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in Appendix C of the draft guidance 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draft guidance.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
Federal Register / Vol. 72, No. 61 / Friday, March 30, 2007 / Notices 15143 

compliance with the flood insurance 

purchase requirements of the Flood 

Disaster Protection Act of 1973, as 

amended. Implementation of various 

requirements of the MPPP should result 

in mortgagors, following receipt of 

notification of the need for flood 

insurance, showing evidence of such a 

policy or purchasing the necessary 

insurance through their local insurance 

agent or appropriate Write Your Own 

(WYO) Company. It is intended that 

NFIP policies be written under the 

MPPP only as a last resort, and only on 

mortgages whose mortgagors have failed 

to respond to the various notifications 

required by the Program. The 

requirements of the MPPP are contained 

in 44 CFR 62.23(l)(1). 

Affected Public: Individuals and 

households; businesses or other forprofit; not-for-profit institutions; farms; 

Federal agencies or employees; and 

State, local or tribal governments. 

Estimated Total Annual Burden 

Hours: 2,386 hours. 

ANNUAL BURDEN HOURS

Project/activity (survey, form(s), focus group, worksheet, 

etc.) 

Number of 

respondents 

Frequency of 

responses 

Burden hours 

per 

respondent 

Annual 

responses 

Total annual 

burden hours 

(A) (B) (C) (D) = (A × B) (E) = (C × D) 

WYO—Lender/Services Coordination ................................. 22 1 .5 22 11 

Lenders/Mortgagors Service Coordination .......................... 250 1 .5 250 125 

WYO Company Policy Issuance .......................................... 6000 1 .25 6000 1500 

WYO Company (New Program Entrant Insurance Company) ................................................................................. 1 1 *750 1 750 

Total .............................................................................. 6,273 ........................ ........................ ........................ 2,386 

* The 750 burden hours per respondent is the amount of time it takes a new program entrant (insurance company) to prepare, train, and compile various needed information. 

Estimated Cost: $107,350. 

Comments: Written comments are 

solicited to (a) evaluate whether the 

proposed data collection is necessary for 

the proper performance of the agency, 

including whether the information shall 

have practical utility; (b) evaluate the 

accuracy of the agency’s estimate of the 

burden of the proposed collection of 

information, including the validity of 

the methodology and assumptions used; 

(c) enhance the quality, utility, and 

clarity of the information to be 

collected; and (d) minimize the burden 

of the collection of information on those 

who are to respond, including through 

the use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology, 

e.g., permitting electronic submission of 

responses. Comments must be 

submitted on or before May 29, 2007. 

ADDRESSES: Interested persons should 

submit written comments to Chief, 

Records Management and Privacy, 

Information Resources Management 

Branch, Information Technology 

Services Division, Federal Emergency 

Management Agency, 500 C Street, SW., 

Room 609, Washington, DC 20472. 

FOR FURTHER INFORMATION CONTACT: 

Contact Edward Connor, Deputy 

Director of Insurance, Mitigation 

Division, Federal Emergency 

Management Agency, Department of 

Homeland Security, 202–646–3429, 

edward.connor@dhs.gov, for additional 

information. You may contact the 

Records Management Branch for copies 

of the proposed collection of 

information at facsimile number (202) 

646–3347or email address: FEMAInformation-Collections@dhs.gov. 

Dated: March 26, 2007. 

John A. Sharetts-Sullivan, 

Chief, Records Management and Privacy, 

Information Resources Management Branch, 

Information Technology Services Division, 

Federal Emergency Management Agency, 

Department of Homeland Security. 

[FR Doc. E7–5910 Filed 3–29–07; 8:45 am] 

BILLING CODE 9110–12–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Bureau of Immigration and Customs 

Enforcement 

Agency Information Collection 

Activities: Extension of an Existing 

Information Collection; Comment 

Request 

ACTION: 60-Day Notice of Information 

Collection Under Review; Form G–146, 

Nonimmigrant Checkout Letter; OMB 

Control No. 1653–0020. 

The Department of Homeland 

Security, U.S. Immigration and Customs 

Enforcement (USICE), has submitted the 

following information collection request 

for review and clearance in accordance 

with the Paperwork Reduction Act of 

1995. The information collection is 

published to obtain comments from the 

public and affected agencies. Comments 

are encouraged and will be accepted for 

sixty days until May 29, 2007. 

Written comments and suggestions 

regarding items contained in this notice, 

and especially with regard to the 

estimated public burden and associated 

response time should be directed to the 

Department of Homeland Security 

(DHS), Ricardo Lemus, Chief, Records 

Management Branch, Bureau of 

Immigration and Customs Enforcement, 

425 I Street, NW., Room 1122, 

Washington, DC 20536; (202) 514–3211. 

Comments are encouraged and will be 

accepted for sixty days until May 29, 

2007. Written comments and 

suggestions from the public and affected 

agencies concerning the proposed 

collection of information should address 

one or more of the following four points: 

(1) Evaluate whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information will have 

practical utility; 

(2) Evaluate the accuracy of the 

agencies estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions used; 

(3) Enhance the quality, utility, and 

clarity of the information to be 

collected; and 

(4) Minimize the burden of the 

collection of information on those who 

are to respond, including through the 

use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology, 

e.g., permitting electronic submission of 

responses. 


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