28700 Federal Register / Vol. 72, No. 98 / Tuesday, May 22, 2007 / Notices 

Civilian Health and Medical Program 

Records–VA,’’ last published at 68 FR 

53784 (September 12, 2003). SSNs of 

CHAMPVA beneficiaries will be 

released to CMS pursuant to the routine 

use number 21 as set forth in the system 

notice. 

RECORDS MAINTAINED BY CMS

The matching program will be 

conducted with data maintained by 

CMS in the EDB, System No. 09–70–

0502, published at 67 FR 3203 (January 

23, 2002). Matched data will be released 

to HAC pursuant to the routine use 

number 2 as set forth in the system 

notice. 

INCLUSIVE DATES OF THE MATCH: 

The CMP shall become effective no 

sooner than 40 days after the report of 

the Matching Program is sent to OMB 

and Congress, or 30 days after 

publication in the Federal Register, 

whichever is later. The matching 

program will continue for 18 months 

from the effective date and may be 

extended for an additional 12 months 

thereafter, if certain conditions are met. 

[FR Doc. E7–9789 Filed 5–21–07; 8:45 am] 

BILLING CODE 4120–03–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Notice To Award a Grant 

Program Office: Administration on 

Children, Youth and Families (ACYF)/ 

Family and Youth Services Bureau 

(FYSB). 

Recipient Name: Medical Institute for 

Sexual Health. 

Announcement Type: Notice to 

Award a Grant. 

CFDA Number: 93.235. 

Amount of Award: $207,400. 

Project Period: 5/1/2007–4/30/2008. 

Summary: This is a notice to award a 

grant to the Medical Institute for Sexual 

Health, Austin, TX, in the amount of 

$207,400 to support the development of 

online medical accuracy training for 

abstinence education providers. 

Background: The Medical Institute for 

Sexual Health proposes to develop an 

online instructor-led workshop to train 

abstinence education providers in 

methods to access medically accurate 

sexual health information via the 

internet. Participants will learn to 

identify credible internet resources for 

sexual health information, efficiently 

and effectively search the internet, and 

answer most questions on sexual health 

topics. 

The proposal is within the scope of 

technical assistance activities that the 

Abstinence Education Division of the 

Family and Youth Services Bureau 

(FYSB) provides to grantees with regard 

to integrating medical and scientific 

information into abstinence education 

programming. The Congress, in 

appropriating funds for the program, has 

directed the Administration for 

Children and Families (ACF) to devote 

up to five percent of appropriated funds 

for technical assistance and capacitybuilding for abstinence education 

grantees. In addition, the proposed 

activities of this awardee are outside the 

scope of the ACF’s previous or proposed 

abstinence education competitive 

program announcements and would not 

qualify for any other existing grant 

opportunities. 

For Further Information Contact: 

Stanley Koutstaal, Ph.D., Acting 

Director, Division of Abstinence 

Education, 1250 Maryland Ave., SW., 

Washington, DC 20024, (202) 401–9205, 

Nina.Degeorge@ACF.hhs.gov. 

Dated: May 16, 2007. 

Harry Wilson, 

Associate Commissioner, Family and Youth 

Services Bureau. 

[FR Doc. E7–9824 Filed 5–21–07; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2005E–0248] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; FOSRENOL 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

FOSRENOL 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.fda.gov/dockets/ecomments. 

FOR FURTHER INFORMATION CONTACT: 

Beverly Friedman, Office of Regulatory 

Policy (HFD–007), 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 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 FOSRENOL 

(lanthanum carbonate hydrate). 

FOSRENOL is indicated to reduce 

serum phosphate in patients with end 

stage renal disease. Subsequent to this 

approval, the Patent and Trademark 

Office received a patent term restoration 

application for FOSRENOL (U.S. Patent 

No. 5,968,976) from Shire International 

Licensing, B.V., 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 8, 2005, FDA advised 

the Patent and Trademark Office that 

this human drug product had undergone 

a regulatory review period and that the 

approval of FOSRENOL represented the 

first permitted commercial marketing or 

use of the product. Shortly thereafter, 


jlentini on PROD1PC65 with NOTICES
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 


jlentini on PROD1PC65 with NOTICES