Providing Over-the-Counter Monograph Submissions in Electronic Format; Draft Guidance for Industry; Availability, 58802-58803 [2022-21007]
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58802
Federal Register / Vol. 87, No. 187 / Wednesday, September 28, 2022 / Notices
letter to each organization that has
expressed an interest, attaching a
complete list of all such organizations
and a list of all nominees along with
their current resumes. The letter will
also state that it is the responsibility of
the interested organizations to confer
with one another and to select a
candidate, within 60 days after the
receipt of the FDA letter, to serve as the
nonvoting member to represent industry
interests for the committee. The
interested organizations are not bound
by the list of nominees in selecting a
candidate. However, if no individual is
selected within 60 days, the
Commissioner will select the nonvoting
member to represent industry interests.
III. Application Procedure
Individuals may self-nominate and/or
an organization may nominate one or
more individuals to serve as a nonvoting
industry representative. Contact
information, a current curriculum vitae,
and the name of the committee of
interest should be sent to the FDA
Advisory Committee Membership
Nomination Portal (see ADDRESSES)
within 30 days of publication of this
document (see DATES). FDA will forward
all nominations to the organizations
expressing interest in participating in
the selection process for the committee.
(Persons who nominate themselves as
nonvoting industry representatives will
not participate in the selection process.)
FDA seeks to include the views of
women, and men, members of all racial
and ethnic groups and individuals with
and without disabilities on its advisory
committees and, therefore encourages
nominations of appropriately qualified
candidates from these groups.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to advisory committees.
Dated: September 21, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–20990 Filed 9–27–22; 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–D–2059]
Providing Over-the-Counter
Monograph Submissions in Electronic
Format; Draft Guidance for Industry;
Availability
Food and Drug Administration,
Department of Health and Human
Services (HHS).
AGENCY:
VerDate Sep<11>2014
18:06 Sep 27, 2022
Jkt 256001
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled
‘‘Providing Over-the-Counter
Monograph Submissions in Electronic
Format.’’ This guidance provides
information on providing electronic
submissions to FDA under the Federal
Food, Drug, and Cosmetic Act (FD&C
Act).
DATES: Submit either electronic or
written comments on the draft guidance
by November 28, 2022 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
SUMMARY:
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.’’
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
Instructions: All submissions received
must include the Docket No. FDA–
2022–D–2059 for ‘‘Providing Over-theCounter Monograph Submissions in
Electronic Format.’’ Received comments
will be placed in the docket 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.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
E:\FR\FM\28SEN1.SGM
28SEN1
Federal Register / Vol. 87, No. 187 / Wednesday, September 28, 2022 / Notices
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Trang Tran, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
240–402–7945.
SUPPLEMENTARY INFORMATION:
lotter on DSK11XQN23PROD with NOTICES1
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Providing Over-the-Counter
Monograph Submissions in Electronic
Format.’’ This guidance provides
information on providing electronic
submissions to FDA under section 505G
of the FD&C Act (21 U.S.C. 355h)
(hereafter referred to as over-the-counter
(OTC) monograph submissions). This
guidance is intended to assist submitters
by describing the electronic OTC
monograph submissions requirement in
section 505G(j) of the FD&C Act and
providing recommendations and other
information on how to send such OTC
monograph submissions to FDA in
electronic format.
Section 505G of the FD&C Act was
added by the Coronavirus Aid, Relief,
and Economic Security Act (CARES
Act), Public Law 116–136, which was
enacted on March 27, 2020. Section
505G(j) of the FD&C Act requires that all
OTC monograph submissions must be in
electronic format. As required by
section 505G(l)(3) of the FD&C Act, this
draft guidance, when finalized, specifies
the format of electronic submissions
under section 505G of the FD&C Act.
In support of the CARES Act, FDA
agreed to specific performance goals and
procedures described in the document
entitled ‘‘Over-the-Counter Monograph
User Fee Program Performance Goals
and Procedures—Fiscal Years 2018–
2022,’’ commonly referred to as the
OMUFA commitment letter (the
document can be accessed at https://
www.fda.gov/media/106407/download
and the document with updated goal
dates for fiscal years 2021 to 2025 can
be accessed at https://www.fda.gov/
media/146283/download). In the
OMUFA commitment letter, FDA
committed to issuing this draft guidance
under specific timelines.
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 ‘‘Providing Over-the-Counter
Monograph Submissions in Electronic
VerDate Sep<11>2014
18:06 Sep 27, 2022
Jkt 256001
Format.’’ 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
Under section 505G(o) of the FD&C
Act, the Paperwork Reduction Act of
1995 does not apply to collections of
information made under section 505G of
the FD&C Act. This guidance is being
issued to implement the provisions of
section 505G(l)(3) of the FD&C Act,
which specifies the format of electronic
submissions to FDA under section 505G
of the FD&C Act. Therefore, clearance
by the Office of Management and
Budget under the Paperwork Reduction
Act of 1995 is not required.
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: September 23, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–21007 Filed 9–27–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–D–0987]
Policy for Coronavirus Disease—2019
Tests During the Public Health
Emergency (Revised); Immediately in
Effect Guidance for Commercial
Manufacturers and Food and Drug
Administration Staff; 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
guidance document related to the
Coronavirus Disease 2019 (COVID–19)
public health emergency (PHE) entitled
‘‘Policy for Coronavirus Disease—2019
Tests During the Public Health
Emergency (Revised).’’ FDA is issuing
this guidance to provide FDA’s revised
enforcement policies and review
priorities regarding certain novel
coronavirus (COVID–19) tests for the
duration of the public health
SUMMARY:
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
58803
emergency. Rapid detection of COVID–
19 cases in the United States requires
wide availability of testing to control the
spread of this highly contagious
infection. This document supersedes
‘‘Policy for Coronavirus Disease—2019
Tests During the Public Health
Emergency (Revised)’’ issued November
15, 2021. The guidance identified in this
notice addresses issues related to the
COVID–19 PHE and has been issued in
accordance with the expedited process
FDA announced in the Federal Register
of March 25, 2020, for making available
to the public COVID–19-related
guidances. This guidance has been
implemented without prior comment,
but it remains subject to comment in
accordance with the Agency’s good
guidance practices.
DATES: The announcement of the
guidance is published in the Federal
Register on September 28, 2022.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
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.
E:\FR\FM\28SEN1.SGM
28SEN1
Agencies
[Federal Register Volume 87, Number 187 (Wednesday, September 28, 2022)]
[Notices]
[Pages 58802-58803]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-21007]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-D-2059]
Providing Over-the-Counter Monograph Submissions in Electronic
Format; Draft Guidance for Industry; Availability
AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Providing
Over-the-Counter Monograph Submissions in Electronic Format.'' This
guidance provides information on providing electronic submissions to
FDA under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
DATES: Submit either electronic or written comments on the draft
guidance by November 28, 2022 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.
ADDRESSES: You may submit comments on any guidance at any time as
follows:
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-2022-D-2059 for ``Providing Over-the-Counter Monograph Submissions
in Electronic Format.'' Received comments will be placed in the docket
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.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-
[[Page 58803]]
0002. Send one self-addressed adhesive label to assist that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT: Trang Tran, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Silver Spring, MD 20993-0002, 240-402-7945.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Providing Over-the-Counter Monograph Submissions in
Electronic Format.'' This guidance provides information on providing
electronic submissions to FDA under section 505G of the FD&C Act (21
U.S.C. 355h) (hereafter referred to as over-the-counter (OTC) monograph
submissions). This guidance is intended to assist submitters by
describing the electronic OTC monograph submissions requirement in
section 505G(j) of the FD&C Act and providing recommendations and other
information on how to send such OTC monograph submissions to FDA in
electronic format.
Section 505G of the FD&C Act was added by the Coronavirus Aid,
Relief, and Economic Security Act (CARES Act), Public Law 116-136,
which was enacted on March 27, 2020. Section 505G(j) of the FD&C Act
requires that all OTC monograph submissions must be in electronic
format. As required by section 505G(l)(3) of the FD&C Act, this draft
guidance, when finalized, specifies the format of electronic
submissions under section 505G of the FD&C Act.
In support of the CARES Act, FDA agreed to specific performance
goals and procedures described in the document entitled ``Over-the-
Counter Monograph User Fee Program Performance Goals and Procedures--
Fiscal Years 2018-2022,'' commonly referred to as the OMUFA commitment
letter (the document can be accessed at https://www.fda.gov/media/106407/download and the document with updated goal dates for fiscal
years 2021 to 2025 can be accessed at https://www.fda.gov/media/146283/download). In the OMUFA commitment letter, FDA committed to issuing
this draft guidance under specific timelines.
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 ``Providing
Over-the-Counter Monograph Submissions in Electronic Format.'' 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
Under section 505G(o) of the FD&C Act, the Paperwork Reduction Act
of 1995 does not apply to collections of information made under section
505G of the FD&C Act. This guidance is being issued to implement the
provisions of section 505G(l)(3) of the FD&C Act, which specifies the
format of electronic submissions to FDA under section 505G of the FD&C
Act. Therefore, clearance by the Office of Management and Budget under
the Paperwork Reduction Act of 1995 is not required.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.
Dated: September 23, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-21007 Filed 9-27-22; 8:45 am]
BILLING CODE 4164-01-P