[Federal Register Volume 81, Number 2 (Tuesday, January 5, 2016)]
[Notices]
[Pages 240-242]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-33127]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities: Proposed Collection; 
Comment Request; Draft Guidance for Industry and Review Staff on Target 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.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on the reporting requirements contained in the 
draft guidance for industry and review staff entitled ``Target Product 
Profile--A Strategic Development Process Tool.''

DATES: Submit either electronic or written comments on the collection 
of information by March 7, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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-2007-D-0256 (formerly 2007D-0089) for ``Agency Information 
Collection Activities: Proposed Collection; Comment Request; Draft 
Guidance for Industry and Review Staff on Target Product Profile--A 
Strategic Development Process Tool.'' Received

[[Page 241]]

comments will be placed in the docket and, except for those submitted 
as ``Confidential Submissions,'' publicly viewable at http://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 http://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 http://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.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520) 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, in the Federal Register of March 30, 2007 (72 FR 15141), 
FDA published a notice of availability of the draft guidance document 
with a 60-day notice requesting public comment on the collection of 
information. In response to a request by OMB, FDA is republishing a 
notice of the proposed collection of information set forth in this 
document.
    With respect to the following collection of information, FDA 
invites comments on: (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 of information on respondents, including through the use of 
automated collection techniques, when appropriate, and other forms of 
information technology.
    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. 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.
    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

    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

[[Page 242]]

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 table 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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                      Number of
                                                                     Number of      responses per     Total annual    Average burden      Total hours
                                                                    respondents       respondent       responses       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Target Product Profiles (TPPs)..................................              20              6.6              132               20               2,640
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: December 29, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-33127 Filed 1-4-16; 8:45 am]
BILLING CODE 4164-01-P