Federal Register / Vol. 72, No. 61 / Friday, March 30, 2007 / Notices 15141 

The study will involve 45 

respondents and take approximately 45 

minutes each to complete. These 

estimates are based on FDA’s experience 

with consumer research. 

Dated: March 23, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 07–1577 Filed 3–29–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007D–0089] 

Draft Guidance for Industry and 

Review Staff on Target Product 

Profile—A Strategic Development 

Process Tool; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry and review staff entitled 

‘‘Target Product Profile—A Strategic 

Development Process Tool.’’ The 

purpose of this guidance is to inform 

sponsors and the review staff in the 

Center for Drug Evaluation and Research 

(CDER) of the availability and potential 

usefulness of a target product profile 

(TPP). 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. 

This draft guidance describes the 

purposes of a TPP, provides guidance 

on how to complete a TPP, makes 

suggestions on how to best use a TPP, 

and relates case studies that 

demonstrate the potential usefulness of 

a TPP. 

DATES: Submit written or electronic 

comments on the draft guidance and/or 

on the collection of information by May 

29, 2007. General comments on agency 

guidance documents are welcome at any 

time. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Division of Drug Information (HFD–

240), Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857. Send one selfaddressed adhesive label to assist that 

office in processing your requests. 

Submit written comments on the draft 

guidance and/or on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.fda.gov/dockets/ecomments. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft 

guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Jeanne M. Delasko, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, rm. 6474, 

Silver Spring, MD 20993–0002, 301–

796–0900. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry and review 

staff entitled ‘‘Target Product Profile—A 

Strategic Development Process Tool.’’ In 

1997, a Clinical Development Working 

Group composed of representatives from 

FDA and pharmaceutical sponsors 

began discussions on ways to improve 

sponsor and FDA interactions in the 

drug development process. The 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. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the agency’s current thinking 

on target product profiles. It does not 

create or confer any rights for or on any 

person and does not operate to bind 

FDA or the public. An alternative 

approach may be used if such approach 

satisfies the requirements of the 

applicable statutes and regulations. 

II. The Paperwork Reduction Act of 

1995 

Under the Paperwork Reduction Act 

(44 U.S.C. 3501–3520) (the PRA), 

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, FDA is publishing notice 

of the proposed collection of 

information set forth below. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (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 on respondents, including 

through the use of automated collection 

techniques, when appropriate, and other 

forms of information technology. 

Title: Draft Guidance for Industry and 

Review Staff: Target Product Profile—A 

Strategic Development Process Tool. 

Description: The draft guidance is 

intended to provide sponsors and FDA 

review staff with information regarding 

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. 


cprice-sewell on PROD1PC66 with NOTICES
15142 Federal Register / Vol. 72, No. 61 / Friday, March 30, 2007 / Notices 

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 since 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 as follows: 

• 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 

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 chart 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 BURDEN1

No. of Respondents No. of Responses 

per Respondent 

Total Annual 

Responses 

Hours per 

Response Total Hours 

Target product profiles (TPPs) 20 6.6 132 20 2,640 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

III. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/cder/guidance/ 

index.htm or http://www.fda.gov/ 

ohrms/dockets/default.htm. 

Dated: March 22, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–5949 Filed 3–29–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Federal Emergency 

Management Agency, DHS. 

ACTION: Notice and request for 

comments. 

SUMMARY: The Federal Emergency 

Management Agency (FEMA), as part of 

its continuing effort to reduce 

paperwork and respondent burden, 

invites the general public and other 

Federal agencies to take this 

opportunity to comment on a proposed 

continuing information collection. In 

accordance with the Paperwork 

Reduction Act of 1995, this notice seeks 

comments concerning the National 

Flood Insurance Program—Mortgage 

Portfolio Protection Program (MPPP) 

that is a mechanism used by lending 

institutions mortgage servicing 

companies, and others servicing 

mortgage loan portfolios to bring the 

mortgage loan portfolios into 

compliance with the flood insurance 

purchase requirements of the Flood 

Disaster Protection Act of 1973, as 

amended. 

SUPPLEMENTARY INFORMATION: The 

National Flood Insurance Program 

(NFIP), authorized by the National 

Flood Insurance Act of 1968, Public 

Law 90–448, and expanded by the Flood 

Disaster Protection Act of 1973, Public 

Law 93–234, as amended, provides 

federally backed flood insurance for 

buildings exposed to flood risk. In 

accordance with Public Law 93–234 the 

purchase of flood insurance is 

mandatory when Federal and federally 

related assistance is being provided for 

acquisition or construction of buildings 

located or to be located within FEMA 

identified Special Flood Hazard Areas 

of communities which are participating 

in the program. 

Collection of Information 

Title: National Flood Insurance 

Program—Mortgage Portfolio Protection 

Program (MPPP). 

Type of Information Collection: 

Extension, without change, of a 

currently approved collection. 

OMB Number: 1660–0086. 

Form Numbers: None. 

Abstract: The MPPP is a mechanism 

used by lending institutions mortgage 

servicing companies, and others 

servicing mortgage loan portfolios to 

bring the mortgage loan portfolios into 


cprice-sewell on PROD1PC66 with NOTICES