[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]
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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: 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Comment Request; Draft Guidance for Industry and Review Staff on Target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.
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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draft guidance for industry and review staff entitled ``Target Product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
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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
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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\
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Number of
Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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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.
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