Notice2022-08114
Bioavailability Studies Submitted in NDAs or INDs-General Considerations; Guidance for Industry; Availability
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Published
April 15, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Bioavailability Studies Submitted in NDAs or INDs--General Considerations." This guidance provides recommendations to sponsors planning to include bioavailability (BA) information for drug products in investigational new drug applications (INDs), new drug applications (NDAs), and NDA supplements. This guidance finalizes the draft guidance of the same title issued on February 26, 2019. This guidance also replaces the draft guidance entitled "Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs--General Considerations" issued March 2014.
Full Text
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<title>Federal Register, Volume 87 Issue 73 (Friday, April 15, 2022)</title>
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[Federal Register Volume 87, Number 73 (Friday, April 15, 2022)]
[Notices]
[Pages 22537-22539]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-08114]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-D-4367]
Bioavailability Studies Submitted in NDAs or INDs--General
Considerations; 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 final guidance for industry entitled
``Bioavailability Studies Submitted in NDAs or INDs--General
Considerations.'' This guidance provides recommendations to sponsors
planning to include bioavailability (BA) information for drug products
in investigational new drug applications (INDs), new drug applications
(NDAs), and NDA supplements. This guidance finalizes the draft guidance
of the same title issued on February 26, 2019. This guidance also
replaces the draft guidance entitled ``Bioavailability and
Bioequivalence Studies Submitted in NDAs or INDs--General
Considerations'' issued March 2014.
DATES: The announcement of the guidance is published in the Federal
Register on April 15, 2022.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your
[[Page 22538]]
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<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-2018-D-4367 for ``Bioavailability Studies Submitted in NDAs or
INDs--General Considerations.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
<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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 this 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 guidance document.
FOR FURTHER INFORMATION CONTACT: Dakshina Chilukuri, Food and Drug
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002,
301-796-1515, <a href="/cdn-cgi/l/email-protection#c480a5afb7acadaaa5ea87acada8b1afb1b6ad84a2a0a5eaacacb7eaa3abb2"><span class="__cf_email__" data-cfemail="793d18120a11101718573a1110150c120c0b10391f1d185711110a571e160f">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Bioavailability Studies Submitted in NDAs or INDs--General
Considerations.'' Determining the BA of formulations is critical during
the life cycle of drug products and aids in the FDA's evaluation of the
safety and effectiveness of a product in INDs, NDAs, or NDA
supplements. This guidance provides recommendations to sponsors and
applicants planning to include BA information for drug products in
INDs, NDAs, and NDA supplements. This guidance contains recommendations
on how to meet the BA requirements set forth in part 320 (21 CFR part
320) as they apply to dosage forms intended for oral administration.
The guidance is also applicable to non-orally administered drug
products when it is appropriate to rely on systemic exposure measures
to determine the BA of a drug (e.g., transdermal delivery systems and
certain rectal and nasal drug products). The guidance provides
recommendations on conducting relative BA studies during the
investigational period for an NDA and bioequivalence (BE) studies
during the postapproval period for certain changes to drug products
with an approved NDA.
This guidance finalizes the draft guidance entitled
``Bioavailability Studies in NDAs or INDs--General Considerations''
issued on February 26, 2019 (84 FR 6148) (the 2019 draft guidance).
When FDA issued the 2019 draft guidance, FDA explained that the 2019
draft guidance revised and replaced the draft guidance entitled
``Bioavailability and Bioequivalence Studies Submitted in NDAs or
INDs--General Considerations'' issued on March 2014 (the 2014 draft
guidance) (84 FR 6148). FDA considered comments received on the 2014
draft guidance in preparing the 2019 draft guidance. FDA likewise
considered comments received on the 2019 draft guidance as this
guidance was finalized. Changes from the 2019 draft guidance to the
final guidance include the following: (1) Specifying that individual
pharmacokinetic profiles will be considered for products with complex
release characteristics; (2) clarifying that if the drug labeling
specifies the drug to be taken with food but does not elaborate on the
fed conditions, the sponsor should use a high-fat meal as the fed
condition; (3) adding statistical approaches for dissolution; (4)
clarifying that enzymes can be added to the dissolution medium to
better understand the effect of over-encapsulation on drug release; and
(5) removing the 10 percent alcohol level for dose-dumping studies. In
addition, editorial changes were made to improve clarity.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Bioavailability Studies in NDAs or INDs--
General Considerations.'' 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.
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II. Paperwork Reduction Act of 1995
While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA.
The collections of information in 21 CFR part 314 relating to the
submission of new drug applications, abbreviated new drug applications,
and supplemental applications and the submission of requests to waive
in vivo BA and BE requirements have been approved under OMB control
number 0910-0001.
The collections of information in 21 CFR part 312 relating to the
submission of investigational new drug applications and BA/BE studies
or pharmacogenomic data and the collections of information in part 320
for drug safety reporting have been approved under OMB control numbers
0910-0014 and 0910-0291.
The collections of information in 21 CFR parts 50 and 56 relating
to the protection of human subjects and investigational review boards
have been approved under OMB control number 0910-0130.
The collections of information in 21 CFR 201.56 and 201.57 for the
Requirements on Content and Format of Labeling for Human Prescription
Drug and Biological Products have been approved under OMB control
number 0910-0572.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
<a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs">https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs</a>, <a href="https://www.regulations.gov">https://www.regulations.gov</a>, or <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>.
Dated: April 11, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-08114 Filed 4-14-22; 8:45 am]
BILLING CODE 4164-01-P
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