Subject: NIH GUIDE - V20(30) 08/02/91

From: Bill Jones <[email-masked]>
Date: Thu, 1 Aug 1991 08:13:25 EDT

$$XID NIHGUIDE 19910802 V20N30 P1O1 ************************************
No RFAs present

NIH GUIDE - Vol. 20, No. 30, August 2, 1991

$$INDEX BEGIN **********************************************************

                                   NOTICES

$$INDEX N1 *************************************************************

HUMAN SUBJECTS CERTIFICATIONS AND VERTEBRATE ANIMAL VERIFICATIONS IN
APPLICATIONS FOR NON-COMPETING (TYPE 5) CONTINUATION OF PHS GRANT AWARDS
National Institutes of Health
Index:  NATIONAL INSTITUTES OF HEALTH

$$INDEX N2 *************************************************************

COMMON RULE FOR THE PROTECTION OF HUMAN SUBJECTS
National Institutes of Health
Index:  NATIONAL INSTITUTES OF HEALTH

                   NOTICES OF AVAILABILITY (RFPs AND RFAs)

$$INDEX R1 *************************************************************

SHELF-LIFE EVALUATION OF CLINICAL DRUGS (RFP)
National Cancer Institute
Index:  CANCER

                        ONGOING PROGRAM ANNOUNCEMENTS

$$INDEX P1 *************************************************************

MULTI-INSTITUTIONAL COLLABORATIVE RESEARCH PROJECT (PA-91-81)
National Institute of Mental Health
Index:  MENTAL HEALTH

$$INDEX P2 *************************************************************

ASSOCIATION OF ARTHRITIS, INFLAMMATORY MUSCLE DISEASES AND OTHER
RHEUMATIC MANIFESTATIONS WITH HIV POSITIVITY AND AIDS (PA-91-82)
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Index:  ARTHRITIS, MUSCULOSKELETAL DISEASES, SKIN DISEASES

$$INDEX P3 *************************************************************

CANCER THERAPY RESEARCH IN LUNG CANCER (PA-91-83)
National Cancer Institute
Index:  CANCER

NOTE:  The NIH Guide for Grants and Contracts will not be published
on August 9, 1991.  The next issue will be August 16, 1991.

$$INDEX END ************************************************************

                                   NOTICES

$$N1 BEGIN *************************************************************

HUMAN SUBJECTS CERTIFICATIONS AND VERTEBRATE ANIMAL VERIFICATIONS IN
APPLICATIONS FOR NON-COMPETING (TYPE 5) CONTINUATION OF PHS GRANT AWARDS

P.T. 34; K.W. 1014006, 1014003, 0783005

National Institutes of Health

It has come to the attention of the NIH Grants Policy Office and the
Office for Protection from Research Risks that applicant organizations
often submit applications for non-competing (Type 5) continuation
support that are missing the required approvals for involvement of human
subjects and/or vertebrate animals.  The PHS 2590 application kit for
non-competing (Type 5) continuation support instructs that in activities
involving human subjects and/or vertebrate animals, the applicant
organization is required to provide on the face page of the application
the most recent date of approval by the Institutional Review Board (IRB)
and/or Institutional Animal Care and Use Committee (IACUC).  This
information is to be provided at the time of application submission.
The 60-day grace period, allowed for competing (Type 1 and 2)
applications, may not be invoked for noncompeting (Type 5) continuation
applications.  (See related notice in this issue).  Furthermore, no
application for continuation support may be submitted until the
necessary IRB certification and/or IACUC verification of review has been
obtained (PHS 2590, page 9).  Delay in submitting the required
certification/verification will result in substantial delays in the
award process.

Questions concerning this notice may be addressed to the Grants
Management Office of the NIH awarding unit.

$$N1 END ***************************************************************

$$N2 BEGIN *************************************************************

COMMON RULE FOR THE PROTECTION OF HUMAN SUBJECTS

P.T. 34; K.W. 1014006, 0783005

National Institutes of Health

The Federal Policy for the Protection of Human Subjects was published in
the Federal Register on June 18, 1991, as a final common rule
(56CFR28004).  The common rule applies to sixteen Federal departments
and agencies conducting or supporting research involving human subjects.
These include the Departments of Agriculture, Commerce, Defense,
Education, Energy, Health and Human Services, Housing and Urban
Development, Justice, Transportation, Veterans Affairs, and the Agency
for International Development, Central Intelligence Agency, Consumer
Product Safety Commission, Environmental Protection Agency, National
Science Foundation, and National Aeronautics and Space Administration.
In addition, the Food and Drug Administration simultaneously published
modifications to its regulations to adopt provisions of the common rule.

Publication of the common rule implements a 1981 recommendation of the
former President's Commission for the Study of Ethical Problems in
Medicine and Biomedical and Behavioral Research.  The recommendation
called for a uniform policy governing federally conducted or supported
research involving human subjects based on regulations for the
protection of human subjects of the Department of Health and Human
Services (HHS).  An interagency committee developed the Federal policy
under the auspices of the Office of Science and Technology Policy.  The
policy was first published in 1986 as a proposed "model policy," and
then in 1988 as a Notice of Proposed Common Rule Making.

The common rule provides for protection mechanisms such as prospective
and ongoing review of research by institutional review boards,
assessment of risks and benefits of research to human subjects, an
informed consent process, and a system of institutional assurances of
compliance with regulatory requirements to protect human subjects.

Implementation of the common rule on the part of the departments and
agencies will provide wider application of recognized protections for
research subjects and a more consistent regulatory approach for
institutions conducting Federally supported research.

The common rule is based on and replaces subpart A of the 1981
Department of Health and Human Services regulations for the protection
of human subjects at Title 45 CFR Part 46 and is quite similar to those
regulations.  There are some important differences, however.  For
example:

Grace Period:

The common rule does not explicitly incorporate the regulatory provision
that is a part of the 1981 Department of Health and Human Services'
regulations for a "60-day grace period" for Multiple Project Assurance
Institutional Review Boards (IRBs) to certify IRB review and approval
after a receipt of an application.

The grace period is not meaningful in the context of the review
processes of other departments; hence, it is not appropriate to include
it in a common rule.  The preamble to the rule indicates that HHS
intends to retain administratively the grace period, however.

In response to the Notice of Proposed Rule Making, many institutions
raised concerns about loss of the grace period.  HHS, which includes the
Public Health Service, will still honor the policy that within 60 days
after the date of submission to HHS of an application or proposal, an
institution with an approved assurance covering the proposed research
shall certify that the application or proposal has been reviewed and
approved by the IRB, except whenever there is a specific mandate and
advisory to do so within a different time period, e.g., for certain
HIV-related research (see NIH Guide for Grants and Contracts, Vol. 17,
No. 13, April 8, 1998).

As provided in the regulations at Title 45 CFR Part 46.103(f),
institutions without an assurance on file that covers the research to be
conducted shall certify that the application or proposal has been
approved by the IRB with 30 days after receipt of a request for an
Assurance of Complicance from the Office for Protection from Research
Risks.  If the certification is not submitted within these time limits,
the application or proposal may be returned to the institution.

The above pertains to applications for competing awards.  For
information regarding applications for noncompeting continuation
support, see other notice in this issue.

Exemptions:

The exemptions in Section 101, applicability, differ slightly from those
in the 1981 regulations at Title 45 CFR Part 46.

Applicant institutions should become familiar with the exemptions and be
certain to cite the correct exemption, if applicable, in the PHS 398
Public Health Service Grant Application and in other documents.

There are additional differences between the 1981 HHS regulations and
the common rule with which researchers and administrators will want to
become aware.

Copies of the common rule have been provided to Multiple Project
Assurance Institutions and their Institutional Review Boards.  For
further information, contact:

The Office for Protection from Research Risks
National Institutes of Health
Building 31, Room 5B59
Bethesda, MD  20892
Telephone:  (301) 496-7005

$$N2 END ***************************************************************

                   NOTICES OF AVAILABILITY (RFPs AND RFAs)

$$R1 BEGIN NCI-CM-27721-19 *********************************************

SHELF-LIFE EVALUATION OF CLINICAL DRUGS

RFP AVAILABLE:  NCI-CM-27721-19

P.T. 34; K.W. 0740025, 1003008

National Cancer Institute

The Pharmaceutical Resources Branch of the Developmental Therapeutics
Program, Division of Cancer Treatment, National Cancer Institute (NCI),
is seeking a contractor experienced in analysis and evaluation of
clinical pharmaceuticals to provide proper storage, adequate testing,
and evaluation of the shelf-life of samples of investigational clinical
drug formulations, including both injectable products and oral dosage
forms, and report the results of such testing.  Data provided in these
reports will be used for providing NCI and its investigators with
information regarding the proper storage and handling of various drug
products under investigation, for determining appropriate expiration
dates for the products, and to support NCI Investigational New Drug
Applications (INDs) files with the Food and Drug Administration (FDA).
Storage and inspection of reserve samples as defined by the FDA Current
Good Manufacturing Practices Regulations shall be required.  The
contractor will be responsible for validating each of the analytical
methods in conformance with FDA requirements prior to use.

RFP No. NCI-CM-27721-19 will be issued upon request to Zetherine Gore,
Contract Specialist, on or about July 31, 1991.  Proposals will be due
approximately 45 days thereafter.  The contract period is five years
beginning approximately May 1992.  The NCI expects to award one contract
from this solicitation.

For a copy of RFP NCI-CM-27721-19, send a stamped, self-addressed
envelope to:

Ms. Zetherine Gore
Contract Specialist
Developmental Therapeutics Program
Division of Cancer Treatment
National Cancer Institute
Executive Plaza South, Room 603
Bethesda, MD  20892

$$R1 END ***************************************************************

                        ONGOING PROGRAM ANNOUNCEMENTS

$$P1 BEGIN PA-91-81 ****************************************************

MULTI-INSTITUTIONAL COLLABORATIVE RESEARCH PROJECT

PA AVAILABLE:  PA-91-81

P.T. 34; K.W. 0715095, 0715129

National Institute of Mental Health

The National Institute of Mental Health (NIMH) is accepting applications
for Multi-Institutional Collaborative Research Projects (MICRPs).  These
are investigator-initiated and investigator-coordinated, multi-site
projects.  The purpose of the MICRP (R10) mechanism is to facilitate
research that requires collaboration between or among organizationally
distinct entities and that is best carried out if the independence of
the investigators is maintained, while simultaneously providing a
mechanism for coordination within the overall project.  Unlike the
cooperative agreement (U0l) mechanism, the MICRPs will not have a
Federal collaborator involved in planning or conducting the research.
In contrast with the traditional research project (R0l) award, no
subcontracting will be required to support the collaborative research
projects, and each site will have a Principal Investigator.

This announcement summarizes the guidelines for the preparation, review,
and administration of multi-site collaborative studies in mental health.
Interested parties are encouraged to obtain the Program Announcement
(PA) from the NIMH staff contact listed below.  Applications may be
submitted by any public or private, non-profit or for-profit,
organization, including units of State and local governments.  Women and
minority investigators are especially encouraged to apply.

Separate applications must be submitted from each participating
institution, and applicants must use the form PHS 398 (revised 10/88).
All applications comprising the MICRP must be submitted for the same
receipt deadline and have identical titles.  Complete item 2 of the face
page by typing the title and number of this announcement.

Applications for NIMH grants and cooperative agreements are required to
include both women and minorities in study populations for clinical
research, unless compelling scientific or other justification for not
including either women or minorities is provided.  This requirement is
intended to ensure that research findings will be of benefit to all
persons at risk of the disease, disorder, or condition under study.  For
the purpose of these policies, clinical research involves human studies
of etiology, treatment, diagnosis, prevention, or epidemiology of
diseases, disorders, or conditions, including but not limited to
clinical trials; and minorities include U.S. racial/ethnic minority
populations (specifically, American Indians or Alaskan Natives,
Asian/Pacific Islanders, Blacks, and Hispanics).  NIMH recognizes that
it may not be feasible or appropriate in all clinical research projects
to include representation of the full array of U.S. racial/ethnic
minority populations.  However, applicants are urged to assess carefully
the feasibility of including the broadest possible representation of
minority groups in the project as a whole.

Applications should include a description of the composition of the
proposed study population by gender and racial/ethnic group, and the
rationale for the numbers and kinds of people selected to participate.
This information should be included in the form PHS 398 in Section 2,
A-D, of the Research Plan AND summarized in Section 2, E, Human
Subjects.

Applications should incorporate in their study design gender and/or
minority representation appropriate to the scientific objectives of the
work proposed.  If representation of women or minorities in sufficient
numbers to permit assessment of differential effects is not feasible or
is not appropriate, the reasons for this must be explained and
justified.  The rationale may relate to the purpose of the research, the
health of the subjects, or other compelling circumstances (e.g., if in
the only study population available there is a disproportionate
representation in terms of age distribution, risk factors,
incidence/prevalence, etc., of one gender or minority/majority group).

If the required information is not contained within the application, the
review will be deferred until it is complete.  Peer reviewers will
address specifically whether the research plan in the application
conforms to these policies.  If gender and/or minority
representation/justification are judged to be inadequate, reviewers will
consider this as a deficiency in assigning the priority score to the
application.

All applications/proposals for clinical research are required to address
these policies.  NIMH will not award grants that do not comply with
these policies.

Applications will be received according to the standard PHS review
schedules.  All applications will be reviewed for scientific and
technical merit by an initial review group (IRG), composed primarily of
non-Federal scientific experts, and by the appropriate Advisory Council.
By law, only projects recommended for approval by the IRG and Council
may be considered for funding.

Each application within the R10 will be evaluated on the merit of the
overall project plan, the merit of each site's individual contributions,
and the relationship between these two aspects.  The priority score
assigned to each application will be based on the IRG evaluation of the
merits of the entire project (all sites) proposed for the MICRP as well
as the merit of the individual sites.  Reviewers may decide that the
project can be successfully completed as proposed and recommend approval
with identical priority scores for each application.  The IRG may also
determine that all applications within the proposed MICRP are not
equally meritorious or necessary to accomplish the goals.

Support may be requested for expenses clearly related and necessary to
conduct the research, including both direct and allowable indirect
costs.  Applicants may request support for up to five years.  A
competing continuation (renewal) application may be submitted near the
end of a grant period in order to request funds for the continuation of
the project.

Because of the complex nature of collaborative studies and budgeting
constraints, potential applicants are strongly encouraged to seek
information and consultation from NIMH staff members as listed in the
PA.  Copies of the PA are available from:

Anne Cooley
Division of Extramural Activities
National Institute of Mental Health
Parklawn Building, Room 9-97
5600 Fishers Lane
Rockville, MD  20857
Telephone:  (301) 443-4673

For further information on grants management issues, contact:

Stephen J. Hudak
Chief, Grants Management Section
National Institute of Mental Health
Parklawn Building, Room 7C-23
5600 Fishers Lane
Rockville, MD  20857
Telephone:  (301) 443-4596

This program is described in the Catalog of Federal Domestic Assistance
No. 93.242.  Awards are made under authority of Section 301 of the
Public Health Service Act (42 USC 241), as amended.  Grants must be
administered in accordance with the "PHS Grants Policy Statement
(revised October 1990)."

$$P1 END ***************************************************************

$$P2 BEGIN PA-91-82 ****************************************************

ASSOCIATION OF ARTHRITIS, INFLAMMATORY MUSCLE DISEASES AND OTHER
RHEUMATIC MANIFESTATIONS WITH HIV POSITIVITY AND AIDS

PA:  PA-91-82

P.T. 34; K.W. 0715008, 0715010, 0715026, 0715136

National Institute of Arthritis and Musculoskeletal and Skin Diseases

The Arthritis and Muscle Biology Programs of the National Institute of
Arthritis and Musculoskeletal and Skin Diseases invite research grant
applications to study arthritis and inflammatory muscle and other
rheumatic conditions associated with HIV infection and/or AIDS.  This
program announcement is to encourage research grant applications for
basic, clinical, and epidemiologic research.  Research mechanisms to
support these investigations include traditional research grants (RO1),
Clinical Investigator Awards (K08), and First Independent Research
Support and Transition (FIRST) Awards (R29).

Several investigators have reported the co-occurrence of HIV antibody
positivity or frank AIDS with Reiter's Syndrome and other rheumatic
disorders.  It is unknown whether a causal biological connection exists
between certain arthritides and HIV infection or some of these
co-occurrences are merely coincidental.

Certain arthritides and inflammatory muscle diseases and other rheumatic
disorders may be found more frequently in HIV-positive individuals and
AIDS patients than in the general population, according to reported
observations.  The frequency, spectrum, and natural history of these
conditions in HIV-positive individuals, including AIDS cases, are
unknown.  It has also been noted that a spectrum of disease encompassing
Reiter's syndrome and psoriasis, in particular, appears to be more
severe and increasingly difficult to control as signs of
immunodeficiency develop.  Myositis may be an early presenting feature
of HIV infection, and myopathy secondary to zidovudine therapy has been
reported.

Safety and efficacy of drugs used in the management of arthritis,
inflammatory muscle diseases, and other rheumatic disorders have not
been formally assessed in HIV-positive individuals.  Recent case reports
have suggested that immunosuppressive drugs, particularly methotrexate,
used widely at present in the management of rheumatoid arthritis and
psoriatic arthritis, may accelerate AIDS in HIV-infected individuals.

A previous program announcement (see NIH Guide for Grants and Contracts,
Vol. 17, No. 12, April 1, 1988) was published to encourage research in
this area.  The current solicitation is intended to further stimulate
basic, clinical, and epidemiologic research related to arthritis,
inflammatory muscle diseases, and other rheumatic manifestations in
HIV-positive individuals, including those who have AIDS.  In addition,
it is expected that the increased frequency of these diseases in
HIV-positive individuals will provide unusual opportunities for research
on the pathogenesis and accelerating factors in Reiter's syndrome,
myositis, and other rheumatic diseases of uncertain etiology.

Among the broad spectrum of basic research projects encouraged are
studies of disease pathophysiology and genetics.  Clinical studies may
include prevention of morbidity and mortality or amelioration of
arthritis, inflammatory muscle disease, and other rheumatic
complications.  Epidemiologic studies may focus on etiology, risk
factors for disease development and severity, natural history of
disease, and prognosis for developing disease.  This includes AIDS and
arthritis, inflammatory myopathy, and other rheumatic syndromes as well
as descriptive studies of incidence, prevalence, morbidity, and
mortality.

Investigators are encouraged to work with existing, or proposed,
longitudinal data collection resources and cohorts of patients.
Populations that may be included are those at increased risk for HIV
infection, as well as HIV-positive cohorts who are clearly defined by
their source of exposure.  Investigators are encouraged to use existing
cohorts, such as the Multicenter AIDS Cohort Study (MACS), the HIV
Pulmonary Complications Study, and the AIDS Clinical Trials Group
patients.

SPECIAL INSTRUCTIONS FOR INCLUSION OF WOMEN AND MINORITIES IN CLINICAL
RESEARCH STUDIES

NIH and ADAMHA policy is that applicants for NIH/ADAMHA clinical
research grants and cooperative agreements will be required to include
minorities and women in study populations so that research findings can
be of benefit to all persons at risk of the disease, disorder or
condition under study; special emphasis should be placed on the need for
inclusion of minorities and women in studies of diseases, disorders and
conditions which disproportionately affect them.  This policy is
intended to apply to males and females of all ages.  If women or
minorities are excluded or inadequately represented in clinical
research, particularly in proposed population-based studies, a clear
compelling rationale should be provided.

The composition of the proposed study population must be described in
terms of gender and racial/ethnic group.  In addition, gender and
racial/ethnic issues should be addressed in developing a research design
and sample size appropriate for the scientific objectives of the study.
This information should be included in the form PHS 398 in Section 2,
A-D of the Research Plan AND summarized in Section 2, E, Human Subjects.
Applicants/offerors are urged to assess carefully the feasibility of
including the broadest possible representation of minority groups.
However, NIH recognizes that it may not be feasible or appropriate in
all research projects to include representation of the full array of
United States racial/ethnic minority populations (i.e., Native Americans
(including American Indians or Alakan Natives), Asian/Pacific Islanders,
Blacks, Hispanics).

The rationale for studies on single minority populations groups should
be provided.

For the purpose of this policy, clinical research includes human
biomedical and behavioral studies of etiology, epidemiology, prevention
(and preventive strategies), diagnosis, or treatment of diseases,
disorders or conditions, including but not limited to clinical trials.

The usual NIH policies concerning research on human subjects also apply.
Basic research or clinical studies in which human tissues cannot be
identified or linked to individuals are excluded.  However, every effort
should be made to include human tissues from women and racial/ethnic
minorities when it is important to apply the results of the study
broadly, and this should be addressed by applicants.

For foreign awards, the policy on inclusion of women applies fully;
since the definition of minority differs in other countries, the
applicant must discuss the relevance of research involving foreign
population groups to the United States' population, including
minorities.

If the required information is not contained within the application, the
application will be returned.

Peer reviewers will address specifically whether the research plan in
the application conforms to these policies.  If the representation of
women or minorities in a study design is inadequate to answer the
scientific question(s) addressed AND the justification for the selected
study population is inadequate, it will be considered a scientific
weakness or deficiency in the study design and will be reflected in
assigning the priority score to the application.

All applications for clinical research submitted to NIH are required to
address these policies.  NIH funding components will not award grants or
cooperative agreements that do not comply with these policies.

ELIGIBILITY

Nonprofit organizations and institutions, governments and their
agencies, for-profit organizations, and individuals are eligible to
apply.  Foreign institutions are eligible to apply.

APPLICATION PROCEDURES

Applications will be accepted in accordance with the announced receipt
dates for unsolicited AIDS R01 and R29 applications, January 2, May 1,
and September 1 of each year.  AIDS investigator-initiated applications
received on these dates by the Division of Research Grants will undergo
expedited review.  Applicants for the K08 award must submit applications
to meet the receipt dates listed in the instructions for that mechanism.

All applications must be submitted on form PHS 398 (rev. 10/88).
Application kits are available in the business or grants and contract
office at most research and academic institutions.  Additional
application kits may be obtained from the office of Grants Inquiries,
Division of Research Grants (DRG), NIH, Westwood Building, Room 449,
Bethesda, MD 20892, telephone (301) 496-7441.  The phrase, "Association
of Arthritis, Inflammatory Muscle Diseases and Other Rheumatic
Manifestations with HIV Positivity and AIDS, PA-91-82" must be typed at
item 2 of the face page of the application form 398 (rev. 10/88).  The
original and 24 copies for receipt dates of an R01 or R29 application
submitted for expedited review must be sent to:

Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**

REVIEW PROCEDURES AND CRITERIA

Applications in response to this solicitation will be reviewed in
competition with other research grant applications and in accord with
the expedited NIH peer review procedures for AIDS-related research.  To
expedite the review, investigators must submit PHS human subject
certifications and animal verifications with the applications.
Applications will be reviewed first for technical merit by initial
review groups and then by an appropriate national advisory council.  The
review criteria customarily employed by the NIH for research grant
applications will prevail.

Applicants from institutions that have a General Clinical Research
Center (GCRC) funded by the NIH National Center for Research Resources
may wish to identify the GCRC as a resource for conducting the proposed
research.  In such a case, a letter of agreement from the Program
Director of the GCRC must be included with the application material.

All PHS and NIH grant policies governing research project grants apply
to applications received in response to this program announcement.
Applications will be referred in accordance with customary procedures of
the DRG.

For further information contact:

Lawrence M. Petrucelli, Ph.D.
Arthritis Program Director
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Westwood Building, Room 405
Bethesda, MD  20892
Telephone:  (301) 496-7326

Richard W. Lymn, Ph.D.
Muscle Biology Program Director
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Westwood Building, Room 403B
Bethesda, MD  20892
Telephone:  (301) 496-7495

Reva C. Lawrence, M.P.H.
Epidemiology/Data Systems Program Officer
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Building 31, Room 4Cl3
Bethesda, MD  20892
Telephone:  (301) 496-0434

For administrative and fiscal matters, contact:

Diane Watson
Grants Management Officer
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Westwood Building, Room 407-A
Bethesda, MD  20892
Telephone:  (301) 496-7495

This program is described in the Catalog of Federal Domestic Assistance
No. 93.846, Arthritis, Musculoskeletal and Skin Diseases Research.
Awards will be made under the authority of the Public Health Service
Act, Title III, Section 301 (Public Law 78-410, as amended; 42 USC 241)
and administered under PHS grants policies and Federal Regulations 42
CFR Part 52 and 45 CFR Part 74.  This program is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health
Systems Agency review.

$$P2 END ***************************************************************

$$P3 BEGIN PA-91-83 ****************************************************

CANCER THERAPY RESEARCH IN LUNG CANCER

PA:  PA-91-83

P.T. 34; K.W. 0715035, 0715165, 0745045, 0745062, 0740015, 0765012

National Cancer Institute

Application Receipt Dates:  June 1, October 1, February 1

I. PURPOSE

The National Cancer Institute (NCI) seeks grant applications to conduct
therapeutic studies in lung cancer in human subjects.  This Program
Announcement (PA) encompasses a full range of therapeutic studies and
clinical trials employing surgery, radiation, chemotherapies, or
biologic response modifiers.  The intent of the announcement is to
encourage clinical researchers to translate new insights in the biology
of lung cancer into clinical trials of innovative cancer therapies.

This type of grant solicitation, a Program Announcement, is used to
encourage investigator-initiated research projects in areas of special
importance to the NCI.

HEALTHY PEOPLE 2000

The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2000," a
PHS-led national activity for setting priority areas.  This PA, Clinical
Cancer Therapy Research, is related to the priority area of cancer.
Potential applicants may obtain a copy of "Healthy People 2000" (Full
Report:  Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary
Report:  Stock No. 017-001-00473-1) through the Superintendent of
Documents, Government Printing Office, Washington, D.C. 20402-9325
(telephone 202/783-3238).

II.  BACKGROUND INFORMATION

In the past several years, research efforts into understanding the
biology of lung cancer have been productive.  Laboratory associations
with both dominant (ras, myc) and suppressor (p53, Rb) oncogenes, growth
factors and their receptors (EGF, HerB/neu), and recurrent cytogenetic
abnormalities (3p deletion) have been made with either small cell or
non-small cell lung cancer.  At the same time, promising developments
have occurred in both pre-existing treatment modalities such as
cytotoxics (new combinations of agents) and radiation therapy (new
techniques of administration, radiosensitization and radioprotection),
as well as new approaches such as differentiating agents/retinoids,
biologic response modifiers, and photodynamic therapy and new drugs
(taxol).  Unfortunately, neither the basic nor the therapeutic advances
have yet translated into marked improvement in the treatment of lung
cancer.  Therefore, it is essential to facilitate collaborations between
basic scientists and clinical investigators in order to promote the
rapid incorporation of promising scientific advances into research on a
well-characterized lung cancer patient population.

III.  RESEARCH GOALS AND SCOPE

The Division of Cancer Treatment (DCT) is requesting qualified
investigators to develop research grant (RO1) applications and First
Independent Research Support and Transition (FIRST) Award (R29)
applications involving therapeutic studies of lung cancer patients.
Studies should involve human subjects and be designed to ultimately
improve lung cancer treatment.  The applications may include single or
multi-institutional (e.g., consortia, cooperative groups) research
studies with appropriate biological correlates linked to these studies.
New therapeutic studies may involve drugs, radiation, surgery, or
biologic response modifiers, alone or in combination.  Biological
correlate studies that have clinical relevance to lung cancer therapies
are also appropriate.

Some examples of therapeutic studies include, but are not limited to:

  o  immunotherapies based on surgically obtained tumor specimens;
  o  therapies with novel mechanisms of action (e.g., retinoids);
  o  new radiation therapies, or radiation modifiers, to enhance cell
     kill or protect normal tissues;
  o  biologic response modifiers (e.g., monoclonal antibodies,
     cytokines, tumor vaccines) alone or in combination with other
     therapies;
  o  studies of drug- or radiation-resistance and reversal;
  o  therapies aimed at interfering with growth factor action (e.g.,
     suramin, bombesin analogs);
  o  innovative surgically based multimodality studies.

Some examples of biological correlate studies include:

  o  phenotypic or genotypic alterations that appear to correlate with
     the development of drug- or radiation-resistance;
  o  oncogenes, growth factors, and specific antigen expression on tumor
     cells;
  o  pharmacokinetic and pharmacodynamic measurements;
  o  biochemical pharmacologic parameters;
  o  imaging studies to assess efficacy of treatment.

Applicants from institutions that have a General Clinical Research
Center (GCRC) funded by the NIH National Center for Research Resources
may wish to identify the GCRC as a resource for conducting the proposed
research.  In such a case, a letter of agreement from either the GCRC
program director or Principal Investigator must be included with the
application.

IV.  MECHANISM OF SUPPORT

Support of this program will be by the research project (R01) and the
First Independent Research Support and Transition (FIRST) Award (R29).
Applicants will be responsible for the planning, direction, and
execution of the proposed project.  All PHS and NIH grants policies will
apply to applications received in response to this announcement.
Domestic applicants may request no more than five years of support, and
foreign applicants may request no more than three years.  Applications
submitted in response to this PA will compete for funds with all other
investigator-initiated applications.  The award of grants in response to
this PA is also contingent upon the availability of funds.

V. ELIGIBILITY REQUIREMENTS

Non-profit and for-profit organizations and institutions, governments
and their agencies, and occasionally individuals are eligible to apply.
Both domestic and foreign applicants may apply.  Applications may be
submitted from a single institution or may include arrangements with
multiple institutions (e.g., consortia, clinical cooperative group) if
appropriate.  Applications from minority individuals and women are
encouraged.

VI.  REVIEW PROCEDURES AND CRITERIA

A. REVIEW PROCEDURE

Upon receipt, applications will be reviewed by the Division of Research
Grants (DRG) for completeness.  Incomplete applications will be returned
to the applicant without further consideration.  Applications will be
assigned on the basis of established PHS referral guidelines.
Applications will be reviewed for scientific and technical merit by an
appropriate peer review group convened by the DRG.  Following peer
review, the applications will receive a second-level review by the
appropriate national advisory council/board.

B. SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH
POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL
RESEARCH STUDY POPULATIONS

NIH and ADAMHA policy is that applicants for NIH/ADAMHA clinical
research grants and cooperative agreements will be required to include
minorities and women in study populations so that research findings can
be of benefit to all persons at risk of the disease, disorder or
condition under study; special emphasis should be placed on the need for
inclusion of minorities and women in studies of diseases, disorders and
conditions which disproportionately affect them.  This policy is
intended to apply to males and females of all ages.  If women or
minorities are excluded or inadequately represented in clinical
research, particularly in proposed population-based studies, a clear
compelling rationale should be provided.

The composition of the proposed study population must be described in
terms of gender and racial/ethnic group, together with a rationale for
its choice.  In addition, gender and racial/ethnic issues should be
addressed in developing a research design and sample size appropriate
for the scientific objectives of the study.  This information should be
included in the form PHS 398 in Section 2, A-D of the Research Plan AND
summarized in Section 2, E, Human Subjects.

Applicants are urged to assess carefully the feasibility of including
the broadest possible representation of minority groups.  However, NIH
recognizes that it may not be feasible or appropriate in all research
projects to include representation of the full array of United States
racial/ethnic minority populations (i.e., Native Americans (including
American Indians or Alaskan Natives), Asian/Pacific Islanders, Blacks,
Hispanics).  The rationale for studies on single minority population
groups should be provided.

For the purpose of this policy, clinical research includes human
biomedical and behavioral studies of etiology, epidemiology, prevention
(and preventive strategies), diagnosis, or treatment of diseases,
disorders or conditions, including not but limited to clinical trials.

The usual NIH policies concerning research on human subjects also apply.
Basic research or clinical studies in which human tissues cannot be
identified or linked to individuals are excluded.  However, every effort
should be made to include human tissues from women and racial/ethnic
minorities when it is important to apply the results of the study
broadly, and this should be addressed by applicants.

For foreign awards, the policy on inclusion of women applies fully;
since the definition of minority differs in other countries, the
applicant must discuss the relevance of research involving foreign
population groups to the United States' populations, including
minorities.

If the required information is not contained within the application, the
application will be returned.

Peer reviewers will address specifically whether the research plan in
the application conforms to these policies.  If the representation of
women or minorities in a study design is inadequate to answer the
scientific question(s) addressed AND the justification for the selected
study population is inadequate, it will be considered a scientific
weakness or deficiency in the study design and will be reflected in
assigning the priority score to the application.

All applications for clinical research submitted to NIH are required to
address these policies.  NIH funding components will not award grants or
cooperative agreements that do not comply with these policies.

VII.  METHOD OF APPLYING

The research grant application form PHS 398 (revised 10/88) must be used
in applying for these grants and will be accepted at the standard
application deadlines.  These forms are available at most institutional
business offices; from the Office of Grants Inquiries, Division of
Research Grants, National Institutes of Health, Room 449, Westwood
Building, Bethesda, MD 20892; and from the NCI Program Director named
below.  The title and number of this announcement must be typed in line
2 on the face page of the application.  The typed original application
and six signed exact single-sided photocopies must be submitted or
delivered to:

Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**

IX. INQUIRIES

Written or telephone inquiries concerning the objectives and scope of
this PA and inquiries about whether or not specified proposed research
would be responsive are encouraged and should be directed to the Program
Directors, Ms. Diane Bronzert and Dr. Roy Wu, at the address below.  The
Program Directors welcome the opportunity to clarify any issues or
questions from potential applicants.

For Technical Information:

Ms. Diane A. Bronzert or
Dr. Roy S. Wu
Program Directors
Cancer Therapy Evaluation Program
Division of Cancer Treatment
National Cancer Institute
EPN, Room 734
Bethesda, MD  20892
Telephone:  (301) 496-8866
FAX:  (301) 480-4663

For Business Information:

Ms. Carolyn Mason
Grants Management Specialist
National Cancer Institute
EPS, Room 242
Bethesda, MD  20892
Telephone:  (301) 496-7800 ext. 59

This program is described in the Catalog of Federal Domestic Assistance
No 93.395, Cancer Treatment Research.  Awards are made under the
authorization of the Public Health Service Act, Sections 301, 410, and
411 (Public Law 78-410, 42 USC 241 as amended, Public Law 99-158, 42 USC
285a) and administered under PHS grants policies and Federal Regulations
at 42 CFR Part 52 and 45 CFR Part 74.  This program is not subject to
the intergovernmental review requirements of Executive Order 12372 or
Health Systems Agency review.

**THE MAILING ADDRESS GIVEN FOR SENDING APPLICATIONS TO THE DIVISION OF
RESEARCH GRANTS OR CONTACTING PROGRAM STAFF IN THE WESTWOOD BUILDING IS
THE CENTRAL MAILING ADDRESS FOR THE NATIONAL INSTITUTES OF HEALTH.
APPLICANTS WHO USE EXPRESS MAIL OR A COURIER SERVICE ARE ADVISED TO
FOLLOW THE CARRIER'S REQUIREMENTS FOR SHOWING A STREET ADDRESS.  THE
ADDRESS FOR THE WESTWOOD BUILDING IS:

5333 Westbard Avenue
Bethesda, Maryland 20816

$$P3 END ***************************************************************