[Federal Register Volume 83, Number 131 (Monday, July 9, 2018)]
[Notices]
[Pages 31759-31760]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-14535]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-1895]


Indications and Usage 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Drug and Biological Products--Content and Format; Draft Guidance for 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 or Agency) is announcing 
the availability of a draft guidance for industry entitled 
``Indications and Usage Section of Labeling for Human Prescription Drug 
and Biological Products--Content and Format.'' This guidance is 
intended to assist applicants in writing the Indications and Usage 
section of labeling. The recommendations in this draft guidance are 
intended to help ensure that the labeling is clear, concise, useful, 
and informative and, to the extent possible, consistent in content and 
format within and across drug and therapeutic classes.

DATES: Submit either electronic or written comments on the draft 
guidance by September 7, 2018 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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-2018-D-1895 for ``Indications and Usage Section of Labeling for 
Human Prescription Drug and Biological Products--Content and Format; 
Draft Guidance for Industry; Availability.'' 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.
     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.gpo.gov/fdsys/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.
    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 the office in processing 
your requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Iris Masucci, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Silver Spring, MD 20993-0002, 301-796-2500; 
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

[[Page 31760]]

``Indications and Usage Section of Labeling for Human Prescription Drug 
and Biological Products--Content and Format.'' This guidance provides 
recommendations on the general principles to consider when drafting an 
indication and how to write, organize, and format the information in 
the Indications and Usage section of the labeling. The draft guidance 
provides recommendations on what information to include in the 
indication and when limitations of use should be considered for the 
Indications and Usage section.
    The Indications and Usage section must state that the drug is 
indicated for the treatment, prevention, mitigation, cure, or diagnosis 
of a recognized disease or condition, or of a manifestation of a 
recognized disease or condition, or for the relief of symptoms 
associated with a recognized disease or condition.\1\ The draft 
guidance describes how to clearly convey such information and addresses 
circumstances where other information in addition to the identification 
of the disease or condition may be warranted.
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    \1\ See 21 CFR 201.57(c)(2).
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    The draft guidance describes circumstances in which an indication 
may be broader than the specific parameters of the clinical studies 
supporting approval, as well as those where a narrower indication may 
be appropriate, and explains that the Indications and Usage section 
needs to make clear the scope of the indication. The draft guidance 
also describes circumstances in which an indication in an age group 
broader than the population that was studied may be considered for an 
adult population. However, this approach is generally not appropriate 
across pediatric populations or between adult and pediatric populations 
because of the statutory requirements related to pediatric assessments 
and the unique clinical considerations for pediatric patients. For 
example, pediatric patients may metabolize drugs differently from 
adults (in an age-related manner), are susceptible to different safety 
risks, and often require different dosing regimens, even after 
correction for weight. For these reasons, FDA recommends that age 
groups should be included in indications. An indication should state 
that a drug is approved, for example, ``in adults,'' ``in pediatric 
patients X years of age and older,'' or ``in adults and pediatric 
patients X years of age and older.'' FDA is interested in obtaining 
information and public comment on this recommendation and the 
implications of routinely including age groups in indications.
    This guidance is one in a series of guidances FDA is developing or 
has developed to assist applicants with the content and format of 
labeling for human prescription drug and biological products. In the 
Federal Register of January 24, 2006 (71 FR 3922), FDA published a 
final rule on labeling for human prescription drug and biological 
products. The final rule and additional guidances on labeling can be 
accessed at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/LawsActsandRules/ucm084159.htm. 
The labeling requirements and these guidances are intended to make 
information in prescription drug labeling easier for health care 
practitioners to access, read, and use.
    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 content 
and format of the Indications and Usage section of labeling for human 
prescription drug and biological products. 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. This guidance is not subject to 
Executive Order 12866.

II. The Paperwork Reduction Act of 1995

    This draft 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 201.56 and 201.57 have been 
approved under OMB control number 0910-0572; the collections of 
information in 21 CFR 312.41 have been approved under OMB control 
number 0910-0014; the collections of information in 21 CFR 314.126(c) 
and 314.70 have been approved under OMB control number 0910-0001; and 
the collections of information in 21 CFR 601.12 have been approved 
under OMB control number 0910-0338.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or 
https://www.regulations.gov.

    Dated: June 29, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-14535 Filed 7-6-18; 8:45 am]
 BILLING CODE 4164-01-P