NIOSH EXPLORATORY/DEVELOPMENTAL GRANT PROGRAM (R21)

RELEASE DATE:  December 4, 2003

PA NUMBER:  PA-04-030

March 2, 2006 (NOT-OD-06-046) – Effective with the June 1, 2006 submission date, 
all R03, R21, R33 and R34 applications must be submitted through Grants.gov 
using the electronic SF424 (R&R) application. Accordingly, this funding 
opportunity expires on the date indicated below. A Replacement R21 (PAR-06-408) 
funding opportunity announcement has been issued for the submission date of June 1, 2006 
and submission dates thereafter.

EXPIRATION DATE for R21 Non-AIDS Applications: March 2, 2006
EXPIRATION DATE for R21 AIDS and AIDS-Related Applications: May 2, 2006 

Department of Health and Human Services (DHHS)

PARTICIPATING ORGANIZATION: 
Centers for Disease Control and Prevention (CDC)
 (http://www.cdc.gov) 

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

THIS PA CONTAINS THE FOLLOWING INFORMATION

o Purpose of the PA
o Research Objectives
o Mechanism 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 PA supersedes all previous announcements of the NIOSH 
Exploratory/Developmental Grants (R21) Program.  

The NIOSH, CDC invite grant applications for research related to occupational 
safety and health.  NIOSH research programs support priority areas identified 
in the National Occupational Research Agenda (NORA) as well as applications 
aimed at reducing injury and illness in construction, transportation, 
agriculture, mining, and health care, described in the RESEARCH OBJECTIVES 
section which provides an example of NORA and other occupational safety and 
health research program areas.  Within CDC, the NIOSH is the lead Federal 
Institute responsible for conducting research and making recommendations for 
the prevention of work-related illnesses and injuries.  Visit the NIOSH 
homepage for a full description of occupational safety and health program 
areas at http://www.cdc.gov/niosh/homepage.html.

The purpose of the NIOSH R21 is to encourage applications from institutions 
that are interested in testing innovative or conceptually creative ideas that 
are scientifically sound and may advance our understanding of safety and 
occupational health.  Another objective is to encourage necessary initial 
development to provide a basis for important future research that can be used 
in preventing occupational diseases and injuries.  This purpose is shared by 
other Centers of the Public Health Service (PHS) within the CDC.

RESEARCH OBJECTIVES

In today's society, Americans are working more hours than ever before.  The 
workplace environment profoundly affects health; simply by going to work each 
day, we may face hazards that threaten our health and safety.  Risking one's 
life or health should never be considered merely part of the job.  In 1970, 
Congress passed the Occupational Safety and Health Act to ensure Americans the 
right to "safe and healthful working conditions," yet workplace hazards 
continue to inflict a tremendous toll in both human and economic costs.  
Private industry employers reported 5.3 million work injuries in 2000 and 
363,000 cases of occupational illness.  An average of 16 American workers die 
each day from injuries on the job (in 2000, there were 5915 fatal work 
injuries).  Moreover, even the most conservative estimates find that about 137 
additional workers die each day from workplace diseases.  Additionally, in 
1999 occupational injuries and deaths cost $123 billion in wages and lost 
productivity, administrative expenses, health care and other costs.  This does 
not include the cost of occupational disease.  These occupational injuries and 
diseases create needless human suffering, a tremendous burden upon health care 
resources, and an enormous drain on U.S. productivity.

NIOSH is the lead Federal Institute responsible for conducting research and 
making recommendations for the prevention of work related illnesses and 
injuries.  NIOSH=s mandate includes the support of research in numerous 
occupational safety and health areas in addition to the topics identified in 
the NORA, described below. Investigators are encouraged to discuss their 
research topics with NIOSH program staff to determine the relevance to 
occupational health and safety. 

Because of the diverse nature of occupational safety and health issues, many 
other research topics are supported by NIOSH in addition to the NORA topics.  
Thus, NIOSH supports research in many other areas related to occupational 
disease and injury including; violence, biomarkers, emergency response, 
mining, bioterrorism, agricultural related illnesses and injuries, and other 
occupational safety and health issues.  Visit the NIOSH homepage for more 
information on NIOSH=s research program areas at 
http://www.cdc.gov/niosh/homepage.html.
  
In 1996, NIOSH and its partners in the public and private sectors developed 
the NORA to provide a framework to guide occupational safety and health 
research into the next decade.  Approximately 500 organizations and 
individuals outside NIOSH provided input into the development of NORA.  The 
agenda identifies 21 research priorities and reflects an attempt to consider 
both current and emerging needs.  The priority areas are not ranked; each is 
considered to be of equal importance.  The NORA priority research areas are 
grouped into three categories: Disease and Injury, Work Environment and 
Workforce, and Research Tools and Approaches.

NORA Priority Research Areas are:

Disease and Injury
1.  Allergic and Irritant Dermatitis
2.  Asthma and Chronic Obstructive Pulmonary Disease
3.  Fertility and Pregnancy Abnormalities
4.  Hearing Loss
5.  Infectious Diseases
6.  Low Back Disorders
7.  Musculoskeletal Disorders of the Upper Extremities
8.  Traumatic Injuries

Work Environment and Workforce
9.  Emerging Technologies
10. Indoor Environment
11. Mixed Exposures
12. Organization of Work
13. Special Populations at Risk

Research Tools and Approaches
14. Cancer Research Methods
15. Control Technology and Personal Protective Equipment
16. Exposure Assessment Methods
17. Health Services Research
18. Intervention Effectiveness Research
19. Risk Assessment Methods
20. Social and Economic Consequences of Workplace Illness and Injury
21. Surveillance Research Methods

Potential applicants may obtain a copy of the publication "National 
Occupational Research Agenda" (HHS, CDC, NIOSH Publication No.96-115) from the 
NIOSH, telephone (800) 356-674 or on the internet at 
http://www.cdc.gov/niosh/nora.html.

Applications responding to this announcement will be reviewed for their 
responsiveness to program interests and their potential for developing 
knowledge that can be used in preventing occupational diseases and injuries.  
Applicants should provide a statement about which NIOSH research area is being 
addressed and a rationale for how the proposal will contribute to the 
specified priority area (this information should be placed in the "Background 
and Significance" section of the "Research Plan" of the application).  
Potential applicants with questions concerning the acceptability of their 
proposed work are strongly encouraged to seek assistance from the NIOSH 
program staff listed in this announcement under the section "Where to Send 
Inquiries."

The R21 mechanism is intended to encourage new exploratory and developmental 
research projects.  For example, such projects could assess the feasibility of 
a novel area of investigation or a new experimental system that has the 
potential to enhance health-related research. Another example could include 
the unique and innovative use of an existing methodology to explore a new 
scientific area. These studies may involve considerable risk but may lead to a 
breakthrough in a particular area, or to the development of novel techniques, 
agents, methodologies, models or applications that could have major impact on 
occupational safety and health research.

Translational research that is focused on bringing research results to the 
workplace is a priority to NIOSH. Investigators are encouraged to conduct 
projects in this emerging area.

Applications for R21 awards should describe projects distinct from those 
supported through the traditional investigator initiated research project 
grant (R01) mechanism.  For example, long-term projects, or projects designed 
to increase knowledge in a well-established area will not be considered for 
R21 awards.  Applications submitted under this mechanism should be exploratory 
and novel.  These studies should break new ground or extend previous 
discoveries toward new directions or applications.  Projects of limited cost 
or scope that use widely accepted approaches and methods within well 
established fields are better suited for the NIOSH R03 small grant mechanism. 
Information on the R03 program can be in the National Institutes of Health 
Guide.

MECHANISMS OF SUPPORT

This PA will use the NIOSH R21 Grant award mechanism. As an applicant, you 
will be solely responsible for planning, directing, and executing the proposed 
project.  An individual may not receive more than one R21 award for this 
announcement.

The applicant may request a project period of up to two years with a combined 
budget for direct costs of up $275,000 for the two year period.  Applications 
exceeding $275,000 for the two year period will be considered unresponsive and 
returned without further consideration.  For example, the applicant may 
request $100,000 direct costs in the first year and $175,000 direct costs in 
the second year.  The request should be tailored to the needs of the project. 
 
Normally, no more than $200,000 may be requested in any single year.  

This PA uses just-in-time concepts.  It also uses the modular budgeting 
format. (see http://grants.nih.gov/grants/funding/modular/modular.htm).   All 
applications submitted in response to this announcement must use the modular 
budget format.  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.  

Exploratory/developmental grant support is for new projects only; competing 
continuation applications will not be accepted.   Two revisions of a 
previously reviewed exploratory/developmental grant application may be 
submitted as defined in NIH Policy at 
http://grants.nih.gov/grants/policy/amendedapps.htm.

Applications submitted in response to this program announcement follow the 
standard receipt, review and award cycles, see 
http://grants.nih.gov/grants/dates.htm for more information. 

ELIGIBLE INSTITUTIONS 

You may submit an application 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 and foreign institutions/organizations
o Faith-based or community based organizations
o Indian Tribes, Tribal Government, College and/or 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 under-represented racial and 
ethnic groups as well as individuals with disabilities are always encouraged 
to apply for NIOSH/CDC programs.

SPECIAL REQUIREMENTS

Applicants are encouraged to use the NIOSH R21 to explore the feasibility of 
an innovative research question or approach, which may not qualify through 
existing research grant programs, or may not be competitive as a standard R01.

This award is not intended to supplement ongoing or other proposed research; 
nor is it intended to be a mechanism for providing institutional support.  
No minimum time commitment (percent effort) has been established for the R21 
award, although the commitment should be appropriate to meet the goals of the 
proposed investigation.

WHERE TO SEND INQUIRIES

We encourage your inquiries concerning this PA and welcome the opportunity to 
answer questions from potential applicants. Inquiries may fall into two areas: 
 scientific/research and financial or grants management issues.

o Direct your questions about scientific/research issues to:

For exposure assessment method, control technology, emerging technology, 
surveillance, and mixed exposure studies contact:

Susan B. Board, M.S.
Office of Extramural Programs
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention
1600 Clifton Road, N.E.
Executive Park Building 24, Room 1415, MS E-74
Atlanta, GA  30333
Telephone: (404) 498-2512
FAX: (404) 498-2517
Email: sboard@cdc.gov

For dermatitis, cancer research methods, fertility and pregnancy 
abnormalities, hearing loss, health services research, infectious diseases, 
indoor environment, organization of work, and special populations contact:

Adele Childress, Ph.D., M.S.P.H.
Office of Extramural Programs
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention
1600 Clifton Road, N.E.
Executive Park Building 24, Room 1429, MS E-74
Atlanta, GA  30333
Telephone: (404) 498-2509
FAX: (404) 498-2571
Email: achildress@cdc.gov

For asthma and COPD, social and economic consequences, intervention 
effectiveness, musculoskeletal disorders, risk assessment methods, and 
traumatic injuries and all other occupational safety and health issues 
contact:

Michael J. Galvin, Jr., Ph.D.
Office of Extramural Programs
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention
1600 Clifton Road, N.E.
Executive Park Building 24, Room 1536, MS E-74
Atlanta, GA  30333
Telephone: (404) 498-2524
FAX: (404) 498-2571
Email: mgalvin@cdc.gov

Direct your questions about financial or grants management matters to:

Peter E. Grandillo Jr.
Acquisition & Assistance Field Branch
Centers for Disease Control & Prevention
626 Cochrans Mill Road
Pittsburgh, PA 15236-0070
Telephone: (412) 386-6834
Fax: (412) 386-6429
Email: PNG2@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 
is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an 
interactive format.  For further assistance contact GrantsInfo, Telephone 
(301) 435-0714, Email: GrantsInfo@nih.gov.

The title and number of this announcement must be typed on line 2 of the face 
page of the application form and the YES box must be checked.

APPLICATION RECEIPT DATES: Applications submitted in response to this R21 
program announcement will be accepted at the standard application deadlines, 
which are available at http://grants1.nih.gov/grants/dates.htm.  Application 
deadlines are also indicated in the PHS 398 application kit.

SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of 
the application, including the checklist, and five signed photocopies in one 
package to:

Center for Scientific Review (CSR)
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express/courier service)

APPLICATION PROCESSING: Applications must be mailed on or before the receipt 
dates described at 
http://grants.nih.gov/grants/funding/submissionschedule.htm.  The CSR will 
not accept any application in response to this PA that is essentially the same 
as one currently pending initial review unless the applicant withdraws the 
pending application.  The CSR will not accept any application that is 
essentially the same as one already reviewed.  This does not preclude the 
submission of a substantial revision of an unfunded version of an application 
already reviewed, but such application must include an Introduction addressing 
the previous critique.

Although there is no immediate acknowledgement of the receipt of an 
application, applicants are generally notified of the review and funding 
assignment within 8 weeks.

PEER REVIEW PROCESS

Applications submitted for this PA will be assigned on the basis of 
established PHS referral guidelines.  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 the appropriate advisory committee or 
board.
  
REVIEW CRITERIA

The NIOSH R21 grant is a mechanism for supporting novel scientific ideas or 
new model systems, tools or technologies that have the potential to 
significantly advance our knowledge or the status of health-related research. 
Because the research plan is limited to 15 pages, an R21 application need not 
have extensive background material or preliminary information as one might 
normally expect in an R01 application.  Accordingly, reviewers will focus 
their evaluation on the conceptual framework, the level of innovation, and the 
potential to significantly advance our knowledge or understanding.  Reviewers 
will place less emphasis on methodological details and certain indicators 
traditionally used in evaluating the scientific merit of R01 applications 
including supportive preliminary data. Appropriate justification for the 
proposed work can be provided through literature citations, data from other 
sources, or, when available, from investigator-generated data.  Preliminary 
data are not required for R21 applications.

The goals of NIOSH-supported research are to deliver on the nation=s promise: 
Safety and health at work for all people through research and prevention.  
Specific goals toward that end are enumerated by priority area listed in the 
Institute=s NORA. In the written comments, reviewers will be asked to discuss 
the following aspects of the application in order to judge the likelihood that 
the proposed research will have a substantial impact on the pursuit of these 
goals: 

o Significance 
o Approach 
o Innovation
o Investigator
o Environment

The scientific review group will address and consider each of these criteria 
in assigning your application=s overall score, weighting them as appropriate 
for each application.  Your 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, you 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).
 
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 

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

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).  NIOSH has adopted this policy for this 
announcement. 

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 
Office of Management and Budget (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. NIOSH has adopted this policy for this 
announcement. 

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.  NIOSH has adopted this policy for this 
announcement.

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.  NIOSH 
has adopted this policy for this announcement.

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 (FOIA): 
The OMB Circular A-110 has been revised to provide public access to research 
data through the 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 
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 Health Insurance Portability and 
Accountability Act (HIPPA) 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 HIPPA 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. 

INTERNET ADDRESS (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, 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: 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 improve the quality of life.  This 
PA 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 CFDA 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(a) [42 U.S.C. 241(a)], the Occupational Safety and Health Act of 1970, 
Section 20(a) [29 U.S.C. 669(a)] [number: 93.262, Occupational Safety and 
Health Research Grants of the National Institute for Occupational Safety and 
Health (NIOSH)], and under Federal Regulations 42 CFR 52 and 45 CFR Parts 
74 and 92.

LOBBYING RESTRICTIONS: Applicants should be aware of restrictions on the use 
of HHS 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 PHS 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, NIOSH/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 NIOSH/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 NIOSH/CDC grants and cooperative agreements need to be careful 
to prevent NIOSH/CDC funds from being used to influence or promote pending 
legislation.  With respect to conferences, public events, publication, and 
“grass roots” activities that relate to specific legislation, recipients of 
NIOSH/CDC funds should give attention to isolating and separating the 
appropriate use of NIOSH/CDC funds from non-NIOSH/CDC funds.  NIOSH/CDC also 
cautions recipients of NIOSH/CDC funds to be careful not to give the 
appearance that NIOSH/CDC funds are being used to carry out activities in a 
manner that is prohibited under Federal law.
 
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

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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