[Federal Register Volume 87, Number 121 (Friday, June 24, 2022)]
[Notices]
[Pages 37861-37863]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-13520]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-4368]


Assessing the Effects of Food on Drugs in Investigational New 
Drugs and New Drug Applications--Clinical Pharmacology 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 ``Assessing 
the Effects of Food on Drugs in INDs and NDAs--Clinical Pharmacology 
Considerations.'' This guidance provides recommendations to sponsors 
planning to conduct food-effect (FE) studies for orally administered 
drug products as part of investigational new drug applications (INDs), 
new drug applications (NDAs), and supplements to these applications. 
This guidance finalizes the draft guidance of the same title issued on 
February 26, 2019.

DATES: The announcement of the guidance is published in the Federal 
Register on June 24, 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:
     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

[[Page 37862]]

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-2018-D-4368 for ``Assessing the Effects of Food on Drugs in INDs 
and NDAs--Clinical Pharmacology Considerations.'' 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 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: Vikram Arya or Brian Booth, Center for 
Drug Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-1499 or 301-796-
1508.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Assessing the Effects of Food on Drugs in INDs and NDAs--
Clinical Pharmacology Considerations.'' Food-drug interactions can have 
a significant impact on the safety and efficacy of the drug and can be 
manifested in different ways. In some cases, co-administration of a 
drug with food can increase the systemic exposure of the drug, leading 
to improved efficacy or higher rates of adverse reactions. In other 
cases, administration of a drug with food can lower the systemic 
absorption of a drug, thereby reducing the efficacy. Hence, assessing 
the effect of food on the absorption of a drug is critical to optimize 
the safety and efficacy of the product and to determine optimum 
instructions for drug administration in relation to food.
    During new drug development, pharmacokinetic studies to assess the 
effect of food on the systemic exposure of the drug are conducted to 
determine: (1) if, and to what extent, food impacts the systemic 
exposure of the drug; (2) whether food increases or decreases the 
variability of the systemic exposure of the drug; and (3) if the effect 
of food is different across meals with different fat or caloric 
contents. It is important to have as detailed an understanding of the 
exposure-response relationships of the drug as possible to interpret 
the results of FE studies. Additionally, an understanding of the 
various clinical dosing scenarios will be important to characterize the 
effect of food and to provide adequate instructions for use of the 
drug.
    This guidance finalizes the draft guidance entitled ``Assessing the 
Effects of Food on Drugs in INDs and NDAs--Clinical Pharmacology 
Considerations'' issued on February 26, 2019 (84 FR 6151). FDA 
considered comments received on the draft guidance as the guidance was 
finalized. Changes from the draft to the final guidance include adding 
a discussion of model-informed drug development approaches to assessing 
the effects of food on drug exposures and the removal of specific 
language regarding the timing of food effect studies and food effect 
studies by population pharmacokinetic analysis.
    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 ``Assessing the Effects of Food on Drugs in 
INDs and NDAs--Clinical Pharmacology 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.

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 have been approved under OMB control 
number 0910-0001. The collections of information in 21 CFR part 312 
have been approved under OMB control number 0910-0014. The collection 
of information in 21 CFR parts 50 and 56 have been approved under OMB 
control number 0910-0130. The collections of information in 21 CFR 
201.56 and 201.57 have been approved under OMB control numbers 0910-
0733 and 0910-0572, and the collections of information related to 
pharmacogenomic data have been approved under OMB control number 0910-
0557.

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III. Electronic Access

    Persons with access to the internet may obtain the 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: June 17, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-13520 Filed 6-23-22; 8:45 am]
BILLING CODE 4164-01-P