RFA-OH-02-011: WORKPLACE VIOLENCE PREVENTION RESEARCH

WORKPLACE VIOLENCE PREVENTION RESEARCH RELEASE DATE: May 2, 2002 RFA: OH-02-011 (This RFA has been modified, see RFA-OH-06-004) PARTICIPATING INSTITUTES AND CENTERS (ICs): National Institute for Occupational Safety and Health (NIOSH) Centers for Disease Control and Prevention (CDC) (http://www.cdc.gov/niosh/homepage.html) LETTER OF INTENT RECEIPT DATE: June 11, 2002 APPLICATION RECEIPT DATE: July 11, 2002 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of the RFA o Research Objectives o Useful References o Mechanism(s)of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigations o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Programmatic 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) announces the availability of funds for fiscal year (FY) 2002 for research grant (R01) applications to support innovative research designed to reduce future health and safety impacts associated with violence in the workplace. The purpose of this announcement is to enhance existing knowledge and improve the safety and health of workers by supporting research on workplace violence which addresses risk factors, development of new interventions, and evaluation of existing interventions. RESEARCH OBJECTIVES Background In the 9-year period from 1992 through 2000, there were an average of 896 workplace homicides in the U.S. each year, ranging from a high of 1,080 in 1994 to a low of 651 in 1999. The most common scenario of workplace homicide was a retail worker killed during the course of a robbery or other crime. Taxicab drivers have the very highest rates of workplace homicide. Other circumstances or perpetrators of workplace homicides include co-workers or former co-workers, customers, clients or patients, and current or former domestic partners. From 1993 to 1999, there were an average 1.7 million nonfatal violent victimizations in the U.S. each year, accounting for 18% of all violent crime during the 7-year period. Of the occupations for which data were available, police officers had the highest rate of workplace violent crime at 261 per 1,000 persons, followed by corrections officers (156 per 1,000) and taxicab drivers (128 per 1,000). The vast majority (75%) of the violent victimizations were simple assaults. Although the risks for fatal workplace violence have been more completely described and recognized over the last decade, there remain a number of questions regarding the nature, magnitude and impact of workplace violence, especially with regard to nonfatal events. As well, with increasing recognition of the problem, employers, workers, labor unions, and others have developed and implemented a range of strategies to address the risk factors for workplace violence. Unfortunately, however, there has been little rigorous evaluation of the effectiveness of the range of efforts undertaken to date. Therefore, regulators, employers, workers, and safety and health professionals do not know the most effective components of a violence prevention program, either generally or for specific high-risk settings. In April 2000, the University of Iowa sponsored a Workplace Violence Intervention Research Workshop in Washington, DC. One of the fundamental organizing principles from the workshop is that research and prevention efforts may be more clearly understood when workplace violence is divided into four categories: Criminal Intent (Type I) when the perpetrator has no legitimate relationship to the business and is usually committing a crime in conjunction with the violence, Customer/Client (Type II) when the perpetrator has a legitimate relationship with the business and becomes violent while being served by the business, Worker-on- Worker (Type III) when the perpetrator is an employee or past employee of the business who attacks or threatens another employee, and Personal Relationship (Type IV) when the perpetrator does not have a relationship with the workplace, but has a personal relationship with the intended victim. "Workplace Violence: A Report to the Nation" identifies important research questions in each of these four categories. Research Goals Despite efforts on the part of researchers and others in government, industry, labor, and academia, our knowledge regarding the incidence and distribution of workplace violence, especially nonfatal workplace violence, is still incomplete. As well, there has been little rigorous scientific research on the development of new interventions and the effectiveness of existing strategies for the reduction of workplace violence. Risk factor studies are especially needed on nonfatal workplace violence of all four types. There is a particular dearth of information on organizational factors and the risks for workplace violence. Scientific research for the development of new interventions is also needed. Intervention evaluation proposals should include both process and outcome measures. Process measures should be detailed enough to allow for replication of the intervention. Outcome measures of interest include, but are not limited to: incidence, distribution, and magnitude of workplace violence among various worker populations and the costs of workplace violence to victims (i.e. workers), employers, and society. Research proposals need to indicate that the study design and size is sufficient to produce generalizeable results, to detect intervention effects, and to distinguish changes in outcomes of interest from the intervention with confounding variables, such as natural changes, extraneous events, etc. Proposals that focus on or include intervention evaluation will be given priority. USEFUL REFERENCES In April 2000, with funding from the National Institute for Occupational Safety and Health and the National Center for Injury Prevention and Control, the University of Iowa sponsored a Workplace Violence Intervention Research Workshop in Washington, DC. Thirty-seven invited participants representing industry, organized labor, municipal, state, and federal governments, and academia gathered to review the state of knowledge regarding workplace violence and to make recommendations for research. Theme papers from the workshop addressing the roles of surveillance and evaluation research, legislation, and regulation as well as business and labor perspectives on workplace violence were published in the February 2001 issue of the American Journal of Preventive Medicine. The discussions and recommendations from the workshop were summarized in "Workplace Violence: A Report to the Nation" published in February 2001. The full report is available at www.public-health.uiowa.edu/iprc MECHANISM OF SUPPORT The administrative and funding instrument to be used for this program will be a research grant (R01). The total requested project period for an application submitted in response to this RFA may not exceed five (5) years. The award and level of support depends on the receipt of applications of high scientific merit. Although this program is provided for in the financial plans of NIOSH, the award pursuant to this RFA is contingent upon the availability of funds for this purpose. This RFA uses just-in-time concepts. This RFA uses the detailed budget format rather than the modular budget format. FUNDS AVAILABLE NIOSH intends to commit approximately $1,500,000 in FY 2002 to fund 4-7 research grant awards (R01). The maximum amount that may be requested is $250,000 in direct costs for both risk factor research and new intervention research and $400,000 in direct costs for intervention evaluation research. Awards will be made for a twelve-month budget period within a project period up to three (3) years for both risk factor and new intervention research and up to five (5) years for intervention evaluation research. USE OF FUNDS Applicants should include in their budgets funds for one trip per year for an annual meeting of grantees to provide an opportunity for the exchange of program and scientific information, to be held in Morgantown, WV. 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 or foreign Note: Title 2 of the 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. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from under-represented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIOSH programs. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into two areas: scientific/research and financial or grants management issues. This RFA and other CDC Announcements can be found on the CDC HomePage (www.cdc.gov) under the Funding section (see Grants and Cooperative Agreements scroll down to Occupational Safety and Health). This RFA can also be found on the NIOSH HomePage (www.cdc.gov/niosh) under Funding Opportunities. Direct inquiries regarding programmatic issues to: Lee M. Sanderson, 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 1429, MS E-74 Atlanta, GA 30333 Telephone: 404/498-2546 FAX: 404/498-2571 Email: lsanderson@cdc.gov Direct inquiries regarding grants management business matters to: Mildred Garner or Robert Williams Announcement Number OH-02-010 Grants Management Branch, Procurement and Grants Office Centers for Disease Control and Prevention (CDC) 2920 Brandywine Road, Suite 3000 Atlanta, Georgia 30341 Telephone: 770-488-2745 or 770-488-2656 Email: mgarner@cdc.gov or rww8@cdc.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent by June 11, 2002, 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 should be sent to: Gwendolyn Cattledge, Ph.D., M.S.E.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 1423, MS E-74 Atlanta, GA 30333 Telephone: 404/498-2508 FAX: 404/498-2571 Email: gcattledge@cdc.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at https://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. Information to prepare a detailed budget is provided in the 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: https://grants.nih.gov/grants/funding/phs398/labels.pdf SENDING AN APPLICATION TO NIOSH: Submit a signed, typewritten original of the application, including the Checklist, and three signed photocopies, in one package to: Center for Scientific Review (CSR) National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must also be sent to: Gwendolyn Cattledge, Ph.D., M.S.E.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 1423, MS E-74 Atlanta, GA 30333 Telephone: 404/498-2508 FAX: 404/498-2571 Email: gcattledge@cdc.gov APPLICATION PROCESSING: Applications must be received by July 11, 2002. If an application is received after that date, it will be returned to the applicant without review. The CDC and NIOSH 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. CDC and NIOSH 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 application already reviewed, but such an application must include an introduction addressing the previous critique. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by CDC and responsiveness by NIOSH. Incomplete or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by 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 Receive a written critique 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 second level of review by the NIOSH Secondary Review Committee. REVIEW CRITERIA The criteria that NIOSH will use to review applications for scientific merit and for meeting program objectives are provided below. In the written comments, reviewers will be asked to discuss the following aspects of your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment o Other 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 essential to move a field forward. (1) SIGNIFICANCE: Did the applicant communicate the public health importance of occupational violence? Have the broad, long-term objectives of the project and expected accomplishments been defined? Does this research address an important problem related to the topical research issues outlined in this announcement? Does the application describe the importance of the proposed research and the role it will play in reducing the occupational safety burden of violence in the workplace? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of this research on the concepts or methods that drive this field? (2) APPROACH: Are the conceptual framework, design (including composition of study population), 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? Is the time line proposed for the project suitable and realistic? (3) 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? (4) INVESTIGATORS: Are the principal investigator and collaborators appropriately trained and well-suited to carry out this work? Is the research proposed appropriate to the experience level of the principal investigator and other researchers? (5) ENVIRONMENT: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there documentation of cooperation from industry, unions, communities, or other participants in the project, where applicable? Is there evidence of institutional support and availability of resources necessary to perform the project? (6) OTHER: Adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the project. The adequacy of the proposed protection of humans to the extent that they may be adversely affected by the project proposed in the application. Does the applicant fully describe the involvement of human subjects and protections? The reasonableness of the proposed budget and duration to the proposed research. PROGRAMMATIC REVIEW CRITERIA (1) Magnitude and severity of the condition (problem) in the worker population. (2) Likelihood of developing applied technical knowledge for the prevention of occupational safety and health hazards on a national or regional basis. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: June 11, 2002 Application Receipt Date: July 11, 2002 Anticipated Award Date: September 30,2002 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit o Availability of funds o Programmatic priorities o Program balance for the three study types (priority for funding at least one risk factor research project, one intervention research project and one intervention evaluation project) provided applications are of sufficient scientific merit. REQUIRED FEDERAL CITATIONS INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS: It is the policy of the CDC to ensure that individuals of both sexes and the various racial and ethnic groups will be included in CDC-supported research projects involving human subjects, whenever feasible and appropriate. Racial and ethnic groups are those defined in OMB Directive No. 15 and include American Indian or Alaska Native, Asian, Black or African American, Hispanic or Latino, Native Hawaiian or other Pacific Islander. Applicants shall ensure that women, racial and ethnic minority populations are appropriately represented in applications for research involving human subjects. Where clear and compelling rationale exist that inclusion is inappropriate or not feasible, this situation must be explained as part of the application. This policy does not apply to research studies when the investigator cannot control the race, ethnicity, and/or sex of subjects. Further guidance to this policy is contained in the Federal Register, Vol. 60, No. 179, pages 47947-47951, and dated Friday, September 15, 1995. All investigators proposing research involving human subjects should read the NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research-Amended, October 9, 2001, published in the NIH Guide for Grants and Contracts on October 9, 2001, https://grants.nih.gov/grants/funding/women_min/women_min.htm .,a complete copy of the updated Guidelines are available at https://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: It is the policy of NIH 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. This policy will be followed by NIOSH for this announcement. 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 https://grants.nih.gov/grants/funding/children/children.htm Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: If the proposed project involves research on human subjects, the applicant must comply with the Department of Health and Human Services (DHHS) Regulations (Title 45 Code of Federal Regulations Part 46) regarding the protection of human research subjects. All awardees of CDC grants and cooperative agreements and their performance sites engaged in human subjects research must file an assurance of compliance with the regulations and have continuing reviews of the research protocol by appropriate institutional review boards. In order to obtain a federal-wide Assurance (FWA) of Protection for Human Subjects, the applicant must complete an on-line application at the Office for Human Research Protections (OHRP) website or write to the OHRP for an application. OHRP will verify that the signatory official and the Human Subjects Protections Administrator have completed the OHRP Assurance Training/Education Module before approving the FWA. Existing Multiple Project Assurances (MPAs), Cooperative Project Assurances (CPAs), and Single Project Assurances (SPAs) remain in full effect until they expire or until December 31, 2003, whichever comes first. To obtain a FWA contact the OHRP at: http://www.hhs.gov/ohrp/assurances/assurances_index.html or write to: Office for Human Research Protections (OHRP) Department of Health and Human Services 6100 Executive Boulevard, Suite 3B01, MSC 7501 Rockville, Maryland 20892-7507 (Note: For Express or Hand Delivered Mail, Use Zip Code 20852) Note: In addition to other applicable committees, Indian Health Service (IHS) institutional review committees must also review the project if any component of IHS will be involved with or will support the research. If any American Indian community is involved, its tribal government must also approve the applicable portion of that project. Note: Investigators in states with existing statutes covering guidance for the protection of humans, will be asked to submit documentation detailing fully the state authority. If a state does not have statutory authority for all the human subjects activities proposed in the application, the awardee must obtain human subject clearances as described above. The project plan in the application must fully describe the involvement of human subjects and protections. This information should be included in the Human Subjects Research Section of PHS 398. 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-(45 CFR 74.36) 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. Guidance is provided at: https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm Applicants may wish to place data collected under this RFA 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. URLS IN NIOSH GRANT APPLICATIONS OR APPENDICES: All applications and proposals must be self-contained within specified page limitations. Unless otherwise specified, 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. Reviewers are cautioned 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 Center for Disease Control and Prevention (CDC) appropriated funds shall be used, other than for normal and recognized executive-legislative relationships, for publicity or propaganda purposes, for the preparation, distribution, or use of any kit, pamphlet, booklet, publication, radio, television, or video presentation designed to support or defeat legislation pending before the Congress or any State or local legislature, except in presentation to the Congress or any State or local legislature itself. No part of the appropriated funds shall be used to pay the salary or expenses of any grant or contract recipient, or agent acting for such recipient, related to any activity designed to influence legislation or appropriations pending before the Congress or any State or local legislature. Any activity designed to influence action in regard to a particular piece of pending legislation would be considered lobbying. That is lobbying for or against pending legislation, as well as indirect or grass roots: lobbying efforts by award recipients that are directed at inducing members of the public to contact their elected representatives at the Federal or State levels to urge support of, or opposition to, pending legislative proposals is prohibited. As a matter of policy, CDC extends the prohibitions to lobbying with respect to local legislation and local legislative bodies. The provisions are not intended to prohibit all interaction with the legislative branch, or to prohibit educational efforts pertaining to public health. Clearly there are circumstances when it is advisable and permissible to provide information to the legislative branch in order to foster implementation of prevention strategies to promote public health. However, it would not be permissible to influence, directly or indirectly, a specific piece of pending legislation. It remains permissible to use CDC funds to engage in activity to enhance prevention, collect and analyze data, publish and disseminate results of research and surveillance data, implement prevention strategies, conduct community outreach services, provide leadership and training, and foster safe and 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. SMOKE-FREE WORKPLACE: CDC strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products, and Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities that receive Federal funds in which education, library, day care, health care, and early childhood development services are provided to children. SMALL, MINORITY, AND WOMEN-OWNED BUSINESS: It is a national policy to place a fair share of purchases with small, minority and women-owned business firms. The Department of Health and Human Services is strongly committed to the objective of this policy and encourages all recipients of its grants and cooperative agreements to take affirmative steps to ensure such fairness. In particular, recipients should: 1. Place small, minority, women-owned business firms on bidders mailing lists. 2. Solicit these firms whenever they are potential sources of supplies, equipment, construction, or services. 3. Where feasible, divide total requirements into smaller needs, and set delivery schedules that will encourage participation by these firms. 4. Use the assistance of the Minority Business Development Agency of the Department of Commerce, the Office of Small and Disadvantaged Business Utilization, DHHS, and similar state and local offices. RESEARCH INTEGRITY: The signature of the institution official on the face page of the application submitted under this Program Announcement is certifying compliance with the Department of Health and Human Services (DHHS) regulations in Title 42 Part 50, Subpart A, entitled Responsibility of PHS Awardee and Applicant Institutions for Dealing with and Reporting Possible Misconduct in Science. The regulation places several requirements on institutions receiving or applying for funds under the PHS Act that are monitored by the DHHS Office of Research Integrity"s (ORI) Assurance Program. For examples: Section 50.103(a) of the regulation states: Each institution that applies for or receives assistance under the Act for any project or program which involves the conduct of biomedical or behavioral research must have an assurance satisfactory to the Secretary (DHHS) that the applicant: (1) Has established an administrative process, that meets the requirements of this subpart, for reviewing, investigating, and reporting allegations of misconduct in science in connection with PHS- sponsored biomedical and behavioral research conducted at the applicant institution or sponsored by the applicant, and (2) Will comply with its own administrative process and the requirements of this Subpart. Section 50.103(b) of the regulation states that: an applicant or recipient institution shall make an annual submission to the [ORI] as follows: (1) The institution"s assurance shall be submitted to the [ORI], on a form prescribed by the Secretary,...and updated annually thereafter...(2) An institution shall submit, along with its annual assurance, such aggregate information on allegations, inquiries, and investigations as the Secretary may prescribe. HEALTHY PEOPLE 2010: CDC is committed to achieving the health promotion and disease prevention objectives of Healthy People 2010, a national activity to reduce morbidity and mortality and improve the quality of life. For the conference copy of Healthy People 2010, visit the internet site: http://www.health.gov/healthypeople/default.htm AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance Number 93.262 for the National Institute for Occupational Safety and Health (NIOSH). This program is authorized under the Public Health Service Act, as amended, Section 301(a) [42 U.S.C. 241(a)], and the Occupational Safety and Health Act of 1970, Section 20(a) [29 U.S.C. 669(a)]. The applicable program regulation is 42 CFR Part 52. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency Review.

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