Federal Register / Vol. 82, No. 215 / Wednesday, November 8, 2017 / Notices 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Comment Request; Draft Guidance for 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title ‘‘Draft Guidance for Industry and 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 The draft guidance is 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

Guidance recommendations Number of 

respondents 

Number of responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

TPPs .................................................................................... 20 6.6 132 20 2,640 

1There 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 


ethrower on DSK3G9T082PROD with NOTICES
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 

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. 

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. 

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). 


ethrower on DSK3G9T082PROD with NOTICES