BIODEFENSE AND EMERGING INFECTIOUS DISEASE RESEARCH OPPORTUNITIES
RELEASE DATE: June 23, 2004
PA NUMBER: PA-04-119
September 17, 2007 - Expiration Date adjusted to accommodate
recent changes to standing submission deadlines, per NOT-OD-07-093.
January 3, 2007 - Effective with the February 5, 2007 submission date,
all R01 applications must be submitted through Grants.gov using
the electronic SF424 (R&R) application. Accordingly, the R01 portion
of this funding opportunity expires on January 3, 2007. Unsolicited
or investigator-initiated R01 electronic SF424 (R&R) applications may
be submitted through the Research Project Grant (Parent R01) announcement.
March 7, 2006 (NOT-AI-06-023) - This announcement is amended to remove
the R21 Grant from the types of grants supported under PA-04-119.
November 22, 2006 (NOT-AI-07-011) - See Notice NOT-AI-07-011 for notice of R01
application only through PA-07-070.
R01 applications may no longer be submitted in response to PA-04-119
EXPIRATION DATE for R21 Applications: March 2, 2006
EXPIRATION DATE for R01 Non-AIDS Applications: November 2, 2006
EXPIRATION DATE for R01 AIDS and AIDS-Related Applications: January 3, 2007
EXPIRATION DATE for P01 Applications: November 2, 2007 (now January 8, 2008
per NOT-OD-07-093)
Department of Health and Human Services (DHHS)
PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH)
(http://www.nih.gov)
COMPONENT OF PARTICIPATING ORGANIZATION:
National Institute of Allergy and Infectious Diseases (NIAID)
(http://www.niaid.nih.gov)
CATALOGUE OF FEDERAL DOMESTIC ASSISTANCE NUMBERS:
No. 93.855, Immunology, Allergy, and Transplantation Research
No. 93.856, Microbiology and Infectious Diseases Research
APPLICATION RECEIPT DATE(S): Applications submitted in response to this
program announcement will be accepted on the standard application deadlines
for new, competing continuation, and revised research applications (see
http://grants.nih.gov/grants/funding/submissionschedule.htm).
THIS PA CONTAINS THE FOLLOWING INFORMATION
o Purpose of the PA
o Research Objectives
o Mechanisms of Support
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o 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
PURPOSE OF THIS PA
This program announcement (PA) replaces program announcement PA-03-080
BIODEFENSE AND EMERGING INFECTIOUS DISEASES RESEARCH OPPORTUNITIES, published
in the NIH Guide on March 19, 2003 [see
http://grants.nih.gov/grants/guide/pa-files/PA-03-080.html].
This PA is intended to encourage the submission of investigator-initiated
research grant applications in biodefense. The goal is to expedite research
leading to the diagnosis, prevention and treatment of diseases caused by
potential bioterrorism agents.
RESEARCH OBJECTIVES
In response to growing concerns about the use of biological agents in acts of
terrorism, NIAID has expanded its biodefense research program. The ultimate
goal of this expansion is to develop effective diagnostics, vaccines and
therapeutics to protect the public health.
NIAID has a list of high priority agents to help focus accelerated research
efforts. The NIAID Category A, B and C Priority Pathogens are listed at
http://www.niaid.nih.gov/biodefense/bandc_priority.htm. This PA addresses the
need for more basic and applied research on those pathogens, their toxic
products, and the body's immune defenses against them.
Details of the scientific priorities addressed through this PA are available
at: http://www.niaid.nih.gov/biodefense/rfalplat.htm. A list of contacts for
individual subject areas is also provided. Research priorities and contact
persons may change periodically as NIAID goals evolve; investigators are
therefore strongly encouraged to review that information prior to submission.
Research areas appropriate for this PA include, but are not limited to:
o Pathogen biology
o Bacterial toxins
o Immune response
o Microbial immune evasion and enhancement
o Animal models of infection and immunity
o Natural history of infection
o Target discovery for vaccines, therapeutics, adjuvants, and diagnostics
o Biology of arthropod vectors
Applications must specifically address NIAID Category A, B or C priority
pathogens, the diseases caused by them, and/or relevant host immune
responses. Proposals focusing on other microbes will be considered only when
those organisms are established models of infection by Category A, B or C
priority pathogens.
Applications proposing research on environmental/workplace detection and
decontamination are not responsive to this PA.
In some cases, immunological mechanisms relevant to biodefense are broadly
applicable for many pathogens and may be most efficiently studied using model
systems. Immunological research that is not directed at NIAID Category A, B
and C priority pathogens or their products is responsive to this announcement
if it specifically addresses a practical approach to inducing, controlling or
improving the effectiveness of innate or adaptive immune responses to
infection by those pathogens or vaccines to prevent them. Applications may
also address basic immunological mechanisms when understanding those
mechanisms is necessary for the development of protective approaches for
biodefense. Applicants must explain how the proposed research is applicable
to immune responses against the listed agents.
MECHANISMS OF SUPPORT
This PA will use NIH individual research project grant (R01), the program
project grant (P01), and the Exploratory/Developmental Research Project Grant
(R21). The total requested project period for an application submitted in
response to this PA may not exceed five years for an R01 or a P01, and two
years for an R21. The applicant will be solely responsible for planning,
directing, and executing the proposed project.
NIAID uses the R21 grant mechanism to provide short-duration support for
preliminary studies of a highly speculative nature, which are expected to
yield sufficient information upon which to base a well-planned and rigorous
series of further investigations. Applicants for R21 awards may request up to
$275,000 in direct costs over a two-year period, with no single year
exceeding $200,000 in direct costs. Competing continuation applications for
R21 grants are not accepted. Clinical trials will not be supported under R21s
submitted in response to this PA.
Program project grants (P01) support broadly based, multidisciplinary
research programs that have a well-defined, central research focus or
objective. An important feature is that the interrelationships of the
individual scientifically meritorious projects must result in a greater
contribution to the overall program goals than if each project were pursued
individually. The program project grant consists of a minimum of two
interrelated individual research projects that contribute to the program
objective. Support for certain common resources termed cores is allowed
under this mechanism. Such resources must be utilized by two or more projects
within the program project. The total project period for P01 grants may not
exceed five years.
Applicants for P01 grants must follow special application guidelines is
provided in the NIAID Brochure entitled INSTRUCTIONS FOR APPLICATIONS FOR
MULTI-PROJECT AWARDS; this brochure is available via the WWW at:
http://www.niaid.nih.gov/ncn/grants/multibron.htm.
Recognizing that work with NIAID category A, B, and C priority pathogens may
require specialized equipment, NIAID considers it reasonable for applicants
for R01 grants to request as much as $200,000 and applicants for P01 grants
to request as much as $300,000 for equipment in their applications.
This PA uses just-in-time concepts. It also uses the modular as well as the
non-modular budgeting formats (see
http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if
you are submitting an application with direct costs in each year of $250,000
or less, use the modular format. Otherwise follow the instructions for non-
modular research grant applications. 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.
ELIGIBLE INSTITUTIONS
You may submit (an) application(s) if your institution has any of the
following characteristics:
o For-profit or non-profit organizations
o Public or private institutions, such as universities, colleges, hospitals,
and laboratories
o Units of State and local governments
o Eligible agencies of the Federal government
o Domestic or foreign institutions/organizations
o Faith-based or community-based organizations
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.
SPECIAL REQUIREMENTS
CLINICAL STUDIES AND TRIALS: When 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. 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.
SELECT AGENTS: All applicant organizations, domestic and foreign, must comply
with Select Agent regulations (http://www.cdc.gov/od/sap/) and NIH Guidelines
for Research Involving Recombinant DNA Molecules
(http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html). Applicants must
document their ability and willingness to comply.
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 three
areas: scientific/research, peer review, and financial or grants management
issues:
o Direct your general questions about scientific/research issues to:
Samuel S. Perdue, Ph.D.
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases
Room 4115, MSC-6603
6610 Rockledge Drive
Bethesda, MD 20892-6603
Telephone: (301) 402-5083
FAX: (301) 402-2508
Email: sp189u@nih.gov
o Direct your questions about issues related to P01 peer review to:
Edward W. Schroder, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
6700-B Rockledge Drive MSC 7616
Bethesda, MD 20892-7616
Zip code for express couriers: 20817
Phone: 301-435-8537
FAX: 301-402-2638
e-mail: es170m@nih.gov
o Direct your questions about financial or grants management matters to:
Lesia Norwood
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2117, MSC-7614
6700-B Rockledge Drive
Bethesda, MD 20892-7614
Telephone: (301) 402-7146
FAX: 480-3780
Email: ln5t@nih.gov
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant application
instructions and forms (rev. 5/2001). 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
in an interactive format. For further assistance contact GrantsInfo,
Telephone (301) 710-0267, Email: GrantsInfo@nih.gov
The title and number of this program announcement must be typed on line 2 of
the face page of the application form and the YES box must be checked.
SUPPLEMENTARY INSTRUCTIONS
R21, R01 AND P01 APPLICATIONS: R01 applications should follow the standard
instructions in the PHS 398. See the following paragraphs for information
specific to the preparation and submission of P01 and R21 applications.
SUPPLEMENTAL INSTRUCTIONS FOR R21 APPLICATIONS: For submission of an R21
application, applicants must follow the NIH guidelines which are found at
http://grants.nih.gov/grants/funding/r21.htm].
SUPPLEMENTAL INSTRUCTIONS FOR PROGRAM PROJECT (P01) APPLICATIONS: Applicants
for P01 grants must follow special guidelines found in the NIAID Brochure
entitled INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS; this
brochure is available at: http://www.niaid.nih.gov/ncn/grants/multibron.htm.
SENDING AN APPLICATION TO THE NIH
P01 APPLICATION: Submit a signed, typewritten original of the P01
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
Bethesda, MD 20817 (for express/courier service)
At the same time, submit two additional exact copies of the P01 grant
application and all five sets of any appendix material to:
Edward W. Schroder, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
6700-B Rockledge Drive MSC 7616
Bethesda, MD 20892-7616
Zip code for express couriers: 20817
Phone: 301-435-8537
FAX: 301-402-2638
e-mail: es170m@nih.gov
R01 OR R21 APPLICATION: Submit a signed, typewritten original of the R01 or
R21 application, including the checklist, and five signed photocopies and all
appendices 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)
The NIH 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 NIH 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.
CONCURRENT SUBMISSION OF AN R01 AND A COMPONENT PROJECT OF A MULTI-PROJECT
GRANT APPLICATION: Current NIH policy permits a component research project
of a multi-project grant application to be concurrently submitted as a
traditional individual research project (R01) application. If, following
review, both the multi-project application and the R01 application are found
to be in the fundable range, the investigator must relinquish the R01 and
will not have the option to withdraw from the multi-project grant. This is an
NIH policy intended to preserve the scientific integrity of a multi-project
grant, which may be seriously compromised if a strong component project(s) is
removed from the program. Investigators wishing to participate in a multi-
project grant must be aware of this policy before making a commitment to the
Principal Investigator and awarding institution.
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.
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.
SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting
up to $250,000 per year in direct costs must be submitted in a modular grant
format. The modular grant format simplifies the preparation of the budget in
these applications by limiting the level of budgetary detail. Applicants
request direct costs in $25,000 modules. Section C of the research grant
application instructions for the PHS 398 (rev. 5/2001) at
http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step
guidance for preparing modular grants. Additional information on modular
grants is available at
http://grants.nih.gov/grants/funding/modular/modular.htm.
SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR:
Applications requesting $500,000 or more in direct costs for any year must
include a cover letter identifying the NIAID staff member who has agreed to
accept assignment of the application.
Applicants requesting more than $500,000 must carry out the following steps:
1) Contact the IC program staff at least 6 weeks before submitting the
application, i.e., as you are developing plans for the study. The
application need not be completed prior to contacting program staff.
2) Obtain agreement from the IC staff that the IC will accept your
application for review; and,
3) Identify, in a cover letter sent with the application, the IC staff member
who agreed to accept assignment of the application.
This policy applies to all investigator-initiated new (type 1), competing
continuation (type 2), competing supplement (type 3), or any amended or
revised version of these grant application types. Additional information on
this policy is available in the NIH Guide for Grants and Contracts, October
19, 2001 at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html.
PEER REVIEW PROCESS
Applications submitted for this PA will be assigned on the basis of
established PHS referral guidelines. Upon receipt, applications will be
reviewed for completeness by the CSR. Incomplete applications will not be
reviewed.
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 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 national advisory council
or board
REVIEW CRITERIA
Review Criteria for P01 Applications:
The general review criteria for P01 grant applications are presented in the
NIAID brochure entitled "INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT
AWARDS" at http://www.niaid.nih.gov/ncn/grants/multibron.htm.
Review Criteria for R01 and R21 Applications:
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. The scientific review
group will address and consider each of the following criteria in assigning
the application’s overall score, weighting them as appropriate for each
application.
o Significance
o Approach
o Innovation
o Investigator
o Environment
The application does not need to be strong in all categories to be judged
likely to have major scientific impact and thus deserve a high priority
score. For example, an investigator may propose to carry out important work
that by its nature is not innovative but is essential to move a field
forward.
SIGNIFICANCE: Does this study address an important problem? If the aims of
the application are achieved, how will scientific knowledge be advanced?
What will be the effect of these studies on the concepts or methods that
drive this field?
APPROACH: Are the conceptual framework, design, methods, and analyses
adequately developed, well- integrated, and appropriate to the aims of the
project? Does the applicant acknowledge potential problem areas and consider
alternative tactics?
INNOVATION: Does the project employ novel concepts, approaches or methods?
Are the aims original and innovative? Does the project challenge existing
paradigms or develop new methodologies or technologies?
INVESTIGATOR: Is the investigator appropriately trained and well-suited to
carry out this work? Is the work proposed appropriate to the experience
level of the principal investigator and other researchers (if any)?
ENVIRONMENT: Does the scientific 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? Is there evidence of institutional support?
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:
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 criteria included in the
section on Federal Citations, below).
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of
plans to include subjects from both genders, all racial and ethnic groups
(and subgroups), and children as appropriate for the scientific goals of the
research will be assessed. Plans for the recruitment and retention of
subjects will also be evaluated. (See Inclusion Criteria in the sections on
Federal Citations, below).
CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to
be used in the project, the five items described under Section f of the PHS
398 research grant application instructions (rev. 5/2001) will be assessed.
ADDITIONAL REVIEW CONSIDERATIONS
SHARING RESEARCH DATA: Applicants requesting more than $500,000 in direct
costs in any year of the proposed research are expected to 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. (See
instructions and URL to policy in the Federal Citations, below.)
BUDGET: The reasonableness of the proposed budget and the requested period
of support in relation to the proposed research.
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
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 Safety and Monitoring, NIH Guide for
Grants and Contracts, June 12, 1998:
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
SHARING RESEARCH DATA: 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 AMENDMENT "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.
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. This policy announcement is 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).
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 Catalogue of Federal Domestic Assistance at
http://www.cfda.gov/ in the following citations: No. 93.855, Immunology,
Allergy, and Transplantation Research and No. 93.856, Microbiology and
Infectious Diseases Research. Awards are made under authorization of
Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241
and 284) and administered under NIH grants policies and Federal Regulations
42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health
Systems Agency review.
The NIH Grants Policy Statement is available at
http://grants.nih.gov/grants/policy/policy.htm. This document includes
general information about the grant application and review process;
information on the terms and conditions that apply to NIH Grants and
cooperative agreements; and a listing of pertinent offices and officials at
the NIH. All awards are subject to the terms and conditions, cost
principles, and other considerations described in the NIH Grants Policy
Statement.
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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