[Federal Register Volume 87, Number 153 (Wednesday, August 10, 2022)]
[Notices]
[Pages 48678-48681]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-17151]


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

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.

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

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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 information collection 
associated with the Mammography Quality Standards Act.

DATES: Either electronic or written comments on the collection of 
information must be submitted by October 11, 2022.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of October 11, 2022. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are received 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

[[Page 48679]]

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, 240-402-7500.
     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.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the 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, 240-402-7500.

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, 
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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; standards for accreditation and certification 
bodies for mammography facilities; and standards for mammography 
equipment, personnel, and practices, including quality assurance. 
Implementing regulations are found in part 900 (21 CFR part 900). The 
regulations are intended 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.
    FDA meets with its National Mammography Quality Assurance Advisory 
Committee (NMQAAC) for the purposes of advising FDA's mammography 
program on advances in mammography technology and procedures and on 
appropriate quality standards for mammography facilities. NMQAAC is 
made up of representatives of the mammography community, consumer and 
industry groups, and government. The meetings are open to the public 
and time is allotted for public statements on issues of concern in the 
mammography field. The chairperson may also call upon attendees to 
contribute to the committee discussions.
    FDA also regularly meets or holds teleconferences with its approved 
accreditation bodies and State certification agencies to discuss issues 
of mutual concern. We also engage with the Conference of State 
Radiation Program Directors (CRCPD), a professional organization of 
State agencies concerned with radiation protection. The CRCPD has 
established a standing Mammography Committee,

[[Page 48680]]

which meets with FDA mammography staff at least once a year.
    Finally, in recent years, FDA mammography staff have met several 
times with representatives of manufacturers working on the new 
applications of digital technology in mammography to resolve problems 
preventing the making of that technology generally available. FDA 
mammography staff have also worked with representatives of the 
manufacturers to develop quality assurance manuals for full field 
digital mammography units.
    We estimate the burden of this collection of information as 
follows:

                                                       Table 1--Estimated Annual Reporting Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                    Number of
      Activity/21 CFR section/FDA form No.          Number of     responses per   Total annual         Average burden  per response         Total hours
                                                   respondents     respondent       responses                                                   \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
 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)...............               1               1               1  15.....................................              15
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
 assessments--900.4(f).
AB reporting to FDA; facility \4\--900.4(h)....           8,718               1           8,718  1......................................           8,718
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                    1               1               1  2......................................               2
 appeal--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
Certification agency application deficiencies--             0.1               1             0.1  30.....................................               3
 900.21(c)(2).
Certification electronic data transmission--                  5             200           1,000  0.083 (5 minutes)......................              83
 900.22(h).
Changes to standards--900.22(i)................               2               1               2  30.....................................              60
Certification agency minor deficiencies--                     1               1               1  30.....................................              30
 900.24(b).
Appeal of adverse action taken by FDA--                     0.2               1             0.2  16.....................................               3
 900.25(a).
Inspection fee exemption--FDA Form 3422........             419               1             419  0.25 (15 minutes)......................             105
                                                --------------------------------------------------------------------------------------------------------
    Total......................................  ..............  ..............  ..............  .......................................          11,785
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Numbers 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
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                    Number of
            Activity/21 CFR section                 Number of      records per    Total annual       Average burden per recordkeeping       Total hours
                                                  recordkeepers   recordkeeper       records                                                    \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
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                   8,718               4          34,872  1......................................          34,872
 personnel requirements--900.12(a)(4).
Permanent medical record--900.12(c)(4).........           8,718               1           8,718  1......................................           8,718
Procedures for cleaning equipment--                       8,718              52         453,336  0.083 (5 minutes)......................          37,627
 900.12(e)(13).
Audit program--900.12(f).......................           8,718               1           8,718  16.....................................         139,488
Consumer complaints system; facility--                    8,718               2          17,436  1......................................          17,436
 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 review--                 5               1               5  1......................................               5
 900.22(f).
Processes for patient notifications--900.22(g).               3               1               3  1......................................               3
Evaluation of certification agency--900.23.....               5               1               5  20.....................................             100
Appeals--900.25(b).............................               5               1               5  1......................................               5
                                                --------------------------------------------------------------------------------------------------------

[[Page 48681]]

 
    Total......................................  ..............  ..............  ..............  .......................................         238,971
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Total hours have been rounded.


                                                 Table 3--Estimated Annual Third-Party Disclosure Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                    Number of
                                                    Number of      disclosures    Total annual                                              Total hours
            Activity/21 CFR section                respondents         per         disclosures        Average burden per disclosure             \1\
                                                                   respondent
--------------------------------------------------------------------------------------------------------------------------------------------------------
Notification of facilities that AB relinquishes             0.1               1             0.1  200....................................              20
 its accreditation--900.3(f)(2).
Clinical images; facility \2\--900.4(c),                  2,885               1           2,885  1.44...................................           4,154
 900.11(b)(1), and 900.11(b)(2).
Clinical images; AB \3\--900.4(c)..............               5               1               5  416....................................           2,080
Phantom images; facility \2\--900.4(d),                   2,885               1           2,885  0.72 (43 minutes)......................           2,077
 900.11(b)(1), and 900.11(b)(2).
Phantom images; AB \3\--900.4(d)...............               5               1               5  208....................................           1,040
Annual equipment evaluation and survey;                   8,718               1           8,718  1......................................           8,718
 facility \2\--900.4(e), 900.11(b)(1), and
 900.11(b)(2).
Annual equipment evaluation and survey; AB \3\--              5               1               5  1,730..................................           8,650
 900.4(e).
Provisional mammography facility certificate                  0               1               0  0.5 (30 minutes).......................               1
 extension application--900.11(b)(3).
Mammography facility certificate reinstatement              281               1             281  5......................................           1,405
 application--900.11(c).
Lay summary of examination--900.12(c)(2).......           8,718           5,085      44,331,030  0.083 (5 minutes)......................       3,679,475
Lay summary of examination; patient refusal                  87               1              87  0.5 (30 minutes).......................              44
 \4\--900.12(c)(2).
Report of unresolved serious complaints--                    20               1              20  1......................................              20
 900.12(h)(4).
Information regarding compromised quality;                   20               1              20  200....................................           4,000
 facility \2\--900.12(j)(1).
Information regarding compromised quality; AB                20               1              20  320....................................           6,400
 \3\--900.12(j)(1).
Patient notification of serious risk--                        5               1               5  100....................................             500
 900.12(j)(2).
Reconsideration of accreditation--900.15(c)....               5               1               5  2......................................              10
Notification of requirement to correct major                0.4               1             0.4  200....................................              80
 deficiencies--900.24(a).
Notification of loss of approval; major                    0.15               1            0.15  100....................................              15
 deficiencies--900.24(a)(2).
Notification of probationary status--                       0.3               1             0.3  200....................................              60
 900.24(b)(1).
Notification of loss of approval; minor                    0.15               1            0.15  100....................................              15
 deficiencies--900.24(b)(3).
                                                --------------------------------------------------------------------------------------------------------
    Total......................................  ..............  ..............  ..............  .......................................       3,718,764
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Total hours have been rounded.
\2\ Refers to the facility component of the burden for this requirement.
\3\ Refers to the AB component of the burden for this requirement.
\4\ Refers to the situation where a patient specifically does not want to receive the lay summary of her exam.

    Respondents use the Mammography Program Reporting and Information 
System to submit information. Our estimated burden for the information 
collection reflects an overall increase of 28,664 hours and a 
corresponding increase of 9,137,449 responses/records. We attribute 
this adjustment to an increase in the number of submissions we received 
over the last few years. We do not include burden for Sec. Sec.  
900.12(c)(1) and (3), 900.3(f)(1), and 900.24(c) 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, we assume no 
additional reporting burden.

    Dated: August 4, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-17151 Filed 8-9-22; 8:45 am]
BILLING CODE 4164-01-P


