kristoff@GENBANK.BIO.NET (Dave Kristofferson) (09/06/90)
NOTE: The NIH Guide may be split into more than one mail message to
avoid truncation during e-mail distribution. The first message always
begins with the RFP/RFA summary sections followed by the appended
texts of the full RFP/RFAs.
----------------------------------------------------------------------
NIH GUIDE - Vol. 19, No. 32, September 7, 1990
NOTICES
FINAL RULES - GRANTEE REQUIREMENTS FOR DRUG-FREE WORKPLACE ...(84/220)....... 1
Public Health Service
Index: PUBLIC HEALTH SERVICE
NOTICES OF AVAILABILITY (RFPs AND RFAs)
SYNTHESIS OF CONGENERS AND PRODRUGS (RFP) ....................(226/287)...... 2
National Cancer Institute
Index: CANCER
FEASIBILITY STUDIES FOR LARGE-SCALE DNA SEQUENCING OF REGIONS OF
HIGH BIOLOGICAL INTEREST (RFA HG-90-03) ....(290/443, 1204/1545)............. 3
National Center for Human Genome Research
Index: HUMAN GENOME
NATIONAL COOPERATIVE DRUG DISCOVERY GROUPS FOR THE TREATMENT OF
OPPORTUNISTIC INFECTIONS ASSOCIATED WITH ACQUIRED IMMUNE
DEFICIENCY SYNDROME (RFA AI-90-10) .........(446/569, 1548/3005)............. 5
National Institute of Allergy and Infectious Diseases
Index: ALLERGY, INFECTIOUS DISEASES
NATIONAL COOPERATIVE DRUG DISCOVERY GROUPS FOR THE TREATMENT OF HUMAN
IMMUNODEFICIENCY VIRUS INFECTIONS (RFA AI-90-09) ...(572/687, 3008/4355)..... 7
National Institute of Allergy and Infectious Diseases
Index: ALLERGY, INFECTIOUS DISEASES
ONGOING PROGRAM ANNOUNCEMENTS
NATIONAL INSTITUTE ON DRUG ABUSE - ANNOUNCEMENT AND GUIDELINES -
AUGUST 1990 (PA-90-31) .............................(693/892)................ 8
National Institute on Drug Abuse
Index: DRUG ABUSE
NEURAL AND BEHAVIORAL BASES OF COGNITIVE CHANGE WITH AGE (PA-90-32) .........11
National Institute on Aging (895/1113)
Index: AGING
NOTICES
FINAL RULES - GRANTEE REQUIREMENTS FOR DRUG-FREE WORKPLACE
P.T. 34; K.W. 1014006
Public Health Service
The purpose of this notice is to update the information on this subject
published in the April 7, 1989 edition of the NIH GUIDE FOR GRANTS AND
CONTRACTS (Vol. 18, No. 12).
Final rules for implementing the Drug-Free Workplace Act of 1988 (Public Law
100-690, Title V, Subtitle D) were published in the FEDERAL REGISTER, Vol. 55,
No. 102, Friday, May 25, 1990. The Act requires grantees to certify that they
will provide drug-free workplaces; or, in the case of a grantee who is an
individual, certify to the agency that his or her conduct of the grant will be
drug-free. The required certification is a precondition for receiving a grant
from a Federal agency.
Interim final rules on this subject were published in the January 31, 1989
FEDERAL REGISTER (54 FR 4946) and became applicable on March 18, 1989. The
final rules amended the interim rules and became effective July 24, 1990.
Particularly noteworthy items in the final rules include the following:
o Possible components of an employer drug-free workplace program for
grantees are discussed in the Supplementary Information portion of
the publication.
o The definition of "employee" has been made more specific. It now
includes all "direct charge" and most "indirect charge" employees.
o All grantees, including foreign organizations (except where
imposition of this requirement would be inconsistent with the laws
or regulations of the foreign government, as determined by the
agency head), are required to fulfill the obligations associated
with providing a drug-free workplace.
o A drug-free workplace program must be in place within 30 days of
the beginning date of the budget period of the grant award.
Implementing regulations for the Department of Health and Human Services
(DHHS) are set forth in Title 45, Code of Federal Regulations, Part 76,
entitled "Government-Wide Debarment and Suspension (Nonprocurement) and
Government-Wide Requirements for Drug-Free Workplace (Grants)."
The current grant application forms Public Health Service (PHS) 398 and 2590
(Revised 10/88, Reprinted 9/89) contain the assurance for a Drug-Free
Workplace and identification of the "workplace" site(s). The signature of the
OFFICIAL SIGNING FOR APPLICANT ORGANIZATION on the face page of the
application constitutes verification that the applicant organization is in
compliance with the DHHS regulations, including the necessity to notify the
PHS awarding component of a change in the stated workplace site(s). It is
extremely important, therefore, that grantees fully understand the contents of
the drug-free assurance.
As an aid to grantees' understanding of the assurance, the text of the
Certification Regarding Drug-Free Workplace Requirements (Appendix C of the
DHHS regulations) is reprinted below in its entirety. It must be realized
that the certification is a material representation of fact upon which
reliance will be placed by the PHS awarding component. False certification or
violation of the certification shall be grounds for suspension of payments,
suspension or termination of grants, or government-wide suspension or
debarment.
The applicant organization certifies "that it will or will continue to provide
a drug-free workplace by:
(a) Publishing a statement notifying employees that the unlawful
manufacture, distribution, dispensing, possession or use of a
controlled substance is prohibited in the grantee's workplace and
specifying the actions that will be taken against employees for
violation of such prohibition;
(b) Establishing an ongoing drug-free awareness program to inform
employees about:
NIH GUIDE - Vol. 19, No. 32, September 7, 1990 - Page 1
(1) The dangers of drug abuse in the workplace;
(2) The grantee's policy of maintaining a drug-free workplace;
(3) Any available drug counseling, rehabilitation, and employee
assistance programs; and
(4) The penalties that may be imposed upon employees for drug abuse
violations occurring in the workplace;
(c) Making it a requirement that each employee to be engaged in the
performance of the grant be given a copy of the statement required
by paragraph (a);
(d) Notifying the employee in the statement required by paragraph (a)
that, as a condition of employment under the grant, the employee
will:
(1) Abide by the terms of the statement; and
(2) Notify the employer in writing of his or her conviction for a
violation of a criminal drug statute occurring in the workplace no
later than five calendar days after such conviction;
(e) Notifying the agency in writing within ten calendar days after
receiving notice under subparagraph (d)(2) from an employee or
otherwise receiving actual notice of such conviction. Employers of
convicted employees must provide notice, including position title,
to every grant officer or other designee on whose grant activity
the convicted employee was working, unless the Federal agency has
designated a central point for the receipt of such notices. Notice
shall include the identification number(s) of each affected grant;
(f) Taking one of the following actions, within 30 calendar days of
receiving notice under subparagraph (d)(2), with respect to any
employee who is so convicted:
(1) Taking appropriate personnel action against such an employee, up
to and including termination, consistent with the requirements of
the Rehabilitation Act of 1973, as amended; or
(2) Requiring such employee to participate satisfactorily in a drug
abuse assistance or rehabilitation program approved for such
purposes by a Federal, State, or local health, law enforcement, or
other appropriate agency;
(g) Making a good faith effort to continue to maintain a drug-free
workplace through implementation of paragraphs (a), (b), (c), (d),
(e) and (f)." (END OF CERTIFICATION.)
For purposes of paragraph (e) regarding agency notification of criminal drug
convictions, the DHHS has designated the following central point for receipt
of such notices:
Division of Grants Management and Oversight
Office of Management and Acquisition
Department of Health and Human Services
Room 517-D
200 Independence Avenue, S.W.
Washington, D.C. 20201
NOTICES OF AVAILABILITY (RFPs AND RFAs)
SYNTHESIS OF CONGENERS AND PRODRUGS
RFP AVAILABLE: NCI-CM-17512-28
P.T. 34; K.W. 1003006, 1003012, 0740020
National Cancer Institute
The Drug Synthesis and Chemistry Branch (DS&CB) of the Developmental
Therapeutics Program (DTP) of the Division of Cancer Treatment (DCT) of the
National Cancer Institute (NCI) is seeking contractors with expertise in
chemical synthesis and drug design to synthesize a variety of compounds for
evaluation as potential anti-cancer agents. The assigned objectives of this
NIH GUIDE - Vol. 19, No. 32, September 7, 1990 - Page 2
project are to design and synthesize the following: (a) Congeners of lead
compounds having confirmed activity, to enhance activity or potency; (b)
Prodrugs with structural modifications that may provide altered
pharmacokinetics, altered drug transport, improved bio-availability through
increased water solubility, or increased chemical stability; (c) Other altered
structures that possess elements of both congener and prodrug; and (d)
Compounds related to natural products, e.g., alkaloids, heterocycles,
nucleosides, peptides, etc. Each contractor should have available a fully
operational facility, including all necessary equipment and instrumentation
for all aspects of the contract.
The nature of this project requires that the following restriction be applied:
The NCI signs legally binding agreements with certain suppliers (often
pharmaceutical or chemical companies) that state that all information on
compounds submitted by the supplier will be held confidential. The successful
offeror will be expected to synthetically modify such commercially
confidential (discreet) materials. Thus, pharmaceutical or chemical companies
could obtain valuable data on new lead compounds. Therefore, in order to
honor the confidentiality agreement with the original supplier, the NCI
believes that the compounds cannot be sent to potential competitors of the
supplier, and thus pharmaceutical and chemical companies must be excluded from
the competition. The intent of the exclusion is to prevent companies that
sell chemicals or drugs on the open market from gaining undue competitive
advantage by access to privileged inside information. The exclusion does not
apply to companies and/or laboratories whose synthesis activities are
performed on a specific order from another party. It is understood that such
companies do not sell drugs or chemicals on the open market and are thus not
in a position to profit from access to privileged information from NCI.
This is a recompetition of contracts currently held by the Purdue Research
Foundation and the Research Foundation of State University of New York at
Buffalo. It is anticipated that three cost-reimbursement contracts will be
awarded for a period of five years beginning on or about May 31, 1991.
RFP No. NCI-CM-17512-28 will be issued on or about September 17, 1990, and
proposals will be due approximately November 30, 1990.
Copies of the RFP may be obtained by sending a written request to:
Ms. Carolyn E. Barker, Contract Specialist
National Institutes of Health
National Cancer Institute
Research Contracts Branch, TCS
Executive Plaza South, Room 603
9000 Rockville Pike
Bethesda, MD 20892
Telephone: (301) 496-8620
FEASIBILITY STUDIES FOR LARGE-SCALE DNA SEQUENCING OF REGIONS OF HIGH
BIOLOGICAL INTEREST
RFA AVAILABLE: HG-90-03
P.T. 34; K.W. 0755045, 1004000, 0755018
National Center For Human Genome Research
Letter of Intent Receipt Date: October 15, 1990
Application Receipt Date: December 3, 1990
The National Center for Human Genome Research (NCHGR) invites applications for
assistance awards to support feasibility studies using advanced
state-of-the-art DNA sequencing technology to accomplish large-scale
sequencing projects at a higher rate and lower cost than is currently
possible.
This program is described in the Catalog of Federal Domestic Assistance No.
13.172. Awards will be made under the authority of the Public Health Service
Act, Sections 301 (Public Law 78-410, as amended 42 U.S.C. 241) and
administered under PHS grants policies and Federal Regulations 42 CFR Part 52
and 45 CFR Part 74. This program is not subject to the intergovernmental
review requirement of Executive Order 12373 or to Health System Agency review.
BACKGROUND
The NCHGR sponsors basic and applied research concerned with the development
and application of new technologies for the characterization and analysis of
NIH GUIDE - Vol. 19, No. 32, September 7, 1990 - Page 3
the human genome and the genomes of important model organisms. The activities
encompassed by the NCHGR program include genetic and physical mapping, DNA
sequencing, and informatics related to mapping and sequencing.
With respect to the DNA sequencing component of the Human Genome Program, the
rates of sequence acquisition achievable today must be increased at least 10-
to 100-fold, and DNA sequencing costs must be reduced at least 10-fold before
large-scale sequencing, on the order of a human chromosome, can be considered.
To date, current or improved methods have not been used at the megabase level
to determine whether, when combined with economies of scale, new strategies,
improved automation, and/or new technologies, significant cost reductions are
possible. The purpose of this Request for Applications (RFA) is to support
investigator-initiated research projects that will extend the limits of
advanced state-of-the-art technology considerably further than has yet been
attempted.
DEFINITION OF LARGE-SCALE SEQUENCING
The Program Advisory Committee on the Human Genome has suggested that, at the
present time, a reasonable definition of a "large-scale sequencing project" is
one that attempts to determine on the order of three megabase pairs of
(largely) contiguous sequence in three years. Continuity is an important
characteristic of the DNA sequence to be obtained; the scientific problems
that arise in considering sequencing a one-megabase region are different from
those involved in sequencing 1000 one-kilobase regions. The Committee
estimated that a rate of 2-5 megabase pairs of DNA sequence per year in the
subsequent years should be attainable. Reduction of the cost of DNA
sequencing to approximately $0.75 per base pair within three years and to
$0.50 per base pair within five years was also recommended to be a reasonable
guide. These levels are well beyond anything that has been achieved to date,
and applicants are encouraged to consider them as guidelines. The NCHGR
encourages discussion of these guidelines by applicants.
DATA MANAGEMENT
Another essential component of DNA sequencing projects that also needs to be
investigated on a large scale is data management. It is understood that
different sequencing strategies will have different data handling needs and,
therefore, no one solution to data management problems for large-scale
sequencing is likely. The informatics priorities for this RFA will be
primarily directed toward the design, development, and testing of software for
data acquisition, assembly, and management.
RESEARCH SCOPE
Projects responsive to this RFA should test hypotheses and new research
strategies designed to yield new information on the feasibility of determining
large amounts of DNA sequence rapidly and in a cost-effective manner. It is
anticipated that such projects will involve an integrated approach that
addresses a number of identifiable aspects of the problem, including: 1) The
biological materials to be sequenced, e.g., genomic DNA or overlapping clones
representing a megabase-sized region. Applicants are encouraged to select DNA
comprising regions of high biological interest; 2) scale-up of DNA sequencing
technology to allow large-scale, high-throughput, and low-cost acquisition of
DNA sequence data; 3) types and rates of errors that are expected; 4) overall
strategies, quality control systems, and management plans; 5) data
acquisition, data management, sequence assembly, and error estimation.
DATA RELEASE
The policy of the U.S. Public Health Service (PHS) states that "when resources
are developed with PHS funds and the associated research findings have been
published . . . it is essential that they be made readily available for
research purposes to the scientific community." Applicants will be expected
to follow this policy. Generating large amounts of DNA sequence will raise
additional questions with respect to data release and public accessibility to
DNA sequence data because much of this data will never be published in
journals or will not be published in its entirety. The NCHGR considers the
timely release of data to the scientific community to be critical and
encourages applicants to release all sequence data, including those that are
not published, to a public database in a timely fashion. Although it will not
be used as a review criteria, the NCHGR is interested in the investigator's
analysis and evaluation of issues related to the timely release of data such
as a timetable for data release, the criteria for "finished" DNA sequence
(i.e., sequence that is ready to be publicly released), and the intervals
(e.g., number of nucleotides or number of months) at which data will be
released.
NIH GUIDE - Vol. 19, No. 32, September 7, 1990 - Page 4
MECHANISM OF SUPPORT
Support for this program will be through research grants (R01s). Applicants
may request up to five years of support. For grants awarded for more than
three years, competitive renewals will be due at the end of the third year to
allow a determination of whether the project is satisfactorily meeting its
stated objectives. As a result of that review, funds may be continued at the
level recommended or reduced to phase out the project by the end of the
original project period.
An annual meeting is being planned to assist grantees receiving funds under
this RFA in maintaining communication with other investigators working on the
development of large-scale DNA sequencing methods and in obtaining rapid
access to those developments. Funds for travel to this meeting for as many as
two investigators may be requested.
The total amount of support available for grants under this RFA (approximately
$6 million), is contingent upon the appropriation of funds for this purpose.
It is anticipated that up to three awards will be made during fiscal year
1991. There is no set limit on the size of each award. Rather, each
investigator should propose a budget adequate to accomplish the work proposed.
LETTER OF INTENT
It is strongly recommended that potential applicants contact NCHGR staff to
discuss research objectives. Potential applicants are asked to submit a
letter of intent by October 15, 1990. This letter should include a
descriptive title of the proposed research, names of principal investigators
and other key investigators and their institutions. The letter of intent is
requested in order to provide an indication of the number and scope of
applications to be reviewed. The letter of intent does not commit the sender
to submit an application nor is it a requirement for submission of an
application. Letters of intent and requests for the full RFA or additional
information should be sent directly to:
Dr. Jane L. Peterson, Chief
Research Centers Branch
National Center for Human Genome Research
Building 38A, Room 610
National Institutes of Health
Bethesda, MD 20892
Telephone: (301) 496-7531
E-mail: jp2@nihcu.bitnet
NATIONAL COOPERATIVE DRUG DISCOVERY GROUPS FOR THE TREATMENT OF OPPORTUNISTIC
INFECTIONS ASSOCIATED WITH ACQUIRED IMMUNE DEFICIENCY SYNDROME
RFA AVAILABLE: AI-90-10
P.T. 34; K.W. 0715008, 0740018, 0740020, 0755025, 1002008
National Institute of Allergy and Infectious Diseases
Letter of Intent Receipt Date: October 1, 1990
Application Receipt Date: December 10, 1990
The National Institute of Allergy and Infectious Diseases (NIAID) announces
availability of a Request for Applications (RFA) for funding of the National
Cooperative Drug Discovery Groups for the Treatment of Opportunistic
Infections Associated with Acquired Immune Deficiency Syndrome (NCDDG-OI). It
is the purpose of this RFA (available upon request) to invite applications
aimed at the discovery of therapeutic agents to treat infections caused by
opportunistic pathogens associated with AIDS. Applications that include
research projects or core components from the private sector (e.g.,
pharmaceutical, chemical, or biotechnological companies) are encouraged.
Opportunistic infections are the major causes of morbidity and mortality in
AIDS patients. Due to the complexity of managing these infections, the
medical and hospitalization costs of HIV-infected individuals are enormous.
Available drugs to treat the opportunistic infections are of limited utility
because of toxicity and other adverse reactions. Therefore, the need exists
for potent and selective therapeutic agents active against the opportunistic
infections (OIs). The purpose of this RFA is to encourage investigators from
diverse fields and expertise to collaborate and explore new avenues utilizing
the recent advances in molecular biology. Units in which these research
talents and resources are combined are termed "NATIONAL COOPERATIVE DRUG
DISCOVERY GROUPS" (NCDDGs). The NCDDG programs would provide a mechanism for
NIH GUIDE - Vol. 19, No. 32, September 7, 1990 - Page 5
a formalized collaboration between scientists from universities,
pharmaceutical companies, and Government. They are envisioned as having the
capacity to generate new approaches and strategies for the treatment of
opportunistic infections in AIDS patients and to rapidly translate their
concepts into potentially effective treatments. The NCDDG can be focused in
one area (synthetic, biochemical, biological) or be a combination of the above
approaches (comprehensive) in composition. Results from the research proposed
should be used to identify and develop information for long-term planning of
potential therapeutic approaches or to recommend new potential treatments
worthy of further development in clinical trials.
The NCDDG-OI initiative has evolved as a part of the NCDDG Program on AIDS
(now referred to as NCDDG-HIV). The NCDDG-HIV Program, launched in 1986, has
funded 27 groups whose research efforts are directed towards the
identification of more selective and effective agents to treat HIV infection.
The studies supported by the NCDDG-HIV Program have led to the identification
of several potential new therapeutic agents. The NCDDG-OI initiative, first
launched in 1989, seeks to stimulate investigations leading to the
identification and preclinical development of agents active against the
various pathogens causing opportunistic infections in AIDS patients. Six
groups have been funded in the first round of awards.
Recent advances in molecular biology, biochemistry, and pathogenesis provide
avenues for innovative approaches. The NCDDG-OI Program will provide
assistance to talented scientists to interact as a unit to carry out the
preclinical research essential for the realization of project objectives. An
NCDDG-OI could be composed of scientists from a combination of academic,
non-profit research, and commercial organizations. Each NCDDG-OI will be
assembled by the Principal Investigator to form a multidisciplinary consortium
representing the various skills needed to successfully design, synthesize, and
evaluate, at the preclinical level, potential therapeutic agents useful in the
treatment of opportunistic infections in AIDS patients. Specifically excluded
from the Group's activities are studies related to clinical evaluation of the
drug.
Projects or cores with proposed animal model development or efficacy testing
in animal models must be integrated within the major goal of targeted drug
discovery and be required to attain the Group's objectives. Funds for
evaluation of new agents in animal models will be withheld until compounds
generated by the Group are available for animal efficacy studies and be
limited to 25 percent effort of the Group. NOTE: Animal component(s) may be
requested by the NIAID to evaluate in animal models compounds other than their
own. When this occurs, and in the event that this has not already been done,
the necessary funds for evaluation will be released. Projects utilizing
non-random screening of natural products, biologics, and/or synthetic
compounds must not exceed 25 percent of the total effort of the Group.
Large-scale random screening of compounds will not be supported under this
RFA.
Awards will be made as Cooperative Agreements. The Cooperative Agreement
funding mechanism differs from the traditional research grant in that the
Government component (NIAID) awarding the Cooperative Agreement anticipates
substantial programmatic involvement during performance. The nature of NIAID
staff participation is described in the RFA. However, the Principal
Investigator must define his/her objectives in accord with his/her own
interests and perceptions of approaches to the treatment of AIDS-associated
opportunistic infections.
The applicant institution and the Principal Investigator will be responsible
for the Group's application. Awards will be made to the applicant institution
on behalf of the group as a whole and not to individual research projects
within the Group. The applicant institution will provide a Central Operations
Office for the Group. The applicant institution will be responsible for the
performance of the entire Group and will be accountable for the funds awarded.
The participation of the Government through the NIAID extramural staff is
aimed at facilitating a concerted effort by all members of the Group by making
available to the Group biological materials for testing, appropriate existing
data bases, ancillary testing, and other resources available under existing
contracts and to provide appropriate scientific input. The interaction of
academic and non-profit research institutions with commercial organizations
and Government is expected to favor efficient invention of agents active
against OIs in AIDS patients and will facilitate their subsequent development
for clinical trials.
NIAID anticipates making multiple awards for periods up to five years and has
set aside $2.0 - 2.5 million total costs for the first year's funding. The
amount spent will be dependent on the continuing availability of funds for
this purpose and the quality and diversity of approved applications.
NIH GUIDE - Vol. 19, No. 32, September 7, 1990 - Page 6
For a copy of this RFA, please contact:
Ms. Barbara Gunter
Developmental Therapeutics Branch
Division of AIDS
National Institute of Allergy and Infectious Diseases
6003 Executive Boulevard, Room 243P
Bethesda, MD 20892
Telephone: (301) 496-8197
NATIONAL COOPERATIVE DRUG DISCOVERY GROUPS FOR THE TREATMENT OF HUMAN
IMMUNODEFICIENCY VIRUS INFECTION
RFA AVAILABLE: AI-90-09
P.T. 34; K.W. 0715008, 0740020, 0755025
National Institute of Allergy and Infectious Diseases
Letter of Intent Receipt Date: October 1, 1990
Application Receipt Date: December 6, 1990
The National Institute of Allergy and Infectious Diseases (NIAID) announces
availability of a Request for Application (RFA) for funding of the National
Cooperative Drug Discovery Groups for the Treatment of Human Immunodeficiency
Virus Infection (NCDDG/HIV). It is the purpose of this RFA (copies available
upon request) to invite applications aimed at the discovery of more effective,
selective, and diverse new agents that can be used for the treatment of HIV,
the etiological agent associated with Acquired Immunodeficiency Syndrome
(AIDS).
Applications that include a research project or a core component from the
private sector (e.g., pharmaceutical, chemical, or biotechnological companies)
are encouraged. Research directed toward drug discovery in the following
areas will be considered responsive to this RFA: humoral and cellular arms of
the immune system; immune-based therapies; structure, biophysical and
biological properties of cellular or viral proteins; biochemistry of
viral-host interactions; inhibitors of enzymatic functions and biochemical
pathways; repressors of HIV regulatory elements; drug metabolism; drug
targeting (peptides, nucleic acids, and other compounds); gene delivery using
viral vectors; ribozymes as repressors of HIV gene function; emergence of
drug-resistant strains and ways to counteract it; viral and cellular
parameters associated with neurological dysfunction; and discovery,
biochemical and biological characterization of promising natural products or
synthetic chemical compounds.
Projects or cores with proposed animal model development or efficacy testing
in animal models must be integrated into and required to attain the Group's
objectives. Funds for evaluation of new agents in animal models will be
withheld until compounds generated by the Group are available for animal
efficacy studies. If proposed, efforts directed to the synthesis or
development of analogues of known anti-HIV nucleosides (which includes
pharmacology and testing in cell-based assays) must not exceed 25 percent of
the total effort of the Group. Projects utilizing non-random cell-based
assays for screening natural products, biologics, and/or synthetic compounds
must not exceed 25 percent of the total effort of the Group.
For reasons stated below, the following research areas currently under intense
investigation or that have already been integrated into other NIH initiatives
are excluded from this RFA: (i) lipophilic carriers of nucleosides; (ii)
prodrugs of known anti-HIV nucleosides; (iii) evaluation of recombinant human
cytokines; (iv) development of soluble CD4 or its conjugated congeners; (v)
large-scale random screening of compounds with potential activity against HIV
in cell culture-based systems; such a program is operated by the National
Cancer Institute; (vi) research on the opportunistic infections associated
with AIDS; a separate RFA for the National Cooperative Drug Discovery Groups
for the Treatment of Opportunistic Infections Associated with AIDS (NCDDG-OI)
is being re-issued.
Each NCDDG/HIV will be assembled by the Principal Investigator to form a
multi-disciplinary consortium representing the various skills needed to
successfully design, implement, and evaluate, at the preclinical level,
therapeutic entities and strategies for the treatment of AIDS. Inasmuch as it
is unlikely that all of the outstanding talents required to exploit
fundamental leads from various scientific disciplines will be found in a
single institution, each Group is envisioned as being multi-institutional as
well. Thus, each NCDDG/HIV will consist of a number of research projects
NIH GUIDE - Vol. 19, No. 32, September 7, 1990 - Page 7
representing the scientific disciplines required to attain the Group's goal
and objectives. The various research projects, including that of the
Principal Investigator, may be mobilized from academia, research institutions,
and/or industry. It is expected that the rationale for design of potential
treatments, the synthesis of specific agents, and the preclinical models for
evaluation will originate within the Group and be based on leads from their
own and others' fundamental research. Specifically excluded from the Group's
activities are activities related to clinical evaluation of the drug.
Awards will be made as Cooperative Agreements. The Cooperative Agreement
funding mechanism differs from the traditional research grant in that the
Government component (NIAID) awarding the Cooperative Agreement anticipates
substantial programmatic involvement during performance. The nature of NIAID
staff participation is described in the RFA. However, the applying Group must
define its objectives in accord with its own interests and perceptions of
approaches to combat HIV infection.
The proposed applicant institution will be responsible for the Group's
application. Awards will be made to the applicant's institution on behalf of
the Group as a whole and not to individual research projects within the Group.
The applicant institution will provide a Central Operations Office for the
Group. The applicant institution will be responsible for the performance of
the entire Group and will be accountable for the funds awarded. The active
participation of the Government through the NIAID extramural staff is aimed at
enhancing and expediting a concerted effort by the Group by making available
biological materials for testing, appropriate existing data bases, and
appropriate ancillary testing and other resources available under existing
contracts. The interaction of academic and non-profit research institutions
with commercial organizations and Government is expected to promote innovative
discoveries of anti-HIV treatment and will facilitate their subsequent
development to clinical trial.
Applications will be reviewed by the appropriate subcommittee of the NIAID
AIDS Research Review Committee. NIAID has set aside $2.5 million for the
initial year's funding. The amount spent will be dependent on the continuing
availability of funds for this purpose and the quality and diversity of
approved applications.
This RFA is available from:
Ms. Barbara Gunter
Developmental Therapeutics Branch
Division of AIDS
National Institute of Allergy and Infectious Diseases
6003 Executive Boulevard
Bethesda, MD 20892
Telephone: (301) 496-8197
ONGOING PROGRAM ANNOUNCEMENTS
NATIONAL INSTITUTE ON DRUG ABUSE - ANNOUNCEMENT AND GUIDELINES - AUGUST 1990
PA: PA-90-31
P.T. 34; K.W. 1002030, 1002019, 1002008, 1003002, 0710080, 0404009, 0785055
National Institute on Drug Abuse
PURPOSE
The purpose of this announcement is to update the National Institute on Drug
Abuse's (NIDA) General Announcement and Guidelines to reflect the priorities
for the current fiscal year.
RESEARCH OBJECTIVES
Applications for drug abuse research support will be considered in the
following areas:
(1) Basic biomedical and neuroscientific research at the genetic, molecular,
organ, and system level; (2) Biochemistry, pharmaceutical/medical chemistry,
and metabolic and pharmacokinetic studies; (3) Epidemiology and natural
history (etiology) of drug abuse; (4) Treatment research; (5) Prevention
research; (6) Behavioral and clinical pharmacology research; (7) AIDS and drug
abuse; and (8) Drug abuse in the workplace.
NIH GUIDE - Vol. 19, No. 32, September 7, 1990 - Page 8
MECHANISMS OF SUPPORT
Support mechanisms include: (1) Research Projects (R01), (2) Small Grants
(R03), (3) Conference Grants (R13), (4) First Independent Research Support and
Transition Awards (R29), (5) Small Business Innovation Research Grants
(SBIR-R43 and R44), (6) Program Projects (P01), and (7) Research Demonstration
and Dissemination Projects (R18--This program will be announced through a
specific request for applications (RFA)).
In addition, NIDA employs a variety of support mechanisms that undergird the
research training and professional development of clinicians and scientists
upon whom future drug abuse research will depend. These include: (1)
Predoctoral and Postdoctoral Individual National Research Service Awards (F31
and F32), (2) Institutional National Research Service Awards (T32), (3) MARC
Undergraduate NRSA Institutional Grants (T34), and (4) Research and Scientist
Development Awards (K02, K05, K20 and K21).
IMPORTANT - The receipt date appearing later in this announcement are for
either project grant mechanism (R01) or AIDS special receipt dates. All other
research support mechanisms listed above may have their own: (1) receipt and
review date schedule; (2) special programmatic considerations for funding
priority.
ELIGIBILITY
Application for research grants may be made by any public or private
non-profit or for-profit institution such as universities, colleges,
hospitals, laboratories, and units of state or local government, and eligible
agencies of the Federal Government. Women and minority populations are
encouraged to apply.
INCLUSION OF MINORITIES IN STUDY POPULATIONS
Applicants are required to give added attention (where feasible and
appropriate) to the inclusion of minorities in study populations for research
into the etiology of diseases, research in behavioral and social sciences,
clinical studies of treatment and treatment outcomes, research on the dynamics
of health care and its impact on disease, and appropriate interventions for
disease prevention and health promotion. If minorities are not included in a
given study, a clear rationale for their exclusion should be provided.
INCLUSION OF WOMEN IN STUDY POPULATIONS
Applicants are required to consider the inclusion of women in the study
populations for all clinical research efforts. Exceptions would be studies of
diseases that exclusively affect males or where involvement of pregnant women
may expose the fetus to undue risks. Gender differences should be noted and
evaluated. If women are not to be included, a clear rationale should be
provide for their exclusion.
In order to provide more precise information to the treatment community, it is
recommended that publications resulting from Alcohol, Drug Abuse, and Mental
Health Administration-supported research in which the study population was
limited to one sex for any reason other than that the disease or condition
studied exclusively affects that sex, should state, in the abstract summary,
the gender of the population studied, e.g., "male patients," "male
volunteers," "female patients," or "female volunteers."
APPLICATION PROCEDURES
Applicants should use the grant application form PHS 398 (Rev. 10/88). The
title and number of this Program Announcement "NIDA-General Announcement,
PA-90-31," should be typed in item number 2 of the face page of the PHS 398
application form. Please identify any AIDS-related application according to
specific instructions included in the application kit, or that are contained
elsewhere in this announcement, or that have been identified through previous
communications in the NIH Guide to Grants and Contracts.
Application kits containing the necessary forms and instructions may be
obtained from offices of sponsored research at most universities, colleges,
medical schools, and other major research facilities. If such a source is not
available, the following office may be contacted for the necessary material:
Grants Management Branch, NIDA, Room 8A-54, 5600 Fishers Lane, Rockville, MD
20857, (301) 443-6710.
NIH GUIDE - Vol. 19, No. 32, September 7, 1990 - Page 9
The signed original and six (6) permanent legible copies of the completed
non-AIDS application and the signed original and 24 permanent legible copies
of the AIDS applications should be sent to:
Division of Research Grants, NIH
Westwood Building, Room 240
Bethesda, MD 20892**
RECEIPT AND REVIEW SCHEDULE
Receipt Dates Initial Advisory Council Earliest
New/Renewal Review Review Start Date
June 1/July 1* Oct./Nov. Jan./Feb. April
Oct. 1/Nov. 1* Feb./Mar. May/June July
Feb. 1/Mar. 1* May/June Sept./Oct. Dec.
* Amended applications (new or renewal are to be submitted on these dates.
EXPEDITED AIDS APPLICATION RECEIPT AND REVIEW SCHEDULE
AIDS receipt dates (or all new, competing, revised and supplemental AIDS
applications, irrespective of type of activity, i.e., R01, R13, R29, P50,
etc.).
Receipt Dates Initial Advisory Council Earliest
New/Renewal Review Review Start Date
Jan 2* Feb./Mar. May/June June
May 1* June/July Sept./Oct. Nov.
Sept 1* Oct./Nov. Jan./Feb. Feb.
* These receipt dates do not apply to those AIDS Program Announcements or RFAs
which specify alternate receipt dates. AIDS applications received after the
above dates will be held until the next AIDS special review cycle.
REVIEW PROCESS
The Division of Research Grants, NIH, serves as a central point for receipt of
applications for most discretionary PHS grant programs. Applications received
under this announcement will be assigned to an Initial Review Group (IRG) in
accordance with established PHS Referral guidelines. The IRGs, consisting
primarily of non-Federal scientific and technical experts, will review the
applications for scientific and technical merit. Notification of the review
recommendations will be sent to the applicant after the initial review.
Applications will receive a second-level review by a National Advisory Council
whose review may be based on policy as well as scientific merit consideration.
Only applications recommended for approval by the Council may be considered
for funding.
AWARD CRITERIA
Applications recommended for approval by an appropriate Advisory Council will
be considered for funding on the basis of overall scientific and technical
merit of the research as determined by peer review, program needs and balance,
and availability of funds.
INQUIRIES
Contacts for Program Information:
Director, Division of Preclinical Research
Room 10A-31
Telephone: (301) 443-1887
Director, Division of Clinical Research
Room 10A-38
Telephone: (301) 443-6697
Director, Division of Epidemiology and Prevention Research
Room 11A-55
Telephone: (301) 443-6637
Director, Division of Applied Research
Room 9A-54
Telephone: (301) 443-6780
NIH GUIDE - Vol. 19, No. 32, September 7, 1990 - Page 10
The street address for the above is
5600 Fishers Lane
Rockville, MD 20857
This program is described in the Catalog of Federal Domestic Assistance No.
13.279. Grants will be awarded under the authority of Section 301 of the
Public Health Service Act, as amended (42 USC 241) and administered in
accordance with the PHS Grants Policy Statement and Federal regulations at 42
CFR Part 52 and 45 CFR Part 74. This program is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health
System Agency review.
NEURAL AND BEHAVIORAL BASES OF COGNITIVE CHANGE WITH AGE
PA: PA-90-32
P.T. 34; K.W. 0710010, 1002030, 0414005
National Institute on Aging
The Neuroscience and Neuropsychology of Aging Program of the National
Institute on Aging (NIA) is soliciting applications for research and training
grants on the neural and psychological mechanisms underlying cognition in
aging.
The purpose of this program announcement is to broaden the scope of cognitive
research on aging into the realm of cognitive neuroscience. Research that is
being encouraged should take advantage of theoretical and experimental
advances in the fields of cognitive science and neuroscience and apply them to
questions of aging. The use of any model system, including computational,
animal, or human, may be appropriate if it will help elucidate the mechanisms
of cognitive change that can occur with aging and experience. While studies
addressing questions of cognitive aging from either neuroscience or cognitive
science perspectives are encouraged, studies that link neuroscience and
cognitive science approaches to aging are particularly desirable in as much as
they can help clarify the interdependence of brain functions and behavioral
capacities in aging.
I. BACKGROUND
Although the search to understand brain/behavior interactions has a long
history, fundamental questions remain unanswered. In particular, the
biological and psychological mechanisms underlying cognition, and how
cognitive processes are altered by age and experience are not fully
understood. Understanding the processes of cognition in aging is a critical
first step in dissociating the effects of normal aging from those due to
disease. In addition, better understanding of cognitive processes in aging is
necessary for planning therapeutic interventions, appropriately utilizing
skills and expertise, and specifying the requirements of an aging society in
the home and workplace. Older adults constitute the fastest growing segment
of populations world-wide. In order to appreciate their abilities, expertise,
needs and impairments, and ultimately to extend their functioning, it is
necessary to develop a better understanding of the mechanisms inherent to
cognitive change in aging.
The Neuroscience and Neuropsychology of Aging Program, NIA, already supports
research on cognitive aging through investigator-initiated applications.
Cognitive research currently being supported includes human studies on
learning, semantic and contextual memory, selective and visual attention, and
music perception in normal aging and in dementing disorders, as well as animal
studies such as an examination of neurobehavioral relations in senescent
hippocampus.
It is the intent of this program announcement to stimulate additional research
in the area of cognition that will further extend our present understanding of
cognitive processes in aging. At present, questions pertaining to cognitive
aging are typically addressed along two parallel tracks: neuroscientists use
molecular biological, neurochemical, or neurophysiological techniques to
define the structural and functional alterations and plastic adaptations that
can occur with brain aging; and psychologists use behavioral techniques to
study the sparing and loss of cognitive and perceptual capacities that can
occur with aging and develop theories and models of cognitive processes. In a
sense, these studies are limited in that questions of brain structure and
function are often addressed independently from questions of behavior.
Stronger linkage between descriptions of information processing,
specifications of brain activity, and behavior is necessary if we are to
NIH GUIDE - Vol. 19, No. 32, September 7, 1990 - Page 11
understand the mechanisms underlying cognitive changes throughout the aging
process.
II. SCOPE
Applications in response to this program announcement might address questions
such as how processes such as attention, perception, memory, language, problem
solving, or psychomotor functions are controlled or regulated by neural or
psychological mechanisms and how they are affected by normal aging and/or
experience. Studies can draw on recent developments in imaging technology,
computer science, linguistics, clinical and basic neuroscience, and cognitive
and neuropsychology, and may use human, animal, or computational models.
Investigators that address cognition from the perspective of psychosocial and
environmental influences on cognitive functioning in aging should refer to the
program announcement from the Behavioral and Social Research Program of NIA,
Cognitive Functioning and Aging (NIH Guide for Grants and Contracts, Vol. 16,
No. 41, December 18, 1987).
The following is a partial list of topics covered by the present program
announcement. It is not meant to be an exhaustive list. All innovative and
relevant work on cognitive aging is welcome.
Examples of research areas include:
o the nature of the cognitive capacities that appear to decline with
aging versus those that appear to remain intact or improve with age
or experience and their relationship to neural processes;
o applicability of brain imaging (e.g., PET, MRI, MEG),
neurophysiological (e.g., ERP, EEG), and noninvasive
neuropsychological methods to questions of cognitive aging;
o development of computational models at all levels of analysis
ranging from those that model age-associated changes at a single
neuronal level to those studying Hebbian synapses, field effects,
or applying connectionist modeling to questions of altered
cognitive organization in aging;
o interplay of sensation, perception, and cognition in older
individuals; examination of structural or functional and behavioral
changes that occur in the aging brain, and the consequences of
these changes on perceptual integration; studies of the
compensatory and adaptive strategies that are used in older
individuals;
o attentional systems responsible for sustaining and shifting
attention and how these are affected by aging; examination of
age-related changes in the basal forebrain, thalami, and other
subcortical modulatory systems as well as cortical areas and neural
systems involved in attention, arousal, and alertness;
o sparing and loss of linguistic processes in older adults;
o recall and recognition memory changes in aging and their relation
to brain structural and functional changes, including long-term
potentiation;
o differences between changes in contextual memory, working memory,
and prospective memory that can occur in aging and their relation
to cortical and subcortical changes;
o neural and psychological bases for age-associated changes in
aspects of implicit memory, skill learning, and classical
conditioning with aging;
o relative stability of semantic memory and intact lexical and
semantic priming with aging and the correspondence of these
capacities to the relative integrity of more posterior cortical
areas in aging; studies exploring the neural instantiation of
memory subtypes as they are currently conceptualized (e.g.,
procedural vs. declarative and implicit vs. explicit) and the
applicability of these concepts to the functional changes observed
in aging;
o physiological underpinnings of priming, the maintenance of this
memory sub-system in healthy older adults, and the loss of priming
in some demented patient populations
NIH GUIDE - Vol. 19, No. 32, September 7, 1990 - Page 12
o development of sensitive and specific clinical tests for memory or
cognitive assessment;
o reasoning, concept formation, and problem solving ability in aging,
including questions of how the effects of experience are manifested
by alterations in neural systems, structures, and processes with
aging.
III. MECHANISMS OF SUPPORT
The support mechanisms for research proposals in this area are the individual
research project grant (R01), the program project (P01), and the First
Independent Research Support and Transition (FIRST) award (R29). The support
mechanisms for training proposals in this area are the Postdoctoral Individual
National Research Service Award (F32), the National Research Service Award for
Senior Fellows (F33), career grants (K series awards), and the Institutional
National Research Service Training award (T32). Under these mechanisms, the
principal investigator and any participating investigators will plan, direct,
and perform the research or research training.
APPLICATIONS AND REVIEW PROCEDURES
Applications must be prepared on form PHS 398 (Revised 10/88) or the
appropriate training/fellowship application forms using instructions included
in the application kit. These kits are available from the Office of Sponsored
Research of most institutions and from the Division of Research Grants,
National Institutes of Health, Westwood Building, Room 449, Bethesda, MD
20892. Additional application guidelines for NIA P01 applications should be
obtained from the NIA address cited below.
Receipt dates for new research project (R01s and P01s), FIRSTs, and the K
series applications are February 1, June 1, and October 1. Receipt dates for
training applications (F32s, F33s, and T32s) are January 10, May 10, and
September 10.
To identify responses to this announcement, check "yes" and put "Neural and
Behavioral Bases of Cognitive Change with Age, PA-90-32" under item 2 of page
1 of grant applications submitted in response to this program announcement.
Use the mailing label provided in the application kit and mail the signed
original and six copies to:
Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD 20892**
R01s, FIRSTs, and Fs will be reviewed for scientific and technical merit by
appropriate study sections in the Division of Research Grants. P01s, K awards
other than the K04s, and T32s will be reviewed by an appropriate Institute
review group. Secondary review will be by the appropriate national advisory
council. For further information, potential applicants are strongly
encouraged to call or write:
Deborah L. Claman, Ph.D.
Program Director, Neuropsychology of Aging
Neuroscience and Neuropsychology of Aging
National Institute on Aging
National Institutes of Health
Building 31, Room 5C35
Bethesda, MD 20892
Telephone: (301) 496-9350
The NIH requires applicants to include, where feasible and appropriate, women
as well as men and minorities in the study of populations for all clinical and
research efforts and to analyze, where appropriate, differences between these
populations. If women and minorities are not to be included, a clear
rationale for their exclusion should be provided.
This program is described in the Catalog of Federal Domestic Assistance.
Awards will be made under the authority of the Public Health Service Act,
Section 301 (42 USC 241) and administered under PHS grant policies and Federal
Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to
review by a Health Systems Agency.
NIH GUIDE - Vol. 19, No. 32, September 7, 1990 - Page 13
**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
NIH GUIDE - Vol. 19, No. 32, September 7, 1990 - Page 14