1 November 2004 Source: http://www.access.gpo.gov/su_docs/aces/fr-cont.html ----------------------------------------------------------------------- [Federal Register: November 1, 2004 (Volume 69, Number 210)] [Notices] [Page 63392-63398] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr01no04-89] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Grants for Dissertation Awards for Doctoral Candidates for Violence-Related and Unintentional Injury Prevention Research in Minority Communities Announcement Type: New. Funding Opportunity Number: CE05-025. Catalog of Federal Domestic Assistance Number: 93.136. Key Dates: Letter of Intent Deadline: December 1, 2004. Application Deadline: January 31, 2005. I. Funding Opportunity Description Authority: This program is authorized under section 301 (a) [42 U.S.C. 241(a)] of the Public Health Service Act, and section 391 (a)[42 U.S.C. 280 b (a)] of the Public Service Health Act, as amended. Purpose: The purposes of the program are to: Solicit research applications that address the priorities reflected under the heading, ``Research Objectives''. Build the scientific base for the prevention and control of injuries, disabilities, and deaths disproportionately experienced in minority communities. Encourage doctoral candidates from a wide spectrum of disciplines, including epidemiology, medicine, biostatistics, public health, law and criminal justice, behavioral, and social sciences to perform research in order to prevent and control injuries more effectively. Assist students in the completion of their dissertation research on a violence-related or unintentional injury topic. Encourage investigators to build research careers related to the prevention of violence-related or unintentional injuries, disabilities, and deaths in minority communities. This program addresses the ``Healthy People 2010'' focus area of Injury and Violence Prevention. A dissertation represents the most extensive research experience formulated and carried out by a doctoral candidate, with the advice and guidance of a mentor (the chair or another member of the dissertation committee). Dissertation research involves a major investment of the doctoral student's time, energy, and interest and its substance is often the basis for launching a research career. This research initiative is aimed at providing students with assistance to complete their dissertation research on a violence-related or unintentional injury topic and, thereby, increasing representation of junior investigators in violence-related or unintentional injury research. Injuries are the number-one killer of children and young adults in the United States. They are the leading cause of years of potential life lost before age 65. More than five million people in the U.S. report suffering from chronic, injury-related disabilities, and the lives of millions of others have been dramatically affected by injuries to themselves or someone they love. Funding for research to prevent these injuries falls into two categories: violence prevention, and the prevention of unintentional injury. Violence Deaths and injuries associated with interpersonal violence and suicidal behavior are a major public health problem in the United States and around the world. In 1999, more than 46,000 people died from homicide and suicide in the United States. Among 15 to 24 year olds, homicide and suicide rank as the second and the third leading causes of death. Violent deaths are the most visible consequence of violent behavior in our society. Morbidity associated with physical and emotional injuries and disabilities resulting from violence, however, also constitutes an enormous public health problem. For every homicide that occurs each year there are more than 100 non-fatal injuries resulting from interpersonal violence. For every completed suicide it is estimated that there are 20 to 25 suicide attempts. The mortality and morbidity associated with violence are associated with a variety of types of violence including child mistreatment, youth violence, intimate partner violence, sexual violence, elder abuse, and self- directed violence or suicidal behavior. Violence has a disproportionate impact on racial and ethnic minorities. In 1999, homicide was the leading cause of death for African Americans and the second leading cause of death for Hispanics between the ages of 15 and 34. Suicide was the second leading cause of death for American Indians and Alaskan Natives and Asian and Pacific Islanders 15 to 34 years of age. It is important to note that existing research indicates that race or ethnicity, per se, is not a risk factor for violent victimization or a cause of violent behavior. Rather, racial or ethnic status is associated with many other factors that do influence the risk of becoming a victim or behaving violently. As a result, racial and ethnic minorities in the United States experience high rates of both violent victimization and perpetration. A better understanding of the factors that contribute to this vulnerability or protection from such risk is important to furthering effective violence prevention programs that address racial and ethnic minorities. Unintentional Injury Unintentional injuries are a leading cause of death for Americans of all ages, regardless of gender, race, or economic status. Unintentional injuries are the leading cause of death for persons ages 1-34 years, and the fifth leading cause of death overall. Nearly 100,000 people [[Page 63393]] die each year as a result of unintentional injury. In fact, on average, every six minutes someone in the U.S. dies from causes such as motor vehicle crashes, falls, poisonings, drownings, fires, bicycle crashes, suffocation, or pedestrians being struck by motor vehicles. Millions of Americans also experience nonfatal unintentional injuries each year. Approximately one in ten people a year experience a nonfatal injury serious enough to require a visit to an emergency department. Although everyone is vulnerable to injury, some groups are at higher risk for unintentional injuries than others. For example, among all ethnic groups in the U.S., American Indians/Alaska Natives have the highest unintentional injury death rate (i.e., 61 per 100,000 population compared with 41 per 100,000 for African Americans and 36 per 100,000 for Whites). African American children from birth through nine years have unintentional injury death rates almost twice as high as those of White children. Hispanic teenagers have higher motor vehicle occupant death rates than African American or White teenagers after adjusting for amount of travel. There is a critical need for highly qualified scientists to carry out research on violence and unintentional injury that can help in the development, implementation, and evaluation of effective injury prevention programs. In particular, scientists are needed who bring an understanding and sensitivity to the problems of violence and unintentional injury as they affect minority communities. The purpose of this extramural research training grant program is to attract young scientists to the field of injury prevention by encouraging doctoral candidates from a variety of disciplines to conduct violence and unintentional injury prevention research and hopefully carry this focus on throughout their careers. The number of individuals, who are members of minority groups, and who are engaged in injury-related prevention research, is currently small. This research program should also attract young minority scientists to the field of violence and unintentional injury prevention research. Measurable outcomes of the program will be in alignment with one (or more) of the following performance goal(s) for the National Center for Injury Prevention and Control (NCIPC): Increase the capacity of injury prevention and control programs to address the prevention of injuries and violence. Monitor and detect fatal and non-fatal injuries. Conduct a targeted program of research to reduce injury- related death and disability. Research Objectives Applicants are encouraged to propose studies that can feasibly be completed within the available funds and funding period. Proposed research for this Program Announcement must address one of the following research priorities in a minority community. Applications that fail to address these topics will be deemed nonresponsive. Violence Related Injury Any research priority listed in following chapters from NCIPC's research agenda: Preventing Intimate Partner Violence, Sexual Violence, and Child Maltreatment, Preventing Suicidal Behavior, or Preventing Youth Violence. NCIPC's research agenda can be accessed online at the following address: http://www.cdc.gov/ncipc/pub-res/research_agenda/agenda.htm . Unintentional Injury Any research priority listed in following chapters from NCIPC's research agenda; Preventing Injuries at Home and in the Community, Preventing Injuries in Sports, Recreation, and Exercise, or Preventing Transportation Injuries. NCIPC's research agenda can be accessed online at the following address: http://www.cdc.gov/ncipc/pub-res/research_agenda/agenda.htm . Rigorous evaluations are needed to determine the effectiveness of interventions, programs, and policies addressing the prevention of violence. Experimental designs are strongly encouraged. However, NCIPC will consider other evaluation designs, if justified, as required by the needs and constraints in a particular setting. For effective interventions, it is possible to do cost- effectiveness studies. To be comparable to other cost effectiveness studies, they should follow the guidelines in the following references: Gold MR, Siegel JE, Russell LB, Weinstein MC. Cost-effectiveness in Health and Medicine. New York: Oxford University Press, 1996. Haddix AC, Teutsch SM, Corso, PS. Prevention Effectiveness: A Guide to Decision Analysis and Economic Evaluation. Second Edition. New York: Oxford University Press, 2003. For randomized trials, applicants are encouraged to clearly state how study subjects, whether individuals or groups, were selected, randomized, and followed through the trial. One relevant useful guidance document is Moher D, Schulz KF, Altman D. The CONSORT Statement, JAMA 2001; 285:1987-2001. II. Award Information Type of Award: Grant. Mechanism of Support: R49. Fiscal Year Funds: 2005. Approximate Total Funding: $125,000. (This amount is an estimate, and is subject to availability of funds.) Approximate Number of Awards: Five (four awards will be made in the area of violence prevention research and 1 award will be made in the area of unintentional injury prevention research). Approximate Average Award: $ 25,000. (This amount includes both direct and indirect costs.) Floor of Award Range: None. Ceiling of Award Range: $ 25,000. (This amount includes both direct and indirect costs.) Anticipated Award Date: August 30, 2005. Budget Period Length: 12 months. Project Period Length: One year. III. Eligibility Information III.1. Eligible applicants Assistance will be provided to any United States public or private institution. The institution must support an accredited doctoral level training program. The performance site must be domestic. 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. Eligible applicants may enter into contracts, including consortia agreements, as necessary to meet the requirements of the program and strengthen the overall application. A dissertation research training grant may not be transferred to another institution, except under unusual and compelling circumstances (such as if the mentor moves to a new institution and both the mentor and the applicant wish to move together). The responsible program official for CDC must be informed if there is a change of a mentor. A biographical sketch of the new mentor must be provided for approval by the CDC program official. [[Page 63394]] Two copies of the completed dissertation, including abstract, must be submitted to the CDC program official and will constitute the final report of the grant. The dissertation must be officially accepted by the dissertation committee or university official responsible for the candidate's dissertation and must be signed by the responsible university official. Any publications directly resulting from the grant should be reported to the CDC program official. The grantee also should cite receiving support from the NCIPC and CDC, both in the dissertation and any publications directly resulting from the dissertation-training grant. It is especially important that the abstract of your grant application (Description, PHS 398 form page 2) reflects the project's focus, because the abstract will be used to help determine the responsiveness of the application. 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. Grant applications must demonstrate an overall match between the applicant's proposed theme and research objectives and the program priorities as described under the heading, ``Research Objectives.'' Applications must demonstrate effective and well-defined working relationships within the performing organization and with outside entities, which will ensure implementation of the proposed activities. 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 The doctoral candidate must be the designated principal investigator. The principal investigator will be responsible for planning, directing, and executing the proposed project with the advice and consultation of the mentor and dissertation committee. Applicants must be students in good standing enrolled in an accredited doctoral degree program. The applicant must have the skill and academic training to conduct the proposed research and have the authority and responsibility to carry out the proposed project. To receive this funding, applicants must have successfully defended their dissertation proposal. This must be verified in a letter of certification from the mentor (the chair or another member of the dissertation committee). CDC requests that if available, the letter of certification be submitted with the grant application, or before the negotiation and award. Applicants must be conducting or intending to conduct research in one of the areas described under the ``Research Objectives'' in the Program Requirement's section of this announcement. The ability of the principal investigator to carry out injury control research projects as defined under Attachment 1 of this program announcement. The attachment is posted along with this announcement on the CDC Web site: http://www.cdc.gov/ncipc/ncipchm.htm. Applications, which do not meet the above requirements, will be considered non-responsive. Any individual with the skills, knowledge, and resources necessary to carry out the proposed injury research as outlined above is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for CDC programs. Principal investigators are encouraged to submit only one proposal in response to this program announcement. With few exceptions (e.g., research issues needing immediate public health attention), only one application per principal investigator will be funded under this announcement. 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. 5/2001). Forms and instructions are available in an interactive format on the CDC Web site, at the following Internet address: http: //http://www.cdc.gov/od/pgo/forminfo.htm. Forms and instructions are also available in an interactive format on the National Institutes of Health (NIH) website at the following Internet address: http://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 Paper size: 8.5 by 11 inches Page margin size: One inch Printed only on one side of page Single spaced Written in plain language, avoid jargon Your LOI must contain the following information: Descriptive title of the proposed research Name, address, email address, and telephone number of the Principal Investigator Names of other key personnel Participating institutions Number and title of this Program Announcement Brief description of the scope and intent of the proposed research work. Application: Follow the PHS 398 application instructions for content and formatting of your application. If the instructions in this announcement differ in any way from the PHS 398 instructions, follow the instructions in this announcement. 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. 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 http://www.dunandbradstreet.com or call 1-866-705-5711. For more information, see the CDC Web site at: http://www.cdc.gov/od/pgo/funding/pubcommt.htm. This announcement uses the non-modular budgeting format. Follow the PHS-398 instructions for non-modular budget research grant applications. In addition to the instructions provided in the PHS 398 for writing the Description on page 2 of the PHS 398 [[Page 63395]] form, structure the Description using the following components: Statement of the problem; Purpose of the proposed research; Methods, including study population, data sources and any statistical analyses to be performed; Implications for prevention. The Description (abstract) should answer the following questions: Does the Description state the hypothesis? Does the Description describe the objectives and specific aims? Does the Description state the importance of the research and how it is innovative? Does the Description outline the methods that will be used to accomplish the goals? Is the language of the Description simple and easy to understand for a broad audience? You must include a research plan in your application. The research plan should be no more than 15 pages, printed on one side, single spaced, with one half-inch margin, and unreduced 12-point font. The research plan should address activities to be conducted over the entire project period. Use the information in the Research Objectives, Administrative and National Policy Requirements, and Application Review Information sections to develop the application content. The research plan should include the following information: The project's focus, a justification for the research proposed, and a description of the scientific basis for the research. The focus should be based on recommendations in ``Healthy People 2010'' (http://www.healthypeople.gov) and the ``CDC Injury Research Agenda,'' (http://www.cdc.gov/ncipc/pub-res/research_agenda/agenda.htm) and should seek creative approaches that will contribute to a national program for injury control. Specific, measurable, and time-framed objectives. A detailed plan describing the methods, which will achieve the objectives, including their sequence. A comprehensive evaluation plan is an essential component of the application. A description of the roles and responsibilities principal investigator. A description of the involvement of other entities that will relate to the proposed project, if applicable. It should include commitments of support and a clear statement of their roles. An explanation of how the research findings will contribute to the national effort to reduce the morbidity, mortality and disability caused by injuries within three to five years from project start-up. Additional Materials Required In addition to the completed PHS 398 application form, the applicant must also submit the following materials, attached to the application as appendices: A letter from the applicant's mentor which: a. Fully identifies the members of the dissertation committee. b. Certifies that the mentor has read the application and believes that it reflects the work to be completed in the dissertation. (Letters certifying approval of the dissertation proposal must be received before negotiation and award of the grant.) c. Certification that the institution's facilities and general environment are adequate to conduct the proposed research. A tentative time line for completion of the research, the dissertation, and the dissertation defense. An official transcript of the applicant's graduate school record showing that the applicant has completed all required course work for the degree with the exception of the dissertation. A statement of the applicant's career goals and intended career trajectory. A biography of the mentor, limited to two pages (use the Biographical Sketch page in application form PHS 398). Additional requirements that may require you to submit additional documentation with your application are listed in section ``VI.2. Administrative and National Policy Requirements.'' For additional help in preparing your grant application please see the ``frequently asked questions'' section on the NCIPC Web page at: http://www.cdc.gov/ncipc/res-opps/2004pas.htm. IV.3. Submission Dates and Times LOI Deadline Date: December 1, 2004. CDC requests that you send a LOI if you intend to apply for this program. Although the LOI is not required, 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: January 31, 2005. Explanation of Deadlines: Applications must be received in the CDC Procurement and Grants Office (PGO) (not NIH) by 4 p.m. Eastern Time on the deadline date. If you submit your 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. This announcement is the definitive guide on LOI and grant 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 Executive Order 12372 does not apply to this program. 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 (IRB) approvals are in place. Grant funds will not be made available to support the provision of direct care including medical and/or psychiatric care. Eligible applicants may enter into contracts, including consortia agreements, as necessary to meet the requirements of the program and strengthen the overall application. Allowable costs include partial salary support for the applicant; such as interviewer expenses, data processing, participant incentives, statistical consultant services, supplies, dissertation printing costs, and travel to one scientific meeting, if adequately justified. [[Page 63396]] Applicants should also include travel costs for one, two- day trip to CDC in Atlanta to present research findings. Indirect costs for this trainee-related grant are limited to eight percent. 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: NCIPC Extramural Resources Team, Centers for Disease Control and Prevention, National Center for Injury Prevention and Control, 4770 Buford Hwy, NE, Mailstop K-62, Atlanta, GA 30341, Telephone: 770-488-4037, Fax: 770-488-1662, E-mail: CIPERT@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--CE05-025, CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341. At the time of submission, four additional copies of the application, and four copies of all appendices must be sent to: NCIPC Extramural Resources Team, CDC, National Center for Injury Prevention and Control, Address for Express Mail or Delivery Service: 2945 Flowers Road, Yale Building, Room 2054, Atlanta, Georgia 30341. Address for U.S. Postal Service Mail: 4770 Buford Hwy, NE, Mailstop K-62, Atlanta, GA 30341. Applications may not be submitted electronically at this time. 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 grant. 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 improve the control and prevention of disease and injury and to 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 applicant acknowledge potential problem areas and consider alternative tactics? Does the project include plans to measure progress toward achieving the stated objectives? Is there an appropriate work plan included? 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)? Is there a prior history of conducting injury-related research? 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? Is there an appropriate degree of commitment and cooperation of other interested parties as evidenced by letters detailing the nature and extent of the involvement? Additional Review Criteria: In addition to the above criteria, the following items will be considered in the determination of scientific merit and priority score: Dissemination: What plans have been articulated for disseminating findings? 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? This will not be scored; however, an application can be disapproved if the research risks are sufficiently serious and protection against risks is so inadequate as to make the entire application unacceptable. 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. 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. NCIPC has adopted this policy for this announcement. 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 . 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 PGO and for responsiveness by NCIPC. 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 [[Page 63397]] panel convened by the NCIPC in accordance with the review criteria listed above. As part of the initial merit review, all applications will: 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. The primary review will be a peer review conducted by NCIPC Initial Review Group (IRG). Applications may be subjected to a preliminary evaluation (streamline review) by the IRG to determine if the application is of sufficient technical and scientific merit to warrant further review. NCIPC will withdraw from further consideration applications judged to be noncompetitive and promptly notify the principal investigator/program director and the official signing for the applicant organization. Those applications judged to be competitive will be further evaluated by the IRG. These applications will be reviewed for scientific merit using current NIH criteria (a scoring system of 100-500 points) to evaluate the methods and scientific quality of the application. The secondary review will be conducted by the Science and Program Review Subcommittee (SPRS) of the Advisory Committee for Injury Prevention and Control (ACIPC). The ACIPC Federal agency experts will be invited to attend the secondary review and will receive modified briefing books (i.e., abstracts, strengths and weaknesses from summary statements, and project officer's briefing materials). ACIPC Federal agency experts will be encouraged to participate in deliberations when applications address overlapping areas of research interest, so that unwarranted duplication in Federally-funded research can be avoided and special subject area expertise can be shared. The NCIPC Division Associate Directors for Science (ADS) or their designees will attend the secondary review in a similar capacity as the ACIPC Federal agency experts to assure that research priorities of the announcement are understood and to provide background regarding current research activities. Only SPRS members will vote on funding recommendations, and their recommendations will be carried to the entire ACIPC for voting by the ACIPC members in closed session. If any further review is needed by the ACIPC, regarding the recommendations of the SPRS, the factors considered would be the same as those considered by the SPRS. The ACIPC committee's responsibility is to develop funding recommendations for the NCIPC Director based on the results of the primary review, the relevance and balance of proposed research relative to the NCIPC programs and priorities, and to assure that unwarranted duplication of federally-funded research does not occur. The secondary review committee has the latitude to recommend to the NCIPC Director to reach over better-ranked proposals in order to assure maximal impact and balance of proposed research. The factors to be considered will include: The results of the primary review including the application's priority score as the primary factor in the selection process. The relevance and balance of proposed research relative to the NCIPC programs and priorities. The significance of the proposed activities in relation to the priorities and objectives stated in ``Healthy People 2010,'' the Institute of Medicine report, ``Reducing the Burden of Injury,'' and the ``CDC Injury Research Agenda.'' (See Attachment 1, Resource Materials. The attachment is posted along with this announcement on the CDC Web site: http://www.cdc.gov/ncipc/ncipchm.htm.) Budgetary considerations. All awards will be determined by the Director of the NCIPC based on priority scores assigned to applications by the primary review committee IRG, recommendations by the secondary review committee of the Science and Program Review Subcommittee of the ACIPC, consultation with NCIPC senior staff, and the availability of funds. 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; V.3. Anticipated Announcement and Award Dates August 30, 2005 VI. Award Administration Information VI.1. Award Notices Successful applicants will receive a Notice of Grant Award (NGA) from the CDC Procurement and Grants Office. The NGA shall be the only binding, authorizing document between the recipient and CDC. The NGA 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: http://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-3 Animal Subjects Requirements AR-9 Paperwork Reduction Act Requirements AR-10 Smoke-Free Workplace Requirements AR-11 Healthy People 2010 AR-12 Lobbying Restrictions AR-13 Prohibition on Use of CDC Funds for Certain Gun Control Activities AR-21 Small, Minority, and Women-Owned Business AR-22 Research Integrity Additional information on AR-1 through AR-22 can be found on the CDC Web site at the following Internet address: http://www.cdc.gov/od/pgo/funding/ARs.htm . AR-25 Release and Sharing of Data Starting with the December 1, 2003 receipt date, all ``Requests for Applications (RFA)/Program Announcements (PA)'' soliciting proposals for individual research projects of $500,000 or more in total (direct and indirect) costs per year require the applicant to include a plan describing how the final research data will be shared/released or explain why data sharing is not possible. Details on data sharing and release, including information on the timeliness of the data and the name of the project data steward, should be included in a brief paragraph immediately following the ``Research Plan'' section of the PHS 398 form. References to data sharing and release may also be appropriate in other sections of the application (e.g. background and significance, or human subjects requirements). The content of the data sharing and release plan will vary, depending on the data being collected and how the investigator is planning to share the data. The data sharing and release plan will not count toward the application page limit and [[Page 63398]] will not factor into the determining scientific merit or the priority scoring. Investigators should seek guidance from their institutions on issues related to institutional policies, and local IRB rules, as well as local, state and federal laws and regulations, including the Privacy Rule. Further detail on the requirements for addressing data sharing in applications for NCIPC funding may be obtained by contacting NCIPC program staff or by visiting the NCIPC Internet: at http://www.cdc.gov/ncipc/osp/sharing_policy.htm . VI.3. Reporting You must provide CDC with an original, plus two hard copies of the following reports: 1. Financial status report, no more than 90 days after the end of the budget period. 2. The final performance report, no more than 90 days after the end of the project period. The final performance report will be a brief summary (2,500 to 4,000 words in length) written in non-scientific [laymen's] terms. The report should highlight the findings and their implications for injury prevention programs, policies, environmental changes, etc. The grant recipient will also include a description of the dissemination plan for research findings. This plan will include publications in peer-reviewed journals and ways in which research findings will be made available to stakeholders outside of academia (e.g., state injury prevention program staff, community groups, public health injury prevention practitioners, and others). CDC will place the summary report and each grant recipient's final report with the National Technical Information Service (NTIS) to further the agency's efforts to make the information more available and accessible to the public. 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: Paul Smutz, Project Officer, Office of the Director, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention (CDC), 4770 Buford Highway, NE., Mailstop K-02, Atlanta, GA 30341, Telephone: 770- 488-1508, E-mail: pos1@cdc.gov. For questions about peer review, contact: Gwendolyn Cattledge, Scientific Review Administrator, Associate Director for Extramural Research, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention (CDC) 4770 Buford Highway, NE., Mailstop K-02, Atlanta, GA 30341, Telephone: 770-488-1430, E-mail: gxc8@cdc.gov. For financial, grants management, or budget assistance, contact: Pamela Render, Grants Management Specialist, CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341, Telephone: 770/488- 2712, E-mail: PLR3@cdc.gov. VIII. Other Information This and other CDC funding opportunity announcements can be found on the CDC Web site, Internet address: http://www.cdc.gov. Click on ``Funding'' then ``Grants and Cooperative Agreements.'' Dated: October 21, 2004. William P. Nichols, Acting Director, Procurement and Grants Office, Centers for Disease Control and Prevention. [FR Doc. 04-24027 Filed 10-29-04; 8:45 am] BILLING CODE 4163-18-P ----------------------------------------------------------------------- [Federal Register: November 1, 2004 (Volume 69, Number 210)] [Notices] [Page 63388-63389] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr01no04-84] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-04-04JJ] Proposed Data Collections Submitted for Public Comment and Recommendations The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at (404) 498-1210 or send an e-mail to omb@cdc.gov. Send written comments to CDC Desk Officer, Human Resources and Housing Branch, New Executive Office Building, Room 10235, Washington, DC 20503 or by fax to (202) 395-6974. Written comments should be received within 30 days of this notice. Proposed Project Evaluation of Efficacy of Household Water Filtration/Treatment Devices in Households with Private Wells--New--National Center for Environmental Health (NCEH), Centers for Disease Control and Prevention (CDC). Approximately 42.4 million people in the United States are served by private wells. Unlike community water systems, private wells are not regulated by the U.S. Environmental Protection Agency's (EPA) Safe Drinking Water Act (SDWA). Under the SDWA, EPA sets maximum contaminant levels (MCLs) for contaminants in drinking water. A 1997 U.S. General Accounting Office (GAO) report on drinking water concluded that users of private wells may face higher exposure levels to groundwater contaminants than users of community water systems. Increasingly, the public is concerned about drinking water [[Page 63389]] quality, and the public's use of water treatment devices rose from 27% in 1995 to 41% in 2001 (Water Quality Association, 2001 National Consumer Water Quality Survey). Studies evaluating the efficacy of water treatment devices on removal of pathogens and other contaminants have assessed the efficacy of different treatment technologies. The purpose of the proposed study is to evaluate how water treatment device efficacy is affected by user behaviors such as maintenance and selection of appropriate technologies. Working with public health authorities in Florida, Colorado, Maine, Missouri, Nebraska, New Jersey, and Wisconsin, NCEH will recruit 600 households to participate in a study to determine whether people using water treatment devices are protected from exposure to contaminants found in their well water. We plan to recruit households that own private wells and use filtration/treatment devices to treat their tap water for cooking and drinking. Study participants will be selected from geographical areas of each state where groundwater is known or suspected to contain contaminants of public health concern. We will administer a questionnaire at each household to obtain information on selection of water treatment type, adherence to suggested maintenance, and reasons for use of treatment device. We will also obtain samples of treated water and untreated well water at each household to analyze for contaminants of public health concern. The estimated annualized burden is 300 hours. There are no costs to respondents. ---------------------------------------------------------------------------------------------------------------- Average Number of Number of burden per Respondents respondents responses per response (in respondent hrs.) ---------------------------------------------------------------------------------------------------------------- Study Solicitation Questionnaire................................ 1200 1 5/60 Household Questionnaire......................................... 600 1 20/60 ---------------------------------------------------------------------------------------------------------------- Dated: October 26, 2004. B. Kathy Skipper, Acting Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. 04-24317 Filed 10-29-04; 8:45 am] BILLING CODE 4163-18-P --------------------------------------------------------------------------------------- [Federal Register: November 1, 2004 (Volume 69, Number 210)] [Notices] [Page 63389-63390] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr01no04-85] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-04-04KH] Proposed Data Collections Submitted for Public Comment and Recommendations The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at (404) 498-1210 or send an e-mail to omb@cdc.gov. Send written comments to CDC Desk Officer, Human Resources and Housing Branch, New Executive Office Building, Room 10235, Washington, DC 20503 or by fax to (202) 395-6974. Written comments should be received within 30 days of this notice. Proposed Project ACHES (Arthritis Conditions Health Effects Survey)--New--National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC). Background Arthritis and other rheumatic conditions are among the most prevalent diseases and are the most frequent cause of disability in the United States. Health care costs for arthritis were estimated at $86.2 billion for 1997. In 2001, an estimated 33% of U.S. adults (70 million) reported prior diagnosis of arthritis or chronic joint symptoms. As the U.S. population increasingly ``grays,'' the economic and disability burden from arthritis will only grow. Fortunately, arthritis can be successfully managed and its impacts lessened. Exercise, weight loss, medications, joint replacement surgeries and educational and sociobehavioral interventions can decrease pain as well as improve physical function and quality of life. Ultimately, this will reduce health care costs. Unfortunately, relatively little is known nationally about persons with arthritis or chronic joint symptoms to better target these interventions. Current national health surveys and databases have extremely limited coverage about arthritis and the myriad of issues surrounding the conditions. CDC plans to conduct ACHES (Arthritis Conditions Health Effects Survey) to close the information gaps about arthritis. ACHES is a national random digit dial telephone survey dedicated solely to arthritis for the purpose of gathering information on symptoms, limitations, physical functioning levels, effects of arthritis on work, knowledge and attitudes about arthritis, self management of arthritis, current physical activity, anxiety, depression, and demographics of 4,500 persons age 45 years and older with arthritis. 2,250 respondents will be interviewed each year in this two-year study. The information from it will be used to better direct and target national arthritis control efforts. There are no costs to respondents. The approximate annualized burden is 1,750 hours. ---------------------------------------------------------------------------------------------------------------- Number of Avg. burden/ Respondents Form name Number of responses/ response (in respondents respondent hrs.) ---------------------------------------------------------------------------------------------------------------- Adult................................. Screening & Consent..... 12,500 1 3/60 Adult >= 45 years with arthritis...... Survey Instrument....... 2,250 1 30/60 ---------------------------------------------------------------------------------------------------------------- [[Page 63390]] Dated: October 26, 2004. B. Kathy Skipper, Acting Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. 04-24318 Filed 10-29-04; 8:45 am] BILLING CODE 4163-18-P ----------------------------------------------------------------------- [Federal Register: November 1, 2004 (Volume 69, Number 210)] [Notices] [Page 63390] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr01no04-86] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-04-0422X] Proposed Data Collections Submitted for Public Comment and Recommendations The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at (404) 498-1210 or send an e-mail to omb@cdc.gov. Send written comments to CDC Desk Officer, Human Resources and Housing Branch, New Executive Office Building, Room 10235, Washington, DC 20503 or by fax to (202) 395-6974. Written comments should be received within 30 days of this notice. Proposed Project Indicators of the Performance of Local and State Education Agencies in HIV Prevention and Coordinated School Health Program Activities for Adolescent and School Health Programs--New--National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC). This proposed project is an annual Web- based questionnaire to assess programmatic activities among local, state and territorial education agencies (LEA, SEA and TEA) funded by CDC, NCCDPHP, Division of Adolescent and School Health (DASH). Currently, CDC does not fund a standardized annual reporting process within NCCDPHP that assesses HIV prevention activities or coordinated school health program (CSHP) activities among LEAs, SEAs and TEAs. Data gathered from this questionnaire will: (1) Provide standardized information about how HIV prevention and CSHP funds are used by LEAs, SEAs and TEAs; (2) assess the extent to which programmatic adjustments are indicated; (3) provide descriptive and process information about program activities; and (4) provide greater accountability for use of public funds. There will be three Web-based questionnaires corresponding to the specific funding sources from the CDC, NCCDPHP, DASH. Two questionnaires pertain to HIV prevention program activities among LEAs, SEAs and TEAs. The third questionnaire pertains to CSHP activities among SEAs. The two HIV questionnaires will include questions on: --Distribution of professional development and individualized technical assistance on school policies; --Distribution of professional development and individualized technical assistance on education curricula and instruction; --Distribution of professional development and individualized technical assistance assessment of student standards; --Collaboration with external partners; --Targeting priority populations; --Planning and improving projects; and --Information about additional program activities. The third questionnaire, CSHP, will also ask the questions above; however, it will focus on physical activity, nutrition, and tobacco-use prevention activities. It will include additional questions on: --Joint activities of the State Education Agency and State Health Agency (SHA); --Activities of the CSHP state-wide coalition; and --Health promotion programs and environmental approaches to Physical Activity, Nutrition and Tobacco (PANT). There are no costs to respondents except for their time. The approximate annualized burden hours are 718. ---------------------------------------------------------------------------------------------------------------- Average Number of Number of burden per Respondents respondents responses per response (in respondent hrs.) ---------------------------------------------------------------------------------------------------------------- HIV Prevention Questionnaire: Local Education Agency Officials.. 18 1 7 HIV Prevention Questionnaire: State & Territorial Education 55 1 7 Agency Officials............................................... CSHP Questionnaire: State Education Agency Officials............ 23 1 9 ---------------------------------------------------------------------------------------------------------------- Dated: October 26, 2004. B. Kathy Skipper, Acting Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. 04-24319 Filed 10-29-04; 8:45 am] BILLING CODE 4163-18-P ----------------------------------------------------------------------- [Federal Register: November 1, 2004 (Volume 69, Number 210)] [Notices] [Page 63390-63391] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr01no04-87] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-04-0497] Proposed Data Collections Submitted for Public Comment and Recommendations The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at (404) 498-1210 or send an e-mail to omb@cdc.gov. Send written comments to CDC Desk Officer, Human Resources and Housing Branch, New Executive Office Building, Room 10235, Washington, DC 20503 or by fax to (202) 395-6974. Written comments should be received within 30 days of this notice. Proposed Project Evaluating CDC Funded Health Department HIV Prevention Programs, OMB No. 0920-0497--Revision--National Center for HIV, STD, and TB Prevention (NCHSTP), Centers for Disease Control and Prevention (CDC). [[Page 63391]] Background CDC is requesting approval for the continued use of three currently approved forms (under OMB Control No. 0920-0497) for collecting HIV partner counseling and referral services (PCRS) program data. The current forms expire October 31, 2004. This request is for clearance for use of these forms through April, 2006. The extension of the current forms will allow grantees to continue to collect PCRS data as they transition to the new Program Evaluation and Monitoring System (PEMS) over the next year. This clearance will also allow CDC to collect information on how federal funds are allocated by grantees for HIV prevention. CDC funds HIV prevention projects in 65 public health agencies (50 states, 6 cities, 7 territories, Washington, DC, and Puerto Rico) through cooperative agreements. PCRS is one of a number of public health strategies supported by CDC that is designed to control and prevent the spread of HIV. A fundamental feature of PCRS is informing current and past partners of an HIV-infected person that they have been identified as a sex or injection-drug-paraphernalia-sharing partner, and advising them to be tested for HIV. Informing partners of their exposure to HIV is confidential, and partners are not told who reported their name, or when the reported exposure occurred. Notified partners who may not have suspected their risk can choose whether to have HIV counseling and testing. Those who choose to be tested and are found to be HIV positive can receive a medical evaluation, treatment, and prevention services designed to modify their high risk behavior, thereby possibly reducing the number of new HIV infections. HIV prevention programs that conduct PCRS interventions can reach significant numbers of persons at very high risk of contracting HIV. The CDC requires aggregate PCRS program data to determine if interventions are being delivered as intended, gauge the degree to which program performance indicator targets are being achieved, and help agencies improve their programs to better deliver effective PCRS. Until grantees transition to PEMS, it is essential that they be allowed to continue to collect aggregate PCRS data using the existing forms. Each health department funded to conduct PCRS will prepare and submit aggregate PCRS data to the CDC annually. Annualized Burden Table ---------------------------------------------------------------------------------------------------------------- Average Number of Number of burden per Form respondents responses per response (in respondent hrs.) ---------------------------------------------------------------------------------------------------------------- PCRS Process Monitoring Form.................................... 65 1 2 Budget by Major Funding Activities Form......................... 65 1 30/60 Budget by Major Providers Form.................................. 65 1 30/60 ---------------------------------------------------------------------------------------------------------------- Dated: October 25, 2004. Alvin Hall, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. 04-24320 Filed 10-29-04; 8:45 am] BILLING CODE 4163-18-P -----------------------------------------------------------------------