Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance for Industry and Review Staff on Target Product Profile-A Strategic Development Process Tool, 51849-51850 [2017-24335]

Download as PDF 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Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance for Industry and Review Staff on Target Product Profile—A Strategic Development Process Tool AGENCY: Food and Drug Administration, HHS.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 All comments should be identified with the OMB control number 0910–NEW and title ‘‘Draft Guidance for Industry and Review Staff on Target Product Profile— A Strategic Development Process Tool.’’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 The draft guidance is intended to provide sponsors and FDA review staff with information regarding target product profiles (TPPs).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]]

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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.

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

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