INTEGRATED PRECLINICAL/CLINICAL AIDS VACCINE DEVELOPMENT (IPCAVD) PROGRAM RELEASE DATE: April 3, 2003 PA NUMBER: PAR-03-095 (See amendment, NOT-AI-05-034) 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. Replacement U19 (PAR-06-286) funding opportunity announcement has been issued for the submission date of June 1, 2006 and submission dates thereafter. EXPIRATION DATE: November 15, 2005, unless reissued. National Institute of Allergy and Infectious Diseases (NIAID) (http://www.niaid.nih.gov) CATALOGUE OF FEDERAL DOMESTIC ASSISTANCE NUMBERS: No. 93.855, Immunology, Allergy, and Transplantation Research No. 93.856, Microbiology and Infectious Diseases Research APPLICATION RECEIPT DATES: November 13, 2003, November 15, 2004, November 14, 2005 THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of this PA 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 Submitting an Application o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations: PURPOSE OF THIS PA The goal of the IPCAVD Program is to support the translation of meritorious AIDS vaccine concepts from the bench to the clinic. As such, the initiation of human studies is required during the term of the award. RESEARCH OBJECTIVES Background The National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) invites applications for research aimed at obtaining a safe and efficacious vaccine against HIV or AIDS. NIAID supports the progressive stages of AIDS vaccine research and development from basic research through iterative product development and clinical trials. NIAID supports AIDS prophylactic vaccine research and development via three solicited grant programs. The Innovation Grant Program for AIDS Vaccine Research supports high risk/high impact early stage concept evaluation for projects with limited preliminary data. The HIV Vaccine Research and Design (HIVRAD) Program supports a multi-project HIV vaccine design and development research application. The Integrated Preclinical/Clinical AIDS Vaccine Development (IPCAVD) Program, also a multi-project Program, supports iterative product development and late stage vaccine optimization and must include limited human studies. Research Objectives and Scope The IPCAVD Program is designed to support the later, more iterative stages of vaccine research/development and includes limited human studies. Studies responsive to this Program Announcement (PA) can include later stage preclinical research (vaccine optimization studies, immunogenicity/challenge studies, etc), GLP/GMP vaccine production, GLP preclinical toxicology and safety studies, pre-IND/IND preparation and submission, and clinical testing. Preclinical research alone, without clear feasible and realistic plans for progressing to human testing within the period of award is not considered responsive to this particular PA. Applicants are required to delineate in their applications discrete goals with measurable milestones and include criteria that can be used in deciding when to proceed to the next phase of product development towards a testable vaccine in humans. Funding of the final 2 years of the grant will be contingent upon the successful completion of negotiated milestones and the feasibility of clinical testing within the funding period as determined by a mid-point grant review (refer to Special Requirements Section below). MECHANISM OF SUPPORT This PA will use the NIH Multi-project Cooperative Agreement (U19), an "assistance" mechanism, rather than an "acquisition" mechanism. Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Essential elements of the multi-project cooperative agreement mechanism also include: (1) a minimum of two interrelated individual research projects organized around a central theme, (2) collaborative efforts and interaction among independent projects and their investigators to achieve a common goal, (3) a single Principal Investigator who will be scientifically and administratively responsible for the group effort, (4) a single applicant institution that will be legally and financially responsible for the use and disposition of funds awarded, and (5) support provided, as necessary, for "Core" resources or facilities, each of which is expected to be utilized by at least two research projects in order to facilitate the research effort. Details of the responsibilities, relationships and governance of a study funded under a cooperative agreement are discussed later in this document under the section "Terms and Conditions of Award." The total project period for applications submitted in response to this PA may not exceed five years. Applicants for U19 grants must follow special application guidelines in the NIAID Brochure entitled INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS; this brochure is available via the WWW at: http://www.niaid.nih.gov/ncn/grants/multibron.htm. 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 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 Milestones Based on the comments from the peer reviewers, the Program Officer may wish to revise the milestones included in the application through negotiation with the applicant. The agreed upon milestones will be included in the Terms of Award. Decisions regarding funding beyond 3 years will be based on the completion of milestones in the first 2.5 years. Review at 2.5 years At the mid-point of the grant (2.5 years), based on the first two annual reports and any additional information that the PI elects to submit at the 2.5 year anniversary, Program will assess the accomplishment of the milestones and whether the progress as reported will allow, with high probability, initiation of clinical study within the duration of the grant (up to 5 total years). The mid-point grant review will be conducted via conference call or a meeting between the PI and DAIDS staff, and may include members of the External Steering Committee (as described in the Collaborative Responsibilities Section of this PA). If DAIDS determines that that it is highly feasible for the grant to culminate in a human clinical study, the grantee will continue to be funded for years 4 and 5 of the grant. If DAIDS determines that it is not likely that continued funding will lead to a clinical study, the grantee will receive funding for a total of 4 years. Patent Coverage Since applications may involve several institutions, including the private sector, complex patent issues may arise. To avoid delays in the implementation of new vaccines for HIV as a result of intellectual property issues, each multi-project group is required to submit a plan, as part of the application that details: (1) the approach for obtaining patient coverage and licensing, where appropriate, (2) a statement demonstrating acceptance of the approach signed by all parties, and (3) the procedures to be followed for the resolution of legal problems that may potentially develop. 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 letter of intent identifying the NIAID staff member who has agreed to accept assignment of the application. Specifically, applicants requesting more than $500,000 must carry out the following steps: 1) Contact the NIAID program staff person listed in this PA at least 6 weeks before submitting the application. 2) Obtain agreement from the NIAID contact that the IC will accept the application for review and potential consideration for award, and 3) Identify in the letter of intent, the NIAID staff member contacted, a proposed first year budget with the number of Projects, PIs and Institution for each project, specific aims for each project, and a projected budget for the proposed funding period. 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. COOPERATIVE AGREEMENT TERMS AND CONDITIONS OF AWARD The following terms and conditions will be incorporated into the award statement and provided to the Principal Investigator as well as the institutional official at the time of award. These special Terms of Award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS Grant Administration Regulations at 45 CFR part 74 and 92, and other HHS, PHS, and NIH Grant Administration policy statements. The administrative and funding instrument used for this program is the multiproject cooperative agreement (U19), an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during the performance of the activity. Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Consistent with this concept, the dominant role and prime responsibility for the activity resides with the awardees for the project as a whole, although specific tasks and activities in carrying out the research will be shared among the awardees and the NIAID Scientific Coordinator. Cooperative agreements are subject to the administrative requirements outlined in OMB circulars A-102 and A-110. All pertinent HHS, PHS, and NIH grant regulations, policies and procedures, with particular emphasis on PHS regulations at 42 CFR Part 52 and HHS regulations at 45 CFR Part 74, are applicable. These special terms and conditions pertaining to the scope and nature of the interaction between the NIAID and the investigators will be incorporated in the Notice of Grant Award. However, these terms will be in addition to, not in lieu of, the customary programmatic and financial negotiations that occur in the administration of cooperative agreements. 1. Monitoring Clinical Studies When clinical studies or trials are a component of the research proposed, NIAID policy requires that studies be monitored commensurate with the degree of potential risk to study subjects and the complexity of the study. AN UPDATED NIAID policy was published in the NIH Guide on July 8, 2002 and is available at: http://grants.nih.gov/grants/guide/notice-files/ NOT-AI-02-032.html. The full policy, including terms and conditions of award, is available at: http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf. This award provides support for one or more NIH-defined Phase III clinical trials. The NIH Policy for research supported as an NIH Phase III Clinical Trial has been updated in Section III.B. of the "NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research", updated October 9, 2001 (URL listed below under REQUIRED FEDERAL CITATIONS). A description of plans to conduct analyses, as appropriate, by sex/gender and/or racial/ethnic groups must be included in clinical trial protocols and the results of the subset analyses must be reported to NIH in Progress Reports, Competitive Renewal Applications, and in the required Final Progress Report, as stated in Section III.B. of the Guidelines. 2. Awardee Rights and Responsibilities Awardees will have primary responsibility for defining the research objectives, approaches and details of the projects within the guidelines of the PA and for performing the scientific activity. Specifically, awardees have primary responsibility as described below. All awardees are required to host for the Program Officer and NIAID Program Staff an annual site visit review. The PI, all co-PIs, and the External Steering Committee (see below under Collaborative responsibilities) members shall attend this meeting. An update and summary of results generated on each project shall be presented by the PI, co-PI and/or all pertinent staff. These presentations shall include summaries of all goals or milestones (refer to Special Requirement Section of PA) and a description of all problems encountered that may have an impact on the achievement of future goals and milestones. In addition to the annual site visits hosted by the PI, the PI will be afforded the opportunity to submit in writing a mid-point progress report delineating progress on each of the stated milestones and a clear plan for the initiation of a clinical study. Any such supplemental information must be provided to the PO no later than 1 month before the 2.5 year anniversary of the grant award. 3. NIAID Staff Responsibilities NIAID staff assistance will be provided by the Program Officer who will serve as NIAID's Scientific Coordinator. The NIAID Scientific Coordinator will have substantial scientific/programmatic involvement during the conduct of this activity through technical assistance, advice and coordination above and beyond normal program stewardship for grants, as described below: a. Interacting with the PI on a regular basis to monitor study progress, compliance, adherence to protocol, and quality assurance in order to ensure the production of high-quality, unbiased results. Monitoring may include: (a) regular communication with the PI and staff, (b) periodic site visits for discussions with awardee research teams, (c) observation of field data collection and management techniques, quality control, fiscal review, and other relevant matters, as well as (d) attendance at and participation in annual site visit meetings and/or External Steering Committee (refer to Collaborative Responsibilities section below) meetings. The NIAID retains, as an option, periodic external review of progress. NIAID reserves the right to independently monitor any clinical trial to ensure adherence to regulatory requirements. Such review and monitoring may be conducted by organizations contracted by and acting on behalf of NIAID. a. Serving as a resource with respect to ongoing NIAID activities that may be relevant to the research, to facilitate compatibility, avoid unnecessary duplication, and potentially forge collaborations that may enhance the quality and breadth of the study. b. Providing substantial assistance in design and coordination of research activities for awardees including: i. advice on the planning, management, and technical performance of the investigators ii. access to and use of, when appropriate, reagents and assays, and other resources available through NIAID contractors and awardees iii. technical advice and assistance for meeting FDA requirements for investigational drugs iv. review and approval of protocols to ensure that they are within the scope of the original proposal, and that they follow peer review comments and suggestions; and for adequacy of safety, protection of human subjects, and representation of women and minorities as required by Federal regulations. The NIAID PO will monitor protocol progress, and DAIDS may require that a protocol be closed to accrual for reasons including: (a) accrual rate insufficient to complete the study in a timely fashion, (b) accrual goals met early, (c) poor protocol performance, (d) patient safety, human subjects, and women/minority recruitment concerns, (e) study results that are already conclusive, and (f) emergence of new information that diminishes the scientific importance of the study. The NIAID will not permit further expenditure of NIAID funds for a study after requesting closure (except for patients/subjects on-study and final data analysis and reporting). v. review and advice regarding the establishment of mechanisms for quality control and study monitoring d. Recommending continued funding based on: (a) overall study progress, including study subject and/or data accrual, (b) cooperation in carrying out the research, and/or (c) maintenance of high quality research that will allow pooling of data and comparison across multiple grant/cooperative agreement awards for common data elements. 4. Collaborative Responsibilities In addition to the interactions defined above, awardees and NIAID staff shall share responsibility for the organization of an External Steering Committee (ESC). The composition of the ESC membership shall be determined by consensus between the PI and the NIAID PO. The ESC will consist of a minimum of 3 members not directly affiliated with the research scope of the award. The ESC in combination with the PI will be responsible for determining progress of the PI/co-PI during the annual site visit reviews. 5. Arbitration Any disagreement that may arise on scientific or programmatic matters (within the scope of the award) between award recipients and the NIAID may be brought to arbitration. An arbitration panel will be will be formed to review any scientific or programmatic issue that is significantly restricting progress, and will be composed of three members -- one selected by the Steering Committee or by the individual awardee in the event of an individual disagreement, a second member selected by the NIAID, and a third member with expertise in the relevant area who is selected by the two other members. While the decisions of the Arbitration Panel are binding, these special arbitration procedures will in no way affect the awardee's right to appeal an adverse action in accordance with PHS regulations at 42 CFR Part 50, subpart D, and HHS regulations at 45 CFR Part 16. WHERE TO SEND INQUIRIES We encourage inquiries concerning this PA 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: Dr. Michael Pensiero Division of AIDS National Institute of Allergy and Infectious Diseases Room 4109, MSC-7628 6700-B Rockledge Drive Bethesda, MD 20892-7628 Telephone: (301) 435-3749) FAX: (301) 402-3684 E-Mail: mp338m@nih.gov o Direct your questions about peer review issues; address the letter of intent; mail two copies of the application and all five sets of appendices to: Dr. Dianne Tingley Division of Extramural Affairs National Institute of Allergy and Infectious Diseases Room Number 2148A, MSC-7616 6700-B Rockledge Drive Bethesda, MD 20892-7616 Telephone: (301) 496-2550 FAX: (301) 402-2638 Email: dt15g@nih.gov o Direct your questions about financial or grants management matters to: Victoria P. Connors Division of Extramural Affairs National Institute of Allergy and Infectious Diseases Room Number 2121, MSC-7614 6700-B Rockledge Drive Bethesda, MD 20892-7614 Telephone: (301) 402-6579 FAX: (301) 480-3780 Email: vp14v@nih.gov SUBMITTING AN APPLICATION Applicants for U19 grants must follow special application guidelines in the NIAID Brochure entitled INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS; this brochure is available via the WWW at: http://www.niaid.nih.gov/ncn/grants/multibron.htm Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted at the receipt dates noted at the heading of the Program Announcement. 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 exact copies of the grant application and all five sets of any appendix material must be sent to: Dr. Dianne Tingley Division of Extramural Affairs National Institute of Allergy and Infectious Diseases Room Number 2148A, MSC-7616 6700-B Rockledge Drive Bethesda, MD 20892 Telephone: (301) 496-2550 FAX: (301) 402-2638 Email: dt15g@nih.gov Applications that are not received as a single package on the receipt date or that do not conform to the instructions contained in PHS 398 (rev. 5/01) Application Kit (as modified in, and superseded by, the NIAID BROCHURE ENTITLED "INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS"), will be judged non-responsive and will be returned to the applicant. SPECIAL INSTRUCTIONS FOR COMPLETION OF APPLICATIONS IN RESPONSE TO THIS PA: Applicants for U19 cooperative agreements must follow special application guidelines in the NIAID Brochure entitled INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS; this brochure is available from NIAID listed under INQUIRIES via the WWW at: http://www.niaid.nih.gov/ncn/grants/multibron.htm. This brochure presents specific instructions for sections of the PHS 398 (rev. 5/01) application form that should be completed differently than usual. For all other items in the application, follow the usual instructions in the PHS 398. APPLICATION PROCESSING: Applications must be received by the application receipt date listed in the heading of this PA. If an application is received after that date, it will be returned to the applicant without review. 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 application already reviewed, but such application must include an Introduction addressing the previous critique. Concurrent submission of an R01 and a Component Project of a Multi-project Application: Current NIH policy permits a component research project of a multi-project grant application to be concurrently submitted as a traditional individual research project (R01) application. If, following review, both the multi-project application and the R01 application are found to be in the fundable range, the investigator must relinquish the R01 and will not have the option to withdraw from the multi-project grant. This is an NIH policy intended to preserve the scientific integrity of a multi-project grant, which may be seriously compromised if a strong component project(s) is removed from the program. Investigators wishing to participate in a multi-project grant must be aware of this policy before making a commitment to the Principal Investigator and awarding institution. Although there is no immediate acknowledgement of the receipt of a application, applicants are generally notified of the review and funding assignment within 8 weeks. PEER REVIEW PROCESS Applications submitted to this PA will be assigned on the basis of established PHS referral guidelines. U19 applications that are complete and responsive to this PA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIAID. As part of the initial merit review, all applications will: o Receive a written critique 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 second level review by the National Advisory Allergy and Infectious Diseases Council REVIEW CRITERIA The general review criteria for U19 multi-project cooperative agreement applications are presented in the NIAID brochure entitled "INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS" at http://www.niaid.nih.gov/ncn/grants/multibron.htm. ADDITIONAL REVIEW CRITERIA: In addition, the following review criteria 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 DATA SHARING: The adequacy of the proposed plan to share data. BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Programmatic priorities The NIAID gives special consideration for funding, including award of grants beyond the established NIAID percentile and priority score paylines, to scientifically meritorious applications in response to Program Announcements. 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. MONITORING PLAN AND DATA AND SAFETY MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). 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 AMENDMENT "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. This policy announcement is 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://grants.nih.gov/grants/stem_cells.htm 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 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 Catalogue of Federal Domestic Assistance at http://www.cfda.gov/ in the following citations: No. 93.855, Immunology, Allergy, and Transplantation Research and No. 93.856, Microbiology and Infectious Diseases Research. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The NIH Grants Policy Statement is available at http://grants.nih.gov/grants/policy/policy.htm. This document includes general information about the grant application and review process; information on the terms and conditions that apply to NIH Grants and cooperative agreements; and a listing of pertinent offices and officials at the NIH. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. 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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