Academic Partners for Excellence in Environmental Public Health Tracking, 21794-21799 [05-8398]

Download as PDF 21794 Federal Register / Vol. 70, No. 80 / Wednesday, April 27, 2005 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Academic Partners for Excellence in Environmental Public Health Tracking Announcement Type: New. Funding Opportunity Number: RFA EH–05074. Catalog of Federal Domestic Assistance Number: 93.283. Key Dates: Letter of Intent (LOI) Deadline: May 27, 2005. Pre-Application Conference Calls: May 16, 2005. Application Deadline: June 27, 2005. I. Funding Opportunity Description Authority: This program is authorized under section 301 of the Public Health Service Act, [42 U.S.C. section 241], as amended. Purpose: The purpose of the program is to provide expertise and support to the National Environmental Public Health Tracking Program (NEPHTP) in the development and utilization of the National Environmental Public Health Tracking Network (NEPHTN). Additional information about the NEPHTN and funded activities at state and local government levels is provided at https://www.cdc.gov/nceh/tracking. This program addresses the ‘‘Healthy People 2010’’ focus areas of Environmental Health and Public Health Infrastructure. Measurable outcomes of the program will be in alignment with the following performance goal for the National Center for Environmental Health (NCEH): Increase the understanding of the relationship between environmental exposures and health effects. This announcement contains two separate parts: Part I and Part II in order to accommodate the range of specialty activities needed to support the development of the NEPHTN. Each applicant can only apply for one part. Please indicate in your abstract and in the research plan which component your application is directed to. These projects will move the nation toward improved environmental public health surveillance and response capacity for development of the NEPHTN. Detailed description of each project is included under ‘‘Activities.’’ Research Objectives: • Nature of the research problem The environment plays an important role in human development and health. Researchers have linked exposures to some environmental hazards with VerDate jul<14>2003 16:41 Apr 26, 2005 Jkt 205001 specific diseases. Currently, no systems exist at the state or national level to track many of the exposures and health effects that may be related to environmental hazards. In most cases, existing environmental hazard, exposure, and disease tracking systems are not linked together. Because existing systems are not linked, it is difficult to study and monitor relationships among hazards, exposures, and health effects. CDC is developing a National Environmental Public Health Tracking Network that integrates data about environmental hazards and exposures with data about diseases that are possibly linked to the environment. However, to develop this Network, methods for data collection, data linkage, and data analysis will need to be improved and evaluated. Information from this network should guide etiologic research into the relationship between environmental factors and human health. Ultimately, state and local public health agencies must have a trained workforce capable of operating and utilizing an EPHT network to provide substantial public health impact. • Scientific knowledge to be achieved through research supported by this program Increased understanding of: (1) The relationship between environmental hazards, exposures and health effects; (2) the methods required to collect, integrate, analyze, and interpret data; and (3) effective techniques for dissemination of information to protect and improve health. • Objectives of this research program (1) Innovative, cost-effective data collection strategies that state and local health departments can use to obtain valid, high quality data on environmental health effects, exposures, and hazards. (2) Data linkage methods for combined analysis of health and environmental data that could be utilized by state and local environmental public health programs in building an EPHTN. (3) Statistical algorithms that could be used by state and local environmental public health programs to analyze trends and detect patterns of health effects occurrence, population exposure, or hazard levels in the environment that may indicate a problem. (4) Greater understanding of the relationship between particular health effects and environmental exposures and/or hazards. (5) Effective training tools for all areas critical to the development, operation, maintenance, and utilization of an EPHTN. PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 • Identify the types of research and experimental approaches that are being sought to achieve the objectives Research to support these objectives includes public health surveillance methods evaluation, epidemiological studies, and training effectiveness evaluations. Activities: In conducting activities to achieve the purpose of this program, the awardee will be responsible for the activities under Awardee Activities, and CDC will be responsible for the activities listed under CDC Activities. Awardee activities for this program are as follows: Awardee Activities: Recipients under Part I must develop and submit a research plan to address recipient activities a–h. Part I Recipient Activities: Provide lead expertise in the development of public health surveillance methods. These should, at a minimum, include: (a) Evaluating current surveillance methodology and developing innovative, cost-effective data collection strategies (including consideration of non-traditional data sources) that state and local health departments can use to obtain valid, high quality data on environmental health effects, exposures, and hazards. (b) Developing data linkage methods for combined analysis of health and environmental data that could be utilized by state and local environmental public health programs in building an EPHTN. (c) Developing statistical algorithms that could be used by state and local environmental public health programs to analyze trends and detect patterns of, and relationships between, health effects occurrence, population exposure, or hazard levels in the environment; and generating alerts when unusual occurrences of health effect, exposure, or hazard are detected. (d) Conduct an epidemiology study examining the relationship between a health effect and an environmental exposure and/or hazard in collaboration with environmental public health tracking program partners and CDC. This study should utilize data from a state or local environmental public health tracking program, as well as other summary or secondary data sources in the design and/or analysis phase. This may require the development of a research protocol for Institutional Review Board (IRB) review by all cooperating institutions participating in the research project. Where CDC scientists are involved, the CDC IRB will initially review and approve the protocol, with a minimum of an annual E:\FR\FM\27APN1.SGM 27APN1 Federal Register / Vol. 70, No. 80 / Wednesday, April 27, 2005 / Notices review until the research project is completed. (e) Provide training for the nation’s future Environmental Public Health workforce through the provision of student academic tracks in the areas of environmental epidemiology, public health surveillance methods, and/or internship opportunities. (f) Build capacity at the state and local level through the communication of project accomplishments, barriers, and lessons learned with EPHT (surveillance) Program partners and other critical stakeholders at CDCsponsored seminars, stakeholder meetings, quarterly conference calls, and by posting information to an EPHT web forum. (g) Participate in workgroups with EPHT Program partners. Applicant will also be required to work in conjunction with the CDC Environmental Public Health Tracking Program’s Standards and Network Development workgroup and other relevant workgroups and activities critical to the development of the EPHTN. (h) Collaborate with the relevant academic partners for excellence involved with the EPHT Program on training activities to promote the dissemination of knowledge from this focus area to other program partners. Recipients under Part II must develop and submit a research plan to address recipient activities a–h. Part II Recipient Activities: (a) Develop training tools and provide training to state and local health department partners participating in the NEPHT Program, in collaboration with CDC and other funded academic partners involved with the EPHT program. Training should include, but not be limited to, all areas critical to the development, operation, maintenance, and utilization and dissemination of information from the Network. These should include public health surveillance methods, GIS, spatial statistics and other environmental assessment methods, and risk communication. (b) Collaborate with other funded academic partners to identify and develop focus areas for continuous training. (c) Develop and conduct at least two regional and one annual training workshop for Environmental Public Health Tracking grantees covering public health surveillance methods, environmental epidemiology, risk communication, Geographic Information Systems, (GIS), spatial statistics and other assessment methods, prevention effectiveness, program evaluation and other subjects critical to VerDate jul<14>2003 16:41 Apr 26, 2005 Jkt 205001 the development, maintenance, utilization, and dissemination of information from an EPHTN. (d) Conduct an assessment of: (1) The key issues that influence perceptions concerning the risk posed by environmental hazards or exposures; and (2) techniques to communicate information on environmental hazards, exposures, or risk most likely to promote protective actions. This assessment could include comprehensive literature reviews, review of state and local public health communications activities, risk perception surveys, convening a panel of communications experts, or other assessment strategies. As a product of this assessment, develop written guidance on methods to disseminate information from an EPHTN that would most effectively communicate this information to a variety of audiences representing diverse social and cultural backgrounds, including policy makers, healthcare providers, and community representatives. (e) Develop, test, disseminate, and evaluate communication strategies for health effects, exposure and hazard information from a surveillance network (EPHTN) that take into account risk perception differences among various audiences. Collaborate with CDC to promote the dissemination of knowledge from this focus area to other program partners. (f) Provide training for the nation’s future Environmental Public Health workforce through the provision of student academic tracks in the areas of environmental epidemiology, public health surveillance methods, and risk communication strategies and/or internship opportunities. (g) Build capacity at the state and local level through the communication of project accomplishments, barriers, and lessons learned with Environmental Public Health Tracking (surveillance) Program partners and other critical stakeholders at CDC-sponsored seminars, stakeholder meetings, quarterly conference calls, and by posting information to an EPHT web forum. (h) Participate in workgroups with EPHT Program partners. CDC Activities: In a cooperative agreement, CDC staff is substantially involved in the program activities, above and beyond routine grant monitoring. CDC Activities for this program are as follows: a. Foster relationships among academic partners and state and local health departments by assisting in the sharing of information through an EPHT Web site, seminars, an annual PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 21795 stakeholder meeting, quarterly conference calls, and other direct interactions. b. Convene workgroups to foster the development of the NEPHTN. c. Participate in designing, developing, and evaluating surveillance methods. d. Participate in the development of statistical algorithms to analyze trends and detect patterns of health effects occurrence, population exposure, or hazard levels in the environment that may indicate a problem. e. Participate in the protocol development, study implementation, data analysis, interpretation of results, and dissemination of epidemiology study findings including report writing and oral presentation. When involved in a scientific study, the CDC IRB will initially review and approve the protocol, with a minimum annual review until the research project is completed. f. Provide assistance in development of training materials on surveillance methods, evaluation, risk communication, and other topics for state and local agencies and other EPHT Program partners, including the dissemination of information about strategies for communicating health effect, exposure, and hazard information from an EPHT network. II. Award Information Type of Award: Cooperative Agreement. CDC involvement in this program is listed in the Activities Section above. Mechanism of Support: U19— Research Programs (Cooperative Agreements). Fiscal Year Funds: 2005. Approximate Total Funding: $2,000,000 (This amount is an estimate, and is subject to availability of funds.) Approximate Number of Awards: Five. Approximate Average Award: $400,000 (This amount is for the first 12-month budget period.) Floor of Award Range: $350,000. Ceiling of Award Range: $450,000. (This ceiling is for the first 12-month budget period.) Anticipated Award Date: August 1, 2005. Budget Period Length: 12 months. Project Period Length: Five (5) years. Throughout the project period, CDC’s commitment to continuation of awards will be conditioned on the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports), and the determination that continued funding is in the best interest of the Federal Government. E:\FR\FM\27APN1.SGM 27APN1 21796 Federal Register / Vol. 70, No. 80 / Wednesday, April 27, 2005 / Notices III. Eligibility Information III.1. Eligible Applicants Assistance will be provided to United States Schools of Public Health, accredited by the Council on Education of Public Health, which are associated with or have access to programs in environmental epidemiology, environmental sciences, health education, health/risk communication, clinical medicine, and medical informatics. Eligibility is open to these applicants because they provide: (1) The technical expertise in the wide range of disciplines needed to further develop the theoretical and scientific base for environmental public health tracking (surveillance), and develop and test for new methodology essential to support state and local programs; and (2) a training ground for the nation’s future environmental public health workforce. This wide range of disciplines and expertise is often unavailable or difficult to access by state or local public health agencies yet will be required for an environmental public health tracking network to fulfill all the critical functions of a public health surveillance system. III.2. Cost Sharing or Matching Matching funds are not required for this program. III.3. Other If you request a funding amount greater than the ceiling of the award range, your application will be considered non-responsive, and will not be entered into the review process. You will be notified that your application did not meet the submission requirements. Special Requirements: If your application is incomplete or nonresponsive to the requirements listed in this section, it will not be entered into the review process. You will be notified that your application did not meet submission requirements. • Late applications will be considered non-responsive. See section ‘‘IV.3. Submission Dates and Times’’ for more information on deadlines. • All documentation submitted as evidence of eligibility as outlined in Section III.1 above should be placed directly behind the face page (first page) of your application. Applications that fail to submit evidence requested above will be considered non-responsive and returned without review. • Note: Title 2 of the United States Code Section 1611 states that an organization described in Section 501(c)(4) of the Internal Revenue Code that engages in lobbying activities is not eligible to receive Federal funds constituting an award, grant, or loan. VerDate jul<14>2003 16:41 Apr 26, 2005 Jkt 205001 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 under-represented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for CDC programs. IV. Application and Submission Information IV.1. Address To Request Application Package To apply for this funding opportunity, use application form PHS 398 (OMB number 0925–0001 rev. 9/2004). Forms and instructions are available in an interactive format on the CDC Web site, at the following Internet address: https://www.cdc.gov/od/pgo/ forminfo.htm. Forms and instructions are also available in an interactive format on the National Institutes of Health (NIH) Web site at the following Internet address: https://grants.nih.gov/grants/funding/ phs398/phs398.html. If you do not have access to the Internet, or if you have difficulty accessing the forms on-line, you may contact the CDC Procurement and Grants Office Technical Information Management Section (PGO–TIM) staff at: 770–488–2700. Application forms can be mailed to you. IV.2. Content and Form of Application Submission Letter of Intent (LOI): Your LOI must be written in the following format: • Maximum number of pages: Two • Font size: 12-point unreduced • Double spaced • Paper size: 8.5 by 11 inches • Page margin size: One inch • Printed only on one side of page • Written in plain language, avoid jargon Your LOI must contain the following information: • Descriptive title of the proposed application • Component of this announcement, Part I or II, you wish to be considered for • Name, address, E-mail address, telephone number, and fax number of the Principal Investigator • Names of other key personnel • Participating institutions • Number and title of this Announcement Application: Follow the PHS 398 application instructions for content and formatting of your application. For PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 further assistance with the PHS 398 application form, contact PGO–TIM staff at 770–488–2700, or contact GrantsInfo, Telephone 301–435–0714, E-mail: GrantsInfo@nih.gov. Your research plan should address activities to be conducted over the entire project period. You are required to have a Dun and Bradstreet Data Universal Numbering System (DUNS) number to apply for a grant or cooperative agreement from the Federal government. Your DUNS number must be entered on line 11 of the face page of the PHS 398 application form. The DUNS number is a nine-digit identification number, which uniquely identifies business entities. Obtaining a DUNS number is easy and there is no charge. To obtain a DUNS number, access https://www.dunandbradstreet.com or call 1–866–705–5711. For more information, see the CDC Web site at: https://www.cdc.gov/od/pgo/ funding/pubcommt.htm. This announcement uses the nonmodular budgeting format. Additional requirements that may require you to submit additional documentation with your application are listed in section ‘‘VI.2. Administrative and National Policy Requirements.’’ V.3. Submission Dates and Times LOI Deadline Date: May 27, 2005. CDC requests that you send a LOI if you intend to apply for this program. Although the LOI is not mandatory, not binding, and does not enter into the review of your subsequent application, the LOI will be used to gauge the level of interest in this program, and to allow CDC to plan the application review. Application Deadline Date: June 27, 2005. Explanation of Deadlines: LOIs and Applications must be received in the CDC Procurement and Grants Office by 4 p.m. Eastern Time on the deadline date. If you submit your LOI or application by the United States Postal Service or commercial delivery service, you must ensure that the carrier will be able to guarantee delivery by the closing date and time. If CDC receives your submission after closing due to: (1) Carrier error, when the carrier accepted the package with a guarantee for delivery by the closing date and time, or (2) significant weather delays or natural disasters, you will be given the opportunity to submit documentation of the carriers guarantee. If the documentation verifies a carrier problem, CDC will consider the submission as having been received by the deadline. E:\FR\FM\27APN1.SGM 27APN1 Federal Register / Vol. 70, No. 80 / Wednesday, April 27, 2005 / Notices This announcement is the definitive guide on LOI and application content, submission address, and deadline. It supersedes information provided in the application instructions. If your application does not meet the deadline above, it will not be eligible for review, and will be discarded. You will be notified that you did not meet the submission requirements. CDC will not notify you upon receipt of your submission. If you have a question about the receipt of your LOI or application, first contact your courier. If you still have a question, contact the PGO-TIM staff at: 770–488–2700. Before calling, please wait two to three days after the submission deadline. This will allow time for submissions to be processed and logged. IV.4. Intergovernmental Review of Applications Your application is subject to Intergovernmental Review of Federal Programs, as governed by Executive Order (EO) 12372. This order sets up a system for state and local governmental review of proposed federal assistance applications. You should contact your state single point of contact (SPOC) as early as possible to alert the SPOC to prospective applications, and to receive instructions on your state’s process. Click on the following link to get the current SPOC list: https:// www.whitehouse.gov/omb/grants/ spoc.html. IV.5. Funding Restrictions Restrictions, which must be taken into account while writing your budget, are as follows: • Funds relating to the conduct of research will not be released until the appropriate assurances and Institutional Review Board approvals are in place. • Reimbursement of pre-award costs is not allowed. If you are requesting indirect costs in your budget, you must include a copy of your indirect cost rate agreement. If your indirect cost rate is a provisional rate, the agreement should be less than 12 months of age. IV.6. Other Submission Requirements LOI Submission Address: Submit your LOI by express mail, delivery service, fax, or e-mail to: Scientific Review Administrator, Attn: Kathleen Shaver Madden, Ph.D., CDC/Office of Public Health Research, One West Court Square, Suite 7000, Rm 7018, Mailstop D–72, Decatur, GA 30030, Tel: 404–371– 5253, Fax: 404–371–5215, E-mail: kmn0@cdc.gov. Application Submission Address: Submit the original and one hard copy VerDate jul<14>2003 16:41 Apr 26, 2005 Jkt 205001 of your application by mail or express delivery service to: Technical Information Management—RFA EH– 05074, CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341. At the time of submission, four additional copies of the application, and all appendices must be sent to: Scientific Review Administrator, Attn: Kathleen Shaver Madden, Ph.D. (RFA EH–05074), CDC/Office of Public Health Research, One West Court Square, Suite 7000, Rm 7018, Mailstop D–72, Decatur, GA 30030, Tel: 404–371–5253, Fax: 404–371–5215, E-mail: kmn0@cdc.gov. V. Application Review Information V.1. Criteria Applicants are required to provide measures of effectiveness that will demonstrate the accomplishment of the various identified objectives of the cooperative agreement. Measures of effectiveness must relate to the performance goals stated in the ‘‘Purpose’’ section of this announcement. Measures must be objective and quantitative, and must measure the intended outcome. These measures of effectiveness must be submitted with the application and will be an element of evaluation. The goals of CDC-supported research are to advance the understanding of biological systems, improve the control and prevention of disease and injury, and enhance health. In the written comments, reviewers will be asked to evaluate the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of the following criteria equally in assigning the application’s overall score, weighting them as appropriate for each application. The application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative, but is essential to move a field forward. The review criteria are as follows: Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? Approach: Are the conceptual framework, design, methods, and analyses adequately developed, wellintegrated, and appropriate to the aims PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 21797 of the project? Does the project scope reflect a clear understanding of the purpose and requirements of the cooperative agreement and the conceptual framework, intent, and challenges of implementing a National Environmental Public Health Tracking Network? Are the project scope, key objectives, project milestones, products, and performance measures clearly described and appropriate for the project? Are the strategy, schedule, and resources appropriate for timely completion of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics and provide plans for mitigating project risk? Innovation: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? Investigator: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? Are the resumes/curricula vita of key personnel included? If there are several researchers involved, is this there a clear description of how the principal investigator will manage the project team and, if necessary, coordinate with other academic departments or groups participating in this endeavor? Are all researcher and staff roles and responsibilities clearly described and linked to project activities and milestones? Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? Additional Review Criteria: In addition to the above criteria, the following programmatic priorities will be considered in the determination of scientific merit and priority score: 1. Collaborative Relationships: The extent to which the applicant identifies key partners to carry out proposed activities and provides evidence that these organizations/agencies support, and will be actively involved in, carrying out the project. Letters of Support from appropriate personnel, such as department chairs, must be provided if applicant is utilizing affiliate institutions to provide expertise in environmental epidemiology, environmental sciences, health education, health communication, E:\FR\FM\27APN1.SGM 27APN1 21798 Federal Register / Vol. 70, No. 80 / Wednesday, April 27, 2005 / Notices clinical medicine, or medical informatics. The extent to which the applicant describes past and current collaborations with Federal agencies, state and local health and environmental agencies, professional organizations, community-based organizations, and other relevant organizations will be considered. Protection of Human Subjects from Research Risks: Does the application adequately address the requirements of Title 45 CFR Part 46 for the protection of human subjects? The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. Inclusion of Women and Minorities in Research: Does the application adequately address the CDC Policy requirements regarding the inclusion of women, ethnic, and racial groups in the proposed research? This includes: (1) The proposed plan for the inclusion of both sexes and racial and ethnic minority populations for appropriate representation; (2) The proposed justification when representation is limited or absent; (3) A statement as to whether the design of the study is adequate to measure differences when warranted; and (4) A statement as to whether the plans for recruitment and outreach for study participants include the process of establishing partnerships with community (ies) and recognition of mutual benefits. Care and Use of Vertebrate Animals: 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 will be assessed. Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. V.2. Review and Selection Process Applications will be reviewed for completeness by the Procurement and Grants Office (PGO) and for responsiveness by the National Center for Environmental Health (NCEH). Incomplete applications and applications that are non-responsive to the eligibility criteria will not advance through the review process. Applicants will be notified that their application did not meet submission requirements. Applications that are complete and responsive to the announcement will be evaluated for scientific and technical merit by an appropriate peer review group or charter study section convened by the NCEH in accordance with the review criteria listed above. As part of VerDate jul<14>2003 16:41 Apr 26, 2005 Jkt 205001 the initial merit review, all applications may: • Undergo a process in which only those applications deemed to have the highest scientific merit by the review group, generally the top half of the applications under review, will be discussed and assigned a priority score. • Receive a written critique. • Receive a second programmatic level review by the NCEH, Office of Science. Award Criteria: Criteria that will be used to make award decisions during the programmatic review include: • Scientific merit (as determined by peer review) • Availability of funds • Programmatic priorities • Preference may be given to the establishment of academic partnerships in different geographic areas of the United States. V.3. Anticipated Announcement and Award Dates It is anticipated that notification of awards will go out to successful applicants on or before August 31, 2005 with a projected start date on or before October 1, 2005. VI. Award Administration Information VI.1. Award Notices Successful applicants will receive a Notice of Award (NoA) from the CDC Procurement and Grants Office. The NoA shall be the only binding, authorizing document between the recipient and CDC. The NoA will be signed by an authorized Grants Management Officer, and mailed to the recipient fiscal officer identified in the application. Unsuccessful applicants will receive notification of the results of the application review by mail. VI.2. Administrative and National Policy Requirements 45 CFR Part 74 and Part 92 For more information on the Code of Federal Regulations, see the National Archives and Records Administration at the following Internet address: https:// www.access.gpo.gov/nara/cfr/cfr-tablesearch.html. The following additional requirements apply to this project: • AR–1 Human Subjects Requirements • AR–2 Requirements for Inclusion of Women and Racial and Ethnic Minorities in Research • AR–7 Executive Order 12372 • AR–8 Public Health System Reporting Requirements • AR–9 Paperwork Reduction Act Requirements PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 • AR–10 Smoke-Free Workplace Requirements • AR–11 Healthy People 2010 • AR–12 Lobbying Restrictions • AR–22 Research Integrity • AR–24 Health Insurance Portability and Accountability Act Requirements Additional information on these requirements can be found on the CDC web site at the following Internet address: https://www.cdc.gov/od/pgo/ funding/ARs.htm. VI.3. Reporting You must provide CDC with an original, plus two hard copies of the following reports: 1. Interim progress report, (use form PHS 2590, OMB Number 0925–0001, rev. 9/2004 as posted on the CDC website) no less than 90 days before the end of the budget period. The progress report will serve as your non-competing continuation application, and must contain the following elements: a. Current Budget Period Activities Objectives. b. Current Budget Period Financial Progress. c. New Budget Period Program Proposed Activity Objectives. d. Budget. e. Measures of Effectiveness. f. Additional Requested Information. 2. Financial status report, no more than 90 days after the end of the budget period. 3. Final financial and performance reports, no more than 90 days after the end of the project period. These reports must be mailed to the Grants Management Specialist listed in the ‘‘Agency Contacts’’ section of this announcement. VII. Agency Contacts We encourage inquiries concerning this announcement. For general questions, contact: Technical Information Management Section, CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341, Telephone: 770–488–2700. For scientific/research issues, contact: Mildred Williams-Johnson, Ph.D., Scientific Program Administrator, CDC/ ATSDR, 1600 Clifton Road, NE, Mailstop E17, Atlanta, GA 30333, Telephone: 404–498–0639, E-mail: MWilliams-Johnson@cdc.gov. or Judy Qualters, Ph.D; Scientific Program Collaborator, 1600 Clifton Road, NE; M/S E–19, Atlanta, GA 30333, Telephone: 404–498–1270, E-mail: epht@cdc.gov. For questions about peer review, contact: Kathleen Shiver Madden, Ph.D., Scientific Review Administrator, CDC/ E:\FR\FM\27APN1.SGM 27APN1 Federal Register / Vol. 70, No. 80 / Wednesday, April 27, 2005 / Notices Office of Public Health Research, One West Court Square, Suite 7000, Rm 7018, Mailstop D–72, Decatur, GA 30030, Telephone: 404–371–5253, Email: Kmn0@cdc.gov. For financial, grants management, or budget assistance, contact: Edna Green, Grants Management Specialist, CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341, Telephone: 770–488–2743, E-mail: EGreen@cdc.gov. VIII. Other Information This and other CDC funding opportunity announcements can be found on the CDC Web site, Internet address: https://www.cdc.gov. Click on ‘‘Funding’’ then ‘‘Grants and Cooperative Agreements.’’ Additional Information about the Environmental Public Health Tracking Program and current activities of the academic partners can be found at https:// www.cdc.gov/nceh/tracking. Dated: April 21, 2005. William P. Nichols, Director, Procurement and Grants Office, Centers for Disease Control and Prevention. [FR Doc. 05–8398 Filed 4–26–05; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Cellular, Tissue and Gene Therapies Advisory Committee (Formerly Biological Response Modifiers Advisory Committee); Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). At least one portion of the meeting will be closed to the public. Name of Committee: Cellular, Tissue and Gene Therapies Advisory Committee (formerly Biological Response Modifiers Advisory Committee). General Function of the Committee: To provide advice and recommendations to the agency on FDA’s regulatory issues. Date and Time: The meeting will be held on May 20, 2005, from 2 p.m. to approximately 4 p.m. Location: 5515 Security Lane, rm. 1113, Rockville, MD. This meeting will be held by teleconference. The public is welcome to attend the meeting at the VerDate jul<14>2003 16:41 Apr 26, 2005 Jkt 205001 specified location. A speakerphone will be provided at this location for public participation in the meeting. Contact Person: Gail Dapolito or Rosanna L. Harvey, Center for Biologics Evaluation and Research (HFM–71), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 301–827–0314, or FDA Advisory Committee Information Line, 1–800– 741–8138 (301–443–0572 in the Washington, DC area), code 3014512389. Please call the Information Line for up-to-date information on this meeting. Agenda: The committee will receive an update on individual research programs in the Division of Therapeutic Proteins, Center for Drug Evaluation and Research. Procedure: On May 20, 2005, from 2 p.m. to approximately 4 p.m., the meeting is open to the public. Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person by May 13, 2005. Oral presentations from the public will be scheduled between approximately 3 p.m. and 4 p.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before May 13, 2005, and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation. Closed Committee Deliberations: On May 20, 2005, from approximately 4 p.m. to 4:30 p.m., the meeting will be closed to permit discussion where disclosure would constitute a clearly unwarranted invasion of personal privacy (5 U.S.C. 552b(c)(6)). The committee will discuss a review of individual FDA research programs. Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Gail Dapolito at least 7 days in advance of the meeting. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 21799 Dated: April 18, 2005. Sheila Dearybury Walcoff, Associate Commissioner for External Relations. [FR Doc. 05–8353 Filed 4–26–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Cancer Institute Special Emphasis Panel A T32 Application. Date: June 14, 2005. Time: 5 p.m. to 6 p.m. Agenda: To review and evaluate grant applications. Place: Wyndham City Center Hotel, 1143 New Hampshire Ave., NW., Washington, DC 20037. Contact Person: Raymond A. Petryshyn, PhD, Scientific Review Administrator, Resources and Training Review Branch, Division of Extramural Activities, National Cancer Institute, National Institutes of Health, 6116 Executive Blvd., 8th Fl., Room 8109, Bethesda, MD 20892, 301/594–1216, petryshr@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.392, Cancer Construction; 93.393, Cancer Cause and Prevention Research; 93.394, Cancer Detection and Diagnosis Research; 93.395, Cancer Treatment Research; 93.396, Cancer Biology Research; 93.397, Cancer Centers Support; 93.398, Cancer Research Manpower; 93.399, Cancer Control, National Institutes of Health, HHS) Dated: April 19, 2005. LaVerne Y. Stringfield, Director, Office of Federal Advisory Committee Policy. [FR Doc. 05–8414 Filed 4–26–05; 8:45 am] BILLING CODE 4140–01–M E:\FR\FM\27APN1.SGM 27APN1

Agencies

[Federal Register Volume 70, Number 80 (Wednesday, April 27, 2005)]
[Notices]
[Pages 21794-21799]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-8398]



[[Page 21794]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Academic Partners for Excellence in Environmental Public Health 
Tracking

    Announcement Type: New.
    Funding Opportunity Number: RFA EH-05074.
    Catalog of Federal Domestic Assistance Number: 93.283.
    Key Dates:
    Letter of Intent (LOI) Deadline: May 27, 2005.
    Pre-Application Conference Calls: May 16, 2005.
    Application Deadline: June 27, 2005.

I. Funding Opportunity Description

    Authority: This program is authorized under section 301 of the 
Public Health Service Act, [42 U.S.C. section 241], as amended.
    Purpose: The purpose of the program is to provide expertise and 
support to the National Environmental Public Health Tracking Program 
(NEPHTP) in the development and utilization of the National 
Environmental Public Health Tracking Network (NEPHTN). Additional 
information about the NEPHTN and funded activities at state and local 
government levels is provided at https://www.cdc.gov/nceh/tracking. This 
program addresses the ``Healthy People 2010'' focus areas of 
Environmental Health and Public Health Infrastructure.
    Measurable outcomes of the program will be in alignment with the 
following performance goal for the National Center for Environmental 
Health (NCEH): Increase the understanding of the relationship between 
environmental exposures and health effects.
    This announcement contains two separate parts: Part I and Part II 
in order to accommodate the range of specialty activities needed to 
support the development of the NEPHTN. Each applicant can only apply 
for one part. Please indicate in your abstract and in the research plan 
which component your application is directed to. These projects will 
move the nation toward improved environmental public health 
surveillance and response capacity for development of the NEPHTN. 
Detailed description of each project is included under ``Activities.''
    Research Objectives:
     Nature of the research problem
    The environment plays an important role in human development and 
health. Researchers have linked exposures to some environmental hazards 
with specific diseases. Currently, no systems exist at the state or 
national level to track many of the exposures and health effects that 
may be related to environmental hazards. In most cases, existing 
environmental hazard, exposure, and disease tracking systems are not 
linked together. Because existing systems are not linked, it is 
difficult to study and monitor relationships among hazards, exposures, 
and health effects.
    CDC is developing a National Environmental Public Health Tracking 
Network that integrates data about environmental hazards and exposures 
with data about diseases that are possibly linked to the environment. 
However, to develop this Network, methods for data collection, data 
linkage, and data analysis will need to be improved and evaluated. 
Information from this network should guide etiologic research into the 
relationship between environmental factors and human health. 
Ultimately, state and local public health agencies must have a trained 
workforce capable of operating and utilizing an EPHT network to provide 
substantial public health impact.
     Scientific knowledge to be achieved through research 
supported by this program
    Increased understanding of: (1) The relationship between 
environmental hazards, exposures and health effects; (2) the methods 
required to collect, integrate, analyze, and interpret data; and (3) 
effective techniques for dissemination of information to protect and 
improve health.
     Objectives of this research program
    (1) Innovative, cost-effective data collection strategies that 
state and local health departments can use to obtain valid, high 
quality data on environmental health effects, exposures, and hazards.
    (2) Data linkage methods for combined analysis of health and 
environmental data that could be utilized by state and local 
environmental public health programs in building an EPHTN.
    (3) Statistical algorithms that could be used by state and local 
environmental public health programs to analyze trends and detect 
patterns of health effects occurrence, population exposure, or hazard 
levels in the environment that may indicate a problem.
    (4) Greater understanding of the relationship between particular 
health effects and environmental exposures and/or hazards.
    (5) Effective training tools for all areas critical to the 
development, operation, maintenance, and utilization of an EPHTN.
     Identify the types of research and experimental approaches 
that are being sought to achieve the objectives Research to support 
these objectives includes public health surveillance methods 
evaluation, epidemiological studies, and training effectiveness 
evaluations.
    Activities: In conducting activities to achieve the purpose of this 
program, the awardee will be responsible for the activities under 
Awardee Activities, and CDC will be responsible for the activities 
listed under CDC Activities. Awardee activities for this program are as 
follows:
    Awardee Activities: Recipients under Part I must develop and submit 
a research plan to address recipient activities a-h.
    Part I Recipient Activities: Provide lead expertise in the 
development of public health surveillance methods. These should, at a 
minimum, include:
    (a) Evaluating current surveillance methodology and developing 
innovative, cost-effective data collection strategies (including 
consideration of non-traditional data sources) that state and local 
health departments can use to obtain valid, high quality data on 
environmental health effects, exposures, and hazards.
    (b) Developing data linkage methods for combined analysis of health 
and environmental data that could be utilized by state and local 
environmental public health programs in building an EPHTN.
    (c) Developing statistical algorithms that could be used by state 
and local environmental public health programs to analyze trends and 
detect patterns of, and relationships between, health effects 
occurrence, population exposure, or hazard levels in the environment; 
and generating alerts when unusual occurrences of health effect, 
exposure, or hazard are detected.
    (d) Conduct an epidemiology study examining the relationship 
between a health effect and an environmental exposure and/or hazard in 
collaboration with environmental public health tracking program 
partners and CDC. This study should utilize data from a state or local 
environmental public health tracking program, as well as other summary 
or secondary data sources in the design and/or analysis phase. This may 
require the development of a research protocol for Institutional Review 
Board (IRB) review by all cooperating institutions participating in the 
research project. Where CDC scientists are involved, the CDC IRB will 
initially review and approve the protocol, with a minimum of an annual

[[Page 21795]]

review until the research project is completed.
    (e) Provide training for the nation's future Environmental Public 
Health workforce through the provision of student academic tracks in 
the areas of environmental epidemiology, public health surveillance 
methods, and/or internship opportunities.
    (f) Build capacity at the state and local level through the 
communication of project accomplishments, barriers, and lessons learned 
with EPHT (surveillance) Program partners and other critical 
stakeholders at CDC-sponsored seminars, stakeholder meetings, quarterly 
conference calls, and by posting information to an EPHT web forum.
    (g) Participate in workgroups with EPHT Program partners. Applicant 
will also be required to work in conjunction with the CDC Environmental 
Public Health Tracking Program's Standards and Network Development 
workgroup and other relevant workgroups and activities critical to the 
development of the EPHTN.
    (h) Collaborate with the relevant academic partners for excellence 
involved with the EPHT Program on training activities to promote the 
dissemination of knowledge from this focus area to other program 
partners.
    Recipients under Part II must develop and submit a research plan to 
address recipient activities a-h.
    Part II Recipient Activities:
    (a) Develop training tools and provide training to state and local 
health department partners participating in the NEPHT Program, in 
collaboration with CDC and other funded academic partners involved with 
the EPHT program. Training should include, but not be limited to, all 
areas critical to the development, operation, maintenance, and 
utilization and dissemination of information from the Network. These 
should include public health surveillance methods, GIS, spatial 
statistics and other environmental assessment methods, and risk 
communication.
    (b) Collaborate with other funded academic partners to identify and 
develop focus areas for continuous training.
    (c) Develop and conduct at least two regional and one annual 
training workshop for Environmental Public Health Tracking grantees 
covering public health surveillance methods, environmental 
epidemiology, risk communication, Geographic Information Systems, 
(GIS), spatial statistics and other assessment methods, prevention 
effectiveness, program evaluation and other subjects critical to the 
development, maintenance, utilization, and dissemination of information 
from an EPHTN.
    (d) Conduct an assessment of: (1) The key issues that influence 
perceptions concerning the risk posed by environmental hazards or 
exposures; and (2) techniques to communicate information on 
environmental hazards, exposures, or risk most likely to promote 
protective actions. This assessment could include comprehensive 
literature reviews, review of state and local public health 
communications activities, risk perception surveys, convening a panel 
of communications experts, or other assessment strategies. As a product 
of this assessment, develop written guidance on methods to disseminate 
information from an EPHTN that would most effectively communicate this 
information to a variety of audiences representing diverse social and 
cultural backgrounds, including policy makers, healthcare providers, 
and community representatives.
    (e) Develop, test, disseminate, and evaluate communication 
strategies for health effects, exposure and hazard information from a 
surveillance network (EPHTN) that take into account risk perception 
differences among various audiences. Collaborate with CDC to promote 
the dissemination of knowledge from this focus area to other program 
partners.
    (f) Provide training for the nation's future Environmental Public 
Health workforce through the provision of student academic tracks in 
the areas of environmental epidemiology, public health surveillance 
methods, and risk communication strategies and/or internship 
opportunities.
    (g) Build capacity at the state and local level through the 
communication of project accomplishments, barriers, and lessons learned 
with Environmental Public Health Tracking (surveillance) Program 
partners and other critical stakeholders at CDC-sponsored seminars, 
stakeholder meetings, quarterly conference calls, and by posting 
information to an EPHT web forum.
    (h) Participate in workgroups with EPHT Program partners.
    CDC Activities: In a cooperative agreement, CDC staff is 
substantially involved in the program activities, above and beyond 
routine grant monitoring. CDC Activities for this program are as 
follows:
    a. Foster relationships among academic partners and state and local 
health departments by assisting in the sharing of information through 
an EPHT Web site, seminars, an annual stakeholder meeting, quarterly 
conference calls, and other direct interactions.
    b. Convene workgroups to foster the development of the NEPHTN.
    c. Participate in designing, developing, and evaluating 
surveillance methods.
    d. Participate in the development of statistical algorithms to 
analyze trends and detect patterns of health effects occurrence, 
population exposure, or hazard levels in the environment that may 
indicate a problem.
    e. Participate in the protocol development, study implementation, 
data analysis, interpretation of results, and dissemination of 
epidemiology study findings including report writing and oral 
presentation. When involved in a scientific study, the CDC IRB will 
initially review and approve the protocol, with a minimum annual review 
until the research project is completed.
    f. Provide assistance in development of training materials on 
surveillance methods, evaluation, risk communication, and other topics 
for state and local agencies and other EPHT Program partners, including 
the dissemination of information about strategies for communicating 
health effect, exposure, and hazard information from an EPHT network.

II. Award Information

    Type of Award: Cooperative Agreement. CDC involvement in this 
program is listed in the Activities Section above.
    Mechanism of Support: U19--Research Programs (Cooperative 
Agreements).
    Fiscal Year Funds: 2005.
    Approximate Total Funding: $2,000,000 (This amount is an estimate, 
and is subject to availability of funds.) Approximate Number of Awards: 
Five.
    Approximate Average Award: $400,000 (This amount is for the first 
12-month budget period.)
    Floor of Award Range: $350,000.
    Ceiling of Award Range: $450,000. (This ceiling is for the first 
12-month budget period.)
    Anticipated Award Date: August 1, 2005.
    Budget Period Length: 12 months.
    Project Period Length: Five (5) years. Throughout the project 
period, CDC's commitment to continuation of awards will be conditioned 
on the availability of funds, evidence of satisfactory progress by the 
recipient (as documented in required reports), and the determination 
that continued funding is in the best interest of the Federal 
Government.

[[Page 21796]]

III. Eligibility Information

III.1. Eligible Applicants

    Assistance will be provided to United States Schools of Public 
Health, accredited by the Council on Education of Public Health, which 
are associated with or have access to programs in environmental 
epidemiology, environmental sciences, health education, health/risk 
communication, clinical medicine, and medical informatics. Eligibility 
is open to these applicants because they provide: (1) The technical 
expertise in the wide range of disciplines needed to further develop 
the theoretical and scientific base for environmental public health 
tracking (surveillance), and develop and test for new methodology 
essential to support state and local programs; and (2) a training 
ground for the nation's future environmental public health workforce. 
This wide range of disciplines and expertise is often unavailable or 
difficult to access by state or local public health agencies yet will 
be required for an environmental public health tracking network to 
fulfill all the critical functions of a public health surveillance 
system.

III.2. Cost Sharing or Matching

    Matching funds are not required for this program.

III.3. Other

    If you request a funding amount greater than the ceiling of the 
award range, your application will be considered non-responsive, and 
will not be entered into the review process. You will be notified that 
your application did not meet the submission requirements.
    Special Requirements: If your application is incomplete or non-
responsive to the requirements listed in this section, it will not be 
entered into the review process. You will be notified that your 
application did not meet submission requirements.
     Late applications will be considered non-responsive. See 
section ``IV.3. Submission Dates and Times'' for more information on 
deadlines.
     All documentation submitted as evidence of eligibility as 
outlined in Section III.1 above should be placed directly behind the 
face page (first page) of your application. Applications that fail to 
submit evidence requested above will be considered non-responsive and 
returned without review.

     Note: Title 2 of the United States Code Section 1611 
states that an organization described in Section 501(c)(4) of the 
Internal Revenue Code that engages in lobbying activities is not 
eligible to receive Federal funds constituting an award, grant, or 
loan.

    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 under-represented 
racial and ethnic groups as well as individuals with disabilities are 
always encouraged to apply for CDC programs.

IV. Application and Submission Information

IV.1. Address To Request Application Package

    To apply for this funding opportunity, use application form PHS 398 
(OMB number 0925-0001 rev. 9/2004). Forms and instructions are 
available in an interactive format on the CDC Web site, at the 
following Internet address: https://www.cdc.gov/od/pgo/forminfo.htm.
    Forms and instructions are also available in an interactive format 
on the National Institutes of Health (NIH) Web site at the following 
Internet address: https://grants.nih.gov/grants/funding/phs398/
phs398.html.
    If you do not have access to the Internet, or if you have 
difficulty accessing the forms on-line, you may contact the CDC 
Procurement and Grants Office Technical Information Management Section 
(PGO-TIM) staff at: 770-488-2700. Application forms can be mailed to 
you.

IV.2. Content and Form of Application Submission

    Letter of Intent (LOI): Your LOI must be written in the following 
format:
     Maximum number of pages: Two
     Font size: 12-point unreduced
     Double spaced
     Paper size: 8.5 by 11 inches
     Page margin size: One inch
     Printed only on one side of page
     Written in plain language, avoid jargon
    Your LOI must contain the following information:
     Descriptive title of the proposed application
     Component of this announcement, Part I or II, you wish to 
be considered for
     Name, address, E-mail address, telephone number, and fax 
number of the Principal Investigator
     Names of other key personnel
     Participating institutions
     Number and title of this Announcement
    Application: Follow the PHS 398 application instructions for 
content and formatting of your application. For further assistance with 
the PHS 398 application form, contact PGO-TIM staff at 770-488-2700, or 
contact GrantsInfo, Telephone 301-435-0714, E-mail: GrantsInfo@nih.gov.
    Your research plan should address activities to be conducted over 
the entire project period.
    You are required to have a Dun and Bradstreet Data Universal 
Numbering System (DUNS) number to apply for a grant or cooperative 
agreement from the Federal government.
    Your DUNS number must be entered on line 11 of the face page of the 
PHS 398 application form. The DUNS number is a nine-digit 
identification number, which uniquely identifies business entities. 
Obtaining a DUNS number is easy and there is no charge. To obtain a 
DUNS number, access https://www.dunandbradstreet.com or call 1-866-705-
5711.
    For more information, see the CDC Web site at: https://www.cdc.gov/
od/pgo/funding/pubcommt.htm.
    This announcement uses the non-modular budgeting format.
    Additional requirements that may require you to submit additional 
documentation with your application are listed in section ``VI.2. 
Administrative and National Policy Requirements.''

V.3. Submission Dates and Times

    LOI Deadline Date: May 27, 2005.
    CDC requests that you send a LOI if you intend to apply for this 
program. Although the LOI is not mandatory, not binding, and does not 
enter into the review of your subsequent application, the LOI will be 
used to gauge the level of interest in this program, and to allow CDC 
to plan the application review.
    Application Deadline Date: June 27, 2005.
    Explanation of Deadlines: LOIs and Applications must be received in 
the CDC Procurement and Grants Office by 4 p.m. Eastern Time on the 
deadline date. If you submit your LOI or application by the United 
States Postal Service or commercial delivery service, you must ensure 
that the carrier will be able to guarantee delivery by the closing date 
and time. If CDC receives your submission after closing due to: (1) 
Carrier error, when the carrier accepted the package with a guarantee 
for delivery by the closing date and time, or (2) significant weather 
delays or natural disasters, you will be given the opportunity to 
submit documentation of the carriers guarantee. If the documentation 
verifies a carrier problem, CDC will consider the submission as having 
been received by the deadline.

[[Page 21797]]

    This announcement is the definitive guide on LOI and application 
content, submission address, and deadline. It supersedes information 
provided in the application instructions. If your application does not 
meet the deadline above, it will not be eligible for review, and will 
be discarded. You will be notified that you did not meet the submission 
requirements.
    CDC will not notify you upon receipt of your submission. If you 
have a question about the receipt of your LOI or application, first 
contact your courier. If you still have a question, contact the PGO-TIM 
staff at: 770-488-2700. Before calling, please wait two to three days 
after the submission deadline. This will allow time for submissions to 
be processed and logged.

IV.4. Intergovernmental Review of Applications

    Your application is subject to Intergovernmental Review of Federal 
Programs, as governed by Executive Order (EO) 12372. This order sets up 
a system for state and local governmental review of proposed federal 
assistance applications. You should contact your state single point of 
contact (SPOC) as early as possible to alert the SPOC to prospective 
applications, and to receive instructions on your state's process. 
Click on the following link to get the current SPOC list: https://
www.whitehouse.gov/omb/grants/spoc.html.

IV.5. Funding Restrictions

    Restrictions, which must be taken into account while writing your 
budget, are as follows:
     Funds relating to the conduct of research will not be 
released until the appropriate assurances and Institutional Review 
Board approvals are in place.
     Reimbursement of pre-award costs is not allowed.

If you are requesting indirect costs in your budget, you must include a 
copy of your indirect cost rate agreement. If your indirect cost rate 
is a provisional rate, the agreement should be less than 12 months of 
age.

IV.6. Other Submission Requirements

    LOI Submission Address: Submit your LOI by express mail, delivery 
service, fax, or e-mail to: Scientific Review Administrator, Attn: 
Kathleen Shaver Madden, Ph.D., CDC/Office of Public Health Research, 
One West Court Square, Suite 7000, Rm 7018, Mailstop D-72, Decatur, GA 
30030, Tel: 404-371-5253, Fax: 404-371-5215, E-mail: kmn0@cdc.gov.
    Application Submission Address: Submit the original and one hard 
copy of your application by mail or express delivery service to: 
Technical Information Management--RFA EH-05074, CDC Procurement and 
Grants Office, 2920 Brandywine Road, Atlanta, GA 30341.
    At the time of submission, four additional copies of the 
application, and all appendices must be sent to: Scientific Review 
Administrator, Attn: Kathleen Shaver Madden, Ph.D. (RFA EH-05074), CDC/
Office of Public Health Research, One West Court Square, Suite 7000, Rm 
7018, Mailstop D-72, Decatur, GA 30030, Tel: 404-371-5253, Fax: 404-
371-5215, E-mail: kmn0@cdc.gov.

V. Application Review Information

V.1. Criteria

    Applicants are required to provide measures of effectiveness that 
will demonstrate the accomplishment of the various identified 
objectives of the cooperative agreement. Measures of effectiveness must 
relate to the performance goals stated in the ``Purpose'' section of 
this announcement. Measures must be objective and quantitative, and 
must measure the intended outcome. These measures of effectiveness must 
be submitted with the application and will be an element of evaluation.
    The goals of CDC-supported research are to advance the 
understanding of biological systems, improve the control and prevention 
of disease and injury, and enhance health. In the written comments, 
reviewers will be asked to evaluate the application in order to judge 
the likelihood that the proposed research will have a substantial 
impact on the pursuit of these goals.
    The scientific review group will address and consider each of the 
following criteria equally in assigning the application's overall 
score, weighting them as appropriate for each application. The 
application does not need to be strong in all categories to be judged 
likely to have major scientific impact and thus deserve a high priority 
score. For example, an investigator may propose to carry out important 
work that by its nature is not innovative, but is essential to move a 
field forward.
    The review criteria are as follows:
    Significance: Does this study address an important problem? If the 
aims of the application are achieved, how will scientific knowledge be 
advanced? What will be the effect of these studies on the concepts or 
methods that drive this field?
    Approach: Are the conceptual framework, design, methods, and 
analyses adequately developed, well-integrated, and appropriate to the 
aims of the project? Does the project scope reflect a clear 
understanding of the purpose and requirements of the cooperative 
agreement and the conceptual framework, intent, and challenges of 
implementing a National Environmental Public Health Tracking Network? 
Are the project scope, key objectives, project milestones, products, 
and performance measures clearly described and appropriate for the 
project? Are the strategy, schedule, and resources appropriate for 
timely completion of the project? Does the applicant acknowledge 
potential problem areas and consider alternative tactics and provide 
plans for mitigating project risk?
    Innovation: Does the project employ novel concepts, approaches or 
methods? Are the aims original and innovative? Does the project 
challenge existing paradigms or develop new methodologies or 
technologies?
    Investigator: Is the investigator appropriately trained and well 
suited to carry out this work? Is the work proposed appropriate to the 
experience level of the principal investigator and other researchers 
(if any)? Are the resumes/curricula vita of key personnel included? If 
there are several researchers involved, is this there a clear 
description of how the principal investigator will manage the project 
team and, if necessary, coordinate with other academic departments or 
groups participating in this endeavor? Are all researcher and staff 
roles and responsibilities clearly described and linked to project 
activities and milestones?
    Environment: Does the scientific environment in which the work will 
be done contribute to the probability of success? Do the proposed 
experiments take advantage of unique features of the scientific 
environment or employ useful collaborative arrangements? Is there 
evidence of institutional support?
    Additional Review Criteria: In addition to the above criteria, the 
following programmatic priorities will be considered in the 
determination of scientific merit and priority score:
    1. Collaborative Relationships: The extent to which the applicant 
identifies key partners to carry out proposed activities and provides 
evidence that these organizations/agencies support, and will be 
actively involved in, carrying out the project. Letters of Support from 
appropriate personnel, such as department chairs, must be provided if 
applicant is utilizing affiliate institutions to provide expertise in 
environmental epidemiology, environmental sciences, health education, 
health communication,

[[Page 21798]]

clinical medicine, or medical informatics. The extent to which the 
applicant describes past and current collaborations with Federal 
agencies, state and local health and environmental agencies, 
professional organizations, community-based organizations, and other 
relevant organizations will be considered.
    Protection of Human Subjects from Research Risks: Does the 
application adequately address the requirements of Title 45 CFR Part 46 
for the protection of human subjects? The involvement of human subjects 
and protections from research risk relating to their participation in 
the proposed research will be assessed.
    Inclusion of Women and Minorities in Research: Does the application 
adequately address the CDC Policy requirements regarding the inclusion 
of women, ethnic, and racial groups in the proposed research? This 
includes: (1) The proposed plan for the inclusion of both sexes and 
racial and ethnic minority populations for appropriate representation; 
(2) The proposed justification when representation is limited or 
absent; (3) A statement as to whether the design of the study is 
adequate to measure differences when warranted; and (4) A statement as 
to whether the plans for recruitment and outreach for study 
participants include the process of establishing partnerships with 
community (ies) and recognition of mutual benefits.
    Care and Use of Vertebrate Animals: 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 will be assessed.
    Budget: The reasonableness of the proposed budget and the requested 
period of support in relation to the proposed research.

V.2. Review and Selection Process

    Applications will be reviewed for completeness by the Procurement 
and Grants Office (PGO) and for responsiveness by the National Center 
for Environmental Health (NCEH). Incomplete applications and 
applications that are non-responsive to the eligibility criteria will 
not advance through the review process. Applicants will be notified 
that their application did not meet submission requirements.
    Applications that are complete and responsive to the announcement 
will be evaluated for scientific and technical merit by an appropriate 
peer review group or charter study section convened by the NCEH in 
accordance with the review criteria listed above. As part of the 
initial merit review, all applications may:
     Undergo a process in which only those applications deemed 
to have the highest scientific merit by the review group, generally the 
top half of the applications under review, will be discussed and 
assigned a priority score.
     Receive a written critique.
     Receive a second programmatic level review by the NCEH, 
Office of Science.
    Award Criteria: Criteria that will be used to make award decisions 
during the programmatic review include:
     Scientific merit (as determined by peer review)
     Availability of funds
     Programmatic priorities
     Preference may be given to the establishment of academic 
partnerships in different geographic areas of the United States.

V.3. Anticipated Announcement and Award Dates

    It is anticipated that notification of awards will go out to 
successful applicants on or before August 31, 2005 with a projected 
start date on or before October 1, 2005.

VI. Award Administration Information

VI.1. Award Notices

    Successful applicants will receive a Notice of Award (NoA) from the 
CDC Procurement and Grants Office. The NoA shall be the only binding, 
authorizing document between the recipient and CDC. The NoA will be 
signed by an authorized Grants Management Officer, and mailed to the 
recipient fiscal officer identified in the application.
    Unsuccessful applicants will receive notification of the results of 
the application review by mail.

VI.2. Administrative and National Policy Requirements

45 CFR Part 74 and Part 92
    For more information on the Code of Federal Regulations, see the 
National Archives and Records Administration at the following Internet 
address: https://www.access.gpo.gov/nara/cfr/cfr-table-search.html.
    The following additional requirements apply to this project:
     AR-1 Human Subjects Requirements
     AR-2 Requirements for Inclusion of Women and Racial and 
Ethnic Minorities in Research
     AR-7 Executive Order 12372
     AR-8 Public Health System Reporting Requirements
     AR-9 Paperwork Reduction Act Requirements
     AR-10 Smoke-Free Workplace Requirements
     AR-11 Healthy People 2010
     AR-12 Lobbying Restrictions
     AR-22 Research Integrity
     AR-24 Health Insurance Portability and Accountability Act 
Requirements
    Additional information on these requirements can be found on the 
CDC web site at the following Internet address: https://www.cdc.gov/od/
pgo/funding/ARs.htm.

VI.3. Reporting

    You must provide CDC with an original, plus two hard copies of the 
following reports:
    1. Interim progress report, (use form PHS 2590, OMB Number 0925-
0001, rev. 9/2004 as posted on the CDC website) no less than 90 days 
before the end of the budget period. The progress report will serve as 
your non-competing continuation application, and must contain the 
following elements:
    a. Current Budget Period Activities Objectives.
    b. Current Budget Period Financial Progress.
    c. New Budget Period Program Proposed Activity Objectives.
    d. Budget.
    e. Measures of Effectiveness.
    f. Additional Requested Information.
    2. Financial status report, no more than 90 days after the end of 
the budget period.
    3. Final financial and performance reports, no more than 90 days 
after the end of the project period.

These reports must be mailed to the Grants Management Specialist listed 
in the ``Agency Contacts'' section of this announcement.

VII. Agency Contacts

    We encourage inquiries concerning this announcement.
    For general questions, contact: Technical Information Management 
Section, CDC Procurement and Grants Office, 2920 Brandywine Road, 
Atlanta, GA 30341, Telephone: 770-488-2700.
    For scientific/research issues, contact: Mildred Williams-Johnson, 
Ph.D., Scientific Program Administrator, CDC/ATSDR, 1600 Clifton Road, 
NE, Mailstop E17, Atlanta, GA 30333, Telephone: 404-498-0639, E-mail: 
MWilliams-Johnson@cdc.gov. or Judy Qualters, Ph.D; Scientific Program 
Collaborator, 1600 Clifton Road, NE; M/S E-19, Atlanta, GA 30333, 
Telephone: 404-498-1270, E-mail: epht@cdc.gov.
    For questions about peer review, contact: Kathleen Shiver Madden, 
Ph.D., Scientific Review Administrator, CDC/

[[Page 21799]]

Office of Public Health Research, One West Court Square, Suite 7000, Rm 
7018, Mailstop D-72, Decatur, GA 30030, Telephone: 404-371-5253, E-
mail: Kmn0@cdc.gov.
    For financial, grants management, or budget assistance, contact: 
Edna Green, Grants Management Specialist, CDC Procurement and Grants 
Office, 2920 Brandywine Road, Atlanta, GA 30341, Telephone: 770-488-
2743, E-mail: EGreen@cdc.gov.

VIII. Other Information

    This and other CDC funding opportunity announcements can be found 
on the CDC Web site, Internet address: https://www.cdc.gov. Click on 
``Funding'' then ``Grants and Cooperative Agreements.'' Additional 
Information about the Environmental Public Health Tracking Program and 
current activities of the academic partners can be found at https://
www.cdc.gov/nceh/tracking.

    Dated: April 21, 2005.
William P. Nichols,
Director, Procurement and Grants Office, Centers for Disease Control 
and Prevention.
[FR Doc. 05-8398 Filed 4-26-05; 8:45 am]
BILLING CODE 4163-18-P
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