nih guide - vol. 12, no. 12 - december 9, 1983 · nih guide for grants and contracts vol. 12, no....

NIH Guide for Grants and Contracts

Vol. 12, No. 12, December 9,1983U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

IN THIS:I!jSW

Notice Termination of Geriatric Medicine Academic Award .................. Monal Institute on Aging

Index - AGING

Notice Program Project Research Grant Application (POI)

Special D i C ~ v ~ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . N a t i d Institute of Child Health

and Human DevelopmentIndex - CHILD HEALTH AND HUMAN

DEVELOPMENT

Amamement Availability of Request for Applications RFA

Sexually Transmitted Diseases Reseatch Units NIH-NIAID 84-AI44 ...................................

............Page 2

Page 5 National Institute of Allergy and

InfectiausDiseases Index- ALLERGY AND INFECTIOUSDISEASES

Amnmcement Availability of Request for Applications: RFA

Opportunistic Infectionsin AIDS Patients, ...................... Page 7 N W 84-AI45

National Institute of Allergy and InfectiousDiseases Index - ALLERGY AND INFECTIOUSDISEASES

Armomcement Availability of Request for Applications: RFA

Alzheimer Disease Research Centers / 80-AW1 ............................................. Page9

National Institute on Aging Index- AGING

COntirrUted

The NIH Guide is published at irregular intervals to announce scientific initiatives and to provide policy and administrative information to individuals and organizations who need to be kept informed of opportunities, requirements, and changes in grants and contracts activities ad-ministered by the Natlonal Institutes of Health. Two types of supplements are published by the respective awarding units. Those printed on yellow paper concern contracts: solicitations of sources and announcement of availability of requests for proposals. Those printed on blue paper concern invitations for grant applications in well-defined scientific areas to accomplish specific program purposes.

Have You Moved? Ifyou present address differs from that shown on the address label, please send your new address to: Grants and Contract Guide Distrlbu tion Center, Natlonai Institutes of Health, Room B3BN10, Building 31, Bethesda, Maryland 20205, and attach your address label to your letter. Prompt notice of your change of address will prevent your name from being removed from our mailing list.

- Index - Vol. 12, No. 12, December 9, 1983

Announcement Availability for Request for Applications: RFA

Biochemical Epidemiology84-CA-02 ............................................ Page 13

National Cancer Insti tute Index- CANCER

Announcement Availability of Request for Applications: RFA

Cooperative Agreements for Risk Reduction Clinical Trials Examining the Role of Micro and Macronutrients in t h e Prevention of Cancer 84-CA-03 ............................................Page15

National Cancer Institute Index- CANCER

Announcement Availability of Request for Applications: RFA

Specialized Clinical Research Cen te r s for Periodontal Diseases 84-DE42 ................................................Page16

National Institute of Dental Research Index - DENTAL RESEARCH

Announcement Availability of Request for Applications: RFA ..*.

Markers for Pulmonary Endothelial Injury and Repair84-HL-12-P ............................................... Page 1%

Division of Lung Diseases National Heart, Lung, and Blood Insti tute

Index - HEART, LUNG, AND BLOOD

Announcement Availability of Requests for Applications: RFA

Specialized Centers of Research in Transfusion Medicine, National Research and Demonstration Cen te r in Transfusion Medicine 84-HL-135 ...............................................Page 19

Division of Blood Diseases and Resources National Heart , Lung, and Blood Insti tute


Announcement Intermediate Voltage Electron Microscopy

and Image Analysis Resources.. .............................. Page 20 Biotechnology Resources Program Division ofResearch Resources

hdot - RESEARCH RESOURCES

Continued

- Index - VoI. 12, No. 12, December 9, 1983

Announcement Surgical Oncology Research ...................................... Page 2 3 National Cancer Institute

Index- CANCER

Announcement Hypertension in Pregnancy ....................................... Page 26 Nat ional Insti tute of Child Health

and Human Development National Heart , Lung, and Blood Institute

Index - CHILD HEALTH AND HUMAN DEVELOPMENT HEART, LUNG, AND BLOOD INSTITUTE

Announcement Surfactantsfor Perfhmrochemicals ............................... .Page 29 National Heart, Lung, and Blood Institute


Announcement Special Emphasis Research Career Award:

OccupationalSafetyandHealth ............................. .Page31 Department of Health and Human Services Centers for Disease Control National Insti tute for Occupational Safety and Health

Index - OCCUPATIONAL SAFETY AND HEALTH

NIMH Physician Scientist Award ....................................... Page 36 National Institute of Mental Health

Index - NATIONAL INSTITUTE OF MENTAL HEALTH

ClinicalInvestigator Award ............................................ P a g e 4 1 National Institute of Mental Health

Index - NATIONAL INSTITUTE OF MENTAL. HEALTH

NIH GUIDE FOR GRANTS AND CONTRACTS Vol. 12, No. 12 December 9 1983 I

NOTICE

TERMINATION OF GERIATRIC MEDICINE ACADEMIC AWARD

NATIONAL INSTITUTE ON AGING

The National Inst i tute on Aging (NIA) announces tha t , effect ive ' immediately, accep tance of fur ther applications for t h e Geriatr ic Medicine Academic Award will be deferred until fur ther no t ice in t h e NIH Guide to Grants and Contracts .

Existing Ger ia t r ic Medicine Academic Awards a r e in no way a f f ec t ed by this announcement and will be funded by NIA through their expec ted terminat ion da te s within t h e l imitat ions on availabil i ty of funds.

Those applications for t h e Geriatr ic Medicine Academic Award which w e r e received by t h e NIH Division of Research Grants to mee t t h e annual rece ip t d a t e of July 1,1983, will be processed, reviewed, and considered fo r funding on t h e basis of scient i f ic merit . At th i s t ime emphasis in funding is being placed on o ther ca ree r development mechanisms in research and academic leadership, These mechanisms include NIA's Academic Award, Clinical Investigator Award, and Physician Scientist Award.

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NOTICE

PROGRAM PROJECT RESEARCH GRANT APPLICATION (Pol) SPECIAL DIRECTIVES

NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT

The National Inst i tute of Child Heal th and Human Development (NICHD) announces updated direct ives for invest igators submit t ing applications for Program Projec t Grants (Pol 's) which are likely to b e assigned to NICHD for support. These direct ives will apply to a l l new and renewal applications submit ted fo r t h e NIH-DRG application rece ip t da t e , February 1, 1984, and thereaf te r . This not ice rescinds t h e special directives, including t h e dollar ceiling, announced in t h e NIH Guide for Gran t s and Con t rac t s Vol. 9, No. 8, June 6, 1980.

I. SCOPE OF NICHD PROGRAM PROJECT APPLICATIONS

To b e eligible for consideration for award as a program project , an approved application mus t conta in a minimum of three component pro jec ts deemed to be of high scientific merit . Each of t hese projects must be re levant to t h e cen t r a l t heme of t h e program pro jec t application.

11. PREAPPLICATION PROCESS --.

A. Applicants a r e encouraged to communica te in writ ing with NICHD prior to preparat ion And submission of a formal application. Although not mandatory, th i s l e t t e r will assist NICHD staff in determining if t h e proposal falls within t h e mission and research in te res t s of t h e Inst i tute , and if it mee t s t h e c r i t e r i a fo r a program project. I t will a lso permi t t h e appl icant to benef i t f rom consultation with NICHD staff and to obtain cu r ren t NICHD program pro jec t guidelines. Following receipt of t h e wr i t ten communication, potent ia l appl icants will b e contac ted promptly by a n Inst i tute Heal th Scient is t Administrator who will b e available for fu r the r consultation.

B. The wr i t ten communicat ion should provide in no more than two single spaced, typewri t ten pages, t h e following information:

1. A s t a t e m e n t highlighting t h e cen t r a l t h e m e and objectives of t h e proposed program project.

2. A brief description of each component pro jec t including the name of t h e Pro jec t Director and a s t a t e m e n t of how e a c h specific component pro jec t will cont r ibu te to t h e overal l goal of t h e program project.

3. An e s t i m a t e of t h e annual budget and t h e number of years of support requested for t h e to t a l program pro jec t and for each component project.

NIH GUIDE FOR GRANTS AND CONTRACTS Vol. 12, No. 12 December 9 1983 3

4. Depending on t h e cen t r a l t heme of t h e proposal, communications should b e directed to:

Philip Corfman, M.D. Director, Center for Population Research National Inst i tute of Child Health

and Human Development Landow Building - Room 7A-21 Bethesda, Maryland 20205

Telephone: (301) 496-1 101

or

Sumner Yaffe, M.D. Director, Cen te r for Research for Mothers

and Children Landow Building - Room 7C-03 Bethesda, Maryland 20205

Telephone: (301) 496-5097

Population research may include t h e reproductive sciences and t h e demographic and behavioral sciences.

Research re la ted to mothers and children may include menta l re tardat ion and developmental disabilities, human learning and behavior, pregnancy and perinatology, clinical nutri t ion and endocrinology, genet ics and teratology, and developmental biology.

111. THE APPLICATION

The program project application should b e prepared on PHS Form 398 and identified by typing “PROGRAM PROJECT’” in I tem No. 2 of t h e face page. NIH-DRG rece ip t da tes , NICHD review dates , and ear l ies t potent ia l s t a r t da t e s for program projects a r e shown below:

Application Initial Counci1 Ear I iest Receipt Dates Review Review Beginning Dates

February 1 June September December 1

June 1 November January April I

October 1 March June August 1

The original and four copies of t h e comple te application should b e mailed to:

Division of Research Grants National Inst i tutes of Health Westwood Building - Room 240 5333 Westbard Avenue Bethesda, Maryland 20205

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Two copies of t h e comple te application should be mailed under sepa ra t e cover to:

Eileen G. Hasselmeyer, Ph.D. Associate Director for Scientific Review National Inst i tute of Child Health

and Human Development Landow Building - Room 6C08 Bethesda, Maryland 20205

Applications received too late for one cyc le of review will b e held for t h e nex t review cycle.

The scient i f ic review of t h e application will b e conducted by a n NICHD init ial review group, in accordance with NIH peer review procedures. A project site visit is n o t a prerequis i te for consideration by a n NICHD review commit tee . Questions and o ther communicat ions about t h e review of t h e application should b e addressed to t h e Execut ive Secre ta ry of t h e assigned review commi t t ee , Off ice of Scientific Review, NICHD.

Second-level review will be provided by t h e National Advisory Child Health and Human Development Council.


ANNOUNCEMENT

AVAILABILITY OF REQUEsT FOR APPLICATIONS: RFA

-SEXUALLY TRANSMITTED DISEASES RESEARCH UNITS

NIH-NIAID 84-AI44

NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DiSEASES

Application Receipt Date: March 15, 1984

I. BACKGROUND INFORMATION

The National Ins t i tu te of Allergy and Infectious Diseases (NIAID) invites applications for one program pro jec t g ran t to be init iated during FY 1984 for participation in a n ongoing program of research in Sexually Transmit ted Diseases (STD). This RFA will b e issued only once during f iscal year 1984.

One of t h e major hea l th problems in t h e U.S. today is t h a t of sexually t ransmi t ted (venereal) diseases. The explosive r ise in gonococcal infections in t h e last decade, for example, with a n e s t ima ted 2,000,000 gonococcal cases per year , c a n be considered a major infect ious disease epidemic. Many o ther diseases, such as chlamydial infections, geni ta l herpes, en t e r i c infections, and hepat i t is B, a r e known to b e t ransmi t ted by t h e sexual route; t hese a r e now being recognized with increasing frequency. Pelvic inf lammatory disease, t h e most serious sequela of gonococcal infection in females , costs t h e heal th serv ices a n es t imated $1 billion annually.

11. RESEARCH GOALS AND SCOPE

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As one means of achieving the stated goals, t h e NIAID proposes to maintain support of a number of STD research units, o r cen te r s of excel lence, to serve as foci f o r research and training in STD. This RFA is for support of research to be considered for emphasis in th i s program can be on any o r a l l of t h e STDs t h a t a r e current ly recognized as significant public heal th problems. A s t rong cl inical component should be a major p a r t of t h e application.

The research e f fo r t s will focus on any o r a l l of t h e diseases known, o r believed to be t ransmit ted by sexual c o n t a c t or t h e sexual route. The diseases of in te res t in th i s program c a n include: gonorrhea; syphilis; chlamydial infection; Trichomonas; viral infections such as geni ta l herpes, geni ta l warts , hepat i t is B; nonspecific vaginitis; en te r ic diseases; parasi t ic infestations; and Acquired Immune Deficiency Syndrome. Specific a r e a s of research can include: biology or virulence f ac to r s of t h e causa l organism; t h e hosts' immune responses; animal model systems; diagnosis, therapy, and prevent ive measures; and epidemiology, including computer modeling of cont ro l s t ra tegies .

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Eligibility: Domestic universities, medical colleges, hospitals, and laboratories of other public or private institutions a r e eligible.

The program project can be supported for up to five years; renewability is dependent on successful competit ion and the availability of funds. Earliest s t a r t d a t e is September 28, 1984.

Funds available will be in t h e range of $300,000 - $350,000 direct costs. All PHSNIH policies pertaining t o awards and administration of research program projects will be adhered to. The Catalog of Federal Domestic Assistance ci ta t ion is No. 13.856, Microbiology and Infectious Diseases Research.

IV. REVIEW PROCEDURES AND CRITERIA

Initial peer review will be by the Microbiology and Infectious Diseases Research Commit tee of t h e Institute. Final review will b e by t h e National Advisory Allergyand Infectious Diseases Council. Prospective applicants a r e strongly advised to request f rom t h e Insti tute con tac t a n Information Brochure: The Program ProjectGrant, National Insti tute of Allergy and Infectious Diseases. The brochure outlines the method of preparing a program project application and o ther importantfea tures including review criteria.

Proposals considered to be not responsive to t h e t e rms of this RFA by the DRG and NIAID will b e returned t o the investigator.

V. METHOD O F APPLYING

A more detailed RFA is available upon request from the Insti tute contact . A l e t t e r of intent, while not mandatory, is suggested and should be forwarded t o the Insti tute no la te r than January 6, 1984. Applications, on PHS Form 398 (rev. 5/82), a r e available from the applicant's business office, or t he Division of Research Grants (DRG) NIH. An original and six copies should b e sen t t o the DRG. Receipt da t e is March 15, 1984; l a t e applications will be considered nonresponsive t o this RFA.

The words SEXUALLY TRANSMITTED DISEASES PROGRAM PROJECT and the RFA number 84-AI44 should appear in i tem 2 on t h e application face page.

VI. IDENTIFICATION OF CONTACT POINTS

Direct a l l inquiries to:

Milton Puziss, Ph.D., Chief Bacteriology and Virology Branch MIDP National Insti tute of Allergy and

Infectious Diseases National Insti tutes of Health Westwood Building - Room 738 Bethesda, Maryland 20205

Telephone - (301) 496-7728

NM GUIDE FOR GRANTS AND CONTRACTS Vol. 12, No. 12 December 9 1983 7

ANNOUNCEMENT

AVAILABILITY OF REQUEST FOR APPLICATIONS: RFA

OPPORTUNISTIC INFECTIONS IN AIDS PATIENTS

NIAID 84-AI45

NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES

I.

11.

111.


BACKGROUND INFORMATION

The National Inst i tute of Allergy and Infectious Diseases (NIAID) invites applications for regular research g ran t s to be ini t ia ted during f iscal year 1984 on t h e subject of opportunistic infections in individuals a f f l ic ted with a new disease called Acquired Immune Deficiency Syndrome, or AIDS.

AIDS is a serious condition charac te r ized by a specif ic de fec t in na tura l immunity against disease. People who suffer f rom AIDS become susceptible to a var ie ty of l ife-threatening infections. These infections a r e no t o f t en found in people whose immune system is normal, and if they occur, they a r e relatively mild. Many of these l ife-threatening infections a r e caused by t h e opportunistic microorganisms Pneumocystis carinii , Cryptosporidium, ' Mycobacterium Avium and M. intracellulare, and t h e fungal organisms Candida, Aspergillus and Cryptococcus.

RESEARCH GOALS AND SCOPE

The goals of t h e solicited research should focus on t h e seven opportunisticmicroorganisms mentioned above. The specific a reas of research may be basic biology of t h e organisms, mechanisms of pathogenesis, virulence factors , immunogens and immunopathology, immunotherapy and immune prophylaxis, and o ther invest igator se lec ted areas . Experimental sys tems in o the r mammalian hosts may b e used to invest igate t h e basic processes of pathogenesis, virulence, etc. The model systems, however, must r e l a t e to t h e infect ion in humans.

MECHANISM OF SUPPORT

Eligibility - Domest ic universities, medical colleges, hospitals, and laborator ies of o ther public, p r iva te or for prof i t insti tutions a r e eligible.

The project can b e supported for up to five years; renewability is dependent on successful compet i t ion and t h e availabil i ty of funds. Earliest s t a r t d a t e is September 1, 1984.

Funds available for th i s program will approximate $500,000 d i rec t costs for t h e f i rs t year. All Public Health Service (PHS) and National Inst i tutes of Health (NIH) policies pertaining to awards and administration of research projects will apply. The Cata log of Federal Domestic Assistance c i ta t ion is Sec. 13.856, Microbiology and Infectious Diseases Research.

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V.

VI.

REVIEW PROCEDURES AND CRITERIA

Initial peer review will b e by a Study Sect ion of the Division of Research Grants (DRG), NIH. Final review will be by t h e National Advisory Allergy and Infectious Diseases Council.

Applications will b e reviewed by the DRG and NIAID to de termine whether o r n o t they a r e responsive to t h e t e rms of this RFA.

METHOD O F APPLYING

Prospect ive appl icants a r e advised to c o n t a c t t h e Inst i tute representat ives l isted below for additional information concerning programmat ic goals and scope. Prospect ive appl icants a r e encouraged to submit a one page l e t t e r of in t en t t h a t includes a brief description of t h e thrus t of t h e research ac t iv i t ies and ident i ty of t h e Principal Investigator o r o the r key personnel, if known. The Inst i tute reques ts such l e t t e r s for t h e purpose of providing an indication of t h e number and scope of applications to be received. A l e t t e r of in ten t is no t binding, will no t e n t e r i n to t h e review of any application subsequently submit ted, and is not a necessary requirement for application. Proposals a r e to be submi t ted on PHS Form 398 (rev.5/82) available f rom t h e applicant's business office or t h e Division of Research Gran t s (DRC), NIH. An original and six copies should be s e n t to t h e DRG and a copy of t h e face page s e n t to t h e Inst i tute contac t . Rece ip t d a t e is March 16, 1984.

The words "Opportunistic Infections in AIDS Pat ients" and t h e RFA number 84-AI-05 should appear in i t em 2 on t h e application face page.

IDENTIFICATION OF CONTACT POINTS

Direc t a l l inquiries prior to submission to:

Bacter ia l and Fungal

Darrel D. Gwinn, Ph.D. Program Officer , Tuberculosis/Mycology Microbiology and Infectious

Diseases Program National Inst i tute of Allergy

and Infectious Diseases National Inst i tutes of Heal th Westwood Building - Room 738 Bethesda, Maryland 20205

Telephone: (301)496-7728

Paras i t ic

Harley C. Sheffield, Ph.D. Parasitology Program Officer Microbiology and Infectious

Diseases Program National Inst i tute of Allergy

and Infectious Diseases National Inst i tutes of Health Westwood Building - Room 737 Bethesda, Maryland 20205

Telephone: (301) 496-7115


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ANNOUNCEMENT

AVAILABILITY OF REQUEST FOR APPLICATION: RFA

ALZHEIMER DISEASE RESEARCH CENTERS

84-AGO 1

NATIONAL INSTITUTE ON AGING

Application Receipt Date: March 20, 1984 L e t t e r of Intent Receipt Date: February 15,1984

I. BACKGROUND

Of t h e many disabling conditions of t h e aged, one of t h e most serious is Alzheimer disease, a progressive degenerative disease of t h e brain. Alzheimer disease a f f e c t s approximately five to six percent of t h e United States population over age 65. This disease is the most frequent cause of institutionalization of t h e aged in long-term-care facilities. In 1983 t he United States will spend more than $27 billion for t h e care of patients with Alzheimer disease. In developing specific initiatives in t h e 1984 appropriation, t h e Congress provided $3.5 million to t h e National Insti tute on Aging ( N I N for t h e development of a multi-Institute collaborative e f f o r t to establish specialized research centers on Alzheimer disease. Under t h e leadership of the NIA, this effort involves the programmatic contributions and collaboration of the National Insti tute of Mental Health (NIMH), t he National Insti tute of Neurological and Communicative Disorders and Stroke (NINCDS) and t h e National Institute of Allergy and Infectious Diseases (NIAID) to establish up to five specialized centers of excellence for research on Alzheimer disease and re la ted disorders.

11. PROGRAM OBJECTIVES AND SCOPE

The National Insti tute on Aging is inviting grant applications from interested institutions to establish centers of excellence devoted to t h e study of Alzheimer disease and related disorders. This type of solicitation (the RFA) is issued to encourage coordinated multidisciplinary research in a n area of special importance to t h e NIA, NINCDS, NIMH, and NIAID. An Alzheimer Disease Research Center (ADRC) will b e an identifiable organizational unit formed by a

This p rogram is described in the Catalog of Federal Domestic Assistance, No. 13.866, Aging Research. Awards will be made under t h e authority of the Public Health Service Act, Title 111, Section 301 (Public Law 78-410, as amended; 42 USC 241) and administered under PHS grant policies and Federal Regulations 42 CFR P a r t 52 and 45 CFR P a r t 74. This program is not subject to Health Systems Agency Review.

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single university medical cen te r or a consortium of cooperat ing insti tutions, including t h e university aff i l ia ted centers . The general purpose of t he ADRC is to support new research and to enhance ongoing research by providing c o r e support to bring toge ther behavioral , biomedical, and clinical science investigators in a manner t h a t will enr ich t h e e f fec t iveness of Alzheimer disease research and ul t imately improve heal th c a r e delivery. An ADRC will be expected to foster t h ree re la ted functions: conducting multidisciplinary research; training sc ien t i s t s and clinicians (Ph.D., M.D., D.V.M., D.O., D.D.S., R.N.); and teaching and/or t ransferr ing new information concerning Alzheimer disease and re la ted disorders.

To b e eligible for a cen te r g ran t under this program, the potent ia l appl icant insti tution must have ongoing, independently supported research and must propose new research in t h e a r e a of Alzheimer disease and related dementing disorders of t h e aged. Relevant research projects supported by a DHHS agency, t h e VA or a foundation can become aff i l ia ted with a Center . The specific e l emen t s of a n ADRC for which funds will be available in addition to c o r e functions are: (a) new fully conceptual ized research projects, (b) pilot or feasibility s tudies (new init iatives) in biomedical, epidemiological, behavioral and social research, and (c) co re adminis t ra t ive ac t iv i t ies fostering training of investigators and clinicians, information t ransfer , and program enr ichment act ivi t ies , The overal l in ten t is to provide new support for an added dimension, capabili ty, o r potent ia l for accomplishments g r e a t e r than t h a t possible by t h e present ongoing support at t h e appl icant insti tution. The major source of research support sought by the investigators associated with t h e Cen te r must b e through independently funded projects of t h e par t ic ipants . Stipends for t ra inees will no t be avai lable through .-ADRC funding; they must be sought through sepa ra t e avenues of funding, e.g., individual fellowship and/or insti tutional training g ran t awards.

The c o r e concept will be applicable to a l l of t h e ADRC activit ies--research, training and information t ransfer . Core faci l i t ies (shared resources) may be proposed which will enhance productivity o r in o ther ways benef i t a group of invest igators to accomplish t h e s t a t ed goa!s of t h e ADRC. Three types of c o r e uni ts will be mandatory of a l l ADRCs:

(a) an adminis t ra t ive unit to manage t h e overal l ac t iv i t ies of t h e Center ,

(b) a research support unit which serves t h e functions of pa t i en t registry, coordination, and evaluation; and clinical , pathological, social, behavioral and epidemiological d a t a gathering, s torage, coordination and analysis, and

(c) a n autopsy unit , e i t he r on s i t e or available through specified cont rac tua l a r rangment , which serves t h e functions of collecting, storing and distributing brain t issue, and provides rout ine services for biochemical, histological and neuropathological studies.

In addition to t h e above, each ADRC may propose o the r types of cores. These may include specif ic common faci l i t ies for ac t iv i t ies which will b e uti l ized and shared by at leas t two or more components of t h e Center . If exceptional concent ra t ion of resources, invest igators and research a r e present in one or more ADRC cen te r t h a t

*’*focuses in a par t icular a r e a such as neuropathology and brain banking, pa t i en t diagnosis and evaluation, or d a t a registry and epidemiology, it is possible t h a t such

NM CUlDE FOR GRANTS AND CONTRACTS Vol. 12, No. 12 December 9 1983 11

a center may b e designated as a National Coordinating Center in this field. Applicants interested in developing a center with an added specific focus in one of these a reas may contac t t he program administrator for further details.

111. MECHANISM OF SUPPORT

The support mechanism for th i s program will be t h e traditional NIH grant-in-aid. Applicants will plan and execute their own programs. Approximately $3.5 million will be set aside to fund applications which a r e submitted in response to t h e RFA. I t is anticipated t h a t approximately five grants will be awarded under this program. This specific amount will, however, depend on t h e merit and scope of t h e applications received. These applications will not compete for funding within the general pool of dollars available for other investigator- initiated research proposals. Only applications of sufficiently high scientific merit will b e funded. The expected start ing d a t e is September 30, 1984. The current policies and requirements t h a t govern the research grant programs of t he NIH will prevail. No more than one ADRC Grant will be made to any one institution (or, for multicampus institutions, no more than one to each campus). Applications may also be submitted for consortium arrangements among investigators at separate but neighboring institutions who demonstrate a high degree of' multidisciplinarycollaboration.


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A. Review Method: All applications responding to t h e RFA will b e reviewed for scientific and technical merit by a n initial review group which will be convened by t h e Scientific Review Office of t he NIA solely to review these applications. Upon receipt, applications will be reviewed for their responsiveness to the objectives of this RFA. If an application is judged nonresponsive, t h e applicant will be contacted and given an opportunity to submit supplemental information. Although a site visit may be made, each proposal should be complete in itself, and should b e prepared as if no visit is expected.

B. Review Criteria: The f ac to r s to be considered in t h e evaluation of t h e scientific meri t of each application will be those used in the review of traditional research-project g ran t applications, including t h e novelty, originality, and feasibility of t h e approach; t he training, experience, and research competence of t h e investigator; t h e adequacy of t h e research design; t h e suitability of t h e facilities; scientific and administrative leadership of t h e applicant; institutional commitment; academic environment; and t h e appropriateness of the requested budget to the work proposed. As with any award of this nature, t h e scientific qualifications, demonstrated administrative ability, and total commitment of t h e principal investigator and institution to t h e proposal will b e important f ac to r s in judging the overall merit of the application. An additional cri terion will be the importance of the proposed research to t h e objectives of this RFA.

V. METHOD OF APPLYING

A. Format for Application: Submit the application on form PHS 398, t h e application form for the traditional research-project grant. This form is available in an applicant institution's off ice of sponsored research or business off ice , or from the Division of Research Grants (DRG) of the NIH. Use the

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conventional format for a research-project grant application (please observe page limitations) and ensure tha t the points identified in the section on review procedure and criteria a r e fulfilled. To identify these applications as being in response t o the RFA, check "yes1' on i tem 2 of page 1 of the application and enter the title: "ALZHEIMER DISEASE RESEARCH CENTERS" and the RFA number 84-AG-01. Guidelines for ADRC Applicants a r e available from NIA. See section on "Inquiries."

B. Application Procedure: Although not a prerequisite for applying, potentialapplicants a r e encouraged to submit to the program administrator indicated below a non-binding le t ter of intent to apply, post-marked no la ter than February 15, 1984. The le t ter of intent does not influence review or funding decisions, but i t will enable t h e NIA to plan t h e review, and will ensure tha t each potential applicant receives relevant program information prior to expending considerable e f for t in application preparation.

Send or deliver the completed application and four (4) signed, exac t photocopies of i t to:

Division of Research Grants National Institutes of Health Westwood Building - Room 240 Bethesda, Maryland 20205

In addition, at the same t ime two informational copies should be sent under separate cover to:

Chief, Scientific Review Office Office of Planning and Extramural Affairs National Institute on AgingNational Institutes of Health Building 31 - Room 5C-12 Bethesda, Maryland 20205

The deadline for receipt of applications by the NIH Division of Research Grants is March 20, 1984. Applications a f te r this da t e will not be considered. Logistics and managerial practicality necessitate t ha t onlyapplicant institutions in the United S ta tes will be eligible. Additional information and copies of more detailed guidelines which outline the ADRC requirements and the method of applying can be obtained from NIA.

C. Inquiries

Inquiries regarding this announcement or requests for guidelines may b e directed to the program administrator:

Zaven S . Khachaturian, Ph.D. Chief, Physiology of Aging Branch Biomedical Research and Clinical Medicine ProgramNational Institute on AgingNational Institutes of Health Building 31C - Room 5C-27 Bethesda, Maryland 20205

Telephone: (301) 496-9350

...

13 NIH GUIDE FOR GRANTS AND CONTRACTS Vol. 12, No. 12 December 9 1983

ANNOUNCEMENT


BIOCHEMICAL EPIDEMIOLOGY

84-CA-02

NATIONAL CANCER INSTITUTE

Application rece ip t date: May 15, 1984

I. BACKGROUND

Although a signif icant proportion of human cance r s a r e thought to b e a t t r ibu tab le to l i fe s ty le and o ther environmental f ac to r s and therefore potentially preventable, t h e task of identifying the e f f e c t s of specif ic f ac to r s and evaluating their re la t ive importance is a n enormous one. The process of induction and progression of human cance r is exceedingly complex; multiple exposure to a var ie ty of agen t s ove r t ime is t h e rule r a the r than t h e exception, pas t exposure is diff icul t to assess, host f ac to r s which may inf h e n c e susceptibil i ty a r e poorly understood, and t h e importance of promoting and/or anticarcinogenic exposures in humans have not been adequately defined.

Epidemiologic studies have resul ted in t h e identification of f ac to r s which appear to increase or decrease cancer risk and have suggested t h e importance of host-susceptibil i ty factors . The usual epidemiologic techniques, however, have been l imited in the i r abil i ty to reach f i rm conclusions by t h e diff icul t ies in defining pastcarcinogen exposure levels and susceptibil i ty states, in measuring low levels of risk, in evaluat ing direct ly host environmental interactions, and in identifying dietary de te rminants of cancer . Fortunately, a var ie ty of sensit ive and specif ic laboratory methods a r e now becoming available which a r e likely to facilitate epidemiologic investigations by providing b e t t e r measures of exposure to init iators, promoters, anticarcinogens and inhibitors of carcinogenesis. Increased collaboration be tween laboratory sc ien t i s t s and epidemiologists in t h e application of these emerging techniques would b e highly desirable.

This program is described in t h e Catalog of Federal Domestic Assistance number 13.393, Cancer Cause and Prevention Research. Awards a r e under authorizat ion of t h e Public Health Service Act , Sect ion 301(c) and Section 402 (Public Law 78-410, as amended; 42 USC 241; 42 USC 282) and administered under PHS grant policies and Federal Regulations 42 CFR P a r t 52 and 45 CFR P a r t 74. This program is no t subject to Heal th Systems Agency Review.

14

Modifying factors related t o diet and nutrition have been implicated in several epithelial cancers including those of the gastrointestinal t ract and reproductive organs. Hence these types of cancer (among others) might be especially suitable for collaborative studies involving epidemologists and experimentalists.

11. GOALS AND SCOPE

The purpose of this RFA is t o stimulate the development and/or use of objective measures of risk in epidemiologic studies of the etiology of human cancer.

Studies of interest include (1) pilot and feasibility studies which (a) a r e necessary t o adapt laboratory procedures to epidemiologic use, (b) characterize the accuracyand validity of the tests, and/or (c) compare the laboratory procedures with more traditional methods of assessing risk factors; and (2) full-scale epidemiologicstudies using well characterized laboratory procedures. These procedures may measure actual levels of substances directly involved in the carcinogenic process, may measure markers (substances closely correlated with carcinogenic events), or factors which influence susceptibility. Collaboration between epidemiologists and laboratory scientists is encouraged at a l l stages in the development and use of tests in order to promote the efficient transition of research effort from laboratory to field study, although level of involvement of the epidemiologist will vary from consultation to project direction depending upon the stage of test development.

Successful grant awardees under this RFA will be required t o participate in an annual program meeting of one or two days' duration. The meeting will be held in Bethesda, Md., to review and assess overall progress. The respondents should request sufficient funds within the budget t o accommodate expenses for one t o two participants at this meeting.

111. MECHANISM OF SUPPORT

This RFA will use the traditional National Institutes of Health research (NIH) project grant. Responsibility for the planning, direction and execution of the proposed research will be solely that of the applicant. The total project period for applications submitted in response to the present RFA should not exceed three years. The intent is t o fund several individual research project grants, with total costs amounting t o approximately $1.0 million for the first year. This funding level is dependent on the receipt of a sufficient number of applications of high scientific merit. 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 availability of funds for this purpose. Renewal applications will competewith all other unsolicited applications received by the NCI. NIH policies governingregular research project grants, including cost sharing, apply to applicationsreceived in response to this request.

IV. COPIES OF THE BIOCHEMICAL EPIDEMIOLOGY RFA

May be obtained from:

Dr. Genrose D. CopleySpecial Programs Branch Division of Cancer Cause and Prevention National Cancer Institute '4k

Landow Building - Room 8C-16 Bethesda, Maryland 20205

Telephone: (301) 496-9600

-6


ANNOUNCEMENT

AVAILABILITY OF REQUEsT FOR APPLICATIONS: RFA

COOPERATIVE AGREEMENTS FOR RISK REDUCTION CLINICAL TRIALS EXAMINING

THE ROLE OF MICRO AND MACRONUTRIENTS IN THE PREVENTION OF CANCER

84-CA-03

NATIONAL CANCER INSTITUTE

Application Rece ip t Date: February 15, 1984

A prior announcement, "The Role of Micro and Macronutrients in t h e Prevent ion of Cancer" (NIH Guide for Gran t s and Contracts , Vol. 12, No. 5 , May 20, 1983) invited investigators to submit applications for cooperat ive agreements to support risk reduction clinical t r ia l s d i rec ted at examining t h e role of micro and macronutr ients in t h e prevention of cancer . The RFA is hereby reissued.

The Division of Resources, Centers , and Community Activit ies (DRCCA) of t h e NCI invites cooperat ive agreement applications to support risk reduction cl inical t r ia ls directed at examining t h e role of micro and macronutr ients in t h e prevention of cancer . These cl inical tr ials, which exclude focus on skin cancer (except melanoma) a r e to be conducted among normal populations as well as those who a r e at high risk for cancer . Micronutrients include, but a r e not l imited to: beta-carotene, vi tamin A o r analogs, vitamin C, selenium and alpha tocopherol. Macronutrients include fats, vegetables, f rui ts , ce rea l s and fibers.

An applicant, if funded under th i s RFA, will b e supported through t h e coopera t ive agreement mechanism in accordance with t h e policies of t h e Public Health Service (PHS) and National Inst i tutes of Health (NIH).

The awardee will have t h e primary responsibility for t h e planning and direct ion of t h e proposed study. This will involve ac t ive participation and interact ion with t h e NCI staff on both adminis t ra t ive and scient i f ic program act ivi t ies . NCI staff will periodically review progress to ensure t h a t t h e project conforms to the conditions of t h e award.

Applicants a r e n o t res t r ic ted to those who responded to the May 1983 announcement.

The RFA is available from:

Windred F. Malone, Ph.D., M.P.H. Chemoprevention Branch Blair Building - Room 624 National Cancer Inst i tute Bethesda, Maryland 20205

Telephone: (301) 427-8643

16

ANNOUNCEMENT


SPECIALIZED CLINICAL RESEARCH CENTERS FOR PERIODONTAL DISEASES

84-DE42

NATIONAL INSTITUTE OF DENTAL RESEARCH

Application Receipt Date: May I , 1984

The National Inst i tute of Dental Research (NIDR) invi tes applications for one o r more new clinical research cen te r s devoted to periodontal diseases. The NIDR is cur ren t ly supporting th ree Specialized Clinical Research Centers fo r Periodontal Diseases at Forsyth Dental Center , Boston; State University of New York, Buffalo; and Virginia Commonwealth University, Richmond. The f i r s t two centers are in the i r seventh y e a r of support and t h e third cen te r in its sixth year. The object ives of t h e new center(s) a r e to acce le ra t e t h e acquisit ion of new d a t a fo r preventing, diagnosing, and t rea t ing periodontal diseases and to bring their resources, facil i t ies, and manpower to bear on these problems in a concer ted way. The center(s) will b e expec ted to capi ta l ize on t h e recent advances in microbiology, immunology, and pharmacology.

The main object ive of t h e clinical research c e n t e r s is to fac i l i t a t e t h e application of basic research findings in t h e a reas of pharmacology, microbiology, and immunology in clinical investigations of pa t i en t s having periodontal disease. Even though these c e n t e r s should emphasize s tudies of human pat ients , it is recognized t h a t laboratory and animal studies may also b e needed to aid in understanding t h e disease processes. Specifically, t h e center(s) should develop programs to accomplish some or a l l of the following priorit ized objectives:

1. Develop prevent ive measures.

2. Develop diagnostic tests especially for periodontal disease act ivi ty .

3. Improve therapeut ic techniques and regimens.

4. Establish t h e causa t ive organisms in periodontal diseases.

5. Determine t h e host response to these causa t ive organisms.

The substance of each research program may vary according to local expert ise , in te res t , resources, and recru i tment possibilities, bu t t h e projects developed by each cen te r must re la te t o t h e above objectives. Applicants should a t t e m p t to develop a unique program which is complementary ra ther than duplicative of ongoing research. The Insti tution must b e willing t o make a commi tmen t of resources and staff to ensure t h e development,

r.operation, and funct ion of t h e proposed center .

NIH GUIDE FOR GRANTS AND CONTRACTS Vol. 12, No. 12 December 9 1983

Copies of t h e comple te RFA and additional information may b e obtained from:

Dr. Samuel Kakehashi Extramural Programs National Inst i tute of Dental Research Westwood Building - Room 519 Bethesda, Maryland 20205

Telephone: (301) 496-7784

17

18

ANNOUNCEMENT

AVAILABILITY OF REQUEST FOR APPLICATIONS (RFA)

MARKERS FOR PULMONARY ENDOTHELLAL INJURY AND REPAIR

84-HL-12-P

DIVISION OF LUNG DISEASES

NATlONAL HEART, LUNG, AND BLOOD INSTITUTE

Application Receipt Date: April 30, 1984

The Division of Lung Diseases (DLD) National Hear t , Lung, and Blood Inst i tute (NHLBI) announces t h e availabil i ty of a Request for Applications (RFA) on the identification of markers for pulmonary endothelial injury and repair. The main objective of th i s special gran t program is to identify markers of pulmonary endothelial injury and repair and to determine how these markers could b e applied to predic t t h e onset , course, and outcome of a c u t e lung injury due to a var ie ty of causes.

Projec ts should address t h e identification of biochemical markers of a c u t e endothelial injury in t h e lung, such as t h e release of specif ic ant igens from t h e damaged endothelium o r the binding of specif ic molecules by t h e injured endothelium. Studies correlat ing changes in endothelial functions with markers for injury a r e a lso of interest . This announcement may b e of par t icular in te res t to investigators with expert ise in biochemistry, immunology, pharmacology, pathology, cel lular physiology and toxicology.

A l e t t e r of in ten t is requested by February 15, 1984 and t h e deadline for rece ip t of applications is April 30, 1984. The ear l ies t award d a t e for successful applicants will b e in September 1984. Reques ts for copies of th i s RFA should be addressed to:

Carol E. Vreim, Ph.D. Chief , Inters t i t ia l Lung Diseases Branch Division of Lung Diseases National Heart , Lung, Blood Inst i tute National Inst i tutes of Heal th Westwood Building - Room 6A05 Bethesda, Maryland 20205

Telephone: (301) 496-7034

-e

NIH GUIDE FOR GRANTS AND CONTRACTS 19Vol. 12, No. 12 December 9 1983

ANNOUNCEMENT

AVAILABILITY OF REQUEsTS FOR APPLICATIONS (RFA)

SPECIALIZED CENTERS OF RESEARCH IN TRANSFUSION MEDICINE NATIONAL

RESEARCH AND DEMONSTRATION CENTER IN TRANSFUSION MEDICINE

84-HL-13-8

DIVISION OF BLOOD DISEASES AND RESOURCES

NATIONAL HEART, LUNG, AND BLOOD INSTITUTE

Application Receipt Date: June 15, 1984

The Division of Blood Diseases and Resources (DBDR) of t h e National Hear t , Lung, and Blood Inst i tute (NHLBI), NIH supports a comprehensive research program in Transfusion Medicine. This compre hensive research program is intended to b e a multidisciplinary approach d i rec ted at improving t h e availability, s a fe ty and quality of blood and blood products for therapeut ic uses. As p a r t of th i s comprehensive program, t h e NHLBI announces a competition for Specialized Centers of Research (SCOR) in Transfusion Medicine and a compet i t ion for a National Research and Demonstration Cen te r (NRDC) in Transfusion Medicine. Applications received in response to th is request will par t ic ipate in a single competit ion.

A National Research and Demonstration Cen te r in Transfusion Medicine is conceived as an enhancement of t h e SCOR program. I t must include basic and cl inical research ( the tradit ional SCOR components) along with demonstrat ion and educat ion research and a n essential coordinating and integrat ing e f for t . APPLICANTS MAY APPLY FOR EITHER A NATIONAL RESEARCH AND DEMONSTRATION CENTER OR A SCOR. THE SUBMISSION OF A NATIONAL RESEARCH AND DEMONSTRATION CENTER APPLICATION MAY, IN SOME INSTANCES, RESULT IN THE AWARD OF A SCOR GRANT. In o the r words, t h e appl icant insti tution may apply for support as a National Research and Demonstration Cen te r but, a f t e r appropriate peer review, it may b e approved only as a SCOR if t h e o ther components (Demonstration and Education Research and Integration) a r e found deficient.

The requirements and fo rma t s for applications submit ted in response to this announcement and additional information regarding t h e charac te r i s t ics of these mechanisms of support can b e obtained from:

George J. Nemo, Ph.D. Chief, Blood Resources Branch Division of Blood Diseases and Resources National Heart , Lung, and Blood Inst i tute National Insti tutes of Heal th Federal Building - Room 5C10 Bethesda, Maryland 20205

Telephone: (301) 496-1537

20

ANNOUNCEMENT

INTERMEDIATE VOLTAGE ELECTRON MICROSCOPY AND IMAGE ANALYSIS RESOURCES

BIOTECHNOLOGY RESOURCES PROGRAM

DIVISION OF RESEARCH RESOURCES

I. BACKGROUND INFORMATION

The Biotechnology Resources Program (BRP) of t h e Division of Research Resources (DRR) invi tes g ran t applications from interested insti tutions for support of resources in in te rmedia te vol tage e lec t ron microscopy and image analysis to b e used in s t ruc tu re and function s tudies of whole ce l l s and s tudies of substructural fea tures of cells.

The purpose of t h e BRP is to make s ta te-of- the-ar t technological capabi l i t ies available through a research resource to t h e biomedical research community on a regional or nat ional shared basis. The program also emphasizes development of scient i f ic technological capabi l i t ies and methodology to broaden t h e range of application of t h e technology in biomedical research. A comple te resource encompasses f ive essent ia l component activit ies: c o r e research and development,col laborat ive research, service, training, and dissemination of results.

11. AREAS OF RESEARCH INTEREST

A number of new and increasingly sophisticated techniques for investigation of biologically important intracellular s t ruc tures have been developed during t h e pas t two decades. One of these, in te rmedia te vol tage e lec t ron microscopy, is now at a s t age of development in which it can b e applied in biomedical research. The goal of th i s announcement is to encourage t h e development of regionally or nationally shared resources in t h e in te rmedia te vol tage range (300-500 KV) which a r e on t h e leading edge of th i s a r e a of research. The research focus should b e on t h e applications to de termine how t h e ce l l es tabl ishes and maintains its three-dimensional organization, and how i t controls i t s size and shape.

This program is descibed in t h e Catalog of Federal Domestic Assistance No. 13.371, Biotechnology Research. Awards will b e made under t h e authori ty of t h e Public Heal th .qws

Service Act , Ti t le 111, Sect ion 301 (Public Law 78-410, as amended; 42 USC 241) and administered under Public Health Service g ran t policies and Federa l Regulation 42 C F R P a r t 74. This program is no t subject to Health Systems Agency review.

N M GUIDE FOR GRANTS AND CONTRACTS Vol. 12, No. 12 December 9 1983 21

*,I&' 111.

IV.

V. *'lu**

One component in t h e definit ion of a resource is c o r e research and development. Examples of appropriate co re projects include chemically probing t h e propert ies of t h e larger organizat ional en t i t i es t h a t make up p a r t of t h e ce l l , t i l t ing of t h e specimen to fac i l i t a t e t h ree dimensional reconstruction of substructure, and methods fo r analysis of images obtained. Other appropriate c o r e pro jec ts include development of methods to increase t h e applicability of in te rmedia te vol tage EM methods, for example, labeling t h e specimen with appropriate probe molecules to de termine t h e funct ional relationships of non-periodic biological s t ruc ture such as centrioles. O the r topics of in te res t a r e new t h r e e dimensional imaging techniques for periodic s t ructures .

Collaborative research and service applications from sc ien t i s t s in t h e geographical region served should be described in t h e application. These could include studies of t h e a r rangement of nucleosomes in t h e chromatin s t rand, t h e s t ruc tu re and function of mitochondria and o ther par t icu la te components of t h e cytoplasm, t h e th ree dimensional a r rangement of fi laments, microtubules and membranous components, t h e s t ruc tu re of t h e cytoplasmic matrix, o r relationships among these subcellular e lements , especially in large cel ls otherwise diff icul t to study at electron microscopic resolution. Studies re la t ing to biochemistry of t h e ce l l and physiological changes occurring in ce l l s as a consequence of a s t imulus wouId be of potent ia l interest . These examples a r e not intended to b e exhaust ive and o ther innovative proposals fo r user research pro jec ts will b e considered.

MECHANISM O F SUPPORT

The Program provides par t ia l o r full support for equipment, personnel, supplies and o ther allowable costs necessary for t h e establ ishment and operat ion of a resource. In addition to equipment funds and c o r e research and development costs, salar ies and other support needed to make t h e technology available to col laborat ive and service users a r e provided. Because of t h e benef i t s to b e gained by t h e hos t insti tution, it is common for t h e insti tution to par t ic ipa te in t h e funding of a new resource.

APPLICATION PROCEDURES

Applications should b e submit ted on form PHS 398, application for research grant . Application k i t s should be available f rom insti tutional business of f ices or f rom t h e Division of Research Grants (DRG) NIH. Application deadlines a r e February 1, June 1, and October 1. The completed original application and six (6 ) copies should b e sen t to:

Division of Research Grants National Inst i tutes of Heal th Westwood Building - Room 240 5333 Westbard Avenue Bethesda, Maryland 20205

PROGRAM GUIDELINES AND INQUIRIES

Detailed guidelines and special application instructions a r e available f rom t h e BRP. I t is strongly recommended t h a t prospective appl icants discuss t h e proposed

24

D. Studies re levant to s taging of pa t i en t s and identifying prognostic f ac to r s re levant to t h e t r e a t m e n t of cancer patients.

E. Surgical supportive care .

F. Regional chemotherapy or hyperthermia in which a surgical approach to t h e t r ea tmen t site is a major a spec t of t h e procedure.

In making th i s program announcement it is n o t t h e in ten t of t h e NCI to make o r imply any delimitation of investigator-init iated research in t h e cance r field.

111. APPLICATION PROCEDURE

Applications should b e submi t ted on form PHS 398, which is available in t h e business or grants and con t r ac t s o f f i ce at most academic and research insti tutions or from t h e Division of Research Gran t s (DRC), NIH. The t i t l e "Surgical Oncology Research" should be typed in sect ion 2 of t h e f i r s t page of t h e application. Additionally a brief covering l e t t e r should accompany the application indicating it is being submit ted in response to th is program announcement.

The original and five copies of t h e application should be sent or delivered to:

Application Rece ip t Off ice Division of Research Grants National Inst i tutes of Health Westwood Building - Room 240 Bethesda, Maryland 20205

In order to a l e r t t h e DCT to t h e submission of t h e proposals with primary thrus t d i rec ted to surgical oncology research, a copy of t h e covering l e t t e r and an additional copy of t h e application should be s e n t under sepa ra t e cover to:

Ernest V. deMoss, M.D., M.P.H. Head, Surgery Sect ion Clinical Investigations Branch Division of Cancer Trea tment National Cancer Inst i tute Landow Building - Room 4B04 Bethesda, Maryland 20205

Telephone: (301)496-4844


Applications in response to th is announcement will be reviewed on a nationwide basis in competi t ion with e a c h other , and in accord with t h e usual NIH peer review procedures. They will f i r s t be reviewed for scient i f ic and technical mer i t by a review group composed mostly of non-Federal scient i f ic consultants. Following th is initial review, t h e application will b e evaluated for program relevance by t h e National Cancer Advisory Board.

24


*L+l

Where applicable t o a par t icular project review cr i te r ia will consis t of t h e following:

1. Relevance of t h e project to surgical oncology research and t o t h e national cancer e f for t .

2. Feasibility of reaching t h e proposal's objectives.

3. Significance and adequacy of pilot d a t a to t h e proposal's objectives.

4. Qualifications of t h e principle invest igator and supporting personnel to achieve t h e project goals.

5. Adequacy of c o r e faci l i t ies and basic equipment t o support t he project.

6. Availability of suitable pa t ien t and control populations if required.

For fur ther information regarding this announcement and t h e review c r i t e r i a for t he PO1 grant application and t h e R01 grant application, investigators a r e encouraged to con tac t Dr. Ernest V. deMoss at t h e address given above or telephone him at (301) 496-4844. New guidelines have been wri t ten for t h e Program Project Grant (POI) of t h e NCI and will b e published in t h e NIH Guide to Grants and Contracts . Before submitt ing a PO1 application, please discuss a l e t t e r of intent with Dr. deMoss.

'14.

26

ANNOUNCEMENT

HYPERTENSION IN PREGNANCY

NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT

NATIONAL HEART, LUNG,AND BLOOD INSTITUTE

The National Heart , Lung, and Blood Inst i tute (NHLBI) supports a variety of research programs related to mechanisms, t r ea tmen t , and prevention of hypertension. A significant amount of research on hypertension in pregnancy has been car r ied ou t in the past , b u t unfortunately major questions s t i l l remain unanswered.

The National Inst i tute of Child Health and Human Development (NICHD) emphasizes high-risk pregnancy as a priority research area. Various a spec t s of hypertension which compl ica te pregnancy and its outcome a r e being studied by NICHD-supported investigators, including etiology, f e t a l hypoxia, and fetal growth re ta rda t ion and re la ted develop mental pr oblems. This program announcement is intended by both Inst i tutes to focus investigator a t ten t ion on this important area. Applications in response to th is announcement will be considered as applications for t h e regular research g ran t program without special set-aside funds.

I t is es t imated t h a t hypertension in pregnancy accounts for 25,000 sti l lbirths and neonatal deaths, and 20% of materna l dea ths annually in th i s country. Previous research has c lar i f ied some aspec t s of t h e problem. In particular, t h e etiology of pre-eclampsia ( toxemia or pregnancy-induced hypertension) has been associated with uteroplacental ischemia, coagulation defects , immunological defects , a l te ra t ions in synthesis and release of vasoact ive substances, and changes in vasopressor responses. These findings have suggested fu tu re lines of research and may b e re levant to o the r forms of hypertension which appear , or a r e de tec ted , during pregnancy.

The object ive of th i s program announcement is to encourage submission of scientifically meritorious research g ran t applications in such a reas as t h e following:

The etiology and pathophysiology of pre-eclampsia/eclampsia, including methods to d e t e c t abnormal pathophysiology before t h e appearance of clinical hypertension.

Improved techniques to d i f fe ren t ia te pre-eclampsia f rom o the r hypertensive disorders complicating pregnancy.

E f fec t s of materna l hypertension on feto-placental physiology, especially with regard to growth, development and behavior of t h e f e tus and infant.

Development of experimental animal models of t h e various types of hypertension in pregnancy.

r*

. -..

N H GUIDE FOR GRANTS AND CONTRACTS Vol. 12, No. 12 December 9 1983 27

( 5 ) Identification of charac te r i s t ics which place women at higher risk of hypertension in pregnancy, and also of pers is tent or recur ren t hypertension a f t e r pregnancy.

(6 ) The ef f icacy and safe ty of newer types of ant ihypertensive medications during pregnancy.

The above topics a r e examples only and t h e proposed research need n o t b e l imited to them.

APPLICATION SUBMISSION AND REVIEW

Application rece ip t d a t e s fo r th i s program announcement a r e t h e usual rece ip t da t e s fo r new applications: March 1, July 1, and November 1. The ear l ies t possible award d a t e is approximately nine months a f t e r t h e rece ip t date . Applicants should use t h e regular research g ran t application form PHS-398, which is avai lable a t t h e applicants' insti tutional application cont ro l o f f i ce o r f rom t h e Division of Research Gran t s (DRG) NIH.

In order to identify t h e response to th is announcement, check l'yesll and put "Hypertension in Pregnancyt1under i t em 2 on page 1 of those g ran t applications relating to t h e topics identified herein. The completed application should be mailed to:

Division of Research Grants National Inst i tutes of Heal th Westwood Building - Room 240 5333 Westbard Avenue Bethesda, Maryland 20205

In accordance with existing NIH procedure, t h e DRG will assign e a c h application to t h e appropriate study sect ion for review. Applications judged to b e responsive to this program announcement will b e assigned to both t h e NHLBI and NICHD, with primary responsibility based on existing guidelines.

Additional programmatic information may b e obtained by contacting:

Armando Sandoval Hypertension & Kidney Diseases Branch Division of Hear t and Vascular Diseases National Hear t , Lung, and Blood Inst i tute National Inst i tutes of Heal th Federal Building - Room 4C08 Bethesda, Maryland 20205

Telephone: (301) 496-1857

28

or

Donald McNellis, M.D. Pregnancy and Perinatology Sect ion CNED, CRMC, NICHD National Insti tutes of Heal th Landow Building - Room 7C09 9000 Rockville Pike Bethesda, Maryland 20205

Telephone: (301) 496-5575

NM GUIDE FOR GRANTS AND CONTRACTS V O l . 12, No. 12 December 9 1983 29

ANNOUNCEMENT

SURFACTANTS FOR PERFLUOROCHEMICALS

NATIONAL HEART, LUNG, AND BLOOD INSTITUTE

The Division of Blood Diseases and Resources (DBDR), National Heart , Lung, and Blood Inst i tute (NHLBI) encourages g ran t applications re la ted to t h e synthesis and biological tes t ing of novel, nontoxic sur fac tan ts to emulsify perfluorochemicals fo r intravenous use as oxygen carr iers .

The DBDR sponsors fundamental and clinical research act ivi t ies , supported by grants and contracts , re la ted to t h e character izat ion, preservation and use of blood and its components. The Division also supports research re la ted to t h e synthesis, screening and biological ac t iv i ty of oxygen-carrying red ce l l substi tutes.

Perfluorochemicals a r e insoluble in water. Therefore, they must b e emulsified and t h e resulting emulsion must b e extremely s tab le if it is to b e administered intravenously. Perfluorochemical emulsions have been shown to transport oxygen in laboratory animals; one commercially-prepared emulsion is current ly undergoing clinical studies in humans. The product contains approximately 10 to 12 percent (v/v) perfluorochemicals in t h e final preparation. This concentrat ion was chosen because emulsions containing higher concentrat ions of perfluorochemicals a r e unstable. In addition, as t h e concentrat ion of perfluorochemicals in t h e emulsion increases, viscosity a lso increases making such preparations unsafe for clinical use. Nevertheless, high concentrat ions of perfluorochemicals a r e desirable because they require lower levels of administered oxygen to achieve therapeut ic effects.

Highly concent ra ted emulsions of perfluorochemicals with low viscosity can be prepared, but t h e e f f ec t ive su r fac t an t s current ly available a r e too toxic for intravenous use. Considerable evidence indicates t h a t even t h e sur fac tan t presently used in perf luorochemical emulsions is mildly toxic and causes t rans ien t complement ac t iva t ion and leukopenia. Although t h e reaction is usually very modera te and can be prevented by prior s teroid t r ea tmen t , el imination of th is s ide effect would b e desirable.

This announcement is intended to encourage investigator-init iated g ran t applications for studies to develop new, nontoxic su r fac t an t s t h a t have appropriate propert ies for emulsifying perfluorochemicals. In addition, s tudies to eva lua te t h e biological s a fe ty and ef f icacy of t h e result ing preparat ions a r e encouraged.

This program is described in t h e Catalog of Federal Domestic Assistance No. 13.839, Blood Diseases and Resources. Awards will b e made under t h e authori ty of t h e Public Health Service Act , Sect ion 301 (42 USC 241) and adminis tered under PHS g ran t policies and Federal regulations, most specifically 42 CFR P a r t 52 and 45 C F R P a r t 74. This program is not subject to Health Systems Agency review.

30

Applicants should use t h e regular research g ran t application form (PHS 398). These applications a r e available at t h e institution's business off ice or cen t r a l application control office, o r may be requested by writing t o Division of Research Grants (DRG) NIH. The receipt da t e s for zpplications submit ted in response to this announcement a r e t h e usual da t e s for new research g ran t applications of March 1, July 1 and November 1.

The original and six copies of t h e application should b e mailed to:

Division of Research Gran t s National Inst i tutes of Heal th Westwood Building - Room 240 Bethesda, Maryland 20205

Applications received in response to th is announcement will b e assigned for possible funding in accordance with NIH refer ra l guidelines. All applications will b e reviewed by t h e Study Section mechanism managed by t h e DRG and by t h e National Heart , Lung, and Blood Advisory Council o r o ther appropriate advisory coouncil. Applications recommended for approval will compe te for available funds with a l l o the r approved applications.

Inquiries should b e d i rec ted to:

Chief, Blood Resources Branch Division of Blood Diseases and Resources National Heart , Lung, and Blood Insti tute, National Inst i tutes of Heal th Federal Building - Room 5C10 7550 Wisconsin Avenue Bethesda, Maryland 20205

Telephone: (301) 496-1537.


ANNOUNCEMENT

SPECIAL EMPHASIS RESEARCH CAREER AWARD:

OCCUPATIONAL SAFETY AND HEALTH

DEPARTMENT OF HEALTH AND HUMAN SERVICES

CENTERS FOR DISEASE CONTROL

NATIONAL INSTITUTE FOR OCCUPATIONAL SAFETY AND HEALW


The National Insti tute for Occupational Safety and Health (NIOSH), Centers for Disease Control (CDC), announces t h a t competit ive grant applications for Special Emphasis Research Career Awards to support occupational s a fe ty and health research will b e accepted until March 16, 1984. Applications should specify a project s t a r t d a t e of September 1, 1984.

I. PURPOSE

The CDC Special Emphasis Research Career Award (SERCA) is intended to:

..encourage qualified individuals in the early stages of their post-graduate medical and scientific careers to develop research interests and skills in t he a r e a of occupational safety and health;

..provide support for individuals to pursue a program of research in various disciplines related to occupational safety and health a t domestic institutions which offer superior opportunities in these areas; and

..create a pool of highly qualified investigators with experience and skills in occupational safety and health for future roles in related a reas of research.

The CDC Special Emphasis Research Career Award (SERCA) provides the opportunity for a n individual with developing research interests to acquire experience and skill essential to t h e study of occupational safety and health.

11. AUTHORITY

These grants will b e awarded and administered by NIOSH under t h e research and demonstration grant authority of t h e section 20(a) (1) of the Occupational Safety and Health Act of 1970 (29 U.S.C. 669(a)(l)) and section 501 of theFederal Mine Safety and Health Act of 1977 (30 U.S.C. 951). Program regulations applicable to these grants are contained in Part 87 of Title 42, Code of Federal Regulations, "National Institute for Occupational Safety and Health Research and Demonstration Grants." Except as otherwise indicated, t h e basic gran t administration policies of t he Public Health Service a r e applicable to this program. Applications responsive to this announcement a r e not subject to Executive Order No. 12372, Intergovernmental Review of Federal Programs.

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111. PROVISIONS OF THE AWARD

This non-renewable award provides support for a three-year period for individuals engaged in full-time research and related activities. The la t te r may include research career development activities as well as involvement in patient c a r e to the extent t ha t i t will strengthen research skills. The CDC SERCA grant, made to the awardee's parent institution, provides up to $30,000 per year in direct costs including salary support plus fringe benefits. Research costs may include technical assistance, equipment, supplies, consultant costs, domestic travel, publication, and other costs. If the awardee already holds a NIOSH small grant, the amount of the SERCA award will b e reduced by the amount of t h e small grant, up to a maximum reduction of $10,000.

While working closely with a n advisor, t he awardee is expected to developcapabilities in fundamental, applied and/or clinical research in one of the following

Occupational r espiratory diseases

Occupationally-related musculoskeletal injuries

Occupational cancers

Occupationally-related traumatic injuries

Occupationally-related cardiovascular effects

Occupationally-related reproductive effects

Occupationally-related neurologic effects

Occupationally-related noise-induced hearing loss

Occupational skin disease

Occupational psychologic disorders

Engineering controls research

Respirator research

I t should be noted tha t investigators may apply in any a reas related to occupationalsafety and health in the above 12 categories. Applications responding to this announcement will b e reviewed by staff for theirresponsiveness and relevance to occupational safety and health. Those considered non-responsive will be assigned in accordance with regular program guidelines. Potential applicants with questions concerning the acceptability of their proposed work should contact the individuals listed in this announcement.

The applicant must propose a research project of his/her own design which focuses on one of the above 12 areas and which is of such scope that, within three years, evidence of independent investigative capability will b e present. At the completion

.Il*,r

of this three-year award the individual should be bet ter able t o compete in traditional NIOSH research grant award programs.

tIH GUIDE FOR GRANTS AND CONTRACTS Vol. 12, No. 12 December 9 1983 33

A multidisciplinary environment is encouraged; this may include such a reas as epidemiology, biostat is t ics , toxicology, industrial hygiene, sa fe ty , ergonomics, physiology, engineering, various medical speciali t ies, etc. Gran tee Insti tutions a r e a lso encouraged to develop curr icula in t h e research a r e a s being proposed under these awards.

IV. ELIGIBILITY REQUIREMENTS

Candidates fo r t h e CDC SERCA Award must ( 1 ) hold a doctora l degree (e.g., D.D.S., D.O., D.V.M., M.D., Ph.D., Sc.D., etc.); (2) have a minimum of two years p o s t d o c t o r a l research experience; (3) not b e in a tenured position o r above t h e rank of associate professor; (4) b e c i t izens or noncitizen nationals of t h e United States o r its possessions o r te r r i to r ies o r must have been lawfully admi t t ed to t h e U.S. for permanent res idence at t h e t i m e of application.

Eligible appl icants may reside at a var ie ty of insti tutions including non-profit and for-profit organizations. Thus, universities, colleges, research inst i tut ions and o the r public and pr iva te organizations including S t a t e and local governments and small, minority and or woman-owned businesses a r e eligible for these grants. For-profit organizations will b e required to submit a cer t i f ica t ion as to the i r s t a tus as pa r t of their application. Awards a r e made to insti tutions in t h e name of individual applicants.

1 4 1 ' Support under th i s program may no t b e requested to supplement research pro jec ts receiving Federal o r non-Federal support (except as noted above for NIOSH small grants) o r to provide inter im support of projects under review by t h e Public Health Service (PHS). Applicants may, however, hold or apply for a research g ran t in another subject a rea . A g ran t application responsive to th is announcement, bu t essentially t h e s a m e as one submit ted as a regular research g ran t application on t h e same topic, will n o t b e accepted.

V. AVAILABILITY OF FUNDS

The total g ran t award may comprise d i r ec t costs of up to $30,000 per year and additional indirect costs, as appropriate. The g ran t s may be awarded for up to th ree years and will no t be renewable. It is ant ic ipated t h a t t h e t o t a l annual amount available for g ran t s under this program will be approximately $400,000. The specif ic amount to b e funded will, however, depend upon t h e mer i t and scope of t h e applications received and the availabil i ty of funds.

VI. CRITERIA FOR REVIEW

Applications will be initially reviewed by a designated scient i f ic review group on the basis of t h e applicant's scient i f ic achievements and growth, evidence of the applicant's demonstrated commi tmen t to a research career , t h e scient i f ic mer i t and significance of t h e proposed research project , sc ient i f ic competence of the proposed principal investigator and supporting facul ty (where appropriate) in relation to t h e type of research involved, feasibil i ty of t h e project , likelihood of its

4 , m l 8 producing meaningful results, appropriateness of t h e proposed budget, adequacy of t h e applicant's resources available for t h e project , and t h e supportive na tu re of the research environment.

34

A secondary review will a lso b e conducted. Fac tors considered in t h e secondary .Itr

review will include:

o t h e resul ts of t h e initial review

o t h e significance of t h e proposed study to t h e research programs of NIOSH

o National needs and program balance

o policy and budgetary considerations

VII. LETTER O F INTENT

Prospective appl icants a r e asked to submit a one-page l e t t e r of in t en t which includes a very brief synopsis of proposed a reas of research and identification of any o ther par t ic ipat ing institutions. This l e t t e r should b e s e n t by February 17, 1984, to Dr. Roy Fleming at t h e address given under "For Fur ther Information Contact:"; a l e t t e r is n o t required but will assist in t h e planning f o r t h e review. A l e t t e r of intent is not binding and will not en te r into t h e review of any proposal subsequently submitted.

VIII. APPLICATION AND AWARD

Applications should b e submit ted on Form PHS-398 (revised May 1982) or PHS-5161-1 for S t a t e and local government applicants. Forms should be available f rom t h e insti tutional business of f ices or from:

Off ice of Grants Inquiries Division of Research Grants National Inst i tutes of Heal th Westwood Building - Room 449 5333 Westbard Avenue Bethesda, Maryland 20205

The original and six copies of t h e application must b e submit ted to t h e address below on or before t h e specified rece ip t d a t e in accordance with t h e instructions in t h e PHS-398 packet:

Division of Research Gran t s National Inst i tutes of Health Westwood Building - Room 240 Bethesda, Maryland 20205

In developing t h e application please note t h a t t h e conventional presentat ion for g ran t applications should b e used and t h e points identified under "Criteria for Review" must b e fulfilled. The appl icant should indicate t h a t t h e application is being submit ted in response to th is announcement as noted in t h e Form PHS-398 instructions.

An appl icant organizat ion has t h e option of having specific salary and fringe benef i t amounts for individuals omi t ted from t h e copies of t h e application t h a t are made available to outs ide reviewing groups. If t h e appl icant organizat ion e l e c t s to

I GUIDE FOR GRANTS AND CONTRACTS 01. 12, No. 12 December 9 1983 35

U W ’

exercise th i s option, use as te r i sks on t h e original and six copies of t h e application to indicate those individuals for whom salar ies and fr inge benefi ts a r e being requested; t h e subtotals mus t s t i l l b e shown. In addition, submit a n additional copy of page four of Form PHS-398, completed in full with t h e as te r i sks replaced by t h e amount of t h e salary and fringe benef i t s requested for e a c h individual listed. This budget page will b e reserved for internal PHS staff use only.

The instructions in t h e Form PHS-398 packet should be followed concerning deadlines for e i the r delivering or mailing t h e application. The application should b e s e n t o r delivered using t h e mailing label in t h e Form PHS-398 packet.

Awards will b e made based on priority score ranking f rom t h e initial review and emphasis area, as wel l as availabil i ty of funds.

IX. COST SHARING

Grantees will b e expec ted to cost share a minimum of f ive percent .

X. FOR FURTHER INFORMATION CONTACT:

Roy Fleming, Sc.D. Chief, Grants Administration and Review Branch National Inst i tute for Occupational Sa fe ty and Health Cente r s for Disease Control 1600 Clifton Road, N,E. Atlanta , Georgia 30333

Telephone: (404) 329-3343

or

Mr. Leo Sanders Grants Management Officer Centers for Disease Control 1600 Clifton Road, N.E. Atlanta , Georgia 30333

Telephone: (404) 262-6575

(This program is described in t h e Catalog of Federal Domest ic Assistance Program No. 13.262, Occupational Safe ty and Heal th Research Grants.)

36

1

NIMH PHYSICIAN SCIENTISTAWARD

NATIONAL INSTITUTE OF MENTAL HEALTH

The rapid progress being made in mental health clinical research has highlighted the need to increase t h e participation of physicians as research scient is ts in t h e mental health field. The multiplicity of new research findings, the emergence of new research technologies, and t h e grea te r complexity of research methodologies emphasize t h e need to provide physicians with the requisite grounding in basic and clinical research principlesand experience so t h a t they can effectively pursue careers in mental health research.

The National Insti tute of Mental Health (NIMH) announces t h e availability of a Physician Scientist Award which is intended to encourage newly trained physicians to developindependent research skills and experience in the biomedical and/or behavioral sciences. I t is es t imated tha t up to six awards will be made in Fiscal Year 1984.

I. PURPOSE

The primary purpose of t h e NIMH Physician Scientist Award is to enhance the development of physicians in research careers focused on t h e interface of the basic and clinical sciences.

The award will enable newly trained physicians to undertake up to five years of specialized study in basic and clinical sciences with a supervised research experience. The first two to th ree years of t h e program will include both didactic study and research conducted under the supervision of a sponsor who has extensive research experience in a fundamental science such as (but no t limited to) biology, pharmacology, genetics, or psychology. The final two to th ree years will be devoted to ei ther basic or clinical research under the continuing guidance of th i s sponsor.

11. ELIGIBILITY

o For purposes of this announcement, an eligible applicant is a department of psychiatry or other medical science department in a U.S. college o r university school of medicine, or o ther comparable institution, applying on behalf of a specific candidate.

o A candidate must hold t h e M.D., D.O., or equivalent and must have completed at least two postgraduate years of clinical training by the t ime t h e award is made. A candidate, who has been a principal investigator on a Public Health Service (PHS) research grant , is not eligible.

o A candidate should have had clinical training experience with psychiatric disorders, should demonstrate competence in clinical activities,and should provide evidence of a serious commitment t o a research and academic career .

o A candidate for an award must be a ci t izen o r noncitizen national of t h e United S ta t e s or must have been lawfully admit ted to the United S ta tes for permanent residence at the t ime of application.


111.

IV.

Applications for a n NIMH Physician Science Award may not submit a concurrent application for a PHS Research Scientist Development Award, Academic Award, a Clinical Investigator Award, or a New Investigator Research Award.

APPLICATION CHARACTERISTICS

For detailed information on content of t h e application characterist ics, NIMH staff should be contacted for t h e complete announcement.

TERMS AND CONDITIONS OF SUPPORT

The five-year nonrenewable award is based on up to five full-time, 12-month appointments. All funds must b e used on behalf of t h e original candidate. Support is divided into two distinct phases t h a t re la te to t h e individual's progress in becoming a n independent investigator. I t is required t h a t a minimum of 75 percente f fo r t must b e devoted to the research development program. The balance of e f f o r t can b e devoted to other clinical and teaching pursuits only i f they a r e consonant with t h e program goal, i.e., the awardee's development into an independent research investigator.

I t i s desirable for individuals to complete both phases without interruption. In unusual circumstances, it may be permissible to interrupt t he award and delay the s t a r t of Phase I1 in order to engage in further clinical training. In t h e event such a contingency arises, t h e awardee and the sponsor must justify the interruption to NIMH, and obtain t h e approval of t h e NIMH project officer. Although resumptionof support under this program is contingent on t h e availability of funds, NIMH will make every e f f o r t to assure t h a t funds will b e made available to resume the award so t h a t t h e candidate may complete the program.

The awardee and sponsor will be required to submit a special, detailed progress report a t t h e end of Phase I as pa r t of their application for continued support. This progress repor t and t h e application a r e to contain specific information concerning progress and accomplishments and, in particular, an appropriately detailed research plan and protocol for Phase I1 for administrative review and a decision on continuation of t h e award.

Awardees a r e requested to inform NIMH annually, for a period of five years subsequent to completion of the award, about academic status, publications, and research grants o r cont rac ts received.

Awards will be administered under PHS grants policy as s t a t ed in t h e PHS Grants Policy Statement.*

* Public Health Service Grants Policy Statement , DHHS Publication No. (OASH) 82-50-000 GPO-017-020-0090-1 (rev.) December 1, 1982, available for $5.00 from the Superintendent of Documents, U.S. Government Printing Office, Washington, D.C. 20402.

38

'.tr

V. ALLOWABLE COSTS

A. Phase I. Formalized Basic Science Study (24-36 months)

1. Salary: The individual candidate's compensation is to be based on the sponsoring institution's salary scale for physicians at an equivalentexperience level, but funding from this award for salary may not exceed $30,000 per year per individual plus commensuate fringe benefits for essentially full-time (75-100)percent effor t to the endeavor.**

2. Research and Development Support: Up to $10,000 per year may be requested for research project requirements and related support, e.g., technical personnel costs, supplies, equipment, candidate travel, medical insurance premiums, and tuition for necessary courses.

3. Sponsor's Support: A sum of up to 10 percent of t h e primary sponsor's salary and commensurate fringe benefits may be requested annually.

B. Phase 11. Intensive Research (24-36 Months)

1. Salary: Same as Phase I.

2. Research and Development Support: Up to $20,000 per year may be requested for support of research project requirements and related costs as outlined for Phase I. Individuals entering Phase I1 a r e encouraged to apply for separate additional research grant support, if needed,which may be applied for and held with no reduction in t h e -$20,000 provided as research support under this award.

3. Sponsor's Support: A sum of up to 10 percent of the primary, or t he secondary, sponsor's salary and commensurate fringe benefits may be requested; alternatively, with appropriate justification, five percent of the primary sponsorls salary and five percent of the secondarysponsor'salary and fringe benefits may be requested. Under no circumstances may salary be requested for a total of more than 10 percent of one person's time.

4. Indirect Costs (Phase I and 11): Funds will be provided for t he reimbursement of actual indirect costs at a r a t e of up to, but not exceeding eight percent of the total direct costs of each award, exclusive of tuition, fees, and expenditures for equipment.

** NIMH policy encourages supplementation f rom nongovernment sources, e.g., -awacademic departments, voluntary or professional organizations.

NM GUIDE FOR GRANTS AND CONTRACTS Vol. 12, No. 12 December 9 1983 39

VI. CONSULTATION AND APPLICATION PROCEDURES

Potent ia l appl icants a r e urged to seek preapplication consultation from NIMH staff. NIMH is interested in applications from a l l well-qualified individuals; women and minority candidates in par t icular a r e encouraged to apply.

The regular research g ran t application form PHS 398 (rev. 5/82) must b e used in applying for these awards. S t a t e and local agencies should use form PHS 5161. Staff consultation, information, and applications k i t s may b e obtained from:

Dr. Louis A. Wienckowski Research Resources Branch Division of Extramural Research Programs National Inst i tute of Mental Heal th Parklawn Building - Room 10-105 5600 Fishers Lane Rockville, Maryland 20857

Telephone: (301) 443-4347

NIMH Physician Scientist Award should b e typed in i tem 2 of t h e face page of t h e application form.

The signed original and six ( 6 ) copies of t h e completed application should b e s e n t to:

Division of Research Grants National Inst i tutes of Health 5333 Westbard Avenue Bethesda, Maryland 20205

VII. REVIEW PROCESS AND CRITERIA

Applications will undergo pee r review for scient i f ic and technical meri t by Initial Review Groups (IRGs) consisting primarily of non-Federal technical and scient i f ic experts. Applications must a lso b e recommended for approval by t h e National Advisory Mental Heal th Council.

Par t icu lar a t t en t ion will b e given to t h e following:

o Candidate 's qualifications and potent ia l for developing into a productive scientist .

o Sponsor's research productivity and experience in developing young investigators.

o Quality of t h e environment, including the presence of ac t ive research programs and availability of senior investigators for advice and consul tat ion.

o Scientific developmental mer i t of t h e research program.

40

"lir

VIII. AWARD CRITERIA

Applications recommended for approval by t h e National Advisory Mental Heal th Council will be considered for funding on t h e basis of t h e following:

o Overal l mer i t of t h e proposal to t h e research objectives of NIMH. o Program balance.

o Prior i ty given to r e s e a x h c a r e e r development at t h e in te r face of basic/clinical science.

o Availability of funds.

IX. RECEIPT AND REVIEW SCHEDULE

Receipt of Application

February 15, 1984

July I November 1 March 1

Initial Adv is0ry Earl ies t Review Council Review Award Da te

Initial Review Schedule

April 1984 May 1984 July 1, 1984

Subseauent Review Schedule

October/November January/February April February/March May July June September/October December

NIn GUIDE FOR GRANTS AND CONTRACTS Vol. 12, No. 12 December 9 1983 41

Pf

CLINICAL INVESTIGATOR AWARD

NATIONAL INSTITUTE OF MENTAL HEALTH

The National Inst i tute of Mental Health (NIMH) is seeking applications for t h e Clinical Investigator Award. I t i s e s t ima ted t h a t approximately six such awards will b e made in Fiscal Year 1984.

I. PURPOSE

The purpose of t h e Clinical Investigator Award is to develop clinician-scientists and to encourage them to en te r specific a reas of mental heal th research. The award, prompted by t h e need for clinician investigators in impor tan t a r e a s of mental health research, is intended t o encourage qualified physicians, clinical psychologists, social workers, o r :iurses to pursue c a r e e r s in menta l health-relevant research, particularly in t h e a reas specified in this announcement. The award is expected to f ac i l i t a t e a n awardee's transit ion to independent researcher by providing up to t h r e e years of support for intensive supervised research in these a reas under t h e guidance of a preceptor who is an outstanding, active researcher and who has t h e knowledge, background, and research experience required t o be a mentor in t h e field.

"Il-' 11. ELIGIBILITY

A. Applicant Insti tution

For purposes of th i s announcement, an appl icant is a public or pr ivate organization or insti tution, nonprofit o r for-profit, engaged in health-related research and loca ted in t h e United States or its te r r i to r ies and possessions. Such a n insti tution may make application on behalf of a candida te who holds the M.D. o r D.O. degree or a clinically credent ia led psychologist, social worker, or nurse. Psychologist, social worker, or nurse candida tes must hold t h e doc tora te .

B. Candidate

A candidate must have at l eas t two years of clinical training o r experience at the postdoctoral level by t h e t ime t h e award is made. The award i s not intended to support t h e fur ther development of individuals who have had extensive research experience; NIMH provides support for t hese individuals through o the r programs. A candidate who has been a principal investigator on a Public Health Service (PHS) research g ran t is not eligible. A nominee must be a U.S. c i t izen or have been lawfully admi t ted to t h e United S ta t e s for permanent residence.

C. Concurrent Application

A candidate for th i s award may not concurrent ly apply for any PHS Research Scientist Development Award, an award under the National Research Service Award Act , a Physician Scient is t Award, or o the r similar award.

42

111. AREAS OF INTEREST

This award is designed primarily to increase the number of clinical researchers in areas of special need; applications a re particularly encouraged and priority will be given for support of research career development in the following areas:

o Schizophrenia and major affective disorders, including research on genetic factors, diagnostic assessment, pathophysiology, t reatment development and assessment.

o Childhood and adolescent psychopathology, including research on genetic factors, diagnostic assessment, pathophysiology, t reatment development and assessment.

o Clinical epidemiology and clinical services research, including research on the distribution of clinically defined mental disorders in specificclinical settings such as ambulatory medical clinics and State mental hospitals.

o Post-traumatic disorders occasioned by emergencies, including research on sexual assault and natural or manmade disasters in order to assess the short- and long-term psychological and behavioral sequelae for individuals and groups.

IV. APPLICATION CHARACTERISTICS

For detailed information on content of the research plan section of the application,NIMH staff should be contacted for the complete announcement.

V. TERMS AND CONDITIONS OF SUPPORT

The Clinical Investigator Award is for a maximum, nonrenewable period of three years. Support is based on a full-time, 12-month staff appointment. Salary support may be requested up to a maximum of $30,000 annually. The proposed salary must be within the established structure of the grantee institution for persons of equivalent qualifications, experience, and rank. For any candidate whose salary is in excess of $30,000, the institution must provide an assurance in the applicationtha t it will supplement the award from non-Federal funds. The institution providing the additional support, however, may not require additional duties or responsibilities from the candidate which would interfere with the purpose of the award. I t is expected tha t t h e clinical investigator awardee will spend at least 80 percent of h idher t ime in research and other research career developmentactivities during the period, with the remainder being divided among other related academic activities such as teaching, pertinent clinical training, and administrative activities. Up to a total of $15,000 annually may be requested for supplies, tuition, equipment, travel, etc., necessary for t he awardee's research career development program. An awardee is encouraged to apply for mental health small grant or regular research grant support, as appropriate.

Funds will be provided for the reimbursement of indirect costs at a r a t e not t o exceed eight percent of the total allowable direct costs. When requested, the grantee institution's share of the fringe benefits may b e paid as a direct cost (if not treated as an indirect cost) on that portion of the employee's salary provided by the award.


*i"

VI.

VII.

An awardee is requested to inform NIMH annually for a period of f ive years subsequent to complet ion of t h e award about academic s ta tus , publications, and research g ran t s o r c o n t r a c t s received.

Awards will b e adminis tered under PHS g ran t s policy as s t a t e d in t h e Public Health Service Grants Policy Statement.*

CONSULTATION AND APPLICATION PROCESS

Potent ia l appl icants a r e urged to seek preapplication consultation with NIMH staff. NIMH is in te res ted in applications from a l l wel lqua l i f ied individuals. Women and minority candida tes in par t icular a r e encouraged to apply.

The regular research g ran t application form PHS 398 (rev. 5/82) must b e used in applying for these awards. State and local agencies should use form PHS 5161.

Staff consultation, fu r the r information, and application k i t s (including general instructions) a r e avai lable from:

Louis A. Wienckowski, Ph.D. Research Resources Branch Division of Extramural Research Programs Parklawn Building - Room 10-104 5600 Fishers Lane Rockville, Maryland 20857

Telephone: (301) 443-4347

NIMH Clinical Investigator Award should b e typed on l ine 2 of t h e face page of t h e application form.

The signed original and six (6) copies of t h e completed application should be s e n t to:

Division of Research Grants National Inst i tutes of Health 5333 Westbard Avenue Bethesda, Maryland 20205

REVIEW PROCESS AND CRITERIA

Applications will undergo peer review for scient i f ic and technical mer i t by Initial Review Groups (IRCs) consisting primarily of non-Federal technical and scient i f ic

INw * Public Health Service Grants Policy S ta tement , DHHS Publication No. (OASH) 82-50-000 GPO-017-020-0090-1 (rev.) December 1, 1982, available for $5.00 from the Superintendent of Documents, U.S. Government Printing Office, Washington, D.C. 20402.

44

experts. Applications will receive a secondary review for scientific and technical merit and policy considerations by the National Advisory Mental Health Courxil. Only applications recommended-for approval by the Council c a n be considered for funding.

IRCs will give particular a t tent ion to t h e following:

o Candidate's potential for and commitment to a career in research.

o Overall merit of the candidate's 3-year plan for research career development in t h e proposed area of research.

o Past research productivity of t h e preceptor and t h e ability and plans of t h e preceptor to guide t h e candidate in h i d h e r proposed career development.

o Quality and ex ten t of t h e candidate's previous clinical and research training and experience.

o Institution's ability to provide quality facilities, resources, and opportunities necessary to the candidate's research development as indicated in t h e application, and quality of t h e faculty in the department relative to the a reas of study.

VIII. AWARD CRITERIA

In making decisions to fund applications recommended for approval by the Council, Institute staff will use t h e following criteria:

o Overall meri t of t h e proposal as determined by t h e review committee.

o Relevance of t h e proposal to the research program priorities listed in this announcement.

o Program balance.

o Availability of funds.

IX. RECEIPT AND REVIEW SCHEDULE

Receipt of Application

February 15, 1984

July 1 November 1 March 1

Initial Advisory Earliest Review Council Review Award Date

Initial Review Schedule

April 1984 May 1984 July 1, 1984

Subsequent Review Schedule

October/November January/February April February/March May July June September/October December

*U.S. GOVERNnENT PRINTING OFFICE : 1983 0-421-144/310