[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Labeling for Combined Hormonal Contraceptives; Draft Guidance for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the availability of a draft guidance for industry entitled ``Labeling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 This draft guidance provides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recommendations in this draft guidance represent class labeling that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 The draft
guidance reflects many of the modifications to prescribing information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DATES: Submit either electronic or written comments on the draft
guidance by March 5, 2018 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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:
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-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.
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