SMALL GRANTS IN OCCUPATIONAL SAFETY AND HEALTH RESEARCH (R03)

RELEASE DATE:  November 13, 2003  

PA NUMBER:   PA-04-021

EXPIRATION DATE: May 4, 2006

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. This announcement will stay active for 
only the May 1, 2006 AIDS and AIDS-related application submission date. The 
non-AIDS portion of this funding opportunity expires on the date indicated below. 
Replacement R03 (PAR-06-364) funding opportunity announcements 
have been issued for the submission date of June 1, 2006 and submission dates 
for AIDS and non-AIDS applications thereafter.

(This PA replaces PA-01-033)

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)
         
CATALOG OF FEDERAL AND DOMESTIC ASSISTANCE NUMBER: 93.262 

NOTE:  THE POLICIES, GUIDELINES, TERMS, AND CONDITIONS STATED IN THIS 
ANNOUNCEMENT MAY DIFFER FROM THOSE USED BY THE NIH.

THIS PA CONTAINS THE FOLLOWING INFORMATION

o Purpose of the PA
o Research Objectives
o Mechanism(s) of Support 
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Where to Send Inquiries
o Supplemental Instructions
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS PA 

This Program Announcement (PA) redefines the NIOSH Small Grant (R03) 
mechanism, and it supersedes all previous announcements of this grant program. 

The National Institute for Occupational Safety and Health (NIOSH), Centers for 
Disease Control and Prevention (CDC) invites small grant applications for 
research related to occupational safety and health.  NIOSH research programs 
support priority areas identified in the National Occupational Research Agenda 
(NORA) and other significant programs related to occupational safety and 
health.  The overall purpose of this grants program is to develop knowledge 
that can be used in preventing occupational diseases and injuries, and to 
understand better their underlying pathophysiology. The intent of the R03 
award is to support small research projects that can be carried out in a short 
period of time with limited resources.  The characteristics, requirements, 
preparation and review criteria for the small grant application are described 
in this document.  This award may not be used for thesis, dissertation, or 
postdoctoral research.  

RESEARCH OBJECTIVES

NIOSH is the lead Federal Institute responsible for conducting research and 
making recommendations for the prevention of work-related illnesses and 
injuries.  To accomplish this mission, NIOSH supports research to identify and 
investigate the relationships between working conditions and associated 
occupational diseases and injuries; to develop more sensitive means of 
evaluating hazards at work sites, as well as methods for measuring early 
markers of adverse health effects and injuries; to develop new protective 
equipment, engineering control technology, and work practices to reduce the 
risks of occupational hazards; and to evaluate the technical feasibility or 
application of a new or improved occupational safety and health procedure, 
method, technique, or system.  Visit the NIOSH homepage for a full description 
of occupational safety and health program areas 
http://www.cdc.gov/niosh/homepage.html.  

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. In 
2000, private industry employers reported 5.3 million work injuries 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 approximately $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.

In 1996, NIOSH and its partners in the public and private sectors developed 
the National Occupational Research Agenda (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 "National Occupational Research 
Agenda" (HHS, CDC, NIOSH Publication No.96-115) from the National Institute 
for Occupational Safety and Health, telephone (800) 356-4674 or on the 
internet at http://www.cdc.gov/niosh/nora.html.

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 to reduce occupational injuries and illness in 
many other areas including: workplace violence, biomarkers of exposure, 
neurological diseases, and others.  In addition, sector specific research on 
construction, agriculture, mining, and health care topics is also supported. 
Visit the NIOSH homepage for more information on NIOSH’s research program 
areas http://www.cdc.gov/niosh/homepage.html.  

Potential applicants with questions concerning the acceptability of their 
proposed work are strongly encouraged to seek programmatic technical 
assistance from the contact listed in this announcement under the section 
"Where to Send Inquiries."

See USEFUL REFERENCES below AUTHORITIES AND REGULATIONS.

SCOPE

The common characteristic of the small grant is provision of limited funding 
for a short period of time.  Examples of the types of projects that NIOSH
supports with the R03 include the following:  

o  Pilot or feasibility studies
o  Secondary analysis of existing data
o  Small, self-contained projects
o  Development of methodology
o  Development of new technology
o  Translation projects and/or development

MECHANISM(S) OF SUPPORT 

Applicants responding to this PA will use the NIOSH Small Research Grant (R03) 
award mechanism. The applicant will be solely responsible for planning, 
directing, and executing the proposed project. 

A project period of up to two years and a budget for direct costs of up to 
two $25,000 modules or $50,000 per year may be requested. Applications 
exceeding $50,000 in direct costs in any year will be considered unresponsive 
and returned without further consideration.

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/archive/grants/policy/nihgps_2001/part_i_1.htm.  

This is a non-renewable award, thus competing continuation applications will 
not be accepted.  Small grant support may not be used for thesis, 
dissertation, or postdoctoral research.  Only one revision of a previously 
reviewed small grant application may be submitted.  

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(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 Faith-based and community-based organizations
o Indian Tribes, Tribal Government, College and/or Organizations
o Foreign institutions are not eligible to apply.

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

Any individual with the skills, knowledge, and resources necessary to carry 
out the proposed research is invited to work with their institution to develop 
an application for support. Individuals from underrepresented racial and 
ethnic groups as well as individuals with disabilities are always encouraged 
to apply for NIOSH programs. Individuals who are junior investigators (no 
higher than assistant professor) have a higher priority for funding. 
Individuals in training programs are not eligible for this program (masters, 
doctoral, or postdoctoral).  

WHERE TO SEND INQUIRIES

NIOSH encourages your inquiries concerning this PA 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:

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 peer review issues to:

Price Connor, Ph.D.
Office of Extramural Programs
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention
1600 Clifton Road, N.E.
Building 24, Room 1618, MS E-74
Atlanta, GA  30333
Telephone (404) 498-2511
Fax (404) 498-2571
Email: pconnor@cdc.gov

o 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 PA must be type on line 2 of the face page of the 
application form and the YES box must be checked. 

SUPPLEMENTAL INSTRUCTIONS: All instructions for the PHS 398(rev. 5/2001) 
must be followed, with these exceptions:

o Research Plan

Items a - d of the Research Plan (Specific Aims, Background and Significance, 
Preliminary Studies, and Research Design and Methods) may not exceed a total 
of 10 pages. Please note that a Progress Report is not needed; competing 
continuation applications for a small grant will not be accepted.

o Appendix.  The appendix may include original, glossy photographs or color 
images of gels, micrographs, etc. provided that a photocopy (may be reduced 
in size) is also included within the page limits of the research plan. No 
publications or other printed material, with the exception of pre-printed 
questionnaires or surveys, may be included in the appendix.

APPLICATION RECEIPT DATES:  Beginning with the February 1, 2004 receipt date, 
applications submitted in response to this program announcement will be 
accepted at the standard application deadlines, which are available at 
http://grants.nih.gov/grants/dates.htm.  Application deadlines are also 
indicated in the PHS 398 application kit.

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: All R03 applications 
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.

For the NIOSH Small Grant (R03), applicants may request direct costs in 
$25,000 modules, up to a total, annual direct cost request of $50,000 for 
project periods up to two years.  

SENDING AN APPLICATION TO NIOSH: 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 R03 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 by NIOSH in accordance with the standard 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
   
REVIEW CRITERIA

The NIOSH R03 small grant is a mechanism for supporting discrete, well-defined 
projects that realistically can be expected to be completed in two years and 
that require limited levels of funding.  Because the research plan is 
restricted to 10 pages, a small grant application will not have the same level 
of detail or extensive discussion found in an R01 application.  
Accordingly, reviewers should evaluate the conceptual framework and general 
approach to the problem, placing 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 from investigator-generated data.  
Preliminary data are not required, particularly in applications proposing 
pilot or feasibility studies.  
 
The goals of NIOSH-supported research are to advance our knowledge about the 
occurrence and prevention of occupational injuries, illnesses, and hazards.   
In the written comments, reviewers will be asked to discuss the following 
aspects of your 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 scientific review group will address and consider each of these criteria 
in assigning the application's overall score, weighting them as appropriate 
for each application.  The application does not need to be strong in all 
categories to be judged likely to have major scientific impact and thus 
deserve a high priority score.  For example, an investigator may propose to 
carry out important work that by its nature is not innovative but is essential 
to move a field forward.

SIGNIFICANCE: Does this study address an important problem? If the aims of the 
application are achieved, how will scientific knowledge be advanced? What will 
be the effect of these studies on the concepts or methods that drive this 
field?

APPROACH: Are the conceptual framework, design, methods, and analyses 
adequately developed, well-integrated, and appropriate to the aims of the 
project? Does the applicant acknowledge potential problem areas and consider 
alternative tactics?

INNOVATION: Does the project employ novel concepts, approaches or methods? 
Are the aims original and innovative? Does the project challenge existing 
paradigms or develop new methodologies or technologies?

INVESTIGATOR: Is the investigator appropriately trained and well suited to 
carry out this work? Is the work proposed appropriate to the experience level 
of the principal investigator and other researchers (if any)?

ENVIRONMENT: Does the scientific environment in which the work will be done 
contribute to the probability of success? Do the proposed experiments take 
advantage of unique features of the scientific environment or employ useful 
collaborative arrangements? Is there evidence of institutional support?  

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following 
items will be considered in the determination of scientific merit and the 
priority score:

PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human 
subjects and protections from research risk relating to their participation in 
the proposed research will be assessed. (See criteria included in the section 
on Federal Citations, below). 
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
 
INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans 
to include subjects from both genders, all racial and ethnic groups (and 
subgroups), and children as appropriate for the scientific goals of the 
research will be assessed.  Plans for the recruitment and retention of 
subjects will also be evaluated. (See Inclusion Criteria in the sections on 
Federal Citations, below).

CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to 
be used in the project, the five items described under Section f of the PHS 
398 research grant application instructions (rev. 5/2001) will be assessed.

ADDITIONAL REVIEW CONSIDERATIONS 

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
o Individuals who are junior investigators (no higher than assistant 
professor) have a higher priority for funding.

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: (if 
applicable) NIH policy requires education on the protection of human subject 
participants for all investigators submitting NIH proposals for research 
involving human subjects. You will find this policy announcement in the NIH 
Guide for Grants and Contracts Announcement, dated June 5, 2000, at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

HUMAN EMBRYONIC STEM CELLS (hESC): (if applicable) Criteria for federal 
funding of research on hESCs can be found at 
http://stemcells.nih.gov/index.asp and at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.  Only 
research using hESC lines that are registered in the NIH Human Embryonic Stem 
Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). 
It is the responsibility of the applicant to provide, in the project 
description and elsewhere in the application as appropriate, the official NIH 
identifier(s) for the hESC line(s) to be used in the proposed research.  
Applications that do not provide this information will be returned without 
review. 

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The 
Office of Management and Budget (OMB) Circular A-110 has been revised to 
provide public access to research data through the Freedom of Information Act 
(FOIA) under some circumstances.  Data that are (1) first produced in a 
project that is supported in whole or in part with Federal funds and (2) cited 
publicly and officially by a Federal agency in support of an action that has 
the force and effect of law (i.e., a regulation) may be accessed through FOIA. 
It is important for applicants to understand the basic scope of this 
amendment.  NIH has provided guidance at 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this PA in a public 
archive, which can provide protections for the data and manage the 
distribution for an indefinite period of time. If so, the application should 
include a description of the archiving plan in the study design and include 
information about this in the budget justification section of the 
application. In addition, applicants should think about how to structure 
informed consent statements and other human subjects procedures given the 
potential for wider use of data collected under this award.

STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The 
Department of Health and Human Services (DHHS) issued final modification to 
the “Standards for Privacy of Individually Identifiable Health Information”, 
the “Privacy Rule,” on August 14, 2002. The Privacy Rule is a federal 
regulation under the Health Insurance Portability and Accountability Act 
(HIPAA) of 1996 that governs the protection of individually identifiable 
health information, and is administered and enforced by the DHHS Office for 
Civil Rights (OCR). Those who must comply with the Privacy Rule (classified 
under the Rule as “covered entities”) must do so by April 14, 2003 (with the 
exception of small health plans which have an extra year to comply).  

Decisions about applicability and implementation of the Privacy Rule reside 
with the researcher and his/her institution. The OCR website 
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including 
a complete Regulation Text and a set of decision tools on “Am I a covered 
entity?”  Information on the impact of the HIPAA Privacy Rule on NIH processes 
involving the review, funding, and progress monitoring of grants, cooperative 
agreements, and research contracts can be found at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals 
for NIH funding must be self-contained within specified page limitations. 
Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) 
should not be used to provide information necessary to the review because 
reviewers are under no obligation to view the Internet sites.   Furthermore, 
we caution reviewers that their anonymity may be compromised when they 
directly access an Internet site.

HEALTHY PEOPLE 2010: 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/.

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 NISOH?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.
 
AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal 
Domestic Assistance at http://www.cfda.gov/ and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  Awards are made under the authorization of Sections 
301 and 405 of the Public Health Service Act as amended 42 USC 241 and 284, 
and the Occupational Safety and Health Act of 1970, Section 20(a) 29 U.S.C. 
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.

USEFUL REFERENCES

USDOL, 2001. Workplace injuries and illnesses in 2000. News Release 12/18/01; 
Bureau of Labor Statistics

USDOL, 2001. National census of fatal occupational injuries in 2000. News 
Release 8/14/01; Bureau of Labor Statistics

National Safety Council, 2000. Injury Facts, 2000 Edition.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy


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