[Federal Register Volume 88, Number 9 (Friday, January 13, 2023)]
[Notices]
[Pages 2360-2362]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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Prescription Drug and Biological Products--Content and Format; Draft 
Guidance for Industry; Availability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announcing the availability of a draft guidance for industry entitled 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issuing this draft guidance.

DATES: Submit either electronic or written comments on the draft 
guidance by March 14, 2023 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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:
     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-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 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 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:
     Other drugs used before, during, or after drug treatment 
or administration;
     Dosage modifications for adverse reactions or for drug 
interactions;
     Dosage in specific populations (e.g., pediatric patients, 
geriatric patients, patients with renal impairment, patients with 
hepatic impairment);
     Information about switching to the subject drug from other 
products or substitution involving the subject drug;
     Recommendations regarding missed dose(s);
     Recommendations in event of vomiting after oral drug 
administration;
     Recommendations for drug discontinuation or dosage 
reduction when there are risks of withdrawal; and
     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 https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics, or https://www.regulations.gov.

    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


