INFRASTRUCTURE FOR DATA SHARING AND ARCHIVING RELEASE DATE: October 17, 2003 RFA Number: RFA-HD-03-032 (Reissued as RFA-HD-08-020) (see correction NOT-HD-04-003) 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 Child Health and Human Development (NICHD) (http://www.nichd.nih.gov/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.864 LETTER OF INTENT RECEIPT DATE: December 15, 2003 APPLICATION RECEIPT DATE: January 15, 2004 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA The Demographic and Behavioral Sciences Branch (DBSB) of the Center for Population Research (CPR) of the National Institute of Child Health and Human Development (NICHD) invites applications to establish cooperative infrastructure to facilitate data sharing in population research. The purpose of this request is to establish a capability to assist in making large-scale, complex datasets available to the population research community for secondary research analysis. These datasets typically will be those collected with substantial DBSB support. The desired capability to facilitate data sharing must have the following characteristics: (1) the ability to use state-of-the- art computer technology to store, document and access large-scale datasets, (2) the capability to advise the users about the technical aspects of the database, (3) the capability to implement appropriate data security measures to protect the privacy of human subjects in complex datasets, and (4) the ability to maintain effective outreach to maximize the usage of datasets by current and potential data users. RESEARCH OBJECTIVES The primary mission of DBSB is to advance population research by supporting investigations using the methodologies found in demography and allied fields. This research has necessarily featured the analysis of large-scale, population-based datasets. Over time, many important studies have been supported by DBSB that both collect and analyze such data and the field has evolved a sophisticated, albeit informal, system of data sharing. The onus of data sharing has been placed on the investigators and research centers fielding the studies. Recently, this system has faced increasing challenges. The expense of maintaining effective and secure data sharing within the field has grown considerably as datasets have become more complex and more sensitive. Some investigators and institutions lack the technical capability to provide access to data that is highly complex and sensitive with respect to human subjects protection. Moreover, few institutions have the capability to support continued utilization of data after the base grant to collect them terminates. DBSB convened a workshop to discuss these problems and a paper entitled "Data Access and Archiving: Options for the Demographic and Behavioral Sciences Branch" describes the deliberation and recommendations of the workshop. The paper may be accessed at http://www.nichd.nih.gov/cpr/dbs/pubs.htm. In a related development, the NIH has also published a policy of data sharing, http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html, that reinforces the urgency to improve the system of data sharing within the population research community. As a result, DBSB is seeking to create a capability that works cooperatively with and improves upon the current system of data sharing in population research. Currently, datasets created with NICHD funding are shared in a variety of ways. Many investigators simply turn their data over to an existing archive or, if the demand for the data is expected to be minimal, provide data on a case-by-case basis. However, for large, complex and/or sensitive datasets that have the potential for extensive secondary use, more complex systems of sharing have evolved in the population research community. After the data are collected, the Principal Investigator creates and maintains a system to share the data with the research community. During this time, the Principal Investigator usually conducts outreach efforts to help researchers outside of the investigative team and creates the documentation and help infrastructure to allow outside investigators reasonable access to the data. Quite often an interactive system is set up to allow users to notify investigators of any problems with the data and this, in turn, helps the investigators improve the quality of the dataset. Increasingly, data access is provided through the internet although many datasets are distributed via CD-ROM or equivalent media. Often, a multi-tiered access system is used. Data that are free of concerns about the protection of human subjects are circulated widely with a minimum of restrictions concerning research use. Additional data that are sensitive in nature are available only through another tier of protection that usually involves contractual agreements between the investigator and the secondary user with respect to how the data are analyzed and published. Sometimes, the data are so sensitive that they may only be accessed through a supervised system. The Health Insurance Portability and Accountability Act of 1996 (HIPAA) has further complicated data sharing. The Department of Health and Human Services (DHHS) has issued the regulation, "Standards for Privacy of Individually Identifiable Health Information," applicable to entities covered by HIPAA, http://www.hhs.gov/ocr/hipaa/. As population research evolves to embrace some aspects of clinical research or combines traditional population data with health records that are HIPAA regulated, the field must learn to deal with data security as mandated by this law. Objectives and Scope DBSB wishes to preserve this system of data sharing in which the investigators have control of the data through the active life of the project and have the initial burden of creating a data-sharing system that is appropriate for their data. However, DBSB recognizes that investigators need help in designing appropriate systems of data sharing; they may need assistance in improving or augmenting data sharing capability during the project period and they need a mechanism for ensuring data access after their project funding ends. The cooperative infrastructure created by this initiative will provide this help. This initiative will support one or more cooperative agreements to assist Principal Investigators to develop infrastructure and/or to directly provide infrastructure to facilitate the sharing of large-scale datasets in population research. The infrastructure will provide help to investigators in creating and operating an effective and innovative data-sharing system and will be capable of assuming the primary responsibility for maintaining access to the data after the grant support for collecting the data has expired. Specific Objectives Applicants must propose to work cooperatively with DBSB and other grantees supported by this initiative to provide data-sharing infrastructure to support the access of population researchers to data that have, are and will be collected by selected studies. Applicants may request five years of support to provide the following infrastructure: o Consultation infrastructure that will help investigators set up an innovative system of data sharing that is tailored both to provide efficient data access and provide adequate protection to human subjects. o Data access infrastructure that will provide access to data from complex and/or sensitive population research studies. This infrastructure will provide full service access to data that are valuable to the research community but can no longer be provided through the investigator. It may also augment data-sharing infrastructure for ongoing studies, e.g., in cases where highly specialized services are required. The intent of this infrastructure is to improve upon the efforts of individual investigators rather than to substitute for their efforts to share data that are supported through the project grant or related infrastructure or center grant. Applicants may propose to offer the full range of desired infrastructure or may propose to provide a specialized type of infrastructure, e.g., for a particular kind of data or a particular technique for sharing sensitive data. The applicants must propose to work cooperatively with DBSB and other grantees funded through this solicitation to accomplish the goals of the project. For purposes of this RFA, population research is defined as any research relevant to the mission of the DBSB. See http://www.nichd.nih.gov/about/cpr/dbs/dbs.htm for details about DBSB. The types of complex datasets to be serviced by the infrastructure include: The National Survey Of Families And Households (NSFH) (http://www.ssc.wisc.edu/nsfh/home.htm), The Los Angeles Family and Neighborhood survey (LAFANS) (http://www.lasurvey.rand.org/), the National Longitudinal Study of Adolescent Health (Add Health) (http://www.cpc.unc.edu/projects/addhealth/), The Welfare, Children and Families: A Three City Study (Three City Study) (http://www.jhu.edu/~welfare/), The Fragile Families and Child Well-being Study (Fragile Families Study) (http://crcw.princeton.edu/fragilefamilies/), or The New Immigrant Survey (NIS) (http://www.pop.upenn.edu/nis/). In addition, the branch is developing a portfolio of research in the field of population health that is expected to yield complex data for future research. See the Community Child Health RFA (RFA-HD-02-008) for an example of such a development (http://grants2.nih.gov/grants/guide/rfa-files/RFA-HD-02-008.html). MECHANISM OF SUPPORT This RFA will use the NIH Resource-Related Research Project - Cooperative Agreement (U24) award mechanism. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. The anticipated award date is July 01, 2004. The NIH U24 is a cooperative agreement award mechanism in which the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the section "Cooperative Agreement Terms and Conditions of Award." FUNDS AVAILABLE The NICHD intends to commit approximately $750,000 in total costs [Direct plus Facilities and Administrative (F & A) costs] in FY 2004 to support one to four new and/or competing continuation grants in response to this RFA. An applicant may request a project period of up to five years and a budget for direct costs of up to $600,000 per year. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the NICHD provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. ELIGIBLE INSTITUTIONS You may submit an application 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 Faith-based or community-based organizations o Domestic institutions/organizations o Foreign institutions are not eligible to apply 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 his/her 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 Cooperative Agreement Terms and Conditions of Award The following Terms and Conditions will be incorporated into the award statement. They are to be followed in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92, and other HHS and NIH grant administration policies. The administrative and funding instrument used for this program will be the U24, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH scientific and/or programmatic involvement with the PI is anticipated during performance of the activities. Under the cooperative agreement, the NIH purpose is to support and/or stimulate the PI's activities by involvement in and otherwise working jointly with the PI in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the PI for the project as a whole, although specific tasks and activities may be shared between the awardee and the NICHD Project Coordinator. Facilities and Administrative cost (formerly called indirect cost) award procedures apply to cooperative agreements in the same manner as for grants. Business management aspects of these awards will be administered by the NICHD Grants Management Branch in accordance with HHS and NIH grant administrative requirements. 1. Awardee Rights and Responsibilities Awardees have primary authorities and responsibilities to define objectives and approaches, and to plan, conduct, analyze, and publish results, interpretations, and conclusions of their studies. The primary responsibilities of awardees are to: o Define the objectives of the plan to create and provide infrastructure; o Design the necessary strategies and approaches for creating and providing the infrastructure; o Conduct specific studies and operate infrastructure; o Analyze and interpret data and needs of the population research community; o Modify plans and operations as required; o Provide information to the NICHD Project Coordinator concerning progress. Awardees will retain custody of and have primary rights to the data developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies. 2. NIH Responsibilities NICHD Project Coordinator: An NICHD Project Coordinator will have substantial programmatic involvement, above and beyond normal program stewardship. The NICHD Project Coordinator will represent the government's interests on the Steering Committee. The Project Coordinator will provide information on datasets that are candidates for support through the cooperative agreement and will provide an assessment of priority of each dataset in regard to potential support through the cooperative agreement. The Project Coordinator will work to reconcile the capacity of the awardee(s) with the needs of individual investigators who wish to share data, population research centers that are supporting data sharing and the population research community that uses shared data. The Project Coordinator will establish a time and place for each Steering Committee meeting. NICHD Project Officer: The NICHD will appoint a Project Officer, apart from the Project Coordinator, who will: o Carry out continuous review of all activities to ensure that the objectives are being met and that all regulatory, fiscal, and administrative matters are handled according to NIH guidelines. o Have the option to withhold support to a participating institution if technical performance requirements are not met. o Perform other duties required for normal program stewardship of grants. 3. Collaborative Responsibilities Grantees will be expected to cooperate with NICHD and the population research community to ensure that the infrastructure to share data is adequate to meet the needs of population research. This will involve working to support the efforts of individual investigators, providing services directly to the population research community and innovating new solutions as technology permits. Steering Committee A Steering Committee will be established that will create a set of operating procedures that will be published as a manual of operations and the cooperative agreement will be bound by these procedures. The Steering Committee will be the decision-making body for determining which datasets to serve and what help to provide. It will balance available resources with the importance of the dataset to the field and the needs and capabilities of the investigator. The Steering Committee will comprise the Project Coordinator for the grant(s) and the Principal Investigator(s) of the grant(s). Each will have one vote in situations requiring a vote. There will be semi-annual face-to-face one and one-half day meetings of the Steering Committee and other meetings as needed through telephone or internet connections. One face-to-face meeting will occur in Bethesda, MD and the other at the annual meeting of the Population Association of America. Advisory Committee In addition, NICHD will appoint an advisory committee that will meet at least once a year with the Steering Committee to advise on issues such as data security, data access, and priorities for resource allocation. 4. Arbitration Process Any disagreements that may arise in scientific or programmatic matters within the scope of the award between grantees and the NIH may be brought to arbitration. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D, and HHS regulation at 45 CFR Part 16. An Arbitration Panel will help resolve both scientific and programmatic issues that develop during the course of work that restrict progress. The Arbitration Panel will be composed of three members: a member selected by the Steering Committee without NIH staff voting, a member selected by NICHD, and a member with expertise in the relevant area selected by the other two members. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: Jeffery Evans Ph.D., J.D. Demographic and Behavioral Sciences Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8B07, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-1176 FAX: (301) 496-0962 Email: email@example.com o Direct your questions about peer review issues to: Robert Stretch, Ph.D. Director, Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 5B01, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-1485 FAX: (301) 402-4104 Email: firstname.lastname@example.org o Direct your questions about financial or grants management matters to: Kathy Hancock Grants Management Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, 8A17, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-5482 FAX: (301) 402-0915 Email: email@example.com LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NICHD staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: Jeffery Evans Ph.D., J.D. Demographic and Behavioral Sciences Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8B07, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-1176 FAX: (301) 496-0962 Email: firstname.lastname@example.org 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: GrantsInfo@nih.gov. SUPPLEMENTARY INSTRUCTIONS: Applicants should include funds in their budget requests to allow the Principal Investigator to attend two Steering Committee meetings per year, each for one and one-half days. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the Checklist, and three signed photocopies, in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to: Robert Stretch, Ph.D. Director, Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 5B01, MSC 7510 Bethesda, MD 20892-7510 Rockville, MD 20852 (for express/courier service) APPLICATION PROCESSING: Applications must be received on or before the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight weeks. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to an RFA, it is to be prepared as a NEW application. That is, the application for the RFA must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NICHD. Incomplete and/or non-responsive applications will not be reviewed. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NICHD in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed and assigned a priority score o Receive a written critique o Receive a second level review by the National Advisory Child Health and Human Development Council. REVIEW CRITERIA The goals of DBSB-supported research are to advance our understanding of human population processes, understand the causes and consequences of population change and enhance the general child health and human development mission of NICHD. 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 Quality and potential impact of proposed infrastructure program: Reviewers will examine the overall quality, scientific merit, and innovation of the activities to be supported. Reviewers will consider the likelihood, based on existing capabilities and proposed activities, that the proposed program will facilitate data sharing in population research. o Technical competence of key personnel: Reviewers will consider the capability and credentials of the Principal Investigator to direct the infrastructure and maintain high standards of collaboration with the population research community and the specific technical qualifications of key support personnel. o Institutional commitment and environment: Reviewers will assess the nature and level of resource commitment from the institution in which the infrastructure is housed and any cooperating institutions, taking into account the institutional context. Reviewers also will consider the academic and physical environment as it bears on the potential for interaction with scientists from the population research community and allied fields. o Capacity to support the number and variety of datasets vital to the field of population research: Reviewers will assess the applicant's ability to support the number and variety of datasets that are considered vital to population research. o The ability to work cooperatively with individual investigators, population research centers and the NICHD to achieve the goals of the RFA. 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.) ADDITIONAL REVIEW CONSIDERATIONS BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: December 15, 2003 Application Receipt Date: January 15, 2004 Peer Review Date: February/March 2004 Council Review: June 2004 Earliest Anticipated Start Date: July 01, 2004 AWARD CRITERIA Criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities o Balance of data sharing capabilities available to the cooperative project REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is 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 RFA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule," on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Those who must comply with the Privacy Rule (classified under the Rule as "covered entities") must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This RFA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
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