Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Mammography Quality Standards Act Requirements, 64232-64234 [2022-23028]
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64232
Federal Register / Vol. 87, No. 204 / Monday, October 24, 2022 / Notices
it satisfies the requirements of the
applicable statutes and regulations.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
II. Paperwork Reduction Act of 1995
Food and Drug Administration
While this draft guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. Therefore, clearance by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3521) is not required for this guidance.
The previously approved collections of
information are subject to review by
OMB under the PRA. The collections of
information for the submission of
ANDAs have been approved under OMB
control number 0910–0001. Applicant
submission of controlled
correspondence related to generic drug
development and FDA approval is
approved under OMB control number
0910–0797. The collections of
information that support Good
Laboratory Practice (GLP) for
Nonclinical Laboratory Studies have
been approved under OMB control
number 0910–0119. The collections of
information in 21 CFR part 320 for
‘‘Investigational New Drug Safety
Reporting Requirements for Human
Drug and Biological Products and Safety
Reporting Requirements for
Bioavailability and Bioequivalence
Studies in Humans’’ have been
approved under OMB control number
0910–0014. The recordkeeping
requirement for Current Good
Manufacturing Practice (CGMP) sample
retention in 21 CFR 211.170 has been
approved under OMB control number
0910–0139.
[Docket No. FDA–2013–N–0134]
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
Dated: October 18, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–23016 Filed 10–21–22; 8:45 am]
lotter on DSK11XQN23PROD with NOTICES1
17:07 Oct 21, 2022
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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.
SUMMARY:
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, 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; standards for
accreditation and certification bodies for
mammography facilities; and standards
for mammography equipment,
personnel, and practices, including
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Quality Standards Act Requirements
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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 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.
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.
E:\FR\FM\24OCN1.SGM
24OCN1
Federal Register / Vol. 87, No. 204 / Monday, October 24, 2022 / Notices
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.
64233
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN
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—FDA Form 3422 .................
Total .......................................................................
1 Numbers
2 One
time
to
4 Refers to
5 Refers to
3 Refers
Number of
responses per
respondent
Number of
respondents
Activity/21 CFR section/FDA form No.
Average
burden per
response
Total annual
responses
Total hours 1
0.33
0.33
5
1
1
1
0.33
0.33
5
1 ...........................
320 .......................
30 .........................
1
106
150
1
0.1
0.1
0.1
1
1
1
1
1
0.1
0.1
0.1
15 .........................
30 .........................
30 .........................
1 ...........................
15
3
3
1
330
1
330
7 ...........................
2,310
8,718
5
1
0.1
1
1
1
1
1
1
8,718
5
1
0.1
1
1 ...........................
10 .........................
16 .........................
60 .........................
2 ...........................
8,718
50
16
6
2
2
10
0.33
0.1
1
1
1
1
2
10
0.33
0.1
2 ...........................
1 ...........................
320 .......................
30 .........................
4
10
106
3
5
2
1
0.2
419
200
1
1
1
1
1,000
2
1
0.2
419
0.083 (5 minutes)
30 .........................
30 .........................
16 .........................
0.25 (15 minutes)
83
60
30
3
105
........................
........................
........................
..............................
11,785
have been rounded.
burden.
accreditation bodies applying to accredit specific full-field digital mammography units.
the facility component of the burden for this requirement.
the AB component of the burden for this requirement.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN
Number of
recordkeepers
lotter on DSK11XQN23PROD with NOTICES1
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
Average
burden per
recordkeeping
Total annual
records
0.1
5
87
1
1
1
0.1
5
87
0 ...........................
1 ...........................
8 ...........................
1
5
696
8,718
4
34,872
1 ...........................
34,872
8,718
8,718
8,718
8,718
5
5
1
52
1
2
1
1
8,718
453,336
8,718
17,436
5
5
1 ...........................
0.083 (5 minutes)
16 .........................
1 ...........................
1 ...........................
1 ...........................
8,718
37,627
139,488
17,436
5
5
5
5
1
1
5
5
1 ...........................
1 ...........................
5
5
3
5
5
1
1
1
3
5
5
1 ...........................
20 .........................
1 ...........................
3
100
5
........................
........................
........................
..............................
238,971
hours have been rounded.
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64234
Federal Register / Vol. 87, No. 204 / Monday, October 24, 2022 / Notices
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN
Number of
disclosures
per
respondent
Number of
respondents
Activity/21 CFR section
Notification of facilities that AB relinquishes its accreditation—900.3(f)(2).
Clinical images; facility 2—900.4(c), 900.11(b)(1), and
900.11(b)(2).
Clinical images; AB 3—900.4(c) ....................................
Phantom images; facility 2—900.4(d), 900.11(b)(1),
and 900.11(b)(2).
Phantom images; AB 3—900.4(d) .................................
Annual equipment evaluation and survey; facility 2—
900.4(e), 900.11(b)(1), and 900.11(b)(2).
Annual equipment evaluation and survey; AB 3—
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 4—
900.12(c)(2).
Report
of
unresolved
serious
complaints—
900.12(h)(4).
Information regarding compromised quality; facility 2—
900.12(j)(1).
Information regarding compromised quality; AB 3—
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 .......................................................................
Average
burden per
disclosure
Total annual
disclosures
Total hours 1
0.1
1
0.1
200 .......................
20
2,885
1
2,885
1.44 ......................
4,154
5
2,885
1
1
5
2,885
416 .......................
0.72 (43 minutes)
2,080
2,077
5
8,718
1
1
5
8,718
208 .......................
1 ...........................
1,040
8,718
5
1
5
1,730 ....................
8,650
0
1
0
0.5 (30 minutes) ...
1
281
1
281
5 ...........................
1,405
8,718
87
5,085
1
44,331,030
87
0.083 (5 minutes)
0.5 (30 minutes) ...
3,679,475
44
20
1
20
1 ...........................
20
20
1
20
200 .......................
4,000
20
1
20
320 .......................
6,400
5
5
0.4
1
1
1
5
5
0.4
100 .......................
2 ...........................
200 .......................
500
10
80
0.15
1
0.15
100 .......................
15
0.3
0.15
1
1
0.3
0.15
200 .......................
100 .......................
60
15
........................
........................
........................
..............................
3,718,764
1 Total
hours have been rounded.
to the facility component of the burden for this requirement.
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.
2 Refers
lotter on DSK11XQN23PROD with NOTICES1
3 Refers
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
§§ 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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–D–2101]
Human Gene Therapy for
Neurodegenerative Diseases;
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
SUMMARY:
VerDate Sep<11>2014
17:07 Oct 21, 2022
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guidance entitled ‘‘Human Gene
Therapy for Neurodegenerative
Diseases; Guidance for Industry.’’
Neurodegenerative diseases are a
heterogeneous group of disorders
characterized by progressive
degeneration of the structure and
function of the central nervous system
or peripheral nervous system. The
guidance document provides
recommendations to sponsors
developing human gene therapy (GT)
products for neurodegenerative diseases
affecting adult and pediatric patients.
The guidance focuses on considerations
for product development, preclinical
testing, and clinical trial design. The
guidance announced in this notice
finalizes the draft guidance of the same
title dated January 2021.
The announcement of the
guidance is published in the Federal
Register on October 24, 2022.
DATES:
E:\FR\FM\24OCN1.SGM
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]]>Agencies
[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).
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Total..................................... .............. .............. .............. ........................................ 3,718,764
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\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
