MECHANISMS OF OROFACIAL PAIN: ANATOMY, GENOMICS AND PROTEOMICS RELEASE DATE: November 19, 2003 RFA Number: RFA-DE-05-004 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov) COMPONENTS OF PARTICIPATING ORGANIZATION: National Institute of Dental and Craniofacial Research (NIDCR) (http://www.nidr.nih.gov) National Institute of Neurological Disorders and Stroke (NINDS) (http://www.ninds.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S) 93.121 (NIDCR) 93.853 (NINDS) LETTER OF INTENT RECEIPT DATE: April 19, 2004 APPLICATION RECEIPT DATE: May 14, 2004 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 Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Supplementary Instructions 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 Dental and Craniofacial Research (NIDCR), along with the National Institute of Neurological Disorders and Stroke (NINDS), invites applications to stimulate and support innovative, interdisciplinary research studies to elucidate the molecular mechanisms underlying orofacial pain, particularly the discovery of proteins and protein networks critical to processing nociceptive information. The purpose of this RFA is to encourage the use of genomic and proteomic approaches and imaging techniques to clarify the molecular events involved in: 1) acute orofacial pain, 2) the transition from unrelieved acute pain to chronic pain (i.e. neuroplasticity), 3) neuronal hyperexcitability as manifested by hyperalgesia and allodynia, and 4) chronic orofacial pain disorders of an inflammatory and neuropathic origin. This improved understanding could lead to new therapeutic interventions to effectively treat chronic pain conditions. Collaborative projects involving interdisciplinary teams of investigators are strongly encouraged. This Request for Applications contributes to the goals of the NIH Pain Consortium, which is co- chaired by NIDCR, NINDS, and the National Institute of Nursing Research (NINR). RESEARCH OBJECTIVES Background Chronic pain affects a large percentage of the population with an annual cost of about $100 billion. Orofacial pain is reported by more than 20% of the population and is one of the most common reasons for visits to a physician. Inappropriate treatment of acute pain can lead to chronic pain. Compounding the problem is the fact that chronic pain is not well treated with current therapeutics. Opiates are the drugs of choice for chronic pain but have negative aspects of tolerance and other, potentially dangerous, side effects and are not always completely successful in alleviating the pain. Thus, in order to effectively treat chronic pain conditions a better understanding of the underlying etiology and molecular pathogenesis of these conditions is needed. Through this approach, key molecules will be identified that could serve as new therapeutic targets. A noxious stimulus causes acute pain and responses to this stimulus are protective reactions. Normally, once the noxious stimulus is removed, pain disappears. However, in some instances, for example if there is tissue damage, the acute pain persists in the absence of noxious stimuli. This chronic pain may be due to persistent tissue inflammatory responses, damage to the nervous system (neuropathic pain), or unrelieved acute pain. Neuropathic pain is associated with neuronal hyperexcitability in damaged areas, spinal cord, and brain and leads to heightened responses to stressful stimuli. It is clear that neuronal plasticity plays a role in chronic pain, but the triggers that initiate this process and the changes that occur in the peripheral and central nervous systems have not been clearly identified. However, they may include changes in gene expression, redistribution of key membrane receptors or ion channels, changes in neuronal phenotype, alterations in synaptic connectivity, recruitment of silent nociceptors, and loss of fibers. A number of orofacial disorders such as temporomandibular joint disorders (TMJD), dental pain and trigeminal neuralgia are associated with chronic pain. The pathophysiology of these disorders is poorly understood. Thus, there is a need to examine the pain experience at all levels of basic and clinical research. This will entail delineation of peripheral nervous system and central nervous system circuitry involved in the detection of noxious stimuli and the modulation of pain signals, identification of the brain areas responsible for processing and integrating this information, discovery of key proteins involved in transmission of nociceptive stimuli from the periphery to the brain, and assembly of an integrated picture of pain processes. Ion channels, ligand-gated ion channels, neurotrophic factors and their receptors, transcription factors, serine/threonine and tyrosine kinases, and cell adhesion molecules are examples of gene families thought to play important roles in responses to noxious stimuli. Peripheral nociceptor fields, spinal and brainstem relay points, and cerebral cortex are anatomical areas of major interest in pain pathways and are locations where modulation of synaptic activity may alter the pain response. Identifying proteins whose levels of expression, post-translational modification, and subcellular distribution are altered in chronic pain disorders will be important in elucidating nervous system plasticity in response to noxious stimuli. Neuroimaging approaches are important in delineating specific brain regions that process pain signals. Examination of these active areas with genomic and proteomic approaches will help to identify changes in protein expression that may be important in pain sensation. Functional imaging may identify changes in neurotransmitter receptor activity, which, in turn, can elucidate signaling pathways active in processing pain signals. Computer analyses can be performed to establish the existence of integrated genetic networks of expressed genes related to pain and inflammatory processes. By comparing molecular profiles in chronic orofacial pain and in control samples, additional targets for potential therapeutic intervention may be identified. Research Objectives and Scope The objective of this RFA is to encourage the use of genomic and proteomic approaches for the identification of molecular mechanisms involved in orofacial pain disorders in order to gain a better understanding of the pathophysiology of these disorders. Such experimental approaches will reveal the molecular networks that regulate orofacial pain and clarify the pathogenic mechanisms leading to orofacial pain disorders. In addition, these investigations coupled with molecular imaging and biocomputational technologies will provide a basis for gene-based diagnostic criteria and insights for developing novel prevention and therapeutic strategies that are case and patient specific. To accomplish the goals of this solicitation, the establishment of interdisciplinary teams of investigators with expertise in biology, genomics, proteomics, and imaging as well as in clinical and computational sciences is encouraged. The following are some examples of research topics relevant to this RFA but not limited to…. o Elucidation of genes, proteins, and protein modifications involved in the transition from acute to chronic pain using genomic and proteomic approaches; o Examination of the changes in gene and protein expression in trigeminal ganglion, spinal cord, brain stem, and cortex in chronic pain states; o Characterization of changes in protein expression in the neuronal hyperexcitatory state found in chronic pain and the process involved in the induction of hyperexcitability at peripheral nociceptors, spinal cord, ascending pain tracts and in the brain; o Identification of functional protein networks involved in transducing noxious stimuli into pain signals both peripherally and centrally; o Elucidation of the roles of central (including descending modulation) and peripheral (including effector function of afferent fibers) neuronal plasticity in mediating the onset of chronic pain in craniofacial regions; o Determination of the differences in the molecular mechanisms leading to chronic pain caused by inflammatory or neuropathic injury; o Establishment of new model systems that better mimic clinical features of orofacial pain disorders, including those in which deep tissue pain is involved; o Identification of cortical brain areas important in orofacial pain processing through the use of neuroimaging; o Elucidation of the role of estrogen (genomic and non-genomic effects) in the pathophysiology of pain including the influence of estrogen on neurotrophic growth factor expression; o Investigations of orofacial pain using patient material (cell lines, DNA from patient cohorts, etc.) for gene discovery, linkage and candidate gene analyses, and SNP analysis. Applicants are encouraged to obtain biological samples from the NIDCR TMJ Implant Registry and Repository (http://Tmjregistry.org). Prior to requesting samples, applicants should contact Dr. James Fricton [frict001@umn.edu] at the University of Minnesota School of Dentistry, Minneapolis, Minnesota. MECHANISM OF SUPPORT This RFA will use the NIH 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 April 2005. 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 and the modular budgeting formats (see http://grants.nih.gov/grants/funding/modular/modular.htm). 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 NIDCR intends to commit approximately $3.0 million in FY 05 or FY 06 to fund 8 to 10 new grants in response to this RFA. The NINDS intends to commit $700,000 in FY 05 to fund approximately 2 new grants in response to this RFA. The NINDS is especially interested in meritorious applications that are relevant to its mission, including those that relate to neuropathic pain and neurogenic inflammatory pain of craniofacial structures. An applicant may request a project period of up to 5 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 the ICs 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 or foreign institutions/organizations o Faith-based or community-based 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 NIH programs. SPECIAL REQUIREMENTS To the extent possible, applicants should make data from these studies (including gene sets, protein sets, brain images, etc.) available in a form and in a manner that expedites their usefulness to a wide range of researchers. NIH believes that data sharing is essential for expedited translation of research results into knowledge, products, and procedures to improve human health. The NIH endorses the sharing of final research data to serve these and other important scientific goals. The NIH expects and supports the timely release and sharing of final research data from NIH-supported studies for use by other researchers. NIH recognizes that data sharing may be complicated or limited, in some cases, by institutional policies, local IRB rules, as well as local, state and Federal laws and regulations, including the Privacy Rule (available at http://www.hhs.gov/ocr/). The Privacy Rule is a federal regulation that governs how certain health care providers, health care clearinghouses, and health plans, known as "covered entities," use and disclose identifiable health information. As NIH stated in the March 1, 2002 draft data sharing statement (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-035.html), the rights and privacy of people who participate in NIH-sponsored research must be protected at all times. Thus, data intended for broader use should be free of identifiers that would permit linkages to individual research participants and variables that could lead to deductive disclosure of the identity of individual subjects. 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: John W. Kusiak, Ph.D. Director Molecular and Cellular Neurobiology Program Division of Basic and Translational Sciences National Institute of Dental and Craniofacial Research National Institutes of Health 45 Center Drive, Building 45, Room 4AN-18A Bethesda, MD 20892-6402 Telephone: 301-594-7984 FAX: 301-480-8319 Email: kusiakj@mail.nih.gov Linda L. Porter, Ph.D. Systems and Cognitive Neuroscience National Institute of Neurological Disorders and Stroke 6001 Executive Blvd., Room 2113 Bethesda, MD 20892-9521 Telephone: 301-496-9964 FAX: 301-402-2060 Email: lp216a@nih.gov o Direct your questions about peer review issues to: H. George Hausch, Ph.D. Acting Director Division of Extramural Activities National Institute of Dental and Craniofacial Research National Institutes of Health 45 Center Drive, Building 45, Room 4AN-44F Bethesda, MD 20892-6402 Telephone: 301-594-2904 FAX: 301-480-8303 Email: hauschg@mail.nih.gov o Direct your questions about financial or grants management matters to: Mary Daley Chief Grants Management Officer Division of Extramural Activities National Institute of Dental and Craniofacial Research National Institutes of Health 45 Center Drive, Building 45, Room 4AN-44B Bethesda, MD 20892-6402 Telephone: 301-594-4808 FAX: 301-480-3562 Email: daleym@mail.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: John W. Kusiak, Ph.D. Director Molecular and Cellular Neurobiology Program Division of Basic and Translational Sciences National Institute of Dental and Craniofacial Research National Institutes of Health 45 Center Drive, Building 45, Room 4AN-18A Bethesda, MD 20892-6402 Telephone: 301-594-7984 FAX: 301-480-8319 Email: kusiakj@mail.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. SUPPLEMENTARY INSTRUCTIONS 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 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 the appendix material must be sent to: H. George Hausch, Ph.D Acting Director Division of Extramural Activities National Institute of Dental and Craniofacial Research National Institutes of Health 45 Center Drive, Building 45, Room 4AN-44F Bethesda, MD 20892-6402 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 from the previous unfunded version of the application. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NIDCR. Incomplete and/or nonresponsive applications will not be reviewed. 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 NIDCR 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 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 written critique o Receive a second level review by the NIDCR 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 evaluate the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of the following criteria in assigning the application’s overall score, weighting them as appropriate for each application. o Significance o Approach o Innovation o Investigator o Environment 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. SIGNIFICANCE: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? INNOVATION: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? INVESTIGATOR: 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)? ENVIRONMENT: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there 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: 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 REVIEW CONSIDERATIONS SHARING RESEARCH DATA: Applicants requesting more than $500,000 in direct costs in any year of the proposed research must 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. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: April 19, 2004 Application Receipt Date: May 14, 2004 Peer Review Date: October 2004 Council Review: January 2005 Earliest Anticipated Start Date: April 2005 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 SHARING RESEARCH DATA: Starting with the October 1, 2003 receipt date, investigators submitting an NIH application seeking $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. 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 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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