Path: utzoo!utgpu!watserv1!watmath!att!emory!wuarchive!uunet!bionet!GENBANK.BIO.NET!kristoff From: kristoff@GENBANK.BIO.NET (Dave Kristofferson) Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 19, no. 43, 30 November 1990 Message-ID: Date: 5 Dec 90 00:19:46 GMT Sender: kristoff@genbank.bio.net Lines: 1470 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. 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 NIH GUIDE - Vol. 19, No. 43, November 30, 1990 - Page 14 ------------------------- Full text of RFAs ------------------------- REQUEST FOR APPLICATIONS (RFA) EXPLORATORY GRANTS (P20) RFA: DC-91-02 P.T. 34; K.W. 0715050, 0715055, 0720005 EXPLORATORY GRANTS TO DEVELOP NATIONAL MULTI-PURPOSE RESEARCH AND TRAINING CENTERS National Institute on Deafness and Other Communication Disorders Letter of Intent Receipt Date: 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 for 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 develop and 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 is for the development of the essential research and research-related components not fully in place and not supported by other funds. The Exploratory Grant will focus on one or more of the Institute's major research interests: hearing, balance, smell, taste, voice, speech, and language and aspects of relevant areas such as molecular biology, genetics, cellular biology, neurochemistry, immunology, electrical engineering, toxicology, and communication prostheses. Applicants will be responsible for the selection of the unified theme to which each of the four essential components must relate. All of the existing and prospective components must be of high quality, as judged by the NIH standards for biomedical or behavioral research excellence, and all components should be fully in place by the end of the period of the grant award in anticipation of submission of a meritorious grant application for an RTC award. Specifically, the Exploratory Grant program provides funding for: (1) planning and administration, including the planning, evaluation, coordination, and integration of one or more of the components of an RTC and/or (2) small-scale projects, including innovative pilot research, surveys to identify appropriate patient populations, and feasibility studies involving the development or evaluation of methodology in outreach programs. The scope, direction, uniqueness, and execution of activities are left to applicants to develop. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) grant-in-aid (P20 mechanism). Applicants will be responsible for the planning, direction, and execution of the proposed project. Except as otherwise stated in this RFA, awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement. TERMS OF AWARD This RFA is a one-time solicitation with a specified deadline of March 15, 1991. Applications received after this receipt date will be returned. Grants made under this mechanism are not renewable and supplements to these grants are not allowed. Five awards may be made if meritorious grant applications and funds are available. The direct costs for each grant may not exceed $100,000 per year. The project period should be at least one (1) year and may not exceed two (2) years. The earliest possible start date for the initial award is July 1, 1991. Although funding provisions for this Exploratory Grant program are provided for in the Institute's financial plans, the award of grants pursuant to this RFA is also contingent on the availability of funds for this purpose. It is expected that investigators collaborating on the Exploratory Grant will not necessarily derive all of their support from this grant. However, if proposed projects within the Exploratory Grant overlap with current support (for example, with an ongoing R01), the investigator must accept the project support only within the Exploratory Grant. Funds to support research training and the outreach programs for education and information dissemination may not be requested. However, the Exploratory Grant may be used to develop these components. Funds for alteration and renovation are not allowed under the terms of this Exploratory Grant. Funds for the purchase and installation of equipment in excess of $15,000 during the period of the grant are not allowed. SPECIAL REQUIREMENTS Underrepresented minorities, women, and individuals with disabilities: 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 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). In addition, the review criteria include the adequacy of the affirmative plan for the recruitment of underrepresented minorities and disabled individuals in the research training component. (See NIH GUIDE, Volume 18, Number 20, June 9, 1989 for additional information). ELIGIBILITY REQUIREMENTS AND TERMS OF AWARD Non-profit and for-profit organizations and institutions, governments and their agencies are eligible to apply. Foreign institutions are not eligible. Holders of a currently-funded NIH Program Project, Center Grant, or Institutional Training Grant are eligible. REVIEW PROCEDURES AND CRITERIA REVIEW PROCEDURE Applications will be evaluated by Institute Staff to determine whether they are responsive to the requirements and criteria stated in this RFA. Applications judged non-responsive will be returned to the applicant. In preparing proposals, applicants should use supplemental material available from the Institute and direct questions concerning the responsiveness of the proposed research to Institute staff named below under Inquiries. If the number of applications is large compared to the number of awards to be made, the Institute may conduct a preliminary scientific peer review to eliminate those that are clearly not competitive. The Institute will administratively withdraw from competition those applications judged to be non-competitive and notify the applicant and institutional business official. Those applications judged to be both responsive and competitive will be evaluated for scientific and technical merit by a Special Review Committee of the NIDCD. The second level of review will be made by the National Deafness and Other Communication Disorders Advisory Council. REVIEW CRITERIA The overall evaluation of the Exploratory Grant is focused on the potential of the applicant to develop into an RTC. The review criteria for the program encompass both what is in place and what is to be developed. Specific criteria for reviewing the program as an integrated effort and for reviewing each of the components start on page 14 of the complete RFA for RTC (also available in the E-Guide issued December 22, 1989). The complete RFA for RTC and the Guidelines for RTC are available as indicated below under Inquiries. METHOD OF APPLYING The regular research grant application form PHS-398 (revised 10/88) must be used in applying for these grants. The arrangement of materials must follow both the instructions in the PHS Form 398 application kit and the more Specific Instructions detailed below. These forms are available at most institutional business offices; from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Westwood Building, Room 449, Bethesda, Maryland 20892; or from the Institute as specified below under Inquiries. 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 your application such that it may not reach the review committee in time for review. In addition, the title of the application and the RFA number should be typed on line 2 of the face page of the application form. Submit a signed, typewritten original of the application, including the Checklist, and four (4) signed, exact photocopies, in one package to: DIVISION OF RESEARCH GRANTS National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At time of submission, two (2) additional copies of the application should also be sent to: Chief, Scientific Review Branch Division of Extramural Activities National Institute on Deafness and Other Communication Disorders Executive Plaza South, Suite 750 6120 Executive Boulevard Rockville, MD 20892 If the applicant has an approved assurance covering the research (multiple project assurance for human subjects, full assurance of compliance for animal subjects), the applicant should provide with the application certification of institutional review board (IRB) approval if humans are involved and verification of the institutional animal care and use committee (IACUC) approval if animals are involved. These reviews and approvals should occur prior to submission of the applications for award and the certifications and verifications should be submitted with the applications. Failure to provide required certifications and verifications within applications could result in deferral or rejection. If animals or humans will be subjects of the research at performance sites other than the applicant organization, the applicants must identify, within the application, the assurance status of each participant. Failure to provide this information within applications could result in rejection of the applications. Applications must be received by March 15, 1991. 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 that 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. LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes a descriptive title of the proposed application, the name, address, and telephone number of the principal investigator, the names of other key personnel, the participating institutions, and the number or title of this RFA by February 22, 1991. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains is extremely helpful in planning for the review of applications. It allows Institute staff to estimate the potential review workload and to avoid possible conflict of interest in the review. The letter of intent should be sent to: Dr. Earleen Elkins, Chief Scientific Review Branch National Institute on Deafness and Other Communication Disorders National Institutes of Health Executive Plaza South, Suite 750 6120 Executive Boulevard Rockville, MD 20892 Telephone: (301) 496-1804 Fax : (301) 402-0104 INQUIRIES Inquiries concerning the RFA are encouraged by the Institute. Applicants must obtain the following materials: complete RFA for the Exploratory Grant, previously-issued RFA for National Multi-purpose Research and Training Centers, Application Guidelines for RTC, and PHS 398 Application Form. 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) 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 20892 Telephone: (301) 496-1804 Fax: (301) 402-0104 SCHEDULE Letter of Intent: February 22, 1991 Application Receipt Date: MARCH 15, 1991 Initial Review: March 1991 Secondary Review: May 16, 1991 Anticipated Award Date: July 1, 1991 SPECIFIC INSTRUCTIONS Applications in response to this RFA must use the PHS Form 398 (rev. 10/88) and the materials must be arranged in the format of the Guidelines for RTC. If the appropriate format and guidelines are not followed, the application will be returned to the applicant. This arrangement helps the Institute staff and reviewers AND provides a checklist for the applicant institution in preparing the application. Applicants should keep in mind that the written application is the basis of the merit review; site visits will not be conducted for Exploratory Grants. Applicants are encouraged to consult with Institute staff about the technical aspects of preparing the application. Specific instructions that supercede those of the Guidelines for RTC follow: Guidelines for RTC page 6 Use the RFA number for the Exploratory Grant. Guidelines for RTC page 8 The requested support may not exceed two years. Guidelines for RTC page 10 Each of the component projects must be in the format that follows. 1. Describe what is in place. 2. Describe what is planned (developmental phase of planning) through the support of the (a) Exploratory Grant and (b) any other sources of support. 3. Describe any small-scale projects proposed in the format of a regular research grant (R01). 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 (42 USC241), and administered under PHS grant policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to review by a Health Systems Agency. Brought to you by Super Global Mega Corp .com