and Human Services (HHS)
EXPIRED
SBIR/STTR PHASE II COMPETING CONTINUATION AWARDS (NIDA)
RELEASE DATE: July 22, 2003
PA NUMBER: PA-03-154 (The SBIR (R44) portion of this PA has been reissued,
see PA-06-036)
EXPIRATION DATE: December 7, 2005
National Institute on Drug Abuse (NIDA)
(http://www.nida.nih.gov)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.279
THIS PROGRAM ANNOUNCEMENT (PA) CONTAINS THE FOLLOWING INFORMATION
o Purpose of the PA
o Research Objectives
o Mechanisms of Support
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS PA
This PA solicits Small Business Innovation Research (SBIR) and Small
Business Technology Transfer (STTR) grant applications that propose the
advanced stage development of pharmacological treatment agents for drug
and nicotine abuse and dependence. This PA specifically invites
applications for the competing continuation of previously funded Phase
II SBIR and STTR grants, to take existing, promising compounds through
the next step of drug discovery and development. Only SBIR and STTR
Phase II awardees are eligible to submit a competing continuation
application. The previously funded Phase II SBIR/STTR grant need not
have been submitted in response to a particular solicitation, as long
as the research is appropriate to the purpose of this solicitation.
This PA does not support early stage drug development such as the
identification of new targets or lead compounds. The expectation is
that as a result of support from previous SBIR/STTR Phase I and Phase
II grants, a promising new molecular entity (NME) or entities have been
identified as potential pharmacological treatment agents for drug or
nicotine abuse and dependence, and that the entities have gone through
sufficient preclinical testing to justify their continued development.
It is expected that each NME be in an advanced stage of preclinical
development and ready to begin the process for translation into
clinical trials (e.g., pharmacokinetic assays, large-scale production
carried out under Good Manufacturing Practices (GMP), toxicity testing,
formulation and analytical development, and clinical evaluation).
These translational activities would be supported by the competing
continuation of a Phase II SBIR/STTR grant.
RESEARCH OBJECTIVES
Background
Transitioning a new molecular entity, or NME (a term which is applied
by the Food and Drug Administration to new pharmaceutical and
immunological agents) from the preclinical to clinical phase of
development, requires large-scale production of the NME and toxicity
testing, activities which are both costly and time consuming. The cost
and time constraints imposed by advanced stage development of an NME
pose a significant obstacle for small businesses. A recipient of an
NIH SBIR/STTR Phase I and Phase II award normally receives under $1
million, and less than three years of support. Although Phase I and
Phase II SBIR/STTR support is sufficient for initial discovery efforts
(e.g., compound synthesis and some in vitro and in vivo preclinical
pharmacological testing), it is not adequate to support either the kind
of developmental work needed for compliance with the Food and Drug
Administration's requirements for an investigational new drug (IND), or
for clinical trials.
This PA adds up to another three (3) years of support to small
businesses for drug development by providing a second stage of Phase II
SBIR/STTR funding through the mechanism of a SBIR/STTR Phase II
competing continuation grant. It is recognized that an award of this
type may not support the entire medications development timeline for
any given drug. The competing continuation grant will, however, allow
small businesses to carry a medication from the preclinical to the
clinical stage, which will aid in attracting interest and investment by
third parties, and provide an important resource for new
pharmaceuticals for the treatment of substance abuse.
Research topics
The following examples would make appropriate topics for proposed SBIR
or STTR Phase II competing continuation projects. These are meant for
illustrative purposes only and are not exclusive of other appropriate
activities. Research and development efforts can be focused on
medications for the treatment of cocaine, methamphetamine, and other
stimulant abuse, as well as towards opiate, cannabis, PCP and club
drugs. The medications under development should be targeted towards
attainment of abstinence, maintenance, and/or relapse prevention.
o Preclinical studies, including pharmacology and toxicology, beyond
those conducted under the initial SBIR Phase I and Phase II grants.
The studies conducted under the previous grants should be sufficient to
provide a sound rationale for continued development of the entity or
entities.
o Completion of studies as required by the FDA for an IND application.
o Human laboratory clinical trials to determine a medication's safety
profile, metabolism, cardiovascular effects, interaction with drugs of
abuse, etc.
o Clinical studies to assess the efficacy of the medication under
development.
MECHANISMS OF SUPPORT
This PA will use the NIH SBIR and STTR competing continuation award
mechanisms, which is a set aside program (see
http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf). The
applicant will be solely responsible for planning, directing, and
executing the proposed project.
Only competing continuations of previously funded NIH Phase II SBIR or
STTR awards will be accepted under this PA. The expectation is that,
as a result of support from previous SBIR or STTR Phase I and Phase II
grants, sufficient positive findings have been produced that provide a
strong rationale for the continued development of the NME or NMEs under
investigation, and that the development will ultimately lead to
clinical investigations to support Federal regulatory approvals.
The previously funded NIH Phase II grant need not have been submitted
in response to any particular solicitation, but the application for the
competing continuation must propose research and development of
pharmacotherapies for the treatment of substance abuse, and must be a
logical extension of the previously supported Phase II research.
PROJECT PERIOD AND AMOUNT OF AWARD
It is expected that applications will normally not exceed a project
period of three years and total costs of $1,000,000 per year.
CONSULTANT AND CONTRACTUAL COSTS
The total amount of all consultant costs and contractual costs normally
may not exceed 50 percent of the total costs requested for Phase II
SBIR or STTR applications. Competing continuation grant applications
submitted under this PA may exceed these guidelines, however, when well
justified. Examples of well-founded reasons for exceeding these
guidelines include, but are not limited to, subcontracts to clinical
research organizations to carry out aspects of clinical evaluation or
subcontracts to assure compliance with GMP expectations of the FDA.
ELIGIBLE INSTITUTIONS
Eligibility requirements are described in the SBIR/STTR Omnibus
Solicitation. Only small business concerns are eligible to submit
applications. A small business concern is one that, on the date of
award for Phase II agreements, meets ALL of the criteria as described
in the SBIR/STTR Omnibus Solicitation.
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
Any individual with the skills, knowledge, and resources necessary to
carry out the proposed research is invited to work with their
institution to develop an application for support. Individuals from
underrepresented racial and ethnic groups as well as individuals with
disabilities are always encouraged to apply for NIH programs. On an
SBIR application, the principal investigator must have his/her primary
employment (more than 50 percent) with the small business at the time
of award and for the duration of the project. The principal
investigator on an STTR application may be employed with the small
business concern or the participating non-profit research institution
as long as s/he has a formal appointment with or commitment to the
applicant small business concern, which is characterized by an official
relationship between the small business concern and that individual.
WHERE TO SEND INQUIRIES
We encourage your inquiries concerning this PA and welcome the
opportunity to answer questions from potential applicants. Inquiries
may fall into two areas: scientific/research and financial or grants
management issues:
o Direct your questions about scientific/research issues to:
Cathrine Sasek, Ph.D.
SBIR/STTR Coordinator
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Room 5237
Bethesda, MD 20892-9591
Telephone: (301) 443-6071
Fax: (301) 443-
Email: [email protected]
o Direct your questions about financial or grants management matters
to:
Gary Fleming, J.D., M.A.
Grants Management Branch
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Room 3131, MSC 9541
Bethesda, MD 20892-9541
Telephone: (301) 443-6710
FAX: (301) 594-6847
Email: [email protected]
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant
application instructions and forms (rev. 5/2001). The PHS 398 is
available at http://grants.nih.gov/grants/funding/phs398/phs398.html in
an interactive format. Prepare your application in accordance with the
SBIR/STTR Omnibus Solicitation and the PHS 398. Helpful information on
the preparation of the application can be obtained at:
http://grants.nih.gov/grants/funding/sbirgrantsmanship.pdf. For further
assistance contact GrantsInfo, Telephone (301) 710-0267, Email:
[email protected].
APPLICATION RECEIPT DATES: Applications submitted in response to this
PA will be accepted at the standard application deadlines, which are
available at http://grants.nih.gov/grants/dates.htm. Application
deadlines are also indicated in the PHS 398 application kit.
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten
original of the application, including the checklist, and five signed
photocopies in one package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710
Bethesda, MD 20817 (for express/courier service)
APPLICATION PROCESSING: Applications must be mailed on or before the
receipt dates described at
http://grants.nih.gov/grants/funding/submissionschedule.htm. The CSR
will not accept any application in response to this PA that is
essentially the same as one currently pending initial review unless the
applicant withdraws the pending application. The CSR will not accept
any application that is essentially the same as one already reviewed.
This does not preclude the submission of a substantial revision of an
application already reviewed, but such application must include an
Introduction addressing the previous critique.
Although there is no immediate acknowledgement of the receipt of an
application, applicants are generally notified of the review and
funding assignment within 8 weeks.
PEER REVIEW PROCESS
Applications submitted for this PA will be assigned on the basis of
established PHS referral guidelines. An appropriate scientific review
group convened in accordance with the standard NIH peer review
procedures (http://www.csr.nih.gov/refrev.htm) will evaluate
applications for scientific and technical merit.
As part of the initial merit review, all applications will:
o Receive a written critique
o Undergo a selection process in which only those applications deemed
to have the highest scientific merit, generally the top half of
applications under review, will be discussed and assigned a priority
score
o Receive a second level review by an appropriate advisory council or
board.
REVIEW CRITERIA
The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health.
In the written comments, reviewers will be asked to discuss the
following aspects of the application in order to judge the likelihood
that the proposed research will have a substantial impact on the
pursuit of these goals:
o Significance
o Approach
o Innovation
o Investigator
o Environment
ALL SBIR/STTR APPLICATIONS:
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 do they advance scientific knowledge?
Does the proposal lead to enabling technologies (instrumentation,
software, etc.) for further discoveries? What is the throughput and
cost effectiveness of the proposed assay(s)? Will the technology have a
competitive advantage over existing/alternative technologies that can
meet the market needs? What will be the impact on future clinical
trials or on clinical practice?
APPROACH: Are the conceptual framework, design, methods, and analyses
adequately developed, well-integrated, and appropriate to the aims of
the project? This includes the statistical rationale for the study
design and the choice of sample size. Is the proposed plan a sound
approach for establishing technical and commercial feasibility? Does
the applicant acknowledge potential problem areas and consider
alternative strategies? Has the applicant considered how the Phase II
study, if promising, could proceed into eventual definitive testing of
the diagnostic strategy?
INNOVATION: Does the project challenge existing paradigms or employ
novel technologies, approaches, or methods? Are the aims original and
innovative? How is the proposed diagnostic strategy superior to
existing alternatives? What additional uses can be projected for the
proposed assay(s), or what additional groups of patients might benefit
from the new diagnostics strategy?
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? Are the planned statistical and data management
resources adequate?
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the
following items will be applied to ALL applications in the
determination of scientific merit and the priority score:
PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of
human subjects and protections from research risk relating to their
participations in the proposed research will be assessed. (See
additional information and criteria included in the section on Federal
Citations, below).
INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy
of plans to include subjects from both genders, all racial and ethnic
groups (and subgroups), and children as appropriate for the scientific
goals of the research will be assessed. Plans for the recruitment and
retention of subjects will also be evaluated. (See additional
information and Inclusion Criteria in the sections on Federal
Citations, below).
CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals
are to be used in the project, the required five items described under
Vertebrate Animals (section f of the Research Plan instructions) will
be assessed.
Human Subjects:
1. Protection of Human Subjects from Research Risks - for all studies
involving human subjects. See instructions and "Guidance for Preparing
the Human Subjects Research Section."
If an exemption is claimed, is it appropriate for the work proposed? If
no exemption is claimed, are the applicant's responses to the six
required points appropriate?
Are human subjects placed at risk by the proposed study? If so, are the
risks reasonable in relation to the anticipated benefits to the
subjects and others? Are the risks reasonable in relation to the
importance of the knowledge that reasonably may be expected to be
gained?
Are the plans proposed for the protection of human subjects adequate?
2. Inclusion of Women Plan - for clinical research only. Does the
applicant propose a plan for the inclusion of both genders that will
provide their appropriate representation? Does the applicant provide
appropriate justification when representation is limited or absent?
Does the applicant propose appropriate and acceptable plans for
recruitment/outreach and retention of study participants?
3. Inclusion of Minorities Plan - for clinical research only. Does
the applicant propose a plan for the inclusion of minorities that will
provide their appropriate representation? Does the applicant provide
appropriate justification when representation is limited or absent?
Does the applicant propose appropriate and acceptable plans for
recruitment/outreach and retention of study participants?
4. Inclusion of Children Plan - for all studies involving human
subjects. Does the applicant describe an acceptable plan in which the
representation of children of all ages (under the age of 21) is
scientifically appropriate and recruitment/retention is addressed
realistically? If not, does the applicant provide an appropriate
justification for their exclusion?
5. Data and Safety Monitoring Plan for clinical trials only. Does
the applicant describe a Data and Safety Monitoring Plan that defines
the general structure of the monitoring of the medical safety and the
validity and integrity of the trial including mechanisms for reporting
Adverse Events and Serious Adverse Events to the NIH and the IRB?
Animal Welfare: If vertebrate animals are involved, are adequate plans
proposed for their care and use? Are the applicant's responses to the
five required points appropriate? Will the procedures be limited to
those that are unavoidable in the conduct of scientifically sound
research?
Biohazards: Is the use of materials or procedures that are potentially
hazardous to research personnel and/or the environment proposed? Is the
proposed protection adequate?
ADDITIONAL CONSIDERATIONS: The following items may be also be
considered by reviewers but will not be included in the determination
of scientific merit.
BUDGET: The reasonableness of the proposed budget may be considered.
Is the percent effort listed for the PI appropriate for the work
proposed? Is each budget category realistic and justified in terms of
the aims and methods?
PERIOD OF SUPPORT: The appropriateness of the requested period of
support in relation to the proposed research.
In addition to the above criteria, the following criteria will be
applied.
1. Does the activity as proposed address issues related to Federal
regulatory approval processes?
2. What will be the effect of these studies on the concepts or methods
that drive this field?
AMENDED APPLICATIONS: In addition to the above criteria, the following
criteria will be applied to revised applications.
1. Are the responses to comments from the previous SRG review
adequate?
2. Are the improvements in the revised application appropriate?
AWARD CRITERIA
Applications submitted in response to a PA will compete for available
funds with all other recommended SBIR and STTR applications. Portions
of the SBIR and STTR allotments will not be designated for this
initiative. The following will be considered in making funding
decisions:
o Scientific merit of the proposed project as determined by peer review
o Availability of funds
o Relevance to program priorities
For FAST-TRACK applications, the Phase II portion may not be funded
until a Phase I final report and other documents necessary for
continuation have been received and assessed by program staff that the
Phase I milestones have been successfully achieved.
REQUIRED FEDERAL CITATIONS
HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that
applications and proposals involving human subjects must be evaluated
with reference to the risks to the subjects, the adequacy of protection
against these risks, the potential benefits of the research to the
subjects and others, and the importance of the knowledge gained or to
be gained.
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
MONITORING PLAN AND DATA AND SAFETY MONITORING BOARD: Research
components involving Phase I and II clinical trials must include
provisions for assessment of patient eligibility and status, rigorous
data management, quality assurance, and auditing procedures. In
addition, it is NIH policy that all clinical trials require data and
safety monitoring, with the method and degree of monitoring being
commensurate with the risks (NIH Policy for Data and Safety Monitoring,
NIH Guide for Grants and Contracts, June 12, 1998:
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: 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 clinical research
projects unless a clear and compelling justification is provided
indicating 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 clinical research should read the "NIH
Guidelines for Inclusion of Women and Minorities as Subjects in
Clinical Research - Amended, October, 2001," published in the NIH Guide
for Grants and Contracts on October 9, 2001
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines are available at
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition
of clinical research; updated racial and ethnic categories in
compliance with the new OMB standards; clarification of language
governing NIH-defined Phase III clinical trials consistent with the new
PHS Form 398; and updated roles and responsibilities of NIH staff and
the extramural community. The policy continues to require for all NIH-
defined Phase III clinical trials that: a) all applications or
proposals and/or protocols must 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)
investigators must report annual accrual and progress in conducting
analyses, as appropriate, by sex/gender and/or racial/ethnic group
differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN
SUBJECTS: The NIH maintains a policy 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 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 is available at
http://grants.nih.gov/grants/funding/children/children.htm.
REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH
policy requires education on the protection of human subject
participants for all investigators submitting NIH proposals for
research involving human subjects. You will find this policy
announcement in the NIH Guide for Grants and Contracts Announcement,
dated June 5, 2000, at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
HIV/AIDS COUNSELING AND TESTING POLICY FOR THE NATIONAL INSTITUTE ON
DRUG ABUSE: Researchers funded by NIDA who are conducting research in
community outreach settings, clinical, hospital settings, or clinical
laboratories and have ongoing contact with clients at risk for HIV
infection, are strongly encouraged to provide HIV risk reduction
education and counseling. HIV counseling should include offering HIV
testing available on-site or by referral to other HIV testing service
for persons at risk for HIV infection including injecting drug users,
crack cocaine users, and sexually active drug users and their sexual
partners. For more information see
http://grants.nih.gov/grants/guide/notice-files/NOT-DA-01-001.html.
NATIONAL ADVISORY COUNCIL ON DRUG ABUSE RECOMMENDED GUIDELINES FOR THE
ADMINISTRATION OF DRUGS TO HUMAN SUBJECTS: The National Advisory
Council on Drug Abuse recognizes the importance of research involving
the administration of drugs to human subjects and has developed
guidelines relevant to such research. Potential applicants are
encouraged to obtain and review these recommendations of Council before
submitting an application that will administer compounds to human
subjects. The guidelines are available on NIDA's Home Page at
www.nida.nih.gov under the Funding, or may be obtained by calling (301)
443-2755.
HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of
research on hESCs can be found at
http://stemcells.nih.gov/index.asp and at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using hESC lines that are registered in the NIH Human
Embryonic Stem Cell Registry will be eligible for Federal funding (see
http://escr.nih.gov). It is the responsibility of the applicant to
provide the official NIH identifier(s)for the hESC line(s)to be used in
the proposed research. Applications that do not provide this
information will be returned without review.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT:
The Office of Management and Budget (OMB) Circular A-110 has been
revised to provide public access to research data through the Freedom
of Information Act (FOIA) under some circumstances. Data that are (1)
first produced in a project that is supported in whole or in part with
Federal funds and (2) cited publicly and officially by a Federal agency
in support of an action that has the force and effect of law (i.e., a
regulation) may be accessed through FOIA. It is important for
applicants to understand the basic scope of this amendment. NIH has
provided guidance at
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this PA in a public
archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application
should include a description of the archiving plan in the study design
and include information about this in the budget justification section
of the application. In addition, applicants should think about how to
structure informed consent statements and other human subjects
procedures given the potential for wider use of data collected under
this award.
STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION:
The Department of Health and Human Services (DHHS) issued final
modification to the "Standards for Privacy of Individually Identifiable
Health Information", the "Privacy Rule," on August 14, 2002. The
Privacy Rule is a federal regulation under the Health Insurance
Portability and Accountability Act (HIPAA) of 1996 that governs the
protection of individually identifiable health information, and is
administered and enforced by the DHHS Office for Civil Rights (OCR).
Those who must comply with the Privacy Rule (classified under the Rule
as "covered entities") must do so by April 14, 2003 (with the
exception of small health plans which have an extra year to comply).
Decisions about applicability and implementation of the Privacy Rule
reside with the researcher and his/her institution. The OCR website
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule,
including a complete Regulation Text and a set of decision tools on "Am
I a covered entity?" Information on the impact of the HIPAA Privacy
Rule on NIH processes involving the review, funding, and progress
monitoring of grants, cooperative agreements, and research contracts
can be found at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
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. Furthermore, we caution reviewers 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 is related to one or more of the priority areas.
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 at http://www.cfda.gov/ and is not subject
to the intergovernmental review requirements of Executive Order 12372
or Health Systems Agency review. Awards are made under the
authorization of Sections 301 and 405 of the Public Health Service Act
as amended (42 USC 241 and 284and under Federal Regulations 42 CFR 52
and 45 CFR Parts 74 and 92. All awards are subject to the terms and
conditions, cost principles, and other considerations described in the
NIH Grants Policy Statement. The NIH Grants Policy Statement can be
found at http://grants.nih.gov/grants/policy/policy.htm.
The PHS strongly encourages all grant recipients to provide a smoke-
free workplace and discourage the 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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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