CAREER DEVELOPMENT GRANTS IN OCCUPATIONAL SAFETY AND HEALTH RESEARCH (K01)

RELEASE DATE:  May 20, 2004

PA NUMBER:  PAR-04-105 (Reissued as PAR-08-070)

EXPIRATION DATE:  July 2, 2006, unless reissued.

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)

Note:  The policies, guidelines, terms, and conditions stated in this 
announcement may differ from those used by the NIH.

CATALOG OF FEDERAL DOMESTIC ASSISTANCE: 93.262
         
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 Special Requirements
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS PA 

This Program Announcement (PA) supersedes all previous announcements of the 
National Institute for Occupational Safety and Health (NIOSH) Special Emphasis 
Research Career Award (K01) Program.  

The overall purpose of the NIOSH program for Career Development Grants in 
Occupational Safety and Health Research is to make awards over a three-year 
period for investigators who intend to gain experience in a new research area 
and/or one in which an additional supervised research experience will 
substantially add to the research capabilities of the applicant.  In either 
case, applicants would develop their research skills under the guidance of at 
least one mentor who is an accomplished investigator in the relevant research 
area.  The program is open to candidates having faculty appointments and 
holding a Ph.D., M.D., D.V.M., D.O., or equivalent professional degree who 
wish to develop research capabilities in research areas relevant to the 
mission of NIOSH. 

A goal of this program is to provide "hands-on" research at the applicant 
institution, to enhance the institution’s science infrastructure, and to 
develop the research career and teaching skills of the candidate.  By 
developing these capabilities, the candidate will expand the pool of well-
trained scientists who contribute to solving occupational safety and health 
concerns and will be in a position to assist other investigators in the same 
way.  Furthermore, the candidate will enhance his/her skills in training 
students and guiding them to pursuing advanced degrees in this field.

RESEARCH OBJECTIVES

NIOSH invites 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.  Visit the NIOSH homepage for 
descriptions of occupational safety and health program areas 
http://www.cdc.gov/niosh. 

NIOSH supports research to identify and investigate the relationships between 
hazardous 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.  The 
scope of acceptable proposals includes exploratory or pilot studies, as well 
as analyses of data previously collected.

Because of the diverse nature of occupational safety and health issues, other 
research topics besides those that fall under the NORA topics are supported by 
NIOSH.  In addition, research needs may be focused on certain occupational 
sectors, such as construction, transportation, agriculture, mining, and health 
care.
 
In 1996, NIOSH and its partners in the public and private sectors developed 
the NORA to provide a framework to guide occupational safety and health 
research into the next decade.  Approximately 500 organizations and 
individuals outside NIOSH provided input into the development of NORA.  The 
agenda identifies 21 research priorities and reflects an attempt to consider 
both current and emerging needs.  The priority areas are not ranked; each is 
considered to be of equal importance.  The NORA priority research areas are 
grouped into three categories: Disease and Injury, Work Environment and 
Workforce, and Research Tools and Approaches.

NORA Priority Research Areas are:

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

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

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

Potential applicants may obtain a copy of the "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://www2a.cdc.gov/NORA/default.html. 

Questions concerning the acceptability of proposed work are encouraged, and 
scientific/research assistance may be obtained from the contact listed in this 
announcement under the section "Where to Send Inquiries."

See Useful References After AUTHORITY AND REGULATIONS (Below). 

MECHANISM(S) OF SUPPORT 

This PA will use the NIOSH K01 award mechanism.  Responsibility for planning, 
directing, and executing the proposed project is solely that of the applicant. 
The total project period for an application submitted in response to this PA 
is for three years.  Awards are not renewable.  The minimum time commitment is 
50% annually.

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 or community-based organizations 
o Foreign institutions are not eligible to apply 

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

This Career Development Award (K01) is designed to support research of 
scientists who hold a doctoral degree, are not above the rank of assistant 
professor, are employed by a domestic institution, and have research 
experience beyond the doctoral level.  Any scientist or junior faculty who 
qualifies to submit an application according to the above criteria and who 
possesses the skills, knowledge, and resources necessary to carry out the 
proposed research is invited to work with their institution and appropriate 
personnel to develop a proposal for support.  Individuals so qualifying who 
are from underrepresented racial and ethnic groups as well as individuals with 
disabilities are encouraged to apply for research support from NIOSH programs.

Current principal investigators on career awards are not eligible.  A 
candidate for the K01 award may not have pending nor concurrently apply for 
any other career development award.  An individual may not receive more than 
one K01 award.  K01 recipients are encouraged to apply for independent 
research grant support during the period of this award.

Candidates must be U.S. citizens or non-citizen nationals, or must have been 
lawfully admitted for permanent residence by the time of award.  Individuals 
admitted for permanent residence must be able to produce documentation of 
their immigration status such as an Alien Registration Receipt Card (I-551) or 
some other verification of legal admission as a permanent resident.  Non-
citizen nationals, although not U.S. citizens, owe permanent allegiance to the 
U.S.  They are usually born in lands that are not states but are under U.S.
sovereignty, jurisdiction, or administration.  Individuals on temporary or
student visas are not eligible for this award.

SPECIAL REQUIREMENTS

Candidate

The candidate's commitment to a career in occupational safety and health 
research must be described in terms of the candidate's potential to develop 
into an independent investigator.  Immediate and long-term career objectives 
should be discussed, explaining how the award will contribute to their 
attainment.  In defining the career development plan, justification should be 
presented for the proposed period of mentored research experience and how it 
will substantially enhance the candidate’s career.

Mentor 

Each candidate must identify and complete arrangements with at least one 
mentor, preferably at the same institution, who is recognized as an 
accomplished investigator in the proposed research area and who will provide 
guidance for the candidate's development and research plan.  Arrangements with 
mentors at institutions at a distance from the applicant institution will be 
considered, but approaches for ensuring close and active involvement of a 
distant mentor must be clearly outlined in the application.  Plans for 
intensive training of the mentee should be developed with the mentor(s).  The 
establishment of a viable mentoring plan is essential to the success of the 
candidate. 

The commitment of the mentor(s) must be documented in the application in the 
form of letters of recommendation (Do NOT seal).  A mentoring plan that 
describes the candidates interaction with the mentor(s) and his/her staff, how 
it will enhance the candidates research capabilities and teaching skills, and 
steps to assist the candidate and student(s) advance their career goals must 
be delineated in the application.  The mentor(s) must provide an annual 
evaluation of the candidate’s career development.  This evaluation is to be 
included as part of the annual progress report if an award is made.

Provisions of the Award

Amount of Award

The maximum direct cost that may be requested is $100,000.  Applications 
exceeding $100,000 in direct costs in any year will be considered unresponsive 
and returned without further consideration.  Direct costs may include salary 
support (plus fringe benefits), technical assistance, equipment, supplies, 
consultant costs, domestic travel, publications, and other costs.  The 
facilities and administrative costs will be reimbursed at 8 
percent of modified total direct costs.

Salary

The awardee (candidate at the institution) will receive salary support up to a 
maximum of $75,000 per year plus fringe benefits for three years.  These funds 
must be used to support the awardee.  The level of support will be based upon 
the awardee's actual salary and must be consistent with the established salary 
structure of the institution for persons of equivalent qualifications, 
experience, and rank.  The actual salary level will be determined by the 
amount of effort devoted to this program.  Awardees must commit at least 50% 
annual effort to the proposed research project.

In addition to salary support for the awardee, support for up to 5% of the 
mentor's salary plus fringe benefits may also be requested.  If funds are to 
be transferred to the mentor's institution for the mentor's salary, 
arrangements for the transfer of funds and the conduct of activities should be 
formalized in a subcontract agreement with the mentor's institution.  The 
mentor’s salary should not be included in the research and development costs.

Research and Development Costs

Funds beyond that requested for the awardees and mentors salaries will be 
provided for research support.
  
These research support funds may be used for:

o Personnel:  support for technical personnel.

o Equipment:  limited to specialized research equipment essential to the 
proposed program.  In accordance with PHS policy, title to such equipment will 
vest with the grantee institution.

o Supplies:  consumable supplies essential to the proposed program.

o Travel:  essential to the proposed program.

o Other:  publication costs, computer costs, or other costs necessary for the 
research program.
 
Facilities and Administrative (F & A) Costs

F & A costs will be provided at a rate of 8% of the total direct costs of each 
award, exclusive of equipment.  The F & A cost rate on an agreement with the 
mentor's institution may not exceed 8%.

Training in the Responsible Conduct of Research (RCR):  

Candidates must describe plans to receive instruction in the responsible 
conduct of research. The Public Health Service policy on RCR 
(http://ori.hhs.gov/policies/RCR_Policy.shtml#rcr) describes nine core 
instructional areas that comprise RCR:  data acquisition, management, sharing, 
and ownership; mentor/trainee responsibilities; publication practices and 
responsible authorship; peer review; collaborative science; human subjects; 
research involving animals; research misconduct; and conflict of interest and 
commitment.  Plans for RCR training must describe the proposed subject matter, 
format, frequency and duration of instruction.  This description should 
include an explicit statement that the candidate has taken or will take the 
course, and when.  No award will be made if an application lacks this 
component. See the NIH website http://www.nih.gov/sigs/bioethics for resources 
and information on this topic.

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

WHERE TO SEND INQUIRIES

We encourage your inquiries concerning this PA and welcome the opportunity to 
answer questions from potential applicants.  Inquiries may fall into 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, surveillance, hearing 
loss, organization of work fertility and pregnancy abnormalities, social and 
economic consequences of occupational injury and disease, organization of 
work, 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 allergic and irritant dermatitis, cancer research methods, emerging 
technology, health services research, infectious diseases, indoor environment, 
traumatic injuries, musculoskeletal disorders (low back and upper extremities) 
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, intervention effectiveness research methods, health 
services research, cancer research methods, risk assessment methods, 
surveillance research methods, and neurological disorders contact:

Bridgette E. Garrett, 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 1423, MS E-74
Atlanta, GA  30333
Telephone: (404) 498-2508
FAX: (404) 498-2517
Email: bgarrett@cdc.gov

For agriculture centers, construction centers, mining centers and 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:
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:

Cynthia Mitchell
Contracts Management Branch
Centers for Disease Control and Prevention 
626 Cochrans Mill Road
Pittsburgh, Pennsylvania 15236-0070
Telephone: (412) 386-6434
Fax: (412) 386-6429
Email: CMitchell@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:  http://www.dunandbradstreet.com/us/.  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 

It is important to note that instructions, specific to the submission of a K01 
application, supercede those listed in the cited PHS 398 research grant 
application instructions (e.g. page limitations, number of copies, 
applications receipt dates). 

On the application Face Page item 2, check the “YES” box, indicating the 
application is in response to a Program Announcement, and type the Program 
Announcement in the “Number” and “NIOSH Career Development Grants” for the 
“Title.”

APPLICATION RECEIPT DATES: 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

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

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

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

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

PEER REVIEW PROCESS

Applications submitted for this PA will be assigned to NIOSH. Appropriate 
scientific review groups convened by NIOSH in accordance with the standard NIH 
peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate 
applications for scientific and technical merit.

As part of the initial merit review, all applications will:

o Undergo a selection process in which only those applications deemed to have 
the highest scientific merit, generally the top half of applications under 
review, will be discussed and assigned a priority score
o Receive a written critique

REVIEW CRITERIA

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 this application’s overall score, weighting them as 
appropriate for each application.

o Significance 
o Approach 
o Innovation
o Investigator
o Mentor
o Environment

The scientific review group will address and consider each of these criteria 
in assigning your application’s overall score, weighting them as appropriate 
for each application.  Your application does not need to be strong in all 
categories to be judged likely to have major scientific impact and thus 
deserve a high priority score.  For example, you may propose to carry out 
important work that by its nature is not innovative but is essential to move a 
field forward.

The review process for K01 applications will consider the applicant’s 
scientific achievements, the applicant’s research career plan in occupational 
safety and health, and the degree to which the applicants’ institution offers 
a superior research environment (supportive nature, including letter(s) of 
reference from advisor(s) which should accompany the application.

SIGNIFICANCE:  Does the study address an important problem? If the aims of the 
project are achieved, how do they advance scientific knowledge?  What will be 
the effect of these studies on the concepts or methods that drive this field? 
What is the potential that the study will result in a full research project?

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

MENTOR: Are the mentor's accomplishments in the scientific research area(s) 
proposed, plans for mentoring the candidate and students, experience and 
record in training investigators, and commitment for the duration of the 
project appropriate. 

ENVIRONMENT: The applicant institution's ability to provide adequate 
facilities, resources, and opportunities necessary for the candidate's 
training, and the institutional commitment to the candidate.  If the 
mentor(s)' institution is different from the applicant, the quality and extent 
of interaction of the faculty in the basic and clinical sciences, and the 
quality of the research and research training programs at the mentor's 
institution will be considered.

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 Relevance to program priorities
o Need for personnel in specific program areas
o Availability of funds 

REQUIRED FEDERAL CITATIONS 

ANIMAL WELFARE PROTECTION:  Recipients of PHS support for activities involving 
live, vertebrate animals must comply with PHS Policy on Humane Care and Use of 
Laboratory Animals 
(http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf), as 
mandated by the Health Research Extension Act of 1985 
(http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA 
Animal Welfare Regulations 
(http://www.nal.usda.gov/awic/legislat/usdaleg1.htm), as applicable.

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. 

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.

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

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

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/index.html) 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 
"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 of the Public Health Service Act as amended (42 USC 241 under Federal 
Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. And under the Occupational 
Safety and Health Act of 1970, Section 20(a) (29 USC 669(a)).

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. 
Executive Order 12372 does not apply to this program.

The provisions are not intended to prohibit all interaction with the 
legislative branch, or to prohibit educational efforts pertaining to public 
health.  Clearly there are circumstances when it is advisable and permissible 
to provide information to the legislative branch in order to foster 
implementation of prevention strategies to promote public health.  However, it 
would not be permissible to influence, directly or indirectly, a specific 
piece of pending legislation.

It remains permissible to use NIOSH/CDC funds to engage in activity to enhance 
prevention; collect and analyze data; publish and disseminate results of 
research and surveillance data; implement prevention strategies; conduct 
community outreach services; provide leadership and training; and foster safe 
and healthful environments.

Recipients of NIOSH/CDC grants and cooperative agreements need to be careful 
to prevent NIOSH/CDC funds from being used to influence or promote pending 
legislation.  With respect to conferences, public events, publication, and 
“grass roots” activities that relate to specific legislation, recipients of 
NIOSH/CDC funds should give attention to isolating and separating the 
appropriate use of NIOSH/CDC funds from non-NIOSH/CDC funds.  NIOSH/CDC also 
cautions recipients of NIOSH/CDC funds to be careful not to give the 
appearance that NIOSH/CDC funds are being used to carry out activities in a 
manner that is prohibited under Federal law.
 
The PHS strongly encourages all grant recipients to provide a smoke-free 
workplace and discourage the use of all tobacco products.  In addition, Public 
Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain 
facilities (or in some cases, any portion of a facility) in which regular or 
routine education, library, day care, health care, or early childhood 
development services are provided to children.  This is consistent with the 
PHS mission to protect and advance the physical and mental health of the 
American people.

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


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and Human Services (HHS)
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