Limited Competition for Supplemental Grants for Centers for Education and Research (CERTs), 11245-11246 [05-4444]

Download as PDF Federal Register / Vol. 70, No. 44 / Tuesday, March 8, 2005 / Notices 1. Exchange National Bancshares, Inc., Jefferson City, Missouri; to acquire 100 percent of the voting shares of Bank 10, Belton, Missouri. 2. First National Security Company, DeQueen, Arkansas; to acquire 100 percent of the voting shares of First Community Banking Corporation, Hot Springs, Arkansas, and thereby indirectly acquire First National Bank, Hot Springs, Arkansas; First National Bank in Mena, Mena, Arkansas; and First National Bank, Mount Ida, Arkansas. Board of Governors of the Federal Reserve System, March 2, 2005. Robert deV. Frierson, Deputy Secretary of the Board. [FR Doc. 05–4456 Filed 3–7–05; 8:45 am] BILLING CODE 6210–01–P FEDERAL RESERVE SYSTEM Federal Open Market Committee; Domestic Policy Directive of February 1-2, 2005 In accordance with § 271.25 of its rules regarding availability of information (12 CFR part 271), there is set forth below the domestic policy directive issued by the Federal Open Market Committee at its meeting held on February 1-2, 2005.1 The Federal Open Market Committee seeks monetary and financial conditions that will foster price stability and promote sustainable growth in output. To further its long–run objectives, the Committee in the immediate future seeks conditions in reserve markets consistent with increasing the federal funds rate to an average of around 2-1/ 2 percent. By order of the Federal Open Market Committee, February 28, 2005. Vincent R. Reinhart, Secretary, Federal Open Market Committee. [FR Doc. 05–4455 Field 3–7–05; 8:45 am] BILLING CODE 6210–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Limited Competition for Supplemental Grants for Centers for Education and Research (CERTs) Agency for Healthcare Research and Quality, HHS. ACTION: Notice of availability of fund for limited competitive supplements. AGENCY: SUMMARY: This notice informs the research community that the Agency for Healthcare Research and Quality (AHRQ) is requesting applications for competitive supplemental grants from the seven Centers for Education and Research on Therapeutics (CERTs) for which it provided funding in fiscal year 2004. The purpose of the competitive supplements is to provide funds for existing CERTs research centers to build on and to expand their research work and expertise with respect to comparative effectiveness research specifically to carry out short term projects that will address research gaps in priority subject areas identified and published pursuant to section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act (MMA). Since the inception of the CERTs program in 1999, the CERTs research centers have gathered significant data regarding therapeutics, refined research methodologies, and developed collaborative research resources. They are therefore uniquely prepared and suited to efficiently carry out pharmaco-epidemiology and methodological studies related to comparative effectiveness research that is pertinent to developing therapeutic evidence identified as being of high interest to the Medicare, Medicaid or SCHIP programs. For this reason, this solicitation will be for a limited competition among CERTs grantees. DATES: The receipt date for the competitive supplemental grant applications is April 7, 2005. AHRQ will inform the current grantees directly regarding application procedures and format. Submission of the applications should be sent to: Dr. Gerald Calderone, Office of Extramural Research, Education, and Priority Populations, Agency for Healthcare Research and Quality, 540 Gaither Road, Rockville, MD 20850, Phone: (301) 427– 1548, Fax: (301) 427–1561, E-mail: gcaldero@ahrq.gov. ADDRESSES: 1 Copies of the Minutes of the Federal Open Market Committee meeting on February 1-2, 2005, which includes the domestic policy directive issued at the meeting, are available upon request to the Board of Governors of the Federal Reserve System, Washington, D.C. 20551. The minutes are published in the Federal Reserve Bulletin and in the Board’s annual report. VerDate jul<14>2003 19:54 Mar 07, 2005 Jkt 205001 PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 11245 Dr. Scott R. Smith, Center for Outcomes and Evidence, Agency for Healthcare Research and Quality, 540 Gaither Road, Rockville, MD 20850, Phone: (301) 427– 1511, Fax: (301) 427–1520, E-mail: ssmith@ahrq.gov. FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: Background Section 1013 of the MMA directs the Secretary of the Department of health and Human Services (DHHS), acting through the Director of AHRQ, to support research to address priorities identified by the Medicare, Medicaid, and SCHIP programs and other concerned stakeholders, regarding improvement of health care outcomes, comparative clinical effectiveness, and appropriateness of health care items and services (including prescription drugs) either provided or possibly not currently covered under these programs; and strategies for improving program efficiency and effectiveness with attention to the ways in which health care items and services are organized, managed, and delivered under these programs. Pursuant to this section 1013, which may also be found at 42 U.S.C. 229b–7, DHHS published, on December 15, 2004, an initial priority list of ten conditions with respect to which research mandated under this section is to be promptly undertaken. The ten conditions are: • Ischemic heart disease • Cancer • Chronic obstructive pulmonary disease/asthma • Stroke, including control of hypertension • Arthritis and non-traumatic joint disorders • Diabetes mellitus • Dementia, including Alzheimer’s disease • Pneumonia • Peptic ulcer/dyspepsia • Depression and other mood disorders The Centers for Education and Research on Therapeutics (CERTs) program was first developed by AHRQ in accordance with a Congressional authorization in the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105–115) to carry out or support research that would provide objective information on drugs, biologics, and medical devices. Just months after the first CERTs grants were awarded, the CERTs program was incorporated into the AHRQ Reauthorization Act of 1999 (Pub. L. 106–129); its objectives: to increase E:\FR\FM\08MRN1.SGM 08MRN1 11246 Federal Register / Vol. 70, No. 44 / Tuesday, March 8, 2005 / Notices awareness of the benefits and risks of new, existing, or combined uses of therapeutics through education and research and to reduce costs. The CERTs were to disseminate their findings to inform, among others, insurers and government agencies, patients and consumers. Under 42 U.S.C. 299b–1(b), CERTs grantees were to gather, develop and provide evidence related to comparative effectiveness, cost effectiveness and safety of therapeutics. Thus, the mission and work of the CERTs is consistent with and addresses identified priority research requirements of the MMA section 1013. Accordingly, the expedite the conduct of priority research related to health care services and items including prescription drugs, as mandated by section 1013, AHRQ is seeking to carry out the initial work on a competitive basis with the benefit of the existing collaborative organizational frameworks and therapeutics expertise and specialization developed by CERTs with prior AHRQ support. Review AHRQ will consider requests from current CERTs research center grantees to develop short term supplemental research projects specifically gathering, summarizing and assessing available therapeutics evidence with respect to subjects identified as priorities pursuant to MMA section 1013 or formulating and/or addressing methodological issues pertinent to the production of evidence that is needed with research to these priority subject areas. See http:// www.medicare.gov/MedicareReform/ researchtopics.asp. These competitive applications for supplemental grant awards will undergo scientific and technical review using regular AHRQ peer review processes. In addition to criteria set forth in 42 CFR part 67, subpart A, § 67.15(c), the peer review evaluations and recommendations, in particular, will be based on adherence to the agenda and priorities established in accordance with section 1013 of the MMA. Each center may submit a single application for supplemental support of a research project that address clinical or methodological issues pertaining to a knowledge gap regarding the comparative effectiveness of therapeutics for one or more of the ten priority clinical areas of interest to the Medicare, Medicaid and SCHIP programs. Requests are to be limited to projects that can be completed in 12 months or less. Although each CERTs Research Center may be the primary applicant on any one application, AHRQ encourages partnerships between VerDate jul<14>2003 19:54 Mar 07, 2005 Jkt 205001 existing CERTs. The actual number of applications that will be funded is dependent on the number of high quality applications. Dated: February 24, 2005 Carolyn M. Clancy, Director. [FR Doc. 05–4444 Filed 3–7–05; 8:45 am] BILLING CODE 4160–90–M DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Meeting of the ICD–9–CM Coordination and Maintenance Committee National Center for Health Statistics (NCHS), Classifications and Public Health Data Standards Staff, announces the following meeting. Name: ICD–9–CM Coordination and Maintenance Committee meeting. Time and Date: 9 a.m.–4 p.m., March 31–April 1, 2005. Place: Centers for Medicare and Medicaid Services (CMS) Auditorium, 7500 Security Boulevard, Baltimore, Maryland. Status: Open to the public. Purpose: The ICD–9–CM Coordination and Maintenance (C&M) Committee will hold its first meeting of the 2005 calendar year cycle on Thursday and Friday March 31–April 1, 2005. The C&M meeting is a public forum for the presentation of proposed modifications to the International Classification of Diseases, Ninth-Revision, Clinical Modification. Matters to be Discussed: Agenda items include: Sleep disorders Epilepsy Transfusion related lung injury (TRALI) Failed hearing screening Myelitis Macrophage activation syndrome Subtalar joint arthroereisis 360 degree spinal fusion Implantation of interspinous process decompression device Hip arthroplasty ‘‘bearing surfaces External fracture fixation devices Endovascular implantation of graft in thoracic aorta Infusion of liquid radioisotope Radiofrequency Total Occlusion Crossing System ICD–10–Procedure Coding System (PCS) update Addenda Contact Person for Additional Information: Amy Blum, Medical Systems Specialist, Classifications and Public Health Data Standards Staff, NCHS, 3311 Toledo Road, Room 2402, Hyattsville, Maryland 20782, telephone PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 (301) 458–4106 (diagnosis), Amy Gruber, Health Insurance Specialist, Division of Acute Care, CMS, 7500 Security Blvd., Room C4–07–07, Baltimore, Maryland 21244 telephone (410) 786–1542 (procedures). Notice: Because of increased security requirements,(CMS) has instituted stringent procedures for entrance into the building by non-government employees. Persons without a government I.D. will need to show an official form of picture I.D., (such as a drivers license), and sign-in at the security desk upon entering the building. Those who wish to attend a specific ICD–9–CM C&M meeting in the CMS auditorium must submit their name and organization for addition to the meeting visitor list. Those wishing to attend the March 31–April 1, 2005 meeting must submit their name and organization by March 29, 2005 for inclusion on the visitor list. This visitor list will be maintained at the front desk of the CMS building and used by the guards to admit visitors to the meeting. Those who attended previous ICD–9–CM C&M meetings will no longer be automatically added to the visitor list. You must request inclusion of your name prior to each meeting you attend. Register to attend the meeting on-line at: http://cms.hhs.gov/events. Notice: This is a public meeting. However, because of fire code requirements, should the number of attendants meet the capacity of the room, the meeting will be closed. 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 2, 2005. Alvin Hall, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. 05–4428 Filed 3–7–05; 8:45 am] BILLING CODE 4160–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Allergenic Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: E:\FR\FM\08MRN1.SGM Notice. 08MRN1

Agencies

[Federal Register Volume 70, Number 44 (Tuesday, March 8, 2005)]
[Notices]
[Pages 11245-11246]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-4444]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Limited Competition for Supplemental Grants for Centers for 
Education and Research (CERTs)

AGENCY: Agency for Healthcare Research and Quality, HHS.

ACTION: Notice of availability of fund for limited competitive 
supplements.

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

SUMMARY: This notice informs the research community that the Agency for 
Healthcare Research and Quality (AHRQ) is requesting applications for 
competitive supplemental grants from the seven Centers for Education 
and Research on Therapeutics (CERTs) for which it provided funding in 
fiscal year 2004.
    The purpose of the competitive supplements is to provide funds for 
existing CERTs research centers to build on and to expand their 
research work and expertise with respect to comparative effectiveness 
research specifically to carry out short term projects that will 
address research gaps in priority subject areas identified and 
published pursuant to section 1013 of the Medicare Prescription Drug, 
Improvement, and Modernization Act (MMA). Since the inception of the 
CERTs program in 1999, the CERTs research centers have gathered 
significant data regarding therapeutics, refined research 
methodologies, and developed collaborative research resources. They are 
therefore uniquely prepared and suited to efficiently carry out 
pharmaco-epidemiology and methodological studies related to comparative 
effectiveness research that is pertinent to developing therapeutic 
evidence identified as being of high interest to the Medicare, Medicaid 
or SCHIP programs. For this reason, this solicitation will be for a 
limited competition among CERTs grantees.

DATES: The receipt date for the competitive supplemental grant 
applications is April 7, 2005. AHRQ will inform the current grantees 
directly regarding application procedures and format.

ADDRESSES: Submission of the applications should be sent to: Dr. Gerald 
Calderone, Office of Extramural Research, Education, and Priority 
Populations, Agency for Healthcare Research and Quality, 540 Gaither 
Road, Rockville, MD 20850, Phone: (301) 427-1548, Fax: (301) 427-1561, 
E-mail: gcaldero@ahrq.gov.

FOR FURTHER INFORMATION CONTACT: Dr. Scott R. Smith, Center for 
Outcomes and Evidence, Agency for Healthcare Research and Quality, 540 
Gaither Road, Rockville, MD 20850, Phone: (301) 427-1511, Fax: (301) 
427-1520, E-mail: ssmith@ahrq.gov.

SUPPLEMENTARY INFORMATION:

Background

    Section 1013 of the MMA directs the Secretary of the Department of 
health and Human Services (DHHS), acting through the Director of AHRQ, 
to support research to address priorities identified by the Medicare, 
Medicaid, and SCHIP programs and other concerned stakeholders, 
regarding improvement of health care outcomes, comparative clinical 
effectiveness, and appropriateness of health care items and services 
(including prescription drugs) either provided or possibly not 
currently covered under these programs; and strategies for improving 
program efficiency and effectiveness with attention to the ways in 
which health care items and services are organized, managed, and 
delivered under these programs.
    Pursuant to this section 1013, which may also be found at 42 U.S.C. 
229b-7, DHHS published, on December 15, 2004, an initial priority list 
of ten conditions with respect to which research mandated under this 
section is to be promptly undertaken. The ten conditions are:
     Ischemic heart disease
     Cancer
     Chronic obstructive pulmonary disease/asthma
     Stroke, including control of hypertension
     Arthritis and non-traumatic joint disorders
     Diabetes mellitus
     Dementia, including Alzheimer's disease
     Pneumonia
     Peptic ulcer/dyspepsia
     Depression and other mood disorders
    The Centers for Education and Research on Therapeutics (CERTs) 
program was first developed by AHRQ in accordance with a Congressional 
authorization in the Food and Drug Administration Modernization Act of 
1997 (Pub. L. 105-115) to carry out or support research that would 
provide objective information on drugs, biologics, and medical devices. 
Just months after the first CERTs grants were awarded, the CERTs 
program was incorporated into the AHRQ Reauthorization Act of 1999 
(Pub. L. 106-129); its objectives: to increase

[[Page 11246]]

awareness of the benefits and risks of new, existing, or combined uses 
of therapeutics through education and research and to reduce costs. The 
CERTs were to disseminate their findings to inform, among others, 
insurers and government agencies, patients and consumers. Under 42 
U.S.C. 299b-1(b), CERTs grantees were to gather, develop and provide 
evidence related to comparative effectiveness, cost effectiveness and 
safety of therapeutics. Thus, the mission and work of the CERTs is 
consistent with and addresses identified priority research requirements 
of the MMA section 1013. Accordingly, the expedite the conduct of 
priority research related to health care services and items including 
prescription drugs, as mandated by section 1013, AHRQ is seeking to 
carry out the initial work on a competitive basis with the benefit of 
the existing collaborative organizational frameworks and therapeutics 
expertise and specialization developed by CERTs with prior AHRQ 
support.

Review

    AHRQ will consider requests from current CERTs research center 
grantees to develop short term supplemental research projects 
specifically gathering, summarizing and assessing available 
therapeutics evidence with respect to subjects identified as priorities 
pursuant to MMA section 1013 or formulating and/or addressing 
methodological issues pertinent to the production of evidence that is 
needed with research to these priority subject areas. See http://
www.medicare.gov/MedicareReform/researchtopics.asp. These competitive 
applications for supplemental grant awards will undergo scientific and 
technical review using regular AHRQ peer review processes. In addition 
to criteria set forth in 42 CFR part 67, subpart A, Sec.  67.15(c), the 
peer review evaluations and recommendations, in particular, will be 
based on adherence to the agenda and priorities established in 
accordance with section 1013 of the MMA.
    Each center may submit a single application for supplemental 
support of a research project that address clinical or methodological 
issues pertaining to a knowledge gap regarding the comparative 
effectiveness of therapeutics for one or more of the ten priority 
clinical areas of interest to the Medicare, Medicaid and SCHIP 
programs. Requests are to be limited to projects that can be completed 
in 12 months or less. Although each CERTs Research Center may be the 
primary applicant on any one application, AHRQ encourages partnerships 
between existing CERTs. The actual number of applications that will be 
funded is dependent on the number of high quality applications.

    Dated: February 24, 2005
Carolyn M. Clancy,
Director.
[FR Doc. 05-4444 Filed 3-7-05; 8:45 am]
BILLING CODE 4160-90-M