[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Prescription Drug and Biological Products--Content and Format; Draft 
Guidance for Industry; Availability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the availability of a draft guidance for industry entitled ``Product 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 This draft guidance provides recommendations on 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DATES: Submit either electronic or written comments on the draft 
guidance by March 20, 2018 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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


