kristoff@GENBANK.BIO.NET (Dave Kristofferson) (02/01/91)
NIH GUIDE - Vol. 20, No. 5, February 1, 1991
NOTICES
TYPE SIZE IN PHS 398 APPLICATIONS ......................(165/199)........... 1
Division of Research Grants
Index: DIVISION OF RESEARCH GRANTS
STUDY OF GRANT APPLICATIONS TEXTS IN ELECTRONIC FORM ...(202/256)........... 1
Division of Research Grants
Index: DIVISION OF RESEARCH GRANTS
NATIONAL WORKSHOPS ON "PROTECTION OF HUMAN SUBJECTS" ...(259/375)........... 2
National Institutes of Health
Food and Drug Administration
Index: NATIONAL INSTITUTES OF HEALTH
FOOD AND DRUG ADMINISTRATION
NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES
PROGRAM PROJECT GUIDELINES .............................(378/407)........... 3
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Index: ARTHRITIS, MUSCULOSKELETAL DISEASES, SKIN DISEASES
ANNOUNCEMENT OF HHS GRANTS AND CONTRACTS TRAINING COURSE ..(410/520)........ 4
Public Health Service
Index: PUBLIC HEALTH SERVICE
SALARY LIMITATION ON GRANTS AND CONTRACTS .................(523/618)........ 5
National Institutes of Health
Alcohol, Drug Abuse, and Mental Health Administration
Index: NATIONAL INSTITUTES OF HEALTH
ALCOHOL, DRUG ABUSE, AND MENTAL HEALTH ADMINISTRATION
PUBLIC HEALTH SERVICE POLICY RELATING TO DISTRIBUTION OF UNIQUE
RESEARCH RESOURCES PRODUCED WITH PHS FUNDING ..............(621/754)........ 6
Public Health Service
Index: PUBLIC HEALTH SERVICE
NOTICES OF AVAILABILITY (RFPs AND RFAs)
EVALUATION OF VACCINE PROPHYLAXIS AGAINST INFECTIOUS DISEASES IN
CHILDREN (RFP) ............................................(760/804)........ 8
National Institute of Allergy and Infectious Diseases
Index: ALLERGY, INFECTIOUS DISEASES
EVALUATION OF CONTROL MEASURES AGAINST INFECTIOUS DISEASES OTHER
THAN AIDS (RFP) ...........................................(807/845)........ 9
National Institute of Allergy and Infectious Diseases
Index: ALLERGY, INFECTIOUS DISEASES
MATERNAL IMMUNIZATION FOR THE PREVENTION OF INFECTIOUS DISEASES IN
NEONATES AND INFANTS (RFP) ................................(848/885)........ 9
National Institute of Allergy and Infectious Diseases
Index: ALLERGY, INFECTIOUS DISEASES
DEVELOPMENT OF MODELS FOR PEDIATRIC AIDS (RFA AI-91-04) ...(888/992)........10
National Institute of Allergy and Infectious Diseases (1925/2272)
Index: ALLERGY, INFECTIOUS DISEASES
DEVELOPMENT OF MODELS FOR PLACENTAL AND PEDIATRIC METABOLISM, TOXICITY,
AND TRANSPORT OF anti-HIV DRUGS (RFA AI-91-05) ..(995/1104, 2275/2619)......11
National Institute of Allergy and Infectious Diseases
Index: ALLERGY, INFECTIOUS DISEASES
HIV IN MOTHERS AND INFANTS: IMMUNITY AND EARLY DIAGNOSIS (RFA AI-91-06) ...12
National Institute of Allergy and Infectious Diseases (1107/1234)
Index: ALLERGY, INFECTIOUS DISEASES (2622/3184)
ANIMAL MODELS FOR SUDDEN INFANT DEATH SYNDROME (RFA HD-91-05) ..............14
National Institute of Child Health and Human Development (1237/1330)
Index: CHILD HEALTH, HUMAN DEVELOPMENT (3185/3542)
INTERVENTIONS TO PROMOTE APPLICATION OF STATE-OF-THE-ART CANCER
MANAGEMENT IN RURAL AREAS (RFA CA-91-05) ......(1333/1456, 3545/4035).......15
National Cancer Institute
Index: CANCER
KIDNEY AND UROLOGY RESEARCH CENTERS (RFA DK-91-03) ..(1459/1604, 4037/4420).17
National Institute of Diabetes and Digestive and Kidney Diseases
Index: DIABETES, DIGESTIVE DISEASES, KIDNEY DISEASES
SCIENCE EDUCATION PARTNERSHIP AWARD (RFA AD-91-01) (RFA OD-91-01) ..........19
Alcohol, Drug Abuse, and Mental Health Administration (1607/1801)
National Institutes of Health (4822/5405)
Index: ALCOHOL, DRUG ABUSE, AND MENTAL HEALTH ADMINISTRATION
NATIONAL INSTITUTES OF HEALTH
MULTICENTER COOPERATIVE AGREEMENT FOR STUDYING NEURAL TUBE DEFECTS
IN MUTANT MICE (RFA HD-91-01) ................(1804/1881, 4423/4819)........21
National Institute of Child Health and Human Development
Index: CHILD HEALTH, HUMAN DEVELOPMENT
ERRATUM
ADDENDUM: NATIONAL INSTITUTE ON DRUG ABUSE - ANNOUNCEMENT AND
GUIDELINES - AUGUST 1990 (PA-90-31) ..........(1887/1905)...................22
National Institute on Drug Abuse
Index: DRUG ABUSE
NOTICES
TYPE SIZE IN PHS 398 APPLICATIONS
P.T. 34; K.W. 1014006
Division of Research Grants
In an effort to clarify the current guidelines and in response to some
excellent suggestions, we have modified the current guidelines regarding the
type size in the PHS 398 application kit. The following revised guidelines
replace the paragraph under Specific Instructions - Section, (page 12, PHS
398, Rev. 10/88). They are effective with the February 1, 1991 application
receipt deadline.
"It is also essential that type size limitations be observed throughout the
application, or the application will be returned without review. For the
first (face) page, the type density must be 10 characters per inch (cpi).
This limit is to assure that all data typed on this page can be captured for
computer processing without truncation. For the rest of the application, the
type must be standard size, which is 10 to 12 points (approximately 1/8 inch
in height for capital letters). If constant spacing is used, there should be
no more than 15 cpi, whereas proportional spacing should provide an average of
15 cpi. Finally, there must be no more than six lines of text within a
vertical inch. Figures, charts, tables, figure legends, and footnotes may be
smaller in size but must be clear and readily legible. Applications not
meeting these requirements will be returned without review, or may be subject
to deferral."
If you have any questions, contact:
The Referral Office
Division of Research Grants
National Institutes of Health
Westwood Building, Room 248
Bethesda, MD 20892
Telephone: (301) 496-7447
STUDY OF GRANT APPLICATION TEXTS IN ELECTRONIC FORM
P.T. 34; K.W. 1014002, 1004008
Division of Research Grants
The Division of Research Grants (DRG), as part of its ongoing efforts to
improve the efficiency of its review and data management functions, is
studying the feasibility of computer-assisted indexing of grant applications.
To conduct this special study, DRG needs a large data base, in electronic
form, of the textual portions of applications. The application sections of
interest are the 1) Abstract, 2) Specific Aims, 3) Background and
Significance, and 4) Literature Cited (Section 2-I).
Therefore, DRG is asking investigators who already have submitted a competing
application for individual research grant support (R01) and who have the
textual portions of their applications available in an electronic medium
(i.e., stored in a computer or on a floppy disk) to send only these portions
of their applications to:
Dr. John B. Mathis
Division of Research Grants
National Institutes of Health
Westwood Building, Room 2A-05
Bethesda, MD 20892
Telephone: (301) 402-1464
The application sections listed above should be copied as separate files to a
floppy disk (5 1/4" or 3 1/2"). It is most desirable that each file be
converted to its ASCII ("DOS File") equivalent before copying. If this is not
possible, please indicate on the disk label what word processing program was
used to prepare the file.
All data received will be handled as privileged communications and stored in
controlled-access files in the NIH mainframe computer. No applicant names
will be associated with any computer-based files (except as they may appear in
the files themselves). The files will be identified and retrieved by their
NIH GUIDE - Vol. 20, No. 5, February 1, 1991 - Page 1
code designations only. The DRG will take precautions to maintain the
confidentiality of the information submitted.
Please send only files from applications that have been submitted between
August 1, 1989 and July 31, 1990. Indicate on the disk label 1) the
application's title and 2) the study section and the Institute, Center or
Division to which it was assigned.
Note that this request for application information is entirely independent of
the current review and award processes of any of the Institutes, Centers or
Divisions of the Public Health Service, including DRG. Your response to this
announcement should be considered entirely voluntary. Information received as
a result of this announcement will not affect the review or funding of any
grant application in any way. All information received will be used solely
for the study of information management by DRG. All disks received will be
returned to the sender if a return address is enclosed.
NATIONAL WORKSHOPS ON "PROTECTION OF HUMAN SUBJECTS"
P.T. 42; K.W. 0783005
National Institutes of Health
Food and Drug Administration
The National Institutes of Health (NIH) and the Food and Drug Administration
(FDA) are continuing to sponsor a series of workshops on the responsibilities
of researchers, Institutional Review Boards (IRBs), and institutional
officials for the protection of human subjects in research. The workshops are
open to everyone with an interest in research involving human subjects. The
meetings should be of special interest to those persons currently serving or
about to begin serving as a member of an IRB. Issues discussed at these
workshops are relevant to all other Public Health Service agencies. The
current schedule includes the following:
I. WEST COAST WORKSHOP
DATES: February 4-5, 1991
WORKSHOP SITE:
Meridien Hotel
50 Third Street
San Francisco, CA 94103
SPONSOR:
University of California at San Francisco
Box 0400
San Francisco, CA 94143
REGISTRATION CONTACT:
Ms. Phyllis Colbert
Workshop Contact Person
University of California at San Francisco
Box 0400
San Francisco, CA 94143
Telephone: (415) 476-1881
TOPIC: "The Use of Human Subjects in Research: AIDS as a Model of
Complexity"
II. MIDEAST WORKSHOP
DATES: March 4-5, 1991
WORKSHOP SITE:
Friday Center
Laurel Hill Parkway
Chapel Hill, NC 27599-1020
SPONSORS:
University of North Carolina at Chapel Hill
300 Bynum Hall
Chapel Hill, NC 27599-4100
Shaw University
118 E. South Street
Raleigh, NC 27611
NIH GUIDE - Vol. 20, No. 5, February 1, 1991 - Page 2
REGISTRATION CONTACT:
Mr. Al Dawson
Director
Friday Center
Laurel Hill Parkway
C. B. 1020
Chapel Hill, NC 27599-1020
Telephone: (919) 962-1106
TOPIC: "Interpreting the Federal Code for the Protection of Human Subjects"
III. MIDWEST WORKSHOP
DATES: April 11-12, 1991
WORKSHOP SITE:
Ramada Inn, Lakeshore
4900 South Lake Shore Drive
Chicago, IL 60615
SPONSORS:
University of Chicago
970 East 58th Street
Chicago, IL 60637
Chicago State University
95th Street at King Drive
Chicago, IL 60628
REGISTRATION CONTACT:
Mr. Arnold L. Aronoff
Associate Director
Faculty and Administrative Services
University Research Administration
University of Chicago
970 East 58th Street
Chicago, IL 60637
Telephone: (312) 702-8669
TOPIC: "Cultural Diversity, Ethics, and Research: A Workshop on Human
Subject Protection"
NIH/FDA have planned national human subject protections workshops in other
parts of the United States. For further information regarding these workshops
contact:
Darlene Marie Ross
Executive Assistant for Education
Division of Human Subject Protections
Office for Protection from Research Risks
National Institutes of Health
9000 Rockville Pike
Building 31, Room 5B59
Bethesda, MD 20892
Telephone: (301) 496-8101
NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES PROGRAM
PROJECT GUIDELINES
P.T. 34; K.W. 0715010, 0715185, 0705050, 1014006
National Institute of Arthritis and Musculoskeletal and Skin Diseases
The National Institute of Arthritis and Musculoskeletal and Skin Diseases
(NIAMS) announces the availability of revised guidelines for program project
applications that are assigned to NIAMS by the Division of Research Grants
(DRG). The limitation on direct costs requested will remain at $5 million
over 5 years. These guidelines will be used as the basis for the review of
applications received as of June 1, 1991, and thereafter.
The following individual may be contacted for the guidelines and for specific
questions related to such applications:
NIH GUIDE - Vol. 20, No. 5, February 1, 1991 - Page 3
Dr. Michael Lockshin
Director, Extramural Program
National Institute of Arthritis and Musculoskeletal and Skin Diseases
9000 Rockville Pike
Building 31, Room 4C32
Bethesda, MD 20892
Telephone: (301) 496-0802
ANNOUNCEMENT OF HHS GRANTS AND CONTRACTS TRAINING COURSE
P.T. 34; K.W. 1014002, 1014006
Public Health Service
COURSE TITLE: Orientation to U.S. Department of Health and Human Services
Grants and Contracts Activities for Applicants and Recipients of Awards
COURSE DESCRIPTION: This two-day course has been designed to provide
applicants for and recipients of HHS grants and contracts with a better
understanding of the procedures that are to be followed and what is expected
of them in applying for and in the accounting and stewardship of Federal
funds. The first day of the course concentrates on the grants process; the
second day is devoted to contracting. Students will be provided with a broad
overview of how to conduct contract and grant business with HHS including:
how the Department is organized, how the HHS contracts and grants processes
are structured, how to identify grant and contract funding opportunities, how
to submit effective applications and proposals and what to watch out for once
a contract or grant has been awarded by HHS.
TARGET POPULATION: Grant and contract staff of organizations that are
presently doing business with HHS as grantees or contractors, and those that
plan to submit applications for grants or proposals for contracts. The course
is intended for new staff or staff inexperienced with HHS grant and contract
activities.
DATES AND LOCATIONS
April 2-3, 1991, 8:30 am - 5:00 pm; Rockville, MD
June 10-11, 1991; 8:30 am - 5:00 pm; Atlanta, GA (historically black
colleges and universities only)
August 19-20, 1991; 8:30 am - 5:00 pm; Boston, MA
COURSE OUTLINE
o Introduction to HHS Assistance (grants/cooperative agreements) and
Acquisition (contracts): HHS Mission and Organizational Structure;
Assistance vs. Acquisition (The Federal Grant and Cooperative
Agreement Act); HHS Grant and Contract Expenditures and Recipients;
Introduction to Types and Purposes of HHS Grants; Roles of HHS
Grants and Program Management Staffs.
o Seeking and Applying for HHS Grants/Cooperative Agreements:
Sources of Information; Understanding Program Announcements; The
application Package; The Complete, Effective Application;
Competition and Objective Review.
o Negotiation and Award Process for Grants/Cooperative Agreements:
Cost Analysis and Pre-Award Review; Negotiating-- Clarifying and
Revising Proposed Activities; Contents of a Grant Award Document;
Funding Outcomes; General and Special Conditions.
o Grant/Cooperative Agreement Post-Award Issues and Concerns:
Monitoring; Audit; Appeals; Progress Reports; Drawdowns; Financial
Status Reports; Grant Budget Control; Cost Principles and
Unallowable Costs; Purchasing; Property Management.
o Seeking HHS Contracts: Identifying HHS Contracting Opportunities;
The Legal Framework of HHS Contracting; Small Business Contracting
Programs; Roles of HHS Contracting and Project Staffs.
o Responding to Contract Solicitations: Small Purchases-$25,000 or
less; Purchases Greater Than $25,000; Preparing the Technical
Proposal; Preparing the Business Proposal.
o Proposal Submittal, Contract Negotiation, and Award: Proposal
Submission and Evaluation; Negotiation and Award.
NIH GUIDE - Vol. 20, No. 5, February 1, 1991 - Page 4
o Contract Administration: Initial Contract Administration Steps;
Significant Contract Administration Concerns.
CLASS SIZE: Limited to 25 participants per session to maximize interaction.
ATTENDANCE: Those accepted will be expected to attend the entire session,
both full days of the course.
COST: There will be no charge for this course. Travel and accommodations
will be the responsibility of participants. Details on exact location of
courses and suggested accommodations will be provided to those persons
selected.
TO APPLY: On employing organization's letterhead, submit a letter that
provides the following information:
Name of applicant
Employing organization: name, address, and telephone number
Position of applicant
Years of experience in grants, contracts, or both
Principal area of interest (grants, contracts, or both)
Reason for wanting to take this course (100 words or less)
Course session desired
APPLICATION DEADLINES
Selection will be made on a first-come, first-served basis. Only one nominee
will be selected per institution, per session, unless vacancies occur.
SEND APPLICATION TO
Training Coordinator
Grants Policy Branch
Division of Grants and Contracts
Office of the Assistant Secretary for Health
Parklawn Building, 5600 Fishers Lane, Room 17A45
Rockville, MD 20857
Applicants will be notified as to their acceptance or nonacceptance for this
course.
SALARY LIMITATION ON GRANTS AND CONTRACTS
P.T. 34; K.W. 1014006
National Institutes of Health
Alcohol, Drug Abuse, and Mental Health Administration
The purpose of this notice is to inform grant applicants and contract offerors
of the Congressionally-mandated salary limitation provision for the second
consecutive year.
Section 213 of the Appropriations Act of the Department of Health and Human
Services for fiscal year (FY) 1991 (October 1, 1990-September 30, 1991)
(Public Law 101-517) restricts the amount of direct salary of an individual
under a grant or contract award issued by the National Institutes of Health
(NIH) and the Alcohol, Drug Abuse, and Mental Health Administration (ADAMHA)
to a RATE of $120,000 per year. This requirement is the same as it was for FY
1990. (See NIH GUIDE FOR GRANTS AND CONTRACTS, Vol. 19, No. 3, January 19,
1990.)
NIH and ADAMHA will apply the restriction to all grant and contract awards and
to all funding amendments to existing grants and contracts made during FY 1991
and with FY 1991 funds. The salary limitation applies to amounts permitted to
be INCLUDED in grant and contract awards as well as amounts allowed to be
CHARGED to those awards.
However, an individual's institutional salary, per se, is NOT constrained by
this legislative provision.
NIH and ADAMHA grant and contract awards that indicate direct salaries of
individuals in excess of a RATE of $120,000 per year will include an
appropriate notification, such as:
According to the Appropriations Act, "None of the funds
appropriated in this title for the National Institutes of Health
and the Alcohol, Drug Abuse, and Mental Health Administration shall
NIH GUIDE - Vol. 20, No. 5, February 1, 1991 - Page 5
be used to pay the salary of an individual, through a grant or
other extramural mechanism, at a rate in excess of $120,000 per
year." The application/proposal for this project proposed a salary
at a rate greater than $120,000 per year. This award has been
reduced accordingly.
Grant applications and contract proposals submitted to the NIH and ADAMHA
should continue to request funding at the regular rates of pay of all
individuals for whom reimbursement is requested. NIH and ADAMHA will make
downward adjustments of direct salary amounts in excess of the ceiling rate
and fringe benefits based upon the budget approved as part of the original
award. Corresponding indirect costs will also be adjusted.
Following is an EXAMPLE of this process:
Individual's institutional base salary per year $150,000
Research effort requested on grant application
or contract proposal 50%
Direct salary requested $ 75,000
Fringe benefits requested (25% of salary) $ 18,750
Applicant organization's indirect costs rate 47%
Amount requested - salary plus fringe benefits
plus associated indirect costs $137,813
If a grant/contract is to be awarded, the amount included
in the award for the above individual will be calculated
as follows:
Direct salary - restricted to RATE of $120,000 times
effort (50%) to be devoted to project $ 60,000
Fringe benefits (25% of allowable salary) 15,000
Subtotal $ 75,000
Associated indirect costs at 47% of subtotal 35,250
Total amount included due to salary limitation $110,250
Amount of reduction due to salary limitation
($137,813 requested minus $110,250 awarded) $ 27,563
Grantee and contractor organizations are reminded of these important points:
o The salary limitation provision does NOT apply to payments made to
consultants under an NIH or ADAMHA grant or contract (however, as
with all costs, such payments must continue to meet the test of
reasonableness).
o The salary limitation provision DOES apply to those
subawards/subcontracts for substantive work under an NIH or ADAMHA
grant or contract.
o Unobligated funds from a prior grant/contract period "carried over"
INTO a FY 1991 award period ARE subject to the salary limitation
provision.
o In a noncompeting continuation application (type 5) setting, a
grantee organization is NOT permitted to either (1) redistribute an
amount of "excess" salary among other budget categories nor (2)
increase the Principal Investigator's effort on the project, in an
attempt to apply for the full level of funding as previously
recommended by the peer review process.
PUBLIC HEALTH SERVICE POLICY RELATING TO DISTRIBUTION OF UNIQUE RESEARCH
RESOURCES PRODUCED WITH PHS FUNDING
P.T. 36; K.W. 0780010
Public Health Service
This announcement is a revision of the one last appearing in the NIH Guide for
Grants and Contracts on September 16, 1988, Vol. 17, No. 29, pages 1 and 2.
This revised notice contains a number of changes in policy that the agencies
of the Public Health Service (PHS) have determined should be implemented.
Investigators conducting biomedical research frequently develop unique
research resources. Categories of these resources include: synthetic
compounds, organisms, cell lines, viruses, cell products, cloned DNA, as well
as DNA sequences, mapping information, crystallographic coordinates, and
spectroscopic data. Some specific examples are: specialized and/or
genetically defined cell lines, including normal and diseased human cells;
NIH GUIDE - Vol. 20, No. 5, February 1, 1991 - Page 6
monoclonal antibodies; hybridoma cell lines; microbial cells and products;
viruses and viral products; recombinant nucleic acid molecules; DNA probes;
nucleic acid and protein sequences; certain types of animals such as
transgenic mice; and intellectual property such as computer programs. The PHS
provides the following statement of policy concerning unique research
resources developed through PHS awards.
A. Policy on Distribution of Research Resources.
The policy of the PHS is to make available to the public the results and
accomplishments of the activities that it funds. Restricted availability of
unique resources upon which further studies are dependent can impede the
advancement of research and the delivery of medical care. Therefore, when
these resources are developed with PHS funds and the associated research
findings have been published or after they have been provided to the agencies
under contract, it is important that they be made readily available for
research purposes to qualified individuals within the scientific community.
This policy applies to PHS intramural investigators as well as extramural
scientists funded by PHS grants, cooperative agreements, and contracts.
Because of concern that some crystallographers are not making their
coordinates available promptly (see Science, Vol. 245, p. 1179), one of the
national advisory councils of the NIH and the executive committee of another
institute recently adopted resolutions affirming the policy of the
International Union of Crystallographers (IUCr) (Acta Cryst., A45: 658,
1989). The PHS has now adopted the IUCr policy that includes data from
publications based on spectroscopic data such as nuclear magnetic resonance as
well as crystallographic coordinates.
The PHS encourages investigators who have such resources to consult the
appropriate Program Administrators who may be of assistance in determining a
suitable distribution mechanism. Such a mechanism should take into
consideration all applicable Federal regulations including, but not limited
to: those regarding human subjects, animal welfare, and use and handling of
hazardous materials, where applicable. Investigators requesting materials
should provide evidence of having the proper training, experience, and
facilities to make use of the items they request. Program staff of the
agencies will be available to assist in verification of credentials of
requesters where such concern exists on the part of suppliers.
Investigators who believe that they will be unable to implement this policy
should promptly contact the appropriate PHS Program Administrator to discuss
the circumstances, obtain information that might facilitate compliance with
the policy, and reach an understanding in advance of the subsequent award.
For research and development contracts, approval should be obtained from the
PHS Contracting Officer before distribution of unique resources, unless the
terms of the contract permit distribution without prior clearance of the
Contracting Officer. In order to facilitate the availability of unique or
novel biological materials and resources developed with PHS funds,
investigators may distribute the materials through their own laboratory or
institution or submit them, if appropriate, to entities such as the American
Type Culture Collection or other repositories. In the case of unique
biological information, such as DNA sequences or crystallographic coordinates,
investigators are expected to submit them to the appropriate data banks
because they otherwise are not truly accessible to the scientific community.
When distributing unique resources, investigators are to include pertinent
information on the nature, quality, or characterization of the materials.
Investigators must exercise great care to ensure that resources involving
human cells or tissues do not identify original donors or subjects, directly
or through identifiers, such as codes linked to the donors or subjects.
The goals of some programs, e.g., the Human Genome Program, are such that
applicants for certain projects may be required to provide plans for the
sharing of data and materials. These plans will undergo review by program
staff and the national advisory council prior to award.
B. Distribution Costs
Institutions and investigators may charge the requester, if necessary, for the
reasonable cost of production of unique biological materials, and for
packaging and shipping, Such costs may include labor, supplies, and other
directly related expenses. Investigators should note, however, that such a
charge accrues as general program income. This should not be an impediment to
the distribution of materials, but investigators and institutions are advised
that:
NIH GUIDE - Vol. 20, No. 5, February 1, 1991 - Page 7
a) for grants, the income is governed by 45 CFR Part 74 and it must be
reported on the Financial Status Report. Questions regarding these
policies and the treatment of income should be directed to the
Grants Management Officer.
b) for contracts, the income is governed by Federal Acquisition
Regulations (FAR) 45.610-3. Contracting Officers must be contacted
before generating any revenues from the distribution of materials.
Any contract under which research resources would be sold require
specific contract instructions. Existing contracts may require an
amendment and specific approval of the Contracting Officer to
render them allowable.
C. Inventions and Commercialization
Federal policy encourages the commercialization of the products of research
developed as a consequence of Federal funding; therefore, the intent of this
policy is to not discourage, impede, or prohibit the organization that
develops unique research resources or intellectual property from
commercializing the products. Investigators may make their materials
available to others for commercial purposes with appropriate restrictions and
licensing terms as they and their institution deem necessary.
Institutions are reminded that some of these products may be inventions
subject to the various laws and regulations applicable to patents and must be
reported to the Extramural Inventions Reports Office of the NIH. The terms
for licensing of unpatented research products, such as cell lines, monoclonal
antibodies, and other materials and products, should generally be no more
restrictive than would have been the case had they been patented -- for
example, only if there is full public disclosure of the invention/discovery,
availability through a repository, and written agreement to end all fees and
constraints after 17 years. When reporting is required, it should occur at
the earliest possible time. (See 37 CFR 401 and NIH Guide for Grants and
Contracts, Vol. 19, No. 6, February 9, 1990, page 2).
NOTICES OF AVAILABILITY (RFPs AND RFAs)
EVALUATION OF VACCINE PROPHYLAXIS AGAINST INFECTIOUS DISEASES IN CHILDREN
RFP AVAILABLE: NIH-NIAID-DMID-91-33
P.T. 34; K.W. 0740075, 0715125, 0770005
National Institute of Allergy and Infectious Diseases
The Respiratory Diseases Branch, Division of Microbiology and Infectious
Diseases, National Institute of Allergy and Infectious Diseases (NIAID),
requires a dedicated Pediatric Vaccine Prophylaxis against Infectious Diseases
in Children. The Institute has supported efforts to evaluate control measures
for infectious diseases during the past decade and supports Vaccine and
Treatment Evaluation Units (VTEUs) to facilitate these efforts. These VTEUs
have undertaken Phase I and Phase II clinical trials of bacterial and viral
vaccines, other biologicals, and drugs as preventative and therapeutic
measures against infectious diseases in people of all ages. With the
accelerated development of new vaccines, particularly bacterial vaccines,
against infectious diseases in children, the Institute wants to support a
dedicated Pediatric Vaccine Evaluation Unit (PVEU). The major emphasis of the
PVEU will be Phase I and Phase II evaluation of candidate bacterial vaccines
in infants and children. The Contractor must have demonstrated experience in
the clinical evaluation of vaccines and have demonstrated capacity to organize
and administer a clinical study.
This NIAID-sponsored project will take approximately five (5) years to
complete. A Cost Reimbursement Level of Effort contract is anticipated and
one award will be made. This is an announcement for an anticipated Request
for Proposals (RFP). RFP-NIH-NIAID-DMID-91-33 shall be issued on or about
February 4, 1991, with a closing date tentatively set for March 29, 1991.
Requests for the RFP must be directed in writing to:
Paul D. McFarlane
Contract Management Branch
National Institute of Allergy and Infectious Diseases, NIH
Control Data Building, Room 326P
6003 Executive Boulevard
Rockville, MD 20852
NIH GUIDE - Vol. 20, No. 5, February 1, 1991 - Page 8
To receive a copy of the RFP, please supply this office with two
self-addressed mailing labels. All responsible sources may submit a proposal
that will be considered. All requests must be in writing. This advertisement
does not commit the Government to award a contract.
EVALUATION OF CONTROL MEASURES AGAINST INFECTIOUS DISEASES OTHER THAN AIDS
RFP AVAILABLE: NIH-NIAID-DMID-92-1
P.T. 34; K.W. 0795003, 0715125
National Institute of Allergy and Infectious Diseases
The Enteric Diseases Branch, Division of Microbiology and Infectious Diseases,
National Institute of Allergy and Infectious Diseases, has a requirement for a
Vaccine and Treatment Evaluation Unit (VTEU). This VTEU will conduct Phase I
and Phase II Clinical Trials to evaluate candidate vaccines and other
prophylactic/therapeutic measures for infectious diseases other than AIDS. A
VTEU provides volunteer populations, staff, facilities, and expertise to carry
out such work that includes follow-up and focused surveillance. A variety of
vaccine types (live, attenuated, inactivated, subunit, conjugated) for
prevention of viral and bacterial illnesses are expected.
This announcement is for recompetition of contract No. N01-AI-72629 currently
held by the Baylor College of Medicine. The issuance of the Request for
Proposals (RFP) will be on or about February 6, 1991, and proposals will be
due by the close of business on April 3, 1991. One (1) award is anticipated,
and it is expected that the resultant contract will be funded over a period of
five years. Any responsible offeror may submit a proposal that will be
considered by the Government.
To receive a copy of RFP-NIH-NIAID-DMID-92-1, please supply this office with a
written request, citing the RFP number together with two self-addressed
mailing labels addressed to:
Mr. Thomas C. Porter
Contracting Officer
National Institute of Allergy and Infectious diseases
Contract Management Branch
Control Data Building, Room 326P
6003 Executive Boulevard
Bethesda, MD 20892
This advertisement does not commit the Government to make an award.
MATERNAL IMMUNIZATION FOR THE PREVENTION OF INFECTIOUS DISEASES IN NEONATES
AND INFANTS
RFP AVAILABLE: NIH-NIAID-DMID-91-32
P.T. 34; K.W. 0740075, 0775020, 0745027, 0715125, 0403020
National Institute of Allergy and Infectious Diseases
The National Institute of Allergy and Infectious Diseases (NIAID) has a
requirement to evaluate maternal immunization for prophylaxis against
infectious diseases in neonates and infants.
This NIAID-sponsored project will take approximately five (5) years to
complete. A cost-reimbursement contract is anticipated. It is anticipated
that one to two awards will be made.
This is an announcement for an anticipated Request for Proposal (RFP).
RFP-NIH-DMID-91-32 shall be issued on or about February 1, 1991, with a
closing date tentatively set for April 1, 1991.
Requests for the RFP shall be directed in writing to:
John M. O'Brien
Contract Management Branch
6003 Executive Boulevard
Control Data Building, Room 326P
National Institute of Allergy and Infectious Diseases
National Institutes of Health
Bethesda, MD 20892
Telephone: (301) 496-0195
NIH GUIDE - Vol. 20, No. 5, February 1, 1991 - Page 9
To receive a copy of this RFP, please supply this office with two (2)
self-addressed labels. All responsible sources may submit a proposal that
will be considered.
This advertisement does not commit the Government to award.
DEVELOPMENT OF MODELS FOR PEDIATRIC AIDS
RFA AVAILABLE: AI-91-04
P.T. 34; K.W. 0715008, 0755020, 0770005
National Institute of Allergy and Infectious Diseases
Letter of Intent Receipt Date: March 11, 1991
Application Receipt Date: April 22, 1991
The National Institute of Allergy and Infectious Diseases (NIAID) is playing a
central role in the investigation of methods to treat the Acquired
Immunodeficiency Syndrome (AIDS). The disease that occurs in the pediatric
population infected with the human immunodeficiency virus (HIV) is different
from that occuring in adults. Animal models of fetal and neonatal infection
with lentiviruses related to HIV are needed to study aspects of HIV infection
and therapeutic approaches unique to the pediatric population.
OBJECTIVES AND SCOPE
NIAID invites applications for individual research project (RO1) grants to
develop animal models and in vitro models for pediatric HIV infection and
disease. Research considered responsive to this Request for Applications
(RFA) will develop and use (i) an in vitro model of infection of placenta with
HIV suitable for examining the regulation and pathogenesis of HIV and for
identifying unique targets for new therapies; and/or (ii) an animal model of
transmission of virus, studying transplacental transport of virus or infected
cells, the mechanisms of infection and targets for therapies; and/or (iii) an
animal model of lentivirus infection of fetal or neonatal animals for studying
the pathogenesis of the virus, development of disease, and the action of
therapies; and/or (iv) an animal model, using a lentivirus or relevant
retrovirus, to define the viral and/or cellular factors that effect
transplacental infection and that represent potential targets for new
therapies. Investigators should plan to apply the models described above to
the design and evaluation of anti-HIV therapies to prevent or interrupt the
transmission of HIV from mother to offspring. In addition, use of HIV or a
lentivirus such as the simian immunodeficiency virus is preferred. Use of
other retroviruses may be considered responsive IF there is evidence presented
that it models HIV disease closely. Research plans to (i) solely evaluate
various compounds for their ability to cross the placenta in an animal model,
(ii) evaluate vaccine-related therapies or immune responses, (iii) develop or
use models using MuLV retroviruses, or (iv) develop or use transgenic models
or models in which virus is injected directly into the fetus as a model of
transmission are not considered responsive to this announcement.
MECHANISM OF SUPPORT
This RFA will use the R01 grant mechanism. The NIAID has allocated $1,000,000
(total costs) for the initial year of funding applications received in
response to this RFA. It is anticipated that three to five applications will
be funded. The award of grants pursuant to this RFA is contingent upon the
continuing availability of funds for this purpose and upon receipt of a
sufficient number of applications of high scientific merit.
This RFA is a one-time solicitation. Generally, future unsolicited competing
continuation applications will compete with all investigator-initiated
applications and be reviewed by a Division of Research Grants study section.
However, if the NIAID determines that there is a sufficient continuing program
need, the NIAID may announce a request for renewal applications.
APPLICATION SUBMISSION
Eligibility: Any domestic or foreign institution, university, medical
college, hospital, and laboratory or other public, private, or for-profit
institution is eligible.
Letter of Intent: Prospective applicants are asked to submit by March 11,
1991, a letter of intent that includes a descriptive title and a description
(not to exceed one page) of the proposed research.
NIH GUIDE - Vol. 20, No. 5, February 1, 1991 - Page 10
Submission: The regular research grant application form PHS-398 (rev. 10/88)
must be used in applying. To identify responses to this announcement, check
"yes" and type the RFA number and title [RFA AI-91-04, DEVELOPMENT OF MODELS
FOR PEDIATRIC AIDS] in item 2 on page 1 of the grant application. The RFA
label provided with the instructions must be affixed to the bottom of the face
page. Failure to use this label could result in delayed processing of your
application such that it may not reach the review committee in time for
review.
The completed original application and twenty three (23) copies must be mailed
to:
Division of Research Grants
National Institute of Health
Westwood Building, Room 240
Bethesda, MD 20892**
Applications must be received by April 22, 1991. Awards will be based on
scientific merit and the uniqueness of the proposed project. Funding around
September 30, 1991, is anticipated.
INQUIRIES
A more detailed RFA may be obtained from:
Polly R. Sager, Ph.D
Developmental Therapeutics Branch
Division of AIDS, NIAID, NIH
6003 Executive Boulevard, Room 244P
Bethesda, MD 20892
Telephone: (301) 496-0636
FAX: (301) 480-5703
DEVELOPMENT OF MODELS FOR PLACENTAL AND PEDIATRIC METABOLISM, TOXICITY, AND
TRANSPORT OF anti-HIV DRUGS
RFA AVAILABLE: AI-91-05
P.T. 34; K.W. 0785170, 0715008, 0740012, 1007009, 0755025
National Institute of Allergy and Infectious Diseases
Letter of Intent Receipt Date: March 11, 1991
Application Receipt Date: April 22, 1991
The National Institute of Allergy and Infectious Diseases (NIAID) is playing a
central role in the investigation of methods to treat the Acquired
Immunodeficiency Syndrome (AIDS). Children born to HIV-positive mothers and
HIV-infected women are now the fastest growing populations of AIDS patients.
Traditionally, new therapies were available to children and pregnant women
only after extensive clinical experience in other adult populations. Because
of the magnitude and severity of the AIDS epidemic, therapies are now being
tested in children and pregnant women early in clinical development. Animal
and in vitro models are needed to assess the metabolism and transport of AIDS
therapies in the placenta, fetus, and neonate. In addition, the mechanisms of
toxicity of therapeutics to the placenta, fetus, and neonate must be examined.
This information is critical to facilitate the design of clinical evaluations
in HIV-positive pregnant women and their children.
OBJECTIVES AND SCOPE
NIAID invites applications for individual research project (RO1) grants to
develop and use: (i) in vitro models to assess the metabolism, transport, and
mechanisms of toxicity of anti-AIDS therapies in the placenta; (ii) animal
models to assess the transplacental transport of AIDS therapies and to
determine pharmacokinetics parameters to serve as the basis for clinical
trials in humans; (iii) animal models to assess the metabolism and
distribution of AIDS therapies in the fetus and neonatal animals to serve as
the basis for clinical trials in humans; (iv) animal models to assess
mechanisms of toxicity relevant to use of drugs in pregnant women and very
young infants. The emphasis should be on issues of pharmacology and toxicity
that are specific to the use of AIDS therapies in pregnant women and children
born to HIV-positive women. Animal models should be those where placental
function or structure or developmental patterns most closely model humans.
The Developmental Therapeutics Branch of the Division of AIDS will assist in
identifying and providing therapeutic agents to be studied and, where
possible, analytical methods for detection of drugs. Research plans to
NIH GUIDE - Vol. 20, No. 5, February 1, 1991 - Page 11
evaluate standard teratology, reproductive toxicology, or pharmacokinetics in
rodents are not considered responsive to this announcement.
MECHANISM OF SUPPORT
This Request for Applications (RFA) will use the R01 grant mechanism. The
NIAID has allocated $1,000,000 (total costs) for the initial year of funding
applications received in response to this RFA. It is anticipated that three
to five applications will be funded. The award of grants pursuant to this RFA
is contingent upon the continuing availability of funds for this purpose and
upon receipt of a sufficient number of applications of high scientific merit.
This RFA is a one-time solicitation. Generally, future unsolicited competing
continuation applications will compete with all investigator-initiated
applications and be reviewed by a DRG study section. However, should the
NIAID determine that there is a sufficient continuing program need, the NIAID
may announce a request for renewal applications.
APPLICATION SUBMISSION
Eligibility: Any domestic or foreign institution, university, medical
college, hospital, and laboratory or other public, private or for-profit
institution is eligible.
Letter of Intent: Prospective applicants are asked to submit, by March 11,
1991, a letter of intent that includes a descriptive title and a description
(not to exceed one page) of the proposed research.
Submission: The research grant application form PHS-398 (rev. 10/88) must be
used in applying. To identify responses to this announcement, check "yes" and
type the RFA number and title [RFA AI-91-05, DEVELOPMENT OF MODELS FOR
PLACENTAL AND PEDIATRIC METABOLISM, TOXICITY, AND TRANSPORT OF anti-HIV DRUGS
in item 2 on page 1 of the grant application. The RFA label provided with the
instructions must be affixed to the bottom of the face page. Failure to use
this label could result in delayed processing of your application such that it
may not reach the review committee in time for review.
The completed original application and twenty three (23) copies must be mailed
to:
Application Receipt Office
Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD 20892**
Applications must be received by April 22, 1991. Awards will be based on
scientific merit and the uniqueness of the proposed project. Funding around
September 30, 1991, is anticipated.
INQUIRIES
A more detailed RFA may be obtained from:
Polly R. Sager, Ph.D
Developmental Therapeutics Branch
Division of AIDS, NIAID, NIH
6003 Executive Boulevard
Bethesda, MD 20892
Telephone: (301) 496-0636
FAX: (301) 480-5703
The full RFA is also available in the electronic version of the NIH Guide for
Grants and Contracts, the E-Guide.
HIV IN MOTHERS AND INFANTS: IMMUNITY AND EARLY DIAGNOSIS
RFA AVAILABLE: AI-91-06
P.T. 34; K.W. 0715008, 0775020, 0403020, 0710070
National Institute of Allergy and Infectious Diseases
Letter of Intent Receipt Date: March 15, 1991
Application Receipt Date: May 7, 1991
NIH GUIDE - Vol. 20, No. 5, February 1, 1991 - Page 12
PURPOSE: Transmission of the acquired immunodeficiency symdrome (AIDS) virus
to infants occurs in about 20-35 percent of children born of human
immunodeficiency virus-1 (HIV-1) infected mothers. Recent studies suggest
that protective immunity may exist in some mothers that can interrupt viral
transmission to the infant. In addition, preliminary data suggest that there
may be cell-mediated immunity against HIV in infants of infected mothers.
There is a pressing need to determine if an immune response on the part of
either mother or infant can protect the infant from intrauterine or perinatal
infection and/or predict which babies are infected.
RESEARCH OBJECTIVES: Applications are invited that seek to develop innovative
techniques for diagnosis prior to eight weeks of age and/or to determine the
factors that influence perinatal transmission in order to design potential
vaccines and immune-based therapy of infected mothers and/or their infants.
Approaches to this question may include, but are not limited to, the
following:
o Identify in pregnant women the correlates of immunity that appear
to be protective for their infants, particularly in relationship to
the quantity and quality of virus infecting the mother, including
humoral and cell-mediated immune responses.
o Compare immune reactions to HIV-1 of infected and uninfected
infants (less than eight weeks of age) born of HIV-infected
mothers, including, but not limited to, humoral immunity,
cell-mediated immunity, and identification and assessment of
maternally derived cells in infants.
o Develop and evaluate novel methods for early diagnosis during
gestation and in infants less than eight weeks of age by means
including, but not limited to, reliable and practical immunologic,
virologic, and molecular-biologic techniques, safe and reliable
methods for prenatal diagnosis of HIV infection, and evaluation of
the timing and frequency of HIV transmission from mother to
offspring during gestation and the intrapartum period.
Collaboration between scientists and/or institutions is encouraged but not
required for response to this announcement. Access to a patient population
and, if appropriate, a pre-existing sample collection that is sufficient to
allow evaluation of hypotheses must be demonstrated. The use of funds from
these grants to support the actual conduct of clinical trials will be judged
nonresponsive, but plans for immunologic and virologic assessment of samples
from women and infants enrolled in epidemiology or therapy trials that are
supported by other funds are encouraged.
SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL
RESEARCH STUDIES
The following is a brief statement of the NIH and ADAMHA policy regarding the
inclusion of women and minorities in study populations. Applications that are
responsive to this RFA will, by definition, meet the requirement for inclusion
of women. The inclusion of minorities must be addressed in application
submitted responding to this RFA.
For projects involving clinical research, NIH requires applicants to give
special attention to the inclusion of women and minorities in study
populations. If women or minorities are not included or adequately
represented in the study populations for clinical studies, a specific
justification must be provided. Applications without such documentation will
not be accepted for review.
MECHANISM OF SUPPORT
This RFA will use the R01 mechanism. The NIAID has allocated $3,000,000
(total costs) for the initial year of funding applications received in
response to this RFA, with the relative level of support between epidemiologic
and immunologic studies to be determined by Program Staff. The number of
awards to be made is dependent upon receipt of a sufficient number of
applications of high scientific merit and upon the availability of funds. The
earliest possible award date is September 27, 1991. If NIAID determines that
there is a sufficient continuing program need, this RFA will be reissued.
APPLICATION SUBMISSION
Eligibility: Any domestic or foreign institution, university, medical
college, hospital, laboratory or other public, private or for-profit
institution is eligible.
NIH GUIDE - Vol. 20, No. 5, February 1, 1991 - Page 13
Letter of Intent: Prospective applicants are asked to submit, by March 15,
1991, a letter of intent that includes a descriptive title and a description
(not to exceed one page) of the proposed research. Since applications that do
not address areas of program relevance will be considered nonresponsive,
potential applicants are strongly encouraged to discuss their research plans
with program staff before completing their applications.
Submission: The regular research grant application form PHS-398 (rev. 10/88)
must be used in applying. These forms are available at most institutional
business offices and from the Division of Research Grants, NIH, 9000 Rockville
Pike, Westwood Building, Room 449, Bethesda, Maryland 20892. To identify
responses to this announcement, check "yes" and put "HIV IN MOTHERS AND
INFANTS: IMMUNITY AND EARLY DIAGNOSIS (RFA AI-91-06)" under item 2 on page 1
of the grant application. The RFA label provided with the instructions must
be affixed to the bottom of the face page. Failure to use this label could
result in delayed processing of your application so that it may not reach the
review committee in time for review.
The completed original application and twenty three (23) copies must be mailed
to:
Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD 20892**
INQUIRIES: A more detailed RFA may be obtained from:
Patricia E. Fast, M.D., Ph.D. OR Rodney Hoff, M.D., M.P.H.
Vaccine R. and D. Branch Epidemiology Branch
Division of AIDS, NIAID, NIH DAIDS. NIAID, NIH
6003 Executive Blvd., Rm. 203E 6003 Executive Blvd., Rm. 241P
Bethesda, MD 20892 Bethesda, MD 20892
Telephone: (301) 496-8200 Telephone: (301) 496-6177
ANIMAL MODELS FOR SUDDEN INFANT DEATH SYNDROME
RFA AVAILABLE: HD-91-05
P.T. 34; K.W. 0755020, 0715205
National Institute of Child Health and Human Development
Application Receipt Date: May 15, 1991
PURPOSE
The National Institute of Child Health and Human Development (NICHD) is
interested in expanding the scope of research conducted into the causes and
pathologic mechanisms of Sudden Infant Death Syndrome (SIDS). In this
solicitation, the NICHD invites applications for studies using fetal and/or
young developing animals to elucidate environmental factors and developmental
mechanisms during pregnancy and early postnatal life that predispose the young
animal to a SIDS-like event, (i.e., sudden death during a sleep period), or
the inability to recover from hypoxic or other life-threatening stresses.
Information derived from these animal studies is expected to elucidate
potential mechanisms of SIDS under experimental conditions unavailable in
human infants and lead to the development of diagnostic and preventive
strategies.
The Public Health Service is committed to achieving the health promotion and
disease prevention objectives of Healthy People 2000, a PHS-led national
activity. This Request for Applications (RFA), "Animal Models for SIDS", is
related to the priority area of "Maternal and Infant Health".
RESEARCH OBJECTIVES
The primary goals of this RFA are to support research investigations in intact
animals or reduced preparations to examine the effects of relevant prenatal
insults on the development and function of state-dependent regulatory and
life-sustaining systems in infancy; to examine the effects of postnatal
environmental challenges, i.e., insults or new stimuli; and/or to investigate
animal model systems of developmental disorders/susceptibilities that mimic
some aspects of the SIDS phenotype. In the context of these investigations,
parallel studies of unperturbed development and function may be proposed. The
extent of the normative studies should depend on the existing knowledge base.
NIH GUIDE - Vol. 20, No. 5, February 1, 1991 - Page 14
Developmental studies that span the fetal and early postnatal period are
encouraged.
MECHANISM OF SUPPORT
This program will be funded through the traditional individual research grant
award program of NICHD. Grant applications will be reviewed at a single
competition by an initial review group convened by NICHD. It is anticipated
that eight (8) grants will be awarded under this program, contingent upon
receipt of a sufficient number of meritorious applications and the
availability of funds.
APPLICATION PROCEDURES
Applications must be submitted on Form PHS 398 (revised 10/88), available in
business or grants offices at most academic research institutions and from the
Division of Research Grants, NIH. The RFA label available in the 10/88
revision of Application Form 398 must be affixed to the bottom of the face
page. Failure to use this label could result in delayed processing of your
application such that it may not reach the review committee in time for
review. The phrase "ANIMAL MODELS SIDS APPLICATIONS, RFA HD-91-05" must be
typed in item 2 of the face page of the application.
INQUIRIES
Applicants may request a copy of the full RFA from:
Marian Willinger, Ph.D.
Health Scientist Administrator
Pregnancy and Perinatology Branch
Center for Research for Mothers and Children
National Institute of Child Health and Human Development
Executive Plaza North, Room 643
Bethesda, MD 20892
Telephone: (301) 496-5575
The full RFA is also available on the electronic version of the NIH Guide, the
E-Guide.
Inquiries regarding grants management and administrative policy may be
directed to:
Douglas Shawver
Supervisory Grants Management Specialist
Grants Management Branch
Office of Grants and Contracts
National Institute of Child Health and Human Development
Executive Plaza North, Room 505
Bethesda, MD 20892
Telephone: (301) 496-1303
INTERVENTIONS TO PROMOTE APPLICATION OF STATE-OF-THE-ART CANCER MANAGEMENT IN
RURAL AREAS
RFA AVAILABLE: CA-91-05
P.T. 34; K.W. 0715035, 0403004
National Cancer Institute
Letter of Intent Receipt Date: March 20, 1991
Application Receipt Date: May 20, 1991
INTRODUCTION
The National Cancer Institute (NCI) invites applications for research projects
aimed at strengthening the application of state-of-the-art cancer diagnosis
and management practices in rural areas by enhancing links between rural
health care providers and regional cancer specialists. The researchers are to
test methods thath enhance the utilization of existing cancer expertise and
resources by rural providers. The development and evaluation of interventions
that are sensitive to the cancer problems in a selected rural area and are
supported by rural practitioners are important. Researchers are encouraged to
be innovative in the development of interventions. Outcomes should be
designed to capture changes in cancer diagnosis and management.
NIH GUIDE - Vol. 20, No. 5, February 1, 1991 - Page 15
BACKGROUND AND PURPOSE
To date, the treatment programs of the NCI have been designed to conduct
state-of-the-art cancer treatment research through a network of cancer
specialists in university centers and community programs. With this
initiative, the NCI strives to reach practitioners who provide care in rural
communities and link them with cancer specialists. Such ties are critical to
assuring that patients in rural and remote areas have access to the full range
of state-of-the-art cancer care.
RESEARCH GOALS AND SCOPE
The purpose of the project is to test ways of enhancing links between rural
health care providers and cancer specialists. The NCI expects the
interventions to be designed to strengthen associations between the rural
generalist providers and regional cancer specialists, and may include targeted
training, visiting specialists, and/or clinical trials participation.
Evaluation should address indicators of changes in cancer diagnosis and
management practices and efficiency of the intervention.
Based on the characteristics of the health care providers and the patients in
the rural area in which the research is to be conducted, the researchers are
to test approaches to link rural providers and cancer specialists to enhance
state-of-the-art cancer management practices of physicians and nurses in the
selected rural area. The interventions should incorporate, as appropriate,
established resources of the NCI, specifically the Cancer Information Service
(CIS) or the Physicians' Data Query (PDQ) or Cancer FAX. Examples of possible
interventions include:
o review of screening and/or biopsy specimens;
o computer-assisted diagnosis and/or management algorithms;
o free telephone consultation between cancer specialist and
generalist provider;
o PDQ protocols for patient management with specialist consultation
available; and
o telephone hot-line service for consultation.
The research design should consider both process and health outcome measures
as appropriate. The researchers are to focus the intervention on aspects of
current cancer patient management that are well described in the baseline
data. For example, a pattern of head and neck cancer diagnosis at stages III
and IV or the lack of appropriate adjuvant chemotherapy for breast cancer
could be the focus.
While mortality rate changes may be sought, NCI realizes that the research
design may not have the power to discern such changes. An outcome of interest
is the stage of cancer at diagnosis and the proportion of patients who receive
state-of-the-art cancer management in the target rural area. Changes in
practice are extremely important to document, as well as evaluation of the
implementation techniques. Numerous direct and indirect indicators are
possible.
SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL
RESEARCH STUDIES
For projects involving clinical research, NIH requires applicants to give
special attention to the inclusion of women and minorities in study
populations. If women or minorities are not included or adequately
represented in the study populations for clinical studies, a specific
justification for this exclusion or inadequate representation must be
provided. Applications without such documentation will not be accepted for
review.
LETTER OF INTENT
Prospective applicants are asked to submit, by March 20, 1991, a letter of
intent that includes a descriptive title of the proposed research, the name
and address of the Principal Investigator, the names of other key personnel,
the participating institutions, and the number and the title of the RFA in
response to which the application is being submitted.
Although a letter of intent is not required, is not binding, and does not
enter into the review of subsequent applications, it is requested in order to
provide an indication of the number and scope of applications to be reviewed.
NIH GUIDE - Vol. 20, No. 5, February 1, 1991 - Page 16
The letter of intent should be sent to:
Anne R. Bavier, M.N., F.A.A.N.
Program Director, CORB, EDCOP, DCPC
National Cancer Institute
Executive Plaza North, Room 300-E
Bethesda, MD 20892
Telephone: (301) 496-8541
INQUIRIES
Written or telephone inquiries concerning the objectives and scope of this RFA
or inquiries about whether or not specific proposed research would be
responsive are encouraged and should be directed to the program director named
above. The program director welcomes the opportunity to clarify any issues or
questions from potential applicants.
KIDNEY AND UROLOGY RESEARCH CENTERS
RFA AVAILABLE: DK-91-03
P.T. 04; K.W. 0785095, 0785220, 0785055, 0785035, 0710030, 0745027, 0745070
National Institute of Diabetes and Digestive and Kidney Diseases
Letter of Intent Receipt Date: March 15, 1991
Application Receipt Date: July 16, 1991
The Division of Kidney, Urologic and Hematologic Diseases (DKUHD) of the
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
invites applications for research center grants (P50) to be awarded in fiscal
year 1992. NIDDK anticipates the award of up to six competitive center grants
in fiscal year 1992.
BACKGROUND
Kidney and urologic diseases account for substantial and increasing morbidity
and financial burden in the United States. They threaten the health,
well-being, and longevity of over 13 million Americans and accounted for an
estimated cost of at least $50 billion in 1990. Although considerable
progress has been made in understanding the basic physiology and
patho-physiology of the normal renal and urologic systems, there has been only
limited progress in unraveling the mechanisms of those disease processes that
lead to progressive deterioration in the function of these systems.
Nevertheless, major progress has been made in the management of their clinical
consequences. For example, renal dialysis and transplantation are life-saving
procedures and the clinical management of benign prostatic hyperplasia has
improved over the past several years. Unfortunately, these scientific
advances have not led to the means to prevent or reverse these diseases, and
their incidence is steadily increasing. The proposed multidisciplinary
research centers, the George M. O'Brien Kidney and Urologic Diseases Research
Centers, should provide the necessary and appropriate expertise to investigate
topical areas of research related to the pathogenesis of kidney and urologic
diseases such as: immunologically mediated diseases; diabetes mellitus and
other endocrine and metabolic disorders; primary renal hypertension; genetic
abnormalities; bladder physiology and pathophysiology; developmental and
obstructive disorders; and nephrotoxins and toxic cell injury.