[Federal Register Volume 86, Number 105 (Thursday, June 3, 2021)]
[Notices]
[Pages 29789-29790]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-11622]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-D-0391]


Oral Drug Products Administered via Enteral Feeding Tube: In 
Vitro Testing and Labeling Recommendations; Draft Guidance for 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the availability of a draft guidance for industry entitled ``Oral Drug 
Products Administered Via Enteral Feeding Tube: In Vitro Testing and 
Labeling Recommendations.'' This draft guidance provides 
recommendations for consistent in vitro testing of oral drug products 
to demonstrate their suitability to be administered via enteral tube. 
In addition, it supports the development of clear product-specific 
enteral tube administration instructions in labeling for administration 
to patients unable to ingest oral drug products.

DATES: Submit either electronic or written comments on the draft 
guidance by August 2, 2021 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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-2021-D-0391 for ``Oral Drug Products Administered Via Enteral 
Feeding Tube: In Vitro Testing and Labeling Recommendations.'' 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

[[Page 29790]]

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, or Office 
of Policy, Guidance and Policy Development, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5431, 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: Amy Muhlberg, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg., 51, Rm. 3117, Silver Spring, MD 20993-0002, 240-
402-6901; or Shanil Haugen, Center for Devices and Radiological Health, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg., 66, Rm. 
2612, Silver Spring, MD 20993-0002, 301-796-0301.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Oral Drug Products Administered Via Enteral Feeding Tube: In 
Vitro Testing and Labeling Recommendations.'' This draft guidance 
provides recommendations regarding in vitro testing of oral drug 
products, other than solutions, administered via enteral feeding tube 
(hereinafter enteral tube) that are subject to: (1) New drug 
applications (original or supplemental) where applicants are seeking 
and/or revising enteral tube administration instructions and related 
information in labeling; (2) abbreviated new drug applications where 
the reference listed drug contains enteral tube administration 
instructions and related information in labeling; and (3) 
investigational new drug applications where the investigational drug 
product is administered or planned for administration via enteral tube. 
Specifically, the draft guidance provides recommendations for 
consistent in vitro testing of oral drug products to demonstrate their 
suitability to be administered via enteral tube. In addition, it 
supports the development of clear, product-specific enteral tube 
administration instructions in labeling for administration to patients 
unable to ingest oral drug products.
    Enteral tubes are critical for patients who are unable to swallow 
oral dosage forms because of feeding disorders, severe intellectual 
disabilities, neurological disorders, cancers, and other medical 
conditions or therapies that compromise swallowing or the function of 
the proximal gastrointestinal system. It is critical that each drug 
administered via enteral tube is delivered at the correct dose in a 
manner that preserves the drug's expected safety and efficacy profile 
and does not compromise the integrity of the tube.
    Some FDA-approved drug products marketed in the United States 
include instructions for enteral tube administration in their labeling. 
However, testing is not sufficiently widespread or consistent, and the 
content and format of labeling statements regarding administration of 
drug products via enteral tube vary.
    The Agency recognizes the need for consistent in vitro testing to 
ensure safe and effective delivery of drugs that may be administered 
via enteral tube and to identify drugs that cannot be administered 
through an enteral tube without altering the safety and effectiveness 
profile of the drug product or compromising the integrity of the tube.
    The draft guidance covers selection of appropriate enteral tubes 
for testing, selection of the dispersion media and preparation of the 
drug dispersion, and testing conditions and methods. Additional 
recommendations are given for modified release drug products. 
Completion of the recommended testing of a drug product prepared in the 
same manner as it will be prepared for administration to a patient in 
the clinical setting should allow applicants to demonstrate whether a 
drug product is suitable for enteral tube administration and identify 
drug products that are incompatible with enteral tube administration.
    Finally, the draft guidance covers how to summarize information 
regarding administration of the drug product via enteral tube in 
labeling, including example labeling statements for drug products that 
can be safely and effectively administered via enteral tube and 
labeling statements for drug products that are not recommended for 
administration via enteral tube.
    FDA requests comment from the public regarding the extent to which 
the recommendations in the guidance could be applicable to 
nonprescription products marketed under over-the-counter monographs 
that could be administered via enteral tube.
    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 ``Oral Drug 
Products Administered Via Enteral Feeding Tube: In Vitro Testing and 
Labeling Recommendations.'' 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 draft 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 (44 U.S.C. 3501-3521) is not 
required for this draft guidance. The previously approved collections 
of information are subject to review by OMB under the PRA. The 
collections of information in 21 CFR parts 312 and 314 have been 
approved under OMB control numbers 0910-0014 and 0910-0001, 
respectively. The collections of information in 21 CFR 201.56 and 
201.57 have been approved under OMB control number 0910-0572.

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/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products, or https://www.regulations.gov.

    Dated: May 26, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-11622 Filed 6-2-21; 8:45 am]
BILLING CODE 4164-01-P


