[Federal Register Volume 81, Number 110 (Wednesday, June 8, 2016)]
[Notices]
[Pages 36924-36928]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-13522]


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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 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 August 8, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your

[[Page 36925]]

comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2013-N-0134 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Mammography Quality Standards Act 
Requirements.'' Received comments will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at http://www.regulations.gov or at the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [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 (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.)
    We do not expect any respondents for Sec.  900.3(c) because all 
four ABs are approved until April 2020.

[[Page 36926]]

    FDA estimates the burden of this collection of information as 
follows:

                                                       Table 1--Estimated Annual Reporting Burden
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                                                                                                                                               Total
                                                                          Number of       Total       Average                   Total      operating and
         Activity/21 CFR section/FDA form No.             Number of     responses per     annual     burden per     Total      capital      maintenance
                                                         respondents     respondent     responses     response    hours \1\   costs (in      costs (in
                                                                                                                               dollars)      dollars)
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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--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 (FFDM) 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       Total     Average burden                 Total      operating and
              Activity/21 CFR section                  Number of      records per      annual          per          Total      capital      maintenance
                                                     recordkeepers   recordkeeper     records     recordkeeping   hours \1\   costs (in      costs (in
                                                                                                                               dollars)      dollars)
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 36927]]

 
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
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\1\ Total hours have been rounded.


                                               Table 3--Estimated Annual Third-Party Disclosure Burden \1\
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                                                                                                                                               Total
                                                                             Number of                                                     operating and
                 Activity/21 CFR section                     Number of      disclosures    Total annual   Average burden    Total hours     maintenance
                                                            respondents   per respondent    disclosures   per 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)              2,885               1           2,885            1.44           4,154  ..............
 and (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)..............................
Mammography facility certificate reinstatement                       312               1             312               5           1,560      24,000,000
 application--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  ..............

[[Page 36928]]

 
Notification of requirement to correct major                         0.4               1             0.4             200              80              68
 deficiencies--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: June 2, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-13522 Filed 6-7-16; 8:45 am]
 BILLING CODE 4164-01-P