April 2004 | VOL. 4 | www.McGowan.pitt.edu

Under the leadership of Robert L. Kormos, M.D., a team of surgeons from the University of Pittsburgh Medical Center, implanted the HeartMate II, a new left ventricular assist system (LVAS), in a 22-year-old woman on April 7. The implant is the third in the United States and is part of a pilot trial sponsored by Thoratec Corporation to test the safety and potential effectiveness of the HeartMate II.

The device is a miniature rotary pump with axial flow bearings and is intended for patients with end-stage heart failure. A key feature of the design is a sophisticated control system developed by researchers at the McGowan Institute that senses when to increase or decrease the rate of blood flow. Other approved and experimental devices require manual adjustments.

The control system, developed by Institute researchers, involves a patented algorithm that permits the LVAS to respond to the needs of the patient based on the level of activity, generating up to 10 liters of blood flow per minute, a rate that would be required to climb stairs, for example. The controller was the brainchild of James Antaki, Ph.D., a member of the McGowan Institute.

The control system, developed by Institute researchers, involves a patented algorithm that permits the LVAS to respond to the needs of the patient based on the level of activity, generating up to10 liters of blood flow per minute, a rate that would be required to climb stairs, for example. The controller was the brainchild of James Antaki, Ph.D., a member of the McGowan Institute.

"This algorithm is essentially the intelligence of the system. Engineers don't need to stand at the patient's side in order to adjust the device to one of a few fixed settings, which is the case with other devices, even newer ones in trials. We are especially proud of this contribution to the design of HeartMate II," noted Dr. Kormos, who is principal investigator of the Pittsburgh site of the HeartMate II trial. [More]

 

Professor Cooper Named Distinguished Professor

Rory Cooper, Ph.D., chair of the department of rehabilitation science and technology at the School of Health and Rehabilitation Sciences, has been appointed as a Distinguished Professor of Rehabilitation Science and Technology. A Distinguished Professorship is the highest honor the university confers on a member of the professorate.

Dr. Cooper was recruited to the University of Pittsburgh in 1994 to help establish the first formal department of rehabilitation science and technology in the United States. Over the past 10 years, the department and its faculty and staff has become a widely recognized leader in the field.

Over the course of his career, Dr. Cooper has come to be considered one of the pre-eminent international experts in wheelchair design and has made remarkable contributions to the field of mobility research. He founded and directs the Human Engineering Research Laboratories, a joint venture consisting of the University of Pittsburgh Medical Center, the University of Pittsburgh and the VA Pittsburgh Health Care System, and is the author or co-author of more than 200 papers, expanded abstracts and book chapters, and the author of two books, Rehabilitation Engineering Applied to Mobility and Manipulation and Wheelchair Selection and Configuration. [More]

McGowan Faculty Named ‘Young Turks’

McGowan Institute faculty members Dr. Raphael Hirsch and Dr. Flordeliza Villanueva are among six University of Pittsburgh Schools of the Health Sciences faculty members elected to the American Society for Clinical Investigation.

Election to the prestigious American Society for Clinical Investigation (ASCI), also known as the “Young Turks” is in recognition of superb achievements in biomedical research. Established in 1908, the organization is an honor society for physician-scientists, who must be age 45 or younger at the time of their election. Membership, by election only, is conferred on scientific investigators who have been judged to have exceptional records of scholarly achievement in biomedical research. [More]

High Marks to School Of Health and Rehabilitation Sciences

Four graduate programs of the School of Health and Rehabilitation Sciences (SHRS) have earned top spots in U.S. News and World Report’s 2005 annual graduate school ranking guide. The departments of physical therapy, communication science and disorders and occupational therapy rose in the rankings since the last time they were evaluated by the magazine in 2000 and 2001. The U.S. News and World Report rankings were determined by a survey of accredited graduate school deans, faculty and administrators. [More]

 

Study Investigates the Role of Genes and Proteins in Liver Cancer

Satdarshan P. Singh Monga, M.D., has been awarded nearly $2 million by the National Institutes of Health (NIH) and the American Cancer Society to investigate the role of certain genes and proteins in liver cancer and its development.

Projects funded by the grants will focus on the biological mechanisms of tumor formation, specifically those related to the proteins Wnt/beta-catenin and Hepatocyte Growth Factor-Met-Autocrine (HGF/Met). Wnt/beta-catenin and HGF/Met are key components in cell-to-cell interactions, and are known to be genes that have the potential to cause normal cells to become cancerous. [More]

Pittsburgh Team to Lead Largest Study in Voice Disorders

A team under the leadership of Clark Rosen, M.D are participating in a large multi-site prospective clinical trial to gauge the effectiveness of calcium hydroxylapatite (CaHA) injections in patients with vocal cord paralysis, atrophy or paresis. The study, which will be conducted at 15 international sites, is the largest such trial in the field of voice disorders.

In the study, patients will receive injections of CaHA, an FDA-approved implant composed of calcium phosphate, into the injured vocal cord. At follow-up visits at one, three, six and 12 months, researchers will measure the effectiveness of the injections. It is hoped that the CaHA injection material will be an improvement over presently available substances.”
[More]

Cancer Center Selects Partner for Clinical Trials

The University of Pittsburgh Cancer Institute (UPCI) has selected local biotechnology company, ImmunoSite, as its exclusive partner for monitoring patients on clinical trials of a special class of drugs known as immuno-potentiators – drugs specifically designed to attack cancer cells by modifying the patient’s immune system. ImmunoSite will monitor immune system function in patients enrolled in clinical trials of these new and promising drugs at UPCI, accelerating the drug development process and making new agents more readily available to patients.

“ImmunoSite provides UPCI with a tremendous opportunity to quickly and cost effectively understand the influence of vaccines, small molecules or other promising drugs in modulating the patient’s immune system to combat cancer or other diseases,” said Ronald B. Herberman, M.D., director of UPCI.

ImmunoSite’s services will allow UPCI to accelerate the drug development process by providing critical data on the efficacy of immunopotentiating drugs, not only in oncology, but also in areas such as inflammation, autoimmunity, infectious diseases, immunotoxicology and organ transplant rejection. The information derived from monitoring will provide key insights into the drugs’ mechanisms of action, dosing regimens and biological activities, yielding data to support decision-making throughout all phases of clinical trials. [More]

 

Questions : Contact Jo-Anne Drabik at drabikj@upmc.edu or 412-235-5124.

 

Notice: NOT-OD-04-036

May 2004 Conference on the HIPAA Privacy Rule and Research

Release Date: April 1, 2004

Continuing its efforts to educate the research community, the NIH is holding a one-day conference on May 26, 2004 entitled, “HIPAA and the Privacy Rule: One Year Into Privacy Rule Implementation.” The conference will examine how research has been affected by the implementation of the HIPAA Privacy Rule. Topics to be covered include: clinical research, repositories and databases, health services research, mental health research, and public health activities. Speakers include officials from NIH, the HHS Office for Civil Rights, the HHS Office for Human Research Protections, the U.S. Food and Drug Administration, the Centers for Disease Control and Prevention, the Centers for Medicare and Medicaid Services, the Agency for Healthcare Research and Quality, and the Substance Abuse and Mental Health Services Administration. There are no fees to attend this meeting, but participants must pay their own travel and lodging costs. You need to register to attend at: http://www.capconcorp.com/hipaa04/

 

Notice: NOT-RR-04-007

Title: Formalizing Data-Related Concepts Under Existing Program Announcements Addendum to PA-02-141, PAR-03-106, PAR-03-119, and PAR-03-134

Release Date: April 1, 2004

URL: http://grants.nih.gov/grants/guide/notice-files/NOT-RR-04-007.html

Attention to applicants responding to PA-02-141 (http://grants.nih.gov/grants/guide/pa-files/PA-02-141.html), PAR-03-106 (http://grants.nih.gov/grants/guide/pa-files/PAR-03-106.html), PAR-03-119 (http://grants.nih.gov/grants/guide/pa-files/PAR-03-119.html), and PAR-03-134 (http://grants.nih.gov/grants/guide/pa-files/PAR-03-134.html).

This notice is meant to make clear that particular research activities related to the formalization of data concepts are appropriate under these announcements.

The overall goal of these announcements is to support research and development of tools and approaches for computing on data; most of these will likely be implemented in software. Best practices for such endeavors include the explicit formalization of data-related concepts that pertain directly to the software. This would include activities such as: 1) assessing data flow and use; 2) defining the terms used for data, fields, operations, etc.; 3) defining the relationships among terms and functions; 4) defining data models and schemas; and 5) other similar activities. It is important to emphasize that these activities are appropriate as they relate closely to the particular software, itself, or to making the particular software interoperable with other specific software or databases. However, broad efforts at developing ontologies and semantic relationships for entire domains or disciplines would not be considered an appropriate activity under these announcements.

Applicants with questions should contact either Dr. Michael Huerta (mhuerta@helix.nih.gov, 301-443-3563) or Dr. Gregory Farber (farberg@mail.nih.gov, 301-435-0778).

 

Title: Regional Centers of Excellence for Biodefense and Emerging Infectious Diseases Research

Release Date: April 1, 2004

RFA Number: RFA-AI-04-018 (see NOT-AI-04-026)

Expiration Date: September 10, 2004

CFDA Numbers: 93.855 and 93.856

URL:http://grants.nih.gov/grants/guide/rfa-files/RFA-AI-04-018.html

Letter of Intent Receipt Date: August 9, 2004

Application Receipt Date: September 9, 2004

Purpose: The National Institute of Allergy and Infectious Diseases (NIAID) is expanding the Regional Centers of Excellence for Biodefense and Emerging Infectious Diseases Research (RCE) program. The overall goal of the RCE Program is development and maintenance of a strong infrastructure and multifaceted research and development activities that will provide the scientific information and translational research capacity that will lead to the next generation of therapeutics, vaccines and diagnostics against the NIAID Category A-C Agents

(http://www.niaid.nih.gov/biodefense/bandc_priority.htm). To realize this goal, the Centers will be provided with support to: 1) develop and conduct programs of investigator-directed research; 2) train researchers and other personnel for biodefense and emerging infectious diseases research activities; 3) develop and maintain comprehensive core facilities that support the research and training activities of the RCE and make these available to qualified investigators from academia, biotechnology companies, the pharmaceutical industry, and other appropriate entities in the geographic region; 4) develop translational research capacity for testing and validating vaccine, therapeutic and diagnostic concepts for biodefense and emerging infectious diseases; and 5) be prepared and available to provide facilities and scientific support to first-line responders in the event of a national biodefense emergency.

This Request for Applications (RFA) invites research institutions and groups of investigators to form consortia and develop new applications for research programs which address the fundamental research and development questions expected to yield the information required to counter the threat of bioterrorism. Diverse research and development approaches are encouraged as long as they include the following essential features: a research focus on NIAID Category A-C agents including the incorporation of a translational component with the long term goal of developing products for human use. Additionally, consortia must document: institutional commitment; organizational capabilities; ability to develop and expand facilities; plans for training investigators and other participants in the national biodefense effort; and interdisciplinary coordination and collaboration, particularly linkages to federal, state, and local agencies as well as the private sector. Consortia must have a lead team of individuals responsible for the overall management and direction of the RCE. A group of Center member researchers, with expertise in biodefense and emerging infectious diseases, is required to lead the research thrust which underlies all activities of the RCE. Centers should emphasize the use of cutting-edge approaches and technologies.

To ensure that the RCE program contributes maximally and effectively to the NIAID biodefense and emerging infectious diseases effort, the overall direction and scope of activities of the Program and its participant Center sites will be centrally coordinated and monitored by the NIAID Biodefense Network. The Network, which is operated through the RCE Program Office at NIAID, includes the RCE Program Staff, RCE Principal Investigators, and the Principal Investigators of the National Biocontainment and Regional Biocontainment Laboratories

(http://www.niaid.nih.gov/newsroom/releases/nblscorrect21.htm)

To achieve nationwide distribution of the RCEs, the NIAID will use the 10 established DHHS regions:

Region I: CT, ME, MA, NH, RI, VT
Region II: NJ, NY, PR, VI
Region III: DE, D.C., MD, PA, VA, WV
Region IV: KY, MS NC, TN, AL, FL, GA, SC
Region V: IL, IN, MI, MN, OH, WI
Region VI: AR, LA, NM, OK, TX
Region VII: IA, KS, MO, NE
Region VIII: CO, MT, ND, SD, UT, WY
Region IX: AZ, CA, HI, NV, and the six U.S. Associated Pacific jurisdictions
Region X: AK, ID, OR, WA

It is the long-range goal of this program, contingent upon the availability of funds, to establish at least one RCE within each region. NIAID encourages applications from all regions of the country, particularly those that do not have existing RCEs. Applicants from regions with currently funded RCEs should address the additional value of having another Center in the region and how the proposed activities would relate to those ongoing at the established RCE. Although preference is to establish RCEs in those regions that currently do not have one, it is only one of several factors that will be considered in making funding decisions.

 

Title: Specialized Centers for the Protein Structure Initiative

Release Date: April 1, 2004

RFA Number: RFA-GM-05-002

Expiration Date: October 16, 2004

CFDA Numbers: 93.859 and 93.389

URL:http://grants.nih.gov/grants/guide/rfa-files/RFA-GM-05-002.html

Letter of Intent Receipt Date: September 10, 2004

Application Receipt Date: October 15, 2004

Purpose: The National Institute of General Medical Sciences (NIGMS) and the National Center for Research Resources (NCRR) encourage applications for cooperative agreements to support specialized structural genomics research centers for methodology and technology development and new ideas and approaches for protein production and structure determination for classes of challenging proteins. These specialized centers will form one component of the Protein Structure Initiative (PSI) Research Network, the integrated second, or production, phase of the PSI (PSI-2). They will focus on challenging proteins that are not currently amenable to high throughput and therefore represent major bottlenecks of the structural genomics pipeline. These classes of proteins include, but are not limited to, membrane proteins, small protein complexes, and proteins from human and other higher eukaryotes. The specialized centers will also be required to produce and determine the structure of significant numbers of these proteins, especially in the later years of the project.

 

Title: Pathogenesis of SARS Lung Disease: In Vitro Studies and Animal Models

Release Date: April 1, 2004

PA Number: PA-04-080

Expiration Date: After March 2, 2007, unless reissued

CFDA Number: 93.838

URL:http://grants.nih.gov/grants/guide/pa-files/PA-04-080.html

Purpose: The goal of this program announcement is to invite research applications to rapidly advance understanding of the pathogenesis of severe acute respiratory syndrome (SARS) in the lung using the following: in vitro techniques (especially, using human viral isolates, human tissues and cells, and other biological samples); existing animal models of related coronavirus infections (e.g., porcine respiratory CoV); non-human primate models of SARS; new ferret models of SARS; new rodent models of SARS; other appropriate animal models of SARS.

The PA invites R01 applications for both high risk hypothesis generating research and hypothesis driven projects (if sufficient preliminary data are available), relevant to the pathogenesis of human lung disease caused by the human SARS coronavirus (SARS-CoV).

 

Title: Proteomics: Diabetes, Obesity, and Endocrine, Digestive, Kidney, Urologic, and Hematologic Diseases

Release Date: April 1, 2004

PA Number: PA-04-081

Expiration Date: After March 1, 2007 unless reissued.

CFDA Numbers: 93.847 and 93.848

URL:http://grants.nih.gov/grants/guide/pa-files/PA-04-081.html

Purpose: This Program Announcement (PA) encourages projects that advance research to identify and quantitate protein expression patterns, post-translational modification of proteins, and protein-protein interactions on cells, tissues, organ systems to diabetes, obesity, endocrine and metabolic diseases, nutritional function and diseases of the alimentary tract, exocrine pancreas, liver, kidney, bladder and prostate and normal biological processes related to the function of these systems. The development and improvement of innovative proteomic technologies is also encouraged through their application to relevant biological questions related to the pathophysiology of endocrine glands, gastrointestinal tract, liver and kidney, bladder and prostate.

Title: Human Capacity Development Project

Funding Opportunity Number: M-OP-GH-POP-04-961
Date Posted: April 6, 2004

Application Receipt Date: May 14, 2004 Applications are due by 3:00 p.m. Eastern Standard Time on May 14, 2004.

Expected Number of Awards: 1

Estimated Total Program Funding: $250,000,000.00

Cost Sharing or Matching Requirement: Yes

CFDA Number: 000000 -- No Description Available

Description: The Agency for International Development, Bureau for Global Health (GH) is issuing this Request for Applications (RFA), for a Leader with Associates (LWA) Cooperative Agreement, to develop human capacity to implement quality health programs.  Activities funded under this cooperative agreement are expected to improve the delivery of health care services in facilities and communities in both the public and private sector. The Cooperative Agreement will be for five years, for a total estimated amount of 250 million dollars.

 

Title: Large-Scale Centers for the Protein Structure Initiative

Release Date: April 1, 2004

RFA Number: RFA-GM-05-001

Expiration Date: October 16, 2004

CFDA Number: 93.859

URL:http://grants.nih.gov/grants/guide/rfa-files/RFA-GM-05-001.html

Letter of Intent Receipt Date: September 10, 2004

Application Receipt Date: October 15, 2004

Purpose: The National Institute of General Medical Sciences (NIGMS) encourages applications for cooperative agreements to support large-scale structural genomics research centers for the determination of unique protein structures. These centers will form one component of the Protein Structure Initiative (PSI) Research Network, the integrated second, or production, phase of the PSI (PSI-2). Each large-scale center must perform all tasks of structural genomics in a high-throughput operation to produce a large number of unique protein structures to meet the PSI-2 goals for structural coverage of sequenced genes. Each large-scale center must also develop technologies and methodologies that will make the production and structural determination of proteins less expensive, more efficient, and more likely to be successful.

 

Notice: NOT-OD-04-037

Sixth Annual NIH SBIR/STTR Conference, June 23-24, 2004

Release Date: April 5, 2004

URL: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-037.html

The Sixth Annual NIH SBIR/STTR Conference is scheduled for June 23-24, 2004, and will be held on the NIH campus in Bethesda, Maryland. This two-day meeting will focus explicitly on the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs. Funding opportunities for small companies with innovative biomedical or behavioral research ideas with commercial potential will be discussed. New to the conference this year is a poster session presented by NIH SBIR/STTR Phase II awardees, and an in-depth session on the FDA regulatory process. This conference will benefit those who are relatively new to SBIR/STTR as well as those who are more experienced. Registration is free but mandatory. Agenda and registration information are available at the conference website http://grants.nih.gov/grants/funding/sbirconf2004/index.htm.

 

Title: Inter-Institute Program for the Development of AIDS-Related Therapeutics

Release Date: April 7, 2004

Notice: NOT-AI-04-024

URL:http://grants.nih.gov/grants/guide/notice-files/NOT-AI-04-024.html

Letter of Intent Receipt Date: May 1, 2004

Application Receipt Date: June 1, 2004

The Inter-Institute Program for the Development of AIDS-Related Therapeutics (IIP) is co-sponsored by The National Institute of Allergy and Infectious Diseases (NIAID) and National Cancer Institute (NCI). Investigators are invited to submit proposals to this therapeutics development program. IIP is designed to help AIDS research investigators facilitate the pre-clinical development of: 1) therapies for the treatment of HIV disease, AIDS-associated malignancies, opportunistic infections and tuberculosis associated with AIDS, and 2) microbicide-based prevention strategies for HIV. IIP does NOT fund grants. Instead, applications to the program are requests to use IIP drug development resources to conduct specific tasks the applicants themselves are unable to carry out in their efforts to translate basic research findings to applied or clinical practice. Examples of tasks that may be requested include High Throughput Screen (HTS) assay development, evaluation in animal efficacy models, Good Manufacturing Practice (GMP) scale-up synthesis of small molecules and biologics, clinical dosage formulation and manufacturing, and Good Laboratory Practice (GLP) toxicology. Program proposals are solicited twice per year on June 1 and December 1 and reviewed in a competitive manner.

The current deadline for receipt of applications is June 1, 2004; prior to that date (no later than May 1, 2004) a Letter of Intent must be submitted to the Inter-Institute Program Coordinator. Further information about this program, including detailed instructions for preparing proposals and the Letter of Intent, can be found at the program web site at http://dtp.nci.nih.gov/docs/dart.html.

 

Rescinding Notice NOT-AI-04-019 for – Integrated Preclinical/Clinical AIDS Vaccine Development (IPCAVD) Program – PAR-03-095

Release Date: April 6, 2004

Notice: NOT-AI-04-025 (see NOT-AI-04-019)

URL:http://grants.nih.gov/grants/guide/notice-files/NOT-AI-04-025.html

Correction to Receipt Date: November 15, 2004 and November 14, 2005

Incorrect Application Receipt Date: June 23, 2004, June 23, 2005

Purpose: The National Institute of Allergy and Infectious Diseases is amending PAR-03-095 (http://grants.nih.gov/grants/guide/pa-files/PAR-03-095.html) to change the receipt date:

Receipt Dates: The receipt dates in 2004 and 2005 were INCORRECTLY changed on this PAR. The ORIGINAL RECEIPT DATES of November 15, 2004 and November 14, 2005 are still in effect.

This PAR will expire November 15, 2005.

Inquiries: We encourage inquiries concerning this PA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

Direct questions about scientific/research issues to:

Dr. Michael Pensiero
Division of AIDS
National Institute of Allergy and Infectious Diseases
Room Number 4109, MSC-7628
6700-B Rockledge Drive

Telephone: (301) 435-3749
FAX: (301) 402-3684

 

Public Briefing: RFA AI-04-018 Regional Centers of Excellence for Biodefense and Emerging Infectious Diseases Research

Release Date: April 6, 2004

Notice: NOT-AI-04-026

URL:http://grants.nih.gov/grants/guide/notice-files/NOT-AI-04-026.html

Description: The National Institute of Allergy and Infectious Diseases would like to announce that an informational session for individuals representing groups considering submission of applications in response to NIAID’s RFA number AI-04-018 (http://grants.nih.gov/grants/guide/rfa-files/RFA-AI-04-018.html), entitled “REGIONAL CENTERS OF EXCELLENCE FOR BIODEFENSE AND EMERGING INFECTIOUS DISEASES RESEARCH”, will be held on May 5, 2004 from 9:00 am to 12:00 pm.

The meeting will be held in Room 6021, 6610 Rockledge Drive, Bethesda, MD, 20817. Staff from the NIAID Regional Centers of Excellence for Biodefense and Emerging Infectious Diseases Research Program and from the Division of Extramural Activities will provide information about the Program and how to apply and will be available to answer questions pertinent to preparing applications in response to this RFA. Advance registration is not required.

Inquiries:

For questions or further information, contact:

Rona Hirschberg, Ph.D.
Office of Biodefense Research Affairs
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases
Room 5007, MSC-6604
6610 Rockledge Drive
Bethesda. Maryland 20892-6604
Telephone: 301-402-8602
FAX: 301-480-1263
Email: rh199i@nih.gov

 

Centers for Medical Countermeasures Against Radiation: Request for Information (RFI)

ReleaseDate: April 9, 2004

Notice: NOT-AI-04-027

ResponseDueDate: June 1, 2004

URL:http://grants.nih.gov/grants/guide/notice-files/NOT-AI-04-027.html

The National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) is planning to establish a network of Centers for Medical Countermeasures Against Radiation (CMCR) using the cooperative agreement (U19) mechanism. This program is part of a larger national plan to develop effective medical products to prevent and treat injury resulting from radiation after terrorist attack or accidental exposure to radiological or nuclear materials. The proposed network would support individual multi-project research centers conducting cross-disciplinary work in a variety of areas relevant to radiobiology and radiation epidemiology. In October 2004, the NIAID plans to issue a Request for Applications to establish these centers, with a receipt date for applications in February 2005, and an anticipated award date in September 2005.

Growing terrorist threats have highlighted gaps in the research and development of medical countermeasures for protection of the US civilian population against radiation. Few products are currently available for prevention of radiation injury, for treatment of post-exposure injury, or for the rapid identification of exposed individuals requiring treatment. Through this Request for Information (RFI), the NIAID would like to obtain information that is relevant to establishing the CMCR program, and to identify interested sources that are already developing products or research in this area, or that could facilitate the CMCR program and aid in the planning of this new initiative.

This RFI is for information and planning purposes only and should not be construed as a solicitation or as an obligation on the part of the Government. The Government does not intend to award a cooperative agreement on the basis of responses to this RFI nor otherwise pay for the preparation of any information submitted or for the Government’s use of such information.

 

Notice of Availability of Administrative Supplements for Disseminating Evidence – Based Intervention Research Products

ReleaseDate: April 5, 2004

Notice: NOT-CA-04-011

URL:http://grants.nih.gov/grants/guide/notice-files/NOT-CA-04-011.html

The National Cancer Institute is requesting applications for administrative supplements for NCI-funded cancer control intervention research RO1, P01, P50, U01, and U19 grants. Applicants may apply for a supplement to a related R01, P01, P50, U01, or U19 intervention research award, as long as the following conditions are met:

1) The focus of the awarded grant is similar to the focus of the intervention dissemination supplement that is being proposed,

2) There are no funds in the related award related to the proposed dissemination effort.

3) There must be an active parent grant during the entire funding period of this supplement.

4) The Principal Investigator for the supplement must be the Principal Investigator of the parent grant.

These supplements have been designed to provide 1-year funding to cancer control investigators whose intervention efficacy data have been analyzed and who are conducting peer-reviewed research (with an active NCI grant award) related to the intervention program proposed for dissemination. Intervention research across the cancer control continuum that may be eligible for these supplements, includes: tobacco use prevention and cessation; promotion of appropriate changes in diet and physical activity; reduction of sun exposure and ultraviolet (UV) radiation exposure; facilitation of informed decisions about genetic testing for cancer susceptibility; enhancement of screening for breast, cervix and colorectal cancers; quality of care; and improvements in coping skills and quality-of-life for cancer survivors and their families.

Detailed instructions for applying for this supplement will be posted at http://www.dccps.cancer.gov/funding_apply.html#dd.on April 7, 2004. The receipt date for applications is June 30, 2004.

The application should take the form of a request letter that contains sufficient detail to allow assessment of the scientific merit of the proposed dissemination plans and the appropriateness of the request for supplemental funding (see web site for more detailed application information). Budgets should not exceed $125,000 in direct costs for a time period not exceeding 12 months. All requests require an itemized budget and must be countersigned by the grantee institution’s business office. Requests for supplements under this program must comply with NIH policies for inclusion of women, minorities, and children in research involving human subjects.

 

Request for Information on the Translation of Cell-Based Therapies for Cardiovascular Diseases

Release Date: April 9, 2004

Notice: NOT-HL-04-108

URL:http://grants.nih.gov/grants/guide/notice-files/NOT-HL-04-108.html

ResponseDueDate: June 1, 2004

Purpose: The NHLBI is soliciting comments and ideas on approaches to translate and implement cell-based therapies for the treatment of cardiovascular diseases.

Information Requested: The NHLBI seeks your help in identifying (a) the major opportunities to develop and apply cell-based therapies to heart disease; (b) the critical needs to enable progress, and the barriers that may inhibit it; and (c) practical and effective ways to meet the needs, overcome the barriers, and take full advantage of the opportunities. Your thoughts, ideas, and suggestions will be used to help guide future Institute activities designed to expedite the translation of cell-based therapies the treatment of cardiovascular disease and efforts to improve patient care. Respondents are asked to comment on one or more of the issues listed below, but should not feel compelled to address all of them.

1. Please identify the major needs for, and barriers to, translating cell-based therapies to cardiovascular disease and medicine. Specific suggestions concerning steps or requirements that must be met in order to translate cell-based therapies for cardiovascular disease would be helpful.

2. Please suggest approaches the NHLBI can take to meet the needs, overcome the barriers, and take full advantage of the opportunities. Any specific suggestions regarding expertise, capabilities, and resources needed would be valuable.

3. Please comment on the selection of cell type to be used for cell-based therapies for cardiovascular disease. Provide specific suggestions regarding the use of autologous versus allogeneic cells, and the need for isolation, purification, and characterization of the cells.

4. Please consider and comment on safety and regulatory issues that are likely to be encountered in translating cell-based therapies. Please include ideas on how these issues can be addressed.

5. We would appreciate any additional views or opinions that you think would be useful.

 

Title: The Early Detection Research Network: Biomarker Reference Laboratories

Release Date: April 9, 2004

RFA Number: RFA-CA-05-009

Expiration Date: August 17, 2004

CFDA Number: 93.394

URL:http://grants.nih.gov/grants/guide/rfa-files/RFA-CA-05-009.html

Letter of Intent Receipt Date: July 16, 2004

Application Receipt Date: August 16, 2004

This RFA is a reissue of RFA CA-99-008, which was published in the NIH Guide on March 16, 1999.

Purpose: The Division of Cancer Prevention (DCP), National Cancer Institute (NCI), invites new and competing renewal cooperative agreement applications to continue the national Network that has the responsibility for the development, evaluation, and validation of biomarkers for earlier cancer detection and risk assessment. Biomarkers are defined as cellular, biochemical, and molecular (genetic and epigenetic) alterations by which a normal or abnormal biologic process can be recognized or monitored. Biomarkers are measurable in biological media, such as in tissues, cells, or fluids. The Network has four main components: Biomarker Developmental Laboratories (BDLs), Biomarker Reference Laboratories (BRLs) (formerly known as Biomarker Validation Laboratories), Clinical Epidemiology and Validation Centers (CECs)(formerly known as Clinical and Epidemiologic Centers), and a Data Management and Coordinating Center (DMCC). The BDLs have responsibility for the development and characterization of new or the refinement of existing biomarkers and assays. The BRLs serve as a Network resource for clinical and laboratory validation of biomarkers, which include technological development and refinement. The CECs collaboratively conduct clinical and epidemiological research on the Network-wide clinical validation of biomarkers. The DMCC supports statistical and computational analysis and informatics infrastructure and coordinates network-wide meetings and conferences. For further details, see http://www.cancer.gov/edrn.

The Early Detection Research Network (EDRN) Steering Committee (SC) is composed of the Principal Investigators (PIs) in the Network and appropriate NCI staff to coordinate the work of the Network.

The purpose of this Request for Applications (RFA) (CA-05-009) is to invite new and competing renewal applications for the BRLs. An RFA (CA-04-006) for the BDLs was previously published in the NIH guide, September 26, 2003. This RFA is available at http://grants.nih.gov/grants/guide/rfa-files/RFA-CA-04-006.html. The RFA for the CEC (CA-05-005) was published in the NIH Guide on January 14, 2004, and is available at

http://grants.nih.gov/grants/guide/rfa-files/RFA-CA-05-005.html. The RFA for the DMCC is being issued at a later date. Applicants are encouraged to seek funding to participate in more than one component, because it is recognized that collaborations already exist in individual institutions for clinical testing and validation of biomarkers and reagents.

 

Title: Alliances For Graduate Education And The Professoriate (AGEP)

Program Solicitation Number: NSF 04-575 Replaces Document 01-138

Letter of Intent Due Date (required): May 17, 2004

Full Proposal Deadline: July 26, 2004 (due by 5 p.m. proposer's local time)

CFDA Number: 47.076 --- Education and Human Resources

URL:http://www.nsf.gov/pubs/2004/nsf04575/nsf04575.htm

Revisions and Updates: Letters of Intent are required in FY 2004. Level of funding has increased.

Synopsis: The Alliances for Graduate Education and the Professoriate (AGEP) program is intended to increase significantly the number of domestic students receiving doctoral degrees in the sciences, technology, engineering, and mathematics (STEM), with special emphasis on those population groups underrepresented in these fields (i.e., African Americans, Hispanics, American Indians, Alaska Natives, Native Hawaiians or other Pacific Islanders). In addition, AGEP is particularly interested in increasing the number of minorities who will enter the professoriate in these disciplines. Specific objectives of the AGEP program are (1) to develop and implement innovative models for recruiting, mentoring, and retaining minority students in STEM doctoral programs, and (2) to develop effective strategies for identifying and supporting underrepresented minorities who want to pursue academic careers.

 

Title: Collaborative Pediatric Critical Care Research Network

Release Date: April 16, 2004

RFA Number: RFA-HD-04-004

Expiration Date: August 10, 2004

CFDA Number: 93.865

URL:http://grants.nih.gov/grants/guide/rfa-files/RFA-HD-04-004.html

Letter of Intent Receipt Date: July 12, 2004

Application Receipt Date: August 9, 2004

Purpose: The National Institute of Child Health and Human Development (NICHD) invites applications from investigators willing to participate with the NICHD under a cooperative agreement (U10) to initiate a multi-center program designed to investigate the safety and efficacy of treatment and management strategies to care for critically ill children, as well as the pathophysiological bases of critical illness and injury in childhood. This network will promote the efficient comparison of novel critical care treatment methods and management strategies of potential benefit for children who are critically ill. The objective of this Request for Applications (RFA) is to establish and maintain the infrastructure required for a network of approximately six clinical centers to perform multiple clinical trials as well as pertinent descriptive and translational research for children who are critically ill. An RFA for a Data Coordinating Center to support the network is separately published (RFA HD-04-015). The established network of academic centers will be able to study the required numbers of patients using rigorous common protocols and can provide answers more rapidly than individual centers acting alone.

 

Title: Additional Genotyping for the Human Haplotype Map

Release Date: April 16, 2004

RFA Number: RFA-HG-04-005

Expiration Date: June 26, 2004

CFDA Numbers: 93.172, 93.394, 93.389, 93.866, 93.273, 93.173, 93.848, 93.847, 93.849, 93.279, 93.114, 93.862, 93.242, 93.853, and 93.989.

URL:http://grants.nih.gov/grants/guide/rfa-files/RFA-HG-04-005.html

Letter of Intent Receipt Date: May 28, 2004

Application Receipt Date: June 25, 2004

Purpose: This RFA solicits applications for a cooperative agreement to augment the International HapMap Project by supporting the genotyping of approximately 2.25 million single nucleotide polymorphisms (SNPs) across the genome in 270 samples from four populations, at high quality and at a cost of about 1 cent per genotype. The data from this effort will contribute to the development of a map, called the HapMap, of the haplotype patterns in the human genome and of a set of SNPs that are informative about these patterns and the associations among the SNPs. The HapMap is expected to be a key resource that researchers will use to find genes that affect health, disease, and response to drugs and environmental factors. The genotyping supported by this RFA will augment the current efforts of the HapMap Project by substantially increasing the number of SNPs that will be studied, thereby increasing the quality of the HapMap and its usefulness as a resource for understanding human genetic variation and its role in health and disease. This RFA builds on a previous RFA, HG-02-005 Large-Scale Genotyping for the Haplotype Map of the Human Genome (http://grants.nih.gov/grants/guide/rfa-files/RFA-HG-02-005.html).

 

Title: Novel Approaches to Study Polymicrobial Diseases

ReleaseDate: April 15, 2004

PANumber: PA-04-093

ExpirationDate: July 2, 2007, unless reissued.

CFDA Numbers: 93.121 (NIDCR); 93.837 (NHLBI); 93.173 (NIDCD); 93.286 and 93.287 (NIBIB)

URL:http://grants.nih.gov/grants/guide/pa-files/PA-04-093.html

Purpose: The NIH Institutes listed above invite research grant applications to conduct studies designed to develop innovative approaches that would contribute to our understanding of the mechanisms that impact on the virulence of infections involving two or more microorganisms or strains of microorganisms (with the exception of HIV). This announcement encourages investigators to think beyond the one organism-one disease concept and instead to consider the fact that many diseases are caused by the synergistic and inhibitory interactions of bacteria, viruses, parasites, and fungi. Projects should include studies aimed at understanding the cellular and molecular interactions of pathogens with the normal flora as well as the interactions among pathogens themselves, and how commensal organisms can be used to prevent or treat infections; however, this PA is limited to those projects that involve or are based on intermicrobial interactions that have been well documented to occur in clinical settings. In addition, extensive research is needed on the host responses to polymicrobial infections in order to develop new approaches to treat and prevent these infections. The development of co-infection models and the use of genomic and proteomic technologies to identify common virulence mechanisms and host response patterns as well as the development of diagnostic and prognostic microbial/host signature patterns are encouraged. Because of the complexity of such projects, the establishment of collaborative scientific teams, both domestic and international, with diverse scientific disciplines studying polymicrobial diseases, including microbiology, immunology, biochemistry, clinical medicine, pathology, bioengineering, material science, imaging technology, and mathematical modeling are encouraged.

 

Title: Monitoring Atypical HIV Strains Among Persons Newly Diagnosed with HIV Using Dried Blood Spots vs. Diagnostic Sera

Billing Code: 4163-18-P

Announcement Type: New

Funding Opportunity Number: 04118

CFDA Number: 93.944

Letter of Intent Deadline: May 20, 2004

Application Deadline: June 21, 2004

Purpose: The purpose of the program is to expand the ability of health departments to perform surveillance of the prevalence of atypical strains of HIV, including drug resistant strains and non-B subtypes, by piloting the use of dried blood spots as an additional specimen type for this purpose. The use of serum from an HIV diagnostic blood draw for surveillance of atypical strains is the methodology used in several HIV resistance surveillance projects in various stages of implementation with different health departments. Some diagnostic sites and clinical centers cannot currently be included in these projects, due to logistical problems with specimen availability, processing or volume. The purpose of CDC funding for this activity is to allow state and local health departments, including both those already participating in atypical HIV strain surveillance and those not yet participating, to:

(1) Evaluate the feasibility and efficiency of routine use of dried blood spots (DBS) for surveillance of atypical strains of HIV, including drug resistant strains and non-B subtypes, in persons newly diagnosed with HIV, and (2) Monitor the prevalence of atypical HIV strains, including antiretroviral drug resistant strains and non-B subtypes, among persons newly diagnosed with HIV, including those for whom sera from a diagnostic blood draw are not available for surveillance purposes, and those for whom diagnostic sera are used for surveillance of atypical strains.

Compare the prevalence among the two groups.

This project will fulfill the purpose of monitoring prevalence of atypical strains by extending surveillance to sites that would currently be unable to provide sera for genotyping. DBS may also be collected for atypical strain surveillance in other sites where the collection of DBS may be more acceptable or require fewer resources than the collection of diagnostic sera. A comparison of resource requirements for the two methods in a variety of site types will be an important part of the evaluation.

This program addresses the "Healthy People 2010" focus area(s) of HIV.

Measurable outcomes of the program will be in alignment with one (or more) of the following performance goal(s) for the National Center for HIV, STD, and TB Prevention (NCHSTP): Strengthen the capacity nationwide to monitor the epidemic, develop and implement effective HIV prevention interventions and evaluate prevention programs.

The expected outcome is an enhanced ability to collect data on atypical HIV strains in persons newly diagnosed with HIV. Data from surveillance of atypical strains of HIV are used to identify emerging epidemics, monitor trends in transmission, target prevention resources and interventions to areas and populations most heavily affected, and evaluate programs designed to prevent the transmission of HIV.

 

Title: International Collaborations in Infectious Disease Research (ICIDR)

Release Date: April 23, 2004

RFA: RFA-AI-04-017

Expiration Date: October 14, 2004

URL:http://grants.nih.gov/grants/guide/rfa-files/RFA-AI-04-017.html

CFDA Numbers: 93.856, Microbiology and Infectious Diseases Research

93.855, Immunology, Allergy, and Transplantation Research

Letter of Intent Receipt Date: September 13, 2004

Application Receipt Date: October 13, 2004

Purpose: Diseases caused by tropical parasites are a global health problem disproportionately affecting populations residing in less developed countries. The tropical infectious diseases research program of the National Institute of Allergy and Infectious Diseases (NIAID) is predicated on the view that we live in a global community and, therefore, the health problems of the United States cannot be separated from those of the rest of the world. NIAID’s ultimate goal in this research area is attainment of the highest standard of health for a greater proportion of the global health community through the development of new and improved vaccines, diagnostics, and treatments. Fulfillment of NIAID’s commitment to tropical infectious diseases requires the capacity to carry out research in endemic areas.

The goals of the NIAID International Collaborations in Infectious Disease Research (ICIDR) program are to: support high-quality, collaborative research that will lead to or result in prevention, amelioration, and/or improved treatment of tropical infectious diseases caused by protozoa and helminth parasites; increase relevant research experience for both U.S. and foreign investigators; and facilitate and enhance scientific linkages between U.S. and foreign investigators to enhance the independent research capacity of the collaborating foreign institutions and strengthen their scientific infrastructure for further international collaborative arrangements. NIAID seeks to support research that will result in scientifically sound information that can guide relevant clinical and public health policy in endemic countries.

 

Title: CDC Public Health Research: Health Protection Research Initiative Mentored Research Scientist Development Award (KO1)

Release Date: April 22, 2004

RFA Number: RFA-CD-04-001

Expiration Date: June 23, 2004

CFDA Number: 93.063

URL:http://grants.nih.gov/grants/guide/rfa-files/RFA-CD-04-001.html

LetterofIntent Receipt Date: May 24, 2004

Application Receipt Date: June 22, 2004

Note: The policies, guidelines, terms, and conditions stated in this announcement may differ from those used by the NIH.

Purpose: The Centers for Disease Control and Prevention (CDC) Office of Public Health Research (OPHR) announces the availability of FY 2004 public health research funds to support the development of a qualified and experienced cadre of independent public health researchers to address priority health protection issues. Health protection should be interpreted to include activities that 1) promote health/or prevent disease, injury, or disability or 2) protect people from health threats including infectious, environmental, and terrorist threats.

 

Title: CDC Public Health Research: Health Protection Research Initiative Investigator Initiated Research (R01)

Release Date: April 22, 2004

RFA Number: RFA-CD-04-002

Expiration Date: June 23, 2004

CFDA Number: 93.062

URL:http://grants.nih.gov/grants/guide/rfa-files/RFA-CD-04-002.html

Letter of Intent Receipt Date: May 24, 2004

Application Receipt Date: June 22, 2004

Note: The policies, guidelines, terms, and conditions stated in this announcement may differ from those used by the NIH.

Purpose: The Centers for Disease Control and Prevention (CDC), Office of Public Health Research (OPHR) announces the availability of fiscal year (FY) 2004 public health research funds to support innovative public health research that addresses priority health protection issues. Health protection should be interpreted to include activities that 1) promote health and/or prevent disease, injury, or disability or 2) protect people from health threats including infectious, environmental, and terrorist threats. This RFA focuses specifically on health promotion in the workplace.

 

Title: CDC Public Health Research: Health Protection Research Initiative Institutional Research Training Grant

ReleaseDate: April 23, 2004

RFANumber: RFA-CD-04-003

ExpirationDate: June 22, 2004

CFDA Number: 93.061

URL:http://grants.nih.gov/grants/guide/rfa-files/RFA-CD-04-003.html

Letter of Intent Receipt Date: May 24, 2004

Application Receipt Date: June 21, 2004

Note: The policies, guidelines, terms, and conditions stated in this announcement may differ from those used by the NIH.

Purpose: The Centers for Disease Control and Prevention (CDC) Office of Public Health Research (OPHR) announces the availability of FY 2004 public health research funds for institutional training grants to eligible institutions to develop or enhance training programs to provide research training opportunities for individuals, selected by the institution, who are training for careers in specified areas of health protection research. Health protection should be interpreted to include activities that 1) promote health and/or prevent disease, injury, or disability or 2) protect people from health threats including infectious, environmental, and terrorist threats.

 

Title: CDC Public Health Research: Health Protection Research Initiative Centers of Excellence in Health Promotion Economics Center Core Grant

ReleaseDate: April 22, 2004

RFANumber: RFA-CD-04-004

ExpirationDate: June 22, 2004

CFDA Number: 93.061

URL:http://grants.nih.gov/grants/guide/rfa-files/RFA-CD-04-004.html

Letter of Intent Receipt Date: May 24, 2004

Application Receipt Date: June 21, 2004

Note: The policies, guidelines, terms, and conditions stated in this announcement may differ from those used by NIH.

Purpose: The Centers for Disease Control and Prevention (CDC), Office of Science Policy and Technology Transfer (OSPTT), Office of Public Health Research (OPHR) announces the availability of FY 2004 funds to provide core support for the establishment of Centers of Excellence in Health Promotion Economics. This RFA is a component of the CDC’s FY 2004 Health Protection Research initiative. Health protection should be interpreted to include activities that 1) promote health and or prevent disease, injury, or disability or 2) protect people from health threats including infectious, environmental, and terrorist threats. Centers of Excellence in Health Promotion Economics will apply economic theory and methods to areas that have a high probability of improving the efficiency and effectiveness of priority health protection activities. Health promotion economics is defined as the study of the relationship between society’s resources and its efforts to promote health. The demand for health promotion-related goods and services exceeds the available resources, so means must be devised to allocate these resources between competing ends. Research in health promotion economics should be interpreted to include, but not be limited to, that which 1) explores economic priorities, barriers and solutions to developing, implementing, and evaluating health promotion policies, guidelines, recommendations, and programs; 2) examines supply and demand for health promotion including examination of market imperfections and externalities; and 3) evaluates the cost effectiveness and efficiency of such polices and programs. Health promotion focuses on creating policies and developing behaviors that result in lowering the risk of disease, injury and disability. By promoting health (through physical activity, diet, etc.) and preventing disease, injury, and disability (through the use of seat belts, antimicrobial prophylaxis therapy, etc.), people are given the opportunity to achieve their expected lifespan with the best possible quality of health in every life stage.

 

Title: Heterogeneity of Fat Depots: Underlying Basis and Association with Morbidity

Release Date: April 22, 2004

PA Number: PA-04-098

Expiration Date: March 2, 2007

CFDA Numbers: 93.847, 93.848, 93.837 and 93.866

URL:http://grants.nih.gov/grants/guide/pa-files/PA-04-098.html

Purpose: The National Institutes of Diabetes and Digestive and Kidney Diseases (NIDDK), the National Heart, Lung, and Blood Institute (NHLBI) and the National Institute on Aging (NIA) invite investigator-initiated Research Projects (R01 and R21) to investigate the life cycle of adipocytes and other cell types present in various fat depots, such as macrophages, neurons, and endothelial cells. The goal of this initiative is to increase our understanding of the interactions among the cell populations in order to identify biomarkers of changes in cellular physiology and metabolism brought on by the obese state, which are truly associated with the development of co-morbidities such as diabetes, atherosclerosis, and hypertension. The long term goal of this initiative is to identify markers of obesity associated with disease risk that could yield new targets for therapeutics to disrupt this link.

 

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