Document ID: FDA-2014-D-1551-0015
Agency: fda
Document Type: Notice
Title: Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products—Content and Format; Draft Guidance for Industry; Availability
Posted Date: 2020-07-30T04:00Z

[Federal Register Volume 85, Number 147 (Thursday, July 30, 2020)]
[Notices]
[Pages 45894-45895]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-16530]

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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Draft Guidance for Industry; Availability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 of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) 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the availability of a draft guidance for industry entitled ``Pregnancy, 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 This draft guidance 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 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. This draft guidance revises 
the draft guidance issued in December 2014. This revision provides 
clarification and additional information on recommendations to 
applicants submitting new drug applications (NDAs), biologics license 
applications (BLAs) (for biological products that are regulated as 
drugs), and efficacy supplements to approved NDAs or BLAs.

DATES: Submit either electronic or written comments on the draft 
guidance by September 28, 2020 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as 
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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-1551 for ``Pregnancy, Lactation, and Reproductive Potential: 
Labeling for Human Prescription Drug and Biological Products--Content 
and Format.'' Received comments will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at https://www.regulations.gov or at the Dockets Management 
Staff 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 https://www.regulations.gov. 
Submit

[[Page 45895]]

both copies to the Dockets Management Staff. 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 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: 
https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    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 20993-0002, or 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.

FOR FURTHER INFORMATION CONTACT: Denise Johnson-Lyles, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 6469, Silver Spring, MD 20993-0002, 301-
796-6169; or Stephen Ripley, Center for Biologics Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
71, Rm. 7301, Silver Spring, MD 20993-0002, 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 final rule, Content and Format of Labeling for Human 
Prescription Drug and Biological Products; Requirements for Pregnancy 
and Lactation Labeling, referred to as the PLLR, which published 
December 4, 2014 (79 FR 72063), modified the labeling requirements for 
human prescription drug and biological products. The PLLR amended FDA's 
regulations governing the content and format of the ``Pregnancy,'' 
``Labor and Delivery,'' and ``Nursing Mothers'' subsections of the 
``Use in Specific Populations'' section of the existing labeling for 
human prescription drug and biological products. This guidance is 
intended to assist applicants in complying with the 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, as described in the PLLR. 
This draft guidance revises the draft guidance of the same name issued 
December 4, 2014 (79 FR 72104). The revisions provide clarification and 
additional information on recommendations in response to public 
comments and the Agency's regulatory experience implementing the PLLR. 
Changes to this draft guidance from the previous draft guidance include 
the addition of the following:
     Information on formatting, omitting information, and 
pregnancy registries.
     Clarifying information related to the Risk Summary 
heading, risk statements, and human and animal data.
     Information on labeling for section 8.3 Females and Males 
of Reproductive Potential, including information on pregnancy testing, 
contraception, and infertility.
     Procedural information on implementation and submission of 
draft labeling to the Agency for review.
    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 current thinking of FDA on ``Pregnancy, 
Lactation, and Reproductive Potential: Labeling for Human Prescription 
Drug and Biological Products--Content and Format.'' 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

    FDA tentatively concludes that this draft guidance contains no 
collection of information. Therefore, clearance by the Office of 
Management and Budget (OMB) under the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3501-3521) is not required.
    However, this draft guidance refers to previously approved 
collections of information. These collections of information are 
subject to review by the OMB under the PRA. The collection of 
information in 21 CFR 201.56 and 201.57 for preparing and submitting 
labeling has been approved under OMB control number 0910-0572. The 
collections of information in 21 CFR 314.70 and 314.97 for submitting 
supplements to an approved application, in 21 CFR 314.50(e) for 
submitting labeling for an application, and 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 approved under 
OMB control number 0910-0624.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics, or 
https://www.regulations.gov.

    Dated: July 27, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-16530 Filed 7-29-20; 8:45 am]
BILLING CODE 4164-01-P