INNOVATIVE TOXICOLOGY MODELS FOR DRUG EVALUATION: SBIR/STTR INITIATIVE
Release Date: October 25, 2000
PA NUMBER: PAR-01-004
National Cancer Institute
National Institute of Diabetes, Digestive and Kidney Diseases
National Institute of Drug Abuse
Letter of Intent Receipt Dates: December 7, 2000 and October 10, 2001
Application Receipt Dates: January 11, 2001 and November 14, 2001
PURPOSE
Recent advances in cancer biology, molecular biology, combinatorial chemistry,
and screening technology provide unprecedented opportunities for discovery of
new disease therapies. Drug discovery can now be focused on specific
molecular or regulatory sites within cells. The National Cancer Institute
(NCI) considers exploitation of this knowledge and technology for discovery of
new agents to treat or prevent cancer a high priority as stated in its Bypass
Budget (http://2001.cancer.gov). It is expected that research focused on
discovery and validation of new targets for therapy and screening design
efforts to identify agents that effect these targets will result in a
multitude of new chemical and biological agents with potential for clinical
benefit. However, before such agents can be tested and used widely in
patients, safety and acceptable toxicity to critical organs must be
demonstrated. Current practices and procedures for safety evaluations are
costly and time consuming. Developments in genomics and proteomics will
provide new approaches to quickly and effectively evaluate the expected large
numbers of new agents.
This Program Announcement (PA) encourages the small business community to
develop, standardize, and validate new and innovative assays which determine
or predict specific organ toxicities (e.g., cardiotoxicity, gastrointestinal
toxicity, hepatotoxicity, nephrotoxicity, ototoxicity, bladder toxicity,
neurotoxicity, pulmonary toxicity, and endocrine toxicity, including
pancreatic beta cell toxicity) of potential therapeutic agents for the
treatment and prevention of diseases of interest to the NCI, National
Institute of Diabetes, Digestive and Kidney Diseases (NIDDK) and the National
Institute of Drug Abuse (NIDA). Agents that have been evaluated in both
animals and man can be utilized retrospectively to validate the utility,
sensitivity, and reproducibility of the assay and to determine if other
factors such as agent stability, protein binding, or metabolic activation are
important parameters for interpretation and validation of the assay.
This Program Announcement (PA) must be read in conjunction with the OMNIBUS
SOLICITATION OF THE NATIONAL INSTITUTES OF HEALTH, SMALL BUSINESS INNOVATION
RESEARCH (SBIR) and SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) GRANT
APPLICATIONS (PHS 2000-2).
All of the instructions within the Omnibus Solicitation apply with the
following exceptions:
o Special receipt dates
o Initial review convened by the NCI, Division of Extramural Activities
o Additional review considerations
For this PA, the Modular Grant format will not be used.
This program will utilize the SBIR and STTR mechanisms, but will be run in
parallel with a program of identical scientific scope that will utilize
Exploratory/Developmental Grants mechanism, PAR-00-003 (see
http://grants.nih.gov/grants/guide/pa-files/PAR-00-003.html).
This PA will expire on November 15, 2001. NIH Grants policies apply to these
awards.
RESEARCH OBJECTIVES
Background
Recent advances in all branches of medical sciences provide new insight into
the underlying mechanisms in malignancy and suggest new targets and approaches
for therapy diseases of interest to the NCI, NIDDK, and NIDA. For example
drug discovery can now be focused on targeting key regulatory pathways or
specific macromolecules relevant to cancer and AIDS. Key growth regulatory
pathways and mutated genes are being identified, array technology for
expression of thousands of genes as well as computer-assisted evaluation of
data are available. New technologies in chemistry which allow facile
synthesis of millions of new chemicals, and high resolution structures of
important target proteins are becoming available. These advances taken
together and coupled with high throughput screening, allow identification of
hundreds and maybe thousands of agents which could be seriously considered for
clinical evaluation. Translation of these new technological discoveries and
innovations into clinical benefit for the patient through these newly
discovered agents is essential, however, the later stages in this drug
development process are lengthy and costly. Obviously new procedures are
necessary to decide which of the multitude of new agents should be tested in
humans. It is reasonable to consider that new technological advances which
lead to discovery of new agents could likewise be exploited to expedite the
development and decision process.
Investigations focusing on the hazards of potential drugs or biologicals to
healthy organs in intact experimental animals are the final steps in the
preclinical stages of new drug development. Data generated from these studies
on each new drug are evaluated in light of potential human toxicity and form a
major portion of the information required by the Food and Drug Administration
(FDA) for an Investigational New Drug (IND) application. Preclinical
toxicology studies are generally conducted in two animal species with the
following objectives: to define the Maximum Tolerated Dose (MTD), Dose
Limiting Toxicities (DLTs), schedule-dependency of toxicity, reversibility of
adverse effects, and a safe clinical starting dose (SD). Procedures to obtain
such information for IND filing have significant limitations in aspects such
as cost and time requirements as well as prediction of problems to be
encountered when agents are administered to humans. For example, since animal
studies are very expensive and time-consuming, it is generally impractical to
evaluate numerous analogs of a class of compounds in a species prior to
selection of the best developmental candidate or to decide which of a
multitude of hits identified from screening models should be brought to
clinical evaluation. Another concern is the lack of information gained from
these toxicological studies in regard to molecular or mechanistic mechanisms
for observed toxicities. It cannot be determined if toxicities of new agents
designed to attack a key molecular target are related to actions of inhibition
of that target or to other unknown aspects of the drug’s action in various
organs.
New technology to improve toxicology approaches and define toxicity at the
molecular level are emerging, but as yet none have been validated and accepted
for common use. For example, bacterial strains and transgenic mice have been
engineered to detect mutational activities of agents. Toxicogenomics , e.g.,
analysis of the transcription profile in a cell or organ following toxic agent
administration [Molecular Carcinogenesis 24:153-159 (1999)] is under
development using a variety of approaches, including DNA array analysis. Data
analysis software programs are being written to predict toxicological
endpoints. Individually, these activities may not be sufficient, but they may
be highly valuable when combined with other approaches to develop a total
toxicological profile of specific organ toxicity and molecular mechanisms
responsible for this toxicity.
Objectives and Scope
The goal of this PA is the discovery, development and validation of new assays
and procedures to quickly and cheaply determine toxicological profiles of
potential drugs. It is expected that a molecular definition of toxicity in
the affected organ, tissue or cell would be a component of the procedure.
Approaches for new toxicology assays in response to this initiative are broad
and are determined by the creativity of the applicant. Genetically modified
animals or cell lines, various non-mammalian organisms, in vitro assays
utilizing primary mammalian cells, tissue slices, isolated organs, sub-
cellular fractions or purified enzymes could be utilized for the model.
Computer modeling utilizing existing biological and toxicological data bases
would be appropriate. Genomic and proteomic technology could be exploited to
profile total gene activity or protein expression and thereby establish
molecular correlations with specific toxicities. Molecular endpoints to
evaluate toxicity and high throughput toxicity screening could be used to help
decide which agent of a chemical series should be pursued, to allow
exploration of toxicity at an earlier stage in drug development, or to define
the toxicity profile of agents selected for clinical trial.
The NCI, through the Developmental Therapeutics Program:
http://dtp.nci.nih.gov/, on occasion utilizes its internal resources to foster
drug development by small businesses. For this PA, toxicology data from
previous drug development for cancer and AIDS sponsored by NCI may be made
available to awardees. For additional informational contact Dr. Adaline C.
Smith at the address listed under INQUIRIES.
The overall objective of this PA is to provide a flexible funding mechanism
with regard to budgets and time of funding for small businesses to support the
research activities required to develop and validate innovative toxicology
assays.
MECHANISM OF SUPPORT
Support for this PA is through the SBIR and STTR mechanisms which are set-
aside programs. This PA is a one-time announcement which may be reissued.
Responsibility for the planning, direction and execution of the proposed
project will be solely that of the applicant. Awards will be administered
under NIH grants policy stated in the NIH Grants Policy Statement, NIH
publication 99-8 October 1998.
Applications can be submitted for support as Phase I STTR (R41) or Phase I
SBIR (R43) grants, Phase II STTR (R42) or Phase II SBIR (R44) grants, or the
SBIR/STTR FAST-TRACK option as described in the OMNIBUS SOLICITATION (PHS
2000-2). Phase II applications in response to this PA will only be accepted
as competing continuations of previously funded NIH Phase I SBIR/STTR awards.
The Phase II application must be a logical extension of the Phase I research.
Information on the FAST-TRACK process and the OMNIBUS SOLICITATION are
available at: http://grants.nih.gov/grants/funding/sbirsttr1/index.htm
ELIGIBILITY REQUIREMENTS
Eligibility requirements are described in the OMNIBUS SOLICITATION for
SBIR/STTR grant applications. Any small business, independently owned by
United States citizens or permanent resident aliens, and located in the United
States may apply. The small business must be organized for-profit, cannot be
dominant in its field of expertise, and must have its principal place of
business in the United States. For both Phase I and Phase II, the R&D must be
performed in its entirety in the United States. Including any affiliates, the
company can be the employer of no more than 500 people.
Racial/ethnic minority individuals, women, and persons with disabilities are
encouraged to apply as principal investigators.
INQUIRIES
Inquiries concerning this PA are encouraged. The opportunity to clarify any
issues or questions from potential applicants is welcome.
Direct inquiries regarding programmatic issues to:
Adaline C. Smith, Ph.D., D.A.B.T.
National Cancer Institute
Division of Cancer Treatment and Diagnosis
Toxicology and Pharmacology Branch
6116 Executive Blvd Room 5113, MSC 7458
Bethesda, MD 20892-7458
Telephone: (301) 496-8777
FAX: (301) 480-4836
Email: smithad@mail.nih.gov
Robert Star, M.D.
Senior Scientific Advisor
National Institute of Diabetes, Digestive and Kidney Diseases
Building 31, Room 9A35
31 Center Drive MSC 2560
Bethesda, MD 20892-2560
Telephone: (301) 594-7715
FAX: (301) 496-2830
Email: robert_star@nih.gov
David J. McCann, Ph.D.
Chief, Medications Discovery & Toxicology Branch
National Institute on Drug Abuse
Division of Treatment Research & Development
6001 Executive Boulevard, Room 4123, MSC 9551
Bethesda, MD 20892-9551
Telephone: (301) 443-2999
FAX: (301) 443-2599
Email: dmccann@nih.gov
Direct inquiries regarding fiscal matters to:
Ms. Kathleen Shino
National Cancer Institute
Executive Plaza South, Room 243
6120 Executive Blvd, MSC 8635
Bethesda, MD 20892-7150
Telephone: (301) 496-8635
FAX: (301) 496-8601
Email: shinok@gab.nci.nih.gov
Direct inquiries regarding review matters to:
Ms. Toby Friedberg
Referral Officer
National Cancer Institute
Division of Extramural Activities
6116 Executive Boulevard, Room 8109, MSC 8329
Bethesda, MD 20892-8329
Telephone: (301) 496-3428
FAX: (301) 402-0275
Email: tf12w@nih.gov
LETTER OF INTENT
Prospective applicants are asked to submit, by the dates listed on the first
page of this PA, a letter of intent that includes a descriptive title of the
proposed research, the name, address, and telephone number of the Principal
Investigator, the identities of other key personnel and participating
institutions, and the number and title of the PA in response to which the
application may be submitted. Although a letter of intent is not required, is
not binding, and does not enter into the review of a subsequent application,
the information that it contains allows NCI staff to estimate the potential
review workload and plan the review.
NCI policy requires that all applicants requesting greater than $500,000
direct costs in any one year must obtain approval from NCI Program staff prior
to submission of the application. If greater that $500,000 per year is
requested, this fact must be clearly indicated and approval requested in the
letter of intent.
The letter of intent is to be sent to Dr. Adaline C. Smith at the address
listed under INQUIRIES.
APPLICATION PROCEDURES
This PA must be read in conjunction with the OMNIBUS SOLICITATION FOR SMALL
BUSINESS INNOVATION RESEARCH (SBIR) AND SMALL BUSINESS TECHNOLOGY TRANSFER
(STTR) GRANT APPLICATIONS (PHS 2000-2). All instructions within the
solicitation apply with the following exceptions:
- special receipt dates
- initial review convened by the NCI Division of Extramural Activities
- additional review considerations
Information on the SBIR and STTR programs, OMINBUS SOLICITATION, application
forms, and helpful advice on preparation of applications are available at:
http://grants.nih.gov/grants/funding/sbir.htm. Hard copies of the
SOLICITATIONS, subject to availability, may be obtained from the PHS SBIR/STTR
Solicitation Office, telephone (301) 206-9385, FAX (301) 206-9722, email
a2y@cu.nih.gov.
Applications received in response to this PA are to be prepared as described
in the OMNIBUS SOLICITATION (PHS 2000-2). Phase I applications are located in
the back pages of the SOLICITATION. All applications and proposals for NIH
funding must be self-contained within specified page limitations.
Applications will be accepted up to the dates indicated on the first page of
this PA. The PA title and number must be typed in line 2 on the face page of
the application form.
If an application is received after the application receipt dates, it will be
returned to the applicant without review. The Center for Scientific Review
(CSR) will not accept any application in response to this PA that is
essentially the same as one currently pending review, unless the applicant
withdraws the pending application. This does not preclude the submission of
substantial revisions of applications previously reviewed.
Applications can be submitted for Phase I or Phase II support, or as a
combined Phase I and II (FAST-TRACK). A Phase II application will be accepted
only as continuation of a previously funded Phase I grant. The Phase II
proposal must be a logical extension of the Phase I research but not
necessarily a Phase I project supported in response to this initiative.
PHASE I: Demonstration of feasibility of the innovative approach. Research
should be proposed to provide sufficient reason to continue the assay
development in Phase II. It would be expected that assay methodology would be
established. If two years of support are requested, the goals for the first
year should be clearly stated and not simply a reiteration of specific aims.
Support for the second year will be contingent upon NCI programmatic
evaluation to ensure that investigators are accomplishing the goals presented.
PHASE II: Development of approach to stage at which the assay can be used for
toxicology purposes. Extensive studies designed to validate the approach
would be expected. Validation should include analysis of compounds with known
organ toxicities. Innovative aspects of the research necessary to complete
the projects such as development of new in vivo models which may require
surrogate endpoints should be clearly described. Goals and milestones for
each year of support should be clearly presented. Support for years two to
four, if requested, is dependent upon NCI Programmatic review of progress and
achievement of the proposed goals. For example, if a goal cannot be achieved
such as identification of a known toxicity, the continuation years may not be
supported.
FAST TRACK: Applications may be submitted for combined Phase I and Phase II,
FAST TRACK consideration as described in the OMNIBUS SOLICITATION. However,
due to the complex nature of toxicological assay development, it is
recommended that only well defined and more advanced projects be proposed for
support through this mechanism.
Phase I, FAST TRACK applications must specify clear, measurable milestones
that should be achieved prior to Phase II funding. Failure to provide such
information in the Phase I application and/or sufficient detail in the Phase
II application may be sufficient reason for the peer review committee to
exclude the Phase II from consideration. If so, the applicant may apply later
for Phase II support. Such applications will be reviewed by an appropriate
scientific review group convened by the NIH.
Special provisions described in this PA pertaining to Phase I and Phase II
also apply to FAST TRACK applications.
An additional requirement of the FAST TRACK mechanism is the Product
Development Plan. The small business must submit a Product Development Plan
(limited to ten pages) as an Appendix to the Phase II application addressing
the four areas described in the instructions for FAST TRACK applications in
the OMNIBUS SOLICITATION.
The OMNIBUS SOLICITATION indicates the normal levels of support and period of
time for SBIR and STTR Phase I and Phase II awards. However, for this PA,
budgets up to $250,000 total costs per year (direct costs, indirect costs, and
fixed fee) and time periods up to 2 years for Phase I and $650,000 total costs
per year (direct costs, indirect costs, and fixed fee) and up to 4 years for
Phase II can be requested. For FAST-TRACK applications the total duration of
Phase I plus Phase II cannot exceed 5 years.
SBIR Phase I applications requesting in excess of $100,000 total costs (direct
costs, indirect costs, and fixed fee) per year will use Budget for Phase I
Direct Costs (form page 3 of PHS 6246-1), and justify this request using
Budget Justification form page 4 of PHS 6246-1.
STTR Phase I applications requesting up to $100,000 total costs (direct costs,
indirect costs, and fixed fee) will request budgets using Budget
Justification (form page 5 of PHS 6246-3) ONLY. Present the total amount
requested for direct costs on line 2a of the Face Page of PHS 6246-3. The
applicant small business organization should not submit Budget of Applicant
Organization for Phase I - Direct Costs Only (form page 3 of PHS 6246-3), it
is to be used as a worksheet only. However, the single, partnering
research institution must complete Budget of Research Institution for Phase
I (form page 4) in an abbreviated manner by: (1) Entering the amount of its
participation in the project under Total Costs and (2) Signing and dating
the Certificate of Research Institution Participation portion of the form.
STTR Phase I applications requesting in excess of $100,000 total costs (direct
costs, indirect costs, and fixed fee) will use Budget of Applicant
Organization for Phase I - Direct Costs Only (form page 3 of PHS 6246-3) and
justify this request using Budget Justification (form page 5).
Phase I SBIR and STTR applications requesting a budget more than one year
should follow the following procedures: Photocopy Form Page 3, Budget for
Phase I-Direct Costs Only , and number it Form Page 3a, Use Form Page 3 for
the first year budget and title Form Page 3a Phase I-2nd year budget . (This
page will not be counted against the 25 page limit.), Provide the
appropriate/requested information in the narrative justification (Form Page 4)
for years 1 and 2, Indicate on the Phase I Face page Field 6, Dates of Project
Period, the dates for the ENTIRE project period, Indicate on the Phase I Face
Page in Field 7, the requested Direct Costs and Total Costs for the entire
project period, The summary statement will reflect the recommended budget for
the -01 and -02 years.
Potential applicants are encouraged to contact program staff for guidance and
to read the advice and information on the web sites. However, responsibility
for planning, direction, and execution of the proposed research will be solely
that of the applicant.
The completed original application and one legible copies must be sent or
delivered to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive
Room 1040, MSC 7710
Bethesda, MD 20892-7710
(20817 for express/courier service)
To expedite the review process, at the time of submission, send one additional
copies of the application to:
Ms. Toby Friedberg
Referral Officer
National Cancer Institute
6116 Executive Boulevard, Room 8109, MSC 8329
Bethesda, MD 20892-8329
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-3428
FAX: (301) 402-0275
Applications must be received by the receipt dates listed at the top of the
first page of this PA.
REVIEW CONSIDERATIONS
Upon receipt, applications will be reviewed by CSR staff for completeness and
by NCI program staff for adherence to guidelines. Incomplete applications and
applications not adhering to instructions described above will be returned to
the applicant without further consideration.
Applications that are complete and adhere to the guidelines of this PA will be
evaluated for scientific and technical merit and the documented ability of the
investigators to meet the RESEARCH OBJECTIVES of this PA by an appropriate
peer review group convened by the NCI, Division of Extramural Activities, in
accordance with the peer review criteria listed below. As part of the initial
merit review, all applications will receive a written critique and undergo a
process in which only those applications deemed to have the highest scientific
merit, generally the top half of the applications under review, will be
discussed, assigned a priority score, and receive a second level review by the
appropriate advisory Council of NCI, NIDDK, or NIDA.
Review Criteria:
Review criteria are described in the NIH Omnibus Solicitation and available on
the web at the following URL address:
http://grants.nih.gov/grants/funding/sbirsttr1/index.htm
The goals of NIH-sponsored research are to advance our understanding of
biological systems, improve the control of disease, and enhance health.
Within this framework, the specific goals of this PA are the discovery and
validation of new and innovative assays which predict specific toxicities of
potential drugs. Assays developed under this PA would be expected to be
effective for a quick and cost effective determination of toxicity of
specific compounds and, importantly, to decrease the number of animals
required. The reviewers will comment of the following aspects of the
application in their written critiques in order to judge the likelihood that
the proposed research will have a substantial impact on the pursuit of these
goals. Each of the criteria will be addressed and considered in assigning the
overall score weighting them as appropriate for each application. Note that
the application does not need to be strong in all categories to be judged
likely to have a major impact and thus deserve a high priority rating. For
example, an investigator may propose to carry out important research that by
its nature is not overly innovative but may be essential for development of a
valuable assay.
In considering the scientific and technical merit of each application, the
following criteria will be used as described in the OMNIBUS SOLICITATION (PHS
2000-2).
Significance. Does the study address an important problem? Does the proposed
project have commercial potential to lead to a marketable product or process?
What may be the anticipated commercial and societal benefits of the proposed
activity? If the aims of the application are achieved, how will scientific
knowledge be advanced? Does the proposal lead to enabling technologies
(instrumentation, software, etc.) for further discoveries? Will the
technology have a competitive advantage over existing/alternative technologies
that can meet the market needs?
Approach. Are the conceptual framework, design, methods, and analyses
adequately developed, well-integrated, and appropriate to the aims of the
project? Is the proposed plan a sound approach for establishing technical and
commercial feasibility? Does the applicant acknowledge potential problem
areas and consider alternative strategies? Are the milestones and evaluation
procedures appropriate?
Innovation. Does the project challenge existing paradigms or employ novel
technologies, approaches or methodologies? Are the aims original and
innovative?
Investigator. Is the principal investigator capable of coordinating and
managing the proposed SBIR/STTR? Is the work proposed appropriate to the
experience level of the principal investigator and other researchers including
consultants and sub-contractors (if any)?
Environment. Is there sufficient access to resources (equipment, facilities,
etc.)? Does the scientific and technological environment in which the work
will be done contribute to the probability of success? Do the proposed
experiments take advantage of unique features of the scientific environment or
employ useful collaborative arrangements?
For Phase II applications: In addition to the above criteria, to what degree
was progress toward the Phase I objectives met and feasibility demonstrated in
providing a solid foundation for the proposed Phase II activity?
For Phase I/Phase II Fast Track applications, the following additional
criteria will be applied: Does the Phase I specify clear, measurable goals
(milestones) that should be achieved prior to initiating Phase II? Did the
applicant submit a concise Product Development Plan that adequately addresses
the four areas described in Section VI. G. of the SBIR/STTR solicitation? To
what extent was the applicant able to obtain letters of interest, additional
funding commitment and/or resources from private sector or non-SBIR/STTR
funding sources that would enhance the likelihood for commercialization?
For all SBIR/STTR applications, in accordance with NIH policy, all
applications will also be reviewed with respect to the following: adequacy of
plans to include both genders, minorities, and their subgroups as appropriate
for the scientific goals of the research, plans for the recruitment and
retention of subjects, adequacy of the proposed protection for humans, animals
or the environment, to the extent they may be adversely affected by the
project proposed in the application, appropriateness of the proposed budget
and duration in relation to the proposed research.
AWARD CRITERIA
Applications will compete for available funds with all other recommended SBIR
and STTR applications. Funding decisions for Phase I or Phase II applications
will be based on quality of the proposed project as determined by peer review,
program priority, potential for commercial success, and availability of funds.
A portion of the SBIR/STTR allotment will not be designated for this
initiative.
FAST TRACK, Phase II applications may be funded following submission of the
Phase I progress report and other documents necessary for continuation. Phase
II applications will be selected for funding based on the initial priority
score, grant Program staff’s assessment of the Phase I progress and
determination that Phase I goals were achieved, the project’s potential for
commercial success, and the availability of funds.
SCHEDULE
Letter of Intent Receipt Dates: December 7, 2000 and October 10, 2001
Application Receipt Dates: January 11, 2001 and November 14, 2001
NCAB Review Dates: May 2001 and May 2002
Earliest Anticipated Award Date July 1, 2001 and July 1, 2002
INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS
It is the policy of the NIH that women and members of minority groups and
their sub-populations must be included in all NIH supported biomedical and
behavioral research projects involving human subjects, unless a clear and
compelling rationale and justification is provided that inclusion is
inappropriate with respect to the health of the subjects or the purpose of the
research. This policy results from the NIH Revitalization Act of 1993
(Section 492B of Public Law 103-43).
All investigators proposing research involving human subjects should read the
UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in
Clinical Research," published in the NIH Guide for Grants and Contracts on
August 2, 2000
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html),
a complete copy of the updated Guidelines are available at
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm: The
revisions relate to NIH defined Phase III clinical trials and require: a) all
applications or proposals and/or protocols to provide a description of plans
to conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable, and b) all
investigators to report accrual, and to conduct and report analyses, as
appropriate, by sex/gender and/or racial/ethnic group differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS
It is the policy of NIH that children (i.e., individuals under the age of 21)
must be included in all human subjects research, conducted or supported by the
NIH, unless there are clear and compelling scientific and ethical reasons not
to include them. This policy applies to all initial (Type 1) applications
submitted for receipt dates after October 1, 1998.
All investigators proposing research involving human subjects should read the
NIH Policy and Guidelines on the Inclusion of Children as Participants in
Research Involving Human Subjects that was published in the NIH Guide for
Grants and Contracts, March 6, 1998, and is available at
http://grants.nih.gov/grants/guide/notice-files/not98-024.html
Investigators also may obtain copies of the policy from the program staff
listed under INQUIRIES, and under funding opportunities at the web site:
http://dtp.nci.nih.gov
URLS IN NIH GRANT APPLICATIONS OR APPENDICES
All applications and proposals for NIH funding must be self-contained within
specified page limitations. Unless otherwise specified in an NIH
solicitation, internet addresses (URLs) should not be used to provide
information necessary to the review because reviewers are under no obligation
to view the Internet sites. Reviewers are cautioned that their anonymity may
be compromised when they directly access an Internet site.
HEALTHY PEOPLE 2010
The Public Health Service (PHS) is committed to achieving the health promotion
and disease prevention objectives of "Healthy People 2010," a PHS-led national
activity for setting priority areas. This PA, Innovative Toxicology Models
for Drug Evaluation , is related to the priority area of cancer. Potential
applicants may obtain a copy of "Healthy People 2010"
at: http://www.health.gov/healthypeople/.
AUTHORITY AND REGULATIONS
This program is described in the Catalog of Federal Domestic Assistance Nos.
93.395, 93.847, 93.848, and 93.849. Awards are made under authorization of
Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241
and 284) and administered under NIH grants policies and Federal Regulations 42
CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health
Systems Agency review.
The PHS strongly encourages all grant and contract recipients to provide a
smoke-free workplace and promote the non-use of all tobacco products. In
addition, Public Law 103-227, the Pro- Children Act of 1994, prohibits smoking
in certain facilities (or in some cases, any portion of a facility) in which
regular or routine education, library, day care, health care or early
childhood development services are provided to children. This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.
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