Notice2023-00619
Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products-Content and Format; Draft Guidance for Industry; Availability
Primary source
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Published
January 13, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products--Content and Format." This guidance is intended to assist applicants in developing the DOSAGE AND ADMINISTRATION section of labeling. The purpose of this guidance is to assist applicants in ensuring that the DOSAGE AND ADMINISTRATION section contains the dosage- and administration-related information needed for safe and effective use of a drug and that the information is clear, concise, and presented in a manner that is pertinent and understandable to health care practitioners. We are withdrawing the guidance for industry entitled "Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products--Content and Format" issued on March 29, 2010, and issuing this draft guidance.
Full Text
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<title>Federal Register, Volume 88 Issue 9 (Friday, January 13, 2023)</title>
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[Federal Register Volume 88, Number 9 (Friday, January 13, 2023)]
[Notices]
[Pages 2360-2362]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-00619]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2007-D-0201]
Dosage and Administration Section of Labeling for Human
Prescription Drug and Biological Products--Content and Format; Draft
Guidance for Industry; Availability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, Agency, or we) is
announcing the availability of a draft guidance for industry entitled
``Dosage and Administration Section of Labeling for Human Prescription
Drug and Biological Products--Content and
[[Page 2361]]
Format.'' This guidance is intended to assist applicants in developing
the DOSAGE AND ADMINISTRATION section of labeling. The purpose of this
guidance is to assist applicants in ensuring that the DOSAGE AND
ADMINISTRATION section contains the dosage- and administration-related
information needed for safe and effective use of a drug and that the
information is clear, concise, and presented in a manner that is
pertinent and understandable to health care practitioners. We are
withdrawing the guidance for industry entitled ``Dosage and
Administration Section of Labeling for Human Prescription Drug and
Biological Products--Content and Format'' issued on March 29, 2010, and
issuing this draft guidance.
DATES: Submit either electronic or written comments on the draft
guidance by March 14, 2023 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-2007-D-0201 for ``Dosage and Administration Section of Labeling for
Human Prescription Drug and Biological Products--Content and Format.''
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 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 the
Office of Communication, Outreach, and Development, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 3128, 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: Eric Brodsky, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6485, Silver Spring, MD 20993-0002, 301-
796-0855; or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Dosage and Administration Section of Labeling for Human
Prescription Drug and Biological Products--Content and Format.'' FDA is
also withdrawing its previous guidance for industry, issued on March
23, 2010 (75 FR 13766), which was entitled ``Dosage and Administration
Section of Labeling for Human Prescription Drug and Biological
Products--Content and Format.''
The draft guidance, when finalized, is intended to assist
applicants in developing the DOSAGE AND ADMINISTRATION section of
labeling to ensure that this section contains the dosage- and
administration-related information needed for safe and effective use of
a drug and that the information is clear, concise, and presented in a
manner that is pertinent and understandable to health care
practitioners. Applicants should follow the recommendations in this
guidance when developing this section for a new drug submitted to FDA
under a new drug application under section 505(b) of the Federal Food,
Drug, and Cosmetic Act or a biologics license application under section
351(a) of the Public Health Service Act, and when revising
[[Page 2362]]
existing information in the labeling for a currently approved drug in a
supplement to such applications.
This draft guidance provides examples of required and recommended
information in the DOSAGE AND ADMINISTRATION section. This guidance
provides recommendations on including certain dosage- and
administration-related information in the DOSAGE AND ADMINISTRATION
section that is particularly critical to the safe and effective use of
the drug (e.g., lack of knowledge of the information or nonadherence to
a recommendation could have serious consequences for patients).
This draft guidance addresses the dosage and route of
administration for each indication in the DOSAGE AND ADMINISTRATION
section and information about the dosage range, the starting or loading
dose and dosage, titration schedule, the maximum recommended dosage,
the maximum recommended duration, monitoring for effectiveness, and
concomitant therapy information in the DOSAGE AND ADMINISTRATION
section, as appropriate.
This draft guidance also addresses the following information in the
DOSAGE AND ADMINISTRATION section:
<bullet> Other drugs used before, during, or after drug treatment
or administration;
<bullet> Dosage modifications for adverse reactions or for drug
interactions;
<bullet> Dosage in specific populations (e.g., pediatric patients,
geriatric patients, patients with renal impairment, patients with
hepatic impairment);
<bullet> Information about switching to the subject drug from other
products or substitution involving the subject drug;
<bullet> Recommendations regarding missed dose(s);
<bullet> Recommendations in event of vomiting after oral drug
administration;
<bullet> Recommendations for drug discontinuation or dosage
reduction when there are risks of withdrawal; and
<bullet> The recommended dosage for fixed-combination drug products
and co-packaged products.
Furthermore, this draft guidance addresses when and how to include
information in the DOSAGE AND ADMINISTRATION section on the preparation
and/or administration of the drug (e.g., parenteral products, a product
stored in the refrigerator or freezer, pharmacy bulk packages, imaging
bulk packages, solid oral dosage forms with qualified liquids or soft
foods, oral dosage forms via enteral feeding tubes, liposome drug
products); instructions to avoid harm related to drug handling and
administration, radiation dosimetry; and information on drug
incompatibilities if the drug is mixed with other drugs. This guidance
also provides information on storage instructions for the reconstituted
or diluted product.
Finally, this draft guidance describes information that should
ordinarily not be included in the DOSAGE AND ADMINISTRATION section.
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 the ``Dosage
and Administration Section of Labeling for Human Prescription Drug and
Biological Products--Content and Format.'' 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
This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
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 21 CFR 314 and 21 CFR 601 have been
approved under OMB control number 0910-0001 and 0910-0338. The
collections of information in 21 CFR 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/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, <a href="https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics">https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Dated: January 10, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-00619 Filed 1-12-23; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on January 13, 2023.
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