THERAPEUTIC OPPORTUNITIES IN PROGRESSIVE STAGES OF SPINAL CORD INJURY RELEASE DATE: August 14, 2003 RFA Number: RFA-NS-04-004 National Institute of Neurological Disorders and Stroke (NINDS) (http://www.ninds.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.853 LETTER OF INTENT RECEIPT DATE: November 24, 2003 APPLICATION RECEIPT DATE: December 23, 2003 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism(s) of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o 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 National Institute of Neurological Disorders and Stroke (NINDS) invites applications for basic studies that define therapeutic opportunities during the progressive stages of spinal cord injury (SCI) from acute through chronic time points. Although numerous neuroprotective and repair strategies have been identified that improve anatomical or functional outcome after SCI in animal models, the causal relationship between cellular or anatomical findings and functional outcomes has not been established. This RFA seeks research to 1) elucidate the mechanisms that underlie recovery induced by neuroprotection or repair strategies in animal models, 2) define progressive changes in acute, subacute or chronic stages after SCI that influence cell survival, regeneration, sprouting and/or recovery of function, 3) target therapeutic strategies in animal models to clinically-relevant stages and types of SCI, based on known pathophysiological processes, anatomical or functional/clinical outcomes. RESEARCH OBJECTIVES Background A quarter of a million Americans are living with functional deficits due to chronic SCI and over 10,000 new cases occur in the U.S. each year. Traumatic SCI occurs suddenly but the physiological and functional changes initiated by the injury progress with time. This progression includes a period of "secondary injury" characterized by immunological reactions, scarring, continuing cell death and cavitation as well as ongoing functional changes in spinal circuitry. Substantial recovery of function near or below the level of injury is seen after most incomplete SCI, which may continue for months to years, and can be facilitated by rehabilitation. Most patients with complete SCI show substantially less spontaneous recovery but also undergo continuing neurological changes that may lead to development of spasticity, autonomic dysreflexia, pain and other complications. To date, few basic science discoveries have been applied clinically to improve functional outcomes. In recent years, however, an expanding community of SCI researchers has reported progress in developing intervention strategies in animal models. Such strategies are reported to limit secondary injury and to enhance regeneration, functionally significant sprouting, and recovery of function. It is important to assess the promise of these interventions with great care. Human SCI is a complex and highly variable condition with functional deficits that greatly depend on the spinal level, severity of injury and the length of time since SCI occurred. It is critical that studies now be designed to use animal models of SCI at appropriate spinal levels or stages to test therapeutic strategies. This will improve the likelihood of success in translation of promising therapies to effective clinical therapies. The concept for this RFA was developed with input from two NINDS workshops, "Translating Promising Strategies for Spinal Cord Injury Therapy" (2003) and the "International Workshop on Brain Banking" breakout session on CNS Trauma (2002). Participants identified issues that bear on future clinical trials, including prognosis in the absence of intervention, mechanism of injury, and timing of the intervention relative to the time course of secondary damage and changes in regenerative potential in the cord. They also noted the need to evaluate varied types of injury (location, extent and duration) and comparative time scales in animal models versus human injury. Evaluating the relevance of strategies that moderately affect locomotion in rodents requires recognition of the differences between rodent and human spinal circuitry and function, and species differences in SCI neuropathology. In addressing recovery, progressive functional changes seen in people after SCI were described, and the need to explore such changes using animals to relate pathological processes or neural plasticity to functional recovery was stressed. Promising strategies for neuroprotection are evolving, including hypothermia, blockers of secondary injury (e.g., steroids and other anti-inflammatory agents, cord irradiation or manipulations of immune cells), and some cellular therapies. Likewise, a number of strategies to promote regeneration have been identified, including application of growth factors and other growth promoting agents, stem cells, glial cells, myelin-inhibitor neutralization, extracellular matrix inhibition, and cell- or matrix-containing guidance channels. Some of these are reported to promote remyelination. Other strategies are based on activity-driven interventions. Most of these studies report incremental improvement in anatomical and locomotor measures, but do not provide evidence that these measures are causally related. Information obtained by use of physiological measures, imaging and indicators of cell survival and function might significantly improve our understanding of the basis of reported functional restoration. In addition, longer studies are needed to assess the persistence of any functional advantage of protective therapies. A common component of effective therapies may be altering function by stimulating endogenous plasticity. The functional importance of this plasticity, compared to that of regenerating axons, has been under- emphasized in most reports citing anatomical and functional repair after application of regeneration strategies. Research focused on assessing the basis of ongoing functional recovery is needed. This natural recovery must also be adequately controlled for in studies aimed at identifying the mechanisms by which repair strategies promote recovery. The "window of opportunity" where repair strategies are effective has not been established preclinically. To define which strategies could be advantageously used in acute and/or chronic injuries, more information is needed about the mechanism(s) of action of particular interventions. Important questions include what the optimal timing of a treatment is, its duration, and when is there essentially no hope for recovery after SCI? Until recently, almost all experimental strategies were applied acutely after SCI in rat models. New research has shown that a one-to-two week delay in the application of some strategies leads to improved recovery in rodent models of incomplete SCI. The mechanism by which these delayed treatments improve functional outcomes is not known, and it is unlikely that this delay models chronic human SCI. There is no definition of acute, subacute and chronic injury in animal models, nor is it known how the temporal progression of SCI in these models relates to corresponding stages of human injury. Such considerations are essential to understanding the effects of the therapeutic strategies, and to improving translation of these strategies to clinical use. Measures of anatomical changes alone are not sufficient, as behavioral recovery can be measured over many weeks, while lesion size is expanding in most experimental models. Finally, validation of treatment strategies in non-rodent animal models could be needed to refine or confirm the efficacy of novel strategies for SCI repair. When rodents do not adequately model human spinal circuitry or pathophysiology, non-rodent models should be utilized to establish relevance for human testing. Objectives and Scope This initiative is based on recent reports that numerous cellular, pharmacological and gene-therapy strategies show promise for the protection and/or repair of the spinal cord after injury. The "promise" is based largely upon evidence of tissue preservation, tract tracing and incremental recovery in behavioral measures. Causal relationships between these measures are not clearly shown in these studies, and the therapeutic potential for application of these strategies is based more on conjecture than on information about specific opportunities for intervention in human SCI. This RFA seeks to address the need for information about the changing state of the spinal cord following injury in relation to 1) the potential for repair and the mechanisms that underlie recovery induced by neuroprotection or repair strategies in animal models, 2) acute, subacute or chronic stages after SCI that influence cell survival, regeneration, sprouting and/or recovery of function, 3) targeting of therapeutic strategies in animal models to specific clinically-relevant stages and types of SCI, based on known pathophysiological processes, anatomical or functional/clinical outcomes. These questions are key prerequisites to translation of promising repair strategies to effective treatment of human SCI. Applications for preclinical (animal) and human studies research are invited, however, no clinical trials will be considered. Appropriate topics for investigation under this RFA would include but are not limited to: o Characterization of the mechanism(s) of action of promising therapeutic strategies to determine if the treatment outcome is based on protection, regeneration, impact on circuits outside the lesion area, or other mechanisms. Promising candidates include cellular, pharmacological, mechanical, genetic, activity-based or combined approaches that affect behavioral outcomes. o Studies to define the progression of therapeutic windows of opportunity following SCI by characterizing pathophysiological processes in animal models as they relate to behavioral outcomes and associated clinical outcomes. Of particular interest: evidence of persistent primary demyelination, relationship of cavity expansion or cell death to loss of function, effects of ongoing inflammatory processes and endogenous plasticity or repair mechanisms on behavioral outcomes. o Studies to determine effective time of administration of a repair strategy, based on known mechanism(s) of action. Species differences in the anatomy or function of circuits and relation to human pathology or behavior after SCI should be addressed. o Experimental protocols that incrementally test components of complex therapies to establish their critical contribution to functional recovery in appropriate animal models and stages of injury. o Utilization of tracing, imaging, or other technologies to detect the long-term fate of implanted cells, their migration and functional status following implantation into sites in or near regions of SCI. o Strategies to alter pathophysiological responses to injury in order to prolong or reinstate a window of opportunity for effective repair of the spinal cord. o Studies to define progressive changes in barriers to regeneration and show under what circumstances targeted strategies that alter these processes can improve outcomes. MECHANISM OF SUPPORT This RFA will use NIH R01 award mechanism. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. Future unsolicited, competing-continuation applications based on this project will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. The anticipated award date is July 2004. Applications that are not funded in the competition described in this RFA may be resubmitted as NEW investigator-initiated applications using the standard receipt dates for NEW applications described in the instructions to the PHS 398 application. This RFA uses just-in-time concepts. It also uses the modular 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 format. Otherwise follow the instructions for non-modular 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 The NINDS intends to commit approximately $1.5 million in FY 2004 to fund three to four new and/or competitive continuation grants in response to this RFA. An applicant may request a project period of up to five years and a budget for direct costs of up to $500,000 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 the NINDS provides 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 or foreign 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 NIH 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 three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: Naomi Kleitman, Ph.D. Program Director, Repair and Plasticity National Institute of Neurological Disorders and Stroke 6001 Executive Blvd., Room 2204, MSC 9525 Bethesda, MD 20892 Telephone: (301) 496-1447 FAX: (301) 480-1080 Email: nk85q@nih.gov o Direct your questions about peer review issues to: Alan Willard, Ph.D. Chief, Scientific Review Branch National Institute of Neurological Disorders and Stroke 6001 Executive Blvd., Room 3208 Bethesda, MD 20892 Telephone: (301) 496-9223 FAX: (301) 402-0182 Email: aw135y@nih.gov o Direct your questions about financial or grants management matters to: Michael J. Loewe Chief, Grants Management Branch National Institute of Neurological Disorders and Stroke 6001 Executive Blvd., Suite 3290, MSC 9537 Bethesda, MD 20892-9537 Telephone: (301) 496-9231 FAX: (301) 402-0219 Email: ml70m@nih.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 a subsequent application, the information that it contains allows IC staff 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. The letter of intent should be sent to: Naomi Kleitman, Ph.D. Program Director, Repair and Plasticity National Institute of Neurological Disorders and Stroke 6001 Executive Blvd., Room 2204, MSC 9525 Bethesda, MD 20892 Rockville, MD 20852 (for express/courier service) Telephone: (301) 496-1447 FAX: (301) 480-1080 Email: nk85q@nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com. The DUNS number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 document is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov. 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/label-bk.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 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 be sent to: Alan Willard, Ph.D. Chief, Scientific Review Branch National Institute of Neurological Disorders and Stroke 6001 Executive Blvd., Room 3208 Bethesda, MD 20892 Rockville, MD 20852 (for express/courier service) Telephone: (301) 496-9223 FAX: (301) 402-0182 Email: aw135y@nih.gov APPLICATION PROCESSING: Applications must be received on or before the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to an RFA, it is to be prepared as a NEW application. That is the application for the RFA must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes. 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 the CSR and responsiveness by the NINDS. Incomplete applications will be returned to the applicant without further consideration. And, if the application is not responsive to the RFA, NIH 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 an appropriate peer review group convened by the NINDS 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 applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed and assigned a priority score o Receive a second level review by the NINDS National Advisory Council or Board. REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to 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, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) SIGNIFICANCE: If the aims of your application are achieved, how do they advance scientific knowledge or development of SCI therapy? What will be the effect of your study on concepts or methods that help understand the mechanisms by which repair strategies restore function after SCI and facilitate translation of these treatment strategies to clinical use? Do the proposed studies relate animal models to literature about or studies of human pathology, physiology or behavior after SCI? (2) APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Is the time window in which a strategy is applied well justified and appropriate to potential future clinical application? Is the course of natural recovery known and adequately controlled for? Do you acknowledge potential problem areas and consider alternative tactics? (3) INNOVATION: Does your project employ novel concepts, approaches or methods? When existing therapeutic strategies are to be tested, is the proposed analysis of the strategies likely to produce new information important to application of that strategy toward treatment of human SCI? Are the aims original and innovative? Does your project develop new methodologies, animal models or technologies? (4) INVESTIGATOR: Are you appropriately trained and well suited to carry out this work? Is the work proposed appropriate to your experience level as the principal investigator and to that of other researchers (if any)? (5) ENVIRONMENT: Does the scientific environment in which your 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 evidence of institutional support? 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: (1) Relevance to human SCI: Is the experimental design and any proposed therapeutic strategy justified in relation to measures of the timing of pathophysiological changes and/or natural recovery after human SCI? Is the effective therapeutic window of the selected strategy likely to be translatable to clinical practice? (2) Responsiveness to Objectives and Scope of this RFA as detailed in the Significance, Approach and Innovation sections above. 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). 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. 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 CONSIDERATIONS DATA SHARING: The adequacy of the proposed plan to share data. BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: November 24, 2003 Application Receipt Date: December 23, 2003 Peer Review Date: March 2004 Council Review: May 2004 Earliest Anticipated Start Date: July 2004 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities. REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm 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 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. 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. 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.health.gov/healthypeople. 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) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm The PHS strongly encourages all grant recipients to provide a smoke- free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
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