72104 Federal Register / Vol. 79, No. 233 / Thursday, December 4, 2014 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–D–1551] 

Pregnancy, Lactation, and 

Reproductive Potential: Labeling for 

Human Prescription Drug and 

Biological Products—Content and 

Format; Draft Guidance for Industry; 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availability of a draft guidance for 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 ‘‘Pregnancy, Lactation, 

and Reproductive Potential: Labeling for 

Human Prescription Drug and Biological 

Products—Content and Format.’’ This 

draft guidance is intended to assist 

applicants in complying with the new 

content and format requirements in the 

Pregnancy, Lactation, and Females and 

Males of Reproductive Potential 

subsections of labeling for human 

prescription drug and biological 

products, as described in the final rule, 

Content and Format of Labeling for 

Human Prescription Drug and 

Biological Products; Requirements for 

Pregnancy and Lactation Labeling. The 

rule, which is being published 

concurrently with this draft guidance, is 

referred to as the ‘‘Pregnancy and 

Lactation Labeling Rule’’ (PLLR). The 

draft guidance will assist applicants in 

developing labeling for new products, 

revising existing labeling, and 

implementing the content and format 

requirements of the PLLR for human 

prescription drug and biological 

products. 

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on the draft guidance by February 2, 

2015. 

ADDRESSES: Submit written requests for 

single copies of this draft guidance to 

the Division of Drug Information, Center 

for Drug Evaluation and Research, Food 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Bldg., 4th 

Floor, Silver Spring, MD 20993, or 

Office of Communication, Outreach and 

Development, Center for Biologics 

Evaluation and Research (CBER), Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. G102, 

Silver Spring, MD 20993. Send one selfaddressed 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 

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: 

Division of Pediatric and Maternal 

Health, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 22, Rm. 6312, Silver Spring, 

MD 20993–0002, 301–796–2200; or 

Stephen Ripley, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993, 240–402– 

7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Pregnancy, Lactation, and 

Reproductive Potential: Labeling for 

Human Prescription Drug and Biological 

Products—Content and Format.’’ The 

draft guidance provides 

recommendations on how to develop 

and revise professional labeling that 

meets the new content and format 

requirements of the Pregnancy, 

Lactation, and Females and Males of 

Reproductive Potential subsections of 

labeling for human prescription drug 

and biological products. Specifically, it 

provides information to assist 

applicants in preparing subsections 8.1 

Pregnancy, 8.2 Lactation, and 8.3 

Females and Males of Reproductive 

Potential of the USE IN SPECIFIC 

POPULATIONS section of the full 

prescribing information under 21 CFR 

201.56(d)(1) and 201.57(c)(9)(i) through 

(iii), as described in the PLLR. 

The PLLR provides a framework to 

clearly communicate information on the 

benefits and risks of drug use during 

pregnancy and lactation to help 

facilitate prescribing decisions. The 

PLLR also includes a subsection on 

females and males of reproductive 

potential to address issues in these 

populations that are linked to pregnancy 

either directly or indirectly. The draft 

guidance provides recommendations to 

applicants submitting new drug 

applications (NDAs), efficacy 

supplements to approved NDAs, 

biologics license applications (BLAs) 

(for biological products that are 

regulated as drugs), and efficacy 

supplements to BLAs, as well as to 

applicants that have previously 

submitted such applications during the 

time periods specified in the 

implementation plan set out in the 

preamble to the PLLR. FDA may revise 

other Agency guidances as needed and 

appropriate to reflect the PLLR content 

and format requirements and the 

recommendations in this guidance, once 

it has been finalized. 

This draft guidance is one of a series 

of guidances FDA is developing, or has 

developed, to assist applicants with the 

content and format of the labeling for 

human prescription drug and biological 

products. In the Federal Register of 

January 24, 2006 (71 FR 3999), FDA 

announced the availability of final 

guidances on the content and format of 

the ‘‘Adverse Reactions’’ (http://

www.fda.gov/downloads/Drugs/

GuidanceComplianceRegulatory

Information/Guidances/ucm075057.pdf) 

and ‘‘Clinical Studies’’ (http://

www.fda.gov/downloads/Drugs/

GuidanceComplianceRegulatory

Information/Guidances/ucm075059.pdf) 

sections of labeling. In the Federal 

Register of October 19, 2009 (74 FR 

53507), FDA announced the availability 

of final guidance on determining 

established pharmacologic class for use 

in the ‘‘Highlights of Prescribing 

Information’’ (http://www.fda.gov/

downloads/Drugs/GuidanceCompliance

RegulatoryInformation/Guidances/

UCM186607.pdf). In the Federal 

Register of March 23, 2010 (75 FR 

13766), FDA announced the availability 

of final guidance on the content and 

format of the ‘‘Dosage and 

Administration’’ section of labeling 

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

GuidanceComplianceRegulatory

Information/Guidances/UCM075066.

pdf). In the Federal Register of October 

12, 2011 (76 FR 63303), FDA announced 

the availability of final guidance on the 

content and format of the ‘‘Warnings 

and Precautions,’’ ‘‘Contraindications,’’ 

and ‘‘Boxed Warning’’ sections of 

labeling (http://www.fda.gov/

downloads/Drugs/GuidanceCompliance

RegulatoryInformation/Guidances/

UCM075096.pdf),and in the Federal 

Register of March 3, 2009 (74 FR 9250), 

FDA announced the availability of draft 

guidance on the content and format of 

the ‘‘Clinical Pharmacology’’ section of 

labeling (http://www.fda.gov/

downloads/Drugs/GuidanceCompliance

RegulatoryInformation/Guidances/

UCM109739.pdf). In the Federal 

Register of February 25, 2013 (78 FR 

12760), FDA announced the availability 

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Federal Register / Vol. 79, No. 233 / Thursday, December 4, 2014 / Notices 72105 

of final guidance implementing the 

‘‘Physician Labeling Rule’’ (January 24, 

2006, 71 FR 3922) content and format 

requirements of labeling for human 

prescription drug and biological 

products under §§ 201.56(d) and 201.57 

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

GuidanceComplianceRegulatory

Information/Guidances/

ucm075082.pdf). In the Federal Register 

of February 28, 2013 (78 FR 13686), 

FDA announced the availability of draft 

guidance on the placement and content 

of pediatric information in the labeling 

for human prescription drug and 

biological products in accordance with 

the Physician Labeling Rule (http://

www.fda.gov/downloads/Drugs/

GuidanceComplianceRegulatory

Information/Guidances/UCM341394.

pdf). 

The labeling requirements and these 

guidances are intended to make 

information in prescription drug 

labeling easier for health care 

practitioners to access, read, and use. 

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 implementing the PLLR content and 

format requirements for labeling for 

human prescription drug and biological 

products. 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 guidance refers to previously 

approved collections of information that 

are subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3520). The collection of 

information in 21 CFR 201.56 and 

201.57 has been approved under OMB 

control number 0910–0572. The 

collection of information in 21 CFR 

314.70 and 314.97 for submitting 

supplements to an approved 

application, the collection of 

information in 21 CFR 314.50(e) for 

submitting labeling for an application, 

and the collection of information in 21 

CFR 314.90 for submitting waiver 

requests for an application have been 

approved under OMB control number 

0910–0001. The collection of 

information in 21 CFR 601.12 for 

submitting supplements to an approved 

application has been approved under 

OMB control number 0910–0338. In 

addition, the information collection 

provisions of the PLLR have been 

submitted to OMB for review, as 

required by section 3507(d) of the 

Paperwork Reduction Act. Prior to the 

effective date of the PLLR, FDA will 

publish a notice in the Federal Register 

announcing OMB’s decision to approve, 

modify, or disapprove the information 

collection provisions in the final rule. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the draft guidance at either 

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

ComplianceRegulatoryInformation/

Guidances/default.htm, http://

www.fda.gov/BiologicsBloodVaccines/

GuidanceComplianceRegulatory

Information/default.htm, or http://

www.regulations.gov. 

Dated: November 25, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–28242 Filed 12–3–14; 8:45 am] 

BILLING CODE 4164–01–P 

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