[Federal Register Volume 84, Number 160 (Monday, August 19, 2019)]
[Notices]
[Pages 42931-42934]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-17734]


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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.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by 
September 18, 2019.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0309. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: 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: 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; 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

[[Page 42932]]

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.)
    In the Federal Register of May 1, 2019 (84 FR 18548), FDA published 
a 60-day notice requesting public comment on the proposed collection of 
information. We received one comment that expressed general concern 
regarding the cost and quality of mammography equipment. However, the 
comment did not refer to any particular provision of the regulations or 
the information collection burden estimate. We note that in the Federal 
Register of March 28, 2019 (84 FR 11669), FDA published a proposed rule 
to update the mammography regulations. As part of the proposed rule, 
FDA prepared a Preliminary Economic Analysis of Impacts. Comments 
received on the proposed rule are currently being considered.
    FDA meets with its National Mammography Quality Assurance Advisory 
Committee (NMQAAC) annually. NMQAAC is made up of representatives of 
the mammography community, consumer and industry groups, and 
government. It is charged with advising FDA's mammography program on 
advances in mammography technology and procedures and on appropriate 
quality standards for mammography facilities. NMQAAC also discusses and 
comments on all guidances before they are made final. 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 meets or holds teleconferences several times a year with 
its approved accreditation bodies and State certification agencies to 
discuss issues of mutual concern. The Agency has also long enjoyed a 
good relationship with the Conference of State Radiation Program 
Directors (CRCPD), which is the professional organization of the 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.
    FDA estimates the burden of this collection of information as 
follows:

                                               Table 3--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                              Total
 Activity/21 CFR section/FDA     Number of       Number of      Total annual      Average burden  per      Total hours   Total  capital   operating and
          Form No.              respondents    responses per      responses            response                \1\            costs        maintenance
                                                 respondent                                                                                   costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Notification of intent to               0.33                1            0.33  1.......................               1  ..............  ...............
 become an AB--900.3(b)(1).
Application for approval as             0.33                1            0.33  320.....................             106         $10,776  ...............
 an AB; full \2\--
 900.3(b)(3).
Application for approval as                5                1               5  30......................             150  ..............  ...............
 an AB; limited \3\--
 900.3(b)(3).
AB renewal of approval--                   1                1               1  15......................              15  ..............  ...............
 900.3(c).
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                      0.1                1             0.1  1.......................               1  ..............  ...............
 relinquish accreditation
 authority--900.3(e).
Summary report describing                330                1             330  7.......................           2,310  ..............          $83,618
 all facility assessments--
 900.4(f).
AB reporting to FDA;                   8,654                1           8,654  1.......................           8,654  ..............            4,663
 facility \4\--900.4(h).
AB reporting to FDA; AB \5\--              5                1               5  10......................              50  ..............  ...............
 900.4(h).
AB financial records--                     1                1               1  16......................              16  ..............  ...............
 900.4(i)(2).
Former AB new application--              0.1                1             0.1  60......................               6  ..............  ...............
 900.6(c)(1).
Reconsideration of                         1                1               1  2.......................               2  ..............  ...............
 accreditation following
 appeal--900.15(d)(3)(ii).
Application for alternative                2                1               2  2.......................               4  ..............  ...............
 standard--900.18(c).
Alternative standard                      10                1              10  1.......................              10  ..............  ...............
 amendment--900.18(e).
Certification agency                    0.33                1            0.33  320.....................             106          32,327              224
 application--900.21(b).
Certification agency                     0.1                1             0.1  30......................               3  ..............  ...............
 application deficiencies--
 900.21(c)(2).
Certification electronic                   5              200           1,000  0.083 (5 minutes).......              83  ..............  ...............
 data transmission--
 900.22(h).
Changes to standards--                     2                1               2  30......................              60  ..............               22
 900.22(i).
Certification agency minor                 1                1               1  30......................              30  ..............  ...............
 deficiencies--900.24(b).
Appeal of adverse action                 0.2                1             0.2  16......................               3  ..............  ...............
 taken by FDA--900.25(a).
Inspection fee exemption--               700                1             700  0.25 (15 minutes).......             175  ..............  ...............
 Form FDA 3422.
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[[Page 42933]]

 
    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
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                              Total
                                  Number of       Number of     Total annual      Average burden  per      Total hours   Total  capital   operating and
   Activity/21 CFR section      recordkeepers    records per       records           recordkeeping             \1\            costs        maintenance
                                                recordkeeper                                                                                  costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
AB transfer of facility                   0.1               1             0.1  0.......................               1  ..............  ...............
 records--900.3(f)(1).
Consumer complaints system;                 5               1               5  1.......................               5  ..............  ...............
 AB--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                 8,654              52         450,008  0.083 (5 minutes).......          37,351  ..............  ...............
 equipment--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               5               1               5  1.......................               5  ..............  ...............
 of interest--900.22(a).
Processes for suspension and                5               1               5  1.......................               5  ..............  ...............
 revocation of certificates--
 900.22(d).
Processes for appeals--                     5               1               5  1.......................               5  ..............  ...............
 900.22(e).
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                 5               1               5  20......................             100  ..............  ...............
 agency--900.23.
Appeals--900.25(b)...........               5               1               5  1.......................               5  ..............  ...............
                              --------------------------------------------------------------------------------------------------------------------------
    Total....................  ..............  ..............  ..............  ........................         237,223          30,171               32
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Total hours have been rounded.


                                               Table 3--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                              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).
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).

[[Page 42934]]

 
Information regarding compromised                 20                1              20  320.............................           6,400              646
 quality; AB \4\--900.12(j)(1).
Patient notification of serious                    5                1               5  100.............................             500           20,878
 risk--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: August 12, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-17734 Filed 8-16-19; 8:45 am]
 BILLING CODE 4164-01-P