Agency Information Collection Activities; Proposed Collection; Comment Request; Q-Submission Program for Medical Devices, 48488-48490 [2022-17058]
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FDA intends to make background
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Notice of this meeting is given under
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Dated: August 1, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–17059 Filed 8–8–22; 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; Proposed Collection;
Comment Request; Q-Submission
Program for Medical Devices
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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 information
collections associated with the QSubmission Program for medical
devices.
SUMMARY:
Either electronic or written
comments on the collection of
information must be submitted by
October 11, 2022.
DATES:
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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
October 11, 2022. Comments received
by mail/hand delivery/courier (for
written/paper submissions) will be
considered timely if they are received
on or before that date.
ADDRESSES:
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
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2012–D–0530 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; QSubmission Program for Medical
Devices.’’ Received comments, those
filed in a timely manner (see
ADDRESSES), will be placed in the docket
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jspears on DSK121TN23PROD with NOTICES
Federal Register / Vol. 87, No. 152 / Tuesday, August 9, 2022 / Notices
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A–12M, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3521), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
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1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
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 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
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48489
Q-Submissions, estimate that an average
of 137 hours is needed to prepare a QSubmission.
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#2). 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
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
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Federal Register / Vol. 87, No. 152 / Tuesday, August 9, 2022 / Notices
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.
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: August 2, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–17058 Filed 8–8–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Biodefense Science Board
Public Meeting
Office of the Assistant
Secretary for Preparedness and
Response (ASPR), Department of Health
and Human Services (HHS).
ACTION: Notice.
AGENCY:
The National Biodefense
Science Board (NBSB or the Board),
authorized under Section 319M of the
Public Health Service (PHS) Act, as
added by Section 402 of the Pandemic
and All-Hazards Preparedness Act of
2006 and amended by Section 404 of the
Pandemic and All-Hazards
Preparedness Reauthorization Act, will
hold a public meeting. The NBSB
provides expert advice and guidance to
the Department of Health and Human
Services (HHS) regarding current and
future chemical, biological, radiological,
and nuclear threats, as well as other
matters related to disaster preparedness
and response. The Assistant Secretary
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SUMMARY:
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for Preparedness and Response (ASPR)
manages and convenes the NBSB on
behalf the Secretary. A detailed agenda
and Zoom registration instructions will
be posted on the ASPR website at least
two weeks in advance.
DATES: The public meeting will be held
on September 29, 2022 beginning at 11
a.m. Eastern time.
FOR FURTHER INFORMATION CONTACT:
CAPT Christopher Perdue, NBSB
Designated Federal Official, NBSB@
hhs.gov, 202–401–5837.
SUPPLEMENTARY INFORMATION: Those
interested may attend the meeting via a
toll-free phone number or Zoom
teleconference, which requires preregistration. The meeting link to preregister will be posted on the meeting
website. The online meeting will
include American Sign Language
interpretation and live captioning.
Members of the public may provide
written comments or submit questions
at any time via email to NBSB@hhs.gov.
Additionally, the NBSB invites
stakeholders to request up to seven
minutes to address the Board in-person
during the meeting. The Board wishes to
hear from experts from relevant
biomedical, biodefense, or health
industries; faculty or researchers at
academic institutions; health
professionals, health system experts, or
those who work in health care consumer
organizations; or experts in state, Tribal,
territorial, or local government agencies.
Requests to provide remarks to the
NBSB during the public meeting must
be sent to NBSB@hhs.gov by September
15, 2022. In that request, please provide
the speaker’s name, title, position, and
organization with a brief description of
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the topic that they will address.
Requests to speak to the Board will be
approved in consultation with the Board
Chair and based on time available
during the meeting. Obvious
commercial bias, to include any form of
advertising, marketing, or solicitation,
will not be allowed.
Dawn O’Connell,
Assistant Secretary for Preparedness and
Response.
[FR Doc. 2022–16978 Filed 8–8–22; 8:45 am]
BILLING CODE 4150–37–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Aging; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Aging Special Emphasis Panel SARS–CoV–2
infection and genetic variations effects on
Risk of Cognitive Decline.
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]]>Agencies
[Federal Register Volume 87, Number 152 (Tuesday, August 9, 2022)]
[Notices]
[Pages 48488-48490]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-17058]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-D-0530]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Q-Submission Program for Medical Devices
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: 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 information collections associated with the
Q-Submission Program for medical devices.
DATES: Either electronic or written comments on the collection of
information must be submitted by October 11, 2022.
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 October 11, 2022. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be 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 manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2012-D-0530 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Q-Submission Program for Medical
Devices.'' Received comments, those filed in a timely manner (see
ADDRESSES), will be placed in the docket
[[Page 48489]]
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794,
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
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#2). 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 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
[[Page 48490]]
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.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
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``Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program''
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Q-Submissions:
CDRH..................................... 2,160 1 2,160 137.................................. 295,920
CBER..................................... 60 1 60 137.................................. 8,220
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Q-Submissions Using eSTAR (21 CFR Part 814, Subparts A Through E; Section 745A(b) of the FD&C Act)
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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
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Total................................ .............. .............. .............. ..................................... 406,438
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\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: August 2, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-17058 Filed 8-8-22; 8:45 am]
BILLING CODE 4164-01-P
