NIAID COMPETING CONTINUATION OF SBIR/STTR PH II AWARDS
RELEASE DATE: October 31, 2003
RFA Number: RFA-AI-04-005
Department of Health and Human Services (DHHS)
PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH)
(http://www.nih.gov)
COMPONENTS OF PARTICIPATING ORGANIZATION:
National Institute of Allergy and Infectious Diseases (NIAID)
(http://www.niaid.nih.gov)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S):
No. 93.855, Immunology, Allergy, and Transplantation Research
No. 93.856, Microbiology and Infectious Diseases Research
LETTER OF INTENT RECEIPT DATE: December 14, 2003
APPLICATION RECEIPT DATE: January 16, 2004
THIS RFA CONTAINS THE FOLLOWING INFORMATION
o Notice of Additional Instructions
o Purpose of the RFA
o Research Objectives
o Eligible Applications
o Mechanism(s) of Support
o Project Period and Amount of Award
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations
NOTICE: This Request for Application (RFA) 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 (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 SBIR/STTR Omnibus Solicitation apply with the
following exceptions:
o Special receipt date and mailing instructions
o Additional eligibility and significance requirements
o Extended project period and amount of award
o Requirement for critical path and annual milestones
o Mandatory NIAID "Clinical Terms of Award" for clinical research
o Initial review convened by the NIAID Division of Extramural Activities
o Additional review considerations
PURPOSE OF THIS RFA
This RFA invites applications for the competing continuation of eligible SBIR
or STTR Phase II awardees to continue the process of developing a product
that requires clinical evaluation and FDA approval. An "eligible application"
must develop one of the following products: therapeutics (drugs or
antibodies) to treat HIV or HIV-related opportunistic infections, anti-
inflammatory therapeutics, improved transplantation strategies, or other new
or improved vaccines, antiviral or antimicrobial agents for infectious
diseases.
The progress from an eligible SBIR/STTR Phase II grant should be commensurate
with previous support and indicate the merit of continued NIH research and
development (R&D) funding. Activities supported by a competing continuation
of a Phase II SBIR/STTR grant may include additional pre-clinical R&D,
clinical testing, and other R&D activities needed to meet requirements of the
FDA. A competing continuation SBIR/STTR Phase II award may not be used to
conduct early stage research (e.g., identifying targets for drugs, initial
identification of lead compounds, etc.).
RESEARCH OBJECTIVES
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 R&D needs. An additional provision of these programs is
the expected commercialization of the research. Certain types of research
require clinical evaluation and FDA approvals before the Phase III of the
small business research pathway can 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
FDA.
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 research to commercialization 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,
effectiveness, 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
improvement of public health. The intent of the NIAID SBIR/STTR Phase II
competing continuation awards is to support such R&D.
ELIGIBLE APPLICATIONS
Eligible to apply for NIAID SBIR/STTR Phase II competing continuation awards
under this RFA 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 a product that requires
clinical evaluation and FDA approval. Only applications on one of the
following products will be considered responsive to this RFA:
o therapeutics (drugs or antibodies) to treat HIV infections
o therapeutics (drugs or antibodies) for HIV-related opportunistic infections
o anti-inflammatory therapeutics
o improved transplantation strategies
o new or improved vaccines, antiviral or antimicrobial agents for infectious
diseases
Applications that are not considered responsive to one of these topics will
be returned without review. Applications may be submitted either before or
after expiration of the eligible Phase II budget period.
MECHANISM(S) OF SUPPORT
This RFA usually uses the Phase II SBIR (R44) and STTR (R42) grant
mechanisms, which are set-aside programs. The application for the competing
continuation must propose R&D that represents a logical extension of the
previously supported Phase II research. When awarded as a grant, the
applicant is responsible for planning, directing, and executing the proposed
project. When appropriate, NIAID may offer to award Phase II SBIR/STTR
competing continuation applications using a small business cooperative
agreement SBIR (U44) or STTR (U42) mechanism. In the cooperative agreement
mechanism, the Principal Investigator retains the primary responsibility and
dominant role for planning, directing, and executing the proposed project,
with NIAID staff being substantially involved as a partner with the Principal
Investigator.
This RFA uses just-in-time concepts. This RFA does not use modular budget
format.
Cost-sharing arrangements are strongly encouraged since the SBIR/STTR
programs cannot support all activities that may be required to advance a
project to feasibility demonstration in a clinical trial.
Except as otherwise stated in this RFA, awards will be administered according
to the NIH Grants Policy Statement (NIHGPS), currently available at
http://grants.nih.gov/grants/policy/nihgps_2001.
PROJECT PERIOD AND AMOUNT OF AWARD
The SBIR/STTR Omnibus Solicitation indicates the statutory guidelines of
funding support and project duration periods for SBIR and STTR Phase I and
Phase II awards. Competing continuation applications for SBIR/STTR Phase II
awards may be for a project period of up to three years and a budget not to
exceed a total cost of $1 million per year (including direct cost, F&A, and
fee/profit) provided the time period and amount are well justified.
FUNDS AVAILABLE
NIAID intends to commit approximately $4 million to fund 4-6 SBIR competing
continuation awards and $1 million to fund 1-2 STTR competing continuation
awards in FY2004 or FY2005. Although the financial plans of the NIAID provide
support for this program, awards pursuant to this RFA are contingent upon the
availability of funds and the receipt of a sufficient number of meritorious
applications.
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 RFA 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 for safety,
toxicity, or efficacy testing in animals, 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 competing Phase II applications, the small business MUST perform at
least 30% of the R&D and the partnering research institution must perform at
least 40% of the proposed R&D.
ELIGIBLE INSTITUTIONS:
Eligibility requirements are described in the SBIR/STTR Omnibus Solicitation.
See http://grants.nih.gov/grants/funding/sbirsttr2/PhaseII_SBIRSTTR.pdf (PDF)
or http://grants.nih.gov/grants/funding/sbirsttr2/PhaseII_SBIRSTTR.doc (MS
Word). Only small business concerns are eligible to submit applications. A
small business concern is one that, on the date of award for both Phase I and
Phase II agreements, meets ALL of the criteria as described in the SBIR/STTR
Omnibus Solicitation. The competing continuation application must be a
continuation of a previously funded Phase II (R44) SBIR or Phase II STTR
(R42) grant focusing on R&D of a product or products ultimately requiring
clinical testing and Federal regulatory approval.
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. Individuals from underrepresented racial and ethnic
groups, as well as individuals with disabilities, are encouraged to apply for
NIH programs. The Principal Investigator (PI) on an SBIR application 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 PI on
an STTR application may be employed with the small business concern or the
participating non-profit research institution as long as she or 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.
SPECIAL REQUIREMENTS
Follow the Instructions for the Significance Section of an NIH SBIR/STTR
Phase II Application. In addition, include the following in this section:
Item b. Significance Section
o Describe what makes the project eligible for a competing continuation Phase
II award.
o Describe a critical path(s) to product approval with detailed milestones to
be reached during each year of the proposed project period. A milestone is
defined as a specific R&D achievement that either demonstrates an essential
product attribute or completes a step necessary to advance the product
towards completion. Examples of milestones include, but are not limited to:
passing toxicity studies; demonstrating sufficient bio-availability; showing
efficacy in an animal model; completion of a prototype of a diagnostic tool;
FDA submission and acceptance of an Investigational New Drug Application
(IND) or an Investigational Device Exemptions (IDE); initiation of a clinical
trial; and follow-on funding.
o List in table format the milestones that have been achieved to date and
those for each grant year of the proposed project. Include in the table the
remaining milestones after the proposed grant period and estimated timeline
to complete the product R&D.
Additional milestones may be suggested by the review committee. The review
committee may also suggest which, if any, of the milestones should be
identified in the Terms of Award as essential for annual non-competitive
renewal. Failure to achieve annual milestones may be grounds for not
continuing future years of an award.
Item c. Phase II Final Report
Label this section, "Phase II Final Report." Follow the Instructions for the
Phase I Final Report of an NIH SBIR/STTR Phase II Application except replace
all references to "Phase I" with "Phase II."
Clinical Terms of Award
When human clinical studies or trials are a component of the research
proposed, NIAID policy requires that studies be monitored commensurate with
the degree of potential risk to study subjects and the complexity of the
study. Terms and Conditions of Award will be included with awards. AN
UPDATED NIAID policy was published in the NIH Guide on July 8, 2002 and is
available at:
http://grants.nih.gov/grants/guide/notice-files/NOT-AI-02-032.html.
The full policy, including terms and conditions of award, is available at:
http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf.
A mandatory milestone for projects involving humans is the approval of the
final clinical protocol by NIAID prior to the accrual of subjects into the
trial. Applications that contain or comprise a clinical trial should also
include a budget item for preparation of a clinical protocol. Protocol
development must be consistent with Federal and NIAID specific regulations
governing the conduct of human subjects research
(http://www.hhs.gov/ohrp/assurances/assurances_index.html). Potential applicants are
encouraged to contact appropriate NIAID program staff concerning this policy.
Commercialization Plan
All Phase II SBIR/STTR grant applications, including Phase II competing
continuation applications, require a Commercialization Plan, described in
item J of the Instructions for Preparation of Phase II Applications. These
Instructions describe the contents to be included in the following sections:
1. Value of the SBIR/STTR Project, Expected Outcomes, and Impact.
2. Company.
3. Market, Customer, and Competition.
4. Intellectual Property (IP) Protection.
5. Finance Plan.
6. Production and Marketing Plan.
7. Revenue Stream.
If relevant, applicants may replace sections 5 with licensing, mergers or
acquisition plans, section 6 with the milestones necessary for one of the
section 5 events, and section 7 with a description of commitments, if any,
from potential partners or buyers. Although applicants may consider this new
section 7 too confidential to include, when provided it may enhance the
enthusiasm of reviewers.
WHERE TO SEND INQUIRIES
We encourage your inquiries concerning this RFA and welcome the opportunity
to answer questions from potential applicants. Inquiries may fall into three
areas: general SBIR issues, specific scientific research and development
issues, review issues, and financial or grants management issues.
Frequently asked "Questions and Answers" about this RFA may be found at
http://www.niaid.nih.gov/ncn/sbir/parfaq.htm.
General SBIR Issues
Potential applicants are strongly encouraged to contact Dr. Gregory Milman
before proceeding with an NIAID competing continuation SBIR/STTR Phase II
application.
Gregory Milman, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2153, MSC-7610
6700-B Rockledge Drive
Bethesda, MD 20892-7610 (US Mail)
Rockville, MD 20817-7610 (Delivery Services)
Telephone (301) 496-8666
Fax: (301) 402-0369
Email: gm16s@nih.gov
Specific Scientific Research and Development Issues
Applicants are directed to a list of research areas and program staff for
each area at http://www.niaid.nih.gov/ncn/staff/default.htm
Review Issues
Madelon Halula, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3116, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616 (US Mail)
Rockville, MD 20817-7616 (Delivery Services)
Telephone (301) 402-2636
Fax: (301) 402-2638
Email: mh30x@nih.gov
Financial or Grants Management Issues
Ms. Pamela Fleming
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2119, MSC 7614
6700-B Rockledge Drive
Bethesda, MD 20892-7614
Bethesda, (MD 20817-7614 for express/courier service)
Telephone: (301) 402-6580
FAX: (301) 480-3780
Email: pf49e@nih.gov
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that includes
the following information:
o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel
o Participating institution(s)
o Number and title of this RFA
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 NIAID staff to estimate the potential review workload and
plan the review.
The letter of intent is to be sent by the date listed at the beginning of
this document. The letter of intent should be sent to:
Madelon Halula, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3116, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616 (US Mail)
Rockville, MD 20817-7616 (Delivery Services)
Telephone (301) 402-2636
Fax: (301) 402-2638
Email: mh30x@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.) Effective October
1, 2003, applications must have a DUN and Bradstreet (D&B) Data Universal
Numbering System (DUNS) number as the Universal Identifier when applying for
Federal grants or cooperative agreements. The DUNS number can be obtained by
calling (866) 705-5711 or through the web site at
http://www.dunandbradstreet.com/. The DUNS number should be entered on line
11 of the face page of the PHS 398 form. 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 for advice and 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 on the 5/2001 version of
the PHS 398. For further assistance contact GrantsInfo, Telephone: (301)
710-0267, Email: GrantsInfo@nih.gov.
USING THE RFA LABEL: The RFA label available in the PHS 398 application form
must be affixed to the bottom of the face page of the application. Type the
RFA number on the label. Failure to use this label could result in delayed
processing of the application such that it may not reach the review committee
in time for review. In addition, the RFA title and number must be typed on
line 2 of the face page of the application form and the YES box must be
marked. The RFA label is also available at:
http://grants.nih.gov/grants/funding/phs398/labels.doc or
http://grants.nih.gov/grants/funding/phs398/labels.pdf.
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of
the application, including the checklist, and three 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 (for USPS EXPRESS or REGULAR MAIL)
Bethesda, MD 20817 (for EXPRESS/COURIER NON-USPS SERVICE)
At the time of submission, two additional copies of the application must be
sent to:
Madelon Halula, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3116, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616 (US Mail)
Rockville, MD 20817-7616 (Delivery Services)
Telephone (301) 402-2636
Fax: (301) 402-2638
Email: mh30x@nih.gov
RECEIPT OF APPLICATIONS. Applications must be received on or before the
receipt date listed on the first page of this announcement. If an application
is received after that date, it will be returned to the applicant without
review.
APPLICATIONS HAND-DELIVERED BY INDIVIDUALS TO NIAID WILL NOT BE ACCEPTED.
This policy does not apply to courier deliveries (i.e. FEDEX, UPS, DHL,
etc.) (http://grants.nih.gov/grants/guide/notice-files/NOT-CA-02-002.html.)
This policy is similar to and consistent with the policy for applications
addressed to Centers for Scientific Review as published in the NIH Guide
Notice http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html.
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.
The Center for Scientific Research (CSR) will not accept any application in
response to this RFA 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. However, when a previously unfunded application, originally
submitted as an investigator-initiated application, is to be submitted in
response to an RFA, it is to be prepared as a NEW application. That is, the
application for the RFA must not include an Introduction describing the
changes and improvements made, and the text must not be marked to indicate
the changes from the previous unfunded version of the application.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the CSR and
responsiveness by the NIAID. Incomplete and/or nonresponsive applications
will not be reviewed. Applications that are complete and responsive to the
RFA will be evaluated for scientific and technical merit by an appropriate
peer review group convened by the NIAID in accordance with the review
criteria stated below. As part of the initial merit review, all applications
will:
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 written critique
o Receive a second level review by the National Advisory Allergy and
Infectious Diseases Council.
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 evaluate the application in
order to judge the likelihood that the proposed research will have a
substantial impact on the pursuit of these goals within the context of the
SBIR/STTR Program. The scientific review group will address and consider
each of the following criteria in assigning the application’s overall score:
o Significance
o Approach
o Innovation
o Investigator
o Environment
1. Significance: Does this study address an important public health
problem? Is the proposed project in one of the NIAID Small Business Highest
Priority Areas? Does the proposed project have commercial potential to lead
to a marketable product or process that requires FDA approval? 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., vaccine
platforms) for further discoveries? Will the technology have a competitive
advantage over existing/alternate technologies or products.
2. Approach: Does the proposed project describe a critical path for FDA
approval and licensing with milestones and a timeline for those milestones to
be achieved during each year of the proposed project period; milestones that
will remain after the proposed funding period to complete the product R&D?
Are there additional milestones that the review committee suggests be
included? The review committee may suggest which, if any, of the milestones
and timelines should be included in the Terms of Award. 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?
3. Innovation: Does the project challenge existing paradigms or employ
novel technologies, approaches or methodologies? Are the aims and/or products
original and innovative?
4. Investigators: Is the Principal Investigator capable of coordinating and
managing the proposed R&D? Are the work and management activities proposed
appropriate to the experience level of the Principal Investigator and other
researchers, including consultants and subcontractors (if any)? Are the roles
and relationships of the Principal Investigator, key personnel, consultants,
and contractors appropriate for the work proposed?
5. Environment: Do the proposed contracts, if any, have the capability of
producing the expected product or service in the time frame proposed? 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? To what extent was the applicant able to obtain
letters of interest, additional funding commitments, and/or resources from
the private sector or non-SBIR/ STTR funding sources (cost-sharing) that
would enhance the likelihood for commercialization?
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following
items will be considered in the determination of scientific merit and the
priority score:
COMMERCIALIZATION PLAN: The Commercialization Plan (formerly the Product
Development Plan) should be used to evaluate the probability that the product
will eventually receive FDA approval and become available. If licensing,
mergers or acquisition plans are anticipated in order to produce the product,
are the milestones for these events described and reasonable?
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).
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).
Human Subjects:
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?
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?
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?
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?
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 entity and mechanisms for reporting Adverse
Events to the NIH and the IRB?
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. 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 REVIEW CONSIDERATIONS: The following items may be also be
considered by reviewers but will not be included in the determination of
scientific merit.
SHARING RESEARCH DATA: Applicants requesting more than $500,000 in direct
costs in any year of the proposed research must include a data sharing plan
in their application. The reasonableness of the data sharing plan or the
rationale for not sharing research data will be assessed by the reviewers.
However, reviewers will not factor the proposed data sharing plan into the
determination of scientific merit or priority score.
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.
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: December 14, 2003
Application Receipt Date: January 16, 2004
Peer Review Date: June/July 2004
Council Review: September 2004
Earliest Anticipated Start Date: September/October 2004
AWARD CRITERIA
Applications submitted in response to a RFA will compete for available funds
with all other recommended SBIR and STTR applications but NIAID paylines for
other SBIR or STTR applications do not apply to applications in response to
this RFA. 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 for applications in response to this RFA
o Relevance to NIAID priorities
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
DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for
all types of clinical trials, including physiologic, toxicity, and dose-
finding studies (phase I); efficacy studies (phase II); efficacy,
effectiveness and comparative trials (phase III). The establishment of data
and safety monitoring boards (DSMBs) is required for multi-site clinical
trials involving interventions that entail potential risk to the
participants. (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).
SHARING RESEARCH DATA: Starting with the October 1, 2003 receipt date,
investigators submitting an NIH application seeking $500,000 or more in
direct costs in any single year are expected to include a plan for data
sharing or state why this is not possible.
http://grants.nih.gov/grants/policy/data_sharing. Investigators should seek
guidance from their institutions, on issues related to institutional
policies, local IRB rules, as well as local, state and Federal laws and
regulations, including the Privacy Rule. Reviewers will consider the data
sharing plan but will not factor the plan into the determination of the
scientific merit or the priority score.
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://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, in the project
description and elsewhere in the application as appropriate, 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 RFA 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
RFA 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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