
[Federal Register Volume 81, Number 233 (Monday, December 5, 2016)]
[Notices]
[Pages 87563-87565]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-29125]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0095]


Clinical Pharmacology Section of Labeling for Human Prescription 
Drug and Biological Products--Content and Format; Guidance for 
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a guidance for industry entitled ``Clinical 
Pharmacology Section of Labeling for Human Prescription Drug and 
Biological Products--Content and Format.'' This guidance is one of a 
series of guidance documents intended to assist applicants in complying 
with FDA regulations on the content and form at of labeling for human 
prescription drug and biological products. The guidance describes the 
recommended information to include in the CLINICAL PHARMACOLOGY section 
of labeling that pertains to the safe and effective use of human 
prescription drug and biological products. This guidance finalizes the 
2014 revised draft guidance entitled ``Clinical Pharmacology Labeling 
for Human Prescription Drug and Biological Products--Considerations, 
Content, and Format.''

[[Page 87564]]


DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: You may submit comments 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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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-2009-D-0095 for ``Clinical Pharmacology Section of Labeling 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 Division of Dockets Management 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 Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    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 to the Office of 
Communication, Outreach and Development, Center for Biologics 
Evaluation and Research (CBER), 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: Joseph Grillo, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 3177, Silver Spring, MD 20993-0002, 301-
796-5008; 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

    In the Federal Register of January 24, 2006 (71 FR 3922), FDA 
published a final rule entitled ``Requirements on Content and Format of 
Labeling for Human Prescription Drug and Biological Products'' to 
revise the Agency's previous regulations on labeling (effective June 
30, 2006). The final rule, commonly referred to as the Physician 
Labeling Rule (PLR), is designed to make information in prescription 
drug labeling easier for health care practitioners to access, read, and 
use, thereby increasing the extent to which health care providers rely 
on labeling for prescribing decisions.
    In the Federal Registerof March 3, 2009 (74 FR 9250), FDA announced 
the availability of a draft guidance on the format and content of the 
CLINICAL PHARMACOLOGY section of labeling. After considering received 
comments on the 2009 draft guidance, the Agency announced the 
availability of a revised draft guidance entitled ``Clinical 
Pharmacology Labeling for Human Prescription Drug and Biological 
Products--Considerations, Content, and Format'' in the Federal Register 
of August 14, 2014 (79 FR 47650). After carefully reviewing received 
comments on the 2014 revised draft guidance and in light of the 
Agency's increased regulatory experience implementing the PLR and FDA's 
labeling and communication initiatives to ensure consistency and 
clarity, FDA has finalized the guidance.

II. Guidance

    FDA is announcing the availability of a guidance for industry 
entitled ``Clinical Pharmacology Section of Labeling for Human 
Prescription Drug and Biological Products--Content and Format'' as one 
of a series of guidance documents intended to assist applicants in 
complying with FDA regulations on the content and format of labeling 
for human prescription drug and biological products. This guidance 
provides clarity on the information that should be included in section 
12 CLINICAL PHARMACOLOGY of the prescription

[[Page 87565]]

drug labeling under the PLR (21 CFR 201.57(c)(13)) and provides 
guidance on the inclusion of clinical recommendations based on clinical 
pharmacology findings in other sections of the labeling. The guidance 
is also intended to ensure consistency, as appropriate, in labeling of 
the CLINICAL PHARMACOLOGY section for all prescription drug products 
approved by FDA.
    This guidance provides a general framework and set of 
recommendations that should be adapted to specific drugs and their 
conditions of use. Not all of the information identified in this 
guidance for inclusion in the CLINICAL PHARMACOLOGY section of product 
labeling will be applicable for every drug. For the purposes of this 
notice, all references to drugs include both human drugs and biological 
products unless otherwise specified.
    The guidance outlines the use of subsections, headings, and 
subheadings to provide organization for the CLINCAL PHARMACOLOGY 
section in labeling. The guidance also emphasizes the importance of 
providing variability measures related to pharmacokinetic measures and 
parameters, pharmacodynamic measures, and other clinical pharmacology 
study results.
    In addition to clarifications and edits throughout the guidance on 
various subsections of section 12, some notable changes from the 
revised draft guidance include:
     Addressing whether applicants are expected to revise 
current approved labeling if reserved sections 12.4 and 12.5 have 
already been used for other topics, and
     Providing revised recommendations on the inclusion of 
pregnancy and lactation information to be consistent with 
recommendations in FDA's ``Pregnancy and Lactation Labeling Rule'' 
(https://www.federalregister.gov/documents/2014/12/04/2014-28241/content-and-format-of-labeling-for-human-prescription-drug-and-biological-products-requirements-for) (December 2014) and draft 
guidance for industry entitled ``Pregnancy, Lactation, and Reproductive 
Potential: Labeling for Human Prescription Drug and Biological 
Products--Content and Format'' (http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm425398.pdf) 
(December 2014).
    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 inclusion of clinical pharmacology 
information in section 12 CLINICAL PHARMACOLOGY of product labeling. 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 
requirement of the applicable statutes and regulations.

III. The Paperwork Reduction Act of 1995

    This 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 21 CFR 201.56 and 201.57 have 
been approved under OMB control number 0910-0572; the collections of 
information related to pharmacogenomic data have been approved under 
OMB control number 0910-0557.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or 
https://www.regulations.gov.

    Dated: November 29, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-29125 Filed 12-2-16; 8:45 am]
 BILLING CODE 4164-01-P


