Notice2021-11622
Oral Drug Products Administered via Enteral Feeding Tube: In Vitro Testing and Labeling Recommendations; Draft Guidance for Industry; Availability
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Published
June 3, 2021
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Oral Drug Products Administered Via Enteral Feeding Tube: In Vitro Testing and Labeling Recommendations." This draft guidance provides recommendations for consistent in vitro testing of oral drug products to demonstrate their suitability to be administered via enteral tube.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.
Full Text
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<title>Federal Register, Volume 86 Issue 105 (Thursday, June 3, 2021)</title>
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[Federal Register Volume 86, Number 105 (Thursday, June 3, 2021)]
[Notices]
[Pages 29789-29790]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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Vitro Testing and Labeling Recommendations; Draft Guidance for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the availability of a draft guidance for industry entitled ``Oral Drug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 This draft guidance provides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DATES: Submit either electronic or written comments on the draft
guidance by August 2, 2021 to ensure that the Agency considers your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:
<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 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-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 <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
[[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 <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.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products">https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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
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