Statement of Identity and Strength-Content and Format of Labeling for Human Nonprescription Drug Products; Draft Guidance for Industry; Availability, 55438-55440 [2022-19500]
Download as PDF
55438
Dated: September 2, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–19491 Filed 9–8–22; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–D–1837]
BILLING CODE 4164–01–C
jspears on DSK121TN23PROD with NOTICES
Statement of Identity and Strength—
Content and Format of Labeling for
Human Nonprescription Drug
Products; Draft Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled
SUMMARY:
VerDate Sep<11>2014
18:57 Sep 08, 2022
Jkt 256001
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
‘‘Statement of Identity and Strength—
Content and Format of Labeling for
Human Nonprescription Drug
Products.’’ This draft guidance provides
recommendations for the content and
format of the required statement of
identity on the labeling of human
nonprescription drug products. This
draft guidance also provides
recommendations on the inclusion of
the drug product’s strength on the
labeling. The recommendations in this
draft guidance are intended to help
manufacturers, packers, distributors,
applicants, relabelers, and sponsors
ensure consistent content and format of
the statement of identity and strength
for all human nonprescription drug
products. Consistent content and format
E:\FR\FM\09SEN1.SGM
09SEN1
EN09SE22.045
Federal Register / Vol. 87, No. 174 / Friday, September 9, 2022 / Notices
Federal Register / Vol. 87, No. 174 / Friday, September 9, 2022 / Notices
of the statement of identity and strength
may aid consumers in comparing
nonprescription drug products and
assist consumers in appropriate selfselection.
Submit either electronic or
written comments on the draft guidance
by November 8, 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draft guidance before it begins work on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:
DATES:
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’’).
jspears on DSK121TN23PROD with NOTICES
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–1837 for ‘‘Statement of Identity
and Strength—Content and Format of
Labeling for Human Nonprescription
Drug Products.’’ Received comments
will be placed in the docket and, except
VerDate Sep<11>2014
18:57 Sep 08, 2022
Jkt 256001
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–
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.
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
55439
FOR FURTHER INFORMATION CONTACT:
Helen Lee, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 5493, Silver Spring,
MD 20993, 301–796–6848.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Statement of Identity and Strength—
Content and Format of Labeling for
Human Nonprescription Drug
Products.’’ This draft guidance provides
recommendations for the content and
format of the required statement of
identity on the labeling of human
nonprescription drug products. This
draft guidance also provides
recommendations on the inclusion of
the drug product’s strength on the
labeling.
Labeling for nonprescription drug
products is intended to enable
consumers to self-select appropriately
and use the nonprescription drug
product safely and effectively without
the supervision of a healthcare
practitioner. Nonprescription drug
products must comply with applicable
labeling requirements for over-thecounter (OTC) products under 21 CFR
part 201, including, but not limited to,
the statement of identity under § 201.61
(21 CFR 201.61). The statement of
identity is one of the principal features
on nonprescription drug product
labeling and consists of the established
name for the nonprescription drug
product, if one exists, followed by an
accurate statement of the general
pharmacological category(ies) or the
principal intended action(s) of the drug.
The labeling of all nonprescription drug
products must display the statement of
identity on the product’s principal
display panel (§ 201.61(a)).
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 ‘‘Statement of Identity and
Strength—Content and Format of
Labeling for Human Nonprescription
Drug Products.’’ 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
This draft guidance refers to proposed
collections of information described in
FDA’s 60-day notice requesting public
comment on the proposed collection of
information entitled ‘‘Agency
E:\FR\FM\09SEN1.SGM
09SEN1
55440
Federal Register / Vol. 87, No. 174 / Friday, September 9, 2022 / Notices
Information Collection Activities;
Proposed Collection; Comment Request;
General Drug Labeling Provisions and
Over-the-Counter Monograph Drug User
Fee Submissions.’’ The proposed
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (PRA) (44 U.S.C.
3501–3521). As required by the PRA,
FDA has published an analysis of these
information collection provisions
elsewhere in this edition of the Federal
Register and will submit them for OMB
approval following the period for public
comment. This draft guidance also
refers to previously approved
collections of information found in FDA
regulations. The collections of
information in 21 CFR part 314 have
been approved under OMB control
number 0910–0001.
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 2, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–19500 Filed 9–8–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–N–1794]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; General Drug
Labeling Provisions and Over-theCounter Monograph Drug User Fee
Submissions
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 revision of an
existing collection of information, and
to allow 60 days for public comment in
jspears on DSK121TN23PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:57 Sep 08, 2022
Jkt 256001
response to the notice. This notice
solicits comments on information
collections related to general drug
product labeling and to over-the-counter
(OTC) Monograph Drug User Fee
(OMUFA) submissions.
DATES: Either electronic or written
comments on the collection of
information must be submitted by
November 8, 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
November 8, 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
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2022–N–1794 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; General
Drug Labeling Provisions and OTC
Monograph Drug User Fee
Submissions.’’ Received comments,
those filed in a timely manner (see
ADDRESSES), 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.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
E:\FR\FM\09SEN1.SGM
09SEN1
Agencies
[Federal Register Volume 87, Number 174 (Friday, September 9, 2022)]
[Notices]
[Pages 55438-55440]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-19500]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-D-1837]
Statement of Identity and Strength--Content and Format of
Labeling for Human Nonprescription Drug Products; Draft Guidance for
Industry; Availability
AGENCY: Food and Drug Administration, 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 ``Statement
of Identity and Strength--Content and Format of Labeling for Human
Nonprescription Drug Products.'' This draft guidance provides
recommendations for the content and format of the required statement of
identity on the labeling of human nonprescription drug products. This
draft guidance also provides recommendations on the inclusion of the
drug product's strength on the labeling. The recommendations in this
draft guidance are intended to help manufacturers, packers,
distributors, applicants, relabelers, and sponsors ensure consistent
content and format of the statement of identity and strength for all
human nonprescription drug products. Consistent content and format
[[Page 55439]]
of the statement of identity and strength may aid consumers in
comparing nonprescription drug products and assist consumers in
appropriate self-selection.
DATES: Submit either electronic or written comments on the draft
guidance by November 8, 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-1837 for ``Statement of Identity and Strength--Content and
Format of Labeling for Human Nonprescription Drug Products.'' 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 20993-0002. 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: Helen Lee, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 22, Rm. 5493, Silver Spring, MD 20993, 301-796-6848.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Statement of Identity and Strength--Content and Format of
Labeling for Human Nonprescription Drug Products.'' This draft guidance
provides recommendations for the content and format of the required
statement of identity on the labeling of human nonprescription drug
products. This draft guidance also provides recommendations on the
inclusion of the drug product's strength on the labeling.
Labeling for nonprescription drug products is intended to enable
consumers to self-select appropriately and use the nonprescription drug
product safely and effectively without the supervision of a healthcare
practitioner. Nonprescription drug products must comply with applicable
labeling requirements for over-the-counter (OTC) products under 21 CFR
part 201, including, but not limited to, the statement of identity
under Sec. 201.61 (21 CFR 201.61). The statement of identity is one of
the principal features on nonprescription drug product labeling and
consists of the established name for the nonprescription drug product,
if one exists, followed by an accurate statement of the general
pharmacological category(ies) or the principal intended action(s) of
the drug. The labeling of all nonprescription drug products must
display the statement of identity on the product's principal display
panel (Sec. 201.61(a)).
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 ``Statement of
Identity and Strength--Content and Format of Labeling for Human
Nonprescription Drug Products.'' 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
This draft guidance refers to proposed collections of information
described in FDA's 60-day notice requesting public comment on the
proposed collection of information entitled ``Agency
[[Page 55440]]
Information Collection Activities; Proposed Collection; Comment
Request; General Drug Labeling Provisions and Over-the-Counter
Monograph Drug User Fee Submissions.'' The proposed collections of
information are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C.
3501-3521). As required by the PRA, FDA has published an analysis of
these information collection provisions elsewhere in this edition of
the Federal Register and will submit them for OMB approval following
the period for public comment. This draft guidance also refers to
previously approved collections of information found in FDA
regulations. The collections of information in 21 CFR part 314 have
been approved under OMB control number 0910-0001.
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 2, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-19500 Filed 9-8-22; 8:45 am]
BILLING CODE 4164-01-P