COMPETING CONTINUATION AWARDS OF SBIR PHASE II GRANTS FOR HEART, LUNG, BLOOD, AND SLEEP DISORDERS RELEASE DATE: December 01, 2003 PA NUMBER: PA-04-028 (This PA has been expired, see NOT-HL-06-117) (Clarification of submission requirements, see NOT-HL-05-124) EXPIRATION DATE: February 1, 2006 IMPORTANT CHANGE: The opportunity to apply for an NHLBI SBIR and STTR Phase II Competing Renewal is available from the PHS 2006-2 SBIR/STTR Omnibus Solicitation. (See Program Descriptions and Research Topics (PDF or MS Word)). Interested applicants must apply using the electronic application package from the parent SBIR (PA-06-120) or STTR (PA-06-121) Funding Opportunity Announcements (FOAs). APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT. Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov) COMPONENT OF PARTICIPATING ORGANIZATION: National Heart, Lung and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.837, 93.838, 93.839 APPLICATION RECEIPT DATE(S): Applications submitted in response to this program announcement will be accepted at the standard application deadlines [April 1, August 1, December 1] THIS PA CONTAINS THE FOLLOWING INFORMATION: o Purpose of the PA o Research Objectives o Mechanism(s) of Support o Project Period and Amount of Award 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 NOTICE: This program announcement (PA) must be read in conjunction with the current Omnibus Solicitation of the National Institutes of Health, Centers for Disease Control and Prevention, and Food and Drug Administration for Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Grant Applications. The solicitation (see http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf) contains information about the SBIR program, regulations governing the program, and information for submission. All of the instructions within the current SBIR Omnibus Solicitation apply. PURPOSE OF THE PA The purpose of this Program Announcement (PA) is to solicit from NHLBI- supported SBIR Phase II awardees, competing continuation applications that propose to continue the process of assessing and improving devices or conducting preclinical studies of products or devices that ultimately require: 1) clinical evaluation, 2) approval by a Federal regulatory agency, and 3) continuing refinements to durable medical equipment (DME) designs such as cost reduction, testing for safety, durability, and reliability, and meeting or establishing standards. Such products include, but are not limited to biological products, devices, drugs, vaccines, medical implants, etc. related to the mission of the NHLBI. Only SBIR Phase II awardees are eligible to submit a competing continuation application. The previously funded Phase II SBIR grant need not have been submitted in response to a particular solicitation, as long as the research is appropriate to the purpose of this solicitation. Since the Phase II competing continuation grant is a new funding mechanism and is contingent on the fiscal and programmatic interests and priorities of the NHLBI, eligible applicants are strongly encouraged to contact their NHLBI Program official prior to submission. RESEARCH OBJECTIVES Background The Small Business Innovation Research (SBIR) program was initiated as a means for government agencies to use small businesses to stimulate technological innovation and to help agencies meet their research and development (R&D) needs. An additional provision of these programs is the expected commercialization of the research. Certain types of research require clinical evaluation and federal regulatory approvals before Phase III of the small business research pathway can be realized. A recipient of NIH SBIR Phase I and Phase II awards normally receives a total of no more than $850 thousand. If the intended commercialized product is a medical device, drug or biologic, the $850 thousand often represents a small fraction of the funds necessary to complete the studies required for approval and licensing by the Food and Drug Administration (FDA) or other federal agencies. The Phase II competing continuation support will allow small businesses to address clinical issues, and other important issues relevant to regulatory approvals by agencies such as the FDA. The SBIR Phase II competing continuation would represent a continuation of support for research and development of such previous work funded by the original Phase II grant. It is expected that promising results from a previous SBIR Phase I and Phase II grant will indicate the merit of further research and development. Clinical investigations and Federal regulatory approvals will ultimately be required to realize the potential of the product being researched and developed. Activities supported by a competing continuation of a Phase II SBIR grant are meant to enable small businesses to complete the necessary preclinical R&D needed for pre-investigational new drug (IND), or investigational device exemption (IDE) filing, or other processes needed to meet the requirements and expectations of Federal regulatory agencies prior to clinical evaluation for safety, toxicity and effectiveness. A competing continuation Phase II award may not be used to conduct early stage research (e.g., identifying targets for drugs, identification of new and more effective compounds or potential diagnostic markers, initial device/software development, optimizing device functionality or initial assay testing, etc.). Examples of Research Topics Examples of research that would be considered responsive to this announcement are listed below for illustrative purposes and are not exclusive of other appropriate activities. o Preclinical studies, including pharmacology and toxicology, beyond those conducted under the Phase I (R43) and initial Phase II (R44) grants. o Completion of studies as required by the Food and Drug Administration (FDA) for Investigational New Drug (IND) or Radioactive Drug Research Committee (RDRC) application. o Assessment of devices with regard to performance standards related to the FDA approval process. o Safety and effectiveness studies of novel medical devices and tissue engineered products. o Biocompatibility studies of surface materials of putative medical implants. o Evaluation of novel imaging approaches for diagnostic purposes. o Clinical studies in support of New Drug Application approval by the FDA. o Clinical studies in support of Pre-Market Approval for biomarkers/medical devices by the FDA. MECHANISM(S) OF SUPPORT This PA uses the SBIR Phase II (R44) mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. An NHLBI SBIR Phase II competing continuation application must be in response to this PA, and the application will be accepted only as a competing continuation of a previously funded NHLBI Phase II SBIR (R44) grant. The previously funded NHLBI Phase II grant need not have been submitted in response to any particular solicitation, but the application for the competing continuation must propose research and development that represents a logical extension of the previously supported Phase II research as described in this announcement. This PA uses just-in-time concepts. 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. PROJECT PERIOD AND AMOUNT OF AWARD For this PA, budgets up to $1,000,000 total costs per year and time periods up to 3 years may be requested for Phase II. Total costs include direct costs, F&A, and fee/profit in accordance with the current SBIR guidelines. (see http://grants.nih.gov/grants/funding/sbirsttr1/index.pdf) The competing continuation grant cannot be renewed. ELIGIBLE INSTITUTIONS Eligibility requirements are described in the SBIR/STTR Omnibus Solicitation. Only small business concerns are eligible to submit applications. A small business concern is one that, on the date of award for both Phase I and Phase II agreements, meets ALL of the criteria as described in the SBIR/STTR Omnibus Solicitation. The competing continuation application must be a continuation of a previously funded NHLBI Phase II (R44) grant focusing on research and development of a product or products ultimately requiring clinical testing and Federal regulatory approval. 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. On an SBIR application, the principal investigator must have his/her primary employment (more than 50%) with the small business at the time of award and for the duration of the project. SPECIAL REQUIREMENTS An applicant must provide evidence that they have contacted the Food and Drug Administration (FDA) for guidance concerning the development of a drug, biologic, or medical device. Such evidence should include FDA correspondence regarding an investigational new drug (IND) application, investigational device exemption (IDE), or pre-market notification (510k) for the applicant’s product development and the status of their project in a timeline related to Federal regulatory approval processes. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PA 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: Heart Suzanne Goldberg, R.N., M.S.N. Division of Heart and Vascular Diseases National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 9174 (MSC 7940) Bethesda, MD 20892-7940 (20817 for Courier) Telephone: (301)435-0532 Fax: (301)480-1336 Email: goldbergsh@mail.nih.gov Rosalie A. Dunn, Ph. D. Division of Heart and Vascular Diseases National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 9196 (MSC 7940) Bethesda, MD 20892-7940 (20817 for Courier) Telephone: (301) 435-0505 Fax: (301) 480-1454 Email: dunn@nhlbi.nih.gov Lung/Sleep Mrs. Ann Rothgeb Division of Lung Diseases National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 10114 (MSC 7952) Bethesda, MD 20892-7952 (20817 for Courier) Telephone: (301) 435-0202 FAX: (301) 480-3557 Email: ar31t@nih.gov Blood Phyllis Mitchell, M.S. Division of Blood Diseases and Resources National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 10163(MSC 7950) Bethesda, MD 20892-7950 (20817 for Courier) Telephone: (301) 435-0481 Fax: (301) 480-1060 Email: mitchelp@nhlbi.nih.gov Liana Harvath,Ph.D. Division of Blood Diseases and Resources National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 10170 (MSC 7950) Bethesda, MD 20892-7950 (20817 for Courier) Telephone: (301) 435-0063 FAX: (301) 480-0868 Email: HarvathL@nhlbi.nih.gov Epidemiology and Clinical Applications Paula T. Einhorn, M.D., M.S. Division of Epidemiology and Clinical Applications National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 8001 (MSC 7936) Bethesda, MD 20892-7936 (20817 for Courier) Telephone: (301) 435-0563 FAX: (301)480-1669 Email: einhornp@nhlbi.nih.gov o Direct your questions about financial or grants management matters to: Shelia Ortiz Grants Operations Branch National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 7171 Bethesda, MD 20892-7926 Telephone: (301) 435-0166 Fax: (301) 480-3310 Email: ortizs@nhlbi.nih.gov SUBMITTING AN APPLICATION The PHS 398 research grant application must be used for all SBIR Phase II applications (new and revised.) Effective October 1, 2003, 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. Prepare your application in accordance with the SBIR/STTR Omnibus Solicitation and the PHS 398. Helpful information for advice and preparation of the application can be obtained at: http://grants.nih.gov/grants/funding/sbirgrantsmanship.pdf. The NIH will return applications that are not submitted on the 5/2001 version of the PHS 398. For further assistance contact GrantsInfo, Telephone: (301) 710-0267, Email: GrantsInfo@nih.gov. The title and number of this PA must be typed on line 2 of the face page of the application. 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 (for USPS Express or Regular Mail) Bethesda, MD 20817 (for Express/courier non-USPS service) Applications must be received by or mailed on or before the receipt dates described on the first page of this program announcement. The CSR will not accept any application in response to this PA 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 unfunded version 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 PA 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 an appropriate 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 ALL SBIR APPLICATIONS 1. Significance: Does the proposed project have commercial potential to lead to a marketable product or process? Does this study address an important problem? What may be the anticipated commercial and societal benefits of the proposed activity? If the aims of the application are achieved, how will scientific knowledge be advanced? Does the proposal lead to enabling technologies (e.g., instrumentation, software) for further discoveries? Will the technology have a competitive advantage over existing/alternate technologies that can meet the market needs? 2. Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Is the proposed plan a sound approach for establishing technical and commercial feasibility? Does the applicant acknowledge potential problem areas and consider alternative strategies? Are the milestones and evaluation procedures appropriate? 3. Innovation: Does the project challenge existing paradigms or employ novel technologies, approaches or methodologies? Are the aims original and innovative? 4. Investigators: Is the Principal Investigator capable of coordinating and managing the proposed SBIR? Is the work proposed appropriate to the experience level of the Principal Investigator and other researchers, including consultants and subcontractors (if any)? Are the relationships of the key personnel to the small business and to other institutions appropriate for the work proposed? 5. Environment: Is there sufficient access to resources (e.g., equipment, facilities)? Does the scientific and technological 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? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will be applied to ALL applications 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 additional information and 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 additional information and Inclusion Criteria in the sections on Federal Citations, below). Human Subjects: 1. Protection of Human Subjects from Research Risks - for all studies involving human subjects. See instructions and "Guidance for Preparing the Human Subjects Research Section. If an exemption is claimed, is it appropriate for the work proposed? If no exemption is claimed, are the applicant's responses to the six required points appropriate? Are human subjects placed at risk by the proposed study? If so, are the risks reasonable in relation to the anticipated benefits to the subjects and others? Are the risks reasonable in relation to the importance of the knowledge that reasonably may be expected to be gained? Are the plans proposed for the protection of human subjects adequate? 2. Inclusion of Women Plan - for clinical research only. Does the applicant propose a plan for the inclusion of both genders that will provide their appropriate representation? Does the applicant provide appropriate justification when representation is limited or absent? Does the applicant propose appropriate and acceptable plans for recruitment/outreach and retention of study participants? 3. Inclusion of Minorities Plan - for clinical research only. Does the applicant propose a plan for the inclusion of minorities that will provide their appropriate representation? Does the applicant provide appropriate justification when representation is limited or absent? Does the applicant propose appropriate and acceptable plans for recruitment/outreach and retention of study participants? 4. Inclusion of Children Plan - for all studies involving human subjects. Does the applicant describe an acceptable plan in which the representation of children of all ages (under the age of 21) is scientifically appropriate and recruitment/retention is addressed realistically? If not, does the applicant provide an appropriate justification for their exclusion? 5. Data and Safety Monitoring Plan for clinical trials only. Does the applicant describe a Data and Safety Monitoring Plan that defines the general structure of the monitoring entity and mechanisms for reporting Adverse Events to the NIH and the IRB? CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the required five items described under Vertebrate Animals (section f of the Research Plan instructions) will be assessed. BIOHAZARDS: Is the use of materials or procedures that are potentially hazardous to research personnel and/or the environment proposed? Is the proposed protection adequate? ADDITIONAL REVIEW CONSIDERATIONS: The following items may be also be considered by reviewers but will not be included in the determination of scientific merit. 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 may be considered. For all applications, is the percent effort listed for the PI appropriate for the work proposed? On applications requesting up to $100,000 total costs, is the overall budget realistic and justified in terms of the aims and methods proposed? On applications requesting over $100,000 in total costs, is each budget category realistic and justified in terms of the aims and methods? PERIOD OF SUPPORT: The appropriateness of the requested period of support in relation to the proposed research. TYPE 2 PHASE II COMPETING CONTINUATION APPLICATIONS In addition to the above review criteria, the following items will be applied to ALL Type 2 Competing Continuation Phase II applications in the determination of scientific merit and the priority score: o Does the activity as proposed address issues related to Federal regulatory approval processes? o What will be the effect of these studies on the concepts or methods that drive this field? 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 RECEIPT AND REVIEW SCHEDULE See http://grants.nih.gov/grants/funding/sbirsttr_receipt_dates.htm 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 $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 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) 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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