82 FR 3332 - Recommended Warning for Over-the-Counter Acetaminophen-Containing Drug Products and Labeling Statements Regarding Serious Skin Reactions; Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 7 (January 11, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 7 (January 11, 2017)
| Page Range | 3332-3333 | |
| FR Document | 2017-00375 |
[Federal Register Volume 82, Number 7 (Wednesday, January 11, 2017)] [Notices] [Pages 3332-3333] From the Federal Register Online [www.thefederalregister.org] [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: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://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 http://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 http://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 http://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: http://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 http://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, [email protected]. 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. http://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: http://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 http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://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
![3332 Federal Register / Vol. 82, No. 7 / Wednesday, January 11, 2017 / Notices
Schedule I synthetic cannabinoids. DEPARTMENT OF HEALTH AND • If you want to submit a comment
Synthetic cannabinoids are marketed HUMAN SERVICES with confidential information that you
under the guise of ‘‘herbal incense,’’ and do not wish to be made available to the
promoted by drug traffickers as legal Food and Drug Administration public submit the comment as a written/
alternatives to marijuana. On May 11, paper submission and in the manner
[Docket No. FDA–2014–D–1862] detailed (see ‘‘Written/Paper
2016, XLR11 was permanently
controlled as a Schedule I substance Recommended Warning for Over-the- Submissions’’ and ‘‘Instructions’’).
under the CSA. As such, additional Counter Acetaminophen-Containing Written/Paper Submissions
permanent controls will not be Drug Products and Labeling Submit written/paper submissions as
necessary to fulfill U.S. obligations if Statements Regarding Serious Skin follows:
XLR–11 is controlled under Schedule II Reactions; Guidance for Industry; • Mail/Hand delivery/Courier (for
of the 1971 Convention on Psychotropic Availability written/paper submissions): Division of
Substances. Dockets Management (HFA–305), Food
AGENCY: Food and Drug Administration,
FDA, on behalf of the Secretary of HHS. and Drug Administration, 5630 Fishers
HHS, invites interested persons to Lane, Rm. 1061, Rockville, MD 20852.
ACTION: Notice of availability. • For written/paper comments
submit comments on the notifications
from the United Nations concerning SUMMARY: The Food and Drug submitted to the Division of Dockets
Administration (FDA) is announcing the Management, FDA will post your
these drug substances. FDA, in
availability of a guidance for industry comment, as well as any attachments,
cooperation with the National Institute
entitled ‘‘Recommended Warning for except for information submitted,
on Drug Abuse, will consider the marked and identified, as confidential,
comments on behalf of HHS in Over-the-Counter Acetaminophen-
Containing Drug Products and Labeling if submitted as detailed in
evaluating the WHO scheduling ‘‘Instructions.’’
recommendations. Then, under section Statements Regarding Serious Skin
Instructions: All submissions received
201(d)(2)(B) of the CSA, HHS will Reactions.’’ This guidance is intended to
must include the Docket No. FDA–
recommend to the Secretary of State inform manufacturers, members of the
2014–D–1862 for ‘‘Recommended
what position the United States should medical and scientific community, and Warning for Over-the-Counter
take when voting on the other interested persons that at this time Acetaminophen-Containing Drug
FDA does not intend to take action Products and Labeling Statements
recommendations for control of
against the marketing of single- and Regarding Serious Skin Reactions;
substances under the Psychotropic
combination-ingredient, Guidance for Industry.’’ Received
Convention at the CND meeting in acetaminophen-containing,
March 2017. comments will be placed in the docket
nonprescription (commonly referred to and, except for those submitted as
Comments regarding the WHO as over-the-counter (OTC)) drug ‘‘Confidential Submissions,’’ publicly
recommendations for control of U– products bearing a warning as described viewable at http://www.regulations.gov
47700 and Butyrylfentanyl under the in the guidance alerting consumers that or at the Division of Dockets
1961 Single Convention will also be the use of acetaminophen may cause Management between 9 a.m. and 4 p.m.,
forwarded to the relevant Agencies for severe skin reactions. Monday through Friday.
consideration in developing the U.S. DATES: Submit either electronic or • Confidential Submissions—To
position regarding narcotic substances written comments on Agency guidances submit a comment with confidential
at the CND meeting. at any time. information that you do not wish to be
ADDRESSES: You may submit comments made publicly available, submit your
IV. Opportunity for Public Meeting
as follows: comments only as a written/paper
FDA does not presently plan to hold submission. You should submit two
Electronic Submissions copies total. One copy will include the
a public meeting. If any person believes
that, in addition to written comments, a Submit electronic comments in the information you claim to be confidential
public meeting would contribute to the following way: with a heading or cover note that states
development of the U.S. position on the • Federal eRulemaking Portal: http:// ‘‘THIS DOCUMENT CONTAINS
substances to be considered for control www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ The
under the Psychotropic Convention, a instructions for submitting comments. Agency will review this copy, including
Comments submitted electronically, the claimed confidential information, in
request for a public meeting and the
including attachments, to http:// its consideration of comments. The
reasons for such a request should be
www.regulations.gov will be posted to second copy, which will have the
sent to James R. Hunter (see FOR the docket unchanged. Because your claimed confidential information
FURTHER INFORMATION CONTACT) on or
comment will be made public, you are redacted/blacked out, will be available
before January 23, 2017. solely responsible for ensuring that your for public viewing and posted on http://
Dated: January 5, 2017. comment does not include any www.regulations.gov. Submit both
Leslie Kux, confidential information that you or a copies to the Division of Dockets
Associate Commissioner for Policy. third party may not wish to be posted, Management. If you do not wish your
such as medical information, your or name and contact information to be
[FR Doc. 2017–00373 Filed 1–10–17; 8:45 am]
anyone else’s Social Security number, or made publicly available, you can
sradovich on DSK3GMQ082PROD with NOTICES
BILLING CODE 4164–01–P
confidential business information, such provide this information on the cover
as a manufacturing process. Please note sheet and not in the body of your
that if you include your name, contact comments and you must identify this
information, or other information that information as ‘‘confidential.’’ Any
identifies you in the body of your information marked as ‘‘confidential’’
comments, that information will be will not be disclosed except in
posted on http://www.regulations.gov. accordance with 21 CFR 10.20 and other
VerDate Sep<11>2014 19:05 Jan 10, 2017 Jkt 241001 PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 E:\FR\FM\11JAN1.SGM 11JAN1](https://thefederalregister.org/doc/82_FR_3339/page/1.svg)
![Federal Register / Vol. 82, No. 7 / Wednesday, January 11, 2017 / Notices 3333
applicable disclosure law. For more contain acetaminophen. These skin have added labeling information about
information about FDA’s posting of reactions can occur with the first-time products that contain both
comments to public dockets, see 80 FR use of acetaminophen or even if acetaminophen and aspirin.
56469, September 18, 2015, or access acetaminophen has been used in the This guidance is being issued
the information at: http://www.fda.gov/ past without any problems. FDA consistent with FDA’s good guidance
regulatoryinformation/dockets/ advised health care professionals to be practices regulation (21 CFR 10.115).
default.htm. aware of this rare risk and consider The guidance represents the current
Docket: For access to the docket to acetaminophen, along with other drugs thinking of FDA on the recommended
read background documents or the already known to have such an warning for OTC acetaminophen-
electronic and written/paper comments association, when assessing patients containing drug products and labeling
received, go to http:// with potentially drug-induced skin statements regarding serious skin
www.regulations.gov and insert the reactions. FDA also advised that anyone reactions. It does not establish any
docket number, found in brackets in the who develops a skin rash or reaction rights for any person and is not binding
heading of this document, into the while using acetaminophen or any other on FDA or the public. You can use an
‘‘Search’’ box and follow the prompts pain reliever/fever reducer should stop alternative approach if it satisfies the
and/or go to the Division of Dockets taking the drug and seek medical requirements of the applicable statutes
Management, 5630 Fishers Lane, Rm. attention right away. Furthermore, the and regulations.
1061, Rockville, MD 20852. announcement advised that anyone who
Submit written requests for single has experienced a serious skin reaction II. Paperwork Reduction Act of 1995
copies of this guidance to the Division when taking acetaminophen in the past Under the guidance, manufacturers
of Drug Information, Center for Drug should not take the drug again and may add to their drug product labeling
Evaluation and Research, Food and should contact their health care a warning statement supplied by FDA
Drug Administration, 10001 New professional to discuss alternative pain that pertains to acetaminophen to
Hampshire Ave., Hillandale Building, relievers/fever reducers. address the risk of serious skin
4th Floor, Silver Spring, MD 20993– In response to FDA’s letters to reactions. Inclusion of the warning
0002. Send one self-addressed adhesive manufacturers holding new drug statement on the labels for these drug
label to assist that office in processing applications and abbreviated new drug products would be exempt from review
your requests. See the SUPPLEMENTARY applications, most manufacturers of
by the Office of Management and
INFORMATION section for electronic acetaminophen-containing prescription
Budget under the Paperwork Reduction
access to the guidance document. and OTC drug products marketed under
Act of 1995 (44 U.S.C. 3501–3520)
FOR FURTHER INFORMATION CONTACT: an approved application now include a
because the public disclosure of
Emily Baker, Office of Unapproved warning statement on their product
information originally supplied by the
Drugs and Labeling Compliance, Center labels to address the risk of serious skin
Federal government to the recipient for
for Drug Evaluation and Research, Food reactions. FDA recommends that
the purpose of disclosure to the public
and Drug Administration, 10903 New manufacturers of all acetaminophen-
is not included within the definition of
Hampshire Ave., Silver Spring, MD containing OTC drug products (both
‘‘collection of information’’ (see 5 CFR
20993–0002, 301–796–7524, single- and combination-ingredient
acetaminophen products) marketed 1320.3(c)(2)).
Emily.Baker@fda.hhs.gov.
under the Tentative Final Monograph III. Electronic Access
SUPPLEMENTARY INFORMATION:
(TFM) for Internal Analgesic,
Antipyretic, and Antirheumatic Drug Persons with access to the Internet
I. Background
Products include in labeling the may obtain the document at either
FDA is announcing the availability of http://www.fda.gov/Drugs/Guidance
a guidance for industry entitled language recommended in this guidance
to warn consumers that acetaminophen ComplianceRegulatoryInformation/
‘‘Recommended Warning for Over-the- Guidances/default.htm or http://
Counter Acetaminophen-Containing may cause severe skin reactions. At this
time, FDA does not intend to take action www.regulations.gov.
Drug Products and Labeling Statements
against the marketing of single- and Dated: January 5, 2017.
Regarding Serious Skin Reactions.’’
combination-ingredient, Leslie Kux,
Acetaminophen, included in many
acetaminophen-containing, OTC drug Associate Commissioner for Policy.
prescription and OTC products, is a
products bearing the recommended [FR Doc. 2017–00375 Filed 1–10–17; 8:45 am]
common active ingredient indicated to
allergy warning that are otherwise
treat pain and reduce fever. On August BILLING CODE 4164–01–P
marketed in compliance with the TFM
1, 2013, FDA issued a Drug Safety
and applicable regulations.
Communication (DSC) informing the In the Federal Registerof November
public that use of acetaminophen has DEPARTMENT OF HEALTH AND
28, 2014 (79 FR 70879), FDA published HUMAN SERVICES
been associated with a risk of rare but a draft guidance entitled
serious skin reactions.1 These skin ‘‘Recommended Warning for Over-the- Food and Drug Administration
reactions, including Stevens-Johnson Counter Acetaminophen-Containing
Syndrome, toxic epidermal necrolysis, Drug Products and Labeling Statements
and acute generalized exanthematous [Docket No. FDA–2017–N–0067]
Regarding Serious Skin Reactions.’’ See:
pustulosis, can be fatal. http://www.fda.gov/downloads/drugs/
The DSC explained that reddening of Joint Meeting of the Drug Safety and
sradovich on DSK3GMQ082PROD with NOTICES
guidancecompliance Risk Management Advisory Committee
the skin, rash, blisters, and detachment regulatoryinformation/guidances/
of the upper surface of the skin can and the Anesthetic and Analgesic Drug
ucm424898.pdf. The November 2014 Products Advisory Committee; Notice
occur with the use of drug products that draft guidance gave interested persons of Meeting; Establishment of a Public
1 FDA Drug Safety Communication: FDA warns of
an opportunity to submit comments Docket; Request for Comments
rare but serious skin reactions with the pain
through January 27, 2015. We have
reliever/fever reducer acetaminophen. http:// made changes to the guidance in AGENCY: Food and Drug Administration,
www.fda.gov/Drugs/DrugSafety/ucm363041.htm. response to comments received and HHS.
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Document Created: 2018-02-01 14:59:36
Document Modified: 2018-02-01 14:59:36
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| Dates | Submit either electronic or written comments on Agency guidances at any time. | |
| 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, [email protected] | |
| FR Citation | 82 FR 3332 |
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