Amendment to the Fiscal Year 2009 Service Area Competition-New and Competing Continuation Funding, 22159 [E8-9009]

Download as PDF 22159 Federal Register / Vol. 73, No. 80 / Thursday, April 24, 2008 / Notices TABLE 1.—SUMMARY OF POSTMARKETING STUDY COMMITMENTS (NUMBERS AS OF SEPTEMBER 30, 2007)—Continued NDAs/ANDAs (% of Total) • Terminated BLAs1 (% of Total) 1 (0.1%) 157 (12%) 81 (20%) 133 26 101 (76%) 21 (81%) 1 (<1%) 0 31 (23%) 5 (19%) 115 (37%)2 • Submitted 3 (1%) 41 (51%) Concluded studies (October 1, 2006—September 30, 2007) • Commitment met • Commitment not met • Study no longer needed or feasible Applications with open postmarketing commitments with annual reports due, but not submitted within 60 days of the anniversary date of U.S. approval 1 On October 1, 2003, FDA completed a consolidation of certain products formerly regulated by CBER into CDER. The previous association of BLA reviews only with CBER is no longer valid; BLAs are now received by both CBER and CDER. Fiscal year statistics for CDER BLA postmarketing study commitments will continue to be counted under BLA totals in this table. 2 Note that this statistic counts all annual reports submitted more than 60 days after the anniversary date of U.S. approval as overdue, including reports that may have been submitted on a modified reporting schedule in accordance with prior FDA agreement. Of the applications categorized as having overdue annual reports using this definition, annual reports were subsequently submitted in FY06 for 115/115 (100 percent) of NDAs/ANDAs and 20/41 (49 percent) of BLAs. Dated: April 15, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–9007 Filed 4–23–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration [CFDA Number 93.224; HRSA–09–095, HRSA–09–096, HRSA–09–097, and HRSA– 09–098] Amendment to the Fiscal Year 2009 Service Area Competition—New and Competing Continuation Funding Health Resources and Services Administration, HHS. ACTION: Change in application deadline and amendment of the available service areas. sroberts on PROD1PC70 with NOTICES AGENCY: SUMMARY: HRSA is announcing the reissuance of Fiscal Year 2009 Service Area Competition—New and Competing Continuation Funding (HRSA Announcement Numbers HRSA–09– 095, HRSA–09–096, HRSA–09–097, and HRSA–09–098). The HRSA Electronic Handbook (EHB) application deadline for project periods beginning in November and December 2008 has been changed and the list of available service areas has been updated. The new EHB application deadline for HRSA–09–095 is May 9, 2008. (The grants.gov application deadline of April 7, 2008 remains the same.) All other VerDate Aug<31>2005 16:15 Apr 23, 2008 Jkt 214001 requirements of HRSA–09–095 remain the same. Please see the chart on pages 6 and 7 of the guidance for a complete listing of all application deadlines. In addition, corrections to two service areas listed in the Service Area Competition guidance have been made. In Appendix F of the guidance, Bismarck, ND, is incorrectly listed as an available service area in fiscal year (FY) 2009. The correct service area that is currently available in FY 2009 is Beulah, ND. Also, Clay, WV, is incorrectly listed as an available service area in FY 2009. The correct service area that is currently available in FY 2009 is Blacksville, WV. Bismarck, ND and Clay, WV, are not available service areas for the FY 2009 Service Area Competition. For a complete listing of all available service areas for the FY 2009 Service Area Competition funding opportunity, please see Appendix F of the guidance. The effective date of this amended Agency guidance is April 24, 2008. Background: HRSA administers the Health Center Program, which supports more than 4,000 health care delivery sites, including community health centers, migrant health centers, health care for the homeless centers, and public housing primary care centers. Health centers serve clients that are primarily low-income and minorities, and deliver comprehensive, culturally competent, quality primary health care services to patients regardless of their ability to pay. Charges for health care services are set according to income. DATES: PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 For questions regarding this notice, please contact Nicole Amado in the Office of Policy and Program Development, Bureau of Primary Health Care, HRSA, at 301–594–4300 or Nicole.Amado@hrsa.hhs.gov. FOR FURTHER INFORMATION CONTACT: Dated: April 17, 2008. Elizabeth M. Duke, Administrator. [FR Doc. E8–9009 Filed 4–23–08; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration National Advisory Committee on Rural Health and Human Services; Notice of Meeting In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), notice is hereby given that the following committee will convene its fifty-ninth meeting. Name: National Advisory Committee on Rural Health and Human Services. Dates and Times: June 2, 2008, 9 a.m.–4:30 p.m. June 3, 2008, 8:45 a.m.–5:15 p.m. June 4, 2008, 8:15 a.m.–10:30 a.m. Place: Siena Hotel, 1505 East Franklin Street, Chapel Hill, NC 27514. Phone: 919– 929–4000. Status: The meeting will be open to the public. Purpose: The National Advisory Committee on Rural Health and Human Services provides advice and recommendations to the Secretary with respect to the delivery, research, E:\FR\FM\24APN1.SGM 24APN1

Agencies

[Federal Register Volume 73, Number 80 (Thursday, April 24, 2008)]
[Notices]
[Page 22159]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-9009]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration

[CFDA Number 93.224; HRSA-09-095, HRSA-09-096, HRSA-09-097, and HRSA-
09-098]


Amendment to the Fiscal Year 2009 Service Area Competition--New 
and Competing Continuation Funding

AGENCY: Health Resources and Services Administration, HHS.

ACTION: Change in application deadline and amendment of the available 
service areas.

-----------------------------------------------------------------------

SUMMARY: HRSA is announcing the reissuance of Fiscal Year 2009 Service 
Area Competition--New and Competing Continuation Funding (HRSA 
Announcement Numbers HRSA-09-095, HRSA-09-096, HRSA-09-097, and HRSA-
09-098). The HRSA Electronic Handbook (EHB) application deadline for 
project periods beginning in November and December 2008 has been 
changed and the list of available service areas has been updated.
    The new EHB application deadline for HRSA-09-095 is May 9, 2008. 
(The grants.gov application deadline of April 7, 2008 remains the 
same.) All other requirements of HRSA-09-095 remain the same. Please 
see the chart on pages 6 and 7 of the guidance for a complete listing 
of all application deadlines.
    In addition, corrections to two service areas listed in the Service 
Area Competition guidance have been made. In Appendix F of the 
guidance, Bismarck, ND, is incorrectly listed as an available service 
area in fiscal year (FY) 2009. The correct service area that is 
currently available in FY 2009 is Beulah, ND. Also, Clay, WV, is 
incorrectly listed as an available service area in FY 2009. The correct 
service area that is currently available in FY 2009 is Blacksville, WV. 
Bismarck, ND and Clay, WV, are not available service areas for the FY 
2009 Service Area Competition. For a complete listing of all available 
service areas for the FY 2009 Service Area Competition funding 
opportunity, please see Appendix F of the guidance.

DATES: The effective date of this amended Agency guidance is April 24, 
2008.
    Background: HRSA administers the Health Center Program, which 
supports more than 4,000 health care delivery sites, including 
community health centers, migrant health centers, health care for the 
homeless centers, and public housing primary care centers. Health 
centers serve clients that are primarily low-income and minorities, and 
deliver comprehensive, culturally competent, quality primary health 
care services to patients regardless of their ability to pay. Charges 
for health care services are set according to income.

FOR FURTHER INFORMATION CONTACT: For questions regarding this notice, 
please contact Nicole Amado in the Office of Policy and Program 
Development, Bureau of Primary Health Care, HRSA, at 301-594-4300 or 
Nicole.Amado@hrsa.hhs.gov.

    Dated: April 17, 2008.
Elizabeth M. Duke,
Administrator.
[FR Doc. E8-9009 Filed 4-23-08; 8:45 am]
BILLING CODE 4165-15-P