and Human Services (HHS)
EXPIRED
COMPETING CONTINUATION AWARDS OF SBIR PHASE II GRANTS FOR HEART, LUNG, BLOOD,
AND SLEEP DISORDERS
RELEASE DATE: December 01, 2003
PA NUMBER: PA-04-028 (This PA has been expired, see NOT-HL-06-117)
(Clarification of submission requirements, see NOT-HL-05-124)
EXPIRATION DATE: February 1, 2006
IMPORTANT CHANGE: The opportunity to apply for an NHLBI 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.
Department of Health and Human Services (DHHS)
PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH)
(http://www.nih.gov)
COMPONENT OF PARTICIPATING ORGANIZATION:
National Heart, Lung and Blood Institute (NHLBI)
(http://www.nhlbi.nih.gov)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.837, 93.838, 93.839
APPLICATION RECEIPT DATE(S): Applications submitted in response to this
program announcement will be accepted at the standard application deadlines
[April 1, August 1, December 1]
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 Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations
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 program, regulations governing the program, and information for
submission. All of the instructions within the current SBIR Omnibus
Solicitation apply.
PURPOSE OF THE PA
The purpose of this Program Announcement (PA) is to solicit from NHLBI-
supported SBIR Phase II awardees, competing continuation applications that
propose to continue the process of assessing and improving devices or
conducting preclinical studies of products or devices that ultimately require:
1) clinical evaluation, 2) approval by a Federal regulatory agency, and 3)
continuing refinements to durable medical equipment (DME) designs such as cost
reduction, testing for safety, durability, and reliability, and meeting or
establishing standards. Such products include, but are not limited to
biological products, devices, drugs, vaccines, medical implants, etc. related
to the mission of the NHLBI. Only SBIR Phase II awardees are eligible to
submit a competing continuation application. The previously funded Phase II
SBIR 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. Since the Phase II competing continuation grant is a new funding
mechanism and is contingent on the fiscal and programmatic interests and
priorities of the NHLBI, eligible applicants are strongly encouraged to
contact their NHLBI Program official prior to submission.
RESEARCH OBJECTIVES
Background
The Small Business Innovation Research (SBIR) program was 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 Phase III
of the small business research pathway can be realized. A recipient of NIH
SBIR Phase I and Phase II awards normally receives a total of no more than
$850 thousand. If the intended commercialized product is a medical device,
drug or biologic, the $850 thousand 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. The
Phase II competing continuation support will allow small businesses to
address clinical issues, and other important issues relevant to regulatory
approvals by agencies such as the FDA.
The SBIR Phase II competing continuation would represent a continuation of
support for research and development of such previous work funded by the
original Phase II grant. It is expected that promising results from a
previous SBIR Phase I and Phase II grant will indicate the merit of further
research and development. 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
grant are meant to enable small businesses to complete the necessary
preclinical R&D needed for pre-investigational new drug (IND), or
investigational device exemption (IDE) filing, or other processes needed to
meet the requirements and expectations of Federal regulatory agencies prior
to clinical evaluation for safety, toxicity and effectiveness. A competing
continuation Phase II award may not be used to conduct early stage research
(e.g., identifying targets for drugs, identification of new and more
effective compounds or potential diagnostic markers, initial device/software
development, optimizing device functionality or initial assay testing, etc.).
Examples of Research Topics
Examples of research that would be considered responsive to this announcement
are listed below 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.
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 Assessment of devices with regard to performance standards related to the
FDA approval process.
o Safety and effectiveness studies of novel medical devices and tissue
engineered products.
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
This PA uses the SBIR Phase II (R44) mechanism. As an applicant, you will be
solely responsible for planning, directing, and executing the proposed
project.
An NHLBI SBIR Phase II competing continuation application must be in response
to this PA, and the application will be accepted only as a competing
continuation of a previously funded NHLBI Phase II SBIR (R44) grant. The
previously funded NHLBI 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 this
announcement.
This PA uses just-in-time concepts. This program does not require cost
sharing as defined in the current NIH Grants Policy Statement at
http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm.
PROJECT PERIOD AND AMOUNT OF AWARD
For this PA, budgets up to $1,000,000 total costs per year and time periods
up to 3 years may be requested for Phase II. Total costs include direct
costs, F&A, and fee/profit in accordance with the current SBIR guidelines.
(see http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf) The competing
continuation grant cannot be renewed.
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
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 NHLBI Phase II (R44) grant
focusing on research and development 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 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.
SPECIAL REQUIREMENTS
An applicant must provide evidence that they have contacted the Food and Drug
Administration (FDA) for guidance concerning the development of a drug,
biologic, or medical device. Such evidence should include FDA correspondence
regarding an investigational new drug (IND) application, investigational
device exemption (IDE), or pre-market notification (510k) for the applicant’s
product development and the status of their project in a timeline related to
Federal regulatory approval processes.
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:
Heart
Suzanne Goldberg, R.N., M.S.N.
Division of Heart and Vascular Diseases
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 9174 (MSC 7940)
Bethesda, MD 20892-7940 (20817 for Courier)
Telephone: (301)435-0532
Fax: (301)480-1336
Email: goldbergsh@mail.nih.gov
Rosalie A. Dunn, Ph. D.
Division of Heart and Vascular Diseases
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 9196 (MSC 7940)
Bethesda, MD 20892-7940 (20817 for Courier)
Telephone: (301) 435-0505
Fax: (301) 480-1454
Email: dunn@nhlbi.nih.gov
Lung/Sleep
Mrs. Ann Rothgeb
Division of Lung Diseases
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 10114 (MSC 7952)
Bethesda, MD 20892-7952 (20817 for Courier)
Telephone: (301) 435-0202
FAX: (301) 480-3557
Email: ar31t@nih.gov
Blood
Phyllis Mitchell, M.S.
Division of Blood Diseases and Resources
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 10163(MSC 7950)
Bethesda, MD 20892-7950 (20817 for Courier)
Telephone: (301) 435-0481
Fax: (301) 480-1060
Email: mitchelp@nhlbi.nih.gov
Liana Harvath,Ph.D.
Division of Blood Diseases and Resources
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 10170 (MSC 7950)
Bethesda, MD 20892-7950 (20817 for Courier)
Telephone: (301) 435-0063
FAX: (301) 480-0868
Email: HarvathL@nhlbi.nih.gov
Epidemiology and Clinical Applications
Paula T. Einhorn, M.D., M.S.
Division of Epidemiology and Clinical Applications
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 8001 (MSC 7936)
Bethesda, MD 20892-7936 (20817 for Courier)
Telephone: (301) 435-0563
FAX: (301)480-1669
Email: einhornp@nhlbi.nih.gov
o Direct your questions about financial or grants management matters to:
Shelia Ortiz
Grants Operations Branch
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7171
Bethesda, MD 20892-7926
Telephone: (301) 435-0166
Fax: (301) 480-3310
Email: ortizs@nhlbi.nih.gov
SUBMITTING AN APPLICATION
The PHS 398 research grant application must be used for all SBIR Phase II
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.
The title and number of this PA must be typed on line 2 of the face page of
the application.
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 (for USPS Express or Regular Mail)
Bethesda, MD 20817 (for Express/courier non-USPS service)
Applications must be received by or mailed on or before the receipt dates
described on the first page of this program announcement. 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 unfunded version 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. Appropriate scientific review groups
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 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 written critique
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 APPLICATIONS
1. 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?
2. 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?
3. Innovation: Does the project challenge existing paradigms or employ
novel technologies, approaches or methodologies? Are the aims original and
innovative?
4. Investigators: Is the Principal Investigator capable of coordinating and
managing the proposed SBIR? 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?
5. 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:
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:
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 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.
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.
TYPE 2 PHASE II COMPETING CONTINUATION APPLICATIONS
In addition to the above review criteria, the following items will be applied
to ALL Type 2 Competing Continuation Phase II 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?
AWARD CRITERIA
Applications submitted in response to a PA will compete for available funds
with all other recommended 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
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 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 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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Department of Health and Human Services (HHS) |
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NIH... Turning Discovery Into Health® |
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