and Human Services (HHS)
EXPIRED
INCIDENCE OF NEEDLESTICK AND SHARPS INJURIES AND MEDICAL SAFETY DEVICE
AVAILABILITY/USE AMONG NON-HOSPITAL HEALTH CARE WORKERS
RELEASE DATE: November 18, 2003
RFA Number: RFA-OH-04-003
Department of Health and Human Services (DHHS)
PARTICIPATING ORGANIZATION:
Centers for Disease Control and Prevention (CDC)
COMPONENT OF PARTICIPATING ORGANIZATION:
National Institute for Occupational Safety and Health (NIOSH)
(http://www.cdc.gov/niosh/homepage.html)
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): CFDA 93.262
LETTER OF INTENT RECEIPT DATE: December 17, 2003
APPLICATION RECEIPT DATE: January 23, 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 and Review Schedule
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS RFA
The National Institute for Occupational Safety and Health (NIOSH), Centers for
Disease Control and Prevention (CDC), invites grant applications for studies
that will contribute to the understanding of the risks of exposure to blood
among health care workers employed in home health care settings. Such
information will contribute significantly to an understanding not only of the
risk for such exposures, but the development of effective intervention
strategies. Because little is known about the incidence of blood exposures in
home health care workers, this RFA has an emphasis on research that examines
the incidence of exposures to blood, risk factors associated with such
exposures, and the availability and use of medical safety devices.
A special feature of this RFA is encouraging applications from researchers and
from membership organizations comprised of health care workers, such as unions
and professional organizations, and collaboration among these groups.
RESEARCH OBJECTIVES
Background
There are nearly twelve million health care workers employed in the United
States. It is estimated that there are approximately 20,000 home care
providers (agencies) serving more than 7 million individuals each year. Health
care workers are at risk of infection from blood-borne pathogens, particularly
human immunodeficiency virus (HIV), hepatitis B virus, and hepatitis C virus.
As of December 2001, the CDC was aware of 57 health care workers in the U.S.
who had been documented as having sero-converted to HIV following occupational
exposures. Approximately 83% of exposures to blood reported by hospital-based
health care workers are by percutaneous injury (i.e., needlestick and sharps
injuries). Mucous membrane exposure accounts for about 13%, skin 3%, and bite
1%. Precise national data are not available on the annual number of
needlesticks and other percutaneous injuries among health care workers since
it has been estimated that about half of these injuries go unreported.
Virtually all of the information on the occurrence of needlestick and sharps
injuries is based on hospital workers. However, it has been estimated that
600,000 to 800,000 such injuries occur annually. In addition to the serious
health consequences of this injury, the emotional impact of a needlestick
injury can be severe and long lasting, even when a serious infection is not
transmitted.
In order to address this public health problem in the context of occupational
injuries, past studies have shown that certain information about blood
exposures need to be considered in a survey design, including relevant
demographic information about survey respondents, general information about
past exposures to blood, and details about the circumstances of recent
exposures. For recent exposures to blood, at least eight critical areas of
information have been shown to be important. These include: 1) route of
exposure, 2) activity during and timing of exposure, 3) specific medical
device being used, 4) relevant characteristics of the source patient, 5)
reasons why the exposure either was or was not reported, 6) suggestions on how
to improve reporting of injuries, 7) whether respondents obtained post-
exposure prophylactic treatment, and 8) precautions that would have prevented
the exposure.
Another critical area for inclusion in such studies is an assessment of past
exposures experienced by employees and, in order to assess under-reporting,
the percentage of exposures reported to the worker=s employer via standard
procedures.
NIOSH has set a goal to describe the occurrence of exposure to blood among
home health care workers in order to subsequently identify appropriate
interventions to reduce the future incidence of exposure to blood-borne
pathogens. This RFA is the first step to accomplish this goal.
Research Objectives
The objective of this RFA is to support research on the incidence of and risk
factors for exposures to blood among home health care workers. Among the
issues that need to be understood are the significant factors that affect
blood exposures such as rate of exposure from needlestick and sharps injuries,
other routes of exposure, and the prevalence and use of medical safety
devices. Research projects should address this occupational issue in an
integrated and comprehensive manner in order that the risk of these exposures
in home health care workers can be understood. In designing their studies,
applicants may consider the inclusion of these data elements in the study
design: the incidence rate of exposure to blood from needlestick and sharps
injuries and other routes of exposure among home health care workers; risk
factors for these exposures; and the prevalence of medical safety device
availability and usage. The applicant should justify the survey sample size.
Investigators may wish to consider conducting either a retrospective or
prospective survey of an entire or random sample of a population of home
health care workers to estimate numbers of exposures and incidence rates by
occupation, setting, medical device, and the availability and usage of medical
safety devices. An important element that investigators may wish to include
in the study design is a comparison of risk factors, rates of exposure, and
availability/use of medical safety devices between these workers and hospital
health care workers; however, the focus of this RFA is on non-hospital
settings.
Investigators may also wish to include in the study design approaches for
estimating the availability and usage of medical safety devices in home care
settings. Another element that investigators may wish to consider is the rate
of vaccination against hepatitis B virus and compliance with recommendations
for post-exposure prophylaxis for hepatitis B virus and human immunodeficiency
virus. Applicants should also consider, study design methods for data
collection that do not rely solely upon employers= or health services= records
to reduce the potential for study bias due to under-reporting of needlestick
injuries. However, an investigator may wish to supplement a survey of home
health care workers with a review of injury records kept by employers.
MECHANISM OF SUPPORT
This RFA will use NIOSH R01 award mechanism. As an applicant you will be
solely responsible for planning, directing, and executing the proposed
project. This RFA is a one-time solicitation. Future unsolicited, competing-
continuation applications based on this project will compete with all
investigator-initiated applications and will be reviewed according to the
customary peer review procedures. The anticipated award date is July 1, 2004.
Applications that are not funded in the competition described in this RFA may
be resubmitted as NEW investigator-initiated applications using the standard
receipt dates for NEW applications described in the instructions to the PHS
398 application.
This RFA uses just-in-time concepts. It also uses the non-modular budgeting
formats. Follow the instructions for non-modular budget 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.
FUNDS AVAILABLE
NIOSH intends to commit approximately $1,000,000 in FY 2004 to fund 2 to 4 new
and/or competitive continuation grants in response to this RFA. An applicant
may request a project period of up to 4 years and a budget for direct costs of
up to $400,000 per year. Applications exceeding $400,000 in direct costs in
any year will be considered unresponsive and returned without further
consideration. 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 NIOSH 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.
ELIGIBILITY 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 institutions/organizations
o Foreign institutions/organizations are not eligible to apply
o Faith-based or community-based organizations
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
Individuals with the skills, knowledge, and resources necessary to carry out
the proposed research are invited to work with their institutions 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 NIOSH programs.
Note: Title 2 United States Code section 1611 states that an organization
described in section 501(c)(4) of the Internal Revenue Code that engages in
lobbying activities is not eligible to receive Federal funds constituting an
award, grant, or loan.
SPECIAL REQUIREMENTS
Applicants should fully describe the plan to recruit study sites across an
industry (to characterize exposures in that industry) and to enroll workers
willing to participate in the study. Letters of cooperation from employers
and unions would provide some measure of the anticipated success of the plan.
The following should be addressed in a clear and organized manner (see also
peer review criteria section):
o Timeline: a detailed timeline for the proposed study must be included in the
application.
o In a separate section labeled, Participant Notification of Study Results,
the applicant should describe plans for notifying participants about their
individual results and the overall results of the study.
Applicants should highlight unique expertise and/or unusual opportunities as
related to the purpose of this RFA. Examples include, but are not limited to:
o Expertise in specialized areas with potential applications to the
issues/questions considered in this RFA, conducting epidemiologic field
studies of working populations, experience in traumatic injuries.
o Access to a range of work sites varied enough to characterize the industry
being studied, and to workers at those sites who are willing to participate in
studies of needlestick and sharps injuries.
o Expertise in assessing needlestick and sharps injuries along with
contributing risk factors in individual job settings, as well as documentation
of all non-hospital health care exposures.
o Expertise in the clinical assessment of psychological factors associated
with traumatic injuries, such as needlestick and sharps injuries.
o Expertise in negotiating with work site management and unions in field
settings.
WHERE TO SEND INQUIRIES
We encourage inquiries concerning this RFA 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 questions about scientific/research issues to:
Adele M. Childress, Ph.D., M.S.P.H
Scientific Program Administrator
Office of Extramural Programs
Centers for Disease Control and Prevention
National Institute for Occupational Safety and Health
1600 Clifton Road, N.E.
Building 24, Room 1537, MS E-74
Atlanta, GA 30333
Telephone: (404) 498-2509
FAX: (404) 498-2571
Email: [email protected]
o Direct your questions about peer review issues to:
Pervis C. Major, Ph.D.
Scientific Review Administrator
Office of Extramural Programs
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention (CDC)
1095 Willowdale Rd
Morgantown, WV 26505
Telephone 304-285-5979
Fax 304-285-6147
Email: [email protected]
o Direct inquiries about financial or grants management matters to:
Ms. Cynthia Mitchell, Contract Specialist
Acquisition and Assistance Field Branch
Centers for Disease Control and Prevention
626 Cochrans Mill Road
Pittsburgh, Pennsylvania 15236-0070
Announcement Number OH-04-001
Telephone: (412) 386-6434
Email: [email protected]
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that includes
the following information:
o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel
o Participating 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 an application, the information that it contains is
used 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 and should be sent by mail to:
Pervis C. Major, Ph.D.
Scientific Review Administrator
Office of Extramural Programs
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention (CDC)
1095 Willowdale Rd
Morgantown, WV 26505
Telephone 304-285-5979
Fax 304-285-6147
Email: [email protected]
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: [email protected].
SUPPLEMENTARY INSTRUCTIONS:
If the proposed project involves organizations or persons other than those
affiliated with the applicant organization, letters of support and/or
cooperation must be included.
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 TO THE NIH: Submit a signed, typewritten original of
the application, including the Checklist, and three signed photocopies, in one
package to:
Center for Scientific Review (CSR)
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710
Bethesda, MD 20817 (for express/courier service)
At the time of submission, two additional copies of the application and all
copies of appendix material must also be sent to:
Pervis C. Major, Ph.D.
Scientific Review Administrator
Office of Extramural Programs
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention (CDC)
1095 Willowdale Rd
Morgantown, WV 26505
Telephone 304-285-5979
Fax 304-285-6147
Email: [email protected]
APPLICATION PROCESSING: Applications must be received by the application
receipt date listed in the heading of the 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.
The Center for Scientific Review (CSR) will not accept any application in
response to this RFA that is essentially the same as one currently pending
initial review, unless the applicant withdraws the pending application.
However, when a previously unfunded application, originally submitted as an
investigator-initiated application, is to be submitted in response to an RFA,
it is to be prepared as a NEW application. That is, the application for the
RFA must not include an Introduction describing the changes and improvements
made, and the text must not be marked to indicate the changes from the
previous unfunded version of the application.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by CSR and
responsiveness by NIOSH. Incomplete and/or nonresponsive applications will
not be reviewed.
Applications that are complete and responsive to the RFA will be evaluated for
scientific and technical merit by a scientific review group convened by NIOSH
in accordance with the review criteria stated below. As part of the initial
merit review, all applications will:
o Undergo a process in which only those applicants deemed to have the highest
scientific or technical merit, generally the top half of the applications
under review, will be discussed and assigned a priority score.
o Receive a written critique.
o Receive a second level of review by the NIOSH Secondary Review Committee.
REVIEW CRITERIA
The goals of NIOSH-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, it may propose to carry out important work that by its nature is
not innovative but essential to move a field forward.
SIGNIFICANCE: Does the proposed research project satisfy an important public
health, occupational health, or infection control need?
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 approaches? Will the research project be able to provide reliable
estimates of the incidence rate of exposure to blood, particularly needlestick
and sharps injuries? Will the research project be able to identify risk
factors for exposures to blood? Will the research project be able to estimate
the availability and use of medical safety devices among the facilities
employing the respondents? Does the applicant include health care workers in
occupations (within-home-care settings) with potentially the highest incidence
rates of needlestick injury? Does the applicant demonstrate access to health
care workers who are at high risk of occupational exposure to blood, including
letters of support from organizations facilitating access to these workers?
Does the applicant justify the proposed sample size and statistical power
calculations?
INNOVATION: Does the project employ novel concepts, approaches, or methods?
Is the project original and innovative? Does the project develop new
methodologies?
INVESTIGATORS: Are the principal investigator and her/his collaborators
appropriately trained and well suited to carry out this work? Do they have
adequate experience in the areas of occupational health, infection control,
epidemiology, and project management to carry out this work? Is the work
proposed appropriate to the experience level of the principal investigator and
her/his collaborators?
ENVIRONMENT: Are the applicant’s facilities, equipment, and other resources
adequate for the performance of this project? Is there evidence of
institutional support? Are the methods for assuring privacy and maintaining
confidentiality of participant records, including specific protections for
Internet-based data systems adequate?
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 all 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
Scientific Review Criteria
o BUDGET: The reasonableness of the proposed budget and the requested period
of support in relation to the proposed research.
o Availability of special opportunities for furthering research programs
through the use of unusual talent resources, populations, or environmental
conditions in other countries which are not readily available in the United
States or which provide augmentation of existing U.S. resources.
Programmatic Review Criteria
o Magnitude of the problem in terms of numbers of workers affected.
o Severity of the disease or injury in the worker population.
o Likelihood of developing applied technical knowledge for the prevention of
occupational safety and health hazards.
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: December 17, 2003
Application Receipt Date: January 23, 2004
Earliest Anticipated Start Date: July 1, 2004
AWARD CRITERIA
Award criteria that will be used to make award decisions include:
o Scientific merit
o Availability of funds
o Programmatic priorities
REQUIRED FEDERAL CITATIONS
HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that
applications and proposals involving human subjects must be evaluated with
reference to the risks to the subjects, the adequacy of protection against
these risks, the potential benefits of the research to the subjects and
others, and the importance of the knowledge gained or to be gained.
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for
all types of clinical trials, including physiologic, toxicity, and dose-
finding studies (phase I); efficacy studies (phase II), efficacy,
effectiveness and comparative trials (phase III). The establishment of data
and safety monitoring boards (DSMBs) is required for multi-site clinical
trials involving interventions that entail potential risk to the participants.
(NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and
Contracts, June 12, 1998:
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
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
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.
LOBBYING RESTRICTIONS: Applicants should be aware of restrictions on the use
of Health and Human Services (DHHS) funds for lobbying of Federal or State
legislative bodies. Under the provisions of 31 U.S.C. Section 1352,
recipients (and their subtier contractors)are prohibited from using
appropriated Federal funds (other than profits from a Federal contract) for
lobbying congress or any Federal agency in connection with the award of a
particular contract, grant, cooperative agreement, or loan. This includes
grants/cooperative agreements that, in whole or in part, involve conferences
for which Federal funds cannot be used directly or indirectly to encourage
participants to lobby or to instruct participants on how to lobby.
In addition, no part of the Centers for Disease Control and Prevention (CDC)
appropriated funds shall be used, other than for normal and recognized
executive-legislative relationships, for publicity or propaganda purposes, for
the preparation, distribution, or use of any kit, pamphlet, booklet,
publication, radio, television, or video presentation designed to support or
defeat legislation pending before the Congress or any State or local
legislature, except in presentation to the Congress or any State or local
legislature itself. No part of the appropriated funds shall be used to pay
the salary or expenses of any grant or contract recipient, or agent acting for
such recipient, related to any activity designed to influence legislation or
appropriations pending before the Congress or any State or local legislature.
Any activity designed to influence action in regard to a particular piece of
pending legislation would be considered lobbying. That is lobbying for or
against pending legislation, as well as indirect or grass roots: lobbying
efforts by award recipients that are directed at inducing members of the
public to contact their elected representatives at the Federal or State levels
to urge support of, or opposition to, pending legislative proposals is
prohibited. As a matter of policy, CDC extends the prohibitions to lobbying
with respect to local legislation and local legislative bodies.
The provisions are not intended to prohibit all interaction with the
legislative branch, or to prohibit educational efforts pertaining to public
health. Clearly there are circumstances when it is advisable and permissible
to provide information to the legislative branch in order to foster
implementation of prevention strategies to promote public health. However, it
would not be permissible to influence, directly or indirectly, a specific
piece of pending legislation.
It remains permissible to use CDC funds to engage in activity to enhance
prevention; collect and analyze data; publish and disseminate results of
research and surveillance data; implement prevention strategies; conduct
community outreach services; provide leadership and training; and foster safe
and healthful environments.
Recipients of CDC grants and cooperative agreements need to be careful to
prevent CDC funds from being used to influence or promote pending legislation.
With respect to conferences, public events, publication, and grassroots
activities that relate to specific legislation, recipients of CDC funds should
give attention to isolating and separating the appropriate use of CDC funds
from non-CDC funds. CDC also cautions recipients of CDC funds to be careful
not to give the appearance that CDC funds are being used to carry out
activities in a manner that is prohibited under Federal law.
HEALTHY PEOPLE 2010: The CDC is committed to achieving the health promotion
and disease prevention objectives of "Healthy People 2010," a national
activity for reducing morbidity and mortality and improving the quality of
life. This RFA is related to one or more focus 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 Sections
301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284),
the Occupational Safety and Health Act of 1970, Section 20(a)[29 USC 669(a)],
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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NIH... Turning Discovery Into Health® |
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