Document ID: FDA-2018-D-4693-0001
Agency: fda
Document Type: Notice
Title: Postapproval Pregnancy Safety Studies; Draft Guidance for Industry; Availability
Posted Date: 2019-05-09T04:00Z

[Federal Register Volume 84, Number 90 (Thursday, May 9, 2019)]
[Notices]
[Pages 20371-20373]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-09527]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-4693]

Postapproval Pregnancy Safety Studies; Draft Guidance for 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the availability of a draft guidance for industry entitled 
``Postapproval Pregnancy Safety Studies.'' When finalized, the purpose 
of this guidance will be to provide sponsors and investigators with 
recommendations on how to design investigations to assess the outcomes 
of pregnancies in women exposed to drugs and biological products 
regulated by FDA (i.e., pregnancy safety studies). This draft guidance, 
when finalized, will represent the current thinking of FDA on 
postapproval pregnancy safety studies. This draft guidance is intended 
to help industry develop more comprehensive and scientifically sound 
studies to assess the safety of drug and biological products during 
pregnancy in the postmarketing setting. The previous guidance for 
industry entitled ``Establishing Pregnancy Exposure Registries,'' 
issued on August 23, 2002, has been withdrawn.

DATES: Submit either electronic or written comments on the draft 
guidance by July 8, 2019 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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'').

[[Page 20372]]

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-4693 for ``Postapproval Pregnancy Safety Studies; Draft 
Guidance for Industry; Availability.'' 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 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 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, 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 ``Postapproval Pregnancy Safety Studies.'' When finalized, the 
purpose of this guidance will be to provide sponsors and investigators 
with recommendations on how to design investigations to assess the 
outcomes of pregnancies in women exposed to drugs and biological 
products regulated by FDA. Currently, collection of safety data in 
drugs and biological products used during pregnancy usually occurs 
after approval. Pregnancy registries have been used to collect these 
data. However, in the years since FDA first issued guidance on this 
topic, scientific methodologies for assessing safety in pregnancy in 
the postmarketing setting have evolved.
    FDA held a 2-day public meeting in 2014 during which stakeholders, 
including birth defect experts from academia, industry, professional 
organizations, and patient groups, discussed the use of pregnancy 
registries and other epidemiologic studies to collect postmarketing 
safety data on the use of drug and biological products during 
pregnancy. In addition, FDA conducted reviews of pregnancy registries, 
including assessment of pregnancy registry methods and enrollment.
    This draft guidance, when finalized, will represent the current 
thinking of FDA on postapproval pregnancy safety studies. Based on FDA 
reviews and the 2014 public meeting, the revisions in this draft 
guidance reflect the most up-to-date recommendations for protocol 
specifications and scientific standards for pregnancy safety studies 
and include a broader scope of methods for collection of safety 
information for drug and biological products used during pregnancy, 
including pharmacovigilance activities and other postapproval safety 
studies. The previous guidance for industry entitled ``Establishing 
Pregnancy Exposure Registries,'' issued on August 23, 2002, has been 
withdrawn.
    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 postapproval 
pregnancy safety studies. 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. The Paperwork Reduction Act of 1995

    This 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 
collections of information have been approved under OMB control number 
0910-0001 as follows: (1) 21 CFR 314.50(d) for submitting technical 
sections of the content and format of a new drug application for 
pregnancy registry design considerations; (2) 21 CFR 314.80(c)(2)(iii) 
for submitting postmarketing safety reports; and (3) 21 CFR 
314.81(b)(2)(vii) for submitting postmarketing study updates in annual 
reports. The collections of information in 21 CFR 312.23(a)(6) for 
submitting pregnancy registry design considerations in a protocol for 
investigational new drug applications have been approved under OMB 
control number 0910-0014. The collections of

[[Page 20373]]

information in 21 CFR 310.305(c) and 21 CFR 314.80(c)(2)(iii) and (e) 
for submitting postmarketing safety reports have been approved under 
OMB control number 0910-0230. The collections of information for 
submitting postmarketing safety reports under MedWatch have been 
approved under OMB control number 0910-0291. The collections of 
information in 21 CFR 201.56 and 201.57, including 21 CFR 
201.57(c)(9)(i)(A) for preparing human prescription drug labeling to 
include pregnancy registries and relevant contact information under the 
subheading Pregnancy Exposure Registry have been approved under OMB 
control number 0910-0572. The collections of information contained in 
the guidance for clinical trial sponsors entitled ``Establishment and 
Operation of Clinical Trial Data Monitoring Committees'' (available at 
https://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm127073.pdf) have been approved under OMB control number 0910-0581. 
The collections of information in the ``Content and Format of Labeling 
for Human Prescription Drug and Biological Products; Requirements for 
Pregnancy and Lactation Labeling'' final rule have been approved under 
OMB control number 0910-0624. The collections of information in 21 CFR 
50.25 for the elements of informed consent have been approved under OMB 
control number 0910-0755.

III. Electronic Access

    Persons with access to the internet may obtain the document 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. 2019-09527 Filed 5-8-19; 8:45 am]
BILLING CODE 4164-01-P