INCIDENCE OF NEEDLESTICK AND SHARPS INJURIES AND MEDICAL SAFETY DEVICE 
AVAILABILITY/USE AMONG NON-HOSPITAL HEALTH CARE WORKERS

RELEASE DATE:  November 18, 2003
                                                                
RFA Number:  RFA-OH-04-003

Department of Health and Human Services (DHHS)

PARTICIPATING ORGANIZATION: 
Centers for Disease Control and Prevention (CDC) 

COMPONENT OF PARTICIPATING ORGANIZATION: 
National Institute for Occupational Safety and Health (NIOSH) 
 (http://www.cdc.gov/niosh/homepage.html)

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

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): CFDA 93.262

LETTER OF INTENT RECEIPT DATE: December 17, 2003
APPLICATION RECEIPT DATE: January 23, 2004

THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Research Objectives
o Mechanism(s)of Support 
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements 
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Supplementary Instructions
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS RFA

The National Institute for Occupational Safety and Health (NIOSH), Centers for 
Disease Control and Prevention (CDC), invites grant applications for studies 
that will contribute to the understanding of the risks of exposure to blood 
among health care workers employed in home health care settings.  Such 
information will contribute significantly to an understanding not only of the 
risk for such exposures, but the development of effective intervention 
strategies. Because little is known about the incidence of blood exposures in 
home health care workers, this RFA has an emphasis on research that examines 
the incidence of exposures to blood, risk factors associated with such 
exposures, and the availability and use of medical safety devices. 

A special feature of this RFA is encouraging applications from researchers and 
from membership organizations comprised of health care workers, such as unions 
and professional organizations, and collaboration among these groups.

RESEARCH OBJECTIVES

Background

There are nearly twelve million health care workers employed in the United 
States. It is estimated that there are approximately 20,000 home care 
providers (agencies) serving more than 7 million individuals each year. Health 
care workers are at risk of infection from blood-borne pathogens, particularly 
human immunodeficiency virus (HIV), hepatitis B virus, and hepatitis C virus. 
As of December 2001, the CDC was aware of 57 health care workers in the U.S. 
who had been documented as having sero-converted to HIV following occupational 
exposures.  Approximately 83% of exposures to blood reported by hospital-based 
health care workers are by percutaneous injury (i.e., needlestick and sharps 
injuries).  Mucous membrane exposure accounts for about 13%, skin 3%, and bite 
1%.  Precise national data are not available on the annual number of 
needlesticks and other percutaneous injuries among health care workers since 
it has been estimated that about half of these injuries go unreported. 
Virtually all of the information on the occurrence of needlestick and sharps 
injuries is based on hospital workers.  However, it has been estimated that 
600,000 to 800,000 such injuries occur annually.  In addition to the serious 
health consequences of this injury, the emotional impact of a needlestick 
injury can be severe and long lasting, even when a serious infection is not 
transmitted.   

In order to address this public health problem in the context of occupational 
injuries, past studies have shown that certain information about blood 
exposures need to be considered in a survey design, including relevant 
demographic information about survey respondents, general information about 
past exposures to blood, and details about the circumstances of recent 
exposures.  For recent exposures to blood, at least eight critical areas of 
information have been shown to be important.  These include: 1) route of 
exposure, 2) activity during and timing of exposure, 3) specific medical 
device being used, 4) relevant characteristics of the source patient, 5) 
reasons why the exposure either was or was not reported, 6) suggestions on how 
to improve reporting of injuries, 7) whether respondents obtained post-
exposure prophylactic treatment, and 8) precautions that would have prevented 
the exposure.

Another critical area for inclusion in such studies is an assessment of past 
exposures experienced by employees and, in order to assess under-reporting, 
the percentage of exposures reported to the worker=s employer via standard 
procedures.

NIOSH has set a goal to describe the occurrence of exposure to blood among 
home health care workers in order to subsequently identify appropriate 
interventions to reduce the future incidence of exposure to blood-borne 
pathogens.  This RFA is the first step to accomplish this goal. 

Research Objectives

The objective of this RFA is to support research on the incidence of and risk 
factors for exposures to blood among home health care workers.  Among the 
issues that need to be understood are the significant factors that affect 
blood exposures such as rate of exposure from needlestick and sharps injuries, 
other routes of exposure, and the prevalence and use of medical safety 
devices. Research projects should address this occupational issue in an 
integrated and comprehensive manner in order that the risk of these exposures 
in home health care workers can be understood. In designing their studies, 
applicants may consider the inclusion of these data elements in the study 
design: the incidence rate of exposure to blood from needlestick and sharps 
injuries and other routes of exposure among home health care workers; risk 
factors for these exposures; and the prevalence of medical safety device 
availability and usage.  The applicant should justify the survey sample size. 
  
Investigators may wish to consider conducting either a retrospective or 
prospective survey of an entire or random sample of a population of home 
health care workers to estimate numbers of exposures and incidence rates by 
occupation, setting, medical device, and the availability and usage of medical 
safety devices.  An important element that investigators may wish to include 
in the study design is a comparison of risk factors, rates of exposure, and 
availability/use of medical safety devices between these workers and hospital 
health care workers; however, the focus of this RFA is on non-hospital 
settings. 

Investigators may also wish to include in the study design approaches for 
estimating the availability and usage of medical safety devices in home care 
settings.  Another element that investigators may wish to consider is the rate 
of vaccination against hepatitis B virus and compliance with recommendations 
for post-exposure prophylaxis for hepatitis B virus and human immunodeficiency 
virus.  Applicants should also consider, study design methods for data 
collection that do not rely solely upon employers= or health services= records 
to reduce the potential for study bias due to under-reporting of needlestick 
injuries.  However, an investigator may wish to supplement a survey of home 
health care workers with a review of injury records kept by employers.

MECHANISM OF SUPPORT

This RFA will use NIOSH R01 award mechanism.  As an applicant you will be 
solely responsible for planning, directing, and executing the proposed 
project.  This RFA is a one-time solicitation.  Future unsolicited, competing-
continuation applications based on this project will compete with all 
investigator-initiated applications and will be reviewed according to the 
customary peer review procedures. The anticipated award date is July 1, 2004. 
Applications that are not funded in the competition described in this RFA may 
be resubmitted as NEW investigator-initiated applications using the standard 
receipt dates for NEW applications described in the instructions to the PHS 
398 application.

This RFA uses just-in-time concepts.  It also uses the non-modular budgeting 
formats.  Follow the instructions for non-modular budget research grant 
applications.  This program does not require cost sharing as defined in the 
current NIH Grants Policy Statement at 
http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm.  
                   
FUNDS AVAILABLE

NIOSH intends to commit approximately $1,000,000 in FY 2004 to fund 2 to 4 new 
and/or competitive continuation grants in response to this RFA.  An applicant 
may request a project period of up to 4 years and a budget for direct costs of 
up to $400,000 per year.  Applications exceeding $400,000 in direct costs in 
any year will be considered unresponsive and returned without further 
consideration. Because the nature and scope of the proposed research will vary 
from application to application, it is anticipated that the size and duration 
of each award will also vary.  Although the financial plans of NIOSH provide 
support for this program, awards pursuant to this RFA are contingent upon the 
availability of funds and the receipt of a sufficient number of meritorious 
applications.

ELIGIBILITY INSTITUTIONS

You may submit (an) application(s) if your institution has any of the 
following characteristics:
   
o For-profit or non-profit organizations 
o Public or private institutions, such as universities, colleges, hospitals, 
and laboratories 
o Units of State and local governments
o Eligible agencies of the Federal government  
o Domestic institutions/organizations
o Foreign institutions/organizations are not eligible to apply
o Faith-based or community-based organizations 

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

Individuals with the skills, knowledge, and resources necessary to carry out 
the proposed research are invited to work with their institutions to develop 
an application for support.  Individuals from underrepresented racial and 
ethnic groups as well as individuals with disabilities are always encouraged 
to apply for NIOSH programs.

Note: Title 2 United States Code section 1611 states that an organization 
described in section 501(c)(4) of the Internal Revenue Code that engages in 
lobbying activities is not eligible to receive Federal funds constituting an 
award, grant, or loan.

SPECIAL REQUIREMENTS

Applicants should fully describe the plan to recruit study sites across an 
industry (to characterize exposures in that industry) and to enroll workers 
willing to participate in the study.  Letters of cooperation from employers 
and unions would provide some measure of the anticipated success of the plan.

The following should be addressed in a clear and organized manner (see also 
peer review criteria section):

o Timeline: a detailed timeline for the proposed study must be included in the 
application.

o In a separate section labeled, “Participant Notification of Study Results,” 
the applicant should describe plans for notifying participants about their 
individual results and the overall results of the study. 

Applicants should highlight unique expertise and/or unusual opportunities as 
related to the purpose of this RFA.  Examples include, but are not limited to: 

o Expertise in specialized areas with potential applications to the 
issues/questions considered in this RFA, conducting epidemiologic field 
studies of working populations, experience in traumatic injuries.

o Access to a range of work sites varied enough to characterize the industry 
being studied, and to workers at those sites who are willing to participate in 
studies of needlestick and sharps injuries.

o Expertise in assessing needlestick and sharps injuries along with 
contributing risk factors in individual job settings, as well as documentation 
of all non-hospital health care exposures.

o Expertise in the clinical assessment of psychological factors associated 
with traumatic injuries, such as needlestick and sharps injuries.

o Expertise in negotiating with work site management and unions in field 
settings.

WHERE TO SEND INQUIRIES

We encourage inquiries concerning this RFA and welcome the opportunity to 
answer questions from potential applicants. Inquiries may fall into three 
areas: scientific/research, peer review, and financial or grants management 
issues:  

o Direct your questions about scientific/research issues to:

Adele M. Childress, Ph.D., M.S.P.H
Scientific Program Administrator
Office of Extramural Programs
Centers for Disease Control and Prevention
National Institute for Occupational Safety and Health
1600 Clifton Road, N.E.
Building 24, Room 1537, MS E-74
Atlanta, GA  30333
Telephone:  (404) 498-2509
FAX:  (404) 498-2571
Email: achildress@cdc.gov

o Direct your questions about peer review issues to:

Pervis C. Major, Ph.D.
Scientific Review Administrator
Office of Extramural Programs
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention (CDC)
1095 Willowdale Rd
Morgantown, WV 26505
Telephone 304-285-5979
Fax 304-285-6147
Email: pmajor@cdc.gov 

o Direct inquiries about financial or grants management matters to:

Ms. Cynthia Mitchell, Contract Specialist
Acquisition and Assistance Field Branch
Centers for Disease Control and Prevention 
626 Cochrans Mill Road
Pittsburgh, Pennsylvania 15236-0070
Announcement Number OH-04-001
Telephone:  (412) 386-6434
Email: CMitchell@cdc.gov

LETTER OF INTENT

Prospective applicants are asked to submit a letter of intent that includes 
the following information:

o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel
o Participating institutions
o Number and title of this RFA

Although a letter of intent is not required, is not binding, and does not 
enter into the review of an application, the information that it contains is 
used to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed at the beginning of this 
document and should be sent by mail to: 

Pervis C. Major, Ph.D.
Scientific Review Administrator
Office of Extramural Programs
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention (CDC)
1095 Willowdale Rd
Morgantown, WV 26505
Telephone 304-285-5979
Fax 304-285-6147
Email: pmajor@cdc.gov 

SUBMITTING AN APPLICATION   

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001). Applications must have a DUN and 
Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the 
Universal Identifier when applying for Federal grants or cooperative 
agreements. The DUNS number can be obtained by calling (866) 705-5711 or 
through the web site at http://www.dunandbradstreet.com/. The DUNS number 
should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 
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:

If the proposed project involves organizations or persons other than those 
affiliated with the applicant organization, letters of support and/or 
cooperation must be included. 

USING THE RFA LABEL: The RFA label, available in the PHS 398 (rev.5/2001) 
application form, must be affixed to the bottom of the face page of the 
application.  Type the RFA number on the label.  Failure to use this label 
could result in delayed processing of the application such that it may not 
reach the review committee in time for review.  In addition, the RFA title and 
number must be typed on line 2 of the face page of the application form and 
the YES box must be marked. The RFA label is also available at: 
http://grants.nih.gov/grants/funding/phs398/labels.pdf.

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

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

At the time of submission, two additional copies of the application and all 
copies of appendix material must also be sent to:

Pervis C. Major, Ph.D.
Scientific Review Administrator
Office of Extramural Programs
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention (CDC)
1095 Willowdale Rd
Morgantown, WV 26505
Telephone 304-285-5979
Fax 304-285-6147
Email: pmajor@cdc.gov 

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

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

The Center for Scientific Review (CSR) will not accept any application in 
response to this RFA that is essentially the same as one currently pending 
initial review, unless the applicant withdraws the pending application.  
However, when a previously unfunded application, originally submitted as an 
investigator-initiated application, is to be submitted in response to an RFA, 
it is to be prepared as a NEW application.  That is, the application for the 
RFA must not include an Introduction describing the changes and improvements 
made, and the text must not be marked to indicate the changes from the 
previous unfunded version of the application.  

PEER REVIEW PROCESS

Upon receipt, applications will be reviewed for completeness by CSR and 
responsiveness by NIOSH.  Incomplete and/or nonresponsive applications will 
not be reviewed.

Applications that are complete and responsive to the RFA will be evaluated for 
scientific and technical merit by a scientific review group convened by NIOSH 
in accordance with the review criteria stated below.  As part of the initial 
merit review, all applications will:

o Undergo a process in which only those applicants deemed to have the highest 
scientific or technical merit, generally the top half of the applications 
under review, will be discussed and assigned a priority score.
o Receive a written critique.
o Receive a second level of review by the NIOSH Secondary Review Committee.

REVIEW CRITERIA

The goals of NIOSH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  In 
the written comments, reviewers will be asked to evaluate the application in 
order to judge the likelihood that the proposed research will have a 
substantial impact on the pursuit of these goals. The scientific review group 
will address and consider each of the following criteria in assigning the 
application’s overall score, weighting them as appropriate for each 
application. 

o Significance
o Approach
o Innovation
o Investigator
o Environment

The application does not need to be strong in all categories to be judged 
likely to have major scientific impact and thus deserve a high priority score. 
For example, it may propose to carry out important work that by its nature is 
not innovative but essential to move a field forward.

SIGNIFICANCE:  Does the proposed research project satisfy an important public 
health, occupational health, or infection control need?   

APPROACH:  Are the conceptual framework, design, methods, and analyses 
adequately developed, well integrated, and appropriate to the aims of the 
project?  Does the applicant acknowledge potential problem areas and consider 
alternative approaches?  Will the research project be able to provide reliable 
estimates of the incidence rate of exposure to blood, particularly needlestick 
and sharps injuries?  Will the research project be able to identify risk 
factors for exposures to blood?  Will the research project be able to estimate 
the availability and use of medical safety devices among the facilities 
employing the respondents?   Does the applicant include health care workers in 
occupations (within-home-care settings) with potentially the highest incidence 
rates of needlestick injury?  Does the applicant demonstrate access to health 
care workers who are at high risk of occupational exposure to blood, including 
letters of support from organizations facilitating access to these workers?  
Does the applicant justify the proposed sample size and statistical power 
calculations?   

INNOVATION:  Does the project employ novel concepts, approaches, or methods?  
Is the project original and innovative?  Does the project develop new 
methodologies? 

INVESTIGATORS:  Are the principal investigator and her/his collaborators 
appropriately trained and well suited to carry out this work?  Do they have 
adequate experience in the areas of occupational health, infection control, 
epidemiology, and project management to carry out this work?  Is the work 
proposed appropriate to the experience level of the principal investigator and 
her/his collaborators?

ENVIRONMENT:  Are the applicant’s facilities, equipment, and other resources 
adequate for the performance of this project?  Is there evidence of 
institutional support?  Are the methods for assuring privacy and maintaining 
confidentiality of participant records, including specific protections for 
Internet-based data systems adequate?

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

PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human 
subjects and protections from research risk relating to their participation in 
the proposed research will be assessed. (See criteria included in the section 
on Federal Citations, below).
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm

INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans 
to include subjects from all genders, all racial and ethnic groups (and 
subgroups), and children as appropriate for the scientific goals of the 
research will be assessed.  Plans for the recruitment and retention of 
subjects will also be evaluated. (See Inclusion Criteria in the sections on 
Federal Citations, below).

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

ADDITIONAL REVIEW CONSIDERATIONS 

Scientific Review Criteria

o BUDGET: The reasonableness of the proposed budget and the requested period 
of support in relation to the proposed research.  

o Availability of special opportunities for furthering research programs 
through the use of unusual talent resources, populations, or environmental 
conditions in other countries which are not readily available in the United 
States or which provide augmentation of existing U.S. resources.  

Programmatic Review Criteria

o Magnitude of the problem in terms of numbers of workers affected.
o Severity of the disease or injury in the worker population.
o Likelihood of developing applied technical knowledge for the prevention of 
occupational safety and health hazards.

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date: December 17, 2003
Application Receipt Date: January 23, 2004
Earliest Anticipated Start Date: July 1, 2004

AWARD CRITERIA

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

o Scientific merit
o Availability of funds
o Programmatic priorities

REQUIRED FEDERAL CITATIONS

HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that 
applications and proposals involving human subjects must be evaluated with 
reference to the risks to the subjects, the adequacy of protection against 
these risks, the potential benefits of the research to the subjects and 
others, and the importance of the knowledge gained or to be gained.
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm

DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for 
all types of clinical trials, including physiologic, toxicity, and dose-
finding studies (phase I); efficacy studies (phase II), efficacy, 
effectiveness and comparative trials (phase III). The establishment of data 
and safety monitoring boards (DSMBs) is required for multi-site clinical 
trials involving interventions that entail potential risk to the participants. 
(NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and 
Contracts, June 12, 1998: 
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).  

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

All investigators proposing clinical research should read the "NIH Guidelines 
for Inclusion of Women and Minorities as Subjects in Clinical Research - 
Amended, October, 2001," published in the NIH Guide for Grants and Contracts 
on October 9, 2001 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); 
a complete copy of the updated Guidelines are available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. 
The amended policy incorporates: the use of an NIH definition of clinical 
research; updated racial and ethnic categories in compliance with the new OMB 
standards; clarification of language governing NIH-defined Phase III clinical 
trials consistent with the new PHS Form 398; and updated roles and 
responsibilities of NIH staff and the extramural community.  The policy 
continues to require for all NIH-defined Phase III clinical trials that: a) 
all applications or proposals and/or protocols must provide a description of 
plans to conduct analyses, as appropriate, to address differences by 
sex/gender and/or racial/ethnic groups, including subgroups if applicable; and 
b) investigators must report annual accrual and progress in conducting 
analyses, as appropriate, by sex/gender and/or racial/ethnic group 
differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: 
The NIH maintains a policy that children (i.e., individuals under the age of 
21) must be included in all human subjects’ research, conducted or supported 
by the NIH, unless there are scientific and ethical reasons not to include 
them. This policy applies to all initial (Type 1) applications submitted for 
receipt dates after October 1, 1998.

All investigators proposing research involving human subjects should read the 
"NIH Policy and Guidelines" on the inclusion of children as participants in 
research involving human subjects that is available at 
http://grants.nih.gov/grants/funding/children/children.htm

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

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

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

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

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

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

LOBBYING RESTRICTIONS: Applicants should be aware of restrictions on the use 
of Health and Human Services (DHHS) funds for lobbying of Federal or State 
legislative bodies.  Under the provisions of 31 U.S.C. Section 1352, 
recipients (and their subtier contractors)are prohibited from using 
appropriated Federal funds (other than profits from a Federal contract) for 
lobbying congress or any Federal agency in connection with the award of a 
particular contract, grant, cooperative agreement, or loan.  This includes 
grants/cooperative agreements that, in whole or in part, involve conferences 
for which Federal funds cannot be used directly or indirectly to encourage 
participants to lobby or to instruct participants on how to lobby.

In addition, no part of the Centers for Disease Control and Prevention (CDC) 
appropriated funds shall be used, other than for normal and recognized 
executive-legislative relationships, for publicity or propaganda purposes, for 
the preparation, distribution, or use of any kit, pamphlet, booklet, 
publication, radio, television, or video presentation designed to support or 
defeat legislation pending before the Congress or any State or local 
legislature, except in presentation to the Congress or any State or local 
legislature itself.  No part of the appropriated funds shall be used to pay 
the salary or expenses of any grant or contract recipient, or agent acting for 
such recipient, related to any activity designed to influence legislation or 
appropriations pending before the Congress or any State or local legislature.

Any activity designed to influence action in regard to a particular piece of 
pending legislation would be considered “lobbying.”  That is lobbying for or 
against pending legislation, as well as indirect or “grass roots: lobbying 
efforts by award recipients that are directed at inducing members of the 
public to contact their elected representatives at the Federal or State levels 
to urge support of, or opposition to, pending legislative proposals is 
prohibited.  As a matter of policy, CDC extends the prohibitions to lobbying 
with respect to local legislation and local legislative bodies.

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

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

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

HEALTHY PEOPLE 2010: The CDC is committed to achieving the health promotion 
and disease prevention objectives of "Healthy People 2010," a national 
activity for reducing morbidity and mortality and improving the quality of 
life. This RFA is related to one or more focus areas. Potential applicants may 
obtain a copy of "Healthy People 2010" at http://www.healthypeople.gov/.

AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal 
Domestic Assistance at http://www.cfda.gov/ and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  Awards are made under the authorization of Sections 
301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284), 
the Occupational Safety and Health Act of 1970, Section 20(a)[29 USC 669(a)], 
and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards 
are subject to the terms and conditions, cost principles, and other 
considerations described in the NIH Grants Policy Statement.  The NIH Grants 
Policy Statement can be found at 
http://grants.nih.gov/grants/policy/policy.htm. 

The PHS strongly encourages all grant recipients to provide a smoke-free 
workplace and discourage the use of all tobacco products.  In addition, Public 
Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain 
facilities (or in some cases, any portion of a facility) in which regular or 
routine education, library, day care, health care, or early childhood 
development services are provided to children.  This is consistent with the 
PHS mission to protect and advance the physical and mental health of the 
American people.

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