[Federal Register Volume 86, Number 160 (Monday, August 23, 2021)]
[Notices]
[Pages 47117-47118]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-18073]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-D-1464]
Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs
Submitted Under an Abbreviated New Drug Application; Draft Guidance for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the availability of a revised draft guidance for industry entitled
``Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs
Submitted Under an ANDA.'' This revised draft supersedes the draft
guidance entitled ``Bioequivalence Studies With Pharmacokinetic
Endpoints for Drug Products Submitted Under an ANDA,'' which was
announced in the Federal Register on December 5, 2013. This revised
draft guidance provides recommendations to applicants planning to
include bioequivalence (BE) information in abbreviated new drug
applications (ANDAs) and ANDA supplements. In addition, this guidance
describes how to meet the BE requirements set forth in the Federal
Food, Drug, and Cosmetic Act (FD&C Act) and FDA regulations.
DATES: Submit either electronic or written comments on the draft
guidance by October 22, 2021 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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-
[[Page 47118]]
2013-D-1464 for ``Bioequivalence Studies With Pharmacokinetic Endpoints
for Drugs Submitted Under an ANDA.'' 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, 240-402-7500.
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.govinfo.gov/content/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, 240-402-7500.
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: David Coppersmith, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1673, Silver Spring, MD 20993-0002, 301-
796-9193.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a revised draft guidance for
industry entitled ``Bioequivalence Studies With Pharmacokinetic
Endpoints for Drugs Submitted Under an ANDA.'' The revised draft
guidance supersedes the draft guidance ``Bioequivalence Studies With
Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA,'' which
was announced in the Federal Register on December 5, 2013 (78 FR
73199). FDA received nine comments on the draft guidance, which were
considered before publication of this revised draft guidance.
This revised draft guidance provides recommendations to applicants
planning to include BE information in ANDAs and ANDA supplements. In
addition, this guidance describes how to meet the BE requirements set
forth in the FD&C Act and FDA regulations. This guidance is generally
applicable to dosage forms intended for oral administration and to non-
orally administered drug products in which reliance on systemic
exposure measures is suitable for documenting BE (e.g., transdermal
delivery systems and certain rectal and nasal drug products). This
guidance will also be useful to applicants planning BE studies intended
to be conducted during the post-approval period for changes to a drug
product approved in an ANDA. FDA recommends that applicants consult
this revised draft guidance, in conjunction with any relevant product-
specific guidances for industry, when considering the appropriate BE
study and/or other studies for a proposed drug product.
This 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
``Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs
Submitted Under an ANDA.'' 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. Paperwork Reduction Act of 1995
FDA tentatively concludes that this draft guidance contains no
collection of information. Therefore, clearance by the Office of
Management and Budget under the Paperwork Reduction Act of 1995 is not
required.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.
Dated: August 18, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-18073 Filed 8-20-21; 8:45 am]
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