Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Mammography Quality Standards Act Requirements, 42931-42934 [2019-17734]
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Federal Register / Vol. 84, No. 160 / Monday, August 19, 2019 / Notices
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Dated: August 13, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–17703 Filed 8–16–19; 8:45 am]
BILLING CODE 4164–01–P
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.
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 oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0309. Also
SUMMARY:
PO 00000
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42931
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, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
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 FDAapproved 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
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Federal Register / Vol. 84, No. 160 / Monday, August 19, 2019 / Notices
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
jspears on DSK3GMQ082PROD with NOTICES
Activity/21 CFR section/FDA
Form No.
Notification of intent to become
an AB—900.3(b)(1).
Application for approval as an
AB; full 2—900.3(b)(3).
Application for approval as an
AB; limited 3—900.3(b)(3).
AB renewal of approval—900.3(c)
AB application deficiencies—
900.3(d)(2).
AB resubmission of denied applications—900.3(d)(5).
Letter of intent to relinquish accreditation authority—900.3(e).
Summary report describing all facility assessments—900.4(f).
AB reporting to FDA; facility 4—
900.4(h).
AB reporting to FDA; AB 5—
900.4(h).
AB financial records—900.4(i)(2)
Former AB new application—
900.6(c)(1).
Reconsideration of accreditation
following appeal—
900.15(d)(3)(ii).
Application for alternative standard—900.18(c).
Alternative standard amendment—900.18(e).
Certification agency application—
900.21(b).
Certification agency application
deficiencies—900.21(c)(2).
Certification electronic data transmission—900.22(h).
Changes to standards—900.22(i)
Certification agency minor deficiencies—900.24(b).
Appeal of adverse action taken
by FDA—900.25(a).
Inspection fee exemption—Form
FDA 3422.
VerDate Sep<11>2014
16:29 Aug 16, 2019
Number of
responses per
respondent
Number of
respondents
Total annual
responses
Average burden
per response
Total hours 1
Total
capital costs
Total
operating and
maintenance
costs
0.33
1
0.33
1 ..................................
1
........................
..........................
0.33
1
0.33
320 ..............................
106
$10,776
..........................
5
1
5
30 ................................
150
........................
..........................
1
0.1
1
1
1
0.1
15 ................................
30 ................................
15
3
........................
........................
..........................
..........................
0.1
1
0.1
30 ................................
3
........................
..........................
0.1
1
0.1
1 ..................................
1
........................
..........................
330
1
330
7 ..................................
2,310
........................
$83,618
8,654
1
8,654
1 ..................................
8,654
........................
4,663
5
1
5
10 ................................
50
........................
..........................
1
0.1
1
1
1
0.1
16 ................................
60 ................................
16
6
........................
........................
..........................
..........................
1
1
1
2 ..................................
2
........................
..........................
2
1
2
2 ..................................
4
........................
..........................
10
1
10
1 ..................................
10
........................
..........................
0.33
1
0.33
320 ..............................
106
32,327
224
0.1
1
0.1
30 ................................
3
........................
..........................
5
200
1,000
0.083 (5 minutes) .......
83
........................
..........................
2
1
1
1
2
1
30 ................................
30 ................................
60
30
........................
........................
22
..........................
0.2
1
0.2
16 ................................
3
........................
..........................
700
1
700
0.25 (15 minutes) .......
175
........................
..........................
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Federal Register / Vol. 84, No. 160 / Monday, August 19, 2019 / Notices
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1—Continued
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average burden
per response
........................
..........................
........................
.....................................
Activity/21 CFR section/FDA
Form No.
Total ......................................
Total hours 1
11,791
Total
operating and
maintenance
costs
Total
capital costs
43,103
88,527
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
Number of
recordkeepers
Activity/21 CFR section
AB transfer of facility records—
900.3(f)(1).
Consumer complaints system;
AB—900.4(g).
Documentation of interpreting physician initial requirements—
900.12(a)(1)(i)(B)(2).
Documentation of interpreting physician personnel requirements—
900.12(a)(4).
Permanent medical record—
900.12(c)(4).
Procedures for cleaning equipment—900.12(e)(13).
Audit program—900.12(f) ...............
Consumer complaints system; facility—900.12(h)(2).
Certification agency conflict of interest—900.22(a).
Processes for suspension and revocation of certificates—900.22(d).
Processes for appeals—900.22(e)
Processes for additional mammography review—900.22(f).
Processes for patient notifications—900.22(g).
Evaluation of certification agency—
900.23.
Appeals—900.25(b) .......................
Total ........................................
1 Total
Number of
records per
recordkeeper
Total annual
records
Average burden
per recordkeeping
Total hours 1
Total
capital costs
Total
operating and
maintenance
costs
0.1
1
0.1
0 ..................................
1
........................
..........................
5
1
5
1 ..................................
5
........................
..........................
87
1
87
8 ..................................
696
........................
..........................
8,654
4
34,616
1 ..................................
34,616
........................
..........................
8,654
1
8,654
1 ..................................
8,654
$30,171
..........................
8,654
52
450,008
0.083 (5 minutes) .......
37,351
........................
..........................
8,654
8,654
1
2
8,654
17,308
16 ................................
1 ..................................
138,464
17,308
........................
........................
..........................
..........................
5
1
5
1 ..................................
5
........................
..........................
5
1
5
1 ..................................
5
........................
..........................
5
5
1
1
5
5
1 ..................................
1 ..................................
5
5
........................
........................
..........................
..........................
3
1
3
1 ..................................
3
........................
$32
5
1
5
20 ................................
100
........................
..........................
5
1
5
1 ..................................
5
........................
..........................
........................
........................
........................
.....................................
237,223
30,171
32
hours have been rounded.
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
jspears on DSK3GMQ082PROD with NOTICES
Notification of facilities that AB relinquishes its accreditation—900.3(f)(2).
Clinical images; facility 3—900.4(c), 900.11(b)(1),
and 900.11(b)(2).
Clinical images; AB 4—900.4(c) ...............................
Phantom images; facility 3—900.4(d), 900.11(b)(1),
and 900.11(b)(2).
Phantom images; AB 4—900.4(d) ............................
Annual equipment evaluation and survey; facility 3—900.4(e), 900.11(b)(1), and 900.11(b)(2).
Annual equipment evaluation and survey; AB 4—
900.4(e).
Provisional mammography facility certificate extension application—900.11(b)(3).
Mammography facility certificate reinstatement application—900.11(c).
Lay summary of examination—900.12(c)(2) ............
Lay summary of examination; patient refusal 5—
900.12(c)(2).
Report of unresolved serious complaints—
900.12(h)(4).
Information regarding compromised quality; facility 3—900.12(j)(1).
VerDate Sep<11>2014
16:29 Aug 16, 2019
Number of
disclosures
per respondent
Number of
respondents
Activity/21 CFR section
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PO 00000
Total annual
disclosures
Average burden
per disclosure
Total hours 2
Total
operating and
maintenance
costs
0.1
1
0.1
200 ..............................
20
$54
2,885
1
2,885
1.44 .............................
4,154
248,670
5
2,885
1
1
5
2,885
416 ..............................
0.72 (43 minutes) .......
2,080
2,077
..........................
..........................
5
8,654
1
1
5
8,654
208 ..............................
1 ..................................
1,040
8,654
..........................
9,325
5
1
5
1,730 ...........................
8,650
..........................
0
1
0
0.5 (30 minutes) .........
1
..........................
312
1
312
5 ..................................
1,560
..........................
8,654
87
5,085
1
44,055,590
87
0.083 (5 minutes) .......
0.5 (30 minutes) .........
3,652,464
44
25,861,265
..........................
20
1
20
1 ..................................
20
..........................
20
1
20
200 ..............................
4,000
324
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Federal Register / Vol. 84, No. 160 / Monday, August 19, 2019 / Notices
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1—Continued
Number of
disclosures
per respondent
Number of
respondents
Activity/21 CFR section
Information regarding compromised quality; AB 4—
900.12(j)(1).
Patient notification of serious risk—900.12(j)(2) ......
Reconsideration of accreditation—900.15(c) ...........
Notification of requirement to correct major deficiencies—900.24(a).
Notification of loss of approval; major deficiencies—900.24(a)(2).
Notification of probationary status—900.24(b)(1) ....
Notification of loss of approval; minor deficiencies—900.24(b)(3).
Total ..................................................................
Total annual
disclosures
Average burden
per disclosure
Total hours 2
Total
operating and
maintenance
costs
20
1
20
320 ..............................
6,400
646
5
5
0.4
1
1
1
5
5
0.4
100 ..............................
2 ..................................
200 ..............................
500
10
80
20,878
..........................
73
0.15
1
0.15
100 ..............................
15
27
0.3
0.15
1
1
0.3
0.15
200 ..............................
100 ..............................
60
15
55
27
........................
..........................
........................
.....................................
3,691,842
26,141,344
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 § 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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Tick-Borne Disease
Working Group
Office of the Assistant
Secretary for Health, Office of the
Secretary, Department of Health and
Human Services.
ACTION: Notice.
AGENCY:
As stipulated by the Federal
Advisory Committee Act, the
Department of Health and Human
Services (HHS) is hereby giving notice
that the Tick-Borne Disease Working
Group (TBDWG) will hold a meeting.
The meeting will be open to the public.
For this meeting, the Working Group
will receive updates from the eight
subcommittees formed at the June 4,
2019, meeting and continue to focus on
plans to develop the next report to the
jspears on DSK3GMQ082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
16:29 Aug 16, 2019
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HHS Secretary and Congress on federal
tick-borne activities and research, taking
into consideration the 2018 report. The
2020 report will address a wide range of
federal activities and research related to
tick-borne diseases, such as,
surveillance, prevention, diagnosis,
diagnostics, and treatment; identify gaps
in tick-borne disease research; and
provide recommendations to the HHS
Secretary regarding changes or
improvements to such activities and
research. In developing the report, the
TBDWG will solicit stakeholder input.
DATES: The meeting will be online via
webcast and will be held on September
12, 2019, from 8:30 a.m. to 5 p.m. ET
(times are tentative and subject to
change). The confirmed times and
agenda items for the meeting will be
posted on the website for the TBDWG at
https://www.hhs.gov/ash/advisorycommittees/tickbornedisease/meetings/
2019-9-12/ when this
information becomes available.
ADDRESSES: Members of the public may
also attend the meeting via webcast.
Instructions for attending the virtual
meeting will be posted one week prior
to the meeting at https://www.hhs.gov/
ash/advisory-committees/
tickbornedisease/meetings/2019-9-12/
index.html.
FOR FURTHER INFORMATION CONTACT:
James Berger, Designated Federal Officer
for the TBDWG; Office of Infectious
Disease and HIV/AIDS Policy, Office of
the Assistant Secretary for Health,
Department of Health and Human
Services, Mary E Switzer Building, 330
C Street SW, Suite L100, Washington,
DC 20024. Email: tickbornedisease@
hhs.gov; Phone: 202–795–7697.
SUPPLEMENTARY INFORMATION: The
public will have an opportunity to
present their views to the TBDWG
PO 00000
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Sfmt 9990
during the meeting’s public comment
session or by submitting their views in
writing. Comments should be pertinent
to the meeting discussion. Persons who
wish to provide verbal or written public
comment should review instructions at
https://www.hhs.gov/ash/advisorycommittees/tickbornedisease/meetings/
2019-9-12/ and respond by
midnight Wednesday, September 4,
2019, ET. Verbal comments will be
limited to three minutes each to
accommodate as many speakers as
possible during the 30 minute session.
Written public comments will be
accessible to the TBDWG members and
public on the TBDWG web page prior to
the meeting.
Background and Authority: The TickBorne Disease Working Group was
established on August 10, 2017, in
accordance with Section 2062 of the
21st Century Cures Act, and the Federal
Advisory Committee Act, 5 U.S.C. App.,
as amended, to provide expertise and
review federal efforts related to tickborne diseases to help ensure
interagency coordination and minimize
overlap, examine research priorities,
and identify and address unmet needs.
The TBDWG is required to submit a
report to the HHS Secretary and
Congress on their findings and any
recommendations for the federal
response to tick-borne disease every two
years.
Dated: August 6, 2019.
James Berger,
Designated Federal Officer, Tick-Borne
Disease Working Group, Senior Advisor for
Blood and Tissue Policy, Office of Infectious
Disease and HIV/AIDS Policy.
[FR Doc. 2019–17689 Filed 8–16–19; 8:45 am]
BILLING CODE 4150–28–P
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]]>Agencies
[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]
-----------------------------------------------------------------------
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) 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.
---------------------------------------------------------------------------------------------------------------------------
[[Page 42933]]
Total................... .............. ............... .............. ........................ 11,791 43,103 88,527
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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
