82_FR_52064 82 FR 51849 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance for Industry and Review Staff on Target Product Profile-A Strategic Development Process Tool

82 FR 51849 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance for Industry and Review Staff on Target Product Profile-A Strategic Development Process Tool

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 215 (November 8, 2017)

Page Range51849-51850
FR Document2017-24335

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.

Federal Register, Volume 82 Issue 215 (Wednesday, November 8, 2017) 
[Federal Register Volume 82, Number 215 (Wednesday, November 8, 2017)]
[Notices]
[Pages 51849-51850]
From the Federal Register Online  [www.thefederalregister.org]
[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of Management and Budget Review; Comment Request; Draft Guidance for 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 [email protected]. 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title ``Draft Guidance for Industry and Review Staff on Target Product 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, 
[email protected].

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

Federal Register / Vol. 82, No. 215 / Wednesday, November 8, 2017 / Notices 51849 DEPARTMENT OF HEALTH AND SUPPLEMENTARY INFORMATION: In The TPP is organized according to the HUMAN SERVICES compliance with 44 U.S.C. 3507, FDA key sections of the drug labeling and has submitted the following proposed links drug development activities to Food and Drug Administration collection of information to OMB for specific concepts intended for inclusion review and clearance. in the drug labeling. The TPP is not a [Docket No. FDA–2007–D–0256 (formerly 2007D–0089)] Guidance for Industry and Review Staff long summary. Generally, the TPP is on Target Product Profile—A Strategic shorter than the ultimate annotated draft Agency Information Collection Development Process Tool; OMB labeling because it captures only a Activities; Submission for Office of Control Number 0910–NEW summary of the drug development Management and Budget Review; activities and labeling concepts. Early This information collection request TPPs can be brief depending on the Comment Request; Draft Guidance for supports the above-captioned Agency status of the drug’s development Industry and Review Staff on Target guidance. The draft guidance is process. Product Profile—A Strategic intended to provide sponsors and FDA The Target Product Profile Template Development Process Tool review staff with information regarding in Appendix C of the draft guidance AGENCY: Food and Drug Administration, target product profiles (TPPs). A TPP details the suggested information to be HHS. can be prepared by a sponsor and then included in each section of the TPP. The ACTION: Notice. shared voluntarily with the appropriate TPP includes information from each FDA review staff to facilitate discipline comprising an NDA/BLA. SUMMARY: The Food and Drug communication regarding a particular Within each discipline, the TPP briefly Administration (FDA) is announcing drug development program. The TPP is summarizes the specific studies that that a proposed collection of based on a template that provides a will supply the evidence for each information has been submitted to the summary of drug labeling concepts to conclusion that is a labeling concept. A Office of Management and Budget focus discussions and aid in the TPP is organized according to key (OMB) for review and clearance under understanding between sponsors and sections in the drug’s labeling. Typical the Paperwork Reduction Act of 1995. FDA. The resulting TPP is a format for key sections are: DATES: Fax written comments on the a summary of a drug development program described in terms of labeling • Indications and Usage collection of information by December • Dosage and Administration 8, 2017. concepts. With the TPP, a sponsor specifies the labeling concepts that are • Dosage Forms and Strengths ADDRESSES: To ensure that comments on • Contraindications the goals of the drug development the information collection are received, program, documents the specific studies • Warnings and Precautions OMB recommends that written that are intended to support the labeling • Adverse Reactions comments be faxed to the Office of concepts, and then uses the TPP to • Drug Interactions Information and Regulatory Affairs, assist in a constructive dialogue with • Use in Specific Populations OMB, Attn: FDA Desk Officer, Fax: 202– 395–7285, or emailed to oira_ FDA. The draft guidance describes the • Drug Abuse and Dependence purpose of a TPP, its advantages, and its • Overdosage submission@omb.eop.gov. All optimal use. It also provides comments should be identified with the • Description information on how to complete a TPP • Clinical Pharmacology OMB control number 0910–NEW and and relates case studies that title ‘‘Draft Guidance for Industry and • Nonclinical Toxicology demonstrate a TPP’s usefulness. Review Staff on Target Product Profile— Sponsors are not required to submit a • Clinical Studies A Strategic Development Process Tool.’’ TPP. The TPP does not represent an • References Also include the FDA docket number implicit or explicit obligation on the • How Supplied/Storage and Handling found in brackets in the heading of this sponsor’s part to pursue all stated goals. • Patient Counseling Information document. Submission of a TPP summary does not In the Federal Register of January 5, FOR FURTHER INFORMATION CONTACT: constrain the sponsor to submit draft 2016 (81 FR 240), FDA published a 60- Domini Bean, Office of Operations, labeling in a new drug application day notice requesting public comment Food and Drug Administration, Three (NDA) or biologics license application on the proposed collection of White Flint North, 10A–12M, 11601 (BLA) that is identical to the TPP. The information. No comments were Landsdown St., North Bethesda, MD TPP is part of the proprietary received. 20852, 301–796–5733, PRAStaff@ investigational new drug application FDA estimates the burden of the fda.hhs.gov. (IND) file. information collection as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of re- Average Number of Total annual Guidance recommendations sponses per burden per Total hours respondents responses respondent response TPPs .................................................................................... 20 6.6 132 20 2,640 1 There are no capital or operating and maintenance costs associated with the information collection. ethrower on DSK3G9T082PROD with NOTICES Description of Respondents: Sponsors marketing approval of the drug from FDA annually would prepare and of applications seeking FDA approval to FDA. submit TPPs. According to our records, perform clinical investigations of a Burden Estimate: FDA estimates that this equals approximately 132 TPPs per human drug before applying for sponsors of approximately 10 percent of year. Based on data received from the the number of active INDs submitted to Pharmaceutical Research and VerDate Sep<11>2014 17:26 Nov 07, 2017 Jkt 244001 PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 E:\FR\FM\08NON1.SGM 08NON1

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


Document Created: 2017-11-08 01:20:39
Document Modified: 2017-11-08 01:20:39
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesFax written comments on the collection of information by December 8, 2017.
ContactDomini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, [email protected]
FR Citation82 FR 51849 
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR