EXPIRED
NEUROLOGICAL INDICES OF LONG TERM SOLVENT EXPOSURE IN WORKERS RELEASE DATE: September 8, 2003 RFA Number: RFA-OH-04-001 Department of Health and Human Services 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) NOTE: THE POLICIES, GUIDELINES, TERMS, AND CONDITIONS STATED IN THIS ANNOUNCEMENT MAY DIFFER FROM THOSE USED BY THE NIH. CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): CFDA 93.262 LETTER OF INTENT RECEIPT DATE: November 3, 2003 APPLICATION RECEIPT DATE: December 17, 2003 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 National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC), announces the availability of fiscal year (FY) 2004 funds for grant applications for research on long-term occupational exposures to organic solvents and chronic neurologic effects of such exposures. Projects are sought that use quantifiable techniques to assess long-term exposures to organic solvents, and use objective diagnostic tools to assess the chronic neurologic effects of long-term occupational solvent exposure. Findings from these projects are intended to quantitatively document long-term occupational exposure to organic solvents, objectively characterize related chronic neurologic outcomes, and analyze dose-response relationships between exposures and outcomes. Studies on non- occupational exposures to organic solvents are not responsive to this RFA. RESEARCH OBJECTIVES Background Organic solvents are widely used in manufacturing, transportation, and other industrial sectors. These compounds are used in the manufacture of paints, dyes, agricultural products, and many other products. Because organic solvents are ingredients of many products such as paints and cleaning agents, they are also found in non-manufacturing workplaces and non-work settings. Thus, workers can be exposed to a variety of organic solvents at various exposure levels throughout their lifetime. Some workers may have repeated exposures to very high organic solvent levels many times during the course of their working life. Over the past few decades significant advances have occurred in the field of retrospective exposure assessment and in the diagnostic tools for assessing neurological impairment. Certain industrial sectors such as railroading, painting, manufacturing, and machining have significant numbers of workers potentially exposed to organic solvents. Thus workers in these industrial sectors would be appropriate subjects for studies of chronic neurological effects related to long-term exposures to organic solvents. Although there is substantial literature on the neurological effects of short-term exposures to organic solvents and chronic effects of non-working exposures, the neurological effects of long-term exposures in the workplace are not well understood. The neurological symptoms and objective findings of workers with long-term exposures to organic solvents are not specific to occupational exposures. They can often be attributed to other causes, such as medical conditions and other nonworking-related factors. Some case reports of neurologically impaired workers have used nonspecific symptoms (a measurement of effect) as surrogates for exposure, and individuals with nonworking-related causes of impairment have not been routinely excluded. Some studies have compared neurologically impaired workers who had a history of long-term or heavy solvent exposure with healthy unexposed workers. Nonworking-related causes in the differential diagnosis of the neurological conditions were not routinely ruled out, as would be warranted in medical practice. Such studies are biased to show that exposed persons are neurologically impaired and unexposed persons are not neurologically impaired. They do not prove that organic solvent exposure caused the neurological condition. Cross-sectional studies have not clearly established an association between long-term solvent exposure and chronic neurological impairment, and have not shown evidence of dose-response relationships. Often, these types of studies have been limited by inadequate characterization of the exposure history. When studies have used neuroimaging techniques such as computed tomography (CT), magnetic resonance imaging (MRI), single photon emission computed tomography (SPECT); they have compared neurologically impaired exposed workers with healthy unexposed workers. Despite this bias toward finding abnormalities among the exposed workers, differences between impaired and healthy workers, when found, were not significant, thus leading to questions about the sensitivity of the diagnostic tool for detecting abnormalities and about current hypotheses about the pathologic processes that cause the impairment. Questions were also raised about the specificity of diagnostic tools in differentiating among multiple possible causes of an abnormality. The limitations of previous studies are now better understood, and include selection bias, inadequately quantified exposure assessments, use of nonspecific neurological outcome variables, inclusion of individuals with neurological outcomes from nonworking-related causes, and lack of sensitivity and specificity of neurodiagnostic tools. With the clarification of research needs to address the limitations of earlier studies, the advances in techniques to assess exposures and health outcomes, and the existence of worker populations with long-term exposures to organic solvents, the time may be ripe for studies to quantify long term solvent exposures and neurological and other health outcomes. The results of well designed studies should provide more meaningful results about dose-response relationships between occupational exposures to organic solvents and chronic neurological conditions. They should also lead to better understanding about the causes and characteristics of neurological effects associated with long-term organic solvent exposure. Goals The goals of this initiative are to quantify organic solvent exposures in workers in a selected industry, to objectively and quantitatively assess chronic neurological conditions, and to characterize dose-response relationships between organic solvent exposures and chronic neurological conditions. Railroad workers and construction painters are of particular interest as these groups have documented long-term organic solvent exposures. Since identification of the neurological effects of toxic agents is complex and often times subjective in nature, the approach for this RFA is to encourage (1) the characterization of actual or estimated cumulative exposure to organic solvents, other neurotoxicants such as pesticides, and other workplace exposures, and (2) the use of a battery of objective measurements of neurological function, such as cognitive testing and neuroimaging tools. To establish a dose-response relationship, workers with various levels of solvent exposure, including no exposure, should be included in the study. The study population could include current workers (for whom industrial hygiene measurements of current workplace levels should be obtained) as well as former workers. Nonwork-related factors known to have neurological effects should be controlled for or used as exclusion criteria. See Useful References After AUTHORITY AND REGULATIONS (Below). MECHANISM OF SUPPORT This RFA will use the research project grant (R01) award mechanism(s). As an applicant you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. Future unsolicited, competing-continuation applications based on this project will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. The anticipated award date is February 1, 2004. Applications that are not funded in the competition described in this RFA may be resubmitted as NEW investigator- initiated applications using the standard receipt dates for NEW applications described in the instructions to the PHS 398 application. This PA uses just-in-time concepts. It also uses the modular budgeting as well as the non-modular budgeting formats (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 budget format. Otherwise follow the instructions for non-modular budget research grant applications. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm. FUNDS AVAILABLE NIOSH intends to commit approximately $1,000,000 in fiscal year (FY) 2004 to fund two to three new and/or competitive continuation grants in response to this RFA. An applicant may request a project period of up to three years and a budget for direct costs of up to $400,000 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. 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 organizations o Federally recognized Indian Tribes, Tribal Governments, Colleges, and/or Organizations INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institutions to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIOSH programs. Note: Title 2 United States Code section 1611 states that an organization described in section 501(c)(4) of the Internal Revenue Code that engages in lobbying activities is not eligible to receive Federal funds constituting an award, grant, or loan. SPECIAL REQUIREMENTS Applicants should fully describe the plan to recruit study sites across an industry (to characterize exposures in that industry) and to enroll workers willing to participate in the study. Letters of cooperation from employers and unions would provide some measure of the anticipated success of the plan. The following should be addressed in a clear and organized manner (see also peer review criteria section): o Timeline: a detailed timeline for the proposed study must be included in the application. o In a separate section labeled, Participant Notification of Study Results, the applicant should describe plans for notifying participants about their individual results and the overall results of the study. Applicants should highlight unique expertise and/or unusual opportunities as related to the purpose of this RFA. Examples include, but are not limited to: o Expertise in specialized areas with potential applications to the issues/questions considered in this RFA, conducting epidemiologic field studies of working populations, experience in exposure assessment; o Access to a range of work sites varied enough to characterize the industry being studied, and to workers at those sites who are willing to participate in studies of solvent exposures; o Expertise in assessing solvent and other exposures in individual job settings, as well as documentation of all exposures; o Expertise in neurologic assessment techniques, such as the use of neuroimaging tools and the interpretation of neuroimaging results; o Expertise in the clinical assessment of neurologic conditions and their differential diagnoses. o Expertise in negotiating with work site management and unions in field settings. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues. 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: Michael Galvin, Ph.D. 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 1536, MS E-74 Atlanta, GA 30333 Telephone: (404) 498-2524 FAX: (404) 498-2571 Email: [email protected] 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: [email protected] Direct inquiries about financial or grants management matters to: Ms. Cynthia Mitchell, Contract Specialist Acquisition and Assistance Field Branch Centers for Disease Control and Prevention 626 Cochrans Mill Road Pittsburgh, Pennsylvania 15236-0070 Announcement Number OH-04-001 Telephone: (412) 386-6434 Email: [email protected] 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: [email protected] 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. It can be obtained by calling (866) 705-5711 or on the web at http://www.dunandbradstreet.com. There is no charge for the number. 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: [email protected]. SUPPLEMENTARY INSTRUCTIONS: If the proposed project involves organizations or persons other than those affiliated with the applicant organization, letters of support and/or cooperation must be included. 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 and all copies of appendix material must also be sent to: Pervis C. Major, Ph.D. Scientific Review Administrator Office of Extramural Programs National Institute for Occupational Safety and Health Centers for Disease Control and Prevention (CDC) 1095 Willowdale Rd Morgantown, WV 26505 Telephone 304-285-5979 Fax 304-285-6147 Email: [email protected] 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. 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 an RFA, it is to be prepared as a NEW application. That is, the application for the RFA must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by CSR and responsiveness by NIOSH. Incomplete 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 Undergo a process in which only those applicants deemed to have the highest scientific or technical merit, generally the top half of the applications under review, will be discussed and assigned a priority score. o Receive a written critique. o Receive a second level of review by the NIOSH Secondary Review Committee. REVIEW CRITERIA The 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. 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? What will be the effect of this study on the concepts or methods that drive this field? Is the study population appropriate? Will the proposed research contribute to the overall aims of addressing questions of causation and of better defining the dose-response relationships between varying levels of occupational exposures to organic solvents and neurologic outcomes? 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, such as the limitations of earlier studies, and consider alternative approaches? Does the study have a well defined and described cohort within a specific industry? Does the recruitment plan address the need to enroll workers with a range of exposures to organic solvents (high, medium and low) with sufficient exposure contrast to assess response to exposure? Does the study have an appropriate control population? Is the plan for assembling work sites and participants suitable for this study? Does the project employ standardized, comparable approaches for exposure assessment? Does the study have an appropriate design for determining a history of long-term exposure to organic solvents? Does the study have an appropriate design for reliably quantifying exposures to organic solvents? Does the study use valid, appropriately sensitive and specific, and reliable objective neurodiagnostic tools and techniques? Are the approaches for assessing working memory appropriate and state of the art? Does the study use appropriate validated cognitive testing methods? Does the study adequately address the limitations of neuroimaging and other diagnostic tools? Does the study have an appropriate analysis plan for assessing the relationship between solvent exposure and neurologic changes? Does the study appropriately control for nonworking-related factors related to neurologic impairment? Does the study exclude individuals from the analysis if their neurologic conditions can be explained by nonworking related causes? Is the time line for the study appropriate and well described? 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 the Principal Investigator and his/her team appropriately trained and with adequate experience to conduct both exposure and health assessments in order to evaluate exposure response? Does the team have a multidisciplinary background to design and conduct a prospective epidemiologic field study? Within the team is there expertise in neurologic assessment techniques, such as the use of neuroimaging tools and the interpretation of neuroimaging results, and clinical expertise in neurologic diagnoses? Is the work proposed appropriate to the experience level of the principal investigator and his/her collaborators? 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: 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 Sharing Research Data Applicants requesting more than $500,000 in direct costs in any year of the proposed research are expected to include a data sharing plan in their application. The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or priority score. BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. o Availability of special opportunities for furthering research programs through the use of unusual talent resources, populations, or environmental conditions in other countries which are not readily available in the United States or which provide augmentation of existing U.S. resources. Programmatic Review Criteria o Magnitude of the problem in terms of numbers of workers affected. o Severity of the disease or injury in the worker population. o Priority will be given for studies on railroad workers and construction painters RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: November 3, 2003 Application Receipt Date: December 17, 2003 Earliest Anticipated Start Date: February 1, 2004 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit o Availability of funds o Programmatic priorities o Population studied (railroad workers and construction painters are a priority) REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for all types of clinical trials, including physiologic, toxicity, and dose- finding studies (phase I); efficacy studies (phase II), efficacy, effectiveness and comparative trials (phase III). The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risk to the participants. (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). SHARING RESEARCH DATA: Starting with the October 1, 2003 receipt date, investigators submitting an NIH application seeking more than $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible. http://grants.nih.gov/grants/policy/data_sharing Investigators should seek guidance from their institutions, on issues related to institutional policies, local IRB rules, as well as local, state and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score. INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. 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). Those who must comply with the Privacy Rule (classified under the Rule as "covered entities") must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. LOBBYING RESTRICTIONS: Applicants should be aware of restrictions on the use of Health and Human Services (DHHS) funds for lobbying of Federal or State legislative bodies. Under the provisions of 31 U.S.C. Section 1352, recipients (and their subtier contractors) are prohibited from using appropriated Federal funds (other than profits from a Federal contract) for lobbying congress or any Federal agency in connection with the award of a particular contract, grant, cooperative agreement, or loan. This includes grants/cooperative agreements that, in whole or in part, involve conferences for which Federal funds cannot be used directly or indirectly to encourage participants to lobby or to instruct participants on how to lobby. In addition, no part of the Centers for Disease Control and Prevention (CDC) appropriated funds shall be used, other than for normal and recognized executive-legislative relationships, for publicity or propaganda purposes, for the preparation, distribution, or use of any kit, pamphlet, booklet, publication, radio, television, or video presentation designed to support or defeat legislation pending before the Congress or any State or local legislature, except in presentation to the Congress or any State or local legislature itself. No part of the appropriated funds shall be used to pay the salary or expenses of any grant or contract recipient, or agent acting for such recipient, related to any activity designed to influence legislation or appropriations pending before the Congress or any State or local legislature. Any activity designed to influence action in regard to a particular piece of pending legislation would be considered "lobbying." That is lobbying for or against pending legislation, as well as indirect or "grass roots: lobbying efforts by award recipients that are directed at inducing members of the public to contact their elected representatives at the Federal or State levels to urge support of, or opposition to, pending legislative proposals is prohibited. As a matter of policy, CDC extends the prohibitions to lobbying with respect to local legislation and local legislative bodies. The provisions are not intended to prohibit all interaction with the legislative branch, or to prohibit educational efforts pertaining to public health. Clearly there are circumstances when it is advisable and permissible to provide information to the legislative branch in order to foster implementation of prevention strategies to promote public health. However, it would not be permissible to influence, directly or indirectly, a specific piece of pending legislation. It remains permissible to use CDC funds to engage in activity to enhance prevention; collect and analyze data; publish and disseminate results of research and surveillance data; implement prevention strategies; conduct community outreach services; provide leadership and training; and foster safe and healthful environments. Recipients of CDC grants and cooperative agreements need to be careful to prevent CDC funds from being used to influence or promote pending legislation. With respect to conferences, public events, publication, and "grassroots" activities that relate to specific legislation, recipients of CDC funds should give attention to isolating and separating the appropriate use of CDC funds from non-CDC funds. CDC also cautions recipients of CDC funds to be careful not to give the appearance that CDC funds are being used to carry out activities in a manner that is prohibited under Federal law. HEALTHY PEOPLE 2010: The 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 PA 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 and 405 of the Public Health Service Act as amended (42 USC 241 and 284)(cite appropriate authorizations) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92 (cite relevant regulations). All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm (also cite other relevant policies) 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. 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 Albers JW, Berent S [2000]. Controversies in neurotoxicology: Current status. Neurol Clin 18:741-764. Albers JW, Wald JJ, Garabrant DH, Trask CL, Berent S [2000]. Neurologic evaluation of workers previously diagnosed with solvent-induced toxic encephalopathy. J Occup Environ Med 42:410-423. Frey KA [2000]. Neuroimaging in neurotoxicology. Neurol Clin 18:615-629. Frumkin H, Ducatman A, & Kirkland K [1997]. Solvent exposure in the railroad industry (letter to the editor). J Occup Environ Med 39:926-930. Ridgway P, Nixon TE, Leach JP (2003). Occupational exposure to organic solvents and long-term nervous system damage detectable by brain imaging, neurophysiology or histopathology. Food Chem Toxicol 2003; 41 (2) : 153-87.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
| ||||||
![]() |
Department of Health and Human Services (HHS) |
![]() |
||||
NIH... Turning Discovery Into Health® |