Federal Register / Vol. 72, No. 62 / Monday, April 2, 2007 / Notices 15699 

Dated: March 26, 2007. 

Elaine L. Baker, 

Acting Director, Management Analysis and 

Services Office, Centers for Disease Control 

and Prevention (CDC). 

[FR Doc. E7–6008 Filed 3–30–07; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Board of Scientific Counselors, 

National Center for Health Statistics 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), the Centers for Disease 

Control and Prevention (CDC), National 

Center for Health Statistics (NCHS) 

announces the following meeting of the 

aforementioned committee. 

Times and Dates: 2 p.m.–5:30 p.m., April 

26, 2007. 8:30 a.m.–2 p.m., April 27, 2007. 

Place: NCHS Headquarters, 3311 Toledo 

Road, Hyattsville, Maryland 20782. 

Status: Open to the public, and limited 

only to the space available. The meeting 

room accommodates approximately 100 

people. 

Purpose: This committee is charged with 

providing advice and making 

recommendations to the Secretary, 

Department of Health and Human Services; 

the Director, CDC; and the Director, NCHS, 

regarding the scientific and technical 

program goals and objectives, strategies, and 

priorities of NCHS. 

Matters to be Discussed: The agenda will 

include welcome remarks by the Director, 

NCHS; introduction of members and key 

NCHS staff; scientific presentations and 

discussions; continued discussion of the 

review of the natality program; discussion of 

upcoming program reviews and an open 

session for comments from the public. 

Requests to make oral presentations should 

be submitted in writing to the contact person 

listed below. All requests must contain the 

name, address, telephone number, and 

organizational affiliation of the presenter. 

Written comments should not exceed five 

single-spaced typed pages in length and must 

be received by April 13, 2007. 

The agenda items are subject to change as 

priorities dictate. 

Contact Person For More Information: 

Virginia S. Cain, Ph.D., Director of 

Extramural Research, NCHS/CDC, 3311 

Toledo Road, Room 7211, Hyattsville, 

Maryland 20782, telephone (301) 458–4500, 

fax (301) 458–4020. 

The Director, Management Analysis and 

Services Office, has been delegated the 

authority to sign Federal Register notices 

pertaining to announcements of meetings and 

other committee management activities for 

both CDC and the Agency for Toxic 

Substances and Disease Registry. 

Dated: March 26, 2007. 

Elaine L. Baker, 

Acting Director, Management Analysis and 

Services Office Centers for Disease Control 

and Prevention. 

[FR Doc. E7–6022 Filed 3–30–07; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2005E–0245] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; KEPIVANCE 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

KEPIVANCE 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 biological 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 

biological products, the testing phase 

begins when the exemption to permit 

the clinical investigations of the human 

biological product becomes effective 

and runs until the approval phase 

begins. The approval phase starts with 

the initial complete submission of an 

application to market the human 

biological 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 biological 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 biological product 

KEPIVANCE (palifermin). KEPIVANCE 

is indicated to decrease the incidence 

and duration of severe oral mucositis in 

patients with hematologic malignancies 

receiving myelotoxic therapy requiring 

hematopoietic stem cell support. 

Subsequent to this approval, the Patent 

and Trademark Office received a patent 

term restoration application for 

KEPIVANCE (U.S. Patent No. 5,677,278) 

from Chiron Corp., and the Patent and 

Trademark Office requested FDA’s 

assistance in determining this patent’s 

eligibility for patent term restoration. In 

a letter dated June 14, 2006, FDA 

advised the Patent and Trademark 

Office that this human biological 

product had undergone a regulatory 

review period and that the approval of 

KEPIVANCE represented the first 

permitted commercial marketing or use 

of the product. Shortly 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 

KEPIVANCE is 3,303 days. Of this time, 

3,119 days occurred during the testing 

phase of the regulatory review period, 

while 184 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: December 2, 

1995. FDA has verified the applicant’s 

claim that the date the investigational 

new drug application became effective 

was on December 2, 1995. 

2. The date the application was 

initially submitted with respect to the 

human biological product under section 


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