51158 Federal Register / Vol. 74, No. 191 / Monday, October 5, 2009 / Notices 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. Written comments should 

be received within 60 days of this 

notice. 

Proposed Project 

All-Hazards Public Health Emergency 

Preparedness and Response Generic 

Data Collection—New—Coordinating 

Office for Terrorism Preparedness and 

Emergency Response (COTPER), Centers 

for Disease Control and Prevention 

(CDC). 

Background and Brief Description 

Data from agencies and individuals 

are needed to assist CDC in responding 

to and planning for domestic and 

international all-hazards public health 

emergencies. According to the glossary 

from the National Response Framework 

Resource Center, ‘‘all-hazards’’ is 

defined as ‘‘describing an incident, 

natural or manmade, that warrants 

action to protect life, property, 

environment, and public health or 

safety, and to minimize disruptions of 

government, social, or economic 

activities.’’ This generic IC requests the 

authority to collect a wide array of data 

from traditional and non-traditional 

public health sources to assist in this 

effort. This generic IC will enable CDC 

to collect data during public health 

emergencies (as the response is taking 

place) and after public health 

emergencies (as the recovery is taking 

place) to aid response and recovery 

efforts and to answer pre-determined 

research questions. These data may be 

used to inform our preparedness for 

subsequent emergencies that may 

potentially occur and also inform 

decisions made by CDC Director. 

All-hazards public health emergencies 

are those events that are formally 

declared emergencies by Federal, State 

or local jurisdictions. Declarations can 

be made by the Secretary of the 

Department of Health and Human 

Services (DHHS) under Section 319 of 

the Public Health Service Act and at the 

state or local levels by the Governor, 

state public health officer, city or county 

council or mayor and the local public 

health officer respectively. During and 

after these emergencies, assistance may 

be needed to supplement State and local 

efforts and capabilities to save lives and 

to protect property and public health 

and safety, or to lessen or avert the 

threat of a catastrophe. Also, CDC may 

have to assist the State and local, tribal, 

and territorial levels of government with 

critical data collection to support 

immediate data needs for situational 

awareness. Situational Awareness has 

been defined as ‘‘the perception of 

elements in the environment within a 

volume of time and space, the 

comprehension of their meaning, and 

the projection of their status in the near 

future.’’ 

A three-year OMB approval is 

requested to allow CDC to collect data 

during and after emergencies. Data 

collected under this generic IC will use 

a variety of data collection methods. 

Some of the methods include but are not 

limited to: Personal interviews, 

telephone interviews, focus groups, 

institutional record reviews, medical 

record reviews, and paper or Internet 

questionnaires and other secure 

electronic data exchange. Each proposed 

data collection submitted under this 

generic IC will provide information 

pertaining to that particular public 

health emergency. Respondents will be 

advised of the nature of the activity, the 

length of time required for participation 

and that their participation is voluntary. 

There are no costs to respondents 

except their time. 

ESTIMATED ANNUALIZED BURDEN HOURS

Respondents Number of 

respondents 

Number of responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total 

burden 

(in hours) 

General Public ................................................................................................. 50,000 1 1 50,000 

Total .......................................................................................................... 50,000 

Dated: September 26, 2009. 

Maryam I. Daneshvar, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. E9–23883 Filed 10–2–09; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Administration on Children, Youth and 

Families 

AGENCY: Family and Youth Services 

Bureau, ACYF, ACF, HHS. 

ACTION: Notice to Award Five Expansion 

Supplement Grants. 

CFDA Number: 93.592. 

Legislative Authority: The Family 

Violence Prevention and Services Act, 

42 U.S.C. 10401 through 10421, as 

extended by the Department of Health 

and Human Services Appropriations 

Act, 2009, Public Law 111–8. 

Total Amount of Awards: $400,000. 

Project Period: September 30, 2009— 

September 29, 2010. 

SUMMARY: This notice announces the 

award of expansion supplement grants 

to five grantees under the Family and 

Youth Services Bureau (FYSB)/Family 

Violence Prevention and Services 

Program. Expansion supplement awards 

are made to four technical assistance 

(TA) providers to support their capacity 

to enhance victim services by providing 

more extensive TA to local domestic 

violence programs and State domestic 

violence coalitions under the Open 

Doors to Safety: Capacity-Building Grant 

(Capacity-Building) project. The 

supplemental funds, coupled with the 

TA providers’ expertise, will enable 

Open Doors Safety Capacity-Building 

project grantees to receive more training 

and site-specific consultation, so that 

they may build program capacity. The 

awards will also support State-level 

collaboration between domestic 

violence organizations and child welfare 

agencies. These combined efforts will 

strengthen the ability of domestic 

violence programs and their partners to 

better serve survivors who have diverse 

backgrounds, experiences, and abilities. 


cprice-sewell on DSK2BSOYB1PROD with NOTICES
Federal Register / Vol. 74, No. 191 / Monday, October 5, 2009 / Notices 51159 

Technical assistance provider organizations Amount of 

award Location 

Family Violence Prevention Fund ................................................................................................................ $175,000 San Francisco, CA. 

Domestic Abuse Intervention Programs ...................................................................................................... 50,000 Minneapolis, MN. 

Hektoen Institute, LLC ................................................................................................................................. 50,000 Chicago, IL. 

National Network to End Domestic Violence .............................................................................................. 100,000 Washington, DC. 

A $25,000 expansion supplement 

grant is awarded to the Institute on 

Domestic Violence in the African 

American Community (IDVAAC), 

Minneapolis, MN, for the period of July 

1, 2009 through September 30, 2009, to 

support development of conference 

materials, a scholarly publication on 

healing after domestic violence, and 

conference scholarships. 

Contact for Further Information: 

Marylouise Kelley, Ph.D., Director, 

Family Violence Prevention and 

Services Program, 1250 Maryland 

Avenue, SW., Suite 8216, Washington, 

DC, 20024. Telephone: 202–104–5756 Email: Marylouise.kelley@acf.hhs.gov. 

Dated: September 28, 2009. 

Maiso L. Bryant, 

Acting Commissioner, Administration on 

Children, Youth and Families. 

[FR Doc. E9–23922 Filed 10–2–09; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–E–0057] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; EMEND FOR INJECTION 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for EMEND 

FOR INJECTION 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 which 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.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Beverly Friedman, Office of Regulatory 

Policy, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 51, 

rm. 6222, Silver Spring, MD 20993– 

0002, 301–796–3602. 

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 drug 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 drug 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 EMEND FOR 

INJECTION (fosaprepitant meglumine). 

EMEND FOR INJECTION, in 

combination with other antiemetic 

agents, is indicated for the prevention of 

acute and delayed nausea and vomiting 

associated with initial and repeat 

courses of highly emetogenic cancer 

chemotherapy including high-dose 

cisplatin, and for prevention of nausea 

and vomiting associated with initial and 

repeat courses of moderately emetogenic 

cancer chemotherapy. Subsequent to 

this approval, the Patent and Trademark 

Office received a patent term restoration 

application for EMEND FOR INJECTION 

(U.S. Patent No. 5,691,336) from Merck 

& Co., Inc., and the Patent and 

Trademark Office requested FDA’s 

assistance in determining this patent’s 

eligibility for patent term restoration. In 

a letter dated February 26, 2009, FDA 

advised the Patent and Trademark 

Office that this human drug product had 

undergone a regulatory review period 

and that the approval of EMEND FOR 

INJECTION 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 

EMEND FOR INJECTION is 4,473 days. 

Of this time, 3,810 days occurred during 

the testing phase of the regulatory 

review period, while 663 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(i)) became effective: October 29, 

1995. The applicant claims October 28, 

1995, as the date the investigational new 

drug application (IND) became effective. 

However, FDA records indicate that the 

IND effective date was October 29, 1995, 

which was 30 days after FDA receipt of 

the IND. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 

505(b) of the act: April 3, 2006. The 

applicant claims March 31, 2006, as the 

date the new drug application (NDA) for 

Emend for Injection (NDA 22–023) was 

initially submitted. However, FDA 

records indicate that NDA 22–023 was 

submitted on April 3, 2006. 

3. The date the application was 

approved: January 25, 2008. FDA has 

verified the applicant’s claim that NDA 

22–023 was approved on January 25, 

2008. 

This determination of the regulatory 

review period establishes the maximum 

potential length of a patent extension. 

However, the U.S. Patent and 


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