Federal Register / Vol. 79, No. 229 / Friday, November 28, 2014 / Notices 70879 

1FDA 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. 

Under section 582(h)(4) of the FD&C 

Act, FDA intends to eventually ‘‘update 

. . ., as necessary and appropriate, and 

finalize’’ this document to reflect 

standards for interoperable data 

exchange at the package level. Because 

the DSCSA clearly intends for 

stakeholders to rely upon this guidance 

document before finalization, however, 

FDA is immediately implementing this 

document under 21 CFR 10.115(g)(2). 

As a result, it reflects FDA’s current 

thinking on this topic and is intended 

to provide guidance to stakeholders as 

they implement the DSCSA. Guidance 

documents generally do not create or 

confer any rights for or on any person 

and do not operate to bind FDA or the 

public. An alternative approach may be 

used if such approach satisfies the 

requirements of the applicable statutes 

and regulations. 

II. Paperwork Reduction Act of 1995 

This draft guidance includes 

information collection provisions that 

are subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(PRA) (44 U.S.C. 3501–3520). FDA 

intends to solicit public comment and 

obtain OMB approval for any 

information collections recommended 

in this guidance that are new or that 

would represent modifications to those 

previously approved collections of 

information found in FDA regulations or 

guidances. 

III. Comments 

Interested persons may submit either 

electronic comments regarding this 

document to http://www.regulations.gov 

or written comments to the Division of 

Dockets Management (see ADDRESSES). It 

is only necessary to send one set of 

comments. Identify comments with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday, and 

will be posted to the docket at http://

www.regulations.gov. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at http://

www.fda.gov/Drugs/

GuidanceCompliance

RegulatoryInformation/Guidances/

default.htm, http://www.fda.gov/

BiologicsBloodVaccines/Guidance

ComplianceRegulatoryInformation/

Guidances/default.htm, or http://www.

regulations.gov. 

Dated: November 21, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–28085 Filed 11–26–14; 8:45 am] 

BILLING CODE 4164–01–P 

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; Draft Guidance for 

Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Recommended 

Warning for Over-the-Counter 

Acetaminophen-Containing Drug 

Products and Labeling Statements 

Regarding Serious Skin Reactions.’’ The 

draft guidance is intended to inform 

manufacturers, members of the medical 

and scientific community, and other 

interested persons that at this time we 

do not intend to object to 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 draft guidance alerting consumers 

that the use of acetaminophen may 

cause severe skin reactions. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the Agency 

considers your comment on this draft 

guidance before it begins work on the 

final guidance, submit either electronic 

or written comments on the draft 

guidance by January 27, 2015. 

ADDRESSES: 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, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 2201, 

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. 

Submit electronic comments on the 

guidance to http://www.regulations.gov. 

Submit written comments to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, Rm. 1061, Rockville, 

MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Sudha Shukla, 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, 301–796–3110, 

Sudha.Shukla@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft 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 

contain acetaminophen. These skin 

reactions can occur with the first-time 

use of acetaminophen or at any time 

while it is being taken. 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 the announcement, FDA stated that 

it planned to require manufacturers of 

acetaminophen-containing prescription 


tkelley on DSK3SPTVN1PROD with NOTICES
70880 Federal Register / Vol. 79, No. 229 / Friday, November 28, 2014 / Notices 

drug products to include a warning 

statement on the product labels to 

address the risk of serious skin reactions 

and that it would request the same 

warning be added by manufacturers of 

OTC acetaminophen-containing drug 

products marketed under an approved 

application. In the fall of 2013, FDA 

sent letters to manufacturers holding 

new drug applications (NDA) and 

abbreviated new drug applications 

(ANDA) requiring in some cases and 

requesting in others that the language 

recommended below be included on the 

labeling for all products (both 

prescription and OTC) containing 

acetaminophen marketed under NDAs 

and ANDAs. At this time, most of the 

requested labeling changes have been 

made by the relevant manufacturers. 

FDA also indicated that it planned to 

encourage manufacturers of 

acetaminophen-containing drug 

products marketed under the Tentative 

Final Monograph for Internal Analgesic, 

Antipyretic, and Antirheumatic Drug 

Products for Over-the-Counter Human 

Use, published in the Federal Register 

(53 FR 46204, November 16, 1988) to 

similarly add a warning about serious 

skin reactions to the product labels. As 

noted above, this draft guidance informs 

manufacturers, members of the medical 

and scientific community, and other 

interested persons that at this time we 

do not intend to object to the marketing 

of single- and combination-ingredient, 

acetaminophen-containing, 

nonprescription (commonly referred to 

as OTC) drug products bearing a 

warning as described in the draft 

guidance alerting consumers that the 

use of acetaminophen may cause severe 

skin reactions. 

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 Agency’s current thinking 

on the recommended warning for OTC 

acetaminophen-containing drug 

products and labeling statements 

regarding serious skin reactions. It does 

not create or confer any rights for or on 

any person and does not operate to bind 

FDA or the public. An alternative 

approach may be used if such approach 

satisfies the requirements of the 

applicable statutes and regulations. 

II. Comments 

Interested persons may submit either 

electronic comments regarding this 

document to http://www.regulations.gov 

or written comments to the Division of 

Dockets Management (see ADDRESSES). It 

is only necessary to send one set of 

comments. Identify comments with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday, and 

will be posted to the docket at http://

www.regulations.gov. 

III. Paperwork Reduction Act of 1995 

Under the draft 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)). 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/Drugs/

GuidanceCompliance

RegulatoryInformation/Guidances/

default.htm or http://

www.regulations.gov. 

Dated: November 21, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–28086 Filed 11–26–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The contract proposals and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the contract 

proposals, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel; NIAID Peer Review Meeting. 

Date: December 16, 2014. 

Time: 9:00 a.m. to 12:30 p.m. 

Agenda: To review and evaluate contract 

proposals. 

Place: National Institutes of Health, Room 

4F100, 5601 Fishers Lane, Rockville, MD 

(Telephone Conference Call). 

Contact Person: Vasundhara Varthakavi, 

DVM, Ph.D., Scientific Review Officer, 

Scientific Review Program, DEA/NIAID/NIH/ 

DHHS, 5601 Fishers Lane, Rockville, MD, 

301–496–2550, varthakaviv@niaid.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.855, Allergy, Immunology, 

and Transplantation Research; 93.856, 

Microbiology and Infectious Diseases 

Research, National Institutes of Health, HHS) 

Dated: November 21, 2014. 

David Clary, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2014–28074 Filed 11–26–14; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel, NIH Support for 

Conferences and Scientific Meetings (Parent 

R13/U13). 

Date: December 15–19, 2014. 

Time: 9:00 a.m. to 3:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, Room 

3G62, 5601 Fishers Lane, Rockville, MD 

20852, (Virtual Meeting). 

Contact Person: Travis J. Taylor, Ph.D., 

Scientific Review Program DEA/NIAID/NIH/ 

DHHS, 5601 Fishers Lane, Rockville, MD 

20892, 240–669–5082, Travis.Taylor@

nih.gov. 


tkelley on DSK3SPTVN1PROD with NOTICES