Federal Register, Volume 83 Issue 13 (Friday, January 19, 2018)

[Federal Register Volume 83, Number 13 (Friday, January 19, 2018)]
[Notices]
[Pages 2796-2797]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-00899]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-6969]

Product Title and Initial U.S. Approval in Highlights 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Prescription Drug and Biological Products--Content and Format; Draft
Guidance for Industry; Availability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the availability of a draft guidance for industry entitled ``Product
Title and Initial U.S. Approval in the Highlights of Prescribing
Information for Human Prescription Drug and Biological Products--
Content and Format.'' The labeling regulations for human drug and
biological products require that the Highlights of Prescribing
Information (Highlights) contain a product title and the year of
initial U.S. approval. This draft guidance provides recommendations on
the content and format of the product title and initial U.S. approval
to bring greater consistency to the presentation of these required
elements and to help ensure these elements provide clear and useful
information to the health care provider.

DATES: Submit either electronic or written comments on the draft
guidance by March 20, 2018 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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-2017-D-6969 for ``Product Title and Initial U.S. Approval in
Highlights for Human Prescription Drug and Biological Products--Content
and Format; 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

[[Page 2797]]

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 that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Debra Beitzell, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm 6460, Silver Spring, MD 20993-0002, 301-
796-0700; 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 ``Product Title and Initial U.S. Approval in the Highlights of
Prescribing Information for Human Prescription Drug and Biological
Products--Content and Format.''
On January 24, 2006, FDA published a final rule amending the
requirements for the content and format of labeling for human
prescription drug and biological products (71 FR 3922, January 24,
2006). This rule is known as the physician labeling rule because it
addresses prescription drug labeling that is used by physicians and
other health care providers. Under this rule, the prescribing
information of new and more recently approved prescription drug and
biological products contains the following three sections: Highlights,
Full Prescribing Information: Contents, and Full Prescribing
Information (Sec. 201.56(d)(1) (21 CFR 201.56(d)(1))).
Highlights is required to contain the drug names (proprietary name
and nonproprietary name (established name of the drug or, for
biological products, the proper name)), dosage form, route of
administration, and, if applicable, controlled substance symbol of the
drug or biological product (Sec. 201.57(a)(2) (21 CFR 201.57(a)(2))).
This set of information is referred to as the ``product title'' and
follows the Highlights Limitation Statement. Highlights also must
include the year of initial U.S. approval of the drug or biological
product (Sec. 201.57(a)(3)). The initial U.S. approval must be placed
immediately beneath the product title and is the four-digit year in
which FDA initially approved the new molecular entity, new biological
product, or new combination of active ingredients.
This draft guidance provides recommendations on the content and
format of the product title in Highlights. Recommended sources for
product title terminology also are provided. Appendix A, ``Dosage Form
Terms for Use in Human Drug Product Labeling'' and Appendix B, ``Route
of Administration Terms for Use in Human Drug Product Labeling''
contain lists of recommended dosage form and route of administration
terms, respectively, for use in the product title. This draft guidance
contains recommendations for products with special nomenclature
considerations, recommendations for what not to include in the product
title, and implications for container and carton labeling.
The draft guidance also provides recommendations on the content and
format of the initial U.S. approval in Highlights. Items to consider
when determining the year of initial U.S. approval are included and
drug products requiring special consideration are described.
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 product title and initial U.S. approval in Highlights
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 that 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 Sec. Sec. 201.56 and 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/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or https://www.regulations.gov.

Dated: January 12, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-00899 Filed 1-18-18; 8:45 am]
BILLING CODE 4164-01-P