COMPETING CONTINUATION AWARDS OF SBIR/STTR PHASE II GRANTS FOR PHARMACOLOGICAL
AGENTS AND BIOMARKERS FOR ALCOHOLISM AND ALCOHOL-RELATED DISEASES
RELEASE DATE: May 29, 2003
PA NUMBER: PA-03-129
EXPIRATION DATE: This PA will expire on May 30, 2006, unless re-issued.
IMPORTANT CHANGE: The opportunity to apply for an NIAAA SBIR and STTR Phase II
Competing Renewal is available from the PHS 2006-2 SBIR/STTR Omnibus Solicitation.
(See Program Descriptions and Research Topics (PDF or MS Word)). Interested
applicants must apply using the electronic application package from the parent
SBIR (PA-06-120) or STTR (PA-06-121) Funding Opportunity Announcements (FOAs).
APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
(http://www.niaaa.nih.gov)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.273
APPLICATION RECEIPT DATE(S): NOTICE: This program announcement (PA) must be
read in conjunction with the current Omnibus Solicitation of the National
Institutes of Health, Centers for Disease Control and Prevention, and Food
and Drug Administration for Small Business Innovation Research (SBIR) and
Small Business Technology Transfer (STTR) Grant Applications. The
solicitation (see http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf)
contains information about the SBIR and STTR programs, regulations governing
the programs, and instructional information for submission. All of the
instructions within the current SBIR/STTR Omnibus Solicitation apply.
THIS PA CONTAINS THE FOLLOWING INFORMATION:
o Purpose of the PA
o Research Objectives
o Mechanism(s) of Support
o Project Period and Amount of Award
o Eligibility
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 Receipt and Review Schedule
o Required Federal Citations
PURPOSE OF THE PA
The SBIR/STTR programs were initiated as a means for government agencies to
use small businesses to stimulate technological innovation and to help
agencies meet their research and development (R&D) needs. An additional
provision of these programs is the expected commercialization of the
research. Certain types of research require clinical evaluation and Federal
regulatory approvals before the Phase III of the small business research
pathway can ever be realized. A recipient of an NIH SBIR/STTR Phase I and
Phase II award normally receives no more than $1 million. If the intended
commercialized product is a medical device, drug, or biologic, the $1 million
often represents a small fraction of the funds necessary to complete the
studies required for approval and licensing by the Food and Drug
Administration (FDA) or other Federal agencies.
Moreover, a recipient of an NIH SBIR/STTR Phase I and Phase II award normally
receives less than three years of support. Yet, the process of moving
promising new products from bench to bedside typically takes more than a
decade. The drug discovery timeline, for example, starts with identification
of an agent or class of agents with particular activity, identification and
optimization of lead compounds, and subsequent pre-clinical testing of these
compounds for safety and toxicity. Those agents still considered viable
after such rigorous scrutiny are then brought to human subjects for clinical
evaluation of a variety of aspects of the agent, including safety, efficacy,
and dosage determination. Similarly long timelines obtain for other
products intended to understand, diagnose, prevent, or treat human health
disorders (e.g., medical devices, vaccines).
Despite the cost and the length of time required to move such products from
the laboratory to the patient, these are precisely the products with
potential to contribute significantly to the economy of the nation and to the
health of her people. The intent of the SBIR/STTR Phase II competing
continuation grants is to support such research and development.
The purpose of this Program Announcement (PA) is to solicit from Phase II
SBIR/STTR awardees grant applications that propose to continue the process of
developing products that ultimately require: 1) clinical evaluation and 2)
approval of a Federal regulatory agency. Such products include, but are not
limited to: drugs, vaccines, alcohol-sensitive biochemical markers,
radioligands, medical implants, imaging protocols proposed for clinical use,
and medical devices.
RESEARCH OBJECTIVES
Background
During the past decade advances have been made in medications development to
treat alcoholism. The fruits of these efforts have been highlighted by the
FDA approval of naltrexone, the first medication approved for alcoholism in
the 50 years since the introduction of disulfiram. Acamprosate has also been
studied extensively in Europe and is currently approved for alcoholism
treatment in over 24 countries. Ondansetron and gabapentin are two more
promising medications that are currently being evaluated in clinical trials.
Advances have also been made in understanding the biological mechanisms
underlying alcohol drinking behavior. For example, it is now known that
multiple neurotransmitter, neuromodulator, and hormonal systems can alter
alcohol intake and are either directly or indirectly involved in problematic
drinking. These include opioid, serotonin, dopamine, gamma-aminobutyric acid
(GABA), glutamate, neuropeptide Y (NPY), cannabinoid, and hypothalamic-
pituitary-adrenal (HPA) systems. This recent knowledge has led to many
biological targets for testing novel pharmacological agents.
Because medications mentioned above produce small to medium effects to reduce
or prevent drinking, development and evaluation of new and more potent
medications remain a high priority. Several promising pharmacological agents
could lead to clinical testing. These include, but are not limited to,
memantine, a non-competitive NMDA antagonist; kudzu and its purified active
components (e.g., puerarin); corticotropin-releasing factor (CRF)
antagonists; opioid receptor subtype antagonists such as delta2 antagonist
naltriben; 6-beta naltrexol, an active metabolite of naltrexone; synthetic
neurosteroids; 1-aminocyclopropanecarboxylic acid (ACPC), a NMDA partial
agonist; FG 5974 (and its analogues), a 5-HT1A agonist/5-HT2A antagonist; and
agents with selective affinity to GABAA alpha1 or GABAA alpha5 receptor
subunits.
As basic research reveals promising targets relevant to alcohol abuse and its
consequences, analogs acquired from existing libraries, or newly-synthesized
analogs developed through computational and combinatorial chemistry can be
screened in vitro or in standardized behavioral assays for potential
therapeutic efficacy.
Advances in molecular genetics (e.g., microarray analysis, targeted
mutations, and proteomics) offer a powerful approach for broad-spectrum
scanning of participants in the adaptive process. Individual gene clusters
or functionally-related proteins can be identified in specific brain regions
in temporal relation to alcohol exposure. Such studies may identify
biochemical pathways and brain circuits which are preferentially recruited as
alcohol dependence develops. Receptors or pathways involved in alcohol
drinking and other alcohol effects can be disabled selectively with targeted
knockout strategies.
Progress has also been made in elucidating the mechanisms of alcohol-induced
organ damage. In particular, several primary factors underlying the
pathogenesis of alcoholic liver disease have been identified including
cytokines and reactive oxygen species (ROS). For example, antioxidants, such
as S-adenosyl-L- methionine (SAMe), have been shown to reduce alcohol-induced
liver injury in animals. Potential new treatments of alcoholic liver disease
include antioxidants, such as SAMe and vitamin E; as well as other types of
agents including phosphatidylcholine, a phospholipid; pirfenidone, a new
anti-fibrotic agent; and metformin, an insulin-sensitizing agent.
The development of effective biochemical markers represents a powerful means
for early diagnosis and treatment of alcohol dependent/abuse patients and for
the identification of individuals who have a predisposition for alcoholism.
There are two different types of alcohol-sensitive biochemical markers: trait
markers and state markers.
Trait biomarkers have the ability to detect inborn characteristics of
individuals who are vulnerable for alcoholism. This type of marker would be
invaluable for screening of high-risk individuals (e.g., children of
alcoholics) and targeting them with preventive or early treatment
interventions. In addition, trait markers might assist practitioners in
identifying subpopulations of alcoholics who may need different treatment
strategies. An ideal trait marker should have several features. First, it
should display validity in detecting people susceptible to alcoholism,
particularly before the onset of alcoholism or during periods of stable
abstinence. Second, it should be measured easily and reliably. Third, it
should be specific for only alcoholism and not affected by other medical or
psychiatric disorders or drugs. Since alcoholism is a complex disease, it is
likely that more than one type of gene and protein exist as a trait marker.
State markers or markers of alcohol consumption serve several important
purposes. First, they can assist physicians in diagnosing individuals with
chronic drinking problems, particularly patients who deny excessive drinking.
Moreover, they may also identify individuals in early stages of heavy
drinking, thus avoiding the long-term medical, psychological, and social
consequences of chronic alcoholism. Second, state biomarkers can aid in the
diagnosis and treatment of other diseases (liver diseases, pancreatitis, and
cardiovascular diseases) that were, at least, caused by excessive drinking.
Biomarkers that detect alcohol-induced tissue/organ damage would be
particularly valuable. Third, they are useful in alcohol treatment and
prevention programs. Since the goal of many programs is abstinence,
monitoring relapse is important in gauging success. Last, state biomarkers
are important in clinical alcohol trials. Although measurement of self-
report has become more sophisticated (e.g., Timeline Followback), it still
relies on accurate reporting. These biomarkers would be essential in at least
confirming the self-report.
There are several ideal features of a state marker. These include high
validity, reliability, stability, reasonable cost, practicability,
acceptability to both practitioners and patients, and transportability in
different settings. Several biomarkers are currently being used including
carbohydrate-deficient transferrin (CDT), gamma glutamy transferase (GGT),
aspartate aminotransferase (AST), alanine aminotransferase (ALT), and mean
corpuscular volume (MCV). Many of these markers are elevated due to alcohol-
induced tissue damage. Unfortunately, these markers have limitations, and
thus new markers need to be developed.
Example of Research Topics
These examples are meant for illustrative purposes and are not exclusive of
other appropriate activities:
o Preclinical studies, including pharmacology and toxicology, beyond those
conducted under the Phase I (R43) and initial Phase II (R44) grants. Some in
vivo or in vitro studies would be expected to have been carried out in Phase
I or the initial Phase II grant.
o Completion of studies as required by the Food and Drug Administration
(FDA) for Investigational New Drug (IND) or Radioactive Drug Research
Committee (RDRC) application.
o Development and clinically evaluation of new alcohol-sensitive biomarkers
o Assessment of devices with regard to performance standards related to the
FDA approval process.
o Safety and effectiveness studies of novel medical devices.
o Biocompatibility studies of surface materials of putative medical implants.
o Evaluation of novel imaging approaches for diagnostic purposes.
o Clinical studies in support of New Drug Application approval by the FDA.
o Clinical studies in support of Pre-Market Approval for biomarkers/medical
devices by the FDA.
MECHANISM(S) OF SUPPORT
Unsolicited SBIR/STTR competing continuation applications will not be
accepted. That is, an SBIR/STTR Phase II competing continuation application
must be in response to this PA, and the application will only be accepted as
a competing continuation of a previously funded NIH Phase II SBIR or STTR
award (R44 mechanism, R42 mechanism.) 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 that represents a logical extension of the
previously supported Phase II research as described in the announcement. The
applicant will be solely responsible for planning, directing, and executing
the proposed project.
The SBIR/STTR Phase II competing continuation would represent a continuation
of support for research/research and development of such previous work funded
by the original Phase II R44 grant. The expectation is that as a result of
support from a previous SBIR/STTR Phase I (R43) and Phase II (R44) grant,
promising results had been produced that indicate not only the merit of
further research and development, but also that clinical investigations and
Federal regulatory approvals will ultimately be required to realize the
potential of the product being researched and developed.
Activities supported by a competing continuation of a Phase II SBIR/STTR
grant may include an extension and expansion of preclinical research and
development, clinical testing, and other scientific research and development
activities that would ultimately be useful in meeting the requirements and
expectations of Federal regulatory processes.
A competing continuation Phase II award should not, however, be used to
conduct very early stage research (e.g., identifying targets for drugs,
initial identification of lead compounds, etc.). In addition, like a Phase I
and initial Phase II grant, the competing continuation Phase II award will
not support costs for legal consultation, marketing efforts, etc.
PROJECT PERIOD AND AMOUNT OF AWARD
Awards routinely will be in the range of $750,000 to $1,000,000 total costs
per year for up to three years.
Because the length of time and cost of drug discovery and development
represents a long term research and development commitment, a project period
of up to three years and a budget not to exceed total costs of $1,000,000 per
year (including direct costs, indirect costs and fee/profit) will be
considered under this PA if the time period and amount are well justified.
Consultant and Contractual Costs
The total amount of all consultant costs and contractual costs normally may
not exceed 50% of the total costs requested for initial SBIR Phase II
applications. SBIR Phase II competing continuation grant applications
submitted under this PA may exceed this guideline, however, when well
justified and when those costs are necessary to support clinical studies or
trials and related expenses. Examples of well founded reasons for exceeding
this guideline include, but are not limited to, subcontracts to clinical
research organizations to carry out aspects of clinical evaluation or
subcontracts to assure compliance with Good Manufacturing Practices (GMPs)
expectations of the FDA.
For STTR Phase II applications, the small business MUST perform at least 30%
of the research/R&D and the partnering research institution must perform at
least 40% of the proposed research/R&D.
Commercialization Plan
All Phase II grant applications, including this competing continuation
application, require a "Commercialization Plan [formerly "Product Development
Plan,"] as described in Item j of the SBIR/STTR Phase II instructions (PDF or
MS Word). The Commercialization Plan is meant in part to demonstrate the
commercial viability of the product researched and developed with SBIR
support. Since this Phase II competing continuation application mechanism
supports a more advanced stage of research and development than the R44 Phase
II mechanism, the Commercialization Plan should reflect more advanced plans
and arrangements for commercialization than what might be submitted for an
R44 application. For example, part of a Commercialization Plan that would be
appropriate to drug development supported by a Competing Continuation
application would be a clear indication of an arrangement (e.g., strategic
alliance, letters of support) with another party through which the final
stages of the work might be supported or carried out, including additional
clinical trials, FDA submissions, drug manufacturing and drug
commercialization. This example is meant for illustrative purposes; the
details of any Commercialization Plan will depend upon the particular
circumstances represented in a given application.
ELIGIBILITY
Eligible to apply for SBIR/STTR Phase II competing continuation awards are
NIH SBIR/STTR Phase II awardees that meet the definition of a small business
concern (as described in the NIH SBIR/STTR Phase II instructions) and whose
projects are developing products that would ultimately require clinical
studies and Federal regulatory approval. 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
PA.
ELIGIBLE INSTITUTIONS
The competing continuation application must be a continuation of a previously
completed Phase II (R44) SBIR/ Phase II STTR (R42) grant focusing on research
and development of a product or products ultimately requiring clinical
testing and Federal regulatory approval. To maintain eligibility to seek a
Phase II competing continuation grant, a Phase II grantee organization should
submit an application for the Phase II competing continuation grant within
the first six receipt dates following the expiration of the initial Phase II
budget. Other eligibility requirements for a Phase II competing continuation
grant are identical to those for the initial Phase II (R44) applications and
can be found at
http://grants.nih.gov/grants/funding/sbirsttr2/PhaseII_SBIRSTTR.pdf (PDF) or
http://grants.nih.gov/grants/funding/sbirsttr2/PhaseII_SBIRSTTR.doc (MS Word)
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%) with the
small business at the time of award and for the duration of the project. The
PI 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:
Joanne B. Fertig, Ph.D.
Division of Clinical and Prevention Research
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard, Suite 505 MSC 7003
Bethesda, MD 20892-7003 (for courier, use Rockville, MD 20852)
Telephone: (301) 443-0635
Fax: (301) 443-8774
Email: jfertig@niaaa.nih.gov
Peter B. Silverman, Ph.D.
Division of Basic Research
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard, Suite 402
Bethesda, MD 20892-7003 (for courier, use Rockville, MD 20852)
Tel. 301-402-6966
FAX 301-594-0673
Email: psilverm@mail.nih.gov
o Direct your questions about financial or grants management matters to:
Judy Fox (formerly Simons)
Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard, Suite 505 MSC 7003
Bethesda, MD 20892-7003 (for courier, use Rockville, MD 20852)
Telephone: (301) 443-2434
Email: jsimons@niaaa.nih.gov
SUBMITTING AN APPLICATION
The PHS 398 research grant application must be used for all SBIR/STTR Phase
I, Phase II and Fast-Track applications (new and revised.) The PHS 398 is
available at http://grants.nih.gov/grants/funding/phs398/phs398.html.
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. The NIH will
return applications that are not submitted using the PHS 398 grant
application. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov.
All Phase II SBIR/STTR grant applications, including this competing
continuation application, require a "Commercialization Plan," as described in
item J of the Phase II SBIR Instructions
http://grants.nih.gov/grants/funding/sbir.htm). The Commercialization Plan is
meant, in part, to demonstrate the commercial viability of the product
researched and developed with SBIR support. Since this Phase II competing
continuation application mechanism supports a more advanced stage of research
and development than the R44 Phase II mechanism, the Commercialization Plan
should reflect more advanced plans and arrangements for commercialization
than what might be submitted for an initial R44 application.
For purposes of identification and processing, enter the following title and
number of this PA in item 2 on the face page of the application: PA-03-129;
"COMPETING CONTINUATION PHASE II SBIR/STTR NIAAA"
APPLICATION RECEIPT DATES: Applications submitted in response to this program
announcement 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)
Applications must be received by or mailed on or before the receipt dates
described on the first page of this program announcement. The Center for
Scientific Research (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 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 and assigned a priority score
o Receive a second level review by the appropriate national 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 proposed project have commercial potential to lead to
a marketable product or process? Does this study address an important
problem? 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 (e.g., instrumentation, software) for further discoveries? Will
the technology have a competitive advantage over existing/alternate
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?
Investigators: 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 subcontractors (if any)? Are the relationships of
the key personnel to the small business and to other institutions appropriate
for the work proposed?
Environment: Is there sufficient access to resources (e.g., equipment,
facilities)? 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?
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:
o Does the activity as proposed address issues related to Federal regulatory
approval processes?
o What will be the effect of these studies on the concepts or methods that
drive this field?
PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human
subjects and protections from research risk relating to their participation
in the proposed research will be assessed. (See additional information and
criteria included in the section on Federal Citations, below.)
Protection of Human Subjects from Research Risks - for all studies involving
human subjects. See instructions and "Guidance for Preparing the Human
Subjects Research Section."
o 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?
o 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?
o Are the plans proposed for the protection of human subjects adequate?
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. 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.)
o 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?
o 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?
o 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?
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.
o 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?
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.
For all applications, is the percent effort listed for the PI appropriate for
the work proposed? On applications requesting up to $100,000 total costs, is
the overall budget realistic and justified in terms of the aims and methods
proposed? On applications requesting over $100,000 in total costs, 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.
Amended Applications
In addition to the above criteria, the following criteria will be applied to
revised applications.
- Are the responses to comments from the previous SRG review adequate?
- 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. 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
RECEIPT AND REVIEW SCHEDULE
See http://grants.nih.gov/grants/funding/sbirsttr_receipt_dates.htm
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 SAFETY AND 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 Safety and 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.
HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research
on hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm 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.
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.
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.
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
284)and 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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