Federal Register / Vol. 72, No. 98 / Tuesday, May 22, 2007 / Notices 28701 

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 

FOSRENOL is 2,449 days. Of this time, 

1,538 days occurred during the testing 

phase of the regulatory review period, 

while 911 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: February 13, 

1998. FDA has verified the applicant’s 

claim that the date the investigational 

new drug application became effective 

was on February 13, 1998. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 

505(b) of the act: April 30, 2002. FDA 

has verified the applicant’s claim that 

the new drug application (NDA) for 

FOSRENOL (NDA 21–468) was initially 

submitted on April 30, 2002. 

3. The date the application was 

approved: October 26, 2004. FDA has 

verified the applicant’s claim that NDA 

21–468 was approved on October 26, 

2004. 

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, 

this applicant seeks 951 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 July 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 

November 19, 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: May 7, 2007. 

Jane A. Axelrad, 

Associate Director for Policy, Center for Drug 

Evaluation and Research. 

[FR Doc. E7–9787 Filed 5–21–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Advisory Committee on Infant 

Mortality; Notice of Meeting 

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

the Federal Advisory Committee Act 

(Pub. L. 92–463), notice is hereby given 

of the following meeting: 

Name: Advisory Committee on Infant 

Mortality (ACIM). 

Dates and Times: June 13, 2007, 9 

a.m.–5 p.m. June 14, 2007, 8:30 a.m.–3 

p.m. 

Place: Four Points by Sheraton 

Washington DC Downtown Hotel, 1201 

K Street, NW.,Washington, DC 

20005,(202)–289–7600. 

Status: The meeting is open to the 

public with attendance limited to space 

availability. 

Purpose: The Committee provides 

advice and recommendations to the 

Secretary of Health and Human Services 

on the following: Department of Health 

and Human Services’ programs that 

focus on reducing infant mortality and 

improving the health status of pregnant 

women and infants, and factors affecting 

the continuum of care with respect to 

maternal and child health care. It 

includes outcomes following childbirth; 

strategies to coordinate the variety of 

Federal, State, local and private 

programs and efforts that are designed 

to deal with the health and social 

problems impacting on infant mortality; 

and the implementation of the Healthy 

Start Program and Healthy People 2010 

infant mortality objectives. 

Agenda: Topics that will be discussed 

include the following: Cesarean section 

and its effect on pre-term and infant 

mortality, SIDS and related causes of 

infant death and Preconceptional care. 

Proposed agenda items are subject to 

change as priorities indicate. 

Time will be provided for public 

comments limited to five minutes each; 

comments are to be submitted no later 

than June 1, 2007. 

For Further Information Contact: 

Anyone requiring information regarding 

the Committee should contact Peter C. 

van Dyck, M.D., M.P.H., Executive 

Secretary, ACIM,Health Resources and 

Services Administration (HRSA), Room 

18–05, ParklawnBuilding, 5600 Fishers 

Lane, Rockville, MD 20857, Telephone: 

(301) 443–2170. 

Individuals who are submitting public 

comments or who have questions 

regarding the meeting and location 

should contact David S. de la Cruz, PhD, 

M.P.H., HRSA, Maternal and Child 

Health Bureau, telephone: (301) 443–

6332, e-mail: 

David.delaCruz@hrsa.hhs.gov. 

Dated: May 15, 2007. 

Caroline Lewis, 

Associate Administrator for Management. 

[FR Doc. E7–9784 Filed 5–21–07; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Statement of Organization, Functions 

and Delegations of Authority 

This notice amends Part R of the 

Statement of Organization, Functions 

and Delegations of Authority of the 

Department of Health and Human 

Services (HHS), Health Resources and 

Services Administration (HRSA) (60 FR 

56605–56606 as amended November 6, 

1995; and as last amended at 72 FR 

19540–19544, April 18, 2007.) 

This notice reflects organizational 

changes in the Health Resources and 

Services Administration, Bureau of 

Primary Health Care (RC). Specifically, 

this notice updates the mission 

statement of the Bureau of Primary 

Health Care (RC) and the functional 

statement of the Office of the Associate 

Administrator (RC), and deleted the 

Office of Administrative Management 

(RCM). 

Chapter RC, Bureau of Primary Health 

Care 

Section RC, 00 Mission 

Delete in its entirety and replace with 

the following: 

The mission of the Bureau of Primary 

Health Care is to improve the health of 

the Nation’s underserved communities 

and vulnerable populations by assuring 

access to comprehensive, culturally 

competent, quality primary health care 

services. 

Section RC–10, Organization 

Delete in its entirety and replace with 

the following: 

The Bureau of Primary Health Care 

(BPHC) is headed by an Associate 

Administrator, who reports directly to 


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