Subject: NIH Guide, ll/30/90
From: Dot Baker <[email-masked]>
To: [email-masked]
Date: Wed, 28 Nov 90 13:57 EST

Hi Paul,
  Here comes the NIH Guide for November 30, l990.  Please post to the
NIH Listserver as:
     NIHGUIDE.113090
Thanks.
       Dottie
 ---------------------------- Text of forwarded message -----------------------
 
X-comment: NIH Guide (including TOC) contained 15 pages (1200 lines)
X-comment: RFAs described:  DC-91-02

 

 
NIH GUIDE - Vol. 19, No. 43, November 30, 1990

                                   NOTICES

NATIONAL WORKSHOPS ON "PROTECTION OF HUMAN SUBJECTS" ..(84/204)............. 1
National Institutes of Health
Food and Drug Administration
Index:  NATIONAL INSTITUTES OF HEALTH
        FOOD AND DRUG ADMINISTRATION

NEI INSTITUTIONAL TRAINING GRANTS .....................(207/226)............ 2
National Eye Institute
Index:  EYE

SMALL GRANT PROGRAM FOR PILOT PROJECTS ................(229/246)............ 2
National Eye Institute
Index:  EYE

INVENTIONS:  IMPORTANT NOTICE FOR RESEARCH GRANTEES AND RESEARCH
CONTRACTORS ...........................................(249/344)............ 3
National Institutes of Health
Alcohol, Drug Abuse, and Mental Health Administration
Index:  NATIONAL INSTITUTES OF HEALTH
        ALCOHOL, DRUG ABUSE, AND MENTAL HEALTH ADMINISTRATION

                   NOTICES OF AVAILABILITY (RFPs AND RFAs)

SPECIALIZED RESEARCH CENTER PROGRAMS OR CENTER CORE GRANTS TO SUPPORT
RESEARCH IN REPRODUCTION - REVISION (RFA HD-91-01) ....(350/410)............ 4
National Institute of Child Health and Human Development
Index:  CHILD HEALTH, HUMAN DEVELOPMENT

RESEARCH ON NEURONAL CEROID LIPOFUSCINOSES (BATTEN DISEASE) (RFA NS-91-01) . 5
National Institute of Neurological Disorders and Stroke   (413/558)
Index:  NEUROLOGICAL DISORDERS, STROKE

EXPLORATORY GRANTS TO DEVELOP NATIONAL MULTI-PURPOSE RESEARCH AND
TRAINING CENTERS (RFA DC-91-02) ......(561/648, 1204/1558).................. 7
National Institute on Deafness and Other Communication Disorders
Index:  DEAFNESS, COMMUNICATION DISORDERS

                        ONGOING PROGRAM ANNOUNCEMENTS

SMALL GRANT PROGRAM (PA-91-11) ...............(654/786)..................... 8
National Institute on Deafness and Other Communication Disorders
Index:  DEAFNESS, COMMUNICATION DISORDERS

CLINICAL STUDIES TO PREVENT INSULIN-DEPENDENT DIABETES MELLITUS BY
IMMUNOMODULATION (PA-91-12) ..................(801/969).....................10
National Institute of Diabetes and Digestive and Kidney Diseases
National Institute of Allergy and Infectious Diseases
National Institute of Child Health and Human Development
Index:  DIABETES, DIGESTIVE DISEASES, KIDNEY DISEASES, ALLERGY,
        INFECTIOUS DISEASES, CHILD HEALTH, HUMAN DEVELOPMENT

THE IMMUNOLOGY OF INSULIN-DEPENDENT DIABETES MELLITUS (PA-91-13) ...........12
National Institute of Diabetes and Digestive and Kidney Diseases
National Institute of Allergy and Infectious Diseases    (972/1137)
National Institute of Child Health and Human Development
Index:  DIABETES, DIGESTIVE DISEASES, KIDNEY DISEASES, ALLERGY,
        INFECTIOUS DISEASES, CHILD HEALTH, HUMAN DEVELOPMENT
                                   NOTICES

NATIONAL WORKSHOPS ON "PROTECTION OF HUMAN SUBJECTS"
 
P.T. 42; K.W. 0783005
 
National Institutes of Health
Food and Drug Administration
 
The National Institutes of Health (NIH) and the Food and Drug Administration
(FDA) are continuing to sponsor a series of workshops on responsibilities of
researchers, Institutional Review Boards (IRBs), and institutional officials
for the protection of human subjects in research.  The workshops are open to
everyone with an interest in research involving human subjects.  The meetings
should be of special interest to those persons currently serving or about to
begin serving as a member of an IRB.  Issues discussed at these workshops are
relevant to all other Public Health Service agencies.  The current schedule
includes the following:
 
I.  SOUTHWEST WORKSHOP
 
DATES:  February 4-5, 1991
 
WORKSHOP SITE:
Meridien Hotel
50 Third Street
San Francisco, CA  94103
 
SPONSOR:
University of California at San Francisco
Box 0400
San Francisco, CA  94143
 
REGISTRATION CONTACT:
Ms. Phyllis Colbert
Workshop Contact Person
University of California at San Francisco
Box 0400
San Francisco, CA  94143
Telephone:  (415) 476-1881
 
TOPIC:  "The Use of Human Subjects in Research:  AIDS as a Model of
Complexity"
 
II.  MIDEAST WORKSHOP
 
DATES:  March 4-5, 1991
 
WORKSHOP SITE:
Friday Center
Laurel Hill Parkway
Chapel Hill, NC  27599-1020
 
SPONSORS:
University of North Carolina at Chapel Hill
300 Bynum Hall
Chapel Hill, NC  27599-4100
 
Shaw University
118 E. South Street
Raleigh, NC  27611
 
REGISTRATION CONTACT:
Mr. Al Dawson
Director
Friday Center
Laurel Hill Parkway
C. B. 1020
Chapel Hill, NC  27599-1020
Telephone:  (919) 962-1106
 
TOPIC:  "Problems in Interpreting the Federal Code for the Protection of Human
Subjects"

 

           NIH GUIDE - Vol. 19, No. 43, November 30, 1990 - Page 1
III.  MIDWEST WORKSHOP
 
DATES:  April 11-12, 1991
 
WORKSHOP SITE:
Hyde Park Hilton
4900 Lake Shore Drive
Chicago, IL  60615
 
SPONSORS:
University of Chicago
970 East 58th Street
Chicago, IL  60637
 
Chicago State University
95th Street at King Drive
Chicago, IL  60628
 
REGISTRATION CONTACT:
Mr. Arnold L. Aronoff
Associate Director
Faculty and Administrative Services
University Research Administration
University of Chicago
970 East 58th Street
Chicago, IL  60637
Telephone:  (312) 702-8669
 
TOPIC:  "Cultural Diversity, Ethics, and Research:  A Workshop on Human
Subject Protections"
 
NIH/FDA have planned national human subject protections workshops in other
parts of the United States.  For further information regarding these workshops
contact:
 
Darlene Marie Ross
Executive Assistant for Education
Division of Human Subject Protections
Office for Protection from Research Risks
National Institutes of Health
9000 Rockville Pike
Bldg. 31, Room 5B43B
Bethesda, MD  20892
Telephone:  (301) 496-8101

NEI INSTITUTIONAL TRAINING GRANTS
 
P.T. 44; K.W. 0720005, 1002046, 0715100
 
National Eye Institute
 
The National Eye Institute (NEI) has recently revised its supplemental
instructions for Institutional National Research Service Award applications.
NEI accepts these applications only once a year:  January 10.
 
Investigators are strongly encouraged to obtain a copy of these revised
instructions before submitting an application.  Please contact:
 
Ralph J. Helmsen, Ph.D.
Research Training and Resources Officer
National Eye Institute
National Institutes of Health
Building 31, Room 6A48
Bethesda, MD  20892
Telephone:  (301) 496-5983

SMALL GRANT PROGRAM FOR PILOT PROJECTS
 
P.T. 34; K.W. 1014006
 
National Eye Institute
 
The National Eye Institute (NEI) no longer accepts applications for the Small
Grant Program for Pilot Projects.  The NEI made this decision after an
evaluation of the program and extensive discussions with the National Advisory
Eye Council and its Vision Research Program Planning Subcommittee.  The funds
 
           NIH GUIDE - Vol. 19, No. 43, November 30, 1990 - Page 2
that had been set aside for this program will be used to help fund additional
First Independent Research Support and Transition (FIRST) Awards and Physician
Scientist Awards and to help expand NEI's participation in NIH initiatives for
underrepresented minorities in biomedical research.  Investigators from other
fields who seek support for a new vision research project are encouraged to
discuss their plans with one of NEI's extramural Program Directors.

INVENTIONS:  IMPORTANT NOTICE FOR RESEARCH GRANTEES AND RESEARCH CONTRACTORS
 
P.T. 34; K.W. 1014006, 1014002
 
National Institutes of Health
Alcohol, Drug Abuse, and Mental Health Administration
 
From the Extramural Inventions Office, Building 31, Room 5B-41, NIH, Bethesda,
MD 20892:  The following instructions amplify a current notice (published in
the NIH Guide for Grants and Contracts, Vol. 19, No. 23, June 22, 1990),
regarding grant- and contract-assisted inventions.  Our careful review of
incoming documents has revealed several complications.
 
ACKNOWLEDGEMENT OF GOVERNMENT SUPPORT:  37 CFR 401.14 (f)(4) requires the
grantee/contractor to protect the government's interest in the invention by
including within the specifications of any United States patent application
and any patent issuing thereon covering the subject invention, the following
statement, "This invention was made with government support under (identify
the grant or contract) awarded by (identify the Federal agency).  The
government has certain rights in the invention."  Clearly, this statement is
required in continuation and divisional patent applications as well.
 
Copies of patent applications that fail to acknowledge Government support
continue to be submitted to the Invention Reports Office.  Failure of
applicants to include this clause in the initial submission of the patent
application requires this Office to contact grantees and request them to file
application amendments at additional costs to them.
 
PAPERWORK REDUCTION:  The vast majority of patent applications proceed to
orderly conclusions without Agency intervention.  Consequently, for most
cases, this Office does not need substantial portions of the appreciable
volume of paperwork submitted by grantee organizations in accordance with the
requirements of 37 CFR 401.  While reserving the Government's right to receive
complete documentation upon request, we propose the following alternate
procedure.
 
PATENT APPLICATIONS:  Before submitting copies of patent applications to the
Inventions Reports Office, please remove the detailed specifications,
background, and all drawings and their description.  What will serve instead
as an acceptable alternate are the introductory page with the statement
acknowledging the Government's support plus the summary, abstract, and all
claims.
 
MAILING and REQUESTS FOR ACKNOWLEDGEMENT OF RECEIPT:  For the most part,
documents may be posted via ordinary surface mail.  If the grantee institution
wishes a written response acknowledging receipt of the package, a stamped,
self-addressed return envelope should be furnished.
 
INVENTION UTILIZATION REPORTS:  Grantees are reminded of their obligation
under 35 USC 202 (c)(5), to file periodic (currently biennial) reports on the
utilization of each invention with the funding Agency (NIH).  These reports
shall contain information regarding the status of development, data of first
sale or use, and gross royalties received by the grantee.  Information in
these utilization reports is treated as privileged and confidential and not
subject to disclosure under the Freedom of Information Act.
 
SAMPLE (SIMPLIFIED) LICENSE FORM for use by an Institutional official or any
individual inventor receiving title by waiver from the Federal Agency:
 
                    LICENSE TO THE UNITED STATES GOVERNMENT
 
This instrument confers to the United States Government, as represented by the
Department of Health and Human Services, a nonexclusive, nontransferable,
irrevocable, paid-up license to practice or have practiced on its behalf
throughout the world the following subject invention:

 

 
           NIH GUIDE - Vol. 19, No. 43, November 30, 1990 - Page 3
	Invention Title    :
	Inventor(s)        :
	Patent Application
	   Serial No.      :
	   Filing Date     :
	   Title           :
	Country, if other than the
	   United States   :
 
This license will extend to all divisions or continuations of the patent
application and all patents or re-issues which may be granted thereon.
 
This subject invention was made with government support from Grant/Contract
No. __________________________awarded by the National Institutes of Health.
 
Principal rights to this subject invention have been left with the
Licensor:________________________________________________________________,
subject to the provisions of Title 35 USC 200-212, 37 CFR 401, and 45 CFR 8.
 
Signed:_______________________________________________ Date:______________
 
Typed Name:  Title:
 
                Seal

                   NOTICES OF AVAILABILITY (RFPs AND RFAs)

SPECIALIZED RESEARCH CENTER PROGRAMS OR CENTER CORE GRANTS TO SUPPORT RESEARCH
IN REPRODUCTION - REVISION
 
RFA:  HD-91-01
 
P.T. 04; K.W. 0710110, 0710115, 0413002, 1002042
 
National Institute of Child Health and Human Development
 
Application Receipt Date:  May 6, 1991
 
The Reproductive Sciences Branch (RSB), Center for Population Research (CPR),
National Institute of Child Health and Human Development (NICHD), recently
announced (NIH Guide, Vol. 19, No. 30, page 4, August 17, 1990) the
availability of a Request for Applications (RFA) for Specialized Research
Programs (P50s) or Center Core Grants (P30s) to support research in
reproduction.  This announcement is hereby revised to include clarifications
of policy guidelines relevant to applications to be submitted for this
competition.  These clarifications are as follows:
 
The application should be prepared in a manner consistent with the general
guidelines presented in the publications entitled either P50 SPECIALIZED
RESEARCH CENTER GRANT GUIDELINES or P30 CENTER CORE GRANT GUIDELINES which are
available from the NICHD office listed below.  The current policies and
requirements that govern the research grant programs of NIH will prevail (Code
of Federal Regulations, Title 42, Part 52 and Title 45, Part 75).
Applications prepared for this competition should not propose
multi-institutional consortiums.
 
Applications for grants involving clinical studies should include members of
minority groups and women in the study populations.  Otherwise, a clear
rationale for their exclusion must be provided in the application.
 
The cost of a center will be a material consideration in the selection of
applications for funding.  New Specialized Research Center Grant (P50)
applications should not request more than $600,000 in direct costs for the
first year.  New Center Core Grant (P30) applications should not request more
than $500,000 in direct costs for the first year.  Renewal applications from
existing P30 or P50 Centers should not request initial year direct costs
exceeding 120 percent of the Council recommended direct costs for the final
year of the preceding project period.  Unless prior written approval of the
NICHD has been obtained, applications with requests exceeding these guidelines
will be administratively withdrawn by the NICHD and returned to the applicant.

 

 
 
           NIH GUIDE - Vol. 19, No. 43, November 30, 1990 - Page 4
For further information please contact:
 
Michael E. McClure, Ph.D.
Chief, Reproductive Sciences Branch
Center for Population Research
National Institute of Child Health and Human Development
National Institutes of Health
Executive Plaza North, Suite 603
Bethesda, MD  20892
Telephone:  (301) 496-6515

RESEARCH ON NEURONAL CEROID LIPOFUSCINOSES (BATTEN DISEASE)
 
RFA:  NS-91-01
 
P.T. 34; K.W. 0715138, 1003002, 1002019, 0765033
 
National Institute of Neurological Disorders and Stroke
 
Letter of Intent Receipt Date:  February 1, 1991
Application Receipt Date:  March 15, 1991
 
PURPOSE
 
The neuronal ceroid lipofuscinoses (NCL) are a group of neurodegenerative
diseases of children and adults.  Despite various lines of scientific inquiry,
the cause(s) of NCL remain unknown, with no biochemical, genetic, or single
pathognomonic feature unambiguously identified to aid in understanding and
treating this heterogeneous group of disorders.  This Request for Applications
(RFA) is intended to expand and sustain the NINDS Batten disease research
endeavor through the R01 grant mechanism.
 
RESEARCH GOALS AND SCOPE
 
Research proposals may include but are not limited to the following areas:
 
o Biochemical Studies
 
Biochemical studies should use state-of-the-art techniques to identify and
quantify the structural and mechanistic biochemical defects underlying NCL.
Studies employing either human or animal tissues may be pursued, but careful
attention in protocol designs must be given to identifying and explaining
discrepancies among new and existing data that may arise from differences in
the source, handling and preparation of tissue samples, or variability in
clinical diagnostic criteria.
 
o Genetic Studies
 
Genetic studies should focus on elucidating the hereditary basis of NCL and
explaining the heterogeneity of NCL with respect to age of onset and clinical
manifestations.  Studies applying techniques of molecular biology should focus
on identifying genetic defects associated with particular loci and the
consequences of any defects with respect to the production, processing, and
function of relevant proteins within cells.
 
o Pathology and Diagnosis
 
These studies should contribute to more precise diagnosis and understanding of
the pathology of NCL and facilitate biochemical and genetic projects.
 
MECHANISM OF SUPPORT
 
This is a one-time request that NINDS will support through the regular
research grant (R01) mechanism.  Up to $2 million are available in support of
this program.  Awards will be contingent upon scientific merit and may be made
for a period of one to five years.  Funding for projects beyond the initial
award will be subject to competitive renewal.
 
APPLICATION REQUIREMENTS AND PROCEDURES
 
The application deadline is March 15, 1991.  NINDS invites applications from
those knowledgeable about NCL and also encourages applications from highly
qualified experts in basic and clinical neuroscience who may apply the
expertise, techniques, and insights of their specialized areas to new studies
directly relevant to NCL.  In all cases, however, applications must be related
clearly to NCL and address one or more specific research aims.  Applications
not meeting these criteria will be considered unresponsive and returned.
 
           NIH GUIDE - Vol. 19, No. 43, November 30, 1990 - Page 5
Investigators should carefully consider the appropriate length of time for
their study, and proposals for periods less than five years and smaller
budgets will be accepted without prejudice.  Prospective applicants are
encouraged to communicate with the staff contact who may provide guidance on
the relevance of proposed concepts to the goals of the RFA.  A non-binding
letter of intent that includes a descriptive title, the name of the Principal
Investigator and other Key Investigators, and any other participating
institutions is requested to be submitted directly to the staff contact by
February 1, 1991.
 
Applications should be submitted on Form PHS 398 (revised 10/88).  To identify
response to this RFA, check the "yes" box in Item Number 2 on the face page of
the application and type:  "In response to NS-91-01 Research On Neuronal
Ceroid Lipofuscinoses (Batten Disease)" on line two.  The RFA label available
in the application form PHS 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.
 
Investigators should be aware that NIH requires applicants to give added
attention, where feasible and appropriate, to the inclusion of minorities and
women in study populations.  Gender and minority population differences should
be noted and analyzed wherever possible.  If minorities and/or women are not
included in a given study, a clear reason for their absence must be provided.
Merely including an arbitrary number of minority group and women participants
in a given study is insufficient to guarantee generalization of results.
 
Minority institutions are encouraged to apply, and other institutions are
encouraged to establish collaborative arrangements with minority institutions.
 
Applicants from institutions that have a General Clinical Research Center
(GCRC) funded by the NIH National Center for Research Resources may wish to
identify the GCRC as a resource for conducting the proposed research.  In such
a case, a letter of agreement from either the GCRC program director or
Principal Investigator included with the application is requested.
 
REVIEW PROCEDURES
 
Applications will be reviewed by NIH staff for responsiveness to the RFA.
Responsive applications will be evaluated for scientific/technical merit by a
Special Review Committee convened by the Scientific Review Branch of NINDS
solely for this purpose.  A second-level review will be made by the National
Advisory Neurological Disorders and Stroke Council.
 
The original and four copies of the application should be sent to:
 
Division of Research Grants
Application Receipt Office
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**
 
Two copies of the application also must be sent to:
 
Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke
Federal Building, Room 9C10A
7550 Wisconsin Avenue
Bethesda, MD  20892
 
STAFF CONTACT
 
For further information, potential applicants may contact:
 
Karen J. Skinner, Ph.D
Federal Building, Room 8C-04
National Institute of Neurological Disorders and Stroke
Bethesda, MD  20892
Telephone:  (301) 496-5821
 
This program is described in the Catalog of Federal Domestic Assistance No.
93.853, Clinical Research Related to Neurological Disorders, and 93.854,
Biological Basis Research in the Neurosciences.  Grants will be awarded under
the authority of the Public Health Service Act, Title IV, Section 301 (Public
Law 78-410, as amended:  42 USC 241) and administered under PHS grant policies
and federal regulations 42 CFR Part 52 and 45 CFR 74.  This program is not
subject to health services agency review of the intergovernmental review
requirements of Executive Order 1372.
 
           NIH GUIDE - Vol. 19, No. 43, November 30, 1990 - Page 6
EXPLORATORY GRANTS TO DEVELOP NATIONAL MULTI-PURPOSE RESEARCH AND TRAINING
CENTERS
 
RFA AVAILABLE:  DC-91-02
 
P.T. 34; K.W. 0715050, 0715055, 0720005
 
National Institute on Deafness and Other Communication Disorders
 
Letters of Intent will be due (optional):  February 22, 1991
Application Receipt Date:  March 15, 1991
 
PURPOSE
 
The National Institute on Deafness and Other Communication Disorders (NIDCD)
requests Exploratory Grant applications (P20) from institutions wishing to
develop a National Multi-Purpose Research and Training Center (RTC) for the
multi-disciplinary study of communication sciences and disorders.
 
BACKGROUND
 
In December 1989, NIDCD issued a Request for Applications (RFA) (NIH Guide to
Grants and Contracts, Volume 18, Number 45), announcing its intent to
designate and support a limited number of National Multi-purpose Research and
Training Centers (RTC) for the multi-disciplinary study of communication
sciences and disorders.  The goal of the RTC was the support of basic and
clinical research; research training; continuing education for health
professionals; and dissemination of information to the general public, in one
or more of the program areas of the Institute (hearing, balance, smell, taste,
voice, speech, and language).
 
The purpose of the Exploratory Grant is to plan or strengthen the essential
components of the RTC (noted above) and to enable an institution subsequently
to compete for such a center.  It is expected that particular components for
an RTC may already be in place for some Institutions.
 
The Exploratory Grant program for this RFA provides funding for the
developmental phase of (1) planning and administration of one or more of the
components of an RTC and/or (2) small-scale studies used to develop or test
procedures to be employed in the RTC or to support a particular research
direction.  Up to five awards are possible if meritorious grant applications
and funds are available.
 
The review criteria for Exploratory and RTC Grants include the adequacy of
plans for the inclusion of underrepresented minorities, women, and individuals
with disabilities as research subjects in the basic and clinical research
components of the Exploratory Grant.  For research projects not including any
of these groups a clear rationale must be provided.  (See NIH Guide, Vol. 19,
No. 31, August 24, 1990, and Vol. 19, No. 35, September 28, 1990 for
additional information).
 
MECHANISM OF SUPPORT, NUMBER OF YEARS, AND BUDGET
 
This RFA will be funded through the Exploratory Grant (P20) mechanism.
Exploratory Grants may provide up to two years of support.  Direct costs may
not exceed $100,000 per year.  The Exploratory Grants are not renewable and
supplements to these Grants are not allowed.
 
INQUIRIES
 
Applicants must obtain the following materials before beginning their
applications:  complete RFA for the Exploratory Grant; December 1989 RFA for
National Multi-purpose Research and Training Centers; Application Guidelines:
RTC; and PHS 398 Application Form (rev. 10/88).  Applications should be
developed in close cooperation with NIDCD Program Administrators below who
will provide guidance to applicants on technical and substantive aspects of
this RFA.
 
Maureen Hannley, Ph.D., (Hearing) or
Daniel Sklare, Ph.D., (Balance) or
Judith A. Cooper, Ph.D., (Voice, Speech, and Language) or
Jack Pearl, Ph.D., (Smell and Taste)

 

 
 
           NIH GUIDE - Vol. 19, No. 43, November 30, 1990 - Page 7
Division of Communication Sciences and Disorders
National Institute on Deafness and Other Communication Disorders
National Institutes of Health
Executive Plaza South, Suite 750
6120 Executive Boulevard
Rockville, MD  20852
Telephone:  (301) 496-1804
Fax:  (301) 402-0104

                        ONGOING PROGRAM ANNOUNCEMENTS

SMALL GRANT PROGRAM
 
PA:  PA-91-11
 
P.T. 34; K.W. 0715050, 0715055, 0410001
 
National Institute on Deafness and Other Communication Disorders
 
This announcement for the National Institute on Deafness and Other
Communication Disorders (NIDCD) Small Grant Program supersedes the one issued
in February 1990.  This current Small Grant Program provides support for pilot
research to determine the feasibility of a subsequent research project.  The
research must be focused on areas within the mission of NIDCD, that is,
hearing, balance/vestibular, smell, taste, voice, speech, or language.
 
ELIGIBILITY
 
In contrast to the previous announcement, the current Small Grant Program is
designed solely to support basic and clinical scientists with limited research
experience.  Current or previous recipients of NIH research awards (R01 or
R29) are ineligible for this Small Grant Program.  Participation in the
program by investigators at minority institutions is encouraged.
 
TERMS AND CONDITIONS OF THE AWARD
 
Small grant funds may not be used to support thesis or dissertation research.
 
Applicants may request up to $25,000 (direct costs) per year.  The grant may
not exceed two years and is not renewable.  Following completion of the Small
Grant support, investigators are encouraged to seek support for research
through an Individual Research Project Grant (R01) or a First Independent
Research Support and Transition Award (R29).
 
APPLICATION SUBMISSION AND REVIEW PROCEDURES
 
Only one Small Grant application may be submitted by an individual or
investigative team per receipt date.  Applicants may not submit R01 or R29
applications with the same scientific content concurrently with the submission
of a Small Grant application.
 
The submission, review and award schedule for the Small Grant
Program is:
 
Receipt Dates    Institute Committee   Council        Earliest
  for 1991            Review           Review         Funding
 
January 7        Feb-March             May            July
May 6            June                  Sept-Oct       Dec
September 16     Oct-Nov               Jan-Feb        April
 
A review committee of the NIDCD will evaluate each Small Grant application
with respect to these criteria:
 
  o  significance and scientific merit of the proposed project with
     respect to the existing body of scientific knowledge;
 
  o  scientific merit of the concept and underlying hypotheses;
 
  o  investigator's potential for carrying out the research, as
     demonstrated by publication record and/or previous
     research/clinical experience or training relative to the goals and
     methods of the proposed study;
 
  o  adequacy of the investigator's time commitment to the project;

           NIH GUIDE - Vol. 19, No. 43, November 30, 1990 - Page 8
  o  potential of the proposed studies to lead to more extensive
     research;
 
  o  adequacy of the facilities, supporting personnel, and existing
     equipment for carrying out the proposed studies; and
 
  o  justifications of budget requests.
 
All applications will subsequently be reviewed by the National Deafness and
Other Communication Disorders Advisory Council.  The award of grants is
contingent on receipt of proposals of high scientific merit; responsiveness to
this announcement, including the eligibility of investigators; relevance to
the program; and the availability of appropriated funds.
 
GRANT APPLICATION
 
Use the standard research grant application form, PHS 398 (rev.  10/88).
Application kits are available from the business offices or the offices of
sponsored research of most institutions, the Division of Research Grants,
National Institutes of Health (301-496-7441), and NIDCD Division staff listed
below.
 
Face page.  Item 2.  Type "Small Grant Program NIDCD, PA-91-11".  Check the
"YES" box.
 
Section 2.  Do not exceed five pages.  Applications that exceed the page
limitation or NIH requirements for type size and margins will be returned to
the investigator.  Include the following sections:  specific aims and
significance, progress report/preliminary studies and methods.  Provide
introduction only for revised applications.
 
Applicants are required to include, where feasible and appropriate, minorities
and women as well as men in the study populations for all clinical 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 must be provided.
 
Section 3.  Appendix materials are not allowed.
 
Use the mailing label in the application kit to mail the original and four
copies of the application to the Division of Research Grants.  To expedite the
review, send one copy of the application to:
 
Dr.  Earleen Elkins, Chief, Scientific Review Branch
National Institute on Deafness and Other Communication Disorders
National Institutes of Health
Executive Plaza South, Rm. 750
6120 Executive Plaza Blvd.
Rockville, MD  20852
Telephone:  (301) 496-8683
 
Investigators are encouraged to call (301-496-5061) or write (at the Institute
address noted above) Institute staff responsible for the investigator's
particular area of scientific interest:
 
        Dr. Judith Cooper (voice, speech, language) or
        Dr. Maureen Hannley (hearing) or
        Dr. Jack Pearl (chemical senses) or
        Dr. Daniel Sklare (balance/vestibular)
 
This program is described in the Catalog of Federal Domestic Assistance No.
93.173, Research Related to Deafness and Communication Disorders.  Awards will
be made under the authority of the Public Health Service Act, Section 301
(Public Law 78-410, as amended; 42 USC 241) and administered under PHS grant
policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74.  The
program is not subject to Executive Order 12372.

 

 

 

 
 
           NIH GUIDE - Vol. 19, No. 43, November 30, 1990 - Page 9
CLINICAL STUDIES TO PREVENT INSULIN-DEPENDENT DIABETES MELLITUS BY
IMMUNOMODULATION
 
PA:  PA-91-12
 
P.T. 34; K.W. 0715075, 0710070, 0745040, 0715015, 0785035, 0785050
 
National Institute of Diabetes and Digestive and Kidney Diseases
National Institute of Allergy and Infectious Diseases
National Institute of Child Health and Human Development
 
The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK),
the National Institute of Allergy and Infectious Diseases (NIAID), and the
National Institute of Child Health and Human Development (NICHD) are seeking
applications for clinical studies designed to test the hypothesis that
immunomodulation will prevent insulin-dependent diabetes mellitus (IDDM) in
high-risk populations.
 
BACKGROUND
 
Over the past 10 years, significant progress has been made in defining the
autoimmune etiology and pathophysiology of IDDM.  Several clinical trials of
general immunosuppressive agents in patients with newly diagnosed IDDM have
induced a temporary clinical remission of this disease.  These observations
have led to the hypothesis that immunomodulatory interventions may be
effective in the prevention of this disease in individuals who are
asymptomatic but who are in an earlier period of the autoimmune process.
 
A workshop on Clinical Trials of Immunosuppression for Prevention of IDDM was
held on April 19-20, 1990, in Bethesda, Maryland.  This workshop was sponsored
by the NIDDK, NIAID and NICHD.  It was the charge of this group to assess the
status of scientific and medical knowledge necessary to initiate a clinical
trial of immunomodulatory intervention for the prevention of IDDM.
Participants for the meeting were drawn from the diabetes and immunology
research communities and were chosen to provide a broad range of insight and
judgment in these areas.  Several major issues were extensively discussed, and
consensus was reached in some areas while others remained open for continued
examination, evaluation, and debate.  There was general consensus based on the
published literature and discussion on the following important issues:
 
  1. IDDM in humans is an autoimmune disease and, as such, should be
     amenable to immunotherapeutic intervention;
 
  2. There are measurable parameters that can identify a group of
     individuals at high risk for the development of IDDM; and
 
  3. Further clinical studies in high-risk individuals to explore the
     ability of immunomodulation to alter the natural history of IDDM
     are timely and warranted.
 
A summary of this workshop is available from the NIDDK staff listed at the end
of this announcement.
 
RESEARCH GOALS AND SCOPE
 
The goal of this Program Announcement is to stimulate clinical research that
will evaluate the effectiveness of immunomodulatory therapies for the
prevention of IDDM in high-risk populations.  The research scope of this
program will encompass a range of basic and clinical research disciplines,
such as immunology, endocrinology, genetics, biochemistry, pharmacology,
physiology and pediatrics.  Some examples of relevant research areas to be
addressed by these clinical studies include:
 
  o  Identification and characterization of markers that have value in
     predicting remission or progression in pre-IDDM individuals on
     long-term immunotherapy;
 
  o  Using presently available markers, determine the natural history of
     high-risk individuals; and
 
  o  Evaluation of the effect of immunomodulatory interventions in
     high-risk individuals including efficacy in prevention of
     progression of the autoimmune process and parameters such as
     dosage, duration, and deleterious side affects.
 
These recommendations are not necessarily all inclusive and any new ideas with
credible hypotheses that would appropriately fall within the scope of this
announcement may be the basis for an application.
 
           NIH GUIDE - Vol. 19, No. 43, November 30, 1990 - Page 10
APPLICATION AND REVIEW PROCEDURES
 
The mechanism for support for this program will be the individual research
grant (R01).  The application may include subcontracts or consortia with
multiple institutions.  Applicants should use the standard research grant
application (PHS 398, revised October 1988).  If application kits are not
available at the institution's business office or central application control
office, an individual copy may be requested by writing to the National
Institutes of Health, Division of Research Grants, 5333 Westbard Avenue, Room
449, Bethesda, MD, 20892.
 
The clinical studies anticipated as a result of this announcement will likely
require the screening of large numbers of individuals.  It is anticipated that
this may necessitate the coordinated efforts of several clinical centers.
Because of the complexity of reviewing multi-center clinical studies,
responders to this announcement are advised to submit their applications by
June 1, 1991.
 
Applications in response to this solicitation will be reviewed in accordance
with the usual NIH peer review procedures.  Applications will first be
reviewed for scientific and technical merit by a review group composed mostly
of non-Federal scientific consultants (study section).  Secondary reviews will
be by appropriate national advisory councils.  Applications recommended for
approval will compete for available funds with all other approved applications
assigned to the Institutes.  However, because the Institutes and their
Advisory Councils have identified this research area to be of particular
program interest, applications responsive to this announcement will be brought
to the special attention of the Councils.
 
Applicants from institutions that have a General Clinical Research Center
(GCRC) funded by the NIH National Center of Research Resources may wish to
identify the Center as a resource for conducting the proposed research.  In
such a case, a letter of agreement from the GCRC Program Director should be
included in the application material.
 
Applicants are reminded that applications and awards for extramural support
for clinical research studies involving human subjects should include women
and minorities unless a compelling justification is made for their exclusion.
For further information, consult the statements of NIH policy on the inclusion
of minorities and women in study populations that appeared in the NIH Guide
for Grants and Contracts.  The issue dated August 24, 1990, (Vol. 19, No. 31,
pp. 18-19) announced the policy on women; the policy on minorities appeared
in the issue dated September 28, 1990, (Vol. 19, No. 35, pp. 1-2).
 
In order to identify the application as a response to this Program
Announcement, check "yes" on Item 2 of the application face page with the
title "Clinical Studies to Prevent IDDM by Immunomodulation, PA-91-12."  The
original and six copies of the application should be mailed to:
 
Application Receipt Office
Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**
 
Potential applicants are encouraged to discuss their plans with appropriate
NIH program staff listed below.
 
Dr. Joan T. Harmon
Executive Director, Diabetes Research Program
NIH, NIDDK, DDEM, DPB
Westwood Building, Room 622
Bethesda, MD  20892
Telephone:  (301) 496-7731
 
Dr. Howard B. Dickler
Acting Deputy Director
Division of Allergy, Immunology and Transplantation
NIH, NIAID
Westwood Building, Room 755
Bethesda, MD  20892
Telephone:  (301) 496-7104

 

 
 
           NIH GUIDE - Vol. 19, No. 43, November 30, 1990 - Page 11
Dr. Gilman D. Grave
Chief, Endocrinology, Nutrition and Growth Branch
NIH, NICHD, CRMC
Executive Plaza North - Room 637
Bethesda, MD  20892
Telephone:  (301) 496-5593
 
This program is described in the Catalog of Federal Domestic Assistance No.
93.847, Diabetes, Endocrinology and Metabolism Research.

THE IMMUNOLOGY OF INSULIN-DEPENDENT DIABETES MELLITUS
 
PA:  PA-91-13
 
P.T. 34; K.W. 0715075, 0755030, 0765035, 0710070, 1002004, 1002008, 1002019
 
National Institute of Diabetes and Digestive and Kidney Diseases
National Institute of Allergy and Infectious Diseases
National Institute of Child Health and Human Development
 
This announcement is intended to encourage submission of research proposals to
develop our knowledge and understanding of the etiology and pathophysiology of
insulin-dependent diabetes mellitus (IDDM).  It is anticipated that new
insights into identification and monitoring of individuals at risk for this
disease, as well as novel interventions effective in the prevention of this
disease, will be forthcoming.
 
BACKGROUND
 
Understanding of IDDM has been greatly improved by the elucidation of the role
that the immune system plays in the pathophysiology of the development of this
disease.  Parameters such as islet cell autoantibody (ICA) titers, competitive
insulin autoantibody (CIAA) titers, and reductions in the first phase plasma
insulin response to intravenous glucose (IVGTT) can be employed to select
individuals at high risk for the development of IDDM.  However, the
relationship of these parameters to the natural history or to the etiology of
this disease remains unclear, and the parameters presently identify only a
minority of the individuals who will eventually develop IDDM.
 
At the recent workshop on the Clinical Trials of Immunosuppression for
Prevention of IDDM (April 19-20, 1990, Bethesda, Maryland), general consensus
was reached on several important issues.  First, IDDM is an autoimmune
disease.  Second, there are several parameters that can identify a group of
individuals at high risk for the development of IDDM.  As a result of this
consensus, clinical studies to explore the ability of immunomodulation to
alter the natural history of IDDM are considered timely and warranted.  A
companion Program Announcement designed to be complementary to the present one
is to alert the scientific community of our interest in considering the
support of such clinical studies at the present time.
 
A number of other issues that require further research efforts were discussed
at the workshop.  This Program Announcement specifically seeks to address
these issues.  A summary of this workshop is available from the NIDDK staff
member listed at the end of this announcement.
 
RESEARCH GOALS AND SCOPE
 
The goal of this Program Announcement is to stimulate basic and clinical
research that will elucidate the etiology and pathophysiology of IDDM.
 
The research scope of this program will encompass a wide range of basic and
clinical research disciplines, such as biochemistry, immunology, cellular
biology, endocrinology, genetics, molecular biology, pharmacology and
physiology.  The areas of research recommended include:
 
  o  Development of methods to ascertain beta cell mass in normal,
     high-risk, and diseased individuals;
 
  o  Determination of the natural history of IDDM with respect to the
     presently available selection parameters;
 
  o  Identification of new parameters that will allow early detection of
     susceptible individuals, expansion of screening protocols to the
     general population, or that will correlate with the disease
     process;

 
           NIH GUIDE - Vol. 19, No. 43, November 30, 1990 - Page 12
  o  Identification of the initiating event that triggers the autoimmune
     process in this disease;
 
  o  Establishment of new immunomodulatory interventions tailored
     specifically to IDDM; and
 
  o  Utilization of appropriate animal models to ascertain the efficacy
     of potential interventions.
 
These recommendations are not necessarily all inclusive and any new ideas with
credible hypotheses that would appropriately fall within the scope of this
announcement may be the basis for an application.
 
APPLICATION AND REVIEW PROCEDURES
 
The mechanisms of support for this program will include the individual
research project grant (R01), the First Independent Research Support and
Transition (FIRST) Award (R29), the National Research Service Award (F32 and
F33), and career awards such as the Research Career Development Award (K04),
Clinical Investigator Award (K08) and Physician Scientist Awards (K11).  The
award of grants pursuant to this announcement is contingent upon both the
receipt of proposals of high scientific merit that are responsive to this
announcement and the availability of appropriated funds.
 
Applications will be received by the NIH Division of Research Grants (DRG),
referred to an appropriate Study Section for scientific merit review, and
assigned to individual Institutes for possible funding.  Referral decisions
will be governed by normal programmatic considerations as specified in the
Referral Guidelines of the Public Health Service.
 
Applications in response to this solicitation will be reviewed on a
nation-wide basis in competition with other applications and in accordance
with the usual NIH peer review procedures.  Applications will first be
reviewed for scientific and technical merit by a review group composed mostly
of non-Federal scientific consultants (study section), and then by the
National Advisory Council of the appropriate Institute(s).  The review
criteria customarily employed by the NIH will prevail.
 
Applicants are reminded that applications and awards for extramural support
for clinical research studies involving human subjects should include women
and minorities, unless a compelling justification is made for their exclusion.
For further information, consult the statements of NIH policy on the inclusion
of minorities and women in study populations that appeared in the NIH Guide
for Grants and Contracts.  The issue dated August 24, 1990, (Vol. 19, No. 31,
pp. 18-19) announced the policy on women; the policy on minorities appeared
in the issue dated September 28, 1990, (Vol. 19, No. 35, pp. 1-2).
 
Applications should be submitted on PHS Form 398 (revised October 1988), which
is available in the business or grants and contracts office at most academic
and research institutions.  On the face page of PHS Form 398, under item 2,
indicate that the application was prepared in response to the program
announcement entitled "The Immunology of IDDM, PA-91-13."  The original and
six copies of the application should be sent or delivered to:
 
Application Receipt
Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**
 
Applications will be accepted in accordance with the usual NIH receipt dates
for applications.
 
For further information, investigators may contact one or more of the
following individuals:
 
Dr. Joan T. Harmon
Executive Director, Diabetes Research Program
NIH, NIDDK, DDEM, DPB
Westwood Building, Room 622
Bethesda, MD  20892
Telephone:  (301) 496-7731

 

 
 
           NIH GUIDE - Vol. 19, No. 43, November 30, 1990 - Page 13
Dr. Howard B. Dickler
Acting Deputy Director
Division of Allergy, Immunology and Transplantation
NIH, NIAID
Westwood Building, Room 755
Bethesda, MD  20892
Telephone:  (301) 496-7104
 
Dr. Gilman D. Grave
Chief, Endocrinology, Nutrition and Growth Branch
NIH, NICHD, CRMC
Executive Plaza North, Room 637
Bethesda, MD  20892
Telephone:  (301) 496-5593
 
This program is described in the Catalog of Federal Domestic Assistance No.
93.847, Diabetes, Endocrinology and Metabolism Research.

**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

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 
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