[Federal Register Volume 87, Number 204 (Monday, October 24, 2022)]
[Notices]
[Pages 64232-64234]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-23028]


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

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 or we) 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: Submit written comments (including recommendations) on the 
collection of information by November 23, 2022.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0309. Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Mammography Quality Standards Act Requirements--21 CFR Part 900

OMB Control Number 0910-0309--Extension

    The Mammography Quality Standards Act (Pub. L. 102-539) requires 
the establishment of a Federal certification and inspection program for 
mammography facilities; 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, 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.

[[Page 64233]]

    In the Federal Register of August 8, 2022 (87 FR 48678), we 
published a notice soliciting public comment of the proposed 
information collection. No comments were received.
    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                   5               1               5  30......................................             150
 \3\--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--                       2               1               2  2.......................................               4
 900.18(c).
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                     87               1              87  8.......................................             696
 initial 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
                                               ---------------------------------------------------------------------------------------------------------
    Total.....................................  ..............  ..............  ..............  ........................................         238,971
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Total hours have been rounded.


[[Page 64234]]


                                                 Table 3--Estimated Annual Third-Party Disclosure Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                   Number of
            Activity/21 CFR section                Number of      disclosures    Total annual         Average burden per disclosure         Total hours
                                                  respondents   per respondent    disclosures                                                   \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Notification of facilities that AB                         0.1               1             0.1  200.....................................              20
 relinquishes 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                   5               1               5  1,730...................................           8,650
 \3\--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: October 18, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-23028 Filed 10-21-22; 8:45 am]
BILLING CODE 4164-01-P