CENTERS FOR CONSTRUCTION SAFETY AND HEALTH 

RELEASE DATE:  October 30, 2003

RFA Number:  RFA-OH-04-002

Department of Health and Human Services (DHHS)

PARTICIPATING ORGANIZATIONS: 

National Institute for Occupational Safety and Health, 
Centers for Disease Control and Prevention (NIOSH/CDC) 
 (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):  93.955

LETTER OF INTENT RECEIPT DATE:  March 13, 2004
APPLICATION RECEIPT DATE:  April 13, 2004

THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of the RFA
o Program 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 Pre-Application Conference Call
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations

PURPOSE OF THE RFA

The National Institute for Occupational Safety and Health (NIOSH), Centers 
for Disease Control and Prevention (CDC), announces the availability of 
fiscal year (FY) 2004 funds for cooperative agreement (U50) applications from 
single institutions or consortia of institutions to establish one or more 
Centers for Construction Safety and Health (Construction Centers). The 
purposes of the Construction Centers are to conduct exploratory, 
prevention/intervention, and translation projects that address priority 
construction safety and health problems and provide a national focus for 
construction health and safety issues.  A key role for Construction Centers 
will be their leadership role in translational activities and research. 
Through this integrated approach to knowledge development and translation, 
Construction Centers are intended to have a significant and measurable impact 
on construction health and safety.

PROGRAM OBJECTIVES

Background

The mission of NIOSH/CDC is to help assure safe and healthful working 
conditions for working men and women by providing research, information, and 
training in the field of occupational safety and health. NIOSH provides 
national and world leadership to prevent work-related illness, injury, 
disability, and death by gathering information, conducting scientific 
research, and translating the knowledge gained into products and services.  
One of the strategic goals is the conduct of a focused program of research to 
reduce injuries and illnesses among workers in high-priority areas and high-
risk sectors, including mining, agriculture, construction, and health care. 
In 1996, a National Occupational Research Agenda (NORA), 
http://www.cdc.gov/niosh/nora/, was created to guide NIOSH.  During the 
development of the Agenda, the importance of sector-specific research 
(including construction) was emphasized.  The panel noted that sector-focused 
research has had much success and continues to hold great promise for 
gathering and translating knowledge and information into prevention. The 
Healthy People 2010 agenda, a national activity to reduce morbidity and 
mortality and improve the quality of life includes national objectives for 
high risk sectors.  For example, it includes a 30% reduction goal for work-
related injuries and deaths among construction workers by 2010.  For a copy 
of Healthy People 2010" (Full Report: Stock No. 017-001-00547-9), write or 
call: Superintendent of Documents, Government Printing Office, Washington 
D.C. 20402-9325, telephone (202) 512-1800 or visit the internet site: 
http://www.healthypeople.gov/.

This RFA builds upon an existing NIOSH program on construction safety and 
health that began in 1990.  This program has developed a national 
infrastructure to address issues affecting workers in this industry. The 
program includes intramural and extramural research projects as well as 
collaborative surveillance activities with state health departments.  These 
projects included a large Construction Center as well as investigator-
initiated projects that addressed specific construction issues such as 
hearing loss, roof falls, and vibration injuries. The reduction in traumatic 
injury rates among construction workers since 1990 suggests that the program 
has had some impact.  A compendium of NIOSH supported construction research 
can be found on the NIOSH web site http://www.cdc.gov/niosh/homepage.html, or 
it may be obtained by telephone (800-356-4674), email (pubstaft@cdc.gov), or 
fax (513-533-8573).  The NIOSH publication number is 2003-103.  Additional 
information on the NIOSH construction program is available at 
http://www.cdc.gov/niosh/homepage.html.

Despite these efforts, construction remains one of the industries with the 
highest rates of work-related injuries and deaths in the United States.  From 
1980 to 2001, approximately 1100 construction workers were killed on the job 
each year, more fatal injuries than any other industry.  Furthermore, the 
construction fatality rate has not declined over the past decade. The 
construction environment presents a number of work settings and environments 
many of which vary across the United States.  It can also involve a complex 
work organization, with multiple employers and trades at a worksite.  Thus, 
construction safety and health research must not only address specific 
construction related safety and health problems, but also must examine their 
etiology in the context of the work environment.  

A significant challenge to improving the safety of the construction industry 
is the nature of the businesses.  Of the approximately 600,000 companies, 90% 
employ fewer than 20 workers.  Few small construction companies have formal 
safety programs.  Thus, the adoption of new/improved construction safety and 
health is difficult to achieve, and innovative approaches to the translation 
of research knowledge to construction tools, practices, and environments are 
needed. 

While some employers utilize formal safety programs and training, others are 
less formal and many workers must learn how to work safely through on the job 
experiences.  Additionally, there is an increasing need for construction 
worksites to communicate safety and health information in several languages.  
Construction workers are also at increased risk for occupational morbidity 
from musculoskeletal disorders, certain cancers, reproductive disorders, 
dermatological conditions; hearing loss, stress related mental disorders, and 
occupational lung diseases.  In addition, the work environment such as 
construction vehicles, power lines, hazardous chemicals, and scaffolding 
failures present unique hazards for the construction worker.  Thus, the 
construction environment represents a unique and multifaceted health and 
safety challenge.     

The health and safety issues in the construction sector are complex and 
evolving.  Thus, there is a need for an integrated approach to the health and 
safety issues facing this sector and the construction centers are intended to 
address problems through a coordinated and integrated mix of exploratory, 
prevention/intervention, and translation projects.  The goal of the 
Construction Center Program is to have a significant and measurable impact on 
construction safety and health. 

Goals

This initiative is intended to assemble a cross-disciplinary, multi-
institutional group to address the important issues in construction safety 
and health in a focused manner.  To accomplish this objective, it is 
envisioned that a Construction Center would: 

1.  Conduct hypothesis driven (exploratory) research related to occupational 
safety and health of construction workers.
2.  Develop, implement and evaluate model programs for the prevention of 
illness and injury among construction workers. 
3.  Develop, implement, and evaluate translation projects for the adoption of 
new and existing knowledge into construction settings.

The emphasis of the Construction Centers should be on addressing priority 
occupational health and safety issues using a multi-disciplinary approach.  
Translation projects focus on the translation of extant knowledge (e.g. peer 
reviewed articles) into products or practices that meet construction 
“customer” needs so as to maximize the impact on industry practices.  The 
NIOSH Construction Steering Committee has identified a number of priority 
topics in emerging areas of interest where research will most likely make a 
difference (see http://www.cdc.gov/niosh/homepage.html).  These NIOSH 
identified topics can be grouped into three categories: 
 
o  Health and injury outcome topics which target:
1. Leading types of fatal and non-fatal traumatic injuries in construction. 
2. Low back injuries and other cumulative work-related musculoskeletal 
disorders among construction workers.
3. Occupational illness topics that focus on respiratory disease and hearing 
loss.  Respiratory disease includes airways disease, asthma, chronic 
obstructive lung disease, and silicosis.

o  Chemical and physical exposure topics which target vibration, asphalt 
fumes, lead, and dust particles. 

o  Approach and sector topics that target the following groups and issues 
within construction:
1. Small and self-employed contractors.
2. Special sub-populations at risk within construction such as Hispanic 
workers, day laborers, young workers, aging workers. 
3. The role of design as a primary prevention tool for addressing 
construction hazards.
4. Addressing work organization in construction and improving understanding 
of how it affects health and safety.
5. Working with building owners and clients to promote and evaluate 
construction best practices.
6. Leveraging promising approaches from related high risk sectors such as 
agriculture and mining into construction. 

Other topics relevant to construction health and safety are also appropriate 
for this RFA.  The significance of a project and relevance to the elimination 
of hazards in the construction industry must be fully described and developed 
in the application.  Individual projects should identify the types and 
geographical distribution of the construction issue that will be addressed by 
a project.  In addition, the size and characteristics of the population that 
will be impacted by the project results should be described.

Intervention/prevention and translation projects should include process and 
outcome measures.  Process measures must be detailed enough to allow for 
replication in other areas.  Outcome measures of interest include, but are 
not limited to: exposure to injury hazards, knowledge of safety and health 
hazards, documenting safety and health behavior change, and changes in the 
incidence of disease, injury, or fatality.  

In the development and prioritization of the project topics for the 
Construction Center, applicants are encouraged to consult with stakeholders 
(e.g. construction organizations, construction unions, advisory groups, 
workers, safety and health professionals, and other interested parties).

Construction Centers should include plans to develop linkages and 
communication with other governmental and non-governmental agencies involved 
in construction health and safety, with special emphasis on communications 
and collaborations with other NIOSH/CDC-sponsored construction health and 
safety programs.   

MECHANISM(s) OF SUPPORT

This RFA will use the NIOSH U-54 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 investigator-initiated applications, using the standard 
receipt dates described in the instructions to the PHS 398 application.

The NIOSH U-54 is a cooperative agreement award mechanism.  In the 
cooperative agreement mechanism, the Principal Investigator retains the 
primary responsibility and dominant role for planning, directing, and 
executing the proposed project, with NIOSH staff being substantially involved 
as a partner with the principal Investigator, as described under the section 
“Cooperative Agreement Terms and Conditions of Award”. 

This RFA uses just-in-time concepts.  It does not use the modular budgeting 
formats.  Follow the instructions for a detailed budget research grant 
application.  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 $5,000,000 in FY04 to fund one or more 
new or competing grants in response to this RFA.  An applicant may request a 
project period of up to five years and a budget for direct costs of up to 
$3,600,000 per year.  The total cost requested should not exceed $5,000,000. 
Applications exceeding $5,000,000 in total 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 may 
also vary.  Although the financial plans of NIOSH provide 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.

In years two and four, an additional $100,000 will be provided to support a 
national construction meeting.  This meeting will be planned jointly by NIOSH 
and the successful applicant(s).       

Use of Funds

Applicants should allocate funds for travel for project staff (the 
Construction Center Director and the principal investigator for each project) 
to attend annual meetings held during each project year.  Travel funds should 
also be planned for annual meetings of Construction Center Directors as a 
Coordinating Committee (see Collaborative Responsibilities under Terms and 
Conditions of Award) with NIOSH staff.  For planning purposes, assume that 
the meetings will be held in Washington, DC.

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 
o Faith-based or community-based 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 program 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/CDC 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

The essential characteristics of a Construction Center cooperative agreement 
are:

Overall Characteristics

o  The Construction Center cooperative agreement will support a broadly based 
multi-disciplinary exploratory, prevention/intervention, and translation 
program.  A Construction Center is expected to have the following components 
that together address the objectives of a Center:

1. Administrative, Planning and Outreach Core.  
This component should NOT exceed 25% of the direct cost budget.
2. Multi-Disciplinary Exploratory Research Projects.  
These projects should be at least 20% of the direct cost budget.
3. Prevention/Intervention Projects.  
These projects should be at least 25% of the direct cost budget.
4. Translation Projects.
These projects should be at least 20% of the direct cost budget.
(Projects may overlap these arbitrary divisions.  For example an intervention 
project may also fit as a translation project.  Thus these are intended as 
guidelines to help the principal investigator balance the construction 
centers projects).
         
o  There must be a demonstrated commitment of the applicant’s institution to 
support and encourage the Construction Center.  Such support could be 
demonstrated by release time of faculty, capital improvements that will 
facilitate the program, and/or assistance in the acquisition of scientific 
equipment and supplies.
         
o  The Construction Center’s program should be more than a collection of 
projects, but rather should include a process for the administrative 
integration and oversight of the projects.  The projects should address 
construction issues in an integrated manner that contributes to the overall 
focus of the Center.  Ideally, a Construction Center will address the entire 
continuum of a problem from identification/causation through translation.  
Therefore, under the Heading “OVERALL DESCRIPTION”, the principal 
investigator should clearly describe the theme or themes of the Center, how 
projects address the Center’s theme(s), and how the Center will function as 
an integrated program rather than simply a collection of projects.   

NON-ALLOWABLE COSTS FOR NIOSH CONSTRUCTION CENTER COOPERATIVE AGREEMENT
         
The Construction Center funding mechanism should not be used as a substitute 
for individual research grant support.  It is expected that investigators 
participating in Construction Centers will have a history of independent 
project support in addition to the Construction Center support.  Generally, 
funds for renovation of existing facilities or to purchase substantial 
amounts of equipment will not be allowed.  If such requests are made, they 
must be justified in terms of the critical nature of the 
equipment/renovations for the success of the overall objectives of the 
Construction Center cooperative agreement.
         
ESSENTIAL ELEMENTS OF A CONSTRUCTION CENTER 
         
ADMINISTRATIVE AND PLANNING CORE 
(SHOULD NOT EXCEED 25% OF THE ANNUAL DIRECT COST)
         
The Administrative, Planning and Outreach Core must have strong leaders 
committed to the program, who are capable of providing scientific leadership 
for the administration and integration of the program.  Assessment of the 
ability of the program’s principal investigator to lead a highly integrated 
program of exploratory, prevention/intervention, and translation projects 
will be a significant consideration in the evaluation of the application.  
         
The Administrative, Planning and Outreach Core supports the administrative 
infrastructure for the entire program and should not be duplicated within any 
other components.  The responsibilities and activities for this core include:
         
o  Appropriate and adequate organization and facilities for activities such 
as seminars, workshops, reference collection, computer support, etc.  The 
principal investigator should provide a minimum of 20% time commitment 
(direct and in-kind) and each member of the internal advisory committee (one 
exploratory, prevention/intervention, and translation project investigator) 
should provide a minimum of 5% time commitment for the Construction Center’s 
administration and coordination. 
         
o  Feasibility Projects. Support of feasibility projects in the exploratory, 
prevention/intervention and translation project areas within the NIOSH 
Construction Center is considered fundamental to sustaining the quality, 
breadth, and dynamics of this program.  Investigators should include between 
5% and 10% of the annual direct cost for these projects.  These projects are 
intended for the exploration and development of new and creative exploratory, 
prevention/intervention and translation projects, and are considered an 
important and integral part of the support provided to the Construction 
Center. Therefore, funds should be designated to provide support for short-
term projects (maximum duration of 12 months and $20,000) to explore the 
feasibility of new projects in any of the Center’s program areas 
(exploratory, prevention/intervention, and translation).  This will also 
enable investigators to collect sufficient data to pursue support through 
other funding mechanisms.  Examples of feasibility projects may include but 
are not limited to: 

1.  Provide initial support to develop innovative approaches/lines of 
investigation in the program areas.
2.  Allow exploration of possible innovative new directions representing a 
significant departure from ongoing funded projects in construction sciences 
(exploratory, prevention/intervention, and translation).
3.  Stimulate investigators from other fields of study to apply their 
expertise to construction safety and health issues.
4.  Develop new mechanisms for external or multi-Center collaborative 
partnerships to address emerging construction safety and health concerns.
5.  Provide initial support for a translational activity.

As a general rule, approximately 5% to 10% of the direct cost budget for each 
year should be allocated to the Feasibility Projects Program of a Center.  
While the administrative framework for management of the Center's Feasibility 
Projects Program is left to the Center Director's discretion, certain minimal 
requirements must be met.  Management of the program must include provisions 
for:

1.  A mechanism that ensures preparation and appropriate announcement of the 
availability of feasibility project funding.
2.  A mechanism for merit review of feasibility project proposals.  Copies of 
all proposals, with documentation of their reviews, relative ranking, and 
final action must be retained by the Center.  These records must be available 
to reviewers in the event of a site visit.
3.  A mechanism to maintain a record of subsequent results of each 
feasibility project study (abstract, RO1/R21 submission, etc.) recipient.  
This record must be available to reviewers in the event of a site visit for 
competing renewals.  Input by both the Internal Advisory Committee and the 
External Advisory Committee into the management of the Feasibility Projects 
Program is strongly recommended.
         
o The use of existing state and national databases is encouraged, however, a 
data center/statistical support activity may be included in the 
administrative core if needed for the Center.

o  Outreach Activities:  Essential functions of the outreach component of the 
administrative core include but are not limited to, coordinating and 
collaborating with construction researchers, industry stakeholders, 
construction unions and other organizations to identify key issues and needs.  
They could also include ongoing construction communication efforts and 
convening consensus-development sessions to address complex and/or 
controversial issues with the aim of preventing construction injuries and 
illness.  One topic that could be addressed through this activity would be 
working with building owners and clients (building managers) to develop 
strategies for identifying and adopting construction best practices.  

o  An Internal Advisory Committee is formed from the individual project 
leaders, one from each type of project (exploratory, prevention/intervention 
and translation) that will assist the principal investigator in making 
scientific and administrative decisions in the operation of the program.  
These individuals should provide a minimum time commitment of 5%.    
         
o  An External Advisory Committee, comprised of at least three members who 
are recognized leaders in construction health and safety and regional 
construction experts, will provide overall guidance and advice to the 
principal investigator and program investigators on program direction.   

TYPES OF PROJECTS

Two types of exploratory, prevention/intervention, and translation projects 
may be included in the Construction Center, and both types are encouraged.  
The two types are pilot/short term projects (1 - 2 years, R21 type) and 
comprehensive projects (up to 5 years, R01 type).   Each project (pilot and 
comprehensive) should be related to the overall goals established for the 
Center.  To be funded, a Construction Center must have one project either 
pilot or comprehensive for each topic area (exploratory, 
prevention/intervention, and translation) that is judged to have significant 
and substantial merit.  When appropriate, collaborative research is 
encouraged between Construction Centers and the NIOSH intramural program.   
         
Pilot research projects are intended to provide Construction Center 
investigators an opportunity to obtain the preliminary data needed for the 
submission of a NIOSH/CDC, NIH, EPA, or other peer-reviewed Project Grant 
application (R01 type).  The maximum project period for a pilot project is 2 
years.  Follow the instructions for a NIOSH Exploratory/Developmental (R21) 
grant (see NIH guide: 
http://grants.nih.gov/grants/guide/rfa-files/RFA-OH-00-006.html), 
for additional information on R21 applications). 
         
Comprehensive research projects are intended to provide support for fully 
developed ideas that are ripe for study, and should be consistent with R01 
projects that are typically awarded by NIOSH and NIH.  The project period for 
this type of project is usually three to five years. These projects will 
follow the submission guidelines for a R01 application according to the PHS 
398 application instructions. See NIH guide: 
http://grants.nih.gov/grants/guide/pa-files/PA-99-143.html, for additional 
information on R01 applications.

EXPLORATORY PROJECTS
(SHOULD BE AT LEAST 20% OF THE ANNUAL DIRECT COSTS)

These projects are hypothesis driven projects focused on improving our 
understanding of construction issues.  They may include but are not limited 
to projects involving surveillance, etiology, engineering, risk factor 
characterization, or development of analytical and exposure assessment 
approaches. They may be lab or field projects that provide the basis for 
creation or improvement of interventions.  Exploratory projects should target 
priority topics and should be done as a part of multidisciplinary efforts to 
address important problems and avoid fragmentary efforts are encouraged.  
Other topics relevant to the construction environment are also appropriate.

PREVENTION/INTERVENTION PROJECTS
(SHOULD BE AT LEAST 25% OF THE ANNUAL DIRECT COSTS)
 
This section is for projects in prevention and/or intervention.  These 
studies are for testing promising approaches in actual construction 
settings.  Prevention/intervention projects may include but are not limited 
to actions taken to eliminate or reduce exposure to safety and health hazards 
via practices or policies, or projects to demonstrate the value of screening 
or related approaches to detecting disorders and diseases in early stages. 
They can also examine the value of larger preventive systems (e.g., the 
workers compensation system) in reducing hazards and adverse outcomes. 
Prevention/intervention projects examine the utility and impact of new and 
existing measures in the workplace.  They may include but are not limited to 
combinations of techniques such as control technologies, work practices, 
tools and materials, personal protective equipment, exposure guidelines and 
regulations, worker participation programs, contract language, design 
specifications, and changes in education and training.  

Projects should address significant construction problems and involve 
construction stakeholder input to maximize relevance. The development of 
strong partnerships with organizations that can facilitate the identification 
of project needs and culturally appropriate, prevention, and intervention 
activities is encouraged. These projects should include the active 
participation of target populations identified at the state and national 
level, and include an evaluation plan to determine the efficiency and 
effectiveness of these techniques and programs.  

TRANSLATION PROJECTS
(SHOULD BE AT LEAST 20% OF THE ANNUAL DIRECT COSTS)

These are projects that focus on the translation of extant knowledge (e.g. 
peer reviewed articles) into products or practices that meet construction 
“customer” needs so as to maximize the impact on industry practices.  The 
Principal Investigator (Center Director) should view these projects as the 
tool to move the results from the research environment into the construction 
industry.  As the goal for these projects is the adoption of new/improved 
knowledge in the construction sector, the principal investigator must include 
in the project plan how the study will accomplish this goal.   
 
Translation projects may include but are not limited to technology transfer 
projects or demonstration projects that expand the use of effective 
interventions by a construction trade or industry group.  
Projects may address diffusion research issues to improve understanding of 
what influences construction industry decision-makers, workers, contractors, 
building owners, or others to adopt new practices, tools, and methods to 
improve safety and health performance.  Participatory research projects, 
where research subjects and researchers work as active co-partners on 
translation issues are encouraged.  Social marketing projects and other 
approaches that target important topics such as reducing construction 
fatalities at the industry, state, or national level are also appropriate.  
   
Note to Principal Investigators

Principal investigators are reminded that the intent of the Construction 
Center is not to support a collection of projects (exploratory, 
prevention/intervention, and translation).  Rather, the goal for a NIOSH 
Construction Center is to support multi-disciplinary projects that are 
focused on a construction issue(s)in such a way as to have a meaningful and 
measurable impact on the problem.  For example, a center may have as one 
focus fatal injury reduction and propose exploratory, 
prevention/intervention, and translation projects that address this problem 
in a multidisciplinary manner with a goal of reducing fatalities in 
construction workers.  

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.
         
Direct inquiries regarding programmatic issues to:

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

Direct inquiries regarding peer review 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: pmajor@cdc.gov 

Direct inquiries regarding grants management to:

Cynthia Mitchell
Grants Management Branch, Procurement and Grants Office
Centers for Disease Control and Prevention 
626 Cochrans Mill Road
Pittsburgh, Pennsylvania 15236-0070
Announcement Number OH-04-002
Telephone: (412) 386-6434
FAX: (412) 386-6459
Email: cmitchell@cdc.gov

PRE-APPLICATION CALL

Applicants are invited by NIOSH to participate in a pre-application technical 
assistance telephone conference call on December 17, 2003 at 1:00 PM (Eastern 
time) to discuss:  programmatic issues regarding this program,  how to apply, 
and questions regarding the content of the RFA.  The conference name is 
“Construction” Centers program.  The telephone bridge number is (888) 455-
3612.  Interested parties will need the conference code (41162) to 
participate.  If you experience difficulty connecting to the conference call, 
contact NIOSH staff at (404) 498-2530. 

LETTER OF INTENT

Prospective applicants are asked to submit a letter of intent by the date 
listed at the beginning of the RFA that includes the following information:

o Descriptive title of the proposed program
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.  The letter of intent should 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: pmajor@cdc.gov 

SUBMITTING AN APPLICATION   

Although not a prerequisite for applying, applicants are encouraged to 
consult with NIOSH program staff concerning the technical and other aspects 
of preparing the application.  Applicants should contact NIOSH program staff 
by phone early in the preparation process.  However, applicants should 
understand that advice given by staff is independent from the review process.

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) 435-0714, 
Email: GrantsInfo@nih.gov.

SUPPLEMENTARY INSTRUCTIONS

All projects (exploratory, prevention/intervention, or translation), should 
be consistent with the competitive/peer-reviewed applications that are 
typically awarded by NIOSH and NIH and adhere to the submission guidelines 
for a R01/R21 application following the PHS 398 application instructions.  
The R01 is an investigator initiated project that can request up to 5 years 
of support.  The R21 is for projects that are short-term in nature or for 
pilot projects.

PHS 398 form page 3 contains the section entitled “Research Plan” and 
although some projects are not hypothesis based research, this section should 
be used to describe the specific aims, background and significance, 
preliminary information or data, the project approach, for each project 
(prevention/intervention,  or exploratory research/demonstration).  This 
section should contain sufficient information to address the project’s goals 
and plan to achieve those goals, and should answer the following questions; 
1) What do you intend to do?, 2) Why is the work important?, 3) What has 
already been done?, and 4) How are you going to do the work (see page 15 of 
the 398 instructions for additional guidance).  

Each project type section should begin with a cover sheet that identifies it 
as the beginning of the project section (administrative core, exploratory, 
prevention/intervention, or translation), and the name of a project 
investigator who will be a member of the internal advisory committee should 
be listed.  This page is then followed by as many subsections as there are 
projects under that type.  Each subsection begins with a header page that 
identifies the project investigator and title of the project. The next page 
is the form page 2 of the PHS 398 which provides the description, performance 
sites, and key personnel.  For further instructions refer to the, Table of 
Contents for a Construction Center Application, provided below.

For each R01-type project, the application should not exceed 25 pages for 
items d - g for prevention/intervention, or comprehensive project (see the, 
Table of Contents for a Construction Center Application).  For pilot research 
(R21-type) projects, follow the instructions for a NIOSH 
Exploratory/Developmental grant (R21), see NIH guide:  
http://grants.nih.gov/grants/guide/rfa-files/RFA-OH-00-006.html for 
additional information on R21 applications. A 15 page maximum for items d - g 
should be followed. Refer to the, Table of Contents for a Construction Center 
Application, provided below.

The budget information, other support, etc. should be included in the 
appropriate sections of the application.   

NOTE:  NIOSH will inform successful applicants of the procedures for adding 
exploratory, prevention/intervention, or translation projects in future years 
of support.  Thus, the application should contain only projects for which 
funds are requested for support during year one.

TABLE OF CONTENTS FOR A CONSTRUCTION CENTER APPLICATION

In order to facilitate the preparation and review of the Construction Center 
application, the following Table of Contents should be used.  It is a minor 
modification of the PHS 398 Table of Contents which should be followed as a 
guide.

o Face Page 
o Construction Center Description, Performance Sites, and Personnel, Form 
page 2(use additional continuation pages as needed)
o Table of Contents 
o Detailed Budget for the Initial Budget Period for the entire Construction 
Center
o Budget for the Entire Proposed Period of Support for the Entire 
Construction Center
o Detailed Budget for each Project for the Initial Budget Period Organized by 
areas (exploratory, prevention/intervention, or translation)
o Budget for the Entire Proposed Period for each Project Organized by Cores
o Biographical Sketch-Principal Investigator/Program Director
o Other Biographical Sketches
o Other Support
o Overall Description of the Construction Center (2 page maximum)
o Past Performance/Accomplishments in Last Project Period (existing 
Construction Center)
o Past Performance/Accomplishments Relevant to Construction Center goals (new 
applicants)
o Statement on the Institutional Commitment to the Construction Center (1 
page maximum)
o Human Subjects summary table that lists all the projects and human subjects 
information (title, performance sites, FWAs, IRB approval date/status) 
o Administrative and Planning Core Cover Sheet
o Administrative and Planning Core
o Exploratory Projects Cover Sheet 
o Exploratory Plan A (use as many headings as there are projects)
o Prevention/Intervention Projects Cover Sheet
o Prevention/Intervention Project Plan A (use as many headings as there are 
projects)  
o Translation Projects Cover Sheet 
o Project Plan A (use as many headings as there are projects) 

Note: each project plan should use the following outline
a.  Header Page with Title, Principal Investigator's name, and type of 
project (comprehensive or pilot)
b.  Description, Performance Sites, and Personnel (form page 2)
c.  Highlights of Accomplishments for Past Project Period if it was part of 
an existing Construction Center (1 page maximum)
d.  Specific Aims
e.  Background and Significance
f.  Preliminary Studies/Progress Report
g.  Project Design and Methods 

Items d-g cannot exceed 25 pages (except pilot projects, which cannot exceed 
15 pages)

h.  Human Subjects
i.  Vertebrate Animals
j.  Literature Cited
k.  Consortium/Contractual Arrangements
l.  Consultants and Collaborators, including NIOSH/CDC

Note: Type density and size of the entire application must conform to the 
limits provided on page 3 in the PHS 398 instructions. 

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 CSR: 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 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: pmajor@cdc.gov 

APPLICATION PROCESSING:  Applications must be received on or before the 
application receipt date listed in the heading of this RFA. If an application 
is received after that date, it will be returned to the applicant without 
review. 

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

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/CDC.  Incomplete applications will be returned to the 
applicant without further consideration. 

Applications that are complete and responsive to the RFA will be evaluated 
for scientific and technical merit by an appropriate peer review group 
convened by NIOSH/CDC 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 
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 primary consideration for a Center cooperative agreement application is 
the ability of the Center’s program to bring together quality exploratory, 
prevention/intervention, and translation activities into an interactive, 
multi-disciplinary operation addressing construction issues.

SITE VISITS

A site visit to the applicant institutions may be made (but such site visits 
are not assured) to evaluate the overall merit of the application. The site 
visit team includes members of the Special Emphasis Panel who have expertise 
in major research areas, facilities, and outreach activities of the proposed 
Center, the NIOSH Scientific Review Administrator, and NIOSH staff 
observer(s).

A site visit is not a prerequisite and is not assured for consideration of an 
application by NIOSH.  Therefore, the application is considered a complete 
document for review purposes.  Furthermore, the applicant should not use the 
site visit as an occasion for adding core units, research projects, or 
investigators, for making major changes, or for delivering another exposition 
of the application.  Rather, it should be used by the principal investigator 
and associates to elaborate on the research program and core units, cost 
effectiveness and quality control features of the core units, and on other 
Center activities for which funding is requested, as well as to answer 
reviewers' questions. The site visit team will not consider any component 
core unit that is presented for evaluation at the site visit which has not 
been included in the application.  Budgetary changes also will not be 
considered at the time of a site visit.  The findings of the site visit team 
are reported and discussed by the members of the SEP, which makes the final 
peer review recommendations and assigns the priority score.

General Review Criteria

The criteria that NIOSH will use to review applications for scientific merit 
and for meeting program objectives are provided below.  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 project will 
have a substantial impact on the pursuit of these goals. The review group 
will address and consider each of these criteria in assigning your 
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 a major 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 essential to move a field forward.

Review Criteria for the Projects:

o  SIGNIFICANCE: Merit and significance of the proposed project as determined 
by such factors as content, originality, feasibility, potential long-term 
impact, transportability, and appropriateness.  Does the project address an 
important construction problem?  Does the project address a difficult 
construction problem that if successful would have significant impact?  

o  APPROACH: Demonstration within the proposed project plan of current 
knowledge of intervention practices and effectiveness.  Does the applicant 
acknowledge potential problem areas and consider alternative approaches.  Is 
the project fully described and does it include a plan for the distribution 
of results?  Has the investigator included appropriate methods for the 
analysis of the study results?

o  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?  The project 
does not have to be innovative but can use established methods to have a 
major impact and thus deserve a high priority score.

o  INVESTIGATOR: Qualifications and experience of the principal investigator 
and staff, particularly but not exclusively in areas relevant to the NIOSH’s 
mission of an Construction Center. Individuals with strong subject matter 
skills are expected to play key roles.  Personnel should demonstrate 
knowledge of the needs of their target audience.

o  ENVIRONMENT: Availability of resources necessary to perform project 
objectives.  Strength of commitment by the participating institution(s) as 
evidenced by provisions of appropriate resources, services, and technical 
support.

Review Criteria for the Overall Program:

o  Responsiveness to the objectives of the cooperative agreement program, 
including the applicant's understanding of the objectives of the proposed 
cooperative agreement and the relevance of the proposal to the objectives. 

o  Involvement of key stakeholders (construction and construction contractor 
organizations, unions, and workers)

o  Feasibility of meeting the proposed goals of the cooperative agreement 
program including the proposed schedule for initiating and accomplishing each 
of the activities of the cooperative agreement and the proposed method for 
evaluating the accomplishments. 

o  Degree to which the program design addresses the distinct characteristics, 
specific populations, and needs in construction. 

o  Qualifications of core investigators and the physical and intellectual 
environment of the group as a national resource for construction occupational 
health research and training.

o  Multidisciplinary scope of the program.

o  Degree of interrelationships, collaboration, and synergism of projects 
that might be expected to derive from Center support. 

o  Leadership ability and scientific stature of the Center Director and 
his/her ability to meet the program's demands of time and effort.

o  Provisions for coordinating projects.  The Center must have appropriate 
administrative arrangements and facilities that stimulate collaboration among 
constituent projects and personnel.

o  Effectiveness of the Center in establishing or continuing a  Outreach 
Program that makes maximal use of the Center’s strengths in educating 
construction workers and others about reducing construction injuries and/or 
hazard exposure.

o Institutional commitment to the Center.

OTHER REVIEW CRITERIA FOR ALL PROJECTS

The review group will also examine the appropriateness of proposed project 
budget and duration; the adequacy of plans to include both genders, 
minorities and their subgroups, and children as appropriate for the goals of 
the project including plans for the recruitment and retention of subjects; 
the provisions for the protection of human and animal subjects; and the 
safety of the research environment.

PROGRAMMATIC REVIEW CRITERIA:

o  Magnitude and severity of the occupational health or safety problems 
addressed in the proposal for the construction workplace and among 
construction populations in the region.

o  Likelihood of developing knowledge for the prevention/reduction of 
construction injuries and diseases on a national or regional basis.

o  Overall program addresses recognized construction priorities.

o  Program balance. 

o  Appropriateness of the proposed budget and duration in relation to 
proposed objectives. 

AWARD CRITERIA

Award criteria that will be used to make award decisions include:

o Program merit
o Availability of funds
o Programmatic priorities
o Balance of program areas

TERMS AND CONDITIONS OF AWARD

The Terms and Conditions of Award, below, will be incorporated in all awards 
issued as a result of this RFA. It is critical that each applicant include 
specific plans for responding to these terms.  These special terms of award 
are in addition to and not in lieu of otherwise applicable OMB administrative 
guidelines, HHS Grant Administration Regulations at 45 CFR Parts 74 and 92, 
and PHS Grants Policy Statement.

Under the cooperative agreement, the NIOSH purpose is to support and/or 
stimulate the recipient's activity by involvement in and otherwise working 
jointly with the award recipient in a partner role, but it is not to assume 
direction, prime responsibility, or a dominant role in the activity.  
Consistent with this concept, the dominant role and prime responsibility for 
the activity resides with the awardee(s) for the project as a whole, although 
specific tasks and activities in carrying out the studies will be shared 
among the awardees and the NIOSH collaborators where appropriate, including 
the following:

1. Recipient Responsibilities

The recipient will coordinate project activities, scientifically and 
administratively at the awardee institution and at the other sites that may 
be supported by sub-contractors to this award.  The applicant will have 
primary authority and responsibility to define objectives and approaches; to 
plan, conduct, and analyze data; and to publish results, interpretations, and 
conclusions of studies conducted under the terms and conditions of the 
cooperative agreement award. Recipient will:

o  Serve as a center for consultation and partnership to coordinate work by 
researchers and to coordinate researcher/stakeholder relationships to 
facilitate an effective multidisciplinary program. 

o  Conduct exploratory, prevention/intervention, and translation projects to 
improve construction health and safety. 

o  Collaborate with other NIOSH funded Construction researchers.

o  Disseminate project results.

o  Participate in an annual meeting of project investigators. 

o  Comprehensive Annual Center Report.  In addition to the summary progress 
report required for continuation applications, the Center Director prepares 
and submits separately, following the conclusion of each budget period, a 
comprehensive annual report of all activities relating to the Center. This 
report is submitted electronically. Typically, this report includes:
(a) An "Introduction and Summary" of the program.
(b) Directors report on major accomplishments (highlights).
(c) Detailed progress reports on each project, grouped according to type with 
appropriate references and a list of publications since the last annual 
report.
(d) A progress report on feasibility projects.
(e) A report on the Outreach Program. 
(f) A report on specific improvements in construction safety and health that 
resulted from center activities. 
(g) An administrative report, discussing relevant personnel and other 
matters.

2.  NIOSH Responsibilities

o  Provide technical assistance through site visits and correspondence in the 
areas of program development, implementation, maintenance, and priority 
setting related to the cooperative agreement, if requested. 

o  Provide scientific collaboration, if requested. 

o  Assist in the reporting and dissemination of research results and relevant 
health and safety  and training information to appropriate Federal, State, 
local agencies, health-care providers, the scientific community, construction 
workers, management and union representatives, and other NIOSH Construction 
Centers, if requested. 

3.  Collaborative Responsibilities

If more than one Construction Center is awarded, part of this initiative will 
be the establishment of a Coordinating Committee (CC) that will facilitate 
sharing of information about activities and accomplishments among the 
Centers.  This CC will also provide leadership and work collaboratively to 
address construction safety and health issues at a national level.  The CC 
will be comprised of the principle investigators from the Centers.  NIOSH 
representatives will participate in CC meetings where appropriate but will 
not have voting privileges.  The CC may designate working groups for specific 
purposes, made up of staff members from their Centers.  One such working 
group could be a Construction Centers Translation Committee.  This multi-site 
committee would provide a means to share data that is ripe for translation to 
the construction sector.

It is anticipated that critical issues for understanding and protecting 
construction workers from job risks will be better defined through the 
deliberations of the CC.  The CC will combine the expertise and resources of 
the Centers with those of NIOSH/CDC to achieve a more integrated and 
effective program in construction health and safety.

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).  

SHARING RESEARCH DATA:  Starting with the October 1, 2003 receipt date, 
investigators submitting an NIH application seeking more than $500,000 or 
more in direct costs in any single year are expected to include a plan for 
data sharing or state why this is not possible. 
http://grants.nih.gov/grants/policy/data_sharing  Investigators should seek 
guidance from their institutions, on issues related to institutional 
policies, local IRB rules, as well as local, state and Federal laws and 
regulations, including the Privacy Rule. Reviewers will consider the data 
sharing plan but will not factor the plan into the determination of the 
scientific merit or the priority score.

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of 
the NIH that women and members of minority groups and their sub-populations 
must be included in all NIH-supported clinical research projects unless a 
clear and compelling justification is provided indicating that inclusion is 
inappropriate with respect to the health of the subjects or the purpose of 
the research. This policy results from the NIH Revitalization Act of 1993 
(Section 492B of Public Law 103-43).

All investigators proposing clinical research should read the "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.

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) 
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. 

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 Center 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 healthy 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.

SMOKE-FREE WORKPLACE: CDC strongly encourages all grant recipients to provide 
a smoke-free workplace and promote the non-use of all tobacco products, and 
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in 
certain facilities that receive Federal funds in which , library, day care, 
health care, and early childhood development services are provided to 
children.

SMALL, MINORITY, AND WOMEN-OWNED BUSINESS: It is a national policy to place a 
fair share of purchases with small, minority and women-owned business firms. 
The Department of Health and Human Services is strongly committed to the 
objective of this policy and encourages all recipients of its grants and 
cooperative agreements to take affirmative steps to ensure such fairness. In 
particular, recipients should:

1. Place small, minority, women-owned business firms on bidders mailing 
lists.

2. Solicit these firms whenever they are potential sources of supplies, 
equipment, construction, or services.

3. Where feasible, divide total requirements into smaller needs, and set 
delivery schedules that will encourage participation by these firms.

4. Use the assistance of the Minority Business Development Agency of the 
Department of Commerce, the Office of Small and Disadvantaged Business 
Utilization, DHHS, and similar state and local offices.

RESEARCH INTEGRITY: The signature of the institution official on the face 
page of the application submitted under this Program Announcement is 
certifying compliance with the Department of Health and Human Services (DHHS) 
regulations in Title 42 Part 50, Subpart A, entitled "Responsibility of PHS 
Awardee and Applicant Institutions for Dealing with and Reporting Possible 
Misconduct in Science."
The regulation places several requirements on institutions receiving or 
applying for funds under the PHS Act that are monitored by the DHHS Office of 
Research Integrity's (ORI) Assurance Program. 
For examples:
Section 50.103(a) of the regulation states: "Each institution that applies 
for or receives assistance under the Act for any project or program which 
involves the conduct of biomedical or behavioral research must have an 
assurance satisfactory to the Secretary (DHHS) that the applicant: (1) Has 
established an administrative process, that meets the requirements of this 
subpart, for reviewing, investigating, and reporting allegations of 
misconduct in science in connection with PHS-sponsored biomedical and 
behavioral research conducted at the applicant institution or sponsored by 
the applicant; and (2) Will comply with its own administrative process and 
the requirements of this Subpart."

Section 50.103(b) of the regulation states that: "an applicant or recipient 
institution shall make an annual submission to the [ORI] as follows: (1) The 
institution's assurance shall be submitted to the [ORI], on a form prescribed 
by the Secretary,...and updated annually thereafter...(2) An institution 
shall submit, along with its annual assurance, such aggregate information on 
allegations, inquiries, and investigations as the Secretary may prescribe." 

AUTHORITY AND REGULATIONS

This program is authorized under the Public Health Service Act, as amended, 
Section 301(a) [42 U.S.C. 241(a)], and the Occupational Safety and Health Act 
of 1970, Section 20(a) [29 U.S.C. 669(a)].  The applicable program regulation 
is 42 CFR Part 52.

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	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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