and Human Services (HHS)
EXPIRED
NEUROBIOLOGY OF PERSISTENT PAIN MEDIATED BY THE TRIGEMINAL NERVE RELEASE DATE: September 16, 2003 PA NUMBER: PAS-03-173 March 2, 2006 (NOT-OD-06-046) Effective with the June 1, 2006 submission date, all R03, R21, R33 and R34 applications must be submitted through Grants.gov using the electronic SF424 (R&R) application. Accordingly, this funding opportunity expires on the date indicated below. A replacement R21 (PAS-06-199) funding opportunity announcement has been issued for the submission date of June 1, 2006 and submission dates thereafter. EXPIRATION DATE: Expiration Date for R21 Applications: July 02, 2006 Expiration Date for R01 Applications: July 01, 2006, unless reissued. Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATIONS: National Institutes of Health (NIH) (http://www.nih.gov/) COMPONENTS OF PARTICIPATING ORGANIZATIONS: National Institute of Neurological Disorders and Stroke (NINDS) (http://www.ninds.nih.gov) National Institute of Dental and Craniofacial Research (NIDCR) (http://www.nidcr.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): No. 93.853 (NINDS); 93.121 (NIDCR) THIS PAS CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanism(s) of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Submitting an Application o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA The National Institute of Neurological Disorders and Stroke (NINDS), along with the National Institute of Dental and Craniofacial Research (NIDCR), invite applications to advance our understanding of the neurobiology of persistent pain mediated by the trigeminal nerve and to develop effective therapeutic strategies to alleviate pain associated with disorders of myofascial, nervous, or skeletal tissues of the head and face, which are innervated by this nerve. The purpose of this initiative is to foster research that addresses the mechanisms of pain onset, chronic pain conditions, and responsiveness to pain therapy through novel basic and clinical research. Current knowledge of the neurobiology and neurochemistry of nociception, pain modulation and pain perception needs to be further developed and correlated with clinical manifestations of craniofacial pain to improve therapeutic strategies. This Program Announcement with Set-Aside funds (PAS) contributes to the goals of the NIH Pain Consortium, which is co- chaired by NINDS, NIDCR, and the National Institute of Nursing Research (NINR). RESEARCH OBJECTIVES Chronic pain is a debilitating condition that adversely affects the lives of millions of people. A diverse group of disorders arises from trauma, pathology, structural or degenerative changes, and sometimes unknown causes that affect the deep tissues of the head and face and often lead to severe, chronic pain. The trigeminal brainstem complex, which processes nociceptive input from craniofacial structures differs notably from spinal pain systems. The unique nature of nociceptive processing and varied etiology of pain conditions mediated by the trigeminal nerve contribute to the lack of understanding of the basic mechanisms of pain onset, and the development of chronic pain and abnormal pain responses (allodynia, hyperalgesia). These conditions hinder the development of effective treatment strategies to alleviate chronic pain in structures served by this nerve. Pain disorders mediated by the trigeminal nerve are often associated with severe and persistent pain of deep tissues, which may be of neuronal, muscular, joint, or vascular origin. Chronic pain mediated by the trigeminal nerve complex is a predominant feature of conditions such as migraine disorder, trigeminal neuralgia (TN), temporomandibular disorders (TMD), and dry eye syndrome. This diverse group of disorders involves neurochemical, physiological and molecular changes associated with deep tissue and nerve injury, which are signaled by the peripheral and central nervous system components of the trigeminal nerve. This nerve conveys afferent signals of tactile, thermal, and nociceptive stimuli from numerous structures of the head, including facial skin, jaw musculature, temporomandibular joints, ears, cornea, dura, and cranial vasculature. It also sends efferent signals that control the muscles of mastication. Nociceptive processing by the trigeminal complex differs from that by the spinal system serving the trunk and extremities: Specialized structures of the head are innervated by unique fiber contributions and nociceptive afferents are uniquely distributed and connected within the trigeminal spinal nucleus. Currently, the pain syndromes that involve the deep tissues of the head and face are categorized primarily on symptomatic, rather than on pathophysiologic grounds. Migraine is a disabling disorder, of which headache is one of several components. Studies suggest that the trigeminal nerve complex provides the signaling pathway for generation of pain associated with migraine. Pain often manifests in the periorbital facial area, the somatic territory innervated by the ophthalmic division of the trigeminal nerve. Afferents arising from this division of the nerve also innervate proximal regions of the cerebral blood vessels and meningeal vasculature and sinuses. Stimulation of perivascular trigeminal sensory afferent fibers releases vasoactive neuropeptides, which elicits dilation of the innervated vessels and transduction of central nociceptive information. It has been suggested that the pain experience may be generated by neurogenic inflammation of the meninges or sensitization of central trigeminal neurons. Although the chemical activation of these perivascular nerve fibers originates in deep tissues, it is referred to the periorbital area by convergence of trigeminal visceral and somatic fibers in the brainstem. The pain of migraine is perceived in the somatic territory of the nerve. Trigeminal neuralgia is characterized by intense pain arising from abnormal processing of signals from one or more of the peripheral branches of the trigeminal nerve. Innocuous stimuli to the territory innervated by the trigeminal nerve, such as a light breeze or movement, may trigger sudden, severe, electric shock-like or stabbing pain. Most often, the pain presents intermittently, affecting one side of the jaw or cheek. The etiology of TN remains uncertain, but one postulate is that vascular compression may occur at the point of entry of the nerve into the brainstem. The compression is thought to cause myelin damage leading to generation of abnormal impulses. The pain is perceived as arising from tactile stimuli to the face, but may actually be referred to the unaffected skin region from afferent signals arising from nociceptive stimuli to deep muscular or vascular tissues. Temporomandibular disorders encompass a group of conditions characterized by orofacial pain and tenderness of the masticatory muscles, the temporomandibular joint and associated structures, or both. Pain and dysfunction most commonly are of myofascial origin, but may also arise from intra-articular derangements, such as dislocation of the jaw, damage of the condyle, or arthritic changes. Localization, duration and temporal patterns of pain vary, but typically it is described as aching pain in the temporomandibular region that persists beyond the duration of the precipitating cause. The pain may be debilitating and may last for months or even years. Dry eye syndrome is a painful condition characterized by a chronic lack of sufficient lubrication and moisture of the cornea. It may be associated with damage to the trigeminal nerve and is often a symptom of systemic diseases such as lupus and rheumatoid arthritis. Craniofacial/deep tissue persistent pain conditions are diverse, but shared objectives for future research directions on these disorders can be defined. Appropriate mechanism-based models are needed to optimize basic and clinical research. The factors that influence the age-at-onset and gender selectivity associated with these conditions need to be identified and considered when developing treatment strategies. Inadequate diagnostic criteria that often lead to inappropriate or untimely treatment of these conditions need to be better defined and used. A better understanding of the basic mechanisms underlying the onset of pain, the shift to a chronic pain state and the development of abnormal pain responses must be gained in order to develop effective pain therapies. Progress towards effective pain management of these disorders lags behind that for other pain conditions. GOALS The current PAS encourages the integration of basic research on the neurobiology of persistent pain mediated by the trigeminal nerve with clinical observations in humans suffering from these pain conditions. This PAS encourages the translation of relevant research using animal models into clinical trials aimed at improving pain treatment in humans. Carefully designed studies that cut across scientific disciplines will be necessary to accomplish these goals. Experts from many clinical and basic research arenas will be needed to establish correlations between clinical manifestations and underlying mechanisms that are crucial to development and assessment of effective therapeutic interventions. Investigators in the fields of neurobiology, genetics, immunology, endocrinology, anesthesiology, neurology, and epidemiology are encouraged to submit proposals that will contribute to the successful achievement of the goals of this PAS. Potential research questions include, but are not limited to the following issues: o Development of model systems that appropriately mimic the clinical features of syndromes associated with deep tissue pain in the head and neck region, in order to provide optimal tools for basic and clinical studies; o Effective application of research paradigms in animal models and in human studies of persistent trigeminal nerve mediated pain into clinical research on human subjects in order to develop mechanistically derived pain therapies (development and application of clinically relevant assays of pain in human studies); o Characterization of the immune and inflammatory mechanisms in the pathophysiology of craniofacial/deep tissue persistent pain through determination of the role of glial cells and cytokine release in central and peripheral pain pathways, and clinical assessment of relevant findings; o Discovery of mechanisms of plasticity at the neurochemical, molecular and cellular level, which contribute to abnormal pain responses (hyperalgesia, allodynia) and persistent pain associated with disorders of tissues innvervated by the trigeminal nerve; o Neuroimaging of pain signaling pathways to elucidate the roles of central (including descending modulation) and peripheral plasticity in mediating the onset, persistence, and management of chronic pain associated with migraine and other pain disorders of the head and neck; o Characterization of changes in gene and protein expression along the components of the trigeminal nerve complex in response to nociceptive stimuli using gene chip technology, and determination of how these changes contribute to development of chronic pain and abnormal pain responses; o Identification of the factors that contribute to the high level of co- morbidity of craniofacial with musculoskeletal, gastrointestinal, and pelvic pain disorders through exploration of the central integration and processing of afferent input from craniofacial structures with that from non- craniofacial structures; o Elucidation of the role of acid-sensitive ion channels in deep tissues of the head and neck in onset of pain and the development of abnormal pain responses and chronic pain; o Determination of factors that underlie gender, age, and ethnic variations in pain experience of craniofacial disorders in order to provide more appropriate and individualized pain management for these groups; o Characterization of sensory, cognitive, affective, and other biobehavioral responses to noxious stimulation and pain perception in humans; o Determination of the usefulness of exercise in pain management through clinical trials (inhibition of hyperalgesia and allodynia, and alleviation of chronic pain); o Determination of the role of growth factors in pathophysiology of chronic pain associated with head and neck structures disorders and integration of relevant findings with clinical trials to assess pain therapies; o Determination of the role of hormonal systems (genomic and non-genomic effects) and the potential interactions between steroidal hormones and growth factors in pathophysiology and management of pain associated with migraine headache and other pain disorders of head and neck structures; o Development and testing of novel mechanism-based therapies for improved management of chronic pain associated with craniofacial disorders through appropriate clinical trials. SUMMARY The purpose of this PAS is to stimulate novel, multidisciplinary research that will lead to better understanding and treatment of craniofacial/deep tissue persistent pain. Integration of preclinical and clinical research will be a critical factor towards achieving this goal. MECHANISMS OF SUPPORT This PAS will use the NIH R01 and R21 award mechanisms. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. For further information on the R21 mechanism, including Institute-specific information, see http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html. This PAS 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 NINDS has set aside $1,200,000 total costs, in addition to funds available for applications sent in response to this program announcement that score within the NINDS payline (see NINDS Funding Strategy http://www.ninds.nih.gov/funding/ninds_funding_strategy.htm), depending on the overall scientific merit of the application and the availability of funds throughout the duration of this solicitation ($400,000/year for 3 years). The NIDCR has set aside $300,000 in total costs in FY 2004 and 2005 to fund one meritorious application each year that is appropriate to basic science related to the NIDCR mission. Although the National Institute on Drug Abuse (NIDA) is not a co-sponsor of this PA, it is interested in the support of research related to pain mediated by the trigeminal nerve. As such, the NIDA would be interested in meritorious applications submitted in response to this announcement that are relevant to its mission and competitive within its funding plan. Direct your questions about research/scientific issues to: David Thomas, Ph.D.; National Institute of Drug Abuse; Telephone: (301)443-6975; Email: [email protected]. 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 and 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. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PAS and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into two areas: scientific/research and financial or grants management issues: o Direct your questions about scientific/research issues to: Linda 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: [email protected] John W. Kusiak, Ph.D. Director Molecular and Cellular Neurobiology Program Division of Basic and Translational Sciences National Institute of Dental and Craniofacial Research Natcher, Building 45, Room 4AN-18A Bethesda, MD 20892-6402 Telephone: 301-594-7984 FAX: 301-480-8319 Email: [email protected] o Direct your questions about financial or grants management matters to: Denise Chatman Grants Management Branch National Institute of Neurological Disorders and Stroke 6001 Executive Blvd., Room 3269 Bethesda, MD 20892 Telephone: (301) 496-3993 Email: [email protected] Mary Daley Chief Grants Management Officer Division of Extramural Activities National Institute of Dental and Craniofacial Research Natcher, Building 45, Room 4AN-44B Bethesda, MD 20892-6402 Telephone: 301-594-4808 FAX: 301-480-3562 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. 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 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: [email protected]. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted at the standard application deadlines, which are available at http://grants.nih.gov/grants/dates.htm. Application deadlines are also indicated in the PHS 398 application kit. 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. SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR: Applications requesting $500,000 or more in direct costs for any year must include a cover letter identifying the NIH staff member within one of NIH institutes or centers who has agreed to accept assignment of the application. Applicants requesting more than $500,000 must carry out the following steps: 1) Contact the IC program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study; 2) Obtain agreement from the IC staff that the IC will accept your application for consideration for award; and, 3) Identify, in a cover letter sent with the application, the staff member and IC who agreed to accept assignment of the application. This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the checklist, and five 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) APPLICATION PROCESSING: Applications must be mailed on or before the receipt dates described at http://grants.nih.gov/grants/funding/submissionschedule.htm. The CSR will not accept any application in response to this PAS that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique. 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. PEER REVIEW PROCESS Applications submitted for this PAS will be assigned on the basis of established PHS referral guidelines. Appropriate scientific review groups convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications will: o Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score o Receive a written critique o Receive a second level review by the appropriate 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. 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. 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 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 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. AWARD CRITERIA Applications submitted in response to a PA will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Relevance to program 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 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. See 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. 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 PA 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) http://www.cfda.gov/ 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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