[Federal Register Volume 85, Number 15 (Thursday, January 23, 2020)]
[Notices]
[Pages 3924-3925]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-01072]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2007-D-0369]
Product-Specific Guidance for Levonorgestrel; Intrauterine
Device; Revised Draft Guidance for Industry; Availability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, Agency, or we) is
announcing the availability of a revised draft guidance for industry,
entitled ``Draft Guidance for Levonorgestrel.'' The revised draft
guidance, when finalized, will provide product-specific recommendations
on, among other things, the design of bioequivalence (BE) studies to
support abbreviated new drug applications (ANDAs) for a levonorgestrel
intrauterine device.
DATES: Submit either electronic or written comments on the draft
guidance by March 23, 2020 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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 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 3925]]
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-2007-D-0369 for ``Product-Specific Guidance for Levonorgestrel;
Intrauterine Device.'' Received comments will be placed in the docket
and, except for those submitted as ``Confidential Submissions,'' will
be publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff office 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.
FOR FURTHER INFORMATION CONTACT: Wendy Good, Center for Drug Evaluation
and Research (HFD-600), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 4730, Silver Spring, MD 20993-0002, 301-
796-5850.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of June 11, 2010 (75 FR 33311), FDA
announced the availability of a guidance for industry entitled
``Bioequivalence Recommendations for Specific Products,'' which
explained the process that would be used to make product-specific
guidances available to the public on FDA's website at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs.
As described in that guidance, FDA adopted this process to develop
and disseminate product-specific guidances and to provide a meaningful
opportunity for the public to consider and comment on the guidances.
This notice announces the availability of a revised draft guidance on a
generic levonorgestrel intrauterine device.
FDA initially approved new drug application 21225 for MIRENA
(levonorgestrel intrauterine device) in December 2000. In April 2014,
FDA issued a draft product-specific guidance for industry on a generic
levonorgestrel intrauterine device. FDA subsequently withdrew that
draft guidance in October 2014 because the recommended in vitro studies
lacked adequate specificity. We are now issuing a revised draft
guidance for industry on a generic levonorgestrel intrauterine device
(``Draft Guidance on Levonorgestrel'') with recommendations for a
combination of two studies, in vitro testing and an in vivo/ex vivo
study, to demonstrate BE.
In December 2015, Bayer HealthCare LLC, manufacturer of the
reference listed drug MIRENA, submitted a citizen petition requesting
that FDA withhold approval of any ANDA for a generic version of MIRENA
unless certain conditions were satisfied, including conditions related
to demonstrating BE ((Docket No. FDA-2015-P-4600), available at https://www.regulations.gov). FDA is reviewing the issues raised in that
petition. However, FDA will consider any comments received on the
guidance entitled, ``Draft Guidance on Levonorgestrel,'' before
responding to the citizen petition.
The revised draft guidance is being issued consistent with FDA's
good guidance practices regulation (21 CFR 10.115). The revised draft
guidance, when finalized, will represent the current thinking of FDA on
the design of BE studies to support ANDAs for a levonorgestrel
intrauterine device. 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.
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: January 14, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-01072 Filed 1-22-20; 8:45 am]
BILLING CODE 4164-01-P