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) 710-0267, 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.


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