83_FR_15229 83 FR 15161 - Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials; Draft Guidance; Availability

83 FR 15161 - Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials; Draft Guidance; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 68 (April 9, 2018)

Page Range15161-15162
FR Document2018-07151

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials.'' This draft guidance discusses the ethical and scientific issues when considering the inclusion of pregnant women in clinical trials of drugs and biological products. This draft guidance is intended to advance scientific research in pregnant women, and discusses issues that should be considered within the framework of human subject protection regulations.

Federal Register, Volume 83 Issue 68 (Monday, April 9, 2018) 
[Federal Register Volume 83, Number 68 (Monday, April 9, 2018)]
[Notices]
[Pages 15161-15162]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-07151]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-1201]


Pregnant Women: Scientific and Ethical Considerations for 
Inclusion in Clinical Trials; Draft Guidance; Availability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the availability of a draft guidance for industry entitled ``Pregnant 
Women: Scientific and Ethical Considerations for Inclusion in Clinical 
Trials.'' This draft guidance discusses the ethical and scientific 
issues when considering the inclusion of pregnant women in clinical 
trials of drugs and biological products. This draft guidance is 
intended to advance scientific research in pregnant women, and 
discusses issues that should be considered within the framework of 
human subject protection regulations.

DATES: Submit either electronic or written comments on the draft 
guidance by June 8, 2018 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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

[[Page 15162]]

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-1201 for ``Pregnant Women: Scientific and Ethical 
Considerations for Inclusion in Clinical Trials; Draft Guidance; 
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.thefederalregister.org/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. 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.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Pregnant Women: Scientific and Ethical Considerations for 
Inclusion in Clinical Trials.'' Currently, collection of safety data on 
prescription drugs and biological products used during pregnancy 
usually occurs after approval, and clinicians and patients must 
undertake a risk-benefit analysis for the use of such products in 
pregnant women with limited human safety information. Historically, 
pregnant women have been an understudied population and there have been 
barriers to obtaining data from pregnant women in clinical trials, 
including concerns about protecting women and their fetuses from 
research-related risks. However, data are needed to inform safe and 
effective treatment during pregnancy, and in certain situations, it is 
ethically and scientifically appropriate to collect data in pregnant 
women in clinical trials conducted during drug development.
    This draft guidance discusses the ethical and scientific issues 
when considering the inclusion of pregnant women in clinical trials of 
drugs and biological products. This draft guidance is intended to 
advance scientific research in pregnant women, and discusses issues 
that should be considered within the framework of human subject 
protection regulations.
    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 scientific and 
ethical considerations for inclusion of pregnant women in clinical 
trials. 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. Electronic Access

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

    Dated: April 3, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-07151 Filed 4-6-18; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 68 / Monday, April 9, 2018 / Notices 15161 necessary for activities related to the assurance provided by 100 percent frequency, we added to § 111.75(a)(1), manufacturing, packaging, labeling, or identity testing, the identity of the an exemption from the requirement of holding dietary supplements to ensure dietary ingredient before use. 100 percent identity testing when a the quality of the dietary supplement. Section 111.75(a)(1) reflects our manufacturer petitions the Agency for Section 111.75(a)(1) of our regulations determination that manufacturers that such an exemption to 100 percent (21 CFR 111.75(a)(1)) establishes a test or examine 100 percent of the identity testing under 21 CFR 10.30 and procedure for a petition to request an incoming dietary ingredients for the Agency grants such exemption. exemption from 100 percent identity identity can be assured of the identity Such a procedure would be consistent testing of dietary ingredients. Under of the ingredient. However, we with our stated goal, as described in the § 111.75(a)(1)(ii), manufacturers may recognize that it may be possible for a CGMP final rule, of providing flexibility request an exemption from the manufacturer to demonstrate, through in the CGMP requirements. Section requirements set forth in various methods and processes in use 111.75(a)(1)(ii) sets forth the § 111.75(a)(1)(i) when the dietary over time for its particular operation, information a manufacturer is required ingredient is obtained from one or more that a system of less than 100 percent to submit in such a petition. The suppliers identified in the petition. The identity testing would result in no regulation also contains a requirement regulation clarifies that we are willing to material diminution of assurance of the to ensure that the manufacturer keeps consider, on a case-by-case basis, a identity of the dietary ingredient as our response to a petition submitted manufacturer’s conclusion, supported compared to the assurance provided by under § 111.75(a)(1)(ii) as a record by appropriate data and information in 100 percent identity testing. To provide under § 111.95 (21 CFR 111.95). The the petition submission, that it has an opportunity for a manufacturer to collection of information in § 111.95 has developed a system that it would make such a showing and reduce the been approved under OMB control implement as a sound, consistent means frequency of identity testing of number 0910–0606. of establishing, with no material components that are dietary ingredients FDA estimates the burden of this diminution of assurance compared to from 100 percent to some lower collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of Total Average Number of 21 CFR section/activity responses per annual burden per Total hours respondents respondent responses response 111.75(a)(1)(ii); Determining whether specifications are met .................................................................................. 1 1 1 8 8 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Since OMB’s last approval of the DEPARTMENT OF HEALTH AND by June 8, 2018 to ensure that the information collection, we have HUMAN SERVICES Agency considers your comment on this received no petitions. We therefore draft guidance before it begins work on retain the currently approved estimated Food and Drug Administration the final version of the guidance. burden, which assumes no more than [Docket No. FDA–2018–D–1201] ADDRESSES: You may submit comments one petition will be submitted annually. on any guidance at any time as follows: We further assume it would take Pregnant Women: Scientific and Electronic Submissions respondents 8 hours to prepare the Ethical Considerations for Inclusion in factual and legal information necessary Clinical Trials; Draft Guidance; Submit electronic comments in the to support a petition for exemption and Availability following way: to prepare the petition, for a total of 8 • Federal eRulemaking Portal: AGENCY: Food and Drug Administration, https://www.regulations.gov. Follow the burden hours annually. These figures HHS. instructions for submitting comments. are based on our experience with the ACTION: Notice of availability. Comments submitted electronically, information collection. including attachments, to https:// Dated: April 3, 2018. SUMMARY: The Food and Drug www.regulations.gov will be posted to Leslie Kux, Administration (FDA or Agency) is the docket unchanged. Because your Associate Commissioner for Policy. announcing the availability of a draft comment will be made public, you are guidance for industry entitled ‘‘Pregnant solely responsible for ensuring that your [FR Doc. 2018–07156 Filed 4–6–18; 8:45 am] Women: Scientific and Ethical comment does not include any BILLING CODE 4164–01–P Considerations for Inclusion in Clinical confidential information that you or a Trials.’’ This draft guidance discusses third party may not wish to be posted, the ethical and scientific issues when such as medical information, your or considering the inclusion of pregnant anyone else’s Social Security number, or women in clinical trials of drugs and confidential business information, such biological products. This draft guidance as a manufacturing process. Please note sradovich on DSK3GMQ082PROD with NOTICES is intended to advance scientific that if you include your name, contact research in pregnant women, and information, or other information that discusses issues that should be identifies you in the body of your considered within the framework of comments, that information will be human subject protection regulations. posted on https://www.regulations.gov. DATES: Submit either electronic or • If you want to submit a comment written comments on the draft guidance with confidential information that you VerDate Sep<11>2014 18:06 Apr 06, 2018 Jkt 244001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 E:\FR\FM\09APN1.SGM 09APN1

15162 Federal Register / Vol. 83, No. 68 / Monday, April 9, 2018 / Notices do not wish to be made available to the fdsys/pkg/FR-2015-09-18/pdf/2015- biological products. This draft guidance public, submit the comment as a 23389.pdf. is intended to advance scientific written/paper submission and in the Docket: For access to the docket to research in pregnant women, and manner detailed (see ‘‘Written/Paper read background documents or the discusses issues that should be Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments considered within the framework of received, go to https:// human subject protection regulations. Written/Paper Submissions www.regulations.gov and insert the This draft guidance is being issued Submit written/paper submissions as docket number, found in brackets in the consistent with FDA’s good guidance follows: heading of this document, into the practices regulation (21 CFR 10.115). • Mail/Hand delivery/Courier (for ‘‘Search’’ box and follow the prompts The draft guidance, when finalized, will written/paper submissions): Dockets and/or go to the Dockets Management represent the current thinking of FDA Management Staff (HFA–305), Food and Staff, 5630 Fishers Lane, Rm. 1061, on scientific and ethical considerations Drug Administration, 5630 Fishers Rockville, MD 20852. for inclusion of pregnant women in Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any clinical trials. It does not establish any • For written/paper comments guidance at any time (see 21 CFR rights for any person and is not binding submitted to the Dockets Management 10.115(g)(5)). on FDA or the public. You can use an Staff, FDA will post your comment, as Submit written requests for single alternative approach if it satisfies the well as any attachments, except for copies of the draft guidance to the requirements of the applicable statutes information submitted, marked and Division of Drug Information, Center for and regulations. This guidance is not identified, as confidential, if submitted Drug Evaluation and Research, Food subject to Executive Order 12866. as detailed in ‘‘Instructions.’’ and Drug Administration, 10001 New II. Electronic Access Instructions: All submissions received Hampshire Ave., Hillandale Building, must include the Docket No. FDA– 4th Floor, Silver Spring, MD 20993– Persons with access to the internet 2018–D–1201 for ‘‘Pregnant Women: 0002. Send one self-addressed adhesive may obtain the draft guidance at either Scientific and Ethical Considerations for label to assist that office in processing https://www.fda.gov/Drugs/Guidance Inclusion in Clinical Trials; Draft your requests. See the SUPPLEMENTARY ComplianceRegulatoryInformation/ Guidance; Availability.’’ Received INFORMATION section for electronic Guidances/default.htm or https:// comments will be placed in the docket access to the draft guidance document. www.regulations.gov. and, except for those submitted as FOR FURTHER INFORMATION CONTACT: Dated: April 3, 2018. ‘‘Confidential Submissions,’’ publicly Denise Johnson-Lyles, Center for Drug Leslie Kux, viewable at https://www.regulations.gov Evaluation and Research, Food and Associate Commissioner for Policy. or at the Dockets Management Staff Drug Administration, 10903 New [FR Doc. 2018–07151 Filed 4–6–18; 8:45 am] between 9 a.m. and 4 p.m., Monday Hampshire Ave., Bldg. 22, Rm. 6469, BILLING CODE 4164–01–P through Friday. Silver Spring, MD 20993, 301–796– • Confidential Submissions—To 6169. submit a comment with confidential SUPPLEMENTARY INFORMATION: DEPARTMENT OF HEALTH AND information that you do not wish to be HUMAN SERVICES made publicly available, submit your I. Background comments only as a written/paper FDA is announcing the availability of Health Resources and Services submission. You should submit two a draft guidance for industry entitled Administration copies total. One copy will include the ‘‘Pregnant Women: Scientific and Agency Information Collection information you claim to be confidential Ethical Considerations for Inclusion in Activities: Submission to OMB for with a heading or cover note that states Clinical Trials.’’ Currently, collection of Review and Approval; Public Comment ‘‘THIS DOCUMENT CONTAINS safety data on prescription drugs and Request; NURSE Corps Loan CONFIDENTIAL INFORMATION.’’ The biological products used during Repayment Program, OMB #0915– Agency will review this copy, including pregnancy usually occurs after approval, 0140—Revision the claimed confidential information, in and clinicians and patients must its consideration of comments. The undertake a risk-benefit analysis for the AGENCY: Health Resources and Services second copy, which will have the use of such products in pregnant Administration (HRSA), Department of claimed confidential information women with limited human safety Health and Human Services. redacted/blacked out, will be available information. Historically, pregnant ACTION: Notice. for public viewing and posted on women have been an understudied https://www.regulations.gov. Submit population and there have been barriers SUMMARY: In compliance with the both copies to the Dockets Management to obtaining data from pregnant women Paperwork Reduction Act of 1995, Staff. If you do not wish your name and in clinical trials, including concerns HRSA has submitted an Information contact information to be made publicly about protecting women and their Collection Request (ICR) to the Office of available, you can provide this fetuses from research-related risks. Management and Budget (OMB) for information on the cover sheet and not However, data are needed to inform safe review and approval. Comments in the body of your comments and you and effective treatment during submitted during the first public review must identify this information as pregnancy, and in certain situations, it of this ICR will be provided to OMB. ‘‘confidential.’’ Any information marked OMB will accept further comments from sradovich on DSK3GMQ082PROD with NOTICES is ethically and scientifically as ‘‘confidential’’ will not be disclosed appropriate to collect data in pregnant the public during the review and except in accordance with 21 CFR 10.20 women in clinical trials conducted approval period. and other applicable disclosure law. For during drug development. DATES: Comments on this ICR should be more information about FDA’s posting This draft guidance discusses the received no later than May 9, 2018. of comments to public dockets, see 80 ethical and scientific issues when ADDRESSES: Submit your comments, FR 56469, September 18, 2015, or access considering the inclusion of pregnant including the ICR Title, to the desk the information at: https://www.gpo.gov/ women in clinical trials of drugs and officer for HRSA, either by email to VerDate Sep<11>2014 18:06 Apr 06, 2018 Jkt 244001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 E:\FR\FM\09APN1.SGM 09APN1


Document Created: 2018-04-07 02:39:15
Document Modified: 2018-04-07 02:39:15
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of availability.
DatesSubmit either electronic or written comments on the draft guidance by June 8, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
ContactDenise 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.
FR Citation83 FR 15161 
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