              Number of                       Average                      operating and
                  Activity/21 CFR Section                      Number of   disclosures per   Total annual    burden per     Total hours     maintenance
                                                              respondents     respondent     disclosures     disclosure         \2\         costs  (in
                                                                                                                                             dollars)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Notification of facilities that AB relinquishes its                  0.1                 1           0.1         200                  20              50
 accreditation--900.3(f)(2)................................
Clinical images; facility \3\--900.4(c), 900.11(b)(1) and        2,885                   1       2,885             1.44            4,154  ..............
 (2).......................................................
Clinical images; AB \4\--900.4(c)..........................          5                   1           5           416               2,080         230,773
Phantom images; facility \3\--900.4(d), 900.11(b)(1) and         2,885                   1       2,885             0.72            2,077  ..............
 (2).......................................................
Phantom images; AB \4\--900.4(d)...........................          5                   1           5           208               1,040  ..............
Annual equipment evaluation and survey; facility \3\--           8,654                   1       8,654             1               8,654           8,654
 900.4(e), 900.11(b)(1) and (2)............................
Annual equipment evaluation and survey; AB \4\--900.4(e)...          5                   1           5         1,730               8,650  ..............
Provisional mammography facility certificate extension               0                   1           0             0.5                 1  ..............
 application--900.11(b)(3).................................

[[Page 55466]]

 
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  44,055,590             0.083       3,652,464  ..............
Lay summary of examination; patient refusal \5\--                   87                   1          87             0.5                44  ..............
 900.12(c)(2)..............................................
Report of unresolved serious complaints--900.12(h)(4)......         20                   1          20             1                  20  ..............
Information regarding compromised quality; facility \3\--           20                   1          20           200               4,000             300
 900.12(j)(1)..............................................
Information regarding compromised quality; AB \4\--                 20                   1          20           320               6,400             600
 900.12(j)(1)..............................................
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--               0.15                1           0.15        100                  15           25.50
 900.24(a)(2)..............................................
Notification of probationary status--900.24(b)(1)..........          0.3                 1           0.3         200                  60              51
Notification of loss of approval; minor deficiencies--               0.15                1           0.15        100                  15           25.50
 900.24(b)(3)..............................................
                                                            --------------------------------------------------------------------------------------------
    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.
\3\ Refers to the facility component of the burden for this requirement.
\4\ Refers to the AB 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.


    Dated: August 15, 2016.
Peter Lurie,
Associate Commissioner for Public Health Strategy and Analysis.
[FR Doc. 2016-19808 Filed 8-18-16; 8:45 am]
 BILLING CODE 4164-01-P