[Federal Register Volume 72, Number 61 (Friday, March 30, 2007)]
[Notices]
[Pages 15141-15142]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-5949]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007D-0089]


Draft Guidance for Industry and Review Staff on Target Product 
Profile--A Strategic Development Process Tool; Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry and review staff entitled 
``Target Product Profile--A Strategic Development Process Tool.'' The 
purpose of this guidance is to inform sponsors and the review staff in 
the Center for Drug Evaluation and Research (CDER) of the availability 
and potential usefulness of a target product profile (TPP). 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. This draft guidance describes the 
purposes of a TPP, provides guidance on how to complete a TPP, makes 
suggestions on how to best use a TPP, and relates case studies that 
demonstrate the potential usefulness of a TPP.

DATES:  Submit written or electronic comments on the draft guidance 
and/or on the collection of information by May 29, 2007. General 
comments on agency guidance documents are welcome at any time.

ADDRESSES:  Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 
Evaluation and Research, Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857. Send one self-addressed adhesive label to 
assist that office in processing your requests. Submit written comments 
on the draft guidance and/or on the collection of information to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic 
comments to http://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the draft guidance 
document.

FOR FURTHER INFORMATION CONTACT: Jeanne M. Delasko, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, rm. 6474, Silver Spring, MD 20993-0002, 301-
796-0900.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
and review staff entitled ``Target Product Profile--A Strategic 
Development Process Tool.'' In 1997, a Clinical Development Working 
Group composed of representatives from FDA and pharmaceutical sponsors 
began discussions on ways to improve sponsor and FDA interactions in 
the drug development process. The working group recommended use of 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.
    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 agency's current thinking on target 
product profiles. It does not create or confer any rights for or on any 
person and does not operate to bind FDA or the public. An alternative 
approach may be used if such approach satisfies the requirements of the 
applicable statutes and regulations.

II. The Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act (44 U.S.C. 3501-3520) (the PRA), 
Federal agencies must obtain approval from the Office of Management and 
Budget (OMB) for each collection of information they conduct or 
sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3) 
and 5 CFR 1320.3(c) and includes agency requests or requirements that 
members of the public submit reports, keep records, or provide 
information to a third party. Section 3506(c)(2)(A) of the PRA (44 
U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day 
notice in the Federal Register concerning each proposed collection of 
information before submitting the collection to OMB for approval. To 
comply with this requirement, FDA is publishing notice of the proposed 
collection of information set forth below.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection on respondents, including 
through the use of automated collection techniques, when appropriate, 
and other forms of information technology.
    Title: Draft Guidance for Industry and Review Staff: Target Product 
Profile--A Strategic Development Process Tool.
    Description: The draft guidance is intended to provide sponsors and 
FDA review staff with information regarding 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. A Clinical Development Working Group recommended 
use of 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.

[[Page 15142]]

    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 since 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 as 
follows:
     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
    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. This would equal approximately 132 TPPs per 
year. Based on data received from the Pharmaceutical Research and 
Manufacturers of America, we estimate that approximately 20 sponsors 
would submit TPPs and that each TPP would take approximately 20 hours 
to prepare and submit to FDA. Based on the previous methodology and 
assumptions, the following chart provides an estimate of the annual 
reporting burden for the voluntary submission of TPPs under the draft 
guidance. FDA requests comments on this analysis of information 
collection burdens.

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                              No. of         No. of Responses       Total Annual        Hours per
                                                           Respondents        per Respondent         Responses           Response         Total Hours
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Target product profiles (TPPs)                                         20                   6.6                132                 20              2,640
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/cder/guidance/index.htm or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: March 22, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-5949 Filed 3-29-07; 8:45 am]
BILLING CODE 4160-01-S