83 FR 31759 - Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products-Content and Format; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 131 (July 9, 2018)

Page Range		31759-31760
FR Document		2018-14535

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products--Content and Format.''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 The recommendations in this draft guidance are intended to help ensure that the labeling is clear, concise, useful, and informative and, to the extent possible, consistent in content and format within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.

Federal Register, Volume 83 Issue 131 (Monday, July 9, 2018)

[Federal Register Volume 83, Number 131 (Monday, July 9, 2018)]
[Notices]
[Pages 31759-31760]
From the Federal Register Online [www.thefederalregister.org]
[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Drug and Biological Products--Content and Format; Draft Guidance for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the availability of a draft guidance for industry entitled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 The recommendations in this draft guidance are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DATES: Submit either electronic or written comments on the draft
guidance by September 7, 2018 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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.thefederalregister.org/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.
---------------------------------------------------------------------------

\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

31760 Federal Register / Vol. 83, No. 131 / Monday, July 9, 2018 / Notices

‘‘Indications and Usage Section of This guidance is one in a series of Information/Guidances/default.htm, or
Labeling for Human Prescription Drug guidances FDA is developing or has https://www.regulations.gov.
and Biological Products—Content and developed to assist applicants with the Dated: June 29, 2018.
Format.’’ This guidance provides content and format of labeling for Leslie Kux,
recommendations on the general human prescription drug and biological
Associate Commissioner for Policy.
principles to consider when drafting an products. In the Federal Register of
indication and how to write, organize, [FR Doc. 2018–14535 Filed 7–6–18; 8:45 am]
January 24, 2006 (71 FR 3922), FDA
and format the information in the published a final rule on labeling for BILLING CODE 4164–01–P

Indications and Usage section of the human prescription drug and biological
labeling. The draft guidance provides products. The final rule and additional
recommendations on what information DEPARTMENT OF HEALTH AND
guidances on labeling can be accessed at
to include in the indication and when HUMAN SERVICES
https://www.fda.gov/Drugs/Guidance
limitations of use should be considered ComplianceRegulatoryInformation/Laws Food and Drug Administration
for the Indications and Usage section. ActsandRules/ucm084159.htm. The
The Indications and Usage section labeling requirements and these [Docket No. FDA–2016–D–0545]
must state that the drug is indicated for guidances are intended to make
the treatment, prevention, mitigation, information in prescription drug Revised Recommendations for
cure, or diagnosis of a recognized labeling easier for health care Reducing the Risk of Zika Virus
disease or condition, or of a practitioners to access, read, and use. Transmission by Blood and Blood
manifestation of a recognized disease or Components; Guidance for Industry;
This draft guidance is being issued Availability
condition, or for the relief of symptoms consistent with FDA’s good guidance
associated with a recognized disease or practices regulation (21 CFR 10.115). AGENCY: Food and Drug Administration,
condition.1 The draft guidance describes The draft guidance, when finalized, will HHS.
how to clearly convey such information represent the current thinking of FDA
and addresses circumstances where ACTION: Notice of availability.
on the content and format of the
other information in addition to the SUMMARY: The Food and Drug
Indications and Usage section of
identification of the disease or condition Administration (FDA or Agency) is
labeling for human prescription drug
may be warranted. announcing the availability of a final
The draft guidance describes and biological products. It does not
establish any rights for any person and guidance for industry entitled ‘‘Revised
circumstances in which an indication Recommendations for Reducing the Risk
may be broader than the specific is not binding on FDA or the public.
You can use an alternative approach if of Zika Virus Transmission by Blood
parameters of the clinical studies and Blood Components; Guidance for
supporting approval, as well as those it satisfies the requirements of the
applicable statutes and regulations. This Industry.’’ The guidance document
where a narrower indication may be provides blood establishments that
appropriate, and explains that the guidance is not subject to Executive
Order 12866. collect Whole Blood and blood
Indications and Usage section needs to components with revised
make clear the scope of the indication. II. The Paperwork Reduction Act of recommendations to reduce the risk of
The draft guidance also describes 1995 transmission of Zika virus (ZIKV) by
circumstances in which an indication in blood and blood components. The
an age group broader than the This draft guidance refers to
previously approved collections of guidance does not apply to the
population that was studied may be
information found in FDA regulations. collection of Source Plasma. The
considered for an adult population.
These collections of information are guidance announced in this notice
However, this approach is generally not
subject to review by the Office of supersedes the document of the same
appropriate across pediatric populations
Management and Budget (OMB) under title dated August 2016 (August 2016
or between adult and pediatric
the Paperwork Reduction Act of 1995 Guidance).
populations because of the statutory
requirements related to pediatric (44 U.S.C. 3501–3520). The collections DATES: The announcement of the
assessments and the unique clinical of information in 21 CFR 201.56 and guidance is published in the Federal
considerations for pediatric patients. 201.57 have been approved under OMB Register on July 9, 2018.
For example, pediatric patients may control number 0910–0572; the ADDRESSES: You may submit either
metabolize drugs differently from adults collections of information in 21 CFR electronic or written comments on
(in an age-related manner), are 312.41 have been approved under OMB Agency guidances at any time as
susceptible to different safety risks, and control number 0910–0014; the follows:
often require different dosing regimens, collections of information in 21 CFR
even after correction for weight. For 314.126(c) and 314.70 have been Electronic Submissions
these reasons, FDA recommends that approved under OMB control number Submit electronic comments in the
age groups should be included in 0910–0001; and the collections of following way:
indications. An indication should state information in 21 CFR 601.12 have been • Federal eRulemaking Portal:
that a drug is approved, for example, ‘‘in approved under OMB control number https://www.regulations.gov. Follow the
adults,’’ ‘‘in pediatric patients X years of 0910–0338. instructions for submitting comments.
age and older,’’ or ‘‘in adults and Comments submitted electronically,
III. Electronic Access
including attachments, to https://
sradovich on DSK3GMQ082PROD with NOTICES

pediatric patients X years of age and
older.’’ FDA is interested in obtaining Persons with access to the internet www.regulations.gov will be posted to
information and public comment on this may obtain the draft guidance at https:// the docket unchanged. Because your
recommendation and the implications www.fda.gov/Drugs/Guidance comment will be made public, you are
of routinely including age groups in ComplianceRegulatoryInformation/ solely responsible for ensuring that your
indications. Guidances/default.htm, https:// comment does not include any
www.fda.gov/BiologicsBloodVaccines/ confidential information that you or a
1 See 21 CFR 201.57(c)(2). GuidanceComplianceRegulatory third party may not wish to be posted,

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Document Created: 2018-07-07 00:41:49
Document Modified: 2018-07-07 00:41:49

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice of availability.
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.
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.
FR Citation		83 FR 31759

83 FR 31759 - Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products-Content and Format; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 131 (July 9, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration