[Federal Register Volume 84, Number 90 (Thursday, May 9, 2019)]
[Notices]
[Pages 20367-20368]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-09528]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-4525]


Clinical Lactation Studies: Considerations for Study Design; 
Draft Guidance for Industry; Availability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the availability of a draft guidance for industry entitled ``Clinical 
Lactation Studies: Considerations for Study Design.'' This guidance 
reflects FDA's current recommendations to sponsors regarding lactation 
studies during drug development. This guidance provides recommendations 
to facilitate the conduct of lactation studies. Such studies can inform 
breastfeeding with drug use recommendations included in the Lactation 
subsection of labeling. The recommendations in this guidance also 
reflect discussions from the 2007 Pediatric Advisory Committee meeting 
and the 2016 Lactation Workshop, which considered how data from 
clinical lactation studies can inform the safety of a drug when used 
during lactation. This guidance replaces the draft guidance for 
industry entitled ``Clinical Lactation Studies--Study Design, Data 
Analysis, and Recommendations for Labeling'' issued February 2005.

DATES: Submit either electronic or written comments on the draft 
guidance by July 8, 2019 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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-2018-D-4525 for ``Clinical Lactation Studies: Considerations for 
Study Design.'' 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

[[Page 20368]]

claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit 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.gpo.gov/fdsys/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 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.

FOR FURTHER INFORMATION CONTACT: Jian Wang, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Avenue, 
Bldg. 22, Rm 5309, Silver Spring, MD 20993-0002, 301-796-3846; 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 ``Clinical Lactation Studies: Considerations for Study 
Design.'' This guidance reflects FDA's current recommendations 
regarding lactation studies during drug development. This guidance 
provides recommendations to facilitate the conduct of lactation 
studies. Such studies can inform breastfeeding with drug use 
recommendations included in the Lactation subsection of labeling. The 
recommendations in this guidance also reflect discussions at the 2007 
Pediatric Advisory Committee meeting (see https://wayback.archive-it.org/7993/20170403222238/https://www.fda.gov/ohrms/dockets/ac/oc07.htm#pac) and the 2016 Lactation Workshop (see https://www.fda.gov/Drugs/NewsEvents/ucm486761.htm), which considered how data from 
clinical lactation studies can inform the safety of a drug when used 
during lactation. However, this guidance does not address specific 
lactation labeling recommendations because these topics are addressed 
in 21 CFR 201.57(c)(9)(ii) and the draft guidance for industry 
``Pregnancy, Lactation, and Reproductive Potential: Labeling for Human 
Prescription Drug and Biological Products--Content and Format'' 
(available at https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm425398.pdf). This guidance replaces the 
draft guidance for industry entitled ``Clinical Lactation Studies--
Study Design, Data Analysis, and Recommendations for Labeling'' issued 
February 8, 2005 (70 FR 6697).
    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 ``Clinical 
Lactation Studies: Considerations for Study Design.'' 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. This guidance 
is not subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
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 part 314, including the submission 
of labeling under Sec. Sec.  314.50(e)(2)(ii) and 314.50(l)(1)(i), has 
been approved under OMB control number 0910-0001. The submission of 
prescription drug labeling under Sec. Sec.  201.56 and 201.57 has been 
approved under OMB control number 0910-0572. The collection of 
information in 21 CFR part 312 has been approved under OMB control 
number 0910-0014. The collections of information in 21 CFR parts 50 and 
56 (Protection of Human Subjects: Informed Consent; Institutional 
Review Boards) have been approved under OMB control number 0910-0755.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or https://www.regulations.gov.

    Dated: May 3, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-09528 Filed 5-8-19; 8:45 am]
 BILLING CODE 4164-01-P