kristoff@GENBANK.BIO.NET (Dave Kristofferson) (07/27/90)
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. 27, July 20, 1990
NOTICES
RECEIPT DATES FOR AIDS COMPETING APPLICATIONS ..........(84/126)............. 1
National Institutes of Health
Index: NATIONAL INSTITUTES OF HEALTH
NOTICES OF AVAILABILITY (RFPs AND RFAs)
SURVEILLANCE EPIDEMIOLOGY AND END RESULTS EXPANSION (RFP) ..(132/170)........ 1
National Cancer Institute
Index: CANCER
SYNTHESIS OF CONGENERS AND PRODRUGS OF ANTI-AIDS COMPOUNDS (RFP) ..(173/229). 2
National Cancer Institute
Index: CANCER
NATURAL PRODUCTS LEAD-BASED SYNTHESIS (RFP) ...............(241/278)......... 3
National Cancer Institute
Index: CANCER
PROXY MEASURES FOR SERIOUS CHILDHOOD INJURIES (RFA HD-90-11) ..(281/380)..... 3
National Institute of Child Health and Human Development (484/770)
Index: CHILD HEALTH, HUMAN DEVELOPMENT
ERRATUM
UPDATE ON THE NIH POLICY REGARDING PROGRAM PROJECT, AND OTHER COMPLEX
MULTIFACETED, UNSOLICITED GRANT APPLICATIONS ................(404/421)....... 5
National Institutes of Health
Index: NATIONAL INSTITUTES OF HEALTH
NOTICES
RECEIPT DATES FOR AIDS COMPETING APPLICATIONS
P.T. 34; K.W. 0715008, 1014006
National Institutes of Health
In the March 11, 1988, NIH Guide for Grants and Contracts (Vol. 17, No. 9),
the NIH announced the establishment of the dates of January 2, May 1, and
September 1 as receipt dates (for May, October, and February Advisory
Councils, respectively) for investigator-initiated Acquired Immune Deficiency
Syndrome (AIDS) research grant applications. These receipt dates differ from
those for other applications and have been established in order to accomplish
the receipt-to-award process in an accelerated fashion, as mandated by law.
While that announcement also allowed for submission of AIDS-related
applications on regular receipt dates, with the recent chartering of initial
review groups specifically for the review of AIDS applications it is now
necessary for all applicants submitting investigator-initiated AIDS-related
applications to adhere strictly to the AIDS receipt dates.
It must be stressed that the above receipt dates are for competing
continuation (Type 2) and supplemental (Type 3) applications, as well as for
new (Type 1) applications. Thus, for example, while some current grantees may
have had their last competing AIDS-related application peer reviewed by an
initial review group other than one of the recently established AIDS review
groups, all subsequent competing continuation applications must be submitted
for the receipt dates listed above for review by these AIDS initial review
groups.
AIDS-related applications include those which propose studies on the etiology,
epidemiology, natural history, pathology, diagnosis, treatment or prevention
of AIDS or the various sequellae specifically associated with the syndrome.
Basic studies of the HIV virus, such as virology, molecular genetics,
immunology, and in vivo or in vitro models of human HIV infection aimed at
elucidating the mechanism of the AIDS infectious process are direcly
applicable. Preparation and screening of anti-AIDS agents as well as vaccine
development in both preclinical and clinical studies are included. Relevant
studies of blood and blood products, neurological effects of HIV infection,
behavioral research, and prevention of high-risk behaviors, and education
projects are also acceptable. The final determination of AIDS relatedness is
the responsibility of the Division of Research Grants (DRG), NIH. For further
guidance, applicants are advised to contact the Referral Office, DRG, at (301)
496-7447.
NOTICES OF AVAILABILITY (RFPs AND RFAs)
SURVEILLANCE EPIDEMIOLOGY AND END RESULTS EXPANSION
RFP AVAILABLE: NCI-CN-05302-03
P.T. 34; K.W. 0785055, 0413001, 0715035, 0755018
National Cancer Institute
The National Cancer Institute, Division of Cancer Prevention and Control, is
soliciting proposals for an Expansion of the Surveillance, Epidemiology and
End Results (SEER) Program. The thrust of this proposed project is to: 1)
obtain within the geographic area of coverage, data on all newly diagnosed
cases of cancer beginning January 1, 1990 forward; 2) obtain cancer patient
survival data on all cases diagnosed in 1990 forward; 3) monitor trends in the
incidence of specific forms of cancer, particularly with respect to
demographic and social characteristics of the population; and 4) assess the
completeness and accuracy of all data collected. Offerors must provide
documentation of authority to collect data for their identified coverage area
and will be required to have a Hispanic population of at least 300,000 in
their coverage area.
Requests for this solicitation must be in writing and reference RFP No.
NCI-CN-05302-03. The RFP will be available approximately July 30, 1990, and
will be due approximately September 13, 1990.
The National Cancer Institute expects to make one award from this
solicitation.
NIH GUIDE - Vol. 19, No. 27, July 20, 1990 - Page 1
Copies of the RFP may be obtained by sending a written request to:
Mrs. Shirley Kyle, Contracting Officer
National Institutes of Health
National Cancer Institute
Research Contracts Branch, PCCS
Executive Plaza South, Room 635
9000 Rockville Pike
Bethesda, MD 20892
Telephone: (301) 496-8603
SYNTHESIS OF CONGENERS AND PRODRUGS OF ANTI-AIDS COMPOUNDS
RFP AVAILABLE: NCI-CM-17513-28
P.T. 34; K.W. 1003006, 1003012, 0755025, 0715008
National Cancer Institute
The Drug Synthesis and Chemistry Branch (DS&CB), of the Developmental
Therapeutics Program (DTP), Division of Cancer Treatment (DCT), 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-AIDS agents. The assigned objectives of this 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) which 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 compounds must be excluded from
the competition. For purposes of this restriction, a pharmaceutical or
chemical company is defined as an organization which sells drugs and chemicals
to the general public for profit.
This is a recompetition of contracts currently held by the University of
Alabama, Georgia Tech Research Corp. (Georgia Inst. of Technology), 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 three years beginning on or about May 30,
1991.
RFP No. NCI-CM-17513-28 was issued on July 16 and is available upon request to
Carolyn Barker, Contract Specialist, and proposals will be due approximately
nine weeks thereafter.
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
NIH GUIDE - Vol. 19, No. 27, July 20, 1990 - Page 2
NATURAL PRODUCTS LEAD-BASED SYNTHESIS
RFP AVAILABLE: NCI-CM-17502-19
P.T. 34; K.W. 0750025, 1003006, 1003012, 0715008, 0715035
National Cancer Institute
The Drug Synthesis and Chemistry Branch of the Developmental Therapeutics
Program, Division of Cancer Treatment (DCT), National Cancer Institute (NCI),
is seeking contractors with established expertise in the field of enantio- and
stereoselective synthesis of complex molecules to prepare natural products and
their derivatives for evaluation as antitumor and AIDS antiviral agents. The
NCI signs legally binding agreements with some suppliers (often pharmceutical
or chemical companies) which state that all information on compounds donated
by those suppliers will be held confidential. The successful offeror may be
assigned a confidential compound as a synthesis or modification target. If
the contractor were a chemical or pharmaceutical company they could gain
valuable data on confidential new lead compounds. The NCI believes that in
order to honor the confidentiality agreement with suppliers and in order to
avoid any chance of transmitting privileged data to a competitor,
pharmaceutical and chemical companies must be excluded from this competitive
procurement.
RFP No. NCI-CM-17502 will be issued, upon written request to Zethering Gore,
Contract Specialist, the week of July 16, 1990. Proposals will be due
approximately seven weeks thereafter. The contract period is to be for three
years, beginning approximately March 1991.
Copies of the RFP may be obtained by sending a written request to:
Ms. Zethering Gore, Contract Specialist
National Institute of Health
National Cancer Institute
Research Contracts Branch, TCS
Executive Plaza South, Room 603
9000 Rockville Pike
Bethesda, MD 20892
PROXY MEASURES FOR SERIOUS CHILDHOOD INJURIES
RFA AVAILABLE: HD-90-11
P.T. 34; K.W. 0715027, 0770005, 0413001, 0404000, 0775000
National Institute of Child Health and Human Development
Application Receipt Date: November 30, 1990
The Human Learning and Behavior Branch (HLB) of the Center for Research for
Mothers and Children (CRMC), National Institute of Child Health and Human
Development (NICHD), invites grant applications for research to develop
measures which are proxy or substitutes for serious, potentially fatal, or
handicapping injuries in children and youth. These measures are needed to
develop and evaluate interventions for serious injuries without depending on
the actual occurrence of these injuries. Such measures used in lieu of fatal
or handicapping injuries are considered proxy measures for serious injuries.
In the United States, injuries are the leading cause of death and disability
among children and young adults. They account for about half of all deaths in
children under 15 years and almost 80 percent of deaths in the 15 to 24 age
group. Clearly, injury is one of the most important challenges facing the
health and scientific community in reducing mortality and suffering in
childhood. However death and disability due to injury is still a relatively
uncommon event. Studies aimed at development and evaluation of intervention
strategies are complicated by the large samples required and dependence on
tragic events as outcome measures. Therefore, measures are needed which
predict the probability of serious injury more accurately than existing
measures and can be used as dependent measures without depending on actual
occurrence of these injures. Such measures must be observable and measurable.
They may consist of sociodemographic, behavioral, physiological or even
genetic variables or combinations of such variables. They could comprise a
set of variables which describes the process for serious injuries as a model
and as distinct from that for minor injuries. The relationship of the
occurrence of serious injuries to minor injuries is a central issue for this
research.
NIH GUIDE - Vol. 19, No. 27, July 20, 1990 - Page 3
The major injuries experienced by children vary by age, location, and other
factors. Therefore, no one measure or set of measures is likely to predict
all injuries of children. However, this research must focus on at least one
major type or cause of injury for at least one age group and should apply or
generalize to more than one injury or age group.
It is anticipated that the development and validation of such measures may
require the use of large populations or data bases with sufficient information
regarding childhood injuries. However, development of proxy measures for
serious injury would also require longitudinal follow-up and additional
information than is currently available with cross-sectional samples.
Linkages between existing data bases may prove useful.
The product of this research should be a measure or set of measures which
would predict the probability of serious injury with greater accuracy than any
other currently existing measure. The proxy measure(s) must also be
sufficiently accurate so that with evaluation of interventions, changes in the
measure will reflect changes in the actual rates of serious injury with
sufficient power to be used for this purpose. Suggested examples of possible
proxy measures for serious injury include: minor injuries (if strong
correlation with serious injuries is demonstrated), safety or injury related
behavior, or a set of demographic and/or other descriptive variables which
highly predict the probability of injury.
This Request for Applications (RFA) is intended to be one component of a
program of childhood injury research within NICHD and other Public Health
Service agencies. The focus of this announcement is to develop measures which
are proxy for serious injuries to children. Based upon understanding gained
from this and other research, interventions can be developed and evaluated as
part of future planned funding initiatives.
The PHS urges applicants for grants to give added attention (where feasible
and appropriate) to the inclusion of minorities and females in study
populations for research in the behavioral and social sciences. If minorities
and females are not included in a given study, a clear rationale for their
exclusion should be provided. Investigators are reminded that merely
including arbitrary numbers of minority group and females participants in a
given study is insufficient to guarantee generalization of results.
Applications should be submitted on Form PHS-398 (rev. 10/88), which is
available in the business or grants and contracts office at most academic and
research institutions or from the Division of Research Grants, NIH.
Applications prepared in response to this RFA should be received by November
30, 1990. The RFA label available in the 10/88 revision of Application Form
398 must be affixed to the bottom of the face page. Failure to use this label
could result in delayed processing of the application, such that it may not
reach the review committee in time for review.
It is anticipated that two awards will be made as a result of this
announcement through the grant-in-aid (RO1) mechanism used by the NICHD. For
a copy of the detailed RFA fully describing the specific areas of research
sought, contact the following:
Peter C. Scheidt. M.D., M.P.H.
Human Learning and Behavior Branch
National Institute of Child Health and Human Development
Room 633, EPN
9000 Rockville Pike
Bethesda, MD 20892
Telephone: (301) 496-6591
NIH GUIDE - Vol. 19, No. 27, July 20, 1990 - Page 4
ERRATUM
UPDATE ON THE NIH POLICY REGARDING PROGRAM PROJECT, AND OTHER COMPLEX
MULTIFACETED, UNSOLICITED GRANT APPLICATIONS
P.T. 34; K.W. 0710030, 1014006
National Institutes of Health
This announcement as published in the NIH Guide for Grants and Contracts on
June 11, 1990, Vol. 19, No. 23, contained an incorrect address for Dr. Judith
Vaitukaitis of the National Center for Research Resources. The following is
the correct address:
National Center for Research Resources
5333 Westbard Avenue
Westwood Building, Room 8A16
Bethesda, MD 20892
Att: Dr. Judith Vaitukaitis
Telephone: (301) 496-6023
NIH GUIDE - Vol. 19, No. 27, July 20, 1990 - Page 5
PROXY MEASURES FOR SERIOUS CHILDHOOD INJURIES
RFA: HD-90-11
P.T. 34; K.W. 0715027, 0770005, 0413001, 0404000, 0775000
National Institute of Child Health and Human Development
Letter of Intent Receipt Date: October 31, 1990
Application Receipt Date: November 30,1990
I. BACKGROUND INFORMATION
The Human Learning and Behavior Branch (HLB) of the Center
for Research for Mothers and Children (CRMC), National
Institute of Child Health and Human Development (NICHD),
supports research in behavioral pediatrics, which focuses on
applying principles of human learning and development to
health and illness behaviors of children. A part of this
research effort seeks to determine the role of behavior at
various levels in the etiology of childhood injuries and to
develop effective interventions based on principles
governing human behavior to enhance the prevention of
unintentional injuries to children. In 1987, NICHD
developed a five-year research initiative to improve
approaches to prevention of childhood injury. This
initiative, based on recommendations by a panel of experts
in behavioral science and injury research, includes the
development of specific methodologies important for
advancement of this field. As part of this program of
research toward prevention of childhood injury, this Request
for Applications (RFA)
invites scientists to submit grant applications for research
concerned with one aspect of methods needed for research,
the development of proxy measures for serious injuries.
In the United States, injuries are the leading cause of
death and disability among children and young adults. They
account for about half of all deaths in children under 15
years and almost 80 percent of deaths in the 15 to 24 year
age group. In children, as in adults, motor vehicles
crashes are the leading cause of injury-related deaths,
followed by fires/burns, drowning, choking on food/objects
(for children 1-4 years), firearms (for ages 5-14 years) and
falls. Injuries incapacitate about two million children for
two weeks or longer, and at least 100,000 children suffer
permanent disabilities each year. Clearly, injury is one of
the most important challenges facing the health and
scientific community in reducing mortality and suffering in
childhood.
Until recently, the majority of research on childhood injury
has been extremely limited and focused primarily on
descriptive epidemiology. With increasing recognition of
the magnitude of the threat of injuries to children, injury
prevention research has begun to receive greater emphasis
and support. In 1986, NICHD held a workshop on Approaches
to Research in Childhood Injury to formulate questions for
research, identify key methodologies needing development,
and stimulate investigation in this area. The
proceedings of this workshop were published in the American
Journal of Diseases of Children, Vol. 142, June 1988, and
formed the basis for development of the five-year initiative
of research toward prevention of childhood injuries. One
recommendation of the workshop and a component of the
research initiative is addressed by the Objective and Scope
of this RFA.
II. OBJECTIVE AND SCOPE
The prevention of death and/or disability from injury is of
highest priority. Though unintentional injury is the most
frequent cause of mortality for children and youth over one
year of age, death due to unintentional injury is,
fortunately, still a relatively uncommon event. It has been
estimated that to collect prospective information on 100
children with injuries severe enough to result in
hospitalization requires collection of data on about 12,000
children for five years. Studies aimed at development and
evaluation of intervention strategies are complicated by the
large samples required and by the necessity to depend on
these tragic events as outcome measures. Therefore, it is
highly desirable to develop the capability to conduct
research regarding development and evaluation of
interventions for serious injuries without depending on the
actual occurrence of these injuries. Such measures used in
lieu of fatal or handicapping injuries are considered proxy
measures for serious injuries.
This RFA invites scientists to submit grant applications for
research to develop measures which are proxy or substitutes
for serious, potentially fatal, or handicapping injuries in
children and youth. The exact nature of such measures or
groups of measures is currently undetermined and open ended.
They must be observable and measurable. They may consist of
sets of sociodemographic, behavioral, physiological, or even
genetic variables or combinations of such variables. They
could comprise a set of variables which describes the
process for serious injury as a model and as distinct from
that for minor injuries. The relationship of the occurrence
of serious injuries to minor injuries is a central issue for
this research. Are individuals who experience serious
injury distinguishable or indistinguishable from the much
larger population of individuals with minor injuries?
The major injuries experienced by children vary by age,
location, and other factors. Therefore, no one measure or
set of measures is likely to predict all injuries of
children. However, this research must focus on at least one
major type or cause of injury for at least one age group and
should apply or generalize to more than one injury or age
group.
It is anticipated that the development and validation of
such measures may require the use of large populations or
data bases with sufficient information regarding childhood
injuries. Examples of such existing data bases include
national vital statistics, nationally representative surveys
like the NCHS Child Health Survey, or large trauma
registries. However, development of proxy measures for
serious injury would also require longitudinal follow-up and
additional information than is currently available with
cross-sectional samples. Furthermore, creative linkages
between existing data bases may also prove useful.
The product of this research should be a measure or set of
measures which would predict the probability of serious
injury with greater accuracy than any other currently
existing measure. The proxy measure(s) must also be
sufficiently accurate so that with evaluation of
interventions, changes in the measure will reflect changes
in the actual rates of serious injury with sufficient power
to be used for this purpose. As an example from another
area, if one is interested in adolescent sexual activity as
a difficult to measure unobservable target behavior,
associated factors which predict this behavior might be
proximity to sexually active peers, length of dating
relationship with someone of the opposite sex, or frequency
of calls or contact with the opposite sex. Suggested
examples of possible proxy measures for serious injury
include: minor injuries (if strong correlation with serious
injuries is demonstrated), safety or injury related
behavior, or a set of demographic and/or other descriptive
variables which highly predict the probability of injury.
III. MECHANISM OF SUPPORT
The support mechanisms for this program will be the
individual research project grant (RO1). This solicitation
is included in the plans for Fiscal Year 1991. It is
anticipated that two grants will be awarded, depending on
the overall merit of the applications and final availability
of funds.
Applicants will furnish estimates of the time which will be
required to conduct the proposed research. Ordinarily,
grants are supported from one to a maximum of five years.
The current policies and requirements that govern the
research grant programs of NIH will prevail.
IV. REVIEW PROCEDURES AND CRITERIA
Applications will be reviewed by NICHD staff for
responsiveness to the RFA. Non-responsive applications will
be returned to the applicant. The applicant then has the
option to resubmit to NIH and have it assigned for review in
the same manner as unsolicited grant applications during the
next review cycle.
If the application submitted in response to this RFA is
substantially similar to a research grant application already
submitted to the NIH for review, but has not yet been reviewed,
the applicant will be asked to withdraw either the pending
application or the new one. Simultaneous submission of
identical applications will not be allowed, nor will essentially
identical applications be reviewed by different review committees.
Therefore, an application cannot be submitted in response to this
RFA which is essentially identical to one that has already been
reviewed. This does not preclude the submission of substantial
revisions of applications already reviewed, but such applications
must include an introduction addressing the previous critique.
Responsive applications may be subjected to triage by a
peer-review group to determine their scientific merit
relative to the other applications received in response to
this RFA. PHS will withdraw from competition those
applications judged to be noncompetitive and notify the
applicant and institutional business official. Those
applications judged to be competitive will be further
evaluated for scientific/technical merit by a review panel
convened solely for this purpose by the Scientific Review
Program, NICHD. The factors to be used in evaluating the
scientific merit of each application will be those used in
judging individual research project grant applications,
including originality of the proposed research and
feasibility of approach; quality of theoretical-conceptual
framework; adequacy of research design; appropriateness of
data analysis techniques; suitability of facilities;
training, experience, and research competence of
investigators; and soundness of proposed budget.
The PHS urges applicants for grants to give added attention
(where feasible and appropriate) to the inclusion of
minorities and females in study populations for research in the
behavioral and social sciences. If minorities and females are not
included in a given study, a clear rationale for their
exclusion should be provided. Investigators are reminded
that merely including arbitrary numbers of minority group and females
participants in a given study is insufficient to guarantee
generalization of results.
V. APPLICATION PROCEDURE
Potential applicants are invited to send a letter of intent
that includes a brief descriptive title, the name of the
principal investigator(s), and other participating
institutions, to Dr. Peter
C. Scheidt at the address listed at the end of the RFA. A
letter of intent is neither binding nor required as a pre-
condition of applying for an NIH award; however, it could be
helpful to establish contact with appropriate NICHD staff
and would facilitate organization of the special initial
review group for applications received in response to the
announcement.
Applications should be submitted on Form PHS-398 (rev. 10/88) which is
available in the business or grants and contracts office at
most academic and research institutions or from the Division
of Research Grants, NIH. Applications prepared in response
to this RFA should be received by November 30, 1990.
The RFA label available in the 10/88 revision of
Application Form 398 must be affixed to the bottom of the
face page. Failure to use this label could result in
delayed processing of the application such that it may not
reach the review committee in time for review.
The phrase "PREPARED IN RESPONSE TO RFA HD-90-11: Proxy
Measures for Serious Childhood Injuries," should be typed
on line two of the application face page.
The original and four copies of the application
should be sent or delivered to:
Application Receipt Office
Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD 20892**
In addition,
two copies of the application
must be sent under separate cover to:
Laurance Johnston, Ph.D.
Scientific Review Program
National Institute of Child Health
and Human Development, NIH
Room 520A, Executive Plaza North
Rockville, MD 20892
Applications must be received by November 30, 1990. Those
received after this date will not be accepted.
Letter of intent October 31, 1990
Application receipt date November 30,1990
Initial review February 1991
Review by National Advisory Child
Health and Human Development Council May 1991
Anticipated award date July 1991
Inquiries regarding this announcement and letters of intent
should be directed to:
Peter C. Scheidt, M.D., M.P.H.
Human Learning and Behavior Branch
National Institute of Child Health and Human
Development
EPN, Room 633
9000 Rockville Pike
Bethesda, MD 20892
Telephone: (301) 496-6591
This program is described in the catalog of Federal Domestic
Assistance No. 13,865, Research for Mothers and Children.
Awards will be made under the authority of the Public Health
Service Act, Section 301 (42 USC241), and administered under
and 45 CFR Part 74. This program is not subject to review
by a Health Systems Agency.