Recommended Warning for Over-the-Counter Acetaminophen-Containing Drug Products and Labeling Statements Regarding Serious Skin Reactions; Guidance for Industry; Availability, 3332-3333 [2017-00375]
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Federal Register / Vol. 82, No. 7 / Wednesday, January 11, 2017 / Notices
Schedule I synthetic cannabinoids.
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reasons for such a request should be
sent to James R. Hunter (see FOR
FURTHER INFORMATION CONTACT) on or
before January 23, 2017.
sradovich on DSK3GMQ082PROD with NOTICES
Dated: January 5, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–00373 Filed 1–10–17; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
19:05 Jan 10, 2017
Jkt 241001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–D–1862]
Recommended Warning for Over-theCounter Acetaminophen-Containing
Drug Products and Labeling
Statements Regarding Serious Skin
Reactions; Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘Recommended Warning for
Over-the-Counter AcetaminophenContaining Drug Products and Labeling
Statements Regarding Serious Skin
Reactions.’’ This guidance is intended to
inform manufacturers, members of the
medical and scientific community, and
other interested persons that at this time
FDA does not intend to take action
against the marketing of single- and
combination-ingredient,
acetaminophen-containing,
nonprescription (commonly referred to
as over-the-counter (OTC)) drug
products bearing a warning as described
in the guidance alerting consumers that
the use of acetaminophen may cause
severe skin reactions.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: You may submit comments
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.
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
• 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): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, 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–
2014–D–1862 for ‘‘Recommended
Warning for Over-the-Counter
Acetaminophen-Containing Drug
Products and Labeling Statements
Regarding Serious Skin Reactions;
Guidance for Industry.’’ 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 Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
• 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 Division of Dockets
Management. 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
E:\FR\FM\11JAN1.SGM
11JAN1
Federal Register / Vol. 82, No. 7 / Wednesday, January 11, 2017 / Notices
sradovich on DSK3GMQ082PROD with NOTICES
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.fda.gov/
regulatoryinformation/dockets/
default.htm.
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 Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
Submit written requests for single
copies of this 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 guidance document.
FOR FURTHER INFORMATION CONTACT:
Emily Baker, Office of Unapproved
Drugs and Labeling Compliance, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20993–0002, 301–796–7524,
Emily.Baker@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘Recommended Warning for Over-theCounter Acetaminophen-Containing
Drug Products and Labeling Statements
Regarding Serious Skin Reactions.’’
Acetaminophen, included in many
prescription and OTC products, is a
common active ingredient indicated to
treat pain and reduce fever. On August
1, 2013, FDA issued a Drug Safety
Communication (DSC) informing the
public that use of acetaminophen has
been associated with a risk of rare but
serious skin reactions.1 These skin
reactions, including Stevens-Johnson
Syndrome, toxic epidermal necrolysis,
and acute generalized exanthematous
pustulosis, can be fatal.
The DSC explained that reddening of
the skin, rash, blisters, and detachment
of the upper surface of the skin can
occur with the use of drug products that
1 FDA Drug Safety Communication: FDA warns of
rare but serious skin reactions with the pain
reliever/fever reducer acetaminophen. https://
www.fda.gov/Drugs/DrugSafety/ucm363041.htm.
VerDate Sep<11>2014
19:05 Jan 10, 2017
Jkt 241001
contain acetaminophen. These skin
reactions can occur with the first-time
use of acetaminophen or even if
acetaminophen has been used in the
past without any problems. FDA
advised health care professionals to be
aware of this rare risk and consider
acetaminophen, along with other drugs
already known to have such an
association, when assessing patients
with potentially drug-induced skin
reactions. FDA also advised that anyone
who develops a skin rash or reaction
while using acetaminophen or any other
pain reliever/fever reducer should stop
taking the drug and seek medical
attention right away. Furthermore, the
announcement advised that anyone who
has experienced a serious skin reaction
when taking acetaminophen in the past
should not take the drug again and
should contact their health care
professional to discuss alternative pain
relievers/fever reducers.
In response to FDA’s letters to
manufacturers holding new drug
applications and abbreviated new drug
applications, most manufacturers of
acetaminophen-containing prescription
and OTC drug products marketed under
an approved application now include a
warning statement on their product
labels to address the risk of serious skin
reactions. FDA recommends that
manufacturers of all acetaminophencontaining OTC drug products (both
single- and combination-ingredient
acetaminophen products) marketed
under the Tentative Final Monograph
(TFM) for Internal Analgesic,
Antipyretic, and Antirheumatic Drug
Products include in labeling the
language recommended in this guidance
to warn consumers that acetaminophen
may cause severe skin reactions. At this
time, FDA does not intend to take action
against the marketing of single- and
combination-ingredient,
acetaminophen-containing, OTC drug
products bearing the recommended
allergy warning that are otherwise
marketed in compliance with the TFM
and applicable regulations.
In the Federal Registerof November
28, 2014 (79 FR 70879), FDA published
a draft guidance entitled
‘‘Recommended Warning for Over-theCounter Acetaminophen-Containing
Drug Products and Labeling Statements
Regarding Serious Skin Reactions.’’ See:
https://www.fda.gov/downloads/drugs/
guidancecompliance
regulatoryinformation/guidances/
ucm424898.pdf. The November 2014
draft guidance gave interested persons
an opportunity to submit comments
through January 27, 2015. We have
made changes to the guidance in
response to comments received and
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
3333
have added labeling information about
products that contain both
acetaminophen and aspirin.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on the recommended
warning for OTC acetaminophencontaining drug products and labeling
statements regarding serious skin
reactions. 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 the guidance, manufacturers
may add to their drug product labeling
a warning statement supplied by FDA
that pertains to acetaminophen to
address the risk of serious skin
reactions. Inclusion of the warning
statement on the labels for these drug
products would be exempt from review
by the Office of Management and
Budget under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501–3520)
because the public disclosure of
information originally supplied by the
Federal government to the recipient for
the purpose of disclosure to the public
is not included within the definition of
‘‘collection of information’’ (see 5 CFR
1320.3(c)(2)).
III. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: January 5, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–00375 Filed 1–10–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–0067]
Joint Meeting of the Drug Safety and
Risk Management Advisory Committee
and the Anesthetic and Analgesic Drug
Products Advisory Committee; Notice
of Meeting; Establishment of a Public
Docket; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
E:\FR\FM\11JAN1.SGM
11JAN1
Agencies
[Federal Register Volume 82, Number 7 (Wednesday, January 11, 2017)]
[Notices]
[Pages 3332-3333]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-00375]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-D-1862]
Recommended Warning for Over-the-Counter Acetaminophen-Containing
Drug Products and Labeling Statements Regarding Serious Skin Reactions;
Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``Recommended Warning
for Over-the-Counter Acetaminophen-Containing Drug Products and
Labeling Statements Regarding Serious Skin Reactions.'' This guidance
is intended to inform manufacturers, members of the medical and
scientific community, and other interested persons that at this time
FDA does not intend to take action against the marketing of single- and
combination-ingredient, acetaminophen-containing, nonprescription
(commonly referred to as over-the-counter (OTC)) drug products bearing
a warning as described in the guidance alerting consumers that the use
of acetaminophen may cause severe skin reactions.
DATES: Submit either electronic or written comments on Agency guidances
at any time.
ADDRESSES: You may submit comments 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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, 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-2014-D-1862 for ``Recommended Warning for Over-the-Counter
Acetaminophen-Containing Drug Products and Labeling Statements
Regarding Serious Skin Reactions; Guidance for Industry.'' 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 Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
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 Division of Dockets Management. 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
[[Page 3333]]
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.fda.gov/regulatoryinformation/dockets/default.htm.
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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
Submit written requests for single copies of this 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 guidance document.
FOR FURTHER INFORMATION CONTACT: Emily Baker, Office of Unapproved
Drugs and Labeling Compliance, Center for Drug Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring,
MD 20993-0002, 301-796-7524, Emily.Baker@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Recommended Warning for Over-the-Counter Acetaminophen-
Containing Drug Products and Labeling Statements Regarding Serious Skin
Reactions.'' Acetaminophen, included in many prescription and OTC
products, is a common active ingredient indicated to treat pain and
reduce fever. On August 1, 2013, FDA issued a Drug Safety Communication
(DSC) informing the public that use of acetaminophen has been
associated with a risk of rare but serious skin reactions.\1\ These
skin reactions, including Stevens-Johnson Syndrome, toxic epidermal
necrolysis, and acute generalized exanthematous pustulosis, can be
fatal.
---------------------------------------------------------------------------
\1\ FDA Drug Safety Communication: FDA warns of rare but serious
skin reactions with the pain reliever/fever reducer acetaminophen.
https://www.fda.gov/Drugs/DrugSafety/ucm363041.htm.
---------------------------------------------------------------------------
The DSC explained that reddening of the skin, rash, blisters, and
detachment of the upper surface of the skin can occur with the use of
drug products that contain acetaminophen. These skin reactions can
occur with the first-time use of acetaminophen or even if acetaminophen
has been used in the past without any problems. FDA advised health care
professionals to be aware of this rare risk and consider acetaminophen,
along with other drugs already known to have such an association, when
assessing patients with potentially drug-induced skin reactions. FDA
also advised that anyone who develops a skin rash or reaction while
using acetaminophen or any other pain reliever/fever reducer should
stop taking the drug and seek medical attention right away.
Furthermore, the announcement advised that anyone who has experienced a
serious skin reaction when taking acetaminophen in the past should not
take the drug again and should contact their health care professional
to discuss alternative pain relievers/fever reducers.
In response to FDA's letters to manufacturers holding new drug
applications and abbreviated new drug applications, most manufacturers
of acetaminophen-containing prescription and OTC drug products marketed
under an approved application now include a warning statement on their
product labels to address the risk of serious skin reactions. FDA
recommends that manufacturers of all acetaminophen-containing OTC drug
products (both single- and combination-ingredient acetaminophen
products) marketed under the Tentative Final Monograph (TFM) for
Internal Analgesic, Antipyretic, and Antirheumatic Drug Products
include in labeling the language recommended in this guidance to warn
consumers that acetaminophen may cause severe skin reactions. At this
time, FDA does not intend to take action against the marketing of
single- and combination-ingredient, acetaminophen-containing, OTC drug
products bearing the recommended allergy warning that are otherwise
marketed in compliance with the TFM and applicable regulations.
In the Federal Registerof November 28, 2014 (79 FR 70879), FDA
published a draft guidance entitled ``Recommended Warning for Over-the-
Counter Acetaminophen-Containing Drug Products and Labeling Statements
Regarding Serious Skin Reactions.'' See: https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm424898.pdf.
The November 2014 draft guidance gave interested persons an opportunity
to submit comments through January 27, 2015. We have made changes to
the guidance in response to comments received and have added labeling
information about products that contain both acetaminophen and aspirin.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on the recommended warning for OTC
acetaminophen-containing drug products and labeling statements
regarding serious skin reactions. 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 the guidance, manufacturers may add to their drug product
labeling a warning statement supplied by FDA that pertains to
acetaminophen to address the risk of serious skin reactions. Inclusion
of the warning statement on the labels for these drug products would be
exempt from review by the Office of Management and Budget under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) because the
public disclosure of information originally supplied by the Federal
government to the recipient for the purpose of disclosure to the public
is not included within the definition of ``collection of information''
(see 5 CFR 1320.3(c)(2)).
III. Electronic Access
Persons with access to the Internet may obtain the document at
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.
Dated: January 5, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-00375 Filed 1-10-17; 8:45 am]
BILLING CODE 4164-01-P