70878 Federal Register / Vol. 79, No. 229 / Friday, November 28, 2014 / Notices 

the last 3 years, we believe that OMB 

approval of these information collection 

provisions should be extended to 

provide for the potential future need of 

a firm in the dietary supplement 

industry to petition for an exemption 

from 100 percent identity testing of 

dietary ingredients. 

Dated: November 21, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–28087 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–1981] 

The Drug Supply Chain Security Act 

Standards for the Interoperable 

Exchange of Information for Tracing of 

Certain Human, Finished, Prescription 

Drugs: How To Exchange Product 

Tracing Information; 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availability of a draft guidance for 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 ‘‘DSCSA Standards for 

the Interoperable Exchange of 

Information for Tracing of Certain 

Human, Finished, Prescription Drugs: 

How To Exchange Product Tracing 

Information.’’ The draft guidance 

addresses the drug supply chain 

security provisions of the Federal Food, 

Drug, and Cosmetic Act (the FD&C Act), 

which requires the Secretary of the 

Department of Health and Human 

Services to establish initial standards for 

the interoperable exchange of 

transaction information, transaction 

history, and transaction statements, in 

paper or electronic format. Specifically, 

the guidance establishes standards for 

how transaction information, 

transaction history, and transaction 

statements should be exchanged among 

trading partners through the extension 

and/or use of current systems and 

processes. 

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 version of the guidance, submit 

either electronic or written comments 

on the draft guidance by January 27, 

2015. Submit either electronic or 

written comments concerning the 

collection of information proposed in 

the draft guidance by January 27, 2015. 

ADDRESSES: 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single copies of the draft guidance to the 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; or 

the Office of Communication, Outreach 

and Development, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 3128, 

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. 

Submit electronic comments on the 

draft 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: 

Office of Compliance, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Silver Spring, MD 

20993–0002, 301–796–3100, 

drugtrackandtrace@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On November 27, 2013, the Drug 

Supply Chain Security Act (Title II of 

Public Law 113–54) was signed into 

law. Section 202 of the Drug Supply 

Chain Security Act (DSCSA), which 

adds new sections 581 and 582 to the 

FD&C Act (21 U.S.C. 360eee and 

360eee–1), sets forth new definitions 

and requirements related to product 

tracing. The DSCSA outlines critical 

steps to build an electronic, 

interoperable system by November 27, 

2023, that will identify and trace certain 

prescription drugs as they are 

distributed within the United States. 

Starting in 2015, certain trading 

partners (manufacturers, wholesale 

distributors, dispensers, and 

repackagers) are required under sections 

582(b)(1), (c)(1), (d)(1), and (e)(1) of the 

FD&C Act to capture, maintain, and 

provide the subsequent purchaser with 

transaction information, transaction 

history, and a transaction statement 

(product tracing information) for certain 

prescription drug products. 

Manufacturers, wholesale distributors, 

and repackagers must meet these 

requirements by January 1, 2015; 

dispensers must meet them by July 1, 

2015. In addition, each manufacturer, 

wholesale distributor, dispenser, and 

repackager must comply with all 

applicable requirements in the event 

they meet the definition of more than 

one trading partner under section 

582(a)(1), but trading partners are not 

required to duplicate requirements. 

Section 582(a)(2)(A) of the FD&C Act 

directs FDA to establish initial 

standards to facilitate the interoperable 

exchange of transaction information, 

transaction history, and transaction 

statements between trading partners. 

FDA obtained stakeholder input on 

the development of the initial standards 

for the interoperable exchange of 

product tracing information, in paper 

and electronic formats, through a public 

docket established in February 2014, as 

required under section 582(a)(2)(B), and 

a public workshop that was held May 8 

and 9, 2014. The public workshop 

provided a forum for FDA to obtain 

input from stakeholders in the 

pharmaceutical distribution supply 

chain on how trading partners can best 

comply with the requirements for the 

interoperable exchange of product 

tracing information beginning in 2015, 

using currently available standards or 

practices. Comments to the public 

dockets and from the workshop were 

considered in the development of this 

guidance, and will be considered in 

developing additional guidance to 

further elaborate on the standards for 

the interoperable exchange of product 

tracing information. 

This initial draft guidance establishes 

standards to help trading partners 

comply with the requirements of 

sections 582(b)(1), (c)(1), (d)(1), and 

(e)(1) of the FD&C Act to provide the 

subsequent trading partners with 

product tracing information, in paper or 

electronic format, through the extension 

and/or use of current systems and 

processes. Under these provisions, 

trading partners are also required to 

capture and maintain the applicable 

product tracing information for not less 

than 6 years after the date of the 

transaction. Implementation of these 

provisions will help further improve the 

security of the pharmaceutical 

distribution supply chain and increase 

confidence in the safety and 

authenticity of human prescription 

drugs. FDA intends to issue additional 

guidance to facilitate the interoperable 

exchange of product tracing information 

through standardization of data and 

documentation practices. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

This guidance is marked as a ‘‘draft’’ 

consistent with its description in 

section 582(a)(2)(A) of the FD&C Act. 


tkelley on DSK3SPTVN1PROD with NOTICES
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