60854 Federal Register / Vol. 79, No. 195 / Wednesday, October 8, 2014 / Notices 

Hampshire Ave., 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electronic access to the draft guidance 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draft guidance to http://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, drugtrack

andtrace@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘The Effect of Section 585 of the FD&C 

Act on Drug Product Tracing and 

Wholesale Drug Distributor and ThirdParty Logistics Provider Licensing 

Standards and Requirements: Questions 

and Answers.’’ On November 27, 2013, 

the DSCSA (Title II of Pub. L.113–54) 

was signed into law. The DSCSA 

outlines critical steps to build an 

electronic, interoperable system to 

identify and trace certain prescription 

drugs as they are distributed in the 

United States. The DSCSA adds sections 

581 through 585 as Subchapter H of the 

FD&C Act. These sections establish 

definitions (section 581), requirements 

for supply chain participants (section 

582), standards for and licensing of 

wholesale drug distributors (section 

583) and 3PL providers (section 584), 

and a Uniform National Policy (section 

585). 

The DSCSA establishes a Federal 

system for tracing prescription drug 

products through the pharmaceutical 

distribution supply chain and requires 

trading partners to provide, receive, and 

maintain certain product and 

distribution information. The DSCSA 

also requires FDA to establish Federal 

standards for licensing of wholesale 

drug distributors and 3PL providers. 

Section 585 of the FD&C Act sets forth 

a Uniform National Policy, preempting 

States and political subdivisions of 

states from establishing or continuing in 

effect certain standards and 

requirements. FDA is issuing this 

guidance to: (1) Help industry and 

States understand the immediate effects 

of the law and (2) clarify section 585’s 

effect on State product tracing 

requirements and on standards, 

requirements, and regulations with 

respect to wholesale distributor and 3PL 

licensing. 

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 effect of section 585 of the FD&C 

Act on drug product tracing and 

wholesale drug distributor and 3PL 

provider licensing and requirements. 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. 

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/

default.htm, or http://

www.regulations.gov. 

Dated: October 1, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–23972 Filed 10–7–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–D–1473] 

Over-the-Counter Pediatric Liquid Drug 

Products Containing Acetaminophen; 

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 ‘‘Over-the-Counter 

Pediatric Liquid Drug Products 

Containing Acetaminophen.’’ The draft 

guidance is intended to help drug 

manufacturers, packagers, and labelers 

minimize the risk to consumers of 

acetaminophen-related liver damage 

associated with the use of 

nonprescription, also known as overthe-counter (OTC), acetaminophencontaining pediatric liquid drug 

products. This guidance provides 

recommendations for acetaminophen 

concentration, container labels and 

carton labeling, packaging of such 

products, and recommendations 

regarding any associated delivery 

devices. FDA’s recommendations are 

designed to encourage safer use of these 

products by minimizing the potential 

for acetaminophen overdosing due to 

medication errors or accidental 

ingestion. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)), to ensure that the Agency 

considers your comments 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 December 8, 

2014. 

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. 

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: 

Alice Tu, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 22, Rm. 4325, Silver Spring, 

MD 20993–0002, 301–796–7586. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Over-the-Counter Pediatric Liquid 

Drug Products Containing 

Acetaminophen.’’ Acetaminophen is 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 195 / Wednesday, October 8, 2014 / Notices 60855 

1 ‘‘Internal Analgesic, Antipyretic, and 

Antirheumatic Drug Products for Over-the-Counter 

Human Use; Tentative Final Monograph,’’ 53 FR 

46204 (November 16, 1988). Available at http://

www.fda.gov/downloads/Drugs/

DevelopmentApprovalProcess/Development

Resources/Over-the-CounterOTCDrugs/Statusof

OTCRulemakings/UCM078460.pdf. 

2Summary Minutes of the Joint Meeting of the 

Nonprescription Drugs Advisory Committee and the 

Pediatric Advisory Committee, held May 17–18, 

2011, are available at http://www.fda.gov/

downloads/AdvisoryCommittees/Committees

MeetingMaterials/Drugs/NonprescriptionDrugs

AdvisoryCommittee/UCM264147.pdf. 

marketed in many OTC drug products as 

a pain reliever and fever reducer. A 

majority of OTC acetaminophen 

products are currently marketed under 

the conditions stated in FDA’s tentative 

final monograph for internal analgesic, 

antipyretic, and antirheumatic drug 

products for over-the-counter human 

use (the IAAA TFM).1 In addition to the 

drug labeling requirements described in 

section 502 of the Federal Food, Drug, 

and Cosmetic Act (the FD&C Act) (21 

U.S.C. 352) and Title 21 of the Code of 

Federal Regulations (CFR), part 201, 

OTC acetaminophen products must also 

be labeled with liver injury warnings 

and other required information under 

§ 201.326 (21 CFR 201.326). The Agency 

allows acetaminophen to be marketed 

without approval of a new drug 

application (see generally section 505 of 

the FD&C Act (21 U.S.C. 355) and 21 

CFR part 314), in accordance with the 

IAAA TFM, and when the required 

acetaminophen-related warnings and 

other labeling requirements in § 201.326 

are met. However, OTC pediatric liquid 

drug products containing 

acetaminophen have been associated 

with overdoses due to medication errors 

that resulted in serious adverse events, 

including severe liver damage and 

death. In particular, there have been 

many reports of overdose attributed to 

confusion between concentrated 

acetaminophen drops (80 milligrams 

(mg)/0.8 milliliters (mL) and 80 mg/mL) 

and acetaminophen oral liquid (160 mg/ 

5 mL). 

This draft guidance document is part 

of FDA’s ongoing initiative to reduce the 

risk of acetaminophen-related liver 

injury associated with all OTC and 

prescription acetaminophen-containing 

products. As part of that initiative, in 

June 2009, three FDA committees, the 

Drug Safety and Risk Management 

Advisory Committee, the 

Nonprescription Drugs Advisory 

Committee, and the Anesthetic and Life 

Support Drugs Advisory Committee, 

met jointly to consider a range of risk 

reduction measures. Among other 

measures, the Advisory Committees 

recommended moving to a single, 

standardized acetaminophen 

concentration for OTC pediatric liquid 

drug products because the availability of 

multiple concentrations causes 

confusion and errors among both 

consumers and health care 

professionals. In May 2011, FDA 

convened a joint meeting of the 

Nonprescription Drugs Advisory 

Committee and the Pediatric Advisory 

Committee to discuss the use of 

acetaminophen in children. Shortly 

before the meeting, the Consumer 

Healthcare Products Association 

(CHPA) voluntarily proposed to phase 

out all of the existing concentrated drop 

formulations of the OTC, singleingredient, oral, liquid acetaminophen 

drug products for pediatric use and 

market only the 160 mg/5 mL. At the 

Advisory Committee meeting, FDA took 

note of CHPA’s voluntary transition to 

a single concentration of pediatric 

liquid acetaminophen. Among other 

recommendations, the Advisory 

Committees recommended the use of a 

flow restrictor or another feature 

designed to prevent excessive dosing, 

use of a safety dosing syringe to reduce 

accidental ingestion by children, and 

marking dosage delivery devices in 

milliliters only.2

In response to CHPA’s voluntary 

transition to a single concentration of 

OTC liquid acetaminophen products, 

FDA published a Drug Safety 

Communication on December 22, 2011, 

to inform the public of the 160 mg/5 mL 

concentration now marketed for 

children ages 2 to 3 years and to 

recommend that end users of the 

product read the Drug Facts label to 

identify the concentration of the liquid 

acetaminophen, dosage, and directions 

for use. 

FDA is issuing this guidance to 

address ongoing concerns about the 

potential for acetaminophen overdose 

associated with these products and to 

promote their safe use. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance represents the 

Agency’s current thinking on addressing 

safety achieved through drug product 

design and labeling to minimize 

medication errors. 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 

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). The 

collection of information referenced in 

this draft guidance that pertain to the 

format and content requirements for 

OTC drug product labeling (§ 201.66) 

have been approved under OMB control 

number 0910–0340. The labeling 

requirements in § 201.326 are not 

subject to review by the Office of 

Management and Budget because they 

do not constitute a ‘‘collection of 

information’’ under the PRA. Rather, the 

labeling statements are a ‘‘public 

disclosure of information originally 

supplied by the Federal government to 

the recipient for the purpose of 

disclosure to the public’’ (5 CFR 

1320.3(c)(2)). In accordance with the 

PRA, prior to publication of any final 

guidance document, 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 material 

modifications to those previously 

approved collections of information 

found in FDA regulations or guidances. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at http://

www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/

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

regulations.gov. 

Dated: October 1, 2014. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2014–23973 Filed 10–7–14; 8:45 am] 

BILLING CODE 4164–01–P 


asabaliauskas on DSK5VPTVN1PROD with NOTICES