Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance for Industry and Review Staff on Target Product Profile-A Strategic Development Process Tool, 51849-51850 [2017-24335]
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Federal Register / Vol. 82, No. 215 / Wednesday, November 8, 2017 / Notices
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
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Comment Request; Draft Guidance for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.
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 oira_
submission@omb.eop.gov. 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title ‘‘Draft Guidance for Industry and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, PRAStaff@
fda.hhs.gov.
SUMMARY:
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 The draft guidance is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.
51849
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 60day 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
Number of
respondents
Number of responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
TPPs ....................................................................................
ethrower on DSK3G9T082PROD with NOTICES
Guidance recommendations
20
6.6
132
20
2,640
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
VerDate Sep<11>2014
17:26 Nov 07, 2017
Jkt 244001
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
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
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
E:\FR\FM\08NON1.SGM
08NON1
51850
Federal Register / Vol. 82, No. 215 / Wednesday, November 8, 2017 / Notices
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
ethrower on DSK3G9T082PROD with NOTICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; RFA–RM–
17–002: National Centers for Cryo-Electron
Microscopy.
Date: November 30–December 1, 2017.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hyatt Regency Bethesda, One
Bethesda Metro Center, 7400 Wisconsin
Avenue, Bethesda, MD 20814.
Contact Person: Nuria E. Assa-Munt, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4164,
MSC 7806, Bethesda, MD 20892, (301) 451–
1323, assamunu@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; RFA Panel:
Tobacco Regulatory Science A.
Date: December 4, 2017.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Embassy Suites at the Chevy Chase
Pavilion, 4300 Military Road NW.,
Washington, DC 20015.
Contact Person: Wenchi Liang, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3150,
MSC 7770, Bethesda, MD 20892, 301–435–
0681, liangw3@csr.nih.gov.
VerDate Sep<11>2014
17:26 Nov 07, 2017
Jkt 244001
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Vascular
and Hematology AREA Application Review.
Date: December 5, 2017.
Time: 3:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Katherine M. Malinda,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4140,
MSC 7814, Bethesda, MD 20892, 301–435–
0912, Katherine_Malinda@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
Multidisciplinary Studies of HIV and Viral
Hepatitis Co-Infection.
Date: December 6–7, 2017.
Time: 11:00 a.m. to 11:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Virtual Meeting).
Contact Person: Kenneth A. Roebuck,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5106,
MSC 7852, Bethesda, MD 20892, (301) 435–
1166, roebuckk@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Molecular Oncology.
Date: December 6, 2017.
Time: 12:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Virtual Meeting).
Contact Person: Reigh-Yi Lin, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD
20892, 301–827–6009, lin.reigh-yi@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: November 2, 2017.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2017–24263 Filed 11–7–17; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review: Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Thyroid
disorders.
Date: November 17, 2017.
Time: 3:30 p.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Dianne Hardy, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6175,
MSC 7892, Bethesda, MD 20892, 301–435–
1154, dianne.hardy@nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Topics in
Bioengineering.
Date: November 30, 2017.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Admiral Fell Inn, 888 South
Broadway, Baltimore, MD 21231.
Contact Person: Joseph D Mosca, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5158,
MSC 7808, Bethesda, MD 20892, 301–435–
2344, moscajos@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Shared
Instrumentation for Genomics Studies.
Date: December 1, 2017.
Time: 10:00 a.m. to 5:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Luis Dettin, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 2208,
Bethesda, MD 20892, 301–451–1327,
dettinle@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
Cardiovascular and Respiratory AREA (R15).
Date: December 6, 2017.
Time: 12:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
E:\FR\FM\08NON1.SGM
08NON1
]]>Agencies
[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]
[[Page 51849]]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 oira_submission@omb.eop.gov. 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,
PRAStaff@fda.hhs.gov.
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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Guidance recommendations Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
TPPs............................................................... 20 6.6 132 20 2,640
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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
[[Page 51850]]
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
