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Federal Register / Vol. 72, No.

98 / Tuesday, May 22, 2007 / Notices 28701

the Patent and Trademark Office Management between 9 a.m. and 4 p.m., Secretary, ACIM,Health Resources and
requested that FDA determine the Monday through Friday. Services Administration (HRSA), Room
product’s regulatory review period. Dated: May 7, 2007. 18–05, ParklawnBuilding, 5600 Fishers
FDA has determined that the Lane, Rockville, MD 20857, Telephone:
Jane A. Axelrad,
applicable regulatory review period for (301) 443–2170.
FOSRENOL is 2,449 days. Of this time, Associate Director for Policy, Center for Drug Individuals who are submitting public
Evaluation and Research.
1,538 days occurred during the testing comments or who have questions
phase of the regulatory review period, [FR Doc. E7–9787 Filed 5–21–07; 8:45 am] regarding the meeting and location
while 911 days occurred during the BILLING CODE 4160–01–S should contact David S. de la Cruz, PhD,
approval phase. These periods of time M.P.H., HRSA, Maternal and Child
were derived from the following dates: Health Bureau, telephone: (301) 443–
1. The date an exemption under DEPARTMENT OF HEALTH AND 6332, e-mail:
section 505(i) of the Federal Food, Drug, HUMAN SERVICES David.delaCruz@hrsa.hhs.gov.
and Cosmetic Act (the act) (21 U.S.C. Dated: May 15, 2007.
Health Resources and Services
355(i)) became effective: February 13,
Administration Caroline Lewis,
1998. FDA has verified the applicant’s
Associate Administrator for Management.
claim that the date the investigational Advisory Committee on Infant
new drug application became effective [FR Doc. E7–9784 Filed 5–21–07; 8:45 am]
Mortality; Notice of Meeting
was on February 13, 1998. BILLING CODE 4165–15–P
2. The date the application was In accordance with section 10(a)(2) of
initially submitted with respect to the the Federal Advisory Committee Act
human drug product under section (Pub. L. 92–463), notice is hereby given DEPARTMENT OF HEALTH AND
505(b) of the act: April 30, 2002. FDA of the following meeting: HUMAN SERVICES
has verified the applicant’s claim that Name: Advisory Committee on Infant
Health Resources and Services
the new drug application (NDA) for Mortality (ACIM).
Dates and Times: June 13, 2007, 9 Administration
FOSRENOL (NDA 21–468) was initially
submitted on April 30, 2002. a.m.–5 p.m. June 14, 2007, 8:30 a.m.–3 Statement of Organization, Functions
3. The date the application was p.m. and Delegations of Authority
approved: October 26, 2004. FDA has Place: Four Points by Sheraton
verified the applicant’s claim that NDA Washington DC Downtown Hotel, 1201 This notice amends Part R of the
21–468 was approved on October 26, K Street, NW.,Washington, DC Statement of Organization, Functions
2004. 20005,(202)–289–7600. and Delegations of Authority of the
This determination of the regulatory Status: The meeting is open to the Department of Health and Human
review period establishes the maximum public with attendance limited to space Services (HHS), Health Resources and
potential length of a patent extension. availability. Services Administration (HRSA) (60 FR
However, the U.S. Patent and Purpose: The Committee provides 56605–56606 as amended November 6,
Trademark Office applies several advice and recommendations to the 1995; and as last amended at 72 FR
statutory limitations in its calculations Secretary of Health and Human Services 19540–19544, April 18, 2007.)
of the actual period for patent extension. on the following: Department of Health This notice reflects organizational
In its application for patent extension, and Human Services’ programs that changes in the Health Resources and
this applicant seeks 951 days of patent focus on reducing infant mortality and Services Administration, Bureau of
term extension. improving the health status of pregnant Primary Health Care (RC). Specifically,
Anyone with knowledge that any of women and infants, and factors affecting this notice updates the mission
the dates as published are incorrect may the continuum of care with respect to statement of the Bureau of Primary
submit to the Division of Dockets maternal and child health care. It Health Care (RC) and the functional
Management (see ADDRESSES) written or includes outcomes following childbirth; statement of the Office of the Associate
electronic comments and ask for a strategies to coordinate the variety of Administrator (RC), and deleted the
redetermination by July 23, 2007. Federal, State, local and private Office of Administrative Management
Furthermore, any interested person may programs and efforts that are designed (RCM).
petition FDA for a determination to deal with the health and social Chapter RC, Bureau of Primary Health
regarding whether the applicant for problems impacting on infant mortality; Care
extension acted with due diligence and the implementation of the Healthy
during the regulatory review period by Start Program and Healthy People 2010 Section RC, 00 Mission
November 19, 2007. To meet its burden, infant mortality objectives. Delete in its entirety and replace with
the petition must contain sufficient facts Agenda: Topics that will be discussed the following:
to merit an FDA investigation. (See H. include the following: Cesarean section The mission of the Bureau of Primary
Rept. 857, part 1, 98th Cong., 2d sess., and its effect on pre-term and infant Health Care is to improve the health of
pp. 41–42, 1984.) Petitions should be in mortality, SIDS and related causes of the Nation’s underserved communities
the format specified in 21 CFR 10.30. infant death and Preconceptional care. and vulnerable populations by assuring
Comments and petitions should be Proposed agenda items are subject to access to comprehensive, culturally
submitted to the Division of Dockets change as priorities indicate. competent, quality primary health care
Management. Three copies of any Time will be provided for public services.
mailed information are to be submitted, comments limited to five minutes each;
except that individuals may submit one comments are to be submitted no later Section RC–10, Organization
jlentini on PROD1PC65 with NOTICES

copy. Comments are to be identified than June 1, 2007. Delete in its entirety and replace with
with the docket number found in For Further Information Contact: the following:
brackets in the heading of this Anyone requiring information regarding The Bureau of Primary Health Care
document. Comments and petitions may the Committee should contact Peter C. (BPHC) is headed by an Associate
be seen in the Division of Dockets van Dyck, M.D., M.P.H., Executive Administrator, who reports directly to

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