kristoff@GENBANK.BIO.NET (Dave Kristofferson) (04/13/90)
NIH GUIDE - Vol. 19, No. 15, April 13, 1990
NOTICES
NUCLEIC ACID AND PROTEIN SEQUENCE ANALYSIS WORKSHOP FOR BIOMEDICAL
RESEARCHERS ..........................................(84/137)............... 1
National Center for Research Resources
Index: RESEARCH RESOURCES
NIH REGIONAL CONFERENCE IN GRANTS ADMINISTRATION .....(140/193).............. 1
National Institutes of Health
Index: NATIONAL INSTITUTES OF HEALTH
THE NATIONAL DISEASE RESEARCH INTERCHANGE ............(196/226).............. 2
National Center for Research Resources
Index: RESEARCH RESOURCES
NOTICES OF AVAILABILITY (RFPs AND RFAs)
ASSESSMENT OF PDQ AS A MODEL SYSTEM TO DISSEMINATE INFORMATION ABOUT
EFFECTIVE THERAPY (RFP) ..............................(244/286).............. 3
National Cancer Institute
Index: CANCER
NOTICE: AIDS CLINICAL TRIAL INFRASTRUCTURE COOPERATIVE AGREEMENT FOR
MINORITY INSTITUTIONS (RFA 90-AI-04) .................(289/331).............. 3
National Institute of Allergy and Infectious Diseases
Index: ALLERGY, INFECTIOUS DISEASES
CLINICAL STUDIES OF SAFETY AND EFFECTIVENESS OF ORPHAN PRODUCTS
(RFA FDA-OP-90-01) ...................................(334/430, 644/1133).... 4
Food and Drug Administration
Index: FOOD AND DRUG ADMINISTRATION
ONGOING PROGRAM ANNOUNCEMENTS
RESEARCH GRANTS ON NARCOLEPSY (PA-90-03)..............(436/562).............. 5
National Institute of Neurological Disorders and Stroke
Index: NEUROLOGICAL DISORDERS, STROKE
NOTICES
NUCLEIC ACID AND PROTEIN SEQUENCE ANALYSIS WORKSHOP FOR BIOMEDICAL RESEARCHERS
P.T. 42; K.W. 0755045, 0760070, 1004000
National Center for Research Resources
The Pittsburgh Supercomputing Center (PSC) is conducting a three-day workshop
on "Nucleic Acid and Protein Sequence Analysis," August 6-8, 1990. This
workshop is funded by a cooperative agreement award from the Biomedical
Research Technology (BRT) Program, National Center for Research Resources
(NCRR), National Institutes of Health.
The workshop will familiarize biomedical researchers with computational
methods and provide practice in applying supercomputing resources to problems
of concern in macromolecular sequence analysis. The workshop will emphasize
alignment of and pattern extraction from multiple sequences. Participants
will gain practical experience on Pittsburgh Supercomputing Center's Cray
Y-MP/832 in (1) comparing and aligning sequences, (2) identifying informative
patterns in a set of sequences, and (3) using extracted informative patterns
to identify related sequences. Participants will gain experience with
rigorous dynamic programming approaches to multiple sequence alignment as well
as with consensus word approaches; they will also learn how to use profile
analysis effectively on their own problems. Participants are encouraged to
bring sequence analysis problems from their current research.
Workshop Leaders: Stephen Altschul and Greg Schuler from the National Library
of Medicine and Michael Gribskov from the National Cancer Institute-Frederick
Cancer Research Facility.
This three-day workshop will include an optional half-day session on the
afternoon of Sunday, August 5. This session will introduce participants to
VAX VMS and Unicos, the Cray version of the AT&T System V Unix operating
system.
Travel, meals and hotel accommodations are covered for U. S. academic
participants under the cooperative agreement award. A limited number of
openings for industry-based biomedical researchers may be available for a fee
of $1000. Enrollment is limited to 20 participants. The deadline for the
submission of applications is June 4, 1990.
Grants of computing time are also available through this cooperative agreement
award program funded by the Biomedical Research Technology Program, NCRR, NIH.
For application forms and further information, call or write to:
Nancy Kiser
Biomedical Coordinator
Pittsburgh Supercomputing Center
4400 Fifth Avenue
Pittsburgh, PA 15213
Telephone: (412) 268-5206 or 1-800-222-9310 (PA)
1-800-221-1641 (outside PA)
E-mail: kiser@a.psc.edu or
kiser@cpwpsca.bitnet
NIH REGIONAL CONFERENCE IN GRANTS ADMINISTRATION
P.T. 42; K.W. 1014006
National Institutes of Health
A regional conference covering topics related to grants administration at the
National Institutes of Health (NIH) is planned for June 2-3, 1990, at the
Virginia Beach Resort and Conference Center, Virginia Beach, Virginia. The
NIH conference will precede the Society of Research Administrators' Northeast
Section meeting scheduled for this same location from June 4-6, 1990.
The conference is located to attract administrators and faculty from Delaware,
Maryland, Pennsylvania, Virginia, West Virginia, and Washington, D.C. Those
interested from other states are also encouraged to attend. Investigators and
staff from small and minority colleges, for-profit research organizations,
hospitals, universities, and research institutes are also invited.
NIH GUIDE - Vol. 19, No. 15, April 13, 1990 - Page 1
This two-day conference has a dual focus of interest to both researchers and
grants administrators. Discussions of current issues that affect NIH funding
and grants administration are included to give conference participants a
comprehensive, up-to-date view of NIH-sponsored research. The first day of
the conference will be devoted to discussions of budget issues affecting NIH
funding decisions. Preparation of an NIH grant application and the NIH review
process are the agenda topics for Sunday morning's program. The afternoon
will be devoted to policy and procedural issues affecting NIH grants
administration. The format for this conference will include case studies,
group discussions, and formal presentations. Time will be available for
conference participants to meet informally with the NIH representatives and
discuss topics of special interest.
Mr. Geoffrey Grant, Grants Policy Officer in the Office of Extramural Research
at NIH, representatives from the Division of Research Grants, and program and
grants management staff of several awarding components are featured speakers.
Conference schedule and fee information will be mailed early April 1990. For
more information contact:
Mr. Joe Flaherty
Massachusetts Eye and Ear Infirmary
243 Charles Street
Boston, MA 02114
Telephone: (617) 573-3009
or
Ms. Janis Gottlieb
Laurie Imaging Center
141 French Street
New Brunswick, NJ 08901
Telephone: (201) 247-9191
THE NATIONAL DISEASE RESEARCH INTERCHANGE
P.T. 34; K.W. 0780000, 0780005, 0780020, 0755050
National Center for Research Resources
The National Disease Research Interchange (NDRI) is a center for the
procurement, preservation and distribution of normal and diseased human
tissues and organs available for biomedical researchers. NDRI currently
provides 165 different types of human tissue procured from autopsies, eye
banks, surgical procedures, and organ retrieval programs. NDRI tailors the
procurement and preservation of human tissue to the individual researcher's
scientific protocol. Donor information accompanies all distributed tissue
samples. To obtain human tissue for research, investigators must submit a
formal brief application for specific types of tissue. The requests are
reviewed by a committee of advisors for scientific merit and feasibility.
Once approved, a procurement proposal is developed with the investigator for
each specific tissue, outlining the constraints with regard to donor criteria,
tissue size, processing needs, and time/delivery limitations. Investigators
may request to have tissue delivered fresh with or without tissue culture
media, fixed, or frozen. A modest service fee for the retrieval,
preservation, and delivery of tissue is paid by the investigator. To receive
an application or make inquiries, write or call:
The National Disease Research Interchange
2401 Walnut Street, Suite 408
Philadelphia, PA 19103
Telephone: (800) 222-NDRI or (215) 557-7361.
NDRI is supported by a cooperative agreement award from the Biological Models
and Materials Resources Program, National Center for Research Resources, NIH.
NIH GUIDE - Vol. 19, No. 15, April 13, 1990 - Page 2
NOTICES OF AVAILABILITY (RFPs AND RFAs0
ASSESSMENT OF PDQ AS A MODEL TO DISSEMINATE INFORMATION ABOUT EFFECTIVE
THERAPY
RFP AVAILABLE: NCI-CO-03886-59
P.T. 34; K.W. 0715035, 0745070, 1004017, 0730050
National Cancer Institute
The National Cancer Institute (NCI) and the new Agency for Health Care Policy
and Research (AHCPR) are collaborating on a project to evaluate PDQ [Physician
Data Query - an NCI clinical cancer treatment information resource] as a model
system to disseminate information about effective therapy. The purpose of
this project is to determine if the use of explicit standards of care and
guidelines, as represented by PDQ, by physicians will modify their behavior
and increase the delivery of what is judged as treatment(s) most likely to be
effective. The areas of examination should include the characteristics of the
physicians and their practice settings. The contractor shall identify a way
or ways to provide PDQ information to physicians in community practice
settings, i.e., communities outside an academic medical center or major
teaching hospital, and shall examine physicians' behavior when PDQ is
implemented in the different community practice settings (office, clinic,
hospital, etc.) at the point of decision making. The central question to be
answered by this study is whether physician treatment plans become more
congruent with treatment options in PDQ after physicians are presented with
treatment information from PDQ. Success will thus be measured by modification
in physician behavior and patient enrollment in clinical trials.
It is anticipated that a cost-reimbursement type contract will be awarded for
a period of three years beginning September 30, 1990. This is a full and open
competition and all responsible sources may submit a proposal which shall be
considered by the agency. RFP No. NCI-CO-03886-59 will be issued on or about
April 16, 1990, with proposals due approximately 45 days thereafter.
Copies of the RFP may be obtained by sending a written request to:
A. Christine Virts
Contracting Officer,
Research Contracts Branch
National Cancer Institute
9000 Rockville Pike
Executive Plaza South, Room 608
Bethesda, MD 20892
NOTICE: AIDS CLINICAL TRIAL INFRASTRUCTURE COOPERATIVE AGREEMENT FOR MINORITY
INSTITUTIONS
RFA: 90-AI-04
P.T. 34, FF; K.W. 0715008, 0755015, 0404000, 0403004
National Institute of Allergy and Infectious Diseases
Revised Application Receipt Date: June 12, 1990
A National Institute of Allergy and Infectious Diseases (NIAID)-sponsored
Request for Applications (RFA) entitled "AIDS Clinical Trial Infrastructure
Cooperative Agreement for Minority Institutions" was published in the March 2,
1990 (Vol. 19, No. 9, page 6) issue of the NIH Guide for Grants and
Contracts. It stated that receipt of application is April 26, 1990. However,
the receipt date has been changed to June 12, 1990.
A one day Pre-Application Meeting will be held in Bethesda, Maryland, on April
24 for representatives from eligible institutions to discuss elements of, and
clarify issues in, the RFA 90-AI-04 entitled "AIDS Clinical Trial
Infrastructure Cooperative Agreement for Minority Institutions." NIAID
representatives from Review, Grants Management and Division of AIDS staff will
be available at this meeting to answer questions regarding the RFA,
preparation and review of the application, and grants management and
administrative aspects.
NIH GUIDE - Vol. 19, No. 15, April 13, 1990 - Page 3
For more information please contact:
Ms. Tina Johnson
Clinical Research Management Branch
Treatment Research Program
Division of AIDS
National Institute of Allergy and Infectious Diseases
Control Data Bldg., Room 207P
6003 Executive Bldg.
Bethesda, MD 20892
Telephone: (301) 496-8214
CLINICAL STUDIES OF SAFETY AND EFFECTIVENESS OF ORPHAN PRODUCTS
RFA AVAILABLE: FDA-OP-90-01
P.T. 34; K.W. 0715149, 0755015, 0740000
Food and Drug Administration
Application Receipt Date: May 15, 1990
The Food and Drug Administration (FDA) is announcing the availability of funds
for Fiscal Year 1990 to support clinical trials on the safety and
effectiveness of orphan products.
BACKGROUND
The Office of Orphan Products Development (OPD) was established to identify
and facilitate the availability of orphan products. These orphan products
include drugs, biologics, medical devices, and foods for medical purposes
which are indicated for a rare disease or condition (i.e., one affecting fewer
than 200,000 people in the United States). Such products usually lack
adequate commercial sponsorship because they are not considered commercially
attractive for marketing. A subcategory of orphan products are marketed
products for which there is evidence suggesting usefulness in a rare disease
or condition but which are not labeled for that disease or condition because
substantial evidence of safety and effectiveness for that use is lacking.
All funded studies are subject to the requirement of the requirements of the
Federal Food, Drug, and Cosmetic Act and regulations promulgated thereunder.
The goal of the FDA's Orphan Products Development grants program is to
encourage the investigation of new products and new uses for already approved
products, for use in rare diseases or conditions. In support of this goal,
the FDA provides grants to conduct clinical studies intended to provide data
acceptable to the agency which will either result in or substantially
contribute to approval of these new products or new uses. Applicants should
keep this goal in mind and must include in the application a discussion of how
their proposed study will either facilitate product approval or provide
essential data needed for product development. The application will be
returned without review if such information is not included. This requires
the applicant to have had discussions with the responsible FDA reviewing
division regarding the submission of an Investigational New Drug (IND) or
Investigational Device Exemption (IDE) before submitting the grant
application. Application for an IND or IDE must be submitted to FDA and
approval to proceed must be received before a grant or cooperative agreement
will be awarded. (Medical foods may possibly be exempt from this
requirement.)
FDA will consider awarding grants and cooperative agreements to support
clinical studies for determining whether the products are safe and effective
for premarket approval under the act (21 U.S.C. 301 et seq.) or under section
351 of the Public Health Service Act (42 U.S.C. 262). Ordinarily, at least
some preliminary clinical research suggesting effectiveness and relative
safety should already be available.
Applications should be for one discrete clinical trial. The applicant must
provide evidence that the product to be investigated is available to the
applicant in the form needed for the clinical trial. The applicant must also
provide evidence that the patient population has been surveyed and that there
is reasonable assurance that the necessary number of eligible patients are
available for the study.
NIH GUIDE - Vol. 19, No. 15, April 13, 1990 - Page 4
MECHANISM OF SUPPORT
Support will be in the form of grant or cooperative agreement awards which
will be subject to all policies and requirements that govern the research
grant programs of the Public Health Service.
REVIEW PROCEDURES
All applications submitted in response to this request for applications will
be reviewed and evaluated for scientific and technical merit by experts in the
subject field of the specific application and will also be subject to a second
level of review by a National Advisory Council for concurrence of the
recommendations made by the first-level reviewers.
METHOD OF APPLYING
Potential applicants should write or phone the individual listed below for the
full RFA document, which includes instructions for the submission of
applications:
Carol A. Wetmore
Food and Drug Administration
Office of Orphan Products Development, HF-35
5600 Fishers Lane, Room 15-61
Rockville, MD 20857
Telephone: (301) 443-4903
Applications must be submitted to the Food and Drug Administration using PHS
Form 398. The outside of the mailing package and line 2 of the application
face page should be labeled "Response to RFA-FDA-OP-90-1."
ONGOING PROGRAM ANNOUNCEMENTS
RESEARCH GRANTS ON NARCOLEPSY
PA: PA-90-03
P.T. 34; K.W. 0715138, 0715187, 0765035, 1002058, 0745020, 0745070
National Institute of Neurological Disorders and Stroke
I. INTRODUCTION
The National Institute of Neurological Disorders and Stroke (NINDS) encourages
the submission of research project grant applications (R01) related to
narcolepsy.
II. BACKGROUND
Narcolepsy is a neurological condition characterized by irresistible episodes
of sleep. The classic symptoms of narcolepsy are: 1) sleep attacks - sudden
urges to sleep; 2) cataplexy - sudden generalized or partial flaccid
paralysis; 3) hypnagogic hallucinations - sleep onset hallucinations; and 4)
sleep paralysis - generalized paralysis before or at the time of falling
asleep or on awaking. Narcolepsy usually appears during the teen or early
adult years. The natural history of this condition has not been well
described.
The prevalence of narcolepsy in the United States has been estimated to be as
high as one per 1,000. It is a major reason for patient visits to sleep
disorder centers. Cognitive impairment does occur, but may be secondary to
excessive daytime somnolence.
The neural control of sleep states and the relationship to narcolepsy are only
partially understood. In humans, narcolepsy sleep is characterized by a
tendency to go from a waking state to rapid eye movement (REM) sleep with
little or no intervening nonREM sleep. The changes in the motor and
proprioceptive systems during REM sleep have been studied in both human and
animal models. During normal REM sleep, spinal and brainstem alpha motor
neuron hypopolarization produces almost complete atonia of skeletal muscles
via an inhibitory descending reticulospinal pathway. Acetylcholine may be one
of the neurotransmitters involved in this pathway. In narcolepsy, the reflex
inhibition of catalepsy is believed identical to that seen in normal REM
sleep. Modern neuroanatomical, neurophysiological and neurochemical
techniques need to be further applied to increase the understanding of the
pathophysiology of narcolepsy.
NIH GUIDE - Vol. 19, No. 15, April 13, 1990 - Page 5
Studies in narcoleptic dogs, a naturally occurring model, suggest an autosomal
recessive mode of transmission in that animal. However, despite the
experimental evidence in human narcolepsy that there may be an inherited basis
for at least some forms of narcolepsy, the mode of inheritance is unknown.
Genetic analysis of cohorts of narcoleptic patients and identification of
informative families are needed to define the mode of inheritance and to
facilitate the search for gene markers.
In clinical practice, the differentiation between narcolepsy and other
conditions characterized by excessive somonolence may be difficult. Objective
methods for improving diagnosis are needed.
Treatment options are currently limited. There is a paucity of controlled
double-blind studies of possibly effective drugs or other forms of therapy in
the literature. Mechanisms of action of some of the few available therapeutic
modalities have been explored but detailed studies of mechanism of action are
needed.
III. RESEARCH GOALS
The goal of this announcement is to stimulate research in both basic and
clinical aspects of narcolepsy. The scope of this program encompasses both
animal and human studies, which, would utilize a variety of experimental
approaches and methods. If experimental studies on human subjects are
proposed, the protocols should contain recruitment procedures to encourage the
participation of women and minorities.
Examples of areas of potential research include studies on the pathophysiology
of narcolepsy; abnormalities of circadian rhythms, particularly anatomical and
biochemical; the molecular genetics of narcolepsy; and the rational
development of new therapy. Objective diagnostic procedures need to be
developed and validated.
IV. MECHANISM OF SUPPORT
Support for this program will be through the traditional research grant-in-aid
(R01) and First Awards (R29). Successful applicants will direct and carry out
the individual research projects.
V. APPLICATION AND REVIEW PROCEDURES
Applications should be prepared on Form PHS 398 (revised 10/88) according to
instructions contained in the application kit. Application kits are available
from most institutional business offices or may be obtained from the Division
of Research Grants at the address given below. Check "yes" in item two on the
face sheet of the application and type "NINDS Grant Related to Narcolepsy,
PA-90-03" in the space provided.
Applications must be responsive to the program announcement and the goals of
the NINDS. They will be judged on scientific merit and program relevance in
accordance with NIH policy and procedures involving peer review. An initial
review will be by an appropriate study section of the Division of Research
Grants. A second level of review will be by an appropriate National Advisory
Council.
Receipt dates for applications are February 1, June 1, and October 1.
The original and six copies of the application should be mailed to the
following address:
Division of Research Grants
National Institutes of Health
Room 240, Westwood Building
Bethesda, MD 20892**
For further information, applicants may contact:
Charlotte B. McCutchen, M.D.
NIH, NINDS, DCDND, EB
Federal Building, Room 114
7550 Wisconsin Avenue
Bethesda, MD 20892
Telephone: (301) 496-1917
This program is described in the Catalog of Federal Domestic Assistance No.
13.853, Clinical Basis Research, NINDS. Awards will be made under the
authority of the Public Health Service Act, Title IV, Section 30l (Public Law
78-410, as amended; 42 USC 241) and administered under PHS grant policies and
NIH GUIDE - Vol. 19, No. 15, April 13, 1990 - Page 6
Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not
subject to Health Systems Agency Review.
**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. 15, April 13, 1990 - Page 7