kristoff@NET.BIO.NET (Dave Kristofferson) (10/12/89)
Vol. 18, No. 36, October 13, 1989
NOTICES
NIH REGIONAL WORKSHOPS ON IMPLEMENTATION OF THE PHS POLICY ON HUMANE
CARE AND USE OF LABORATORY ANIMALS .......................(84/129)........... 1
National Institutes of Health
Index: NATIONAL INSTITUTES OF HEALTH
EXPANDED GRANT AUTHORITIES FOR RESEARCH ACTIVITIES AT GRANTEE
ORGANIZATIONS ............................................(132/451).......... 1
Public Health Service
Index: PUBLIC HEALTH SERVICE
DATED ANNOUNCEMENTS (RFPs AND RFAs)
THE DEVELOPMENT AND USE OF SENSITIVE, SPECIFIC, RAPID DIAGNOSTIC
TESTS FOR CLINICALLY IMPORTANT MICROBIAL AGENTS (RFA) ..(457/550, 1044/1481). 5
National Institute of Allergy and Infectious Diseases
Index: ALLERGY, INFECTIOUS DISEASES
DIGESTIVE DISEASES CORE CENTERS (RFA) ............(561/690, 1484/1655)....... 7
National Institute of Diabetes and Digestive and Kidney Diseases
Index: DIABETES, DIGESTIVE AND KIDNEY DISEASES
ONGOING PROGRAM ANNOUNCEMENTS
HUMAN GENOME PROGRAM CENTER GRANTS (P30, P50) ...............(696/981)....... 8
National Center for Human Genome Research
Index: HUMAN GENOME
NOTICES
NIH REGIONAL WORKSHOPS ON IMPLEMENTATION OF THE PHS POLICY
ON HUMANE CARE AND USE OF LABORATORY ANIMALS
P.T. 42; K.W. 0201011, 1014003
National Institutes of Health
The National Institutes of Health, Office for Protection from Research Risks,
is continuing to sponsor a series of workshops in implementing the Public
Health Service Policy on the Humane Care and Use of Laboratory Animals. The
workshops are open to institutional administrators, members of animal care and
use committees, laboratory animal veterinarians, investigators and other
institutional staff who have responsibility for high-quality management of
sound institutional animal care and use programs.
Date: October 24-25, 1989
Location: Columbus, Ohio
Contact: Dr. Margaret Duber Snyder
Ohio State University
6089 GoDown Road
Columbus, Ohio 43235
Telephone: (614) 292-9460
Date: December 7-8, 1989
Location: Honolulu, Hawaii
Contact: Ms. Liane Nakmura or
Ms. Becky Makizuru
University of Hawaii
Laboratory Animal Service
2538 The Mall - Snyder Hall, 5th Floor
Honolulu, Hawaii 96822
Telephone: (808) 948-8770
For additional information, contact:
Mrs. Roberta Sonneborn
Executive Assistant for Animal
Welfare Education
National Institutes of Health
Office for Protection from Research Risks
Building 31, Room 5B59
Bethesda, Maryland 20892
EXPANDED GRANT AUTHORITIES FOR RESEARCH ACTIVITIES AT GRANTEE ORGANIZATIONS
P.T. 34; K.W. 1014002, 1014006
Public Health Service
National Institutes of Health
Alcohol, Drug Abuse, and Mental Health Administration
On July 3, 1989, the Office of the Assistant Secretary for Health issued
Circular 89.02 of the PHS Grants Administration Manual, subject as above. As
stated in Section F (Page 7) of the Public Health Service (PHS) Circular, the
provisions of this policy, which became effective on October 1, 1988, "have
previously been announced through other mechanisms." Specifically, the
National Institutes of Health (NIH) and the Alcohol, Drug Abuse, and Mental
Health Administration (ADAMHA) implemented the expanded grant authorities (as
follows) in the NIH GUIDE FOR GRANTS AND CONTRACTS: The NIH announcement was
issued on October 21, 1988 (Vol. 17, No. 34) and the ADAMHA announcement was
issued on April 28, 1989 (Vol. 18, No. 15).
The purpose of this issuance is to make it explicit that NIH and ADAMHA will
follow the policy provisions in the PHS Circular. Thus, the NIH and ADAMHA
notices referenced above are superseded by PHS Circular 89.02, which is
reprinted below in its entirety.
Vol. 18, No. 36, October 13, 1989 - Page 1
PHS Circular 89.02
Grants Administration Manual
Issue Date: July 3, 1989
SUBJECT: EXPANDED GRANT AUTHORITIES FOR RESEARCH ACTIVITIES AT
GRANTEE ORGANIZATIONS
A. BACKGROUND
In March 1986, five Federal agencies, 10 universities in the State of Florida,
and the Government/University/Industry Roundtable of the National Academy of
Sciences/National Research Council undertook a demonstration project, called
the Florida Demonstration Project, designed to address ways in which
administrative burdens on sponsored research could be reduced. The Office of
Management and Budget (OMB), through OMB Memorandum 88-20, has encouraged
Federal agencies to make use of the expanded authority features of the project
which will reduce overhead costs and increase research productivity.
OMB set forth criteria on how to determine who should have the expanded
authority. PHS has taken the view that its research grant recipients are in
compliance with those criteria unless and until actions or situations present
themselves which lead PHS to conclude that it would be in the best interest of
the Government to remove the expanded authority from a particular institution.
This Circular sets forth additional authorities which PHS is extending to
recipients of PHS research grants.
B. APPLICABILITY
The expanded authorities in this Circular are applicable to all PHS research
grants with the following exceptions: (1) Cooperative agreements, (2) awards
to individuals or foreign institutions, (3) class deviations granted by the
Office of the Assistant Secretary for Health (OASH) for a particular program
or class of grants, and (4) when circumstances dictate that the expanded
authority should not be extended to a specific research grant (because of
action such as the designation of the recipient as "high risk").
NIH and ADAMHA have received a class deviation from OASH and are applying the
expanded authorities only to the "R" series of research grants with the
following exceptions: R10, Cooperative Clinical Research Grants; R18,
Research Demonstration and Dissemination Projects; R43, Small Business
Innovation Research Grants - Phase I; and R44, Small Business Innovation
Research Grants - Phase II.
The Notice of Grant Award issued within the covered research programs will
state whether or not the expanded authorities are applicable.
C. EXPANDED AUTHORITIES
Several of the expanded authorities have specific deadlines for submission of
reports or for timely notification to the PHS awarding component. Grantees
should be aware that any pattern of failure to adhere to those deadlines for
reporting or notification shall be grounds for excluding that grantee
institution from these special provisions.
1. EXTENSIONS WITHOUT ADDITIONAL FUNDS
The grantee organization may extend the final budget of a research project ONE
TIME for a period of UP TO 1 YEAR beyond the original expiration date shown on
the Notice of Grant Award. Such an extension may be made when no additional
funds are required to be obligated by the awarding office, there will be no
change in the project's originally approved scope or objectives, AND any one
of the following applies:
a. Additional time beyond the established expiration date is required
to assure adequate completion of the originally approved project;
or
b. Continuity of PHS grant support is required while a competing
continuation application is under review; or
c. The extension is necessary to permit an orderly phaseout of a
project that will not receive continued support.
The fact that funds remain at the expiration date of the grant is not in
itself sufficient justification for an extension without additional funds.
Vol. 18, No. 36, October 13, 1989 - Page 2
The grantee organization must notify the PHS awarding component in writing of
the extension 10 DAYS PRIOR TO the expiration date of the project period.
Upon notification, the PHS awarding component will issue a revised Notice of
Grant Award to reflect the change of the expiration date. Grantees may not
extend project periods previously extended by the PHS awarding component.
In extending the final budget period of the grant through this process, the
grantee agrees to automatically extend the applicability of all certifications
required for funding of the original budget period of the grant to the new
extended period of support, e.g., animal welfare, drug free workplace, human
subjects, misconduct in science, etc.
2. PREAWARD COSTS
A grantee organization may, at its own risk, incur obligations and
expenditures to cover costs prior to the beginning date of an award provided
the following criteria are met:
a. The costs concerned are considered necessary for the conduct of the
project;
b. The costs are allowable under the POTENTIAL award; and
c. PHS written prior approval is obtained when required.
Such preaward costs may be incurred within 90 days prior to the beginning date
of the award without PHS prior approval. Preaward costs incurred more than 90
days prior to the beginning date of the award require PHS written prior
approval.
PHS expects the grantee organization to be fully aware that preaward costs
must not impair its ability to accomplish project objectives or in any way
adversely affect the conduct of the project. Additionally, the incurrence of
costs prior to the award of a grant imposes no obligation on PHS to make an
award.
Please note that this authority is identical to existing PHS policy contained
in the Grants Policy Statement EXCEPT that this Circular deletes the
requirement that the application has been recommended for approval by an
objective review group or by a National Advisory Council.
3. CARRYOVER OF UNOBLIGATED BALANCES
Except for funds restricted on a Notice of Grant Award, grantee organizations
are authorized to carry over unobligated research grant funds remaining at the
end of a budget period.
The grantee organization must notify the PHS awarding component whether they
have elected to carry over unobligated balances and the amount to be carried
over. The notification shall be provided in item 12, "Remarks," of the
Financial Status Report (FSR). A revised Notice of Grant Award will NOT be
issued to reflect the carryover. Any unobligated balance not specified for
carryover on the FSR shall be available for disposition by the PHS awarding
component. Grantee organizations are required to submit the FSR within 90
days after the expiration of a budget period.
4. COST-RELATED PRIOR APPROVALS
The requirements for prior Federal approval of expenditures under the
applicable cost principles are waived, with the following two exceptions:
Prior approval for capital expenditures for land and buildings IS NOT waived
because such capital expenditures are allowable only when the program's
legislation or regulations so permit. Prior approval for indemnification
against liabilities to third parties and any other loss or damage not
compensated by insurance or otherwise IS NOT waived because the Government is
obligated to indemnify the organization only to the extent expressly provided
in the award.
Requirements for allowability, reasonableness, allocability, and consistency
of costs are still applicable.
5. USE OF PROGRAM INCOME
The grantee organization may use the additional costs alternative for the use
of program income, unless regulations or the Notice of Grant Award specify
another alternative or a combination of alternatives.
Vol. 18, No. 36, October 13, 1989 - Page 3
D. PRIOR APPROVAL AUTHORITIES RETAINED BY PHS
1. CHANGE OF SCOPE OR RESEARCH OBJECTIVES.
The grantee organization is required to seek approval from the PHS awarding
component when there is a change in the scope or research objectives of the
project. Actions likely to be considered a change in the scope or objectives
include, but are not limited to, the following:
a. A change in the specific aims approved at the time of award;
b. Substitution of one animal model for another;
c. Any change from the approved use of animals or human subjects;
d. Shifting the emphasis of the research from one disease area to
another;
e. Applying a new technology, i.e., changing assays from those
approved to use of a different type of assay;
f. Transferring the performance of substantive programmatic work to a
third party by contract or any other means;
g. Change in key personnel whose expertise is critical to the approved
project;
h. Significant rebudgeting whether or not it requires approval under
rules governing budget changes; and
i. Incurrence of patient care costs where the need has not previously
been approved by PHS and/or when a grantee desires to rebudget
funds OUT OF the patient care category.
This list clearly is not all-inclusive. In the event of uncertainty as to
whether a particular change is significant enough to require prior approval,
questions should be referred to the Grants Management Officer (GMO) of the PHS
awarding component for final determination.
2. CHANGE IN PRINCIPAL INVESTIGATOR (PI)
The grantee organization is required to seek approval in writing before a
substitute PI is appointed to replace an absent or departed PI. If the PI is
absent from the project for a period of 3 months or more, a substitute PI must
be proposed by the grantee organization and must be approved by the PHS
awarding component. The request for approval of a substitute PI should
include a justification for the change, the curriculum vitae of the individual
proposed, and any budgetary changes resulting from the proposed change.
3. CHANGE OF GRANTEE ORGANIZATION
PHS awarding component approval is required to transfer a grant from one
grantee organization to another. PHS awarding component approval is also
required for successor-in-interest situations. A successor-in-interest may
occur as a result of a merger, divestiture, or other corporate change in which
all or part of the assets involved in the performance of the grant-supported
activity(ies) are transferred to another entity.
4. ACTIONS REQUIRING ADDITIONAL FEDERAL FUNDS
PHS awarding component prior approval is required if the grantee organization
takes action that generates a need for additional Federal funding to carry out
the project.
5. RETENTION OF RESEARCH GRANT FUNDS WHEN A RESEARCH
CAREER DEVELOPMENT AWARD (RCDA) IS AWARDED
Funds budgeted in a PHS-supported research grant for an individual's salary
and/or fringe benefits, but freed as a result of receiving an RCDA for that
individual, may not be used for any other purpose without the prior approval
of the PHS awarding component.
6. AWARD TERMS AND CONDITIONS
Deviations from special terms or conditions stated on the Notice of Grant
Award require prior approval from the PHS awarding component.
Vol. 18, No. 36, October 13, 1989 - Page 4
7. CLOSELY-RELATED WORK
When salaries and/or other activities are being supported by two or more PHS
grant projects from the same awarding component, grantees may charge costs to
the project for which the costs are originally approved or to another
closely-related PHS project only after approval by the GMO.
8. APPROVAL BY THE OFFICE OF THE ASSISTANT SECRETARY FOR PUBLIC
AFFAIRS OF PUBLICATIONS AND AUDIOVISUAL MATERIALS OVER
$25,000 FOR A SINGLE ITEM
9. PREAWARD COSTS INCURRED MORE THAN 90 DAYS PRIOR TO THE
EFFECTIVE DATE OF ANY NEW OR COMPETING CONTINUATION AWARD
10. DRAWINGS/SPECIFICATIONS FOR ALTERATIONS AND RENOVATIONS OVER
$25,000.
In addition, costs for alterations and renovations may not exceed the lesser
of $150,000 or 25 percent of total direct costs during any consecutive 3-year
period unless a waiver is obtained.
11. INDEMNIFICATION AGAINST THIRD PARTIES
12. CAPITAL EXPENDITURES FOR LAND AND BUILDINGS
13. RETROACTIVE APPROVAL
E. METHOD OF OBTAINING PHS AWARDING COMPONENT PRIOR APPROVAL
All requests that require prior approval must be submitted in writing to the
GMO designated on the Notice of Grant Award. All requests must bear the
signature of an authorized official of the business office of the grantee
organization as well as the P.I. The GMO is responsible for informing the
grantee, in writing, of the final disposition of the request. Grantees should
ensure that the written approval or disapproval of such requests is signed by
the GMO who signed the Notice of Grant Award, or his/her designee. Grantees
who take action on the basis of letters or telephone conversations from
unauthorized officials do so at their own risk. Such responses will not be
considered binding by PHS.
F. EFFECTIVE DATE
The provisions of this policy have previously been announced through other
mechanisms. Therefore, this Circular is effective for all research grant
awards covered by the provisions of this Circular which are made on or after
October 1, 1988.
G. EXPIRATION DATE
This Circular will remain in effect until cancelled or until its content is
incorporated into the main body of the PHS Grants Administration Manual.
DATED ANNOUNCEMENTS (RFPs AND RFAs)
THE DEVELOPMENT AND USE OF SENSITIVE, SPECIFIC, RAPID DIAGNOSTIC TESTS FOR
CLINICALLY IMPORTANT MICROBIAL AGENTS
RFA AVAILABLE: 90-AI-01
P.T. 34; K.W. 0755010, 0715125, 0715165, 0715182, 0745020
National Institute of Allergy and Infectious Diseases
Letter of Intent Receipt Date: December 1, 1989
Application Receipt Date: January 16, 1990
The National Institute of Allergy and Infectious Diseases (NIAID) invites
grant applications for basic research which will lead to the improvement or
development of rapid, sensitive and specific diagnostic tests for clinically
significant viruses, bacteria, and other microorganisms. The targeted
infectious diseases include, but are not limited to, respiratory diseases,
cytomegalovirus, hepatitis and other enteric diseases, and sexually
transmitted diseases (STDs). Research on diagnostic tests for HIV are
supported by a separate program.
Vol. 18, No. 36, October 13, 1989 - Page 5
RESEARCH GOALS AND SCOPE
The purpose of this Request for Applications (RFA) is to stimulate basic
research that is expected to lead to the development of novel diagnostic
tests. The research proposed should select strategies that will lead to
improvements in sensitivity, specificity or speed in the diagnosis of a
clinically important infectious disease. The tests should be valid for
individuals of either sex and various ethnic populations. Specifically the
research should be targeted towards diagnostic tests for:
1. Infectious diseases that are currently difficult to diagnose; especially
for diseases for which there is clinical urgency to select an appropriate
therapy.
2. Infections for which only cumbersome or invasive diagnostic methods are
available. Non-invasive procedures and simpler tests are needed.
3. Infectious diseases for which the current tests lack suitable specificity,
sensitivity, or rapidity.
4. Infectious diseases for which more economical tests are needed.
5. Diagnosis of numerous agents in the same specimen at the same time.
Inclusion of women and minorities are encouraged. If they are excluded,
reasons for this exclusion must be included in the application.
The targeted infectious diseases include but are not limited to respiratory
diseases, cytomegalovirus, hepatitis and other enteric infections, and
sexually transmitted diseases (excluding AIDS).
MECHANISM OF SUPPORT
Award(s) will be made as Cooperative Agreements. These are assistance
relationships with substantial involvement of NIAID staff. Universities,
medical colleges, hospitals, and laboratories or other public, private, or for
profit institutions are eligible.
This RFA is a one-time solicitation. NIAID anticipates making four awards as
a result of this RFA. However these anticipated awards are 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 June 1,
1990. It is the intent of the Rapid Diagnosis Program to fund applications in
a manner which will ensure the support of a variety of approaches to the
diagnosis of a variety of diseases caused by viruses and/or other
microorganisms.
INQUIRIES
Investigators seeking information relevant to this RFA should contact Dr.
Catherine Laughlin at the address below. Requests for copies of the complete
RFA and questions regarding review procedures should be addressed to Dr.
Preble at the address below.
Dr. Olivia Preble
Acting Chief, Microbiology and Immunology Review Section
Program and Project Review Branch
National Institute of Allergy and Infectious Diseases
National Institutes of Health
Westwood Building, Room 3A10
Bethesda, Maryland 20892
Telephone: (301) 496-8208
Dr. Catherine Laughlin
Acting Chief, Antiviral Research Branch
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases
Westwood Building, Room 753
Bethesda, Maryland 20892
Telephone: (301) 496-8285
Vol. 18, No. 36, October 13, 1989 - Page 6
DIGESTIVE DISEASES CORE CENTERS
RFA AVAILABLE: 90-DK-01
P.T. 04; K.W. 0715085, 0710030, 0785035, 0715026
National Institute of Diabetes and Digestive and Kidney Diseases
Letter of Intent Receipt Date: December 16, 1989
Application Receipt Date: February 15, l990
The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
invites applications for Digestive Diseases Core Center Grants to be awarded
in Fiscal Year 1991. NIDDK anticipates the award of up to four competitive
Digestive Diseases Core Center Grants in Fiscal Year l991.
BACKGROUND
The NIDDK-supported Digestive Diseases Core Centers are part of an integrated
program of digestive disease-related research support provided by NIDDK.
These centers have provided a focus for increasing collaboration and improving
the cost effectiveness of supported research among groups of successful
investigators at institutions with established comprehensive digestive disease
research base. At least 50 percent of the research base of a Center must be
supported by NIDDK.
OBJECTIVE AND SCOPE
The objective of the Core Centers is to bring together investigators from
relevant disciplines to enhance and extend the effectiveness of research
related to digestive diseases and their complications. A Core Center must be
an identifiable unit within a single university medical center or a consortium
of cooperating institutions, including an affiliated university. The overall
goal of the Core Center is to bring together clinical and basic science
investigators in a manner which will enrich the effectiveness of digestive
disease research. An existing program of excellence in biomedical research in
the area of digestive disease disorders is required. This research should be
in the form of NIH-funded research projects, program projects, or other
peer-reviewed research that is in existence at the time of submission of a
center application. Close cooperation, communication, and collaboration among
all involved personnel of all professional disciplines are ultimate
objectives.
The Core Centers should have a central focus of research investigation. The
central focus should be a digestive disease or group of diseases and at least
half of the research should focus on this area. Examples of a central focus
of research investigation include (but are not restricted to) inflammatory
bowel disease, peptic ulcer disease, pancreatic disease, liver disease and
pediatric gastrointestinal disease. A major area of programmatic interest in
digestive diseases at NIDDK is inflammatory bowel disease including Crohn's
disease and ulcerative colitis. Accordingly, as a part of this Request for
Applications (RFA), NIDDK intends to fund at least one digestive disease
center whose focus of research interest is inflammatory bowel disease.
Applicants should consult with NIDDK staff concerning plans for the
development of the center and the organization of the application.
Digestive Diseases Core Centers are based on the core concept. Cores are
defined as shared resources that enhance productivity or in other ways benefit
a group of investigators working in digestive diseases centers to accomplish
the stated goals of the center. Two other types of activities may also be
supported with center funding--a pilot and feasibility program and an
enrichment program. The pilot and feasibility program provides modest support
for new initiatives or feasibility research studies. This program is directed
at new investigators and at investigators established in other research
disciplines where their expertise may be applied to digestive disease
research. The Core Center Grant may also include limited funds for program
enrichment such as seminars, visiting scientists, consultants, workshops, etc.
MECHANISM OF SUPPORT
NIDDK expects to award up to four Digestive Diseases Core Center Grants in
Fiscal Year l991 on a competitive basis. The receipt of four competitive
continuation applications is anticipated. These applications will compete for
awards along with other applications received in response to this
announcement. Foreign institutions are not eligible to apply. The
anticipated awards will be for five years and are contingent upon the
availability of appropriated funds. The complete RFA (general description and
Vol. 18, No. 36, October 13, 1989 - Page 7
Guidelines for the digestive disease centers) and consultation may be obtained
from:
Maria H. Sjogren, M.D., Director
Digestive Disease Centers Program
Division of Digestive Diseases and Nutrition
Westwood Building, Room 3A15
National Institute of Diabetes and Digestive and Kidney Diseases
Bethesda, Maryland 20892
Telephone: (301) 496-9717
REVIEW PROCEDURES
Applications for the Core Center Grants will be evaluated in national
competition by the NIH grant peer review process. Applications will be
reviewed initially by a special review committee convened by the NIDDK and
subsequently by the National Diabetes and Digestive and Kidney Diseases
Advisory Council.
METHOD OF APPLYING
Potential applicants are urged to submit a letter of intent by December 16,
l989, regarding their application. The letter of intent is nonbinding and is
not a precondition for an award. The letter of intent should include the
name(s) of the principal investigator and principal collaborators, descriptive
titles of the core facilities and pilot/feasibility projects, and the
organization(s) involved. Applications must be submitted using PHS Form 398
(Rev. 10/88). Check the "Yes" box in line 2 of the application face page and
insert "DIGESTIVE DISEASES CORE CENTERS, RFA 90-DK-01." THE RFA LABEL
CONTAINED IN THE APPLICATION KIT MUST BE AFFIXED TO THE BOTTOM OF THE FACE
PAGE OF THE ORIGINAL COPY OF THE APPLICATION. FAILURE TO USE THIS LABEL COULD
RESULT IN DELAYED PROCESSING AND REVIEW OF THE APPLICATION.
Mail the completed application (original and four copies) to:
Application Receipt Office
Division of Research Grants
Westwood Building, Room 240
National Institutes of Health
Bethesda, Maryland 20892**
Simultaneously submit two copies to:
Review Branch, NIDDK
5333 Westbard Avenue
Westwood Building, Room 406
Bethesda, Maryland 20892
The special single receipt date for submissions in response to this
announcement is February 15, l990, with earliest funding December 1, l990.
ONGOING PROGRAM ANNOUNCEMENTS
HUMAN GENOME PROGRAM CENTER GRANTS (P30, P50)
P.T. 34; K.W. 1215018, 0710030, 1002058, 0755045, 1004017, 0780000
National Center for Human Genome Research
First receipt date: February 1, 1990
THIS ANNOUNCEMENT SUPERCEDES AND REPLACES THE ANNOUNCEMENT OF HUMAN GENOME
PROGRAM CENTER GRANTS ISSUED IN VOLUME 18, NO. 25, JULY 21, 1989, OF THE NIH
GUIDE TO GRANTS AND CONTRACTS.
The National Center for Human Genome Research (NCHGR) is interested in
facilitating the establishment of a number of centers in which research is
focussed on achieving the goals of the Human Genome Initiative. To this end,
an announcement was published in the NIH Guide to Grants and Contracts
(referenced above) soliciting applications for Human Genome Program Center
Core Grants (P30s). After receiving comments from the scientific community,
the proposed organizational model for Human Genome Program Centers has been
considered further, and the NCHGR believes that the goals of the Human Genome
Initiative can, at present, best be achieved through support of both center
core grants (P30s) and grants for specialized centers (P50s).
Vol. 18, No. 36, October 13, 1989 - Page 8
This announcement contains a restatement of the characteristics of Human
Genome Program Centers and solicits applications for Human Genome Program
Center Grants using both the P30 and P50 mechanisms. The intent in allowing
the use of either mechanism is to give each applicant institution flexibility
in designing a center structure appropriate to its needs and capabilities. In
general, the P30 center core grant will be most appropriate for institutions
where there is a significant amount of ongoing and closely related genome
research already funded. The P50 specialized center grant will allow
institutions to propose a center that will include a significant amount of new
research. In either case, the overall research program of each proposed Human
Genome Program Center must address a specific defined goal of the Human Genome
Initiative and directly facilitate progress toward the goals of the program as
a whole.
BACKGROUND
The National Institutes of Health are currently engaged, along with several
other Federal, private, and international organizations, in a research program
designed to characterize the human genome and the genomes of selected model
organisms. This research program, which has been named the Human Genome
Initiative, has the following interrelated goals: (1) the construction of
high resolution genetic linkage maps; (2) the development of physical maps,
with an emphasis on methodology that allows investigators access to the mapped
DNA; (3) the determination of the complete nucleotide sequence of the DNA of
selected organisms, including the human; (4) the development of the capability
for collecting, storing, distributing and analyzing the data; and (5) the
development of appropriate new technologies to achieve these goals. The
product of the Human Genome Initiative will be a set of information and
material resources available to the entire research community to facilitate
further research as well as application of the knowledge gained to the
prevention, diagnosis, and therapy of disease.
Attaining the goals of the Human Genome Initiative will require research
projects of different magnitudes and complexities. While many important
projects will be of a scope appropriate to a single investigator or a small
number of investigators, other research projects envisioned will be large
undertakings that can only be addressed adequately by groups of investigators,
representing diverse disciplines, working cooperatively in centers focussed on
a goal of the Human Genome Initiative.
As one means of stimulating the development of directed, large-scale projects,
the NCHGR proposes to encourage the establishment of Human Genome Program
Centers (HGP Centers). It is envisioned that a substantial fraction of the
funds earmarked for the genome program will eventually be devoted to the
support of such centers, with the award of as many as 20 center grants over a
period of years.
Because the NIH Human Genome Program has been charged with reaching specific
goals within relatively short time periods, the P30 and P50 center grant
mechanisms will be used to facilitate the creation of HGP Centers in which
major goals of the program can be addressed in a focussed and comprehensive
way. The center grants will allow research programs to go forward that could
not be supported effectively by the RO1 or PO1 mechanisms. Center grants will
support new or significantly expanded research objectives. In addition, while
the center must be highly coherent in its research objective, it should also
be a hub for collaboration and outreach to the broader scientific community.
It is anticipated that a well-integrated and robust center will become a
resource for the genome community as a whole.
OBJECTIVES AND SCOPE OF HGP CENTERS
The primary purposes of the HGP Centers will be to develop the new technology
needed to accomplish the goals of the Human Genome Initiative and to apply
these technologies to the large-scale generation of mapping and sequencing
information. Each center must have tangible and, where possible, quantifiable
aims that define a specific goal that the center intends to accomplish during
the granting period. The center will be accountable for the attainment of
such milestones through yearly progress reports, an annual center directors
meeting and the competitive renewal process.
The specific objectives of the HGP Centers will be to:
1. Provide support for a group of investigators to collaborate in addressing
a major research goal of the Human Genome Initiative in a comprehensive and
coordinated way;
2. Expedite research by providing needed core resources;
Vol. 18, No. 36, October 13, 1989 - Page 9
3. Recruit new investigators, including nonbiologists;
4. Provide an environment in which large-scale projects can be accommodated
and receive stable support;
5. Stimulate interdisciplinary collaboration and sharing of data and ideas
with investigators who are not part of the center and with private sector
organizations.
In the case of a P30 center core grant, the goal of the center must be derived
from research that is already funded at the institution whereas for a P50
specialized center, new research may be proposed to define the goal.
Additional components that will be supported include an administrative
structure that will relieve individual investigators of the administrative
burden otherwise associated with a large-scale research program, resources to
be shared by the research groups within the center, recruitment of new
scientists into the center, and pilot projects. In many cases, the activity
proposed for the HGP Centers will demand new research directions for some
participants; this is encouraged. The principal investigator of the center
grant will be expected to provide scientific, intellectual and administrative
leadership to the entire HGP Center effort.
ELIGIBILITY
Investigators at academic, nonprofit, or for-profit institutions in the United
States are eligible. Only one center will be funded at any one institution.
While a single institution must be the applicant, multi-institutional
arrangements (consortia) are possible if there is a compelling reason for them
and if there is clear evidence of close interaction among the participants.
Collaboration with industry is encouraged. In such a collaboration the
industrial contribution should be well-integrated into the design and
operation of the center, to encourage cross-fertilization of ideas and rapid
application of the research to practical purposes.
ALLOWABLE COMPONENTS OF HGP CENTER GRANT (P30 and P50) APPLICATIONS
1. Administrative core. This component will include the costs of
administering the entire HGP Center. The portion of the salaries of the
principal investigator and other key individuals corresponding to the
percentage of time devoted to center administration can be included. The
center director must serve on a full-time or significant part-time basis and
should have authority over appointments and space within the center. Costs of
advisory committees, steering committees, and consultants can be included in
the administrative core. Such committees are not required, but it is strongly
recommended that the applicant outline an effective mechanism for obtaining
independent advice to ensure guidance of the center toward the attainment of
the stated goals.
2. Technical Core Facilities. Under this component the applicant should
request any shared facilities or equipment that will be required by the
proposed research program. Examples of shared facilities include a
polynucleotide or protein sequencing laboratory; a cytogenetics laboratory;
shared equipment; a data management and computational resource; or an
instrument development laboratory. This list of core facilities is not
intended to be limiting, nor is it expected that each center will include all
of those listed. Applicants should examine the needs of their particular
programs and request the technical core facilities that would best be suited
to fill these individual needs. It is expected that there will be
considerable diversity among centers in this regard. Resources necessary for
distribution of data or materials to external investigators should be taken
into account, where relevant, in requesting funds for core facilities.
3. Alterations and Renovations. Funds needed for renovation of existing
space may be requested, if such space is needed to house core facilities or
new or expanded research activities. The Public Health Service Grant
Management Policy limits the dollar amount to the lesser of $150,000 or 25
percent of total direct costs over a three-year period. Waivers may be sought
by the NCHGR in exceptional cases. Detailed justification and plans for use
of the space must be provided. Costs of equipping renovated laboratories may
be included if the items are directly related to the research being conducted
in the center.
4. Developmental Funds. The purpose of developmental funding is to provide a
flexible means for the center director to promote growth of the center and
progress toward achieving the research goals of the center. This component
may include: (1) the costs of recruiting new investigators; (2) research
support of new investigators for up to three years, until independent research
Vol. 18, No. 36, October 13, 1989 - Page 10
support is obtained; (3) support for innovative pilot projects not supported
under existing research funding or proposed as a part of the research
component of the center; (4) funds for the development of new resources or
core facilities.
ADDITIONAL COMPONENTS ALLOWABLE IN P30 CENTER CORE GRANTS
Within the administrative core, salary support for the principal investigators
of grants that will be part of the HGP Center may be requested to the extent
such salary is not recovered on the individual research grant(s). The limit
is 50 percent of the salary of the principal investigator involved. Only the
percent of time and effort devoted to the specific research project included
in the center may be claimed. Additionally, interim funds for HGP Center
investigators whose renewal applications were approved but not funded, may be
requested within the developmental funds.
ADDITIONAL COMPONENTS ALLOWABLE IN P50 SPECIALIZED CENTER GRANTS
At least three related, integrated and high quality research projects that
provide a unified approach to a goal of the Human Genome Initiative must be
proposed in the P50 specialized center application. The contribution made by
each project to the focussed theme of the center must be clearly established.
Projects currently supported by existing research grants (RO1s) or program
project grants (PO1s) may be proposed for incorporation into the HGP Center
Grant if they fit closely into the goals of the center. In this case, the
applicant must provide an explanation of the advantage of including the
research program in the center as opposed to maintaining it as a separately
funded entity.
TERM OF SUPPORT
The Human Genome Initiative has established a series of specific goals to be
accomplished in a limited period of time. As the initial goals are reached,
the focus of the HGP Centers and of individual grants will change. In order
to ensure that centers remain focussed on appropriate goals and make
sufficient progress, frequent scientific and programmatic reviews will be
necessary. In addition to yearly staff review through progress reports and
center directors meetings, this will be accomplished by allowing an initial
term of five years with review of any request for renewal of support after the
end of the third year. In the event that the review is not favorable, review
after the end of the first three years will allow sufficient time for
submission and review of a revised application or for orderly phase-out of the
grant. Further terms of support will be for a three- to five-year period.
Many institutions may find that the specialized center mechanism (P50) best
fits their needs at present since they do not have a substantial number of
closely related genome research projects in place. However, at the time of
renewal, the center core grant (P30) mechanism may be the most appropriate
mechanism for continuation and expansion of the center. Such a transition
from a P50 grant to a P30 grant will be encouraged in order to enhance the
flexibility of the center and ensure that high quality research continues to
be supported by NCHGR funds. It is anticipated that as the focus of the Human
Genome Initiative shifts there may be relocation of center grants to different
institutions where expertise exists to attain further goals in the program.
REVIEW PROCEDURES
The first receipt date for applications will be February 1, 1990. Thereafter,
the regular NIH receipt dates for center grant applications will pertain:
June 1, October 1, and February 1 of each year. In order to be considered for
funding in Fiscal Year 1990 (before September 30, 1990), applications must be
received by February 1, 1990.
Applications will be evaluated for scientific merit by an appropriate review
committee constituted for the purpose of evaluating Center Grant applications.
Site visits may be conducted as part of the review process. However,
applicants should present a complete and well-justified written proposal and
not depend on site visits to amplify their application. Subsequent to
evaluation by the initial review committee, applications will be reviewed by a
National Advisory Council.
METHOD OF APPLYING
Applicants should use Standard Form PHS 398, revised 10/88, available from
most institutional business offices or from the Office of Grants Inquiries,
Division of Research Grants, National Institutes of Health, 5333 Westbard
Avenue, Bethesda, Maryland 20892. In order to assure proper identification of
Vol. 18, No. 36, October 13, 1989 - Page 11
the application, line 2 of the application form should state "Human Genome
Program Research Centers" and check the "YES" box.
INQUIRIES
Applicants are strongly urged to contact the individual listed below by
telephone to indicate that they intend to submit an application for a HGP
Center Grant. The purposes of such contact are to provide guidance to the
applicant on the eligibility and acceptability of the proposed center grant
structure and to assist staff in planning the review workload. In addition,
individuals who intend to apply for a HGP Center Grant should request a copy
of the complete application guidelines before initiating the application
process from:
Jane L. Peterson, Ph.D.
Chief, Research Centers Branch
National Center for Human Genome Research
Building 38A, Room 613
National Institutes of Health
Bethesda, Maryland 20894
Telephone: (301) 496-7531
**THE MAILING ADDRESS GIVEN FOR SENDING APPLICATIONS TO THE DIVISION OF
RESEARCH GRANTS OR CONTACTING PROGRAM STAFF IN THE WESTWOOD BUILDING IS THE
CENTRAL MAILING ADDRESS FOR THE NATIONAL INSTITUTES OF HEALTH. APPLICANTS WHO
USE EXPRESS MAIL OR A COURIER SERVICE ARE ADVISED TO FOLLOW THE CARRIER'S
REQUIREMENTS FOR SHOWING A STREET ADDRESS. THE ADDRESS FOR THE WESTWOOD
BUILDING IS:
5333 Westbard Avenue
Bethesda, Maryland 20816