[Federal Register Volume 83, Number 1 (Tuesday, January 2, 2018)]
[Notices]
[Pages 131-133]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-28252]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-1846]


Labeling for Combined Hormonal Contraceptives; Draft Guidance for 
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

[[Page 132]]


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the availability of a draft guidance for industry entitled ``Labeling 
for Combined Hormonal Contraceptives.'' This draft guidance provides 
recommendations on information that should be included in the 
prescribing information for combined hormonal contraceptives (CHCs), 
which contain estrogen and progestin. CHC products include combined 
oral contraceptives (COCs), as well as non-oral products such as 
transdermal systems and vaginal rings. Many of the labeling 
recommendations in this draft guidance represent class labeling that 
should be included in all CHC prescribing information. The draft 
guidance reflects many of the modifications to prescribing information 
mandated by the physician labeling rule (PLR) and the pregnancy and 
lactation labeling rule (PLLR). General advice is provided where 
modifications to the prescribing information for specific products are 
needed.

DATES: Submit either electronic or written comments on the draft 
guidance by March 5, 2018 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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:
    <bullet> 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.
    <bullet> 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:
    <bullet> 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.
    <bullet> 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-2017-D-1846 for ``Labeling for Combined Hormonal Contraceptives; 
Draft Guidance for Industry.'' 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.
    <bullet> 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. 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: Jennifer Dao, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 5333, Silver Spring, MD 20993-0002, 301-
796-8189.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Labeling for Combined Hormonal Contraceptives.'' This draft 
guidance provides recommendations on information that should be 
included in the prescribing information for CHCs, which contain 
estrogen and a progestin. Such products include COCs, as well as non-
oral products such as transdermal systems and vaginal rings. Many of 
the labeling recommendations in this draft guidance represent class 
labeling that should be included in all CHC prescribing information. 
The draft guidance reflects many of the modifications to prescribing 
information mandated by the PLR \1\ and the PLLR.\2\

[[Page 133]]

General advice is provided where modifications of the prescribing 
information for specific products are needed.
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    \1\ See the final rule ``Requirements on Content and Format of 
Labeling for Human Prescription Drug and Biological Products'' (71 
FR 3922, January 24, 2006) (21 CFR 201.56(d)(1) and 201.57(c)(9)(i) 
through (iii)); see also the guidance for industry entitled 
``Labeling for Human Prescription Drug and Biological Products--
Implementing the PLR Content and Format Requirements'' available at 
https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM075082.pdf.
    \2\ See the final rule ``Content and Format of Labeling for 
Human Prescription Drug and Biological Products; Requirements for 
Pregnancy and Lactation Labeling'' (79 FR 72064, December 4, 2014) 
(21 CFR 201.56(d) and 201.57); see also the draft guidance for 
industry entitled ``Pregnancy, Lactation, and Reproductive 
Potential: Labeling for Human Prescription Drug and Biological 
Products--Content and Format'' available at https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM425398.pdf. When final, this guidance will represent FDA's 
current thinking on this topic.
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    FDA previously issued draft guidance on the prescribing information 
for COCs in March 2004 and invited public comment. That draft guidance 
was withdrawn in July 2015. However, the development of the current 
draft guidance took into consideration public comments submitted to the 
2004 draft guidance that were science-based and consistent with current 
PLR and PLLR labeling regulations. This draft guidance has been 
broadened to incorporate the more general class of CHCs.
    FDA invites comments on the content of this draft guidance. In 
particular, FDA seeks comments on the proposed language under section 
7.1 of labeling that identifies a drug interaction with all metabolic 
enzyme inducers. A variety of metabolic enzyme inducers have been 
reported to decrease the plasma concentration of the estrogen and/or 
progestin components of CHCs. FDA seeks comments and data regarding 
specific enzyme inducers or classes of inducers (e.g., cytochrome p450 
3A strong inducers) that interact with CHCs; in particular, comments 
are requested on whether the CHC labeling should include specific 
inducers or classes of inducers, or if it should remain broad and 
essentially cover all possible cytochrome p (CYP) enzyme inducers of 
any pathway and potency.
    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 labeling for 
CHCs. 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 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 collections of information in 21 CFR 201.56 and 201.57 
(``Requirements on Content and Format of Labeling for Human 
Prescription Drug and Biological Products'') are approved under OMB 
control number 0910-0572. The collections of information from the final 
rule entitled ``Content and Format of Labeling for Human Prescription 
Drug and Biological Products; Requirements for Pregnancy and Lactation 
Labeling'' are approved under OMB control number 0910-0624.

III. 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: December 26, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-28252 Filed 12-29-17; 8:45 am]
BILLING CODE 4164-01-P