[Federal Register Volume 88, Number 189 (Monday, October 2, 2023)]
[Notices]
[Pages 67765-67766]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-21558]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-0219]


Human Prescription Drug and Biological Products--Labeling for 
Dosing Based on Weight or Body Surface Area for Ready-to-Use 
Containers--``Dose Banding''; 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 final guidance for industry entitled ``Human 
Prescription Drug and Biological Products--Labeling for Dosing Based on 
Weight or Body Surface Area for Ready-to-Use Containers--`Dose 
Banding.' '' The guidance is intended to assist applicants in 
incorporating dose banding information, based on dosing information of 
a previously approved drug product that is based on weight or body 
surface area (BSA), into the proposed labeling of injectable drug 
products that are the subject of certain marketing applications 
submitted to FDA. This guidance finalizes the draft guidance of the 
same title issued on July 21, 2022.

DATES: The announcement of the guidance is published in the Federal 
Register on October 2, 2023.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
    <bullet> 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.
    <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-2022-D-0219 for ``Human Prescription Drug and Biological Products--
Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-
Use Containers--`Dose Banding.' '' 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.
    <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 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

[[Page 67766]]

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 this 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 guidance document.

FOR FURTHER INFORMATION CONTACT: Chris Wheeler, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 3330, Silver Spring, MD 20993-0002, 301-
796-0151; or Anne Taylor, 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 guidance for industry 
entitled ``Human Prescription Drug and Biological Products--Labeling 
for Dosing Based on Weight or Body Surface Area for Ready-to-Use 
Containers--`Dose Banding.' '' This guidance provides recommendations 
for incorporating dose banding information into the labeling of an 
injectable drug product that is seeking approval through a new drug 
application submitted under section 505(b) of the FD&C Act (21 U.S.C. 
355(b)), a biologics license application submitted under section 351(a) 
of the PHS Act (42 U.S.C. 262(a)), or a supplement to one of these 
approved applications. The recommendations and examples in this 
guidance are relevant to situations in which an applicant (1) proposes 
to develop ready-to-use containers with a range of different strengths 
for an injectable drug product and (2) seeks to incorporate dose 
banding information into the prescribing information based on dosing 
information of a previously approved drug product that is based on 
weight or BSA.
    This guidance finalizes the draft guidance entitled ``Human 
Prescription Drug and Biological Products--Labeling for Dosing Based on 
Weight or Body Surface Area for Ready-to-Use Containers--`Dose Banding' 
'' issued on July 21, 2022 (87 FR 43533). FDA considered comments 
received on the draft guidance as it developed the final guidance. 
Changes from the draft guidance are primarily intended to improve 
clarity.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on ``Human Prescription Drug and Biological 
Products--Labeling for Dosing Based on Weight or Body Surface Area for 
Ready-to-Use Containers--`Dose Banding.' '' 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 guidance contains no new collection of information, it 
does refer to previously approved FDA collections of information. The 
previously approved collections of information are subject to review by 
Office of Management Budget (OMB) under the Paperwork Reduction Act of 
1995 (PRA) (44 U.S.C. 3501-3521). The collections of information in 21 
CFR part 201 have been approved under OMB control number 0910-0572; the 
collections of information in 21 CFR part 314 have been approved under 
OMB control number 0910-0001; and the collections of information in 21 
CFR part 601 have been approved under OMB control number 0910-0338.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: September 26, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-21558 Filed 9-29-23; 8:45 am]
BILLING CODE 4164-01-P