Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Q-Submission Program for Medical Devices, 78693-78694 [2022-27815]
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Federal Register / Vol. 87, No. 245 / Thursday, December 22, 2022 / Notices
submitted controlled correspondence.
As described in the GDUFA III
commitment letter, FDA has also agreed
to review and respond to requests to
clarify ambiguities in the controlled
correspondence response, and the
guidance provides information on how
requestors can submit these requests
and the Agency’s process for responding
to them.
This draft guidance revises the
guidance for industry entitled
‘‘Controlled Correspondence Related to
Generic Drug Development’’ issued in
December 2020. When finalized, this
updated guidance will replace the
December 2020 guidance. Changes from
the 2020 version include updating the
guidance to reflect enhancements in the
GDUFA III commitment letter (e.g.,
including information on controlled
correspondence that can be submitted
during abbreviated new drug
application assessment and after
issuance of a complete response letter or
a tentative approval or approval);
providing additional recommendations
on requests for information related to
inactive ingredients; and other updates
that are intended to clarify FDA’s
recommendations to industry.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on ‘‘Controlled Correspondence Related
to Generic Drug Development.’’ It does
not establish any rights for any person
and is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
lotter on DSK11XQN23PROD with NOTICES1
While this 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 in 21 CFR parts 312 and
314 have been approved under OMB
control numbers 0910–0014 and 0910–
0797, respectively.
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-fda-
VerDate Sep<11>2014
18:01 Dec 21, 2022
Jkt 259001
78693
guidance-documents, or https://
www.regulations.gov.
Q-Submissions Program for Medical
Devices
Dated: December 16, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
OMB Control Number 0910–0756—
Revision
The guidance entitled ‘‘Requests for
Feedback and Meetings for Medical
Device Submissions: The Q-Submission
Program’’ (https://www.fda.gov/media/
114034/download) provides an
overview of the mechanisms available to
submitters through which they can
request feedback from, or a meeting
with, FDA regarding certain potential or
planned medical device submissions
reviewed by the Center for Devices and
Radiological Health (CDRH) and the
Center for Biologics Evaluation and
Research (CBER). The guidance
provides recommendations regarding
certain types of Q-Submissions, such as
Pre-Submissions, Submission Issue
Requests, Study Risk Determinations,
Informational Meetings, and other QSubmission types and other uses of the
Q-Submission Program.
Respondents are medical device
manufacturers subject to FDA’s laws
and regulations. FDA’s annual estimate
of 3,700 submissions is based on recent
trends. FDA’s administrative and
technical staffs, who are familiar with
Q-Submissions, estimate that an average
of 137 hours is needed to prepare a QSubmission.
[FR Doc. 2022–27827 Filed 12–21–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–D–0530]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Q-Submission
Program for Medical Devices
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.
SUMMARY:
Submit written comments
(including recommendations) on the
collection of information by January 23,
2023.
DATES:
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 0910–0756. Also include
the FDA docket number found in
brackets in the heading of this
document.
ADDRESSES:
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:
PO 00000
Frm 00063
Fmt 4703
Sfmt 4703
Early Payor Feedback Program
Prior to submitting a Pre-Submission,
medical device sponsors may request
that one or more payor organizations
join a Pre-Submission meeting. Payors
include public payors such as Centers
for Medicare & Medicaid Services,
private health plans, health technology
assessment groups, and others who
provide input into coverage,
procurement, and reimbursement
decisions. To facilitate such
opportunities to obtain payor input,
FDA provides information about our
Early Payor Feedback Program (EPFP)
and a list of current payor participants
on our website (https://www.fda.gov/
about-fda/cdrh-innovation/payorcommunication-task-force). For payors
to decide which devices to provide
feedback on, we have developed a
voluntary form for manufacturers to
provide basic information regarding
their device. This form is shared with
the payors from whom the manufacturer
is requesting feedback. We expect
preparation and submission of the form
to take no more than 2 hours.
eSTAR for Q-Submissions
Under section 745A(b) of the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 379k–1(b)), amended by
E:\FR\FM\22DEN1.SGM
22DEN1
78694
Federal Register / Vol. 87, No. 245 / Thursday, December 22, 2022 / Notices
section 207 of the FDA Reauthorization
Act of 2017 (Pub. L. 115–52), and
consistent with the Medical Device User
Fee Amendments 2017 (MDUFA IV)
Commitment Letter and the FDA
guidance document entitled ‘‘Providing
Regulatory Submissions for Medical
Devices in Electronic Format—
Submissions Under Section 745A(b) of
the Federal Food, Drug, and Cosmetic
Act’’ (https://www.fda.gov/media/
131064/download), FDA has developed
an ‘‘electronic Submission Template
and Resource’’ (eSTAR) for Qsubmissions to facilitate the preparation
of submissions in electronic format
(https://www.fda.gov/medical-devices/
how-study-and-market-your-device/
voluntary-estar-program). The use of
eSTAR for Q-Submissions is currently
voluntary. We assume approximately 40
percent of Q-Submissions will use
eSTAR and that preparation using
eSTAR will take approximately half the
time of preparing a submission without
using eSTAR.
We estimate a setup burden of 5
minutes for new eSTAR users.
Respondents will only need to set up
eSTAR the first time they use it. We
note that because some respondents
may have already undergone eSTAR set
up for other types of submission, e.g.,
premarket notification, fewer
respondents may need to undergo
eSTAR setup than estimated.
In the Federal Register of August 9,
2022 (87 FR 48488), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
‘‘Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program’’
Q-Submissions:
CDRH ......................................................................
CBER ......................................................................
2,160
60
1
1
2,160
60
137 .....................
137 .....................
295,920
8,220
Q-Submissions using eSTAR (21 CFR part 814, subparts A through E; section 745A(b) of the FD&C Act)
CDRH ......................................................................
CBER ......................................................................
eSTAR setup ...........................................................
Manufacturer request to participate in EPFP .........
1,440
40
1,480
30
1
1
1
1
1,440
40
1,480
30
69 .......................
69 .......................
0.08 (5 minutes)
2 .........................
99,360
2,760
118
60
Total .................................................................
........................
........................
........................
............................
406,438
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Including the EPFP form represents a
revision to this information collection
request. Our estimated burden for the
information collection reflects the
availability of eSTAR to assist electronic
preparation of Q-submissions and
addition of the EPFP form, resulting in
an overall decrease of 85,803 hours.
Dated: December 16, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–27815 Filed 12–21–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
lotter on DSK11XQN23PROD with NOTICES1
[Docket No. FDA–2022–N–3208]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Records and
Reports Concerning Experiences With
Approved New Animal Drugs: Adverse
Event Reports
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
VerDate Sep<11>2014
18:01 Dec 21, 2022
Jkt 259001
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on adverse event
reporting by FDA on new animal drugs
and product manufacturing defects.
DATES: Either electronic or written
comments on the collection of
information must be submitted by
February 21, 2023.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
February 21, 2023. Comments received
by mail/hand delivery/courier (for
written/paper submissions) will be
SUMMARY:
PO 00000
Frm 00064
Fmt 4703
Sfmt 4703
considered timely if they are received
on or before that date.
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
E:\FR\FM\22DEN1.SGM
22DEN1
]]>Agencies
[Federal Register Volume 87, Number 245 (Thursday, December 22, 2022)]
[Notices]
[Pages 78693-78694]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-27815]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-D-0530]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Q-Submission Program
for Medical Devices
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: Submit written comments (including recommendations) on the
collection of information by January 23, 2023.
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 0910-0756. 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.
Q-Submissions Program for Medical Devices
OMB Control Number 0910-0756--Revision
The guidance entitled ``Requests for Feedback and Meetings for
Medical Device Submissions: The Q-Submission Program'' (https://www.fda.gov/media/114034/download) provides an overview of the
mechanisms available to submitters through which they can request
feedback from, or a meeting with, FDA regarding certain potential or
planned medical device submissions reviewed by the Center for Devices
and Radiological Health (CDRH) and the Center for Biologics Evaluation
and Research (CBER). The guidance provides recommendations regarding
certain types of Q-Submissions, such as Pre-Submissions, Submission
Issue Requests, Study Risk Determinations, Informational Meetings, and
other Q-Submission types and other uses of the Q-Submission Program.
Respondents are medical device manufacturers subject to FDA's laws
and regulations. FDA's annual estimate of 3,700 submissions is based on
recent trends. FDA's administrative and technical staffs, who are
familiar with Q-Submissions, estimate that an average of 137 hours is
needed to prepare a Q-Submission.
Early Payor Feedback Program
Prior to submitting a Pre-Submission, medical device sponsors may
request that one or more payor organizations join a Pre-Submission
meeting. Payors include public payors such as Centers for Medicare &
Medicaid Services, private health plans, health technology assessment
groups, and others who provide input into coverage, procurement, and
reimbursement decisions. To facilitate such opportunities to obtain
payor input, FDA provides information about our Early Payor Feedback
Program (EPFP) and a list of current payor participants on our website
(https://www.fda.gov/about-fda/cdrh-innovation/payor-communication-task-force). For payors to decide which devices to provide feedback on,
we have developed a voluntary form for manufacturers to provide basic
information regarding their device. This form is shared with the payors
from whom the manufacturer is requesting feedback. We expect
preparation and submission of the form to take no more than 2 hours.
eSTAR for Q-Submissions
Under section 745A(b) of the Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 379k-1(b)), amended by
[[Page 78694]]
section 207 of the FDA Reauthorization Act of 2017 (Pub. L. 115-52),
and consistent with the Medical Device User Fee Amendments 2017 (MDUFA
IV) Commitment Letter and the FDA guidance document entitled
``Providing Regulatory Submissions for Medical Devices in Electronic
Format--Submissions Under Section 745A(b) of the Federal Food, Drug,
and Cosmetic Act'' (https://www.fda.gov/media/131064/download), FDA has
developed an ``electronic Submission Template and Resource'' (eSTAR)
for Q-submissions to facilitate the preparation of submissions in
electronic format (https://www.fda.gov/medical-devices/how-study-and-market-your-device/voluntary-estar-program). The use of eSTAR for Q-
Submissions is currently voluntary. We assume approximately 40 percent
of Q-Submissions will use eSTAR and that preparation using eSTAR will
take approximately half the time of preparing a submission without
using eSTAR.
We estimate a setup burden of 5 minutes for new eSTAR users.
Respondents will only need to set up eSTAR the first time they use it.
We note that because some respondents may have already undergone eSTAR
set up for other types of submission, e.g., premarket notification,
fewer respondents may need to undergo eSTAR setup than estimated.
In the Federal Register of August 9, 2022 (87 FR 48488), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
``Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program''
--------------------------------------------------------------------------------------------------------------------------------------------------------
Q-Submissions:
CDRH......................................... 2,160 1 2,160 137.................................. 295,920
CBER......................................... 60 1 60 137.................................. 8,220
--------------------------------------------------------------------------------------------------------------------------------------------------------
Q-Submissions using eSTAR (21 CFR part 814, subparts A through E; section 745A(b) of the FD&C Act)
--------------------------------------------------------------------------------------------------------------------------------------------------------
CDRH......................................... 1,440 1 1,440 69................................... 99,360
CBER......................................... 40 1 40 69................................... 2,760
eSTAR setup.................................. 1,480 1 1,480 0.08 (5 minutes)..................... 118
Manufacturer request to participate in EPFP.. 30 1 30 2.................................... 60
----------------------------------------------------------------------------------------------------------
Total.................................... .............. .............. .............. ..................................... 406,438
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Including the EPFP form represents a revision to this information
collection request. Our estimated burden for the information collection
reflects the availability of eSTAR to assist electronic preparation of
Q-submissions and addition of the EPFP form, resulting in an overall
decrease of 85,803 hours.
Dated: December 16, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-27815 Filed 12-21-22; 8:45 am]
BILLING CODE 4164-01-P
