Vol. 18, No. 1, January 13, 1989 NOTICES REMINDER: LETTERS OF REFERENCE ...........................(84/111)......... 1 Division of Research Grants Index: RESEARCH GRANTS WORKSHOP-ETHICAL ISSUES IN SENSITIVE BEHAVIORAL RESEARCH INVOLVING MINORS .. 1 National Institutes of Health (114/143) Index: NATIONAL INSTITUTES OF HEALTH NOTICE OF AVAILABILITY - RECOMMENDED COUNCIL GUIDELINES ON ETHYL ALCOHOL ADMINISTRATION IN HUMAN EXPERIMENTATION ...........(146/174)........ 1 National Institute on Alcohol Abuse and Alcoholism Index: ALCOHOL ABUSE, ALCOHOLISM NOTICE OF MEETING .........................................(177/229)........ 2 National Institutes of Health Index: NATIONAL INSTITUTES OF HEALTH NOTICE OF MEETING .........................................(241/301)........ 3 Public Responsibility in Medicine and Research Index: PUBLIC RESPONSIBILITY IN MEDICINE AND RESEARCH REQUIREMENTS FOR DRUG-FREE WORKPLACE: GRANT AND CONTRACT AWARDEES ......... 3 Public Health Service (304/355) Index: PUBLIC HEALTH SERVICE EXPANDED AUTHORITIES FOR GRANTEE ORGANIZATIONS -- CLARIFICATION OF APPLICABILITY TO CERTAIN GRANT AWARD MECHANISMS ........(358/392)........ 4 National Institutes of Health Index: NATIONAL INSTITUTES OF HEALTH DATED ANNOUNCEMENTS (RFPs AND RFAs) LIVER TISSUE PROCUREMENT AND DISTRIBUTION SYSTEM (LTPADS) (RFP) (404/446)... 5 National Institute of Diabetes, and Digestive and Kidney Diseases Index: DIABETES, DIGESTIVE AND KIDNEY DISEASES EVALUATION OF PHYSICIAN ATTITUDES AND PRACTICE REGARDING CHOLESTEROL AND CORONARY HEART DISEASE (CHD) (RFP) .........(449/499)....... 5 National Heart, Lung, and Blood Institute Index: HEART, LUNG, AND BLOOD PHASE II-B RANDOMIZED CONTROLLED STUDY OF TISSUE PLASMINOGEN ACTIVATOR FOR ACUTE ISCHEMIC STROKE - CLINICAL CENTER ......(502/550)....... 6 National Institute of Neurological Disorders and Stroke Index: NEUROLOGICAL DISORDERS, STROKE THE RELATIONSHIP BETWEEN BLOOD AND TISSUE MICRONUTRIENT LEVELS IN HUMANS ... 7 National Cancer Institute (561/653, 1622/1914) Index: CANCER NEW TECHNIQUES SMALL GRANTS FOR ALCOHOL RESEARCHERS (RFA) ...(656/748)...... 8 National Institute on Alcohol Abuse and Alcoholism (656/748, 1204/1618) Index: ALCOHOL ABUSE, ALCOHOLISM DRUG DEVELOPMENT--MEDICINAL CHEMISTRY CONSIDERATIONS (RFA) ...(751/815)..... 9 National Institute on Drug Abuse Index: DRUG ABUSE ONGOING PROGRAM ANNOUNCEMENTS RESEARCH ON MENTAL HEALTH SERVICES FOR CHILDREN AND ADOLESCENTS (821/854)...10 National Institute of Mental Health Index: MENTAL HEALTH RESEARCH RELATED TO NURSING CARE OF PERSONS WITH HIV ........(857/986)......10 National Center for Nursing Research Index: NURSING RESEARCH NATIONAL RESEARCH SERVICE AWARD INSTITUTIONAL TRAINING GRANTS (T32) ........12 National Center for Nursing Research (989/1084) Index: NURSING RESEARCH RESEARCH AND RESEARCH DEMONSTRATIONS ON HOMELESS SEVERELY MENTALLY ILL ADULTS AND HOMELESS FAMILIES WITH CHILDREN WHO ARE AT RISK OF SEVERE EMOTIONAL DISTURBANCE .....................(1087/1144)....13 National Institute of Mental Health Index: MENTAL HEALTH NOTICES REMINDER: LETTERS OF REFERENCE P.T. 22, 34; K.W. 1014002, 1014006 Division of Research Grants Previous announcements in the NIH Guide for Grants and Contracts have instructed applicants for the Research Career Development Award (RCDA), the First Independent Research Support and Transition (FIRST) Award, and individual and senior National Research Service Award (NRSA) Fellowships to submit letters of reference with their application. The NIH is now reminding applicants submitting REVISED applications for RCDA, FIRST, and NRSA fellowships that they must again submit letters of reference. Otherwise their applications will be returned without review. For RCDA applications, both new and revised, reference guidelines to be sent to referees are included in the PHS 398 kit (revised 9/86). For NRSA fellowship applications, new and revised, the reference form (PHS 416-3) is included in the PHS 416-1 kit (revised 6/85). For FIRST Award applications, new and revised, there are no special reference forms or printed guidelines to be sent to the referees. Applicants should contact their referees well in advance of the application submission date, advising referees to return the letters of reference to the applicant in sealed envelopes as soon as possible. To protect the utility and confidentiality of reference letters, applicants are asked not to open the sealed envelopes. The sealed envelopes MUST be attached to the front of the original applications. WORKSHOP - ETHICAL ISSUES IN SENSITIVE BEHAVIORAL RESEARCH INVOLVING MINORS P.T. 42, FF; K.W. 0783005, 0783010, 0404000 National Institutes of Health The National Institutes of Health is sponsoring a two-day program on some of the most current and provocative topics related to ethical and legal issues associated with sensitive behavioral research involving minors. The workshop is open to everyone with an interest in research involving minors. Specific information about the workshop is as follows: Dates: February 13-14, 1989 Location: San Mateo, CA Title of Workshop: "Ethical Issues in Sensitive Behavioral Research Involving Minors" Contact: Ms. Darlene M. Ross Education Program Coordinator Office for Protection from Research Risks National Institutes of Health Building 31, Room 5B62 Bethesda, Maryland 20892 Telephone: (301) 496-8101 NOTICE OF AVAILABILITY - RECOMMENDED COUNCIL GUIDELINES ON ETHYL ALCOHOL ADMINISTRATION IN HUMAN EXPERIMENTATION P.T. 34; K.W. 0783005, 0404003 National Institute on Alcohol Abuse and Alcoholism The National Advisory Council on Alcohol Abuse and Alcoholism has recently developed "Recommended Council Guidelines on Ethyl Alcohol Administration in Human Experimentation." The Council Guidelines include information on ethical issues, methodological issues, and other issues of importance to human subject research involving the administration of alcohol. The Guidelines are advisory to applicants, Institutional Review Boards, Initial Review Groups, and others Vol. 18, No. 1, January 13, 1989 - Page 1 to help ensure that appropriate consideration is given to relevant issues in the development and review of research protocols involving alcohol administration. The Guidelines are intended to reflect current research practices and experience in the alcohol research field as opposed to being Federal regulations or requirements. Copies of the Guidelines are available from: National Institute on Alcohol Abuse and Alcoholism Office of Scientific Affairs Parklawn Building, Room 16C-20 5600 Fishers Lane Rockville, Maryland 20857 Telephone: (301) 443-4375 NOTICE OF MEETING P.T. 42, FF; K.W. 0710030, 0720005 National Institutes of Health Notice is hereby given that the National Institutes of Health (NIH) will hold the first two of a series of five regional public meetings to be conducted under the auspices of the Office of the Director, NIH, on "Programs for Support of Minorities in Biomedical Research." The purpose of the meetings is two-fold: 1. to provide current information concerning the activities of the NIH by describing in broad terms existing programs offered by NIH; and 2. to solicit through public testimony the views of biomedical researchers, university faculty and administrators, students, representatives of professional societies, and other interested parties regarding the nature and scope of programs to attract and support minorities in biomedical research. The first meeting will be held on Wednesday, March 8, 1989, from 8:30 a.m. to 5:00 p.m. at Jackson State University, Jackson, Mississippi. Subsequent meetings will be held in Bethesda, Maryland (April 20), Atlanta, Georgia (early Summer), Phoenix, Arizona (late Summer), and Anchorage, Alaska (early Fall). Notice of the exact time and location of additional meetings will be published later. Following presentations by senior NIH staff, a panel comprised of NIH program administrators will spend the remainder of the day receiving testimony from public witnesses. Each witness will be limited to a maximum of ten minutes. Attendance and the number of presentations will be limited to the time and space available. Consequently, all individuals wishing to attend or to present a statement at this public meeting should notify, in writing: William H. Pitlick, Ph.D. Executive Secretary National Institutes of Health Shannon Building, Room 250 Bethesda, Maryland 20892 Those planning to make a presentation at Jackson State should file a one-page summary of their remarks with Dr. Pitlick by February 17, 1989; a copy of the full text should be submitted for the record at the time of the meeting. Additional information may be obtained by calling: Ms. Loretta Beuchert Research Training Office Office of Extramural Research National Institutes of Health Shannon Building, Room 250 Bethesda, Maryland 20892 Telephone: (301) 496-9743 Vol. 18, No. 1, January 13, 1989 - Page 2 NOTICE OF MEETING P.T. 42; K.W. 1014002, 1014003, 0201011 Public Responsibility in Medicine and Research In the past few years, Institutional Animal Care and Use Committees (IACUCs) have been subjected to increased public attention as issues including the selection and role of the committees' community members, attendance by animal welfare advocates at meetings, access by outside groups to minutes, and the acceptable limits of research with animals have been discussed, debated, and litigated within the institutions, the community, and the media. In addition, as the publication of new federal regulations by the United States Department of Agriculture (USDA) is imminent, a whole new series of requirements and policies will be put into place. Upon their implementation, these regulations will affect a wide range of subjects, including psychological well-being of primates, exercise needs of research animals, laboratory specifications, and other - quite detailed - areas of federal and institutional oversight. The problems of animal care committees, research administrators, and investigators cannot be approached in an ad hoc and superficial fashion, and it is widely acknowledged that serious and extensive educational campaigns must be initiated within the institutions and the community, and among the varying interest groups involved with the conduct of animal research. On March 9-10, 1989, at the Park Plaza Hotel in Boston, Public Responsibility in Medicine and Research (PRIM&R) and the Tufts University School of Veterinary Medicine will host a conference entitled, "Institutional Administration, Education, and the Animal Research Committee: Meeting the Challenge." The meeting will focus on the issues raised above and on other new regulatory and judicial developments in the field of animal research and the operation of IACUCs. There will be panel presentations by experienced researchers, animal welfare representatives, federal agency personnel, institutional administrators, and journalists. In addition, an extensive series of basic workshops, or discussion groups where all participants can exchange ideas and information, will be held covering the administration of IACUCs, the review process itself, risk-benefit analysis when reviewing animal research, institutional policy-making, and a range of other problems faced by all who are involved with and/or interested in animal care and research. PRIM&R has set aside a limited number of scholarships for those persons demonstrating need and a limited number of spaces have also been reserved for the press. For a complete program and further information, contact: Joan Rachlin Executive Director or Robyn Carey Assistant Director PRIM&R 132 Boylston Street Boston, Massachusetts 02116 Telephone: (617) 423-4112 or 423-1099 REQUIREMENTS FOR DRUG-FREE WORKPLACE: GRANT AND CONTRACT AWARDEES P.T. 34, 44; K.W. 1014002, 0404009 Public Health Service The purpose of this notice is to provide advance information to grant and contract awardees of the Public Health Service (PHS) on requirements to maintain a drug-free workplace. As part of the omnibus drug legislation enacted November 18, 1988, Congress passed the Drug-Free Workplace Act of 1988 (Public Law 100-690, Title V, Subtitle D). This statute requires grant and contract awardees to certify that they will provide drug-free workplaces. Making the required Vol. 18, No. 1, January 13, 1989 - Page 3 certification is a precondition for receiving a grant or contract from a Federal agency. The certification mainly requires awardee ORGANIZATIONS to: o publish a statement notifying employees that the unlawful manufacture, distribution, dispensation, possession, or use of a controlled substance is prohibited in the workplace and specifying the actions that will be taken against employees for violation of such prohibition; o establish a drug-free awareness program; o require that each employee engaged in the performance of a grant or contract be provided a copy of the published statement; o notify the employee that as a condition of employment, the employee will abide by the terms of the statement; o notify the PHS agency of any employee convicted of a drug violation occurring in the workplace; and o require any employee who is convicted of a drug offense occurring in the workplace to participate in a rehabilitation program. An awardee who is an INDIVIDUAL is required to certify that he or she will not engage in the unlawful manufacture, distribution, dispensation, possession, or use of a controlled substance in conducting any activity under the grant or contract. Federal regulations implementing the Drug-Free Workplace Act will be published by February 16, 1989, and will be effective March 18, 1989. Implementation for grantees will occur via an amendment to the common rule for debarment and suspension -- Title 45 Code of Federal Regulations Part 76 pertains to the Department of Health and Human Services. Requirements for contractors will be found in an amendment to the Federal Acquisition Regulation (Title 48 Code of Federal Regulations Subparts 9.4, 23.5, and 52.2). EXPANDED AUTHORITIES FOR GRANTEE ORGANIZATIONS -- CLARIFICATION OF APPLICABILITY TO CERTAIN GRANT AWARD MECHANISMS P.T. 34; K.W. 1014002, 1014006 National Institutes of Health INTRODUCTION On October 21, 1988, NIH published a notice (NIH Guide for Grants and Contracts, Vol. 17, No. 34) entitled IMPLEMENTATION OF EXPANDED AUTHORITIES FOR GRANTEE ORGANIZATIONS. That notice described four new policy features that transmit significant additional authority to the recipients of most "R" series grant award mechanisms. Implicitly included among the applicable award mechanisms are the following "special" initiatives: o "R01" The Senator Jacob Javits Neuroscience Investigator Award; o "R29" The First Independent Research Support and Transition (FIRST) Award; o "R35" The Outstanding Investigator Grant (OIG); and o "R37" The Method to Extend Research In Time (MERIT) Award. POLICY CLARIFICATION Since their inception, each of the "special" initiatives cited above has included one or two of the features that are now part of the broadly-based "expanded authorities." The purpose of this notice is to make it explicit that these initiatives are covered by the expanded authorities and, therefore, are to be managed in accordance with the guidance set forth in the NIH notice of October 21, 1988. Vol. 18, No. 1, January 13, 1989 - Page 4 DATED ANNOUNCEMENTS (RFPs AND RFAs) LIVER TISSUE PROCUREMENT AND DISTRIBUTION SYSTEM (LTPADS) RFP AVAILABLE: NIH-NIDDK-89-2 P.T. 34; K.W. 0780000, 0780025 National Institute of Diabetes, and Digestive and Kidney Diseases The National Institute of Diabetes and Digestive and Kidney Diseases has a requirement for continuing a Liver Tissue Procurement and Distribution System (LTPADS) for Discarded Tissue from Liver Transplant Recipients. This project is designed to procure, preserve and deliver tissue from a variety of end-stage liver diseases to researchers. This tissue would otherwise be discarded or be unobtainable to most researchers who are not part of a liver transplant center. It is also designed to make normal liver tissue available for researchers when such livers are found to be unsuitable for liver transplantation. A collection network will be established and managed by a single Coordinating Center at a Liver Transplant Center. Approximately 3 Tissue Collection Centers will be selected by the Coordinating Center and will be subcontractors to the Coordinating Center. A current LTPADS is being operated by the University of Minnesota under Contract No. NO1-DK-6-2274 This is an announcement for a Request for Proposal (RFP) No. NIH-NIDDK-89-2 will be issued on or about January 3, 1989, with a closing date tentatively set for March 10, 1989. To receive a copy of this RFP, please supply this office with two self addressed mailing labels. Requests must cite the RFP number referenced above. Since a limited number of copies will be printed, requests shall be filled on first come, first serve basis until the supply is exhausted. Requests for copies of the RFP should be sent to the following address: Mr. Fredric G. Fagan Contracts Management Branch National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building - Room 602 Bethesda, Maryland 20892 This advertisement does not commit the Government to award a contract. EVALUATION OF PHYSICIAN ATTITUDES AND PRACTICE REGARDING CHOLESTEROL AND CORONARY HEART DISEASE (CHD) RFP AVAILABLE: NIH-NHLBI-HV-89-04 P.T. 34; K.W. 0715040, 0730000, 0404000, 0404021 National Heart, Lung, and Blood Institute The National Heart, Lung, and Blood Institute (NHLBI) will make available to interested contractors a request for proposals for readministration of the Cholesterol Awareness Survey (CAS) to assess physician attitudes and practice regarding cholesterol and coronary heart disease in the fall of 1989. The survey is a follow-up to nearly identical surveys conducted by NHLBI in 1983 and 1986. These survey data are used by the NHLBI in the planning and evaluation of the National Cholesterol Education Program (NCEP). The objective of this project is to conduct a telephone survey of approximately 1600 practicing physicians nationwide to ascertain their medical practice regarding cholesterol intervention for the primary prevention of CHD. The survey will replicate the methodology and survey instrument used in the 1983 and 1986 surveys so that results from the three surveys will be comparable. The successful contractor will be required to draw the sample of practicing physicians to yield 1,600 completed interviews with cardiologists, internists, and general and family practitioners; the contractor will assist with the update of the previously used questionnaire and pretest the modified instrument; the contractor will collect the data through telephone interview of the previously described sample; the contractor will be required to present tabulations and preliminary analyses for significance testing and deliver processed interview data mounted on the NIH computer system. Offers ARE NOT requested for development of the survey instrument or questionnaire or for Vol. 18, No. 1, January 13, 1988 - Page 5 detailed statistical analyses of survey results. The previously administered survey instrument will be used with minor variations or updates. Final analyses and narrative interpretation will be done by NHLBI staff. This is not a Request for Proposals. RFP NHLBI-HV-89-04 will be released on or about January 12, 1989 with proposals due on or about February 27, 1989. One (1) award is anticipated by the Government. Your written request should include three (3) labels, self-addressed with your mailing address, and must cite RFP No. NHLBI-HV-89-04. Request for copies of the RFP should be sent to the following address: Sharon M. Kraft, Contract Specialist HLVD Contracts Section, Contracts Operations Branch, DEA National Heart, Lung, and Blood Institute Federal Building, Room 4C04 National Institutes of Health Bethesda, Maryland 20892 Telephone: (301) 496-6815 PHASE II-B RANDOMIZED CONTROLLED STUDY OF TISSUE PLASMINOGEN ACTIVATOR FOR ACUTE ISCHEMIC STROKE - CLINICAL CENTER RFP AVAILABLE: NIH-NINDS-89-03 P.T. 34; K.W. 0755015, 0715200 National Institute of Neurological Disorders and Stroke The National Institute of Neurological Disorders and Stroke (NINDS) has a requirement to evaluate documented dramatic "on the table" improvements in acute ischemic stroke patients as a result of early treatment with tissue plasminogen activator (t-PA) and to evaluate whether early treatment of stroke increases the efficacy and safety of t-PA. One half of the patients eligible in accordance with the criteria listed in the RFP will be treated within 90 minutes of onset of stroke symptoms. The other half of the required number of patients will be treated within 3 hours of onset of stroke symptoms. Emphasis will be placed on the capability to give acute care to stroke victims with urgency comparable to that given heart attack victims. Offerors must provide concise information regarding their capability to accrue the required minimum number of specific subjects indicated in the RFP. Subjects must be under the medical management of one of the physician investigators in an environment that provides adequate hospital, pharmacy, and laboratory services for carrying out the protocol described in the RFP. The incumbent must provide documentation which indicates that the required patients are not committed to other studies performed under contracts or grants, either from universities, drug manufacturers, or other government agencies. The method by which patients will be enrolled must be described in sufficient detail to exclude any doubt that an adequate number of patients will be treated under the protocol. Failure to demonstrate this capability will result in the offeror's proposal being removed from further consideration regardless of the evaluation criteria list in the RFP. This is an announcement of an anticipated RFP. RFP-NIH-NINDS-89-03 will be issued on or about January 20, 1989, with the closing date for receipt of proposals set for March 20, 1989. It is anticipated that the solicitation will result in six to eight contract awards. All responsible sources may submit proposals, which will be considered by this Agency. To receive a copy of the RFP, please supply this office with two self-addressed mailing labels. The RFP will be available upon written request to: Contracting Officer Ref.: RFP-NIH-NINDS-89-03 Contracts Management Branch, DEA National Institute of Neurological Disorders and Stroke, NIH Federal Building, Room 901 Bethesda, Maryland 20892 Vol. 18, No. 1, January 13, 1989 - Page 6 THE RELATIONSHIP BETWEEN BLOOD AND TISSUE MICRONUTRIENT LEVELS IN HUMANS RFA AVAILABLE: 89-CA-07 P.T. 34; K.W. 0715035, 0411005, 0710095 National Cancer Institute Application Receipt Date: March 27, 1989 Letter of Intent Receipt Date: February 3, 1988 I. INTRODUCTION The Division of Cancer Prevention and Control (DCPC), NCI, invites applications for grants to study the relationship between blood and tissue micronutrient levels in humans. Micronutrients of interest are those that have been found to be associated with cancer risk. Studies comparing blood and tissue micronutient levels with cancer risk are also encouraged as is methods development for collecting tissue specimens suitable for the quantitative analysis of micronutrients. It is anticipated that there will be four awards. Much of our knowledge about the relationship between micronutrients and cancer comes from studies in which serum or red blood cell nutrient levels have been correlated with cancer incidence. Although blood micronutrient levels are presumed to reflect tissue levels, human data in this area are limited. In fact, some evidence suggests that in many cases blood levels many not reflect tissue micronutrient content. II. RESEARCH GOALS AND SCOPE The purpose of this RFA is to solicit applications from qualified investigators interested in analyzing blood and tissue micronutrient content in humans. Subjects can include both individuals without established cancer risk factors as well as those with premalignant lesions and cancer. When using subjects with cancer or premalignant lesions such as cervical dysplasia or bronchial metaplasia, comparisons of blood and tissue micronutrient levels with control subjects are encouraged. Tissue micronutrient content of cancerous and or premalignant tissue can also be compared to normal tissue from the same subject. Micronutrients chosen for analysis should be those for which there is evidence indicating an association with cancer risk. Examples of micronutrients of interest are beta carotene, folate, vitamins C and E, calcium, and selenium. When methodology to determine tissue and/or blood micronutrient content is not available, the applicant should develop methods for obtaining tissue and/or blood samples suitable for micronutrient analysis. Ideally, samples should be suitable for multiple analysis. III. MECHANISM OF SUPPORT Support of this program will be through the National Institutes of Health (NIH) grant-in-aid. Applicants will be responsible for the planning, direction, and execution of the proposed project. Except as otherwise stated in this Request for applications (RFA), awards will be administered under PHS grants policy as stated in the Public Health Service Grants policy statement, DHHS Publication No. (OASH)82-50,000, revised January 1, 1987. This RFA is a one-time solicitation. Generally, future unsolicited competing renewal applications will compete with all investigator-initiated applications and be reviewed by the Division of Research Grants (DRG). However, should the NCI determine that there is a sufficient continuing program need, the RFA will be reissued. Approximately $900,000 total costs per year for 4 years will be committed to specifically fund applications which are submitted in response to this RFA. It is anticipated that 4 awards will be made. This funding level is dependent on the receipt of a sufficient number of applications of high scientific merit. The total project period for applications submitted in response to the present RFA should not exceed 4 years. The earliest feasible start date for the initial awards will be November 27, 1989. Although this program is provided for in the financial plans of the National Cancer Institute (NCI), the award of grants pursuant to this RFA is also contingent upon the availablity of funds for this purpose. IV. INQUIRIES A copy of the complete RFA describing the research goals and and scope, the review criteria, and the method of applying can be obtained by contacting: Vol. 18, No. 1, January 13, 1989 - Page 7 Mark J. Messina, Ph.D. Program Director Diet and Cancer Branch National Cancer Institute, DCB 9000 Rockville Pike, EPN 212C Bethesda, Maryland 20892 Telephone: (301) 496-8573 Written or telephone inquiries concerning the objectives and scope of this RFA or inquiries about whether or not specific proposed research would be responsive are encouraged and should be directed to Mark J. Messina, Ph.D. at the above address. The program director welcomes the opportunity to clarify any issues or questions from potential applicants. NEW TECHNIQUES SMALL GRANTS FOR ALCOHOL RESEARCHERS RFA AVAILABLE: AA-89-03 P.T. 34; K.W. 0404003, 1002004, 1002008, 1002019, 0710070 National Institute on Alcohol Abuse and Alcoholism Application Receipt Date: April 3, 1989 INTRODUCTION The Division of Basic Research of the National Institute on Alcohol Abuse and Alcoholism (NIAAA) wishes to encourage established researchers who are NIAAA-supported principal investigators or who have recently been supported by the NIAAA to obtain firsthand experience with new techniques as a "Visiting Researcher" in the laboratory of a "Host" who is an expert in the latest technology in molecular biology, cellular biology, immunology, genetics, neurosciences or other biomedical fields. The new techniques should be an integral part of an original pilot research project conceived by the Visiting Researcher in collaboration with the Host. The proposed research project should generate preliminary data which could strengthen a subsequent application for regular grant support or provide documentation of experience in a defined area. OBJECTIVES AND SCOPE This Request For Applications (RFA) is intended to encourage prospective Visiting Researchers to identify Hosts in order to prepare and submit a New Techniques Small Grant Application. The goal is to provide an opportunity for established alcohol researchers to acquire personal expertise in the utilization of specialized techniques applicable to alcoholism research. The application must be submitted by the Visiting Researcher and his/her institution. The proposed research project, to be performed in the Host's laboratory, need not be directly related to alcohol research. However, the techniques utilized while performing the research project must be directly applicable to the Visiting Researcher's plans for future work in alcoholism research. ELIGIBILITY REQUIREMENTS The proposed Visiting Researcher must be a Principal Investigator on an NIAAA project grant (RO1) or Principal Investigator or Project Director on a component of a program project grant (PO1) or research center grant (P50). However, individuals who have met these criteria within the past three years are also eligible. Visiting Researchers must be citizens or noncitizen nationals of the United States or have been lawfully admitted to the United States for permanent residence. Women and minority investigators are encouraged to apply. The Host must be an independent investigator with expertise in the specialized techniques involved in the application. The Host institution usually is a domestic institution different from that of the Visiting Researcher and usually in a different city. TERMS OF THE AWARD AND AVAILABILITY OF FUNDS This non-renewable award provides a maximum of $17,500 to $35,000 for a 3-6 month period in a Host laboratory with periods less than six months being prorated. The funds are to be used for salaries, supply needs in the Host's laboratory, and travel and subsistence funds for the Visiting Researcher. A subcontract agreement with the Host institution will be necessary if funds are to be provided to the Host's institution. Further details on budget may be Vol. 18, No. 1, January 13, 1989 - Page 8 obtained from NIAAA (See Application and Review Procedures). The proposed activity must be full-time and must include the conduct of research with supervision provided by the Host, or by the Host in association with an expert member of the Host's laboratory. The activity must be scheduled within the 12 months following the date of the award. A minimum time commitment of 3 months is required. In FY 1989, NIAAA anticipates making five to ten awards. However, the funding of applications submitted in response to this RFA is contingent on the actual availability of funds and receipt of applications deemed worthy of support by the NIAAA peer review process. APPLICATION AND REVIEW PROCEDURES There will be a single receipt date of April 3, 1989. Applications received after that date will not be considered. All applications submitted in response to this RFA will be evaluated for scientific and technical merit by an appropriate peer review committee. For the full RFA document, which includes guidance for preparation of applications, potential applicants should contact: Helen M. Chao, Ph.D. Chief, Biomedical Research Branch Division of Basic Research, NIAAA 5600 Fishers Lane, Room 14C-20 Rockville, Maryland 20857 Telephone: (301) 443-4223 DRUG DEVELOPMENT--MEDICINAL CHEMISTRY CONSIDERATIONS RFA AVAILABLE: DA-89-02 P.T. 34; K.W. 0710080, 0755025, 0755060, 1003012 National Institute on Drug Abuse Application Receipt Date: April 3, 1989 There is a need for new drugs for the treatment of drug abuse and related disorders. New therapeutic drugs and biologicals are needed which include: substitutes for abused drugs with less toxic effects, and compounds that block the psychotropic effects of abused drugs, reduce the craving for abused drugs, moderate and/or eliminate the process of withdrawal from abused drugs and block and/or reverse the toxic effects of abused drugs. New grant applications are solicited for the design and synthesis of new drug moieties for all classes of drugs of abuse including cocaine and related compounds, opioids, PCP and related compounds, cannabinoids, and benzodiazepines. This program will support studies which involve rational design of new therapeutic entities by application of structure-activity relationship (SAR) studies, synthesis of analogs, screening for bioactivity, and preliminary studies to determine metabolism and bioavailability followed by dosage form development. Utilization of new techniques such as Computer Aided Drug Design (CADD) are strongly encouraged for these efforts. In addition there is a need for the design of affinity labels to reveal receptor populations using Positron Emission Tomography (PET) and other imaging procedures as diagnostic tools in normal and addicted populations, and the development of new computer assisted techniques for receptor mapping and utilization of theoretical methods to design new drugs and molecular probes. Priority areas include the synthesis of drugs to treat the toxic side effects of drugs of abuse (such as drugs to treat cardiotoxicity of cocaine), synthesis of cannabinoid and cocaine antagonists, synthesis of sigma/PCP receptor specific analogs, and synthesis of PCP receptor ligands that antagonize N-methyl-D-Aspartate receptors (NMDA). Support mechanisms include: (1) Research Projects (R01), (2) Program Projects (P01), and (3) First Independent Research Support and Transition Awards (R29). In addition, NIDA employs a variety of support mechanisms that support research training and research career development for clinicians and scientists upon whom future research will depend. Vol. 18, No. 1, January 13, 1989 - Page 9 For program information, contact: Dr. Rao Rapaka Research Technology Branch, NIDA 5600 Fishers Lane, Room 10A-13 Rockville, Maryland 20857 Telephone: (301) 443-5280 For complete RFA Announcement, contact: Grants Management Branch, OPRM National Institute on Drug Abuse 5600 Fishers Lane, Room 10-25 Rockville, Maryland 20857 Telephone: (301) 443-6710 ONGOING PROGRAM ANNOUNCEMENTS RESEARCH ON MENTAL HEALTH SERVICES FOR CHILDREN AND ADOLESCENTS P.T. 34, AA; K.W. 0715095, 0730050 National Institute of Mental Health The National Institute of Mental Health (NIMH) announces a new initiative to encourage investigator-initiated research on mental health services for children and adolescents. The purpose of this announcement is to support development of scientific knowledge leading to more effective delivery of mental health services to children and adolescents, with special emphasis on those with severe mental disorders, and to their families. Applicants may request support for up to 5 years. It is anticipated that up to $2 million will be available to support new grant awards under this announcement during fiscal year 1989. Funding in future years will depend on annual appropriations. Support under this announcement may be requested through applications for a regular research grant (RO1), small grant (RO3), or First Independent Research Support and Transition (FIRST) award (R29). Applications in response to this announcement will be accepted under the usual Public Health Service receipt and review schedule for new applications. Potential applicants interested in obtaining further information should contact one of the following: Charles Windle, Ph.D., or Kelly Kelleher, M.D., M.P.H. Division of Biometry and Applied Sciences Biometric and Clinical Applications Branch National Institute of Mental Health Room 18C-14 5600 Fishers Lane Rockville, Maryland 20857 Telephone: (301) 443-4233 and (301) 443-1330 RESEARCH RELATED TO NURSING CARE OF PERSONS WITH HIV P.T. 34; K.W. 0715008, 0730050, 0785130 National Center for Nursing Research The mission of the National Center for Nursing Research (NCNR) is to support basic and clinical research and research training in patient care relevant to nursing. The Center's mission also includes validating nursing interventions delivered to patients and their families with the Human Immunodeficiency Virus (HIV) across the disease spectrum. The NCNR is interested in research which addresses interventions to prevent or reduce symptoms, such as chronic fatigue; sleep-wake disturbances; limitations to exercise; pain, nausea, and vomiting; mouth and integument infections, bacterial skin colonization; muscle wasting and weight loss; fear and anxiety associated with disease progression; and the unknown sequelae of therapeutic interventions. These symptoms are serious consequences of the HIV and interventions are needed which effectively ameliorate the physical and psychosocial problems associated with immunosuppression. HIV patients practice a variety of self-care management techniques in order to perform activities of daily living. NCNR is also interested in testing self-care strategies used to ameliorate symptoms of HIV. Vol. 18, No. 1, January 13, 1989 - Page 10 Research documenting effective treatment is needed to describe physical, psychological and social care needs for patient groups of different ages, risk categories, racial backgrounds and ethnic cultures. NCNR is interested in supporting research which builds upon current scientific knowledge of HIV. In order to optimize state of the art information and patient access, collaboration with currently funded clinical treatment centers, such as the National Institute of Allergy and Infectious Diseases (NIAID) AIDS Clinical Trials Program, is encouraged. Research topics related to nursing care include, but are not limited to: o assessing measures to prevent bacteria colonization on the skin and in the gastrointestinal tract; o testing optimum strategies for patient participation in activities of daily living based upon documented adverse physiological and psychological effects of the sequence of therapeutic intervention, time of day of side effect occurrence, and severity of events attributable to either HIV, therapy, or both; o designing exercise and rest protocols to improve patients' physiological and psychological well being; o implementing nutrition measures/dietary interventions to improve host resistance and decrease morbidity; ELIGIBILITY Non-profit organizations and institutions, state and local governments and their agencies, profit-making organizations, and individuals (fellowships only) are eligible to apply. MECHANISMS OF SUPPORT Applications may be submitted for research project grants (R01), Academic Research Enhancement Awards (R15), First Independent Research Support and Transition (FIRST) Awards (R29), Small Business Innovation Research (SBIR) Awards (R43),(R44), Individual National Research Service Awards for Postdoctoral Fellowships (F32), National Research Service Awards for Senior Fellowships (F33), Academic Investigator Awards (K07) or Clinical Investigator Awards (K08). APPLICATION PROCEDURES Applicants should use Form PHS 398, (Rev. 9/86) for research grant, Clinical and Academic Investigator Award applications; Form PHS 416-1 (Rev. 6/85) for individual fellowship applications (F32, F33); or Form PHS 6246-1 for Small Business Innovation Research applications. These forms are available at the Office of Sponsored Research in most institutions or from: Office of Grants Inquiries Division of Research Grants, NIH Westwood Building, Room 240 Bethesda, Maryland 20892 Telephone: (301) 496-7441 In order to expedite the routing of the application form within NIH, the applicant should: (1) check block #2 on the face page of the application, indicating that the application is in response to this announcement; (2) print next to the check box NCNR NURSING CARE/HIV. Investigator initiated RO1 and R29 grant applications must submit their applications for the newly established expedited AIDS receipt dates: Jan. 2, May 1, Sept. 1. Investigators using other mechanisms of support should submit applications for the standard receipt dates specified for those mechanisms. The original and 32 copies of the application are required for the expedited review. Applications for standard review require the original and 6 copies of the application. Completed applications should be submitted according to the deadlines for the review schedule in the relevant application kits and mailed to the following address: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, Maryland 20892** Vol. 18, No. 1, January 13, 1989 - Page 11 REVIEW PROCEDURES AND CRITERIA Applications in response to this announcement will be reviewed in competition with other applications and in accord with the usual NIH peer review procedures and criteria. Applications will be reviewed for scientific and technical merit by an initial review group; second-level review will be by an appropriate National Advisory Council. Second-level review of individual fellowship applications will be conducted by an appropriate second-level review group. All PHS and NIH grant policies apply to applications received in response to this program announcement. INQUIRIES AND CORRESPONDENCE Applicants are encouraged to discuss their proposed project with NCNR staff in advance of formal submission. Such individuals should contact: Dr. Janet Heinrich Dr. Hilary D. Sigmon Director, Division of or Physiologist Extramural Programs National Institutes of Health National Institutes of Health National Center for Nursing Research National Center for Nursing Research Building 31A, Conference Room 3 Building 31, Room B1C02 Bethesda, Maryland 20892 Bethesda, Maryland 20892 Telephone: (301) 496-0523 Telephone: (301) 496-0526 NATIONAL RESEARCH SERVICE AWARD INSTITUTIONAL TRAINING GRANTS (T32) P.T. 44; K.W. 0720005, 0785130, 0710030 National Center for Nursing Research BACKGROUND AND GOALS The National Research Service Award (NRSA) was authorized into law under Section 487 of the Public Health Service Act. One component of NRSA, the institutional training grant, was created to provide for both individual and institutional research and research-training support. Institutional training grants enable eligible schools of nursing to enhance and make available predoctoral and postdoctoral research-training opportunities to individuals who have been selected by the school and who are interested in careers in nursing research and related behavioral, biological, and biomedical research. Appointments are made for full-time training in research. Trainees must sign a payback agreement indicating intent to meet the service or payback provisions required under the Public Health Service Act, Section 487. Institutional training grants may be made for project periods of up to 5 years. No individual may receive more than 5 years of cumulative NRSA support at the predoctoral level and 3 years of cumulative NRSA support at the postdoctoral level. Current NIH funding levels are contained in the NIH Guide to Contract and Grants, Vol., 17, No. 24, July 29, 1988. ELIGIBILITY The institutional training grant is intended for schools of nursing with an established research record and the staff and facilities required to train nurse scientists in a proposed area of research. Preference will be given to those institutions where interdisciplinary collaboration is evident. In order to extend federal support equitably and geographically, only a limited number of institutional training grants will be awarded to any one school of nursing. Trainees must be: (1) citizens of the United States or have been lawfully admitted for permanent residence (individuals on temporary or student visas are not eligible); (2) registered nurses who are enrolled at the postbaccalaureate level in a graduate program leading to a doctor of philosophy degree or equivalent degree. Postdoctoral trainees must have received a doctorate in an area relevant to the proposed research as of the date of appointment. METHOD OF APPLICATION Applications should be prepared on form PHS 398, following the instructions for institutional training grant applications. The PHS 398 application form is available at most institutional business offices or from the Division of Vol. 18, No. 1, January 13, 1989 - Page 12 Research Grants, NIH, (301) 496-7441. The completed original application and six copies should be sent to: Application Receipt Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, Maryland 20892** GENERAL PROVISIONS 1. National Center for Nursing Research (NCNR) institutional training grants are intended to expand the breadth and depth of science in a designated area by providing rigorous predoctoral and postdoctoral training to nurse scientists in schools of nursing with well-established programs of research. 2. Faculty cited in the institutional grant application must be established researchers who have had previous extramural research support, although not necessarily federal support. 3. Applications must discuss ongoing or future initiatives employed to recruit and retain minority applicants in the program. Failure to include minority plans for recruitment will disqualify the application for review. Supplemental administrative support may be requested to add minority students to existing institutional training grants. After evaluation for scientific merit and after assignment of the priority score, reviewers will be asked to comment on each applicant's plans for attracting minority individuals into productive research careers. Comments on this topic will be incorporated into the summary statement as an administrative note to be considered by the National Advisory Council for Nursing Research and the NCNR staff in making recommendations regarding funding. RECEIPT DATE Starting in FY 1990, the NCNR will accept institutional training grant applications on one receipt date per year: May 10. Applications received by May 10 will be reviewed in October by the Nursing Science Review Committee and in February by the National Advisory Council for Nursing Research. The earliest possible beginning dates will be in July of each year. RESEARCH AND RESEARCH DEMONSTRATIONS ON HOMELESS SEVERELY MENTALLY ILL ADULTS AND HOMELESS FAMILIES WITH CHILDREN WHO ARE AT RISK OF SEVERE EMOTIONAL DISTURBANCE P.T. 34, AA; K.W. 0715095, 0715129, 0730050 National Institute of Mental Health The National Institute of Mental Health (NIMH) announces a new initiative to encourage investigator-initiated research and research demonstrations focusing on mental health services for severely mentally ill homeless adults and children. The purpose of this initiative is to accelerate the development of methodologically rigorous knowledge that can contribute to more effective delivery of mental health services to homeless persons, reduce homelessness among the mentally ill, and reduce mental illness among the homeless. Applicants may request support for up to 5 years. In fiscal year 1989, it is expected that approximately $2.5 million will be available to support new research grant awards under this announcement, and up to $2 million will be available to support new research demonstration grants under this announcement. Funding in future years will depend on annual appropriations. Support for research that does not include funds for demonstration services may be requested through applications for a regular research grant (RO1), small grant (RO3), or First Independent Research Support and Transition (FIRST) award (R29). Support for research demonstrations that includes funds for services may be requested through applications for research demonstration grants (R18). To qualify for fiscal year 1989 funding, applications must be received at NIMH by April 10, 1989. Thereafter, applications will be received in accordance with the regular NIMH review schedule. Potential applicants interested in obtaining further information should contact one of the following: Vol. 18, No. 1, January 13, 1989 - Page 13 Ann K. Hohmann, Ph.D., or Charles Windle, Ph.D. Division of Biometry and Applied Sciences Biometric and Clinical Applications Branch Room 18C-14 Telephone: (301) 443-3364 or (301) 443-4233 Eve K. Moscicki, Sc.D., M.P.H. Division of Clinical Research Epidemiology and Psychopathology Research Branch Room 10C-05 Telephone: (301) 443-3774 Debra J. Rog, Ph.D., or Irene Shifren Levine, Ph.D. Program for the Homeless Mentally Ill Division of Education and Service Systems Liaison Room 11C-25 Telephone: (301) 443-3706 The address for all of the above is: National Institute of Mental Health Parklawn Building 5600 Fishers Lane Rockville, Maryland 20857 Vol. 18, No. 1, January 13, 1989 - Page 14 FULL TEXT OF RFAs FOR ONLINE ACCESS NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM REQUEST FOR APPLICATIONS (AA-89-03) December 1988 P.T. 34, K.W. 0404003, 0755030, 1002004, 1002008, 1002058, 0710070, 0710085 New Techniques Small Grants for Alcohol Researchers (Catalog of Federal Domestic Assistance No. 13.273) INTRODUCTION The Division of Basic Research of the National Institute on Alcohol Abuse and Alcoholism (NIAAA) supports research and research training related to the mechanism of actions of alcohol abuse, and the multiple determinants and consequences of alcoholism. Research into the mechanisms of alcohol's action and disease pathophysiology often requires the use of specialized techniques in molecular and cellular biology, immunology, genetics, neurosciences or other biomedical fields. Due to the rapid emergence of new research technology, the research capacity of some established investigators in these fields may be impaired by their lack of experience in the latest techniques. The Division therefore wishes to encourage established researchers who are NIAAA-supported principal investigators, or who have recently been supported by NIAAA, to obtain firsthand experience with new techniques as a "Visiting Researcher" in the laboratory of a "Host" who is an expert in the latest technology in molecular biology, cellular biology, immunology, genetics, neurosciences, or other biomedical fields. The new techniques should be an integral part of an original pilot research project conceived by the Visiting Researcher in collaboration with the Host. The proposed research project should generate preliminary data which could strengthen a subsequent application for regular grant support, or provide documentation of experience in a defined area. OBJECTIVES AND SCOPE This Request For Applications (RFA) is intended to encourage prospective Visiting Researchers to identify Hosts in order to prepare and submit a New Techniques Small Grant Application. The application must be submitted by the Visiting Researcher and his/her institution. The proposed research project, to be performed in the Host's laboratory, need not be directly related to alcohol research. However, the techniques utilized while performing the research project must be directly applicable to the Visiting Researcher's plans for future work in alcoholism research. This program is intended to provide an opportunity for established alcohol researchers to acquire personal expertise in the utilization of specialized techniques applicable to alcoholism research. Examples of these techniques include, but are not limited to: o Recombinant DNA techniques such as gene cloning and sequencing, transfection techniques, and the production of transgenic cell lines and animals. o Molecular genetics techniques, such as multipoint mapping, in situ hybridization, and polymerase chain reaction for gene amplification. o Cell-biology techniques, such as measurement of signal transduction, measurement of receptor-ligand binding, microelectrode puncture, and voltage clamp techniques. o Immunological techniques, such as hybridoma production and fluorescence activated cell sorting. o Neurophysiological techniques, such as patch clamping, microinjection, and microdialysis procedures. o Advanced tissue and cell culture techniques, such as long-term culturing of hepatocytes, neuronal cells, astrocytes, and fibroblasts. o Imaging techniques, such as in vivo 31P-NMR spectroscopy, MRI, PET, and ex vivo autoradiography. o Electron microscopy techniques, such as frozen thin sections, and immunogold localization. ELIGIBILITY REQUIREMENTS: Applications may be submitted by public or private nonprofit or for-profit organizations such as universities, colleges, hospitals, laboratories, units of State or local governments, and eligible agencies of the Federal Government. The proposed Visiting Researcher must be a Principal Investigator on an NIAAA project grant (RO1) or Principal Investigator or Project Director on a component of a program project grant (PO1) or research center grant (P50). However, individuals who have met these criteria within the past 3 years are also eligible. Visiting Researchers must be citizens or noncitizen nationals of the United States, or have been lawfully admitted to the United States for permanent residence. Women and minority investigators are encouraged to apply. The Host must be an independent investigator with expertise in the specialized techniques involved in the application. The Host institution usually is a domestic institution different from that of the Visiting Researcher and usually in a different city. TERMS OF THE AWARD: This non-renewable award provides a maximum of $17,500 to $35,000 for a 3-6 month period in a Host laboratory with periods less than six months being prorated. (Note: The proposed project period may be up to 12 months in order to accommodate scheduling of the proposed research. However, support may be requested for research activities at the Host institution only for a period of 3-6 months.) The funds are to be used for salaries, supply needs in the Host's laboratory, and travel funds for the Visiting Researcher. Of the total funds, a maximum of $5,000 is allowed for salaries of technical personnel in the Host's laboratory, and up to $6,000 is allowed for temporary living accommodations for a 6-month period. A subcontract agreement with the Host institution will be necessary if funds are to be provided to the Host's institution. The proposed activity must be full-time and must include the conduct of research with supervision provided by the Host, or by the Host in association with an expert member of the Host's laboratory. The activity must be scheduled within the 12 months following the date of the award. A minimum time commitment of 3 months is required. Grants must be administered in accordance with the PHS Grants Policy Statement (Rev. January 1, 1987), which is available for $4.50 from the Superintendent of Documents, U.S. Government Printing Office, Washington, D.C. 20402. When ordering copies, the GPO stock number, GPO 017-020-00092-7, should be referenced. Federal regulations at Title 42 CFR Part 52, "Grants for Research Projects," and Title 45 CFR Part 74, "Administration of Grants," are applicable to these awards. The statutory authorities for these grants awards are Sections 301, and 510 of the Public Health Service Act (42 USC 241 and 290bb). APPLICATION RECEIPT DATE There will be a single receipt date of April 3, 1989. Applications received after that date will not be considered. The schedule for review and award is detailed below: Application NIAAA Initial Earliest Receipt Date Review Award April 3, 1989 June/July 1989 September 1989 APPLICATION AND REVIEW State and local government agencies may use form PHS 5161-1 (Rev. 3/86). All other applicants should use the research grant application form PHS 398 (Rev. 9/86). The title of this RFA, New Techniques Small Grants for Alcohol Researchers (RFA AA-89-03), should be typed in item number 2 on the face page of the PHS 398 application form. APPLICANTS SHOULD FOLLOW INSTRUCTIONS AT THE END OF THIS RFA WHEN PREPARING THE APPLICATION. Application kits containing the necessary forms and instructions may be obtained from institutional business offices or offices of sponsored research at most universities, colleges, medical schools, and other major research facilities. Application forms may also be obtained from the National Clearinghouse for Alcohol and Drug Information, Reference Department, P.O. Box 2345, Rockville, MD 20852 (telephone: (301) 468-2600). The RFA label (found in the application kit) must be affixed to the bottom of the face page of the original copy of the application. The original application and four copies are to be sent to the Division of Research Grants using the mailing label in the PHS 398 package. Failure to follow these procedures may result in DELAYED processing of the application such that it may not reach the review committee in time for review. Applications submitted in response to this RFA are not subject to the intergovernmental review requirements of Executive Order 12372, as implemented through the Department of Health and Human Service's regulations at 45 CFR Part 100 and are not subject to Health System Agency review. REVIEW CRITERIA An appropriate NIAAA peer review committee will evaluate each application based on the following criteria: scientific significance and feasibility of the proposed pilot research project; the potential of the proposed pilot research project to provide meaningful preliminary scientific data; relevance of the techniques proposed in the research project to the Visiting Researcher's planned future studies in alcohol research; appropriateness of the proposed research project for efficiently transferring the proposed techniques; appropriateness of the qualifications of all scientific staff involved; appropriateness of the proposed budget and, where applicable, adequacy of procedures to protect human subjects and to assure humane care in the use of laboratory animals. AWARD CRITERIA AND AVAILABILITY OF FUNDS In FY 1989, NIAAA anticipates making five to ten awards. However, the funding of applications submitted in response to this RFA is contingent on the actual availability of funds and receipt of applications deemed worthy of support by the NIAAA peer review process. FOR FURTHER INFORMATION, PROSPECTIVE VISITING RESEARCHERS OR SPONSORS SHOULD CONTACT: Helen M. Chao, Ph.D. Chief, Biomedical Research Branch Division of Basic Research, NIAAA Parklawn Building, Room 14C-20 5600 Fishers Lane Rockville, Maryland 20857 Telephone: (301) 443-4223 NEW TECHNIQUES SMALL GRANTS FOR ALCOHOL RESEARCHERS (Guidance for preparation of applications) Applications are to be submitted by the Visiting Researcher's Institution on or before April 3, 1989, on the standard PHS research grant application form (PHS 398, Rev. 9/86), according to instructions supplied with those forms EXCEPT for the following (See Instruction Sheet for PHS 398, Specific Instructions, pages 12-23): SPECIFIC INSTRUCTIONS - SECTION 1. (page 12): 1. Face page of application Item 2: This application is in response to: NIAAA RFA AA-89-03 on New Techniques Small Grants Item 3a: The Visiting Researcher is the proposed Principal Investigator Item 4: If human subjects are involved in the proposed research the exemption or IRB approval date should be supplied by the Host Institution. Item 5: If vertebrate animals are utilized in the proposed research the IACUC approval date and the Animal Welfare Assurance should be supplied by the Host Institution. Item 6: The anticipated starting date is September 1, 1989. The proposed project period may be up to 12 months in order to accommodate scheduling of the proposed research. However, support may be requested only for a period of 3- 6 months. Please indicate dates for the actual requested period of support (in parentheses). Item 7a: Direct Costs should include the total cost of the subcontract to the Host Institution. Item 9: Performance Site of the proposed research is the Host Institution. Item 10: Not applicable; mark N/A Item 11: The Applicant Organization is the Visiting Researcher's Institution. 2. Application, page 2 Key Personnel Engaged on Project, please list: 1. Principal Investigator (PI) 2. Host 3.Other technical personnel in the Host laboratory directly involved in the research project. 3. Application, page 4 "Detailed Budget for the 3-6 Month Period" should be limited to the following categories: Salary is allowable for the Visiting Researcher. Equipment costs are not allowed. Supplies must be purchased by the PI's laboratory for use in the Host laboratory. Expenses for travel by the Visiting Researcher between the home institution and the Host laboratory are allowable. The Consortium agreement between the Applicant and Host Institutions should contain: 1. Salary for the Host or technical personnel in the Host laboratory (not to exceed $2,500 to $5,000 for a 3-6 month project period, respectively). 2. Expenses for animal per diem and machine time, if appropriate. 3. The corresponding indirect cost. If the Host's Institution is a Federal laboratory, the Host or technical personnel in the Host laboratory will not be eligible for salary compensation. Therefore, consortium agreement will not be necessary. Other Expenses Limited funds, not to exceed $1,000 per month, may be requested for temporary living accommodations. Indirect costs to the applicant institution will be provided according to usual procedures for a project performed on other premises. 4. Application, page 5 Do not complete the Budget Table for Entire Proposed Project Period. Instead, use this page to thoroughly justify your budget requests for the requested project period of 3-6 months. Use ONE additional page if necessary. All requests for funds must be STRONGLY and SPECIFICALLY justified. 5. Biographical Data Not to exceed two pages per person. Biographical data should be provided for ALL proposed technical personnel who are directly involved in the project. The qualifications of the Principal Investigator and the Host should be thoroughly documented. Other current NIAAA grant support for the PI must be described and referenced. SPECIFIC INSTRUCTIONS - SECTION 2 (page 19): 1. Introduction/Background: Not to exceed one-half page. In this section the Visiting Researcher, in collaboration with the Host, should briefly describe the background of the proposed research project. 2. Research plan: A. & B. Specific Aims and Significance: Not to exceed three pages. Describe the research goals and specific aims of the proposed pilot research plan and the techniques to be utilized by the Visiting Researcher. Also describe the advance which will be possible due to the new preliminary research findings and/or the application of new techniques in the Visiting Researcher's alcohol research. C. Progress Report: Not applicable; do not submit. D. Experimental Design and Methods: Not to exceed two pages. Discuss the experimental design and methods of the proposed pilot research project which incorporates the appropriate new techniques listed under Specific Aims. E. & F. Human Subjects and/or Vertebrate Animals: Please follow instructions but limit each section to one-half page. If human subjects and/or vertebrate animals will be used during the project, then the appropriate assurances from the Host Institution must be on file with OPRR/NIH before an award will be made. Certification of IRB or IACUC approval must be included with the application. G. Consultants: Not applicable. I. Literature Cited: No more than 20 of the most relevant references should be cited. SPECIFIC INSTRUCTIONS - SECTION 3 (page 23): Appendix Please include with the application a letter of agreement between the Visiting Researcher and Host Institution regarding mutual acceptance of the terms of agreement in the application. The letter should be countersigned by the respective institutional officials. IMPORTANT: In order to facilitate review of the application by the Office of Scientific Affairs, NIAAA, and to assure the shortened review-award cycle, applications must be received by April 3, 1989. The complete and signed typewritten or word-processed original of the application and four copies (original and 2 copies if using PHS 5161-1) are to be sent in one package (see mailing instructions in the PHS 398 application kit) to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, Maryland 20892** C.O.D. applications will not be accepted. Since this application is in response to an RFA, please follow labeling instructions for RFAs as described in the PHS 398 application kit. Also, because of the short time period for review, applicants are requested to send two additional copies to: Dr. Mark Green Chief, Extramural Project Review Branch Office of Scientific Affairs, NIAAA 16C-20, Parklawn Building 5600 Fishers Lane Rockville, Maryland 20857 REQUEST FOR APPLICATIONS RFA NUMBER: 89-CA-07 RFA TITLE: The Relationship Between Blood and Tissue Micronutrient Levels in Humans APPLICATION RECEIPT DATE: March 27, 1989 LETTER OF INTENT RECEIPT DATE: February 3, 1989 I INTRODUCTION The Division of Cancer Prevention and Control, National Cancer Institute invites applications for grants to study the relationship between blood and tissue micronutrient levels in humans. Micronutrients of interest are those that have been found to be associated with cancer risk. Studies comparing blood and tissue micronutient levels with cancer risk are also encouraged, as is methods development for collecting tissue specimens suitable for the quantitative analysis of micronutrients. It is anticipated that there will be four awards. Much of our knowledge about the relationship between micronutrients and cancer comes from studies in which serum or red blood cell nutrient levels have been correlated with cancer incidence. Although blood micronutrient levels are presumed to reflect tissue levels, human data in this area are limited. In fact, preliminary evidence suggests that in many cases blood levels may not reflect tissue micronutrient content. The appropriateness of using blood levels to reflect tissue nutriture is a critical issue since micronutrients may exert their influence on cancer through actions occurring in specific tissues. Consequently, data on tissues micronutrient content and its relationship to blood levels are needed. The primary objective of this research is to clarify the relationship between blood and tissue levels of micronutrients that have been identified as possible determinants of cancer risk. Where necessary, the applicant should develop methods for obtaining tissue samples appropriate for micronutrient analysis. II BACKGROUND INFORMATION Numerous epidemiologic studies have found correlations between blood micronutrients levels and the incidence and/or risk of cancer. Many of the assumptions about the relationship between diet and cancer are based on these studies. Micronutrients that have been identified as possible determinants of cancer risk are likely to exert their influence through actions occurring in specific tissues. Therefore, the strength of the above mentioned studies is based largely on the assumption that blood micronutrient levels accurately reflect tissue micronutrient content. Some data indicate that in many cases blood levels do not reflect tissue content. Therefore, establishing the reliability of this relationship is critical to understanding the role of micronutrients in cancer risk. The potential insight to be gained by examining tissue micronutrient levels in addition to blood levels is suggested by data indicating that there are differences in micronutrient content between cancerous and normal tissue. Whether these differences contribute to the development of cancer or simply result from the cancer needs to be established. What also needs to be established is whether the sensitivity of blood determinations would be great enough to pick up differences in micronutrient content between normal and cancerous tissue. There is also evidence indicating that tissue repeatedly exposed to stimuli that adversely effect nutrients may become low or deficient in certain nutrients without this change being reflected by blood levels. For example, the lungs of smokers have a significantly lower vitamin E content in comparison to non smokers even though blood vitamin E levels in these two groups are similar. Studies determining the relationship between blood and tissue micronutrient levels are needed. Studies examining this relationship in individuals at increased risk, that is individuals with premalignant lesions and in cancer patients are also encouraged, as are comparisons between these individuals and controls. Finally, methods development when necessary for conducting these studies is also requested. III RESEARCH GOALS The purpose of this RFA is to solicit applications from qualified investigators interested in analyzing blood and tissue micronutrient content in humans. Subjects can include individuals without established cancer risk factors as well as those with premalignant lesions and cancer. When using subjects with cancer or premalignant lesions such as cervical dysplasia or bronchial metaplasia, comparisons of blood and tissue micronutrient levels with control subjects are encouraged. Tissue micronutrient content of cancerous and or premalignant tissue can also be compared to normal tissue from the same subject. Micronutrients chosen for analysis should be those for which there is evidence indicating an association with cancer risk. Examples of micronutrients of interest are beta carotene, folate, vitamins C and E, calcium, and selenium. When methodology to determine tissue and/or blood micronutrient content is not available, the applicant should develop methods for obtaining tissue and/or blood samples suitable for micronutrient analysis. Ideally, samples should be suitable for multiple analysis. IV. MECHANISM OF SUPPORT Support of this program will be through the National Institutes of Health (NIH) grant-in-aid. Applicants will be responsible for the planning, direction, and execution of the proposed project. Except as otherwise stated in this Request for applications (RFA), awards will be administered under PHS grants policy as stated in the Public Health Service Grants policy statement, DHHS Publication No. (OASH)82-50,000, revised January 1, 1987. This RFA is a one-time solicitation. Generally, future unsolicited competing renewal applications will compete with all investigator initiated applications and be reviewed by the Division of Research Grants (DRG). However, should the NCI determine that there is a sufficient continuing program need, the RFA will be reissued. Approximately $900,000 total costs per year for 4 years will be committed to specifically fund applications which are subjected in response to this RFA. It is anticipated that 4 awards will be made. This funding level is dependent on the receipt of a sufficient number of applications of high scientific merit. The total project period for applications submitted in response to the present RFA should not exceed 4 years. The earliest feasible start date for the initial awards will be November 27, 1989. Although this program is provided for in the financial plans of the National Cancer Institute (NCI), the award of grants pursuant to this RFA is also contingent upon the availablity of funds for this purpose. V. SPECIAL REQUIREMENTS Progress reports, should be included in the applications for continuation grants each year by the Principal Investigator. A yearly meeting of Principal Investigators is to be held as a forum to exchange information, and coordinate research interest. The applicants should make allowances for this annual meeting in their budget. VI ELIGIBILITY REQUIREMENTS Both non-profit and for profit organizations and institutions, governments and their agencies, and foreign institutions are eligible to apply. VII REVIEW PROCEDURES AND CRITERIA REVIEW PROCEDURES Upon receipt, applications will be administratively reviewed by the Division of Research Grants (DRG) for completeness. Incomplete applications will be returned to the applicant without furthur consideration. Evaluation for responsiveness to the program requirements and criteria stated in the RFA will be conducted by NCI program staff. Applications which are judged non-responsive will be removed from further consideration but may be submitted as investigator-initiated regular research grant applications at the next receipt date. Questions concerning the responsiveness of proposed research to the RFA should be directed to program staff as described in section X. In case the number of applications is large compared to the number of awards to be made, the NIH may conduct a preliminary scientific peer review to eliminate those applications judged to be noncompetitive and notify the applicant and institutional business official. Those applications judged to be both competitive and responsive will be further evaluated according to the review criteria stated below for scientific and technical merit by an appropriate peer review group convened by the Division of Extramural Activities, NCI and constituted primarily of nonfederal scientists. The second level of review will be conducted by the National Cancer Advisory Board, which considers the special needs of the Institute and priorities of the National Cancer Programn. REVIEW CRITERIA The factors to be considered in evaluating the scientific merit of each response to this RFA will be: 1. Relevance to the overall goals and objectives of the RFA. 2. Scientific merit of the study objective (s), design, and methodology including considerations of toxicity, safety, and quality assurance. 3. Basic and clinical scientific significance as well as originality of the proposed research. 4. Research experience and/or competence of the Principal Investigator and other key personnel to conduct the proposed studies. 5. Adequacy of time (effort) which the Principal Investigator and staff would devote to conduct the proposed studies. 6. Relevance and appropriateness of the specific target population, and assurance as to its accessibility. 7. Identity of sources of data, tissues, fluids, etc., procedures for their collection and analysis, and assurances as to their accessibility. 8. Extent to which the selection of tissues and micronutrients chosen for analysis can be scientifically justified. VIII METHOD OF APPLYING The regular research grant application form PHS-398 (revised 9/86) must be used in applying for these grants. These forms are available at most institutional business offices; from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Room 449, Westwood Building; 5333 Westwood Avenue, Bethesda, Maryland 20892; or from the NCI Program Director named below. The RFA label available in the 9/86 revision of Application Form 398 must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the title of the application and the RFA number should be typed on line 2 of 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 the DRG at the address listed below. The photocopies must be legible and single sided. Division of Research Grants National Institutes of Health Westwood Building, Room 240 5333 Westbard Avenue Bethesda, Maryland 20892 At time of submission, send two (2) additional copies of the application to Referral Officer Division of Extramural Activities National Cancer Institute Room 848, Westwood Building 5333 Westbard Avenue Bethesda, Maryland 20892 Applications must be received by March 27, 1989. Applications received after that date, will not be accepted. Also, the DRG will not accept any application in response to this announcement that is the same as one currently being considered by any other NIH review group or awarding unit. IX. LETTER OF INTENT Prospective applicants are asked to submit, by January 27, 1989, a letter of intent that includes a descriptive title of the proposed research, the name and address of the principal investigator, the names of other key personnel, the participating institutions, and the number and title of the RFA in response to which the application is being submitted. Although a letter of intent is not required, is not binding, and does not enter the review of subsequent applications, the NCI would like to emphasize the benefits to the applicant of having a principal investigator submit a letter of intent. First, it allows NCI staff to estimate the potential review workload and to avoid possible conflict of interest in the review. In addition, program staff will contact those who submit a letter of intent and may be able to assist prospective applicants in clarifying scientific content and objectives of an application, size and focus of a research program, organization of an application, and appropriate use of core components and consultants. Should it appear that the potential applicant has misunderstood the requirements and objectives of the RFA or opted for an inappropriate funding mechanism, NCI staff will be able to inform the applicant. The letter of intent should be sent to: Mark J. Messina, Ph.D. Program Director National Cancer Institute, DCB 9000 Rockville Pike, EPN 212C Bethesda, MD 20892 (301) 496-8573 X. INQUIRIES Written or telephone inquiries concerning the objectives and scope of this RFA are encouraged and should be directed to Mark J. Messina, Ph.D. at the above address. The program director welcomes the opportunity to clarify any issues or questions from potential applicants. This program is described in the Catalog of Federal Domestic Assistance Number 13.3999, Cancer Control. Awards will be made under the authority of the Public Health Service Act. Title IV, Section 403 (Public Law 78-410, as amended; 42 USC 284) and administered under PHS grant policies and federal regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12732 or Health Systems Agency Review. **THE MAILING ADDRESS GIVEN FOR SENDING APPLICATIONS TO THE DIVISION OF RESEARCH GRANTS OR CONTACTING PROGRAM STAFF IN THE WESTWOOD BUILDING IS THE CENTRAL MAILING ADDRESS FOR THE NATIONAL INSTITUTES OF HEALTH. APPLICANTS WHO USE EXPRESS MAIL OR A COURIER SERVICE ARE ADVISED TO FOLLOW THE CARRIER'S REQUIREMENTS FOR SHOWING A STREET ADDRESS. THE ADDRESS FOR THE WESTWOOD BUILDING IS: 5333 Westbard Avenue Bethesda, Maryland 20816