[Federal Register Volume 82, Number 215 (Wednesday, November 8, 2017)]
[Notices]
[Pages 51849-51850]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-24335]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0256 (formerly 2007D-0089)]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Draft Guidance for 
Industry and Review Staff on Target Product Profile--A Strategic 
Development Process Tool

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by 
December 8, 2017.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-NEW and 
title ``Draft Guidance for Industry and Review Staff on Target Product 
Profile--A Strategic Development Process Tool.'' Also include the FDA 
docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Guidance for Industry and Review Staff on Target Product Profile--A 
Strategic Development Process Tool; OMB Control Number 0910-NEW

    This information collection request supports the above-captioned 
Agency guidance. The draft guidance is intended to provide sponsors and 
FDA review staff with information regarding target product profiles 
(TPPs). A TPP can be prepared by a sponsor and then shared voluntarily 
with the appropriate FDA review staff to facilitate communication 
regarding a particular drug development program. The TPP is based on a 
template that provides a summary of drug labeling concepts to focus 
discussions and aid in the understanding between sponsors and FDA. The 
resulting TPP is a format for a summary of a drug development program 
described in terms of labeling concepts. With the TPP, a sponsor 
specifies the labeling concepts that are the goals of the drug 
development program, documents the specific studies that are intended 
to support the labeling concepts, and then uses the TPP to assist in a 
constructive dialogue with FDA. The draft guidance describes the 
purpose of a TPP, its advantages, and its optimal use. It also provides 
information on how to complete a TPP and relates case studies that 
demonstrate a TPP's usefulness.
    Sponsors are not required to submit a TPP. The TPP does not 
represent an implicit or explicit obligation on the sponsor's part to 
pursue all stated goals. Submission of a TPP summary does not constrain 
the sponsor to submit draft labeling in a new drug application (NDA) or 
biologics license application (BLA) that is identical to the TPP. The 
TPP is part of the proprietary investigational new drug application 
(IND) file.
    The TPP is organized according to the key sections of the drug 
labeling and links drug development activities to specific concepts 
intended for inclusion in the drug labeling. The TPP is not a long 
summary. Generally, the TPP is shorter than the ultimate annotated 
draft labeling because it captures only a summary of the drug 
development activities and labeling concepts. Early TPPs can be brief 
depending on the status of the drug's development process.
    The Target Product Profile Template in Appendix C of the draft 
guidance details the suggested information to be included in each 
section of the TPP. The TPP includes information from each discipline 
comprising an NDA/BLA. Within each discipline, the TPP briefly 
summarizes the specific studies that will supply the evidence for each 
conclusion that is a labeling concept. A TPP is organized according to 
key sections in the drug's labeling. Typical key sections are:

 Indications and Usage
 Dosage and Administration
 Dosage Forms and Strengths
 Contraindications
 Warnings and Precautions
 Adverse Reactions
 Drug Interactions
 Use in Specific Populations
 Drug Abuse and Dependence
 Overdosage
 Description
 Clinical Pharmacology
 Nonclinical Toxicology
 Clinical Studies
 References
 How Supplied/Storage and Handling
 Patient Counseling Information

    In the Federal Register of January 5, 2016 (81 FR 240), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of the information collection as follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                         Number of
                      Guidance recommendations                          Number of      responses per     Total annual   Average  burden    Total hours
                                                                       respondents       respondent       responses      per  response
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TPPs...............................................................              20              6.6              132               20            2,640
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\1\ There are no capital or operating and maintenance costs associated with the information collection.

    Description of Respondents: Sponsors of applications seeking FDA 
approval to perform clinical investigations of a human drug before 
applying for marketing approval of the drug from FDA.
    Burden Estimate: FDA estimates that sponsors of approximately 10 
percent of the number of active INDs submitted to FDA annually would 
prepare and submit TPPs. According to our records, this equals 
approximately 132 TPPs per year. Based on data received from the 
Pharmaceutical Research and

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Manufacturers of America, we estimate that approximately 20 sponsors 
would submit TPPs and that each submission would take approximately 20 
hours to prepare. This information is reflected in table 1.

    Dated: November 3, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-24335 Filed 11-7-17; 8:45 am]
 BILLING CODE 4164-01-P