[Federal Register Volume 84, Number 38 (Tuesday, February 26, 2019)]
[Notices]
[Pages 6151-6152]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-03247]



[[Page 6151]]

-----------------------------------------------------------------------

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 
Drug Applications and New Drug Applications--Clinical Pharmacology 
Considerations; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance for industry entitled ``Assessing 
the Effects of Food on Drugs in INDs and NDAs--Clinical Pharmacology 
Considerations.'' This draft guidance provides recommendations to 
sponsors planning to conduct food-effect trials for orally administered 
products as part of investigational new drug applications (INDs), new 
drug applications (NDAs), and supplements to these applications. This 
draft guidance, when final, revises and replaces part of the 2002 FDA 
guidance for industry entitled ``Food-Effect Bioavailability and Fed 
Bioequivalence Studies'' (2002 Food Effect Guidance).

DATES: Submit either electronic or written comments on the draft 
guidance by April 29, 2019 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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-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.
     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: 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 draft guidance for industry 
entitled ``Assessing the Effects of Food on Drugs in INDs and NDAs--
Clinical Pharmacology Considerations.'' Food-drug interactions can 
significantly impact patient outcomes by affecting the pharmacokinetics 
and pharmacodynamics of some drugs. These interactions can potentially 
lead to reduced drug absorption and decreased efficacy or increased 
drug absorption and increased efficacy. Food can also have either a 
positive or negative effect on the incidence and severity of adverse 
events associated with drug use. The timely conduct of well-designed 
food-effect studies is critical to optimize the safety and efficacy of 
the drug product. This draft guidance provides recommendations on the 
following items: (1) When and how to conduct food-effect studies; (2) 
how to report the study results; and (3) how to include appropriate 
language regarding administration of the drug with food in the 
labeling.

[[Page 6152]]

    FDA is specifically seeking feedback on the following issues:
     Please comment on the definition of the meal content. 
Should meal types be defined solely by the calorie and fat content, or 
should carbohydrates and proteins also be included?
     Please comment on the definition of the low-fat meal. Are 
the 400-500 calories and 25 percent fat a sufficient definition of a 
low-fat meal (refer also to table 2)?
     Please comment on the Biopharmaceutics Classification 
System-based waiver for food-effect trials. Does current science 
support this biowaiver?
    Information on fed bioequivalence (BE) studies to be submitted in 
abbreviated new drug applications (ANDAs) can be found in the FDA draft 
guidance for industry entitled ``Bioequivalence Studies with 
Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA.'' Specific 
recommendations concerning fed comparability trials are now found in 
the FDA draft guidance for industry entitled ``Bioavailability Studies 
Submitted in NDAs or INDs--General Considerations.'' When finalized 
these guidances will represent the current thinking of FDA on these 
topics.
    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 ``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. 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 part 314 (21 CFR part 314), 
including Sec. Sec.  314.50 and 314.94, have been approved under OMB 
control number 0910-0001. The collections of information in part 312 
(21 CFR part 312), including Sec.  312.23, 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 numbers 0910-0755 and 
0910-0130. The collections of information in 21 CFR 201.56 and 201.57 
have been approved under OMB control number 0910-0572. The collections 
of information related to pharmacogenomic data have been approved under 
OMB control number 0910-0557.

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: February 20, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-03247 Filed 2-25-19; 8:45 am]
 BILLING CODE 4164-01-P