CDC PUBLIC HEALTH RESEARCH: HEALTH PROTECTION RESEARCH INITIATIVE
INVESTIGATOR INITIATED RESEARCH (R01)
RELEASE DATE: April 22, 2004
RFA Number: RFA-CD-04-002
EXPIRATION DATE: June 23, 2004
Department of Health and Human Services (DHHS)
PARTICIPATING ORGANIZATION:
Centers for Disease Control and Prevention (CDC)
(http://www.cdc.gov)
COMPONENTS OF PARTICIPATING ORGANIZATION:
Office of the Director (OD), Office of Science Policy and Technology
Transfer, Office of Public Health Research, (OPHR)
(http://www.cdc.gov/od/ads)
Note: The policies, guidelines, terms, and conditions stated in this
announcement may differ from those used by the NIH.
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.062
LETTER OF INTENT RECEIPT DATE: May 24, 2004
APPLICATION RECEIPT DATE: June 22, 2004
THIS RFA CONTAINS THE FOLLOWING INFORMATION
o Purpose of This RFA
o Research Objectives
o Mechanism(s) of Support
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 Supplementary Instructions
o Peer Review Process
o Review Criteria
o Receipt Schedule
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS RFA
The Centers for Disease Control and Prevention (CDC), Office of Public
Health Research (OPHR) announces the availability of fiscal year (FY)
2004 public health research funds to support innovative public health
research that addresses priority health protection issues. Health
protection should be interpreted to include activities that 1) promote
health and/or prevent disease, injury, or disability or 2) protect
people from health threats including infectious, environmental, and
terrorist threats. This RFA focuses specifically on health promotion
in the workplace.
RESEARCH OBJECTIVES
Background
The large discrepancies between what Americans spend on health and the
outcomes they experience may stem from how the nations health
knowledge and resources are deployed within the health system and other
sectors of society. Most resources are deployed when people seek care
for specific diseases and health conditions; health protection, health
promotion, and prevention activities account for less than 3% of the
nation’s investment for health services. A major obstacle to
prioritizing health promotion is the fact that there is insufficient
evidence to support specific programs, practices, and policies that
affect health decisions made by people and those responsible for health
policies and programs in the public health, health care delivery, and
educational systems, as well as their counterparts in businesses and
other private sector enterprises, governments, and governmental
agencies. Development of this evidence is hampered by the lack of
support for public health research investigations that encompass the
relevant disciplines across all academic environments. CDC has
initiated this RFA to support investigator-initiated research as one
key component of its public health research agenda to address this gap
in health promotion.
CDC has aligned its priorities and investments with those of the
Department of Health and Human Services to achieve 2 overarching health
protection goals:
1) Health promotion/Disease, injury and disability prevention: All
people will achieve their optimal lifespan with the best possible
quality of health in every life stage. The strategies to accomplish
this goal include developing the knowledge and tools that integrate
perspectives from multiple scientific disciplines to focus on health
evolving in life stages over a lifetime (infants, children,
adolescents, young adults, middle-age adults, and older adults, and in
all situations (at work, in communities, in school, at home). Integral
to the successful accomplishment of this goal is the elimination of
health disparities that afflict many people in our society.
2) Preparedness: People in all communities will be protected from
infectious, environmental, and terrorist threats. The strategies to
accomplish this goal include developing the knowledge and tools that
integrate perspectives from multiple scientific disciplines to focus on
exposure prevention, rapid detection and diagnosis, investigation,
containment, and recovery from health threats.
CDC’s health protection research initiative is designed to support
achievement of these goals, and will help develop and disseminate the
knowledge and tools that can be used by individuals, public health
professionals, health care providers, educators, policy makers,
businesses, private sector organizations, and others to protect and
measurably improve the health of Americans and reduce health
disparities at all life stages and in all settings.
CDC’s intent is to ensure that a diverse pool of highly trained and
creative scientists are supported and encouraged to accomplish the
nation’s public health research agenda. The objective of this RFA is
to support innovative investigations that address CDC’s health
promotion research priorities. The proposed research should add
substantially to the body of knowledge necessary to have a significant
impact on the health status of Americans in one or more life stages.
Objectives and Focus Areas
Applicants should focus their investigations, which will ultimately
make a substantive contribution to CDC’s overarching goals (above) and
a significant impact on people’s health status. Specifically, the
research outcomes should ultimately translate into extended lifespan or
improved quality of health at any or all of the life-stages as defined
in the background portion of this section, and/or should substantively
contribute to people’s protection from non-occupational infectious,
environmental, or terrorist threats. Public health research should
help close the gap between fundamental scientific knowledge and the
information and motivators needed by individuals, families,
communities, or the sectors that serve them to effectively use new
knowledge and tools for making or supporting health decisions. In
addition, the knowledge gained should be useful to public health
practitioners, policy-makers, or even to the self-help or self-
management of diseases, risk factors, or risk conditions by
individuals, communities, and populations.
This first RFA for the health protection research initiative will give
priority to research that identifies innovative cost-effective health
promotion policies, programs, and activities in the workplace or
affecting the workplace. Although important to worker health, this RFA
is not intended to cover research on occupational safety and health
programs, policies, and activities. If resources allow, future RFAs
will expand the scope of this initiative to address health protection
research relevant to other populations and sectors.
The knowledge base needed for successful implementation of health
promotion programs in the workplace needs to be greatly expanded. This
RFA will support investigations with a high probability of identifying
cost-effective interventions that improve the health of the American
workforce and the determinants of their successful implementation. A
desired outcome would be the identification of critical success factors
that could be used to motivate adaptation and implementation of
evidence-based interventions to promote workers health across the
business sector. These might be best processes to complement best
practices derived from clinical or other efficacy studies. A
successful approach to health promotion in the workplace must be
economically sustainable to achieve widespread impact, and
investigations that address this issue are needed.
There are many strategies that could be used to address this RFA, but
this first RFA will give priority to those applications that emphasize
the design and evaluation of interventions and identification of
determinants affecting the successful implementation of evidence-based
cost-effective health promotion interventions in the workplace or that
have impact on the workplace. Hence, the application should address at
least one of the following issues:
1. Identification of cost-effective interventions that improve the
health of employees as measured by:
a. mortality, morbidity, and disability,
b. quality of life (e.g., satisfaction with daily functioning,
energy level, attentiveness),
c. productivity (e.g., increase in on-the-job-productivity,
decrease of absenteeism),
d. employer and/or employee health-related costs.
2. Identification of the determinants of successful implementation
and dissemination of evidence-based health promotion,
interventions among individual employees, or groups of employees,
or employers.
3. Identification of the determinants of successful translation of
evidence-based health promotion interventions to special employee
populations to reduce health disparities.
4. Evaluation of the impact of employee health policy alternatives
on the health of individuals or groups of employees and their
families.
5. Determinants of the economic drivers of health and health
decisions for employers and employees.
6. Identification and evaluation of public health informatics and
communication strategies and tools to improve health decisions,
health alerting, health literacy, or health assessment among
employees and employers.
7. Identification of strategies to improve the workforce’s
protection from urgent non-occupational infectious,
environmental, or terrorist threats.
Because effective health promotion/prevention interventions often
require a trans-disciplinary and trans-sector approach, projects that
include close and ongoing collaborations with business leaders and
affected employees and their representatives in the design, conduct,
interpretation, communication, dissemination, and implementation of the
research are encouraged. Likewise, linkages with experts from the
public health and healthcare delivery system sectors may be critical to
the success of many projects.
MECHANISM OF SUPPORT
This RFA will use the RO1 award mechanism. The applicant is
responsible for planning, directing, and executing the proposed
project. This RFA is a one-time solicitation. Awards are not
renewable.
This RFA uses the modular budgeting as well as the non-modular
budgeting formats, as described on the website:
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 budget format.
Otherwise, follow the instructions for non-modular budget research
grant applications. This program does not require cost sharing, as
defined in the NIH Grants Policy Statement at
http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part2.htm .
FUNDS AVAILABLE
The CDC intends to commit up to $14,000,000 in FY 2004 funds for 20 to
40 new grants in response to this RFA. The award provides up to three
consecutive 12-month budget periods within a project period of up to 3
years with a budget for direct costs of up to $300,000 per year. Direct
costs include salary support (plus fringe benefits), technical
assistance, equipment, supplies, consulting fees, domestic travel,
publications, and other costs. Because the nature and scope of the
proposed research will vary from application to application, it is
anticipated that the size and duration of each award will also vary.
Although the financial plans of CDC 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.
ELIGIBLE INSTITUTIONS
You may submit an application if your institution is a(n):
o Public or private academic institution
o Eligible agency of the federal government
o Unit of state, county, local, or tribal government
o Healthcare organization
o Research institution
The institution must be located in the United States or its territories
and have, or be affiliated with, a well-established research or public
health program, with qualified faculty in public health, basic, or
other research to serve as mentors. The institution must be able to
demonstrate a commitment to adequately supporting the investigator to
ensure successful accomplishment of the research.
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
The Principal Investigator must have a research or a health-
professional doctorate or its equivalent. Principal investigators must
be established in their field with expertise appropriate to the purpose
of this RFA and have specific authority and responsibility to carry out
the proposed project. Examples of appropriate career appointments
could include faculty positions at academic institutions or similar
research positions at other eligible institutions. Individuals from
underrepresented racial and ethnic groups as well as individuals with
disabilities are always encouraged to apply for CDC programs.
SPECIAL REQUIREMENTS
The following are applicant requirements:
1) Applicant should demonstrate effective and well defined
working relationships within the performing organization and
with outside entities which will ensure implementation of the
proposed activities.
2) Principal Investigators are encouraged to submit only one
proposal in response to this program announcement. With few
exceptions, only one application per Principal Investigator
will be funded under this announcement.
WHERE TO SEND INQUIRIES
CDC encourages inquiries concerning this RFA and welcomes 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 questions about scientific/research issues to:
Tanja Popovic, M.D., Ph.D., F.A.A.M.
Acting Associate Director for Science
Office of Science Policy and Technology Transfer
Centers for Disease Control and Prevention
1600 Clifton Road, N.E., Mail Stop D-50
Atlanta, Georgia, 30333
Telephone: (404) 639-7240
Email: TPopovic@cdc.gov
o Direct your questions about peer review issues to:
Catherine Spruill
Office of Science Policy and Technology Transfer
Centers for Disease Control and Prevention
1600 Clifton Road N.E., Mail Stop D-50
Atlanta, Georgia, 30333
Telephone: (404) 639-7240
Email: CSpruill@cdc.gov
o Direct your questions about financial or grants management matters
to:
Sylvia Dawson
Procurements and Grants Office
Centers for Disease Control and Prevention
Koger Office Park, Colgate Building, Mail-Stop E-14
2920 Brandywine Road,
Atlanta, Georgia, 30341-5539
Telephone: (770) 488-2771
Email: SDawson@cdc.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, telephone number, and e-mail address of the
Principal Investigator
o Names of other key personnel
o Participating institutions
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 OPHR 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:
Heidi Steele
Office of Public Health Research
Office of Science Policy and Technology Transfer
Centers for Disease Control and Prevention
1600 Clifton Road N.E., Mail Stop D-50
Atlanta, Georgia, 30333
Telephone: (770) 488-8612
Email: HSteele@cdc.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 document 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.
Instructions provided with this RFA supercede instructions provided in
PHS 398.
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.
USING THE RFA LABEL: The RFA label available in the PHS 398 (rev.
5/2001) 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.pdf.
SENDING AN APPLICATION
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
Bethesda, MD 20892-7710
Bethesda, MD 20817 (for express/courier services)
At the time of submission, two additional copies of the application and
the appendix material must be sent to:
Heidi Steele
Office of Public Health Research
Office of Science Policy and Technology Transfer
Centers for Disease Control and Prevention
1600 Clifton Road N.E., Mail Stop D-50
Atlanta, Georgia, 30333
Telephone: (770) 488-8612
Email: HSteele@cdc.gov
APPLICATION PROCESSING: Applications must be received on or before the
application receipt date listed in the heading of this RFA. If an
application is received after that date, it will be returned to the
applicant without review.
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.
Upon receipt, applications will be reviewed for completeness by Center
for Scientific Review, NIH, and for responsiveness by the Office of
Public Health Research, CDC. Incomplete applications and applications
that are not responsive to the eligibility criteria will not be
reviewed. Applicants will be notified that their applications did not
meet submission requirements.
PEER REVIEW PROCESS
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 CDC in accordance with the review criteria
stated below. CDC uses a peer review process modeled after that of the
NIH, including a streamlined review process, essentially as spelled out
in the website located at: http://www.csr.nih.gov/REVIEW/streamln.htm
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
Applications in the upper half will receive a secondary review by the
secondary review committee.
REVIEW CRITERIA
The goal of this award is to fund research that identifies innovative
cost-effective health promotion policies, programs, and activities in
the workplace or affecting the workplace. Although important to worker
health, this RFA is not intended to cover research on occupational
safety and health programs, policies, and activities. If resources
allow, future RFAs will expand the scope of this initiative to address
health protection research relevant to other populations and sectors.
FIRST LEVEL OF REVIEW: 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 health promotion
issue? 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? What is the
potential impact on the individuals, health care providers, educators,
policy makers, businesses, private sector organizations, and others
engaged in protecting health and promoting healthy environments? Does
this study address any other CDC priorities such as reducing racial and
ethnic health disparities?
APPROACH: Are the conceptual framework, design, methods, and analyses
adequately developed, well integrated, and appropriate to the aims of
the project? Are the measures of effectiveness well defined,
objective, quantitative and relevant to the intended outcome? Are the
measures of effectiveness related to the performance goals stated in
the Purpose section of this announcement? Does the applicant
acknowledge potential problem areas and consider alternative tactics?
Do the proposed methods include the participation and involvement of
the affected population? Does the proposed project include a trans-
disciplinary and trans-sector approach?
INNOVATION: Innovation as applied to health promotion includes entirely
new ideas for intervention activities, new approaches to replication or
applicability research (e.g., adapting previously used intervention or
policy ideas to include new areas of consideration, such as the impact
of obesity on absenteeism), new approaches to achieve dissemination or
implementation of programs or policies previously shown to be
effective, and new approaches to identify factors that contribute to
the success or failure of implementation or to sustaining
interventions. 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)? Has the investigator demonstrated experience in an area
relevant to health protection research? Has the investigator
experience with teams that include various scientific disciplines and
skill in contributing to the confluence of their research findings?
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, at
least one of the following strategies must be employed. The extent to
which one or more of the strategies are employed in the proposed
research will be considered in the determination of scientific merit
and priority score:
1. Cost-effective interventions that improve the health of employees
as measured by:
a. mortality, morbidity, and disability,
b. quality of life (e.g., satisfaction with daily
functioning, energy level, attentiveness)
c. productivity (e.g., increase in on-the-job-productivity,
decrease of absenteeism),
d. employer and/or employee health-related costs.
2. Identification of the determinants of successful implementation
and dissemination of evidence-based interventions among
individual employees, or groups of employees, or employers.
3. Identification of the determinants of successful translation of
evidence-based interventions to special employee populations to
reduce health disparities.
4. Evaluation of the impact of employee health policy alternatives
on the health of individuals or groups of employees and their
families.
5. Determinants of the economic drivers of health and health
decisions for employers and employees.
6. Identification and evaluation of public health informatics and
communication strategies and tools to improve health decisions,
health alerting, health literacy, or health assessment among
employees and employers.
7. Identification of strategies to improve the workforce’s
protection from urgent infectious, environmental, or terrorist
threats.
SECONDARY REVIEW LEVEL: Applications will receive a programmatic review
that will consider the following 1) the potential impact of the
research outcome on workplace or workforce conditions 2) severity of
the problem, and 3) likelihood of rapid application of research results
to known issues in health protection strategies.
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. This will not
be scored; however, an application can be disapproved if the research
risks are sufficiently serious and protection against risks is so
inadequate as to make the entire application unacceptable. (See
criteria included in the section on Federal Citations, below).
INCLUSION OF WOMEN, MINORITIES IN RESEARCH: The adequacy of plans to
address the CDC policy requirements regarding the inclusion of women,
racial and ethnic groups (and subgroups), as appropriate for the
scientific goals of the research. Review criteria include: (1) The
proposed plan for the inclusion of both sexes and racial and ethnic
minority populations for appropriate representation; (2) The proposed
justification when representation is limited or absent; (3) A statement
as to whether the design of the study is adequate to measure
differences when warranted; and (4) A statement as to whether the plans
for recruitment and outreach for study participants include the process
of establishing partnerships with community(ies) and recognition of
mutual benefits. 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: CDC expects researchers who are supported by CDC
funding to make their data available for analysis by other public
health researchers and include a data sharing plan in their
application. CDC requires that mechanisms for, and costs of, data
sharing be included in contracts, cooperative agreements, and
applications for grants. CDC reviewers must check whether applications
for CDC funds include mechanisms for, and costs of, sharing data. The
costs of sharing or archiving data may be included in the amount of
funds requested in applications for first-time or continuation funds.
Applicants for CDC funds who incorporate data release into their study
designs can (1) readily and economically set up procedures for
protecting the identities of research subjects and (2) produce useful
data with appropriate documentation. Awardees who fail to release data
in a timely fashion will be subject to procedures normally used to
address lack of performance (e.g., reduction in funding, restriction of
funds, or grant termination). Researchers who contend that the data
they collect or produce are not appropriate for release must justify
that contention in their applications for CDC funds. 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. CDC’s policy is available at:
http://www.cdc.gov/od/ads/pol-385.htm
BUDGET: The reasonableness of the proposed budget and the requested
period of support in relation to the proposed research.
RECEIPT SCHEDULE
Letter of Intent Receipt Date: May 24, 2004
Application Receipt Date: June 22, 2004
Earliest Anticipated Award Date: September 30, 2004
AWARD CRITERIA
Award criteria that will be used to make award decisions include:
o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic priorities (as determined by the secondary review).
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
INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the
policy of CDC to ensure that individuals of both sexes and the various
racial and ethnic groups will be included in all CDC-supported studies
involving human subjects, whenever feasible and appropriate.
Furthermore, it is CDC policy to identify significant gaps in knowledge
about health problems that affect women and racial and ethnic minority
populations and to encourage studies which address these problems.
Policy available in the Federal Register volume 60 number 179,
September 15, 1995, page 47948-51.
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. Guidance is
available 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).
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 CDC GRANT APPLICATIONS OR APPENDICES: All applications and
proposals for CDC funding must be self-contained within specified page
limitations. Unless otherwise specified in a CDC 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.healthypeople.gov/.
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 Section 301 of the Public Health Service Act as
amended (42 USC section 241). 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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