Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; 510(k) Third-Party Review Program, 65088-65089 [2022-23377]
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65088
Federal Register / Vol. 87, No. 207 / Thursday, October 27, 2022 / Notices
approved under OMB control number
0910–0001. The collections of
information relating to rare disease drug
and biological product development
programs have been approved under
OMB control number 0910–0765.
Dated: October 21, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–23383 Filed 10–26–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA 2016–D–2565]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; 510(k) Third-Party
Review Program
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
28, 2022.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
SUMMARY:
recommendation, to FDA. Third-party
reviewers should maintain records of
their 510(k) reviews and a copy of the
510(k) for a reasonable period of time,
usually 3 years.
Respondents to this information
collection are businesses or government,
and can be for-profit or not-for-profit
organizations.
The guidance ‘‘510(k) Third-Party
Review Program, Guidance for Industry,
Food and Drug Administration Staff and
Third Party Review Organizations’’
(March 2020) (https://www.fda.gov/
regulatory-information/search-fdaguidance-documents/510k-third-partyreview-program) is intended to provide
a comprehensive look into FDA’s
current thinking regarding the 3P510k
review program. This guidance
document also reflects section 523 of
the FD&C Act, which directs FDA to
issue guidance on the factors that will
be used in determining whether a class
I or class II device type, or subset of
such device types, is eligible for review
by an accredited person. The 3P510k
review program is intended to allow
review of devices by third-party 510k
review organizations (3PROs) to provide
manufacturers of these devices an
alternative review process that allows
FDA to best utilize our resources on
higher risk devices.
In the Federal Register of June 24,
2022 (87 FR 37863), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. Although four comments
were received, they were not responsive
to the four collection of information
topics solicited.
FDA estimates the burden of this
collection of information as follows:
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 0910–0375. Also include
the FDA docket number found in
brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Rachel Showalter, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 240–994–7399, PRAStaff@
fda.hhs.gov.
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.
510(k) Third-Party Review Program
OMB Control Number 0910–0375—
Extension
Section 523 of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C.
360m), directs FDA to accredit persons
in the private sector to review certain
premarket notifications (510(k)s; see 21
U.S.C. 360(k)). Participation in the
510(k) third-party (3P510k) review
program by accredited persons is
entirely voluntary. A third party
wishing to participate will submit a
request for accreditation to FDA.
Accredited third-party reviewers have
the ability to review a manufacturer’s
510(k) submission for selected devices.
After reviewing a submission, the
reviewer will forward a copy of the
510(k) submission, along with the
reviewer’s documented review and
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
Activity; guidance document section
Total annual
responses
Average burden
per response
Total hours 2
Requests for accreditation (initial); Section VI .........................................
Requests for accreditation (re-recognition); Section VI ...........................
510(k) reviews conducted by accredited third parties; Section VI ..........
Complaints; Section VII ............................................................................
1
3
9
1
1
1
14
1
1
3
126
1
24 ................................
24 ................................
40 ................................
0.25 (15 minutes) .......
24
72
5,040
1
Total ..................................................................................................
........................
........................
........................
.....................................
5,137
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
2 Totals have been rounded.
khammond on DSKJM1Z7X2PROD with NOTICES
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
Activity; guidance document section
510(k) reviews; Section VII ...............................................................................
Records regarding qualifications to receive FDA recognition as a 3PRO;
Section VII .....................................................................................................
Recordkeeping system regarding complaints; Section VII ...............................
VerDate Sep<11>2014
16:55 Oct 26, 2022
Jkt 259001
PO 00000
Frm 00066
Fmt 4703
Sfmt 4703
Number of
records per
recordkeeper
Average
burden per
recordkeeping
Total annual
records
Total hours
9
14
126
10
1,260
9
9
1
1
9
9
1
2
9
18
E:\FR\FM\27OCN1.SGM
27OCN1
Federal Register / Vol. 87, No. 207 / Thursday, October 27, 2022 / Notices
65089
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued
Activity; guidance document section
Total ...........................................................................................................
khammond on DSKJM1Z7X2PROD with NOTICES
1 There
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
..........................
........................
........................
..........................
Total hours
1,287
are no capital costs or operating and maintenance costs associated with this collection of information.
Estimated Annual Recordkeeping
Burden
decrease to the currently approved
burden.
510(k) reviews: The 3PROs should
retain copies of all 510(k) reviews and
associated correspondence. Based on
FDA’s recent experience with this
program, we estimate the number of
510(k)s submitted for 3P510k review to
be 126 annually; approximately 14
annual reviews for each of the 9 3PROs.
We estimate the average burden per
recordkeeping to be 10 hours.
Records regarding qualifications to
receive FDA recognition as a 3PRO:
Under section 704(f) of the FD&C Act
(21 U.S.C. 374(f)), a 3PRO must
maintain records that support their
initial and continuing qualifications to
receive FDA recognition, including
documentation of the training and
qualifications of the 3PRO and its
personnel; the procedures used by the
3P510k review organization for
handling confidential information; the
compensation arrangements made by
the 3PRO; and the procedures used by
the 3PRO to identify and avoid conflicts
of interest. Additionally, the guidance
states that 3PROs should retain
information on the identity and
qualifications of all personnel who
contributed to the technical review of
each 510(k) submission and other
relevant records. Because most of the
burden of compiling the records is
expressed in the reporting burden for
requests for accreditation, we estimate
the maintenance of such records to be
1 hour per recordkeeping annually.
Recordkeeping system regarding
complaints: Section 523(b)(3)(F)(iv) of
the FD&C Act requires 3PROs to agree
in writing that they will promptly
respond and attempt to resolve
complaints regarding their activities.
The guidance recommends that 3PROs
establish a recordkeeping system for
tracking the submission of those
complaints and how those complaints
were resolved, or attempted to be
resolved. Based on our experience with
the program and the recommendations
in the guidance, we estimate the average
burden per recordkeeping to be 2 hours
annually.
Based on our experience with the
program since our last request for OMB
approval, we have adjusted our burden
estimate, which has resulted in a
Dated: October 21, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
VerDate Sep<11>2014
16:55 Oct 26, 2022
Jkt 259001
[FR Doc. 2022–23377 Filed 10–26–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request: Information
Collection Request Title: Evaluation of
the Maternal and Child Health Bureau
Pediatric Mental Health Care Access
Program and the Screening and
Treatment for Maternal Depression and
Related Behavioral Disorders Program
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with of the
Paperwork Reduction Act of 1995,
HRSA has submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period. OMB may act on
HRSA’s ICR only after the 30 day
comment period for this Notice has
closed.
SUMMARY:
Comments on this ICR should be
received no later than November 28,
2022.
DATES:
Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to 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.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
ADDRESSES:
PO 00000
Frm 00067
Fmt 4703
Sfmt 4703
submitted to OMB for review, email
Samantha Miller, the acting HRSA
Information Collection Clearance Officer
at paperwork@hrsa.gov or call (301)
443–9094.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information collection request title for
reference.
Information Collection Request Title:
Evaluation of the Maternal and Child
Health Bureau Pediatric Mental Health
Care Access Program and the Screening
and Treatment for Maternal Depression
and Related Behavioral Disorders
Program, OMB No. 0906–xxxx–New.
Abstract: This notice describes
information collection requests for two
of HRSA’s Maternal and Child Health
programs: the Pediatric Mental Health
Care Access (PMHCA) program and the
Screening and Treatment for Maternal
Depression and Related Behavioral
Disorders (MDRBD) program. Both of
these programs aim to increase
identification of behavioral health
conditions by providing support for
screening of specified populations (e.g.,
children, adolescents, young adults, and
pregnant and postpartum women,
especially those living in rural, isolated,
and/or underserved areas); providing
clinical behavioral health consultation,
care coordination support (i.e.,
communication/collaboration, accessing
resources, referral services), and training
to health professionals (HP); 1 and
increasing access to clinical
interventions, including by telehealth.
HP education and training will support
the knowledge and skills acquisition
needed to accomplish this goal.
The information will be collected
with recipients of awards that were
issued in 2018 (PMHCA and MDRBD),
2019 (PMHCA), and 2021 (PMHCA).
The 2018, 2019, and 2021 PMHCA
programs are authorized by 42 U.S.C
§ 254c–19 (§ 330M of the Public Health
Service Act), using Section 2712 of the
American Rescue Plan Act of 2021 (P.L.
117–2) for 2021 awardees. The 2018
MDRBD program is authorized by 42
U.S.C. 247b–13a (§ 317L–1 of the Public
1 HPs may include pediatricians, family
physicians, physician assistants, advanced practice
nurses/nurse practitioners, licensed practical
nurses, registered nurses, counselors, social
workers, medical assistants, patient care navigators.
E:\FR\FM\27OCN1.SGM
27OCN1
]]>Agencies
[Federal Register Volume 87, Number 207 (Thursday, October 27, 2022)]
[Notices]
[Pages 65088-65089]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-23377]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA 2016-D-2565]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; 510(k) Third-Party
Review Program
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 28, 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 0910-0375. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Rachel Showalter, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-994-7399,
[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.
510(k) Third-Party Review Program
OMB Control Number 0910-0375--Extension
Section 523 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
(21 U.S.C. 360m), directs FDA to accredit persons in the private sector
to review certain premarket notifications (510(k)s; see 21 U.S.C.
360(k)). Participation in the 510(k) third-party (3P510k) review
program by accredited persons is entirely voluntary. A third party
wishing to participate will submit a request for accreditation to FDA.
Accredited third-party reviewers have the ability to review a
manufacturer's 510(k) submission for selected devices. After reviewing
a submission, the reviewer will forward a copy of the 510(k)
submission, along with the reviewer's documented review and
recommendation, to FDA. Third-party reviewers should maintain records
of their 510(k) reviews and a copy of the 510(k) for a reasonable
period of time, usually 3 years.
Respondents to this information collection are businesses or
government, and can be for-profit or not-for-profit organizations.
The guidance ``510(k) Third-Party Review Program, Guidance for
Industry, Food and Drug Administration Staff and Third Party Review
Organizations'' (March 2020) (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/510k-third-party-review-program) is intended to provide a comprehensive look into FDA's current
thinking regarding the 3P510k review program. This guidance document
also reflects section 523 of the FD&C Act, which directs FDA to issue
guidance on the factors that will be used in determining whether a
class I or class II device type, or subset of such device types, is
eligible for review by an accredited person. The 3P510k review program
is intended to allow review of devices by third-party 510k review
organizations (3PROs) to provide manufacturers of these devices an
alternative review process that allows FDA to best utilize our
resources on higher risk devices.
In the Federal Register of June 24, 2022 (87 FR 37863), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Although four comments were received, they
were not responsive to the four collection of information topics
solicited.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity; guidance document section Number of responses per Total annual Average burden per response Total hours
respondents respondent responses \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Requests for accreditation (initial); Section 1 1 1 24....................................... 24
VI.
Requests for accreditation (re-recognition); 3 1 3 24....................................... 72
Section VI.
510(k) reviews conducted by accredited third 9 14 126 40....................................... 5,040
parties; Section VI.
Complaints; Section VII...................... 1 1 1 0.25 (15 minutes)........................ 1
----------------------------------------------------------------------------------------------------------
Total.................................... .............. .............. .............. ......................................... 5,137
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Totals have been rounded.
Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Activity; guidance document Number of records per Total annual per Total hours
section recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
510(k) reviews; Section VII... 9 14 126 10 1,260
Records regarding 9 1 9 1 9
qualifications to receive FDA
recognition as a 3PRO;
Section VII..................
Recordkeeping system regarding 9 1 9 2 18
complaints; Section VII......
---------------------------------------------------------------------------------
[[Page 65089]]
Total..................... ............... .............. .............. ............... 1,287
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Estimated Annual Recordkeeping Burden
510(k) reviews: The 3PROs should retain copies of all 510(k)
reviews and associated correspondence. Based on FDA's recent experience
with this program, we estimate the number of 510(k)s submitted for
3P510k review to be 126 annually; approximately 14 annual reviews for
each of the 9 3PROs. We estimate the average burden per recordkeeping
to be 10 hours.
Records regarding qualifications to receive FDA recognition as a
3PRO: Under section 704(f) of the FD&C Act (21 U.S.C. 374(f)), a 3PRO
must maintain records that support their initial and continuing
qualifications to receive FDA recognition, including documentation of
the training and qualifications of the 3PRO and its personnel; the
procedures used by the 3P510k review organization for handling
confidential information; the compensation arrangements made by the
3PRO; and the procedures used by the 3PRO to identify and avoid
conflicts of interest. Additionally, the guidance states that 3PROs
should retain information on the identity and qualifications of all
personnel who contributed to the technical review of each 510(k)
submission and other relevant records. Because most of the burden of
compiling the records is expressed in the reporting burden for requests
for accreditation, we estimate the maintenance of such records to be 1
hour per recordkeeping annually.
Recordkeeping system regarding complaints: Section 523(b)(3)(F)(iv)
of the FD&C Act requires 3PROs to agree in writing that they will
promptly respond and attempt to resolve complaints regarding their
activities. The guidance recommends that 3PROs establish a
recordkeeping system for tracking the submission of those complaints
and how those complaints were resolved, or attempted to be resolved.
Based on our experience with the program and the recommendations in the
guidance, we estimate the average burden per recordkeeping to be 2
hours annually.
Based on our experience with the program since our last request for
OMB approval, we have adjusted our burden estimate, which has resulted
in a decrease to the currently approved burden.
Dated: October 21, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-23377 Filed 10-26-22; 8:45 am]
BILLING CODE 4164-01-P
