[Federal Register Volume 84, Number 84 (Wednesday, May 1, 2019)]
[Notices]
[Pages 18548-18551]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-08784]


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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 or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(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 July 1, 2019.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before July 1, 2019. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of July 1, 2019. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://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 comments, that information will be posted on https://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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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, those filed in a timely manner (see 
ADDRESSES), will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. 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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the

[[Page 18549]]

electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
PRAStaff@fda.hhs.gov.

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). 21 CFR 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.)
    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       operating
Activity/21 CFR section/FDA Form No.    Number of     responses   Total annual    Average burden per response    Total hours     capital         and
                                       respondents       per        responses                                        \1\          costs      maintenance
                                                     respondent                                                                                 costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Notification of intent to become an           0.33             1          0.33  1.............................             1
 AB--900.3(b)(1).
Application for approval as an AB;            0.33             1          0.33  320...........................           106       $10,776
 full \2\--900.3(b)(3).
Application for approval as an AB;               5             1             5  30............................           150
 limited \3\--900.3(b)(3).
AB renewal of approval--900.3(c)....             1             1             1  15............................            15
AB application deficiencies--                  0.1             1           0.1  30............................             3
 900.3(d)(2).
AB resubmission of denied                      0.1             1           0.1  30............................             3
 applications--900.3(d)(5).
Letter of intent to relinquish                 0.1             1           0.1  1.............................             1
 accreditation authority--900.3(e).
Summary report describing all                  330             1           330  7.............................         2,310  ............       $83,618
 facility assessments--900.4(f).
AB reporting to FDA; facility \4\--          8,654             1         8,654  1.............................         8,654  ............         4,663
 900.4(h).
AB reporting to FDA; AB \5\--                    5             1             5  10............................            50
 900.4(h).
AB financial records--900.4(i)(2)...             1             1             1  16............................            16
Former AB new application--                    0.1             1           0.1  60............................             6
 900.6(c)(1).
Reconsideration of accreditation                 1             1             1  2.............................             2
 following appeal--900.15(d)(3)(ii).
Application for alternative                      2             1             2  2.............................             4
 standard--900.18(c).
Alternative standard amendment--                10             1            10  1.............................            10
 900.18(e).
Certification agency application--            0.33             1          0.33  320...........................           106        32,327           224
 900.21(b).

[[Page 18550]]

 
Certification agency application               0.1             1           0.1  30............................             3
 deficiencies--900.21(c)(2).
Certification electronic data                    5           200          1000  0.083 (5 minutes).............            83
 transmission--900.22(h).
Changes to standards--900.22(i).....             2             1             2  30............................            60  ............            22
Certification agency minor                       1             1             1  30............................            30
 deficiencies--900.24(b).
Appeal of adverse action taken by              0.2             1           0.2  16............................             3
 FDA--900.25(a).
Inspection fee exemption--Form FDA             700             1           700  0.25 (15 minutes).............           175
 3422.
                                     -------------------------------------------------------------------------------------------------------------------
    Total...........................  ............  ............  ............  ..............................        11,791        43,103        88,527
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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                                                                   Total       operating
      Activity/21 CFR section          Number of     records per  Total annual        Average burden per         Total hours     capital         and
                                     recordkeepers  recordkeeper     records             recordkeeping               \1\          costs      maintenance
                                                                                                                                                costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
AB transfer of facility records--              0.1             1           0.1  0.............................             1
 900.3(f)(1).
Consumer complaints system; AB--                 5             1             5  1.............................             5
 900.4(g).
Documentation of interpreting                   87             1            87  8.............................           696
 physician initial requirements--
 900.12(a)(1)(i)(B)(2).
Documentation of interpreting                8,654             4        34,616  1.............................        34,616
 physician personnel requirements--
 900.12(a)(4).
Permanent medical record--                   8,654             1         8,654  1.............................         8,654       $30,171
 900.12(c)(4).
Procedures for cleaning equipment--          8,654            52       450,008  0.083 (5 minutes).............        37,351
 900.12(e)(13).
Audit program--900.12(f)...........          8,654             1         8,654  16............................       138,464
Consumer complaints system;                  8,654             2        17,308  1.............................        17,308
 facility--900.12(h)(2).
Certification agency conflict of                 5             1             5  1.............................             5
 interest--900.22(a).
Processes for suspension and                     5             1             5  1.............................             5
 revocation of certificates--
 900.22(d).
Processes for appeals--900.22(e)...              5             1             5  1.............................             5
Processes for additional                         5             1             5  1.............................             5
 mammography review--900.22(f).
Processes for patient                            3             1             3  1.............................             3  ............           $32
 notifications--900.22(g).
Evaluation of certification agency--             5             1             5  20............................           100
 900.23.
Appeals--900.25(b).................              5             1             5  1.............................             5
                                    --------------------------------------------------------------------------------------------------------------------
    Total..........................  .............  ............  ............  ..............................       237,223        30,171            32
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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       Number of     Total annual                                        Total hours    operating and
       Activity/21 CFR section           respondents     disclosures     disclosures     Average burden per disclosure          \2\         maintenance
                                                       per respondent                                                                          costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Notification of facilities that AB                0.1               1             0.1  200..............................              20             $54
 relinquishes its accreditation--
 900.3(f)(2).
Clinical images; facility \3\--                 2,885               1           2,885  1.44.............................           4,154         248,670
 900.4(c), 900.11(b)(1), and
 900.11(b)(2).
Clinical images; AB \4\--900.4(c)....               5               1               5  416..............................           2,080
Phantom images; facility \3\--                  2,885               1           2,885  0.72 (43 minutes)................           2,077
 900.4(d), 900.11(b)(1), and
 900.11(b)(2).
Phantom images; AB \4\--900.4(d).....               5               1               5  208..............................           1,040
Annual equipment evaluation and                 8,654               1           8,654  1................................           8,654           9,325
 survey; facility \3\--900.4(e),
 900.11(b)(1), and 900.11(b)(2).
Annual equipment evaluation and                     5               1               5  1,730............................           8,650
 survey; AB \4\--900.4(e).

[[Page 18551]]

 
Provisional mammography facility                    0               1               0  0.5 (30 minutes).................               1
 certificate extension application--
 900.11(b)(3).
Mammography facility certificate                  312               1             312  5................................           1,560
 reinstatement application--900.11(c).
Lay summary of examination--                    8,654           5,085      44,055,590  0.083 (5 minutes)................       3,652,464      25,861,265
 900.12(c)(2).
Lay summary of examination; patient                87               1              87  0.5 (30 minutes).................              44
 refusal \5\--900.12(c)(2).
Report of unresolved serious                       20               1              20  1................................              20
 complaints--900.12(h)(4).
Information regarding compromised                  20               1              20  200..............................           4,000             324
 quality; facility \3\--900.12(j)(1).
Information regarding compromised                  20               1              20  320..............................           6,400             646
 quality; AB \4\--900.12(j)(1).
Patient notification of serious risk--              5               1               5  100..............................             500          20,878
 900.12(j)(2).
Reconsideration of accreditation--                  5               1               5  2................................              10
 900.15(c).
Notification of requirement to                    0.4               1             0.4  200..............................              80              73
 correct major deficiencies--
 900.24(a).
Notification of loss of approval;                0.15               1            0.15  100..............................              15              27
 major deficiencies--900.24(a)(2).
Notification of probationary status--             0.3               1             0.3  200..............................              60              55
 900.24(b)(1).
Notification of loss of approval;                0.15               1            0.15  100..............................              15              27
 minor deficiencies--900.24(b)(3).
                                      ------------------------------------------------------------------------------------------------------------------
    Total............................  ..............  ..............  ..............  .................................       3,691,842      26,141,344
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\1\ There are no capital costs associated with the 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.

    FDA has adjusted the number of respondents for Sec.  900.3(c) ``AB 
renewal of approval'' to one. This adjustment resulted in a 14-hour 
increase to the hour-burden estimate. Additionally, we updated the 
capital costs and operating and maintenance costs by adjusting them for 
inflation since the last update to those estimates. This adjustment 
resulted in a $1,893,071 increase to the estimated capital and 
operating and maintenance costs ($24,410,106 previously; $26,303,177 
current extension request).

    Dated: April 24, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-08784 Filed 4-30-19; 8:45 am]
 BILLING CODE 4164-01-P


