
[Federal Register Volume 78, Number 127 (Tuesday, July 2, 2013)]
[Notices]
[Pages 39731-39734]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-15790]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 August 
1, 2013.

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 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.

Mammography Quality Standards Act Requirements--(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 (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 1 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.

[[Page 39732]]

    In the Federal Register of February 28, 2013 (78 FR 13681), 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
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                               Total
                                                       Number of       Number of     Total annual       Average       Total      Total      operating &
       Activity/21 CFR section/form FDA No.           respondents    responses per     responses      burden per    hours \1\   capital     maintenance
                                                                      respondent                       response                  costs         costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Notification of intent to become an AB--                      0.33               1            0.33               1          1  .........  ..............
 900.3(b)(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--                       0.1               1             0.1              30          3  .........  ..............
 900.3(d)(5)......................................
Letter of intent to relinquish accreditation                   0.1               1             0.1               1          1  .........  ..............
 authority--900.3(e)..............................
Summary report describing all facility                         330               1             330               7      2,310  .........         $77,600
 assessments--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--                     5             200            1000           0.083         83     30,000  ..............
 900.22(h)........................................
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                               Total
                                                       Number of       Number of     Total annual   Average burden    Total      Total      operating &
              Activity/21 CFR section                recordkeepers    records per       records           per       hours \1\   capital     maintenance
                                                                     recordkeeper                    recordkeeping               costs         costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
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).......................

[[Page 39733]]

 
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--                      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 review--                    5               1               5               1          5  .........  ..............
 900.22(f)........................................
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Total hours have been rounded.


                                                  Table 3--Estimated Annual Third-Party Disclosures \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                               Total
                                                                  Number of       Number of     Total annual   Average burden    Total      operating &
                   Activity/21 CFR section                       respondents     disclosures     disclosures   per disclosure  hours \2\    maintenance
                                                                               per respondent                                                  costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
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  ..............
 900.11(b)(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  ..............
 900.11(b)(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 900.11(b)(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)...................................
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\--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 \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)................................................
                                                              ------------------------------------------------------------------------------------------

[[Page 39734]]

 
    Total....................................................  ..............  ..............  ..............  ..............  3,691,842      24,259,921
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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: June 25, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-15790 Filed 7-1-13; 8:45 am]
BILLING CODE 4160-01-P


