CHILDHOOD AGRICULTURAL SAFETY AND HEALTH RESEARCH RELEASE DATE: March 20, 2003 RFA: OH-03-003 (This RFA has been modified, see RFA-OH-07-002) LETTER OF INTENT RECEIPT DATE: April 18, 2003 APPLICATION RECEIPT DATE: May 23, 2003 National Institute for Occupational Safety and Health, (NIOSH), Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (http://www.cdc.gov/niosh/homepage.html) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): CFDA 93.956 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of the RFA o Research Objectives o Mechanism(s)of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA The Centers for Disease Control and Prevention (CDC), National Institute for Occupational Safety and Health (NIOSH) announces the availability of fiscal year (FY) 2003 funds for grant applications for research on childhood agricultural safety and health. Projects are sought which will conduct research to: (1) develop and evaluate new or existing enhanced control technologies to reduce injury to youth exposed to farm hazards, (2) develop and evaluate incentives which encourage adults to protect youth from farm hazards, or (3) identify the economic and social consequences of youth working on farms. Findings from these projects are intended to advance the scientific base of knowledge needed to maximize the safety and health of children exposed to agricultural production hazards. This announcement identifies program needs consistent with the National Occupational Research Agenda (NORA) developed by NIOSH and partners in the public and private sectors to provide a framework to guide occupational safety and health research in the new millennium towards topics which are most pressing and most likely to yield gains to the worker and the nation. The agenda identifies 21 research priorities. NORA priorities with specific relevance to this announcement are: traumatic injuries, special populations at risk, intervention effectiveness research, and social and economic consequences of workplace illness and injury. Information about NORA is available through the NIOSH Home Page; http://www.cdc.gov/niosh/nora/. RESEARCH OBJECTIVES Background Agricultural production, which commonly encompasses farming, consistently ranks among the industries with the highest rates of work-related injuries and deaths in the United States and is unique with respect to children and adolescents. This is the only industry in which the workplace is often also a home. Youth, children and adolescents, who commonly work on farms are exposed to agricultural production hazards. However, exposures to agricultural hazards are not only experienced by working youths, non-working children who live on or visit farms may also be exposed to farm hazards. Research is needed to expand the knowledge base for the development and implementation of effective and appropriate intervention strategies. Surveillance activities by NIOSH over the past four years indicate an estimated 32,800 agriculture-related injuries occurred nationally to children or adolescents under the age of 20 who lived on, worked on, or visited a farm. Forty-four percent or about 15,000 of these injuries were work- related, and 70% of the work injuries were incurred by youth who live on the farm. In fact, youth who live on farms incurred about 72% of all injuries which happen to youth on farms. Fatality surveillance indicates over 100 deaths occur to youth 19 years of age and younger on farms. About 33% of the farm deaths occur to youth 15-19 years of age and males account for 85% of all farm deaths. Nearly 40% of the deaths among males occur between the ages of 15 and 19, while about 40% of the deaths among females happen before the age of five. Two regions of the United States, the South and the Midwest, accounted for 79% of all fatal farm injuries. Farm tractors, farm machinery, stored grain, power lines, manure pits, ponds, and livestock are among the many hazards youth are exposed to in the agricultural workplaces. Children and adolescents may be exposed to agricultural production hazards not only through work activities, but by virtue of living on a farm, accompanying their parents to work, or visiting farms. Goals The goals of childhood agricultural safety and health research grants are to maximize the safety and health of children and adolescents exposed to agricultural hazards through the prioritization, development, or implementation of intervention efforts. Projects are sought in one of three research areas which have been identified as priority areas in the documents Children and Agriculture: Opportunities for Safety and Health: A National Action Plan http://research.marshfieldclinic.org/children/action/title.htm or the Childhood Agricultural Injury Prevention: Progress Report and Updated National Action Plan from the 2001 Summit http://www.marshfieldclinic.org/research/children/childrensReport/ and provided below: o Develop and Evaluate New or Existing Enhanced Control Technologies. Control technologies, in the broadest sense, include any strategy which will control the exposure of children to agricultural hazards. Exposures to agricultural hazards may be reduced through engineering controls and/or administrative controls. Examples of research efforts which are appropriate under this priority area include, but are not limited to: (a) engineering controls: these could encompass the development and evaluation of new, or the application and evaluation of existing, equipment or devices which could prevent childhood agricultural injuries, such as ensuring that agricultural structures have proper barriers and warnings, developing and evaluating play area designs to reduce child exposures to hazards, and developing and evaluating, or evaluating existing, sensor technology to notify operators or automatically shut down machines when children are in harms way and/or (b) administrative controls: these could encompass the evaluation of the impact of changes in work practices, such as limiting the type of work a youth does [e.g., not allowing youth under 16 to drive tractors or evaluation of the impact of the North American Guidelines for Children's Agricultural Tasks (NAGCATs)], modification of work periods, (such as limiting the amount of time a youth works), limiting the exposure of the youth (ensuring equipment in the work environment is properly shielded or limiting loads lifted or carried), and the type and amount of training and supervision given to the young worker. o Develop and Evaluate Incentives which Encourage Adults to Adopt Injury Control Strategies to Protect Youth. Adults are the primary agent for determining the safety of youth on farms. Understanding the factors which cause adults to adopt protective activities for youth on their farms or cease activities which increase risk for youth are important to prevention efforts. Identifying the type, kind and magnitude of incentives which lead adults to adopt injury control strategies can lead to reduced risk for youth who live on, work on, or visit farms. Examples of research efforts which are appropriate under this priority area include, but are not limited to: (a) incentives needed by adults to adopt methods to reduce or eliminate the risk of injury from agricultural production, such as implementing affordable and accessible childcare which is readily available to farm families, or (b) incentives required to establish safe play and recreation areas for youth on farms, or c) for farms that are using young workers, incentives which are successful in getting adults to use model programs for training and supervising young agricultural workers to reduce the risk of injury. o Identify the Economic and/or Social Consequences of Youth Working on Farms. Data on positive as well as negative outcomes of youth's involvement in agriculture are needed to develop a balanced response to protecting children. Examples of research efforts which are appropriate under this priority area include, but are not limited to: (a) studies to estimate the societal and economic costs and consequences associated with childhood agricultural injury; (b) assessments of short- and long-term disability from injuries; (c) assessment of short- and long-term psychosocial outcomes (positive and/or negative) related to children's and adolescents' participation in different types of agricultural work; (d) actual costs to protect youth from hazards on the farm; (e) physical assessments of children and adolescents who have been exposed to agricultural hazards such as agricultural chemicals, organic dusts, toxic gases, nitrates, volatile organic compounds, oils and solvents; and, (f) studies of the impact of noise, vibration, cumulative trauma, and other work or environment-induced health hazards on children and adolescents working on farms. Useful Reference National Committee for Childhood Agricultural Injury Prevention. Children and Agriculture: Opportunities for Safety and Health. Marshfield, WI: Marshfield Clinic. 1996, http://research.marshfieldclinic.org/children/action/title.htm. Lee, B. Gallagher, S. Marlenga, B. and Hard, D. (Eds.). 2002. Childhood Agricultural Injury Prevention: Progress Report and Updated National Action Plan for the 2001 Summit. Marshfield, WI: Marshfield Clinic. http://www.marshfieldclinic.org/research/children/childrensReport/. MECHANISM OF SUPPORT This RFA will use NIOSH individual research project grant (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. The anticipated award date is August 1, 2003 and will be made for a 12-month budget period. Continuation awards within the project period will be made on the basis of satisfactory progress and availability of funds. Applications that are not funded in the competition described in this RFA may be submitted as NEW investigator-initiated applications using the standard receipt dates for NEW applications described in the instructions on the PHS 398 application. This RFA uses just in time concepts. It also uses the modular budget format, rather than the detailed budget format (see http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular format. This program does not require cost sharing. FUNDS AVAILABLE NIOSH intends to commit approximately one million ($ 1,000,000)in fiscal year (FY) 2003 to fund approximately four to six new and/or competitive continuation grants in response to this RFA. An applicant may request a project period of up to 3 years and a budget for direct costs of up to $250,000 per year. 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. Use of Funds Applicants should include in their budget travel funds for one trip per year for an annual meeting with NIOSH scientists to be held in Morgantown, West Virginia. The purpose of this meeting is to provide an opportunity for the exchange and dissemination of scientific information. 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 and foreign o Faith-based or community-based organizations o Indian Tribes, Tribal Governments, Colleges, and/or Organizations 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 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. 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. This RFA and other CDC Announcements can be found on the CDC HomePage at http://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 http://www.cdc.gov/niosh/homepage.html, under Extramural Programs, Current Funding Opportunities. Direct your questions about scientific/research issues to: Adele Childress, Ph.D., MSPH 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 1427, MS E-74 Atlanta, GA 30333 Telephone: (404) 498-2509 FAX: (404) 498-2571 Email: ahc0@cdc.gov Direct your questions about NIOSH agricultural research program issues to: Stephen Olenchock, Ph.D. Agriculture Coordinator Centers for Disease Control and Prevention National Institute for Occupational Safety and Health 1095 Willowdale Road, P04/1119 Morgantown, WV 26505-2888 Telephone: (304) 285-6271 FAX: (304) 285-6075 Email: solenchock@cdc.gov 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 Direct inquiries about financial or grants management matters to: Larry Guess Acting Chief Acquisition and Assistance Field Branch Centers for Disease Control and Prevention 626 Cochrans Mill Road Pittsburgh, Pennsylvania 15236-0070 Announcement Number OH-03-003 Telephone: (412) 386-6826 Email: lguesws@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 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). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone 301/435-0714, Email: GrantsInfo@nih.gov. SUPPLEMENTAL 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. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular grant format. The modular grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-by-step guidance for preparing modular grants. Additional information on modular grants is available at http://grants.nih.gov/grants/funding/modular/modular.htm. 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 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) 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. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to this 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. While the investigator may still benefit from the previous review, the RFA application is not to state explicitly how. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by CSR and responsiveness by NIOSH. Incomplete applications will be returned to the applicant without further consideration. And, if the application is not responsive to the RFA, NIOSH staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next appropriate NIH review cycle. 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 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 the 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 The scientific review group will address and consider each of these criteria in assigning the application's overall score, weighting them as appropriate for each application. 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. o SIGNIFICANCE: Does this study address an important problem related to the research areas outlined in this announcement? If the aims of the application are achieved, how will scientific knowledge be advanced? Define the significance of the proposed research to the prioritization, development, or implementation of intervention efforts. What will be the effect of these studies on the concepts or methods that drive this field? o 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? How will the proposed research meet the goals of the program to prioritize, develop, or implement intervention efforts? Does the applicant acknowledge potential problem areas and consider alternative approaches? o INNOVATION: Does the project employ novel concepts, approaches, or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? o INVESTIGATOR: Is the investigator appropriately trained and well-suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers, if any? o ENVIRONMENT: Does the scientific environment in which the work will be performed 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 stakeholders in the project, where applicable? Is there evidence of institutional support and availability of resources necessary to perform the project? 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: o PROTECTIONS 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). o INCLUSIONS OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans to include subject from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below). o 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 CONSIDERATIONS 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 children affected. o Severity of the disease or injury in the population. o Likelihood of developing applied technical knowledge for the prevention of childhood agricultural safety and health hazards on a national or regional basis. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: April 18, 2003 Application Receipt Date: May 23, 2003 Earliest Anticipated Start Date: August 1, 2003 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. MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and 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 CDC that women and members of minority groups and their sub-populations must be included in all CDC-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/women_min.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 CDC 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. 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 http://grants.nih.gov/grants/funding/children/children.htm. HUMAN SUBJECT REGUIREMENTS: 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 performances 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. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: (if applicable) 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. ANIMAL SUBJECTS REQUIREMENTS: If the proposed project involves research on animal subjects, compliance with the "PHS Policy on Humane Care and Use of Laboratory Animals by Awardee Institutions" is required. An applicant (as well as each subcontractor or cooperating institution that has immediate responsibility for animal subjects) proposing to use vertebrate animals in CDC-supported activities must file (or have on file) the Animal Welfare Assurance with the Office of Laboratory Animal Welfare (OLAW) at the National Institutes of Health. The applicant must provide in the application the assurance of compliance number and evidence of review and approval (including the date of the most recent approval) by the Institutional Care and Use Committee (IACUC). Web page http://grants.nih.gov/grants/olaw/olaw.htm 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. URLS IN NIOSH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIOSH funding must be self-contained within specified page limitations. Unless otherwise specified in a NIOSH 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. 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: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This RFA is related to one or more of the priority 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(a) [42 U.S.C. 241(a)], the Occupational Safety and Health Act of 1970, Section 20(a) [29 U.S.C. 669(a)] [number: 93.956, Agricultural Health and Safety Program of the National Institute for Occupational Safety and Health (NIOSH)], and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. 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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NIH Funding Opportunities and Notices


H H S Department of Health
and Human Services

 
  N I H National Institutes of Health (NIH)
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