Federal Register / Vol. 72, No. 35 / Thursday, February 22, 2007 / Notices 7999 

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average burden 

hours per 

response 

Total burden 

hours 

Mentoring ToolKit Web-based Needs Assessment Questionannaire ........... 442 1 .75 332 

Mentoring ToolKit Web-based focus group ................................................... 40 1 1 40 

Mentoring ToolKit Web-based Feedback questionnaire ............................... 100 1 .25 25 

Estimated Total Annual Burden 

Hours: 397 

Additional Information: Copies of the 

proposed collection may be obtained by 

writing to the Administration for 

Children and Families, Office of 

Administration, Office of Information 

Services, 370 L’Enfant Promenade, SW., 

Washington, DC 20447, Attn: ACF 

Reports Clearance Officer. All requests 

should be identified by the title of the 

information collection. E-mail address: 

infocollection@acf.hhs.gov. 

OMB Comment: OMB is required to 

make a decision concerning the 

collection of information between 30 

and 60 days after publication of this 

document in the Federal Register. 

Therefore, a comment is best assured of 

having its full effect if OMB receives it 

within 30 days of publication. Written 

comments and recommendations for the 

proposed information collection should 

be sent directly to the following: Office 

of Management and Budget, Paperwork 

Reduction Project, Fax: 202–395–6974, 

Attn: Desk Officer for the 

Administration for Children and 

Families. 

Dated: February 15, 2007. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 07–790 Filed 2–21–07; 8:45 am] 

BILLING CODE 4184–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2006E–0252] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; LEVEMIR 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

LEVEMIR and is publishing this notice 

of that determination as required by 

law. FDA has made the determination 

because of the submission of an 

application to the Director of Patents 

and Trademarks, Department of 

Commerce, for the extension of a patent 

that claims that human drug product. 

ADDRESSES: Submit written comments 

and petitions 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. 

FOR FURTHER INFORMATION CONTACT: 

Beverly Friedman, Office of Regulatory 

Policy (HFD–7), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–594–2041. 

SUPPLEMENTARY INFORMATION: The Drug 

Price Competition and Patent Term 

Restoration Act of 1984 (Public Law 98–

417) and the Generic Animal Drug and 

Patent Term Restoration Act (Public 

Law 100–670) generally provide that a 

patent may be extended for a period of 

up to 5 years so long as the patented 

item (human drug product, animal drug 

product, medical device, food additive, 

or color additive) was subject to 

regulatory review by FDA before the 

item was marketed. Under these acts, a 

product’s regulatory review period 

forms the basis for determining the 

amount of extension an applicant may 

receive. 

A regulatory review period consists of 

two periods of time: A testing phase and 

an approval phase. For human drug 

products, the testing phase begins when 

the exemption to permit the clinical 

investigations of the human drug 

product becomes effective and runs 

until the approval phase begins. The 

approval phase starts with the initial 

submission of an application to market 

the human drug product and continues 

until FDA grants permission to market 

the product. Although only a portion of 

a regulatory review period may count 

toward the actual amount of extension 

that the Director of Patents and 

Trademarks may award (for example, 

half the testing phase must be 

subtracted, as well as any time that may 

have occurred before the patent was 

issued), FDA’s determination of the 

length of a regulatory review period for 

a human drug product will include all 

of the testing phase and approval phase 

as specified in 35 U.S.C. 156(g)(1)(B). 

FDA recently approved for marketing 

the human drug product LEVEMIR 

(insulin determir (rDNA origin)). 

LEVEMIR is indicated for once or twicedaily subcutaneous administration in 

the treatment of adult patients with 

diabetes mellitus who require basal 

(long acting) insulin for the control of 

hyperglycemia. Subsequent to this 

approval, the Patent and Trademark 

Office received a patent term restoration 

application for LEVEMIR (U.S. Patent 

No. 5,750,497) from Novo Nordisk A/S, 

and the Patent and Trademark Office 

requested FDA’s assistance in 

determining this patent’s eligibility for 

patent term restoration. In a letter dated 

July 24, 2006, FDA advised the Patent 

and Trademark Office that this human 

drug product had undergone a 

regulatory review period and that the 

approval of LEVEMIR represented the 

first permitted commercial marketing or 

use of the product. Thereafter, the 

Patent and Trademark Office requested 

that FDA determine the product’s 

regulatory review period. 

FDA has determined that the 

applicable regulatory review period for 

LEVEMIR is 2,896 days. Of this time, 

1,971 days occurred during the testing 

phase of the regulatory review period, 

while 925 days occurred during the 

approval phase. These periods of time 

were derived from the following dates: 

1. The date an exemption under 

section 505(i) of the Federal Food, Drug, 

and Cosmetic Act (the act) (21 U.S.C. 

355) became effective: July 14, 1997. 

FDA has verified the applicant’s claim 

that the date the investigational new 

drug application became effective was 

on July 14, 1997. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 

505(b) of the act: December 5, 2002. 

FDA has verified the applicant’s claim 

that the new drug application (NDA) for 

LEVIMIR (NDA 21–536) was initially 

submitted on December 5, 2002. 

3. The date the application was 

approved: June 16, 2005. FDA has 

verified the applicant’s claim that NDA 

21–536 was approved on June 16, 2005. 

This determination of the regulatory 

review period establishes the maximum 

potential length of a patent extension. 

However, the U.S. Patent and 

Trademark Office applies several 

statutory limitations in its calculations 

of the actual period for patent extension. 

In its application for patent extension, 


rwilkins on PROD1PC63 with NOTICES
8000 Federal Register / Vol. 72, No. 35 / Thursday, February 22, 2007 / Notices 

this applicant seeks 1,496 days of patent 

term extension. 

Anyone with knowledge that any of 

the dates as published are incorrect may 

submit to the Division of Dockets 

Management (see ADDRESSES) written or 

electronic comments and ask for a 

redetermination by April 23, 2007. 

Furthermore, any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period by 

August 21, 2007. To meet its burden, the 

petition must contain sufficient facts to 

merit an FDA investigation. (See H. 

Rept. 857, part 1, 98th Cong., 2d sess., 

pp. 41–42, 1984.) Petitions should be in 

the format specified in 21 CFR 10.30. 

Comments and petitions should be 

submitted to the Division of Dockets 

Management. Three copies of any 

mailed information are to be submitted, 

except that individuals may submit one 

copy. Comments are to be identified 

with the docket number found in 

brackets in the heading of this 

document. 

Comments and petitions may be seen 

in the Division of Dockets Management 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

Dated: February 3, 2007. 

Jane A. Axelrad, 

Associate Director for Policy, Center for Drug 

Evaluation and Research. 

[FR Doc. E7–3001 Filed 2–21–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

[FEMA–3271–EM] 

Colorado; Amendment No. 3 to Notice 

of an Emergency Declaration 

AGENCY: Federal Emergency 

Management Agency, DHS. 

ACTION: Notice. 

SUMMARY: This notice amends the notice 

of an emergency declaration for the 

State of Colorado (FEMA–3271–EM), 

dated January 7, 2007, and related 

determinations. 

EFFECTIVE DATE: February 12, 2007. 

FOR FURTHER INFORMATION CONTACT: 

Magda Ruiz, Recovery Division, Federal 

Emergency Management Agency, 

Washington, DC 20472, (202) 646–2705. 

SUPPLEMENTARY INFORMATION: The notice 

of an emergency declaration for the 

State of Colorado is hereby amended to 

include the following areas among those 

areas determined to have been adversely 

affected by the catastrophe declared an 

emergency by the President in his 

declaration of January 7, 2007: 

Cheyenne, Huerfano, and Kiowa Counties 

for emergency protective measures (Category 

B), including snow removal, under the Public 

Assistance program for any continuous 48- 

hour period during or proximate to the 

incident period. 

(The following Catalog of Federal Domestic 

Assistance Numbers (CFDA) are to be used 

for reporting and drawing funds: 97.030, 

Community Disaster Loans; 97.031, Cora 

Brown Fund Program; 97.032, Crisis 

Counseling; 97.033, Disaster Legal Services 

Program; 97.034, Disaster Unemployment 

Assistance (DUA); 97.046, Fire Management 

Assistance; 97.048, Individuals and 

Households Housing; 97.049, Individuals and 

Households Disaster Housing Operations; 

97.050 Individuals and Households ProgramOther Needs, 97.036, Public Assistance 

Grants; 97.039, Hazard Mitigation Grant 

Program.) 

R. David Paulison, 

Under Secretary for Federal Emergency 

Management and Director of FEMA. 

[FR Doc. E7–2948 Filed 2–21–07; 8:45 am] 

BILLING CODE 9110–10–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

[FEMA–1680–DR] 

Florida; Major Disaster and Related 

Determinations 

AGENCY: Federal Emergency 

Management Agency, DHS. 

ACTION: Notice. 

SUMMARY: This is a notice of the 

Presidential declaration of a major 

disaster for the State of Florida (FEMA–

1680–DR), dated February 8, 2007, and 

related determinations. 

EFFECTIVE DATE: February 8, 2007. 

FOR FURTHER INFORMATION CONTACT: 

Magda Ruiz, Recovery Division, Federal 

Emergency Management Agency, 

Washington, DC 20472, (202) 646–2705. 

SUPPLEMENTARY INFORMATION: Notice is 

hereby given that, in a letter dated 

February 8, 2007, the President declared 

a major disaster under the authority of 

the Robert T. Stafford Disaster Relief 

and Emergency Assistance Act, 42 

U.S.C. 5121–5206 (the Stafford Act), as 

follows: 

I have determined that the damage in 

certain areas of the State of Florida resulting 

from severe storms, tornadoes, and flooding 

on December 25, 2006, is of sufficient 

severity and magnitude to warrant a major 

disaster declaration under the Robert T. 

Stafford Disaster Relief and Emergency 

Assistance Act, 42 U.S.C. 5121–5206 (the 

Stafford Act). Therefore, I declare that such 

a major disaster exists in the State of Florida. 

In order to provide Federal assistance, you 

are hereby authorized to allocate from funds 

available for these purposes such amounts as 

you find necessary for Federal disaster 

assistance and administrative expenses. 

You are authorized to provide Individual 

Assistance in the designated areas, Hazard 

Mitigation throughout the State, and any 

other forms of assistance under the Stafford 

Act you may deem appropriate. Consistent 

with the requirement that Federal assistance 

be supplemental, any Federal funds provided 

under the Stafford Act for Hazard Mitigation 

and Other Needs Assistance will be limited 

to 75 percent of the total eligible costs. If 

Public Assistance is later warranted, Federal 

funds provided under that program will also 

be limited to 75 percent of the total eligible 

costs. Further, you are authorized to make 

changes to this declaration to the extent 

allowable under the Stafford Act. 

The time period prescribed for the 

implementation of section 310(a), 

Priority to Certain Applications for 

Public Facility and Public Housing 

Assistance, 42 U.S.C. 5153, shall be for 

a period not to exceed six months after 

the date of this declaration. 

The Federal Emergency Management 

Agency (FEMA) hereby gives notice that 

pursuant to the authority vested in the 

Director, under Executive Order 12148, 

as amended, Jesse Munoz, of FEMA is 

appointed to act as the Federal 

Coordinating Officer for this declared 

disaster. 

I do hereby determine the following 

areas of the State of Florida to have been 

affected adversely by this declared 

major disaster: 

Volusia County for Individual Assistance. 

All counties within the State of Florida are 

eligible to apply for assistance under the 

Hazard Mitigation Grant Program. 

(The following Catalog of Federal Domestic 

Assistance Numbers (CFDA) are to be used 

for reporting and drawing funds: 97.030, 

Community Disaster Loans; 97.031, Cora 

Brown Fund Program; 97.032, Crisis 

Counseling; 97.033, Disaster Legal Services 

Program; 97.034, Disaster Unemployment 

Assistance (DUA); 97.046, Fire Management 

Assistance; 97.048, Individuals and 

Households Housing; 97.049, Individuals and 

Households Disaster Housing Operations; 

97.050, Individuals and Households 

Program-Other Needs; 97.036, Public 

Assistance Grants; 97.039, Hazard Mitigation 

Grant Program.) 

R. David Paulison, 

Under Secretary for Federal Emergency 

Management and Director of FEMA. 

[FR Doc. E7–2935 Filed 2–21–07; 8:45 am] 

BILLING CODE 9110–10–P 


rwilkins on PROD1PC63 with NOTICES