Published Sixty-d FRN for 1660-0086

15142

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

The TPP is organized according to the
key sections of the drug labeling and
links drug development activities to
specific conceptsintended 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in Appendix C of the draft guidance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 NDAIBLA.
Within each discipline, the TPP briefly
summarizes the specific studies that
will supply the evidence for each
conclusion that is a labeling concept. A

I

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 SuppliedIStorage and
Handling
Patient Counseling Information
Description of Respondents: Sponsors
of applications seeking FDA approval to
perform clinical investigations of a

No. of Respondents
Target product profiles (TPPs)

No. of Responses
per Respondent

20

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draft guidance.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.

Total Annual
Responses

6.6

Hours per
Response

132

Total Hours
20

2,640

'There are no capital costs or operating and maintenance costs associated with this collection of inlormation.

111. 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 416041-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

Federal Register / Vol. 72, No. 61 /Friday, March 30, 2007 /Notices
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
ANNUAL
BURDEN HOURS

ProjecVactivity (survey, form(s),focus group, worksheet,

...-..,

P ~ C
\

I

Number of
respondents

I

Frequency
responsesof

1

requirements of the MPPP are contained
in 44 CFR 62.23(1)(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.

Burden hours
per
respondent

1

(c)

(B)

(A)

15143

Annual
responses

I
I

Total annual
burden hours
(E) = (C x D)

(D) = (A x B)

WYO-LenderISe~ices Coordination .................................
LendersIMoltgagors Service Coordination ..........................
WYO Company Policy Issuance ..........................................
WYO Company (New Program Entrant Insurance Company) .................................................................................

1

I

/

I

1

2,386
Total ..............................................................................
6.273 ........................ ........................ ........................
'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.connofidhs.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: FEMAInforma [email protected].
Dated: March 26,2007.
John A. Sharetts-Sullivan,

Chief,Records Management and Privacy,
Information Resources Management Branch,
Information TechnologyServices 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 lnformation Collection
Activities: Extension of an Existing
lnformation Collection; Comment
Request

-

ACTION: 60-Day Notice of Information

Collection Under Review; Form 6 1 4 6 ,
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 1 1 2 2 ,
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.