Notices. Notice
12,518 words·~57 min read·
/register/2007/07/06/07-3292A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
BILLING CODE 6715-01-M DEPARTMENT OF HEALTH AND HUMAN SERVICES American Indian/Alaska Native Health Disparities Program AGENCY: Department of Health and Human Services, Office of the Secretary, Office of Public Health and Science, Office of Minority Health. ACTION: Notice. *Announcement Type:* Competitive Initial Announcement of Availability of Funds. *Catalog of Federal Domestic Assistance Number:* The CFDA Number is pending. DATES: To receive consideration, applications must be received by the Office of Grants Management, Office of Public Health and Science (OPHS), Department of Health and Human Services
(DHHS)c/o WilDon Solutions, Office of Grants Management Operations Center, Attention Office of Minority Health, American Indian/Alaska Native Health Disparities Program, no later than 5 p.m. Eastern Time on August 6, 2007. The application due date requirement in this announcement supercedes the instructions in the OPHS-1 form. ADDRESSES: Application kits may be obtained electronically by accessing Grants.gov at *http://www.grants.gov* or GrantSolutions at *www.GrantSolutions.gov.* To obtain a hard copy of the application kit, contact WilDon Solutions at 1-888-203-6161. Applicants may fax a written request to WilDon Solutions at
(703)351-1138 or e-mail the request to *OPHSgrantinfo@teamwildon.com.* Applications must be prepared using Form OPHS-1 “Grant Application,” which is included in the application kit. FOR FURTHER INFORMATION CONTACT: WilDon Solutions, Office of Grants Management Operations Center, 1515 Wilson Blvd., Third Floor Suite 310, Arlington, VA 22209 at 1-888-203-6161, e-mail *OPHSgrantinfo@teamwildon.com,* or fax at 703-351-1138. SUMMARY: This announcement is made by the United States Department of Health and Human Services (HHS or Department), Office of Minority Health
(OMH)located within the Office of Public Health and Science (OPHS), and working in a “One-Department” approach collaboratively with participating HHS agencies and programs (entities). As part of a continuing HHS effort to improve the health and well being of racial and ethnic minorities, the Department announces availability of FY 2007 funding for the American Indian/Alaska Native Health Disparities Program (hereafter referred to as the AI/AN Health Disparities Program). OMH is authorized to conduct this program under 42 U.S.C. 300 u-6, section 1707 of the Public Health Service Act, as amended. The mission of the OMH is to improve the health of racial and ethnic minority populations through the development of policies and programs that address disparities and gaps. OMH serves as the focal point in the HHS for leadership, policy development and coordination, service demonstrations, information exchange, coalition and partnership building, and related efforts to address the health needs of racial and ethnic minorities. OMH activities are implemented in an effort to address *Healthy People 2010,* a comprehensive set of disease prevention and health promotion objectives for the Nation to achieve over the first decade of the 21st century ( *http://www.healthypeople.gov* ). This funding announcement is also made in support of the OMH National Partnership for Action initiative. The mission of the National Partnership for Action is to work with individuals and organizations across the country to create a Nation free of health disparities with quality health outcomes for all by achieving the following five objectives: Increasing awareness of health disparities; strengthening leadership at all levels for addressing health disparities; enhancing patient-provider communication; improving cultural and linguistic competency in delivering health services; and better coordinating and utilizing research and outcome evaluations. The AI/AN Health Disparities Program is intended to strengthen the capacity of Tribal Epidemiology Centers
(TECs)to collect and manage data more effectively and to better understand and develop the link between public health problems and behavior, socioeconomic conditions, and geography. The establishment of the TECs was authorized by Congress to provide support to tribes in the areas of health data acquisition, analysis, and interpretation. The TECs were identified for this program because they are uniquely positioned to be effective in disease surveillance and control programs, assessing the effectiveness of public health programs and recognizing the significance and complexities of tribal communities, and understand their distinct operating systems. TECs recognize the challenge of adapting their services to geographically isolated communities, whose access to information, technology, data, and manpower varies considerably by tribe. TECs must possess a breadth of knowledge about a multitude of health topics, housing, social and economic issues, and evidence-based methodologies to better inform decision-making and planning. TECs recognize the importance of providing services in a culturally sensitive manner, and understand and appreciate tribal history and customs. Health disparities continue to plague the American Indian and Alaska Native communities. Tribal leaders have discussed with HHS the numerous health issues that affect their communities and the dearth of American Indian and Alaska Native health professionals. According to the Centers for Disease Control and Prevention: • Heart disease and cancer are the leading causes of death among American Indians and Alaska Natives; • American Indian and Alaska Native adults are 60% more likely to have a stroke than white adults are; • American Indians and Alaska Natives have a 40% higher AIDS rate than their non-Hispanic counterparts do; • The age-adjusted prevalence of diabetes for American Indians and Alaska Natives is over twice that for all U.S. adults; • The infant mortality rate for the American Indian and Alaska Native populations is 1.7 times higher than the non-Hispanic white population; and • The sudden infant death syndrome
(SIDS)rate is the highest of any population group, more than double that of whites in 1999. However, unlike other ethnic minority groups, American Indians and Alaska Natives frequently contend with issues such as: geographic isolation, inadequate sewage disposal, and occasional conflicts between western medical practices and traditional spiritual beliefs, which prevent them from receiving quality medical care. The American Indian/Alaska Native Health Disparities Program is designed to address these barriers to healthcare as well as concerns raised by Tribal Leaders regarding the lack of American Indian and Alaska Native healthcare professionals, paraprofessionals, and researchers by funding tribal epidemiology centers (TECs). TEC activities include: • Data collection; • Evaluating existing delivery systems, data systems, and other systems that impact the improvement of American Indian and Alaska Native health; • Assisting tribes and urban American Indian and Alaska Native communities in identifying their highest priority health status objectives and the services needed to achieve such objectives, based on epidemiological data; • Making recommendations for the targeting of services needed by tribal, urban, and other American Indian and Alaska Native communities; and • Making recommendations to improve healthcare delivery systems for American Indians and Alaska Natives. However, the mission of TECs is not limited to epidemiological research. TECs are also responsible for the development and implementation of disease control and prevention programs in addition to the coordination of activities with other public health authorities in the region. Different from other potential grant applicants, TECs are ideally situated to work locally and be responsive to the needs and sensitivities of tribal communities while cultivating close collaborative relationships with State and Federal agencies and academic departments. Because of this potential to serve as a bridge between the American Indian and Alaska Native communities and institutions of higher learning, TECs are excellent vehicles for: • Providing research internships and opportunities to current and future American Indian and Alaska Native health professionals; • Increasing awareness within the American Indian and Alaska Native populations of the need for healthcare professionals; • Disseminating information about educational opportunities in the healthcare field; and • Working cooperatively with tribal providers of health and social services in order to avoid duplication of existing services. In FY 2007 the AI/AN Health Disparities Program will support projects that enhance the TECs' capacity to carry out disease surveillance, including the interpretation and dissemination of surveillance data; address vital statistics needs; conduct epidemiologic analysis; investigate disease outbreaks; develop disease control and prevention strategies and programs; and/or coordinate with other health agencies in the region. In addition, to building their data capacity, TECs may form collaborative partnerships and alliances to improve access to quality health and human services, and/or design programs to increase the number of American Indians and Alaska Natives serving as health professionals, para-professionals, and researchers. OMH recognizes the importance of optimizing the use of Federal resources and makes this announcement with the expectation of coordinating its efforts under this program with other HHS agencies that support the TECs (e.g., AHRQ, CDC, IHS, NIH) to ensure that activities are complementary and not duplicative. SUPPLEMENTARY INFORMATION: Table of Contents Section I. Funding Opportunity Description 1. Purpose 2. OMH Expectations 3. Applicant Project Results 4. Project Requirements Section II. Award Information Section III. Eligibility Information 1. Eligible Applicants 2. Cost Sharing or Matching 3. Other Section IV. Application and Submission Information 1. Address to Request Application Package 2. Content and Form of Application Submission 3. Submission Dates and Times 4. Intergovernmental Review 5. Funding Restrictions Section V. Application Review Information 1. Criteria 2. Review and Selection Process 3. Anticipated Award Date Section VI. Award Administration Information 1. Award Notices 2. Administrative and National Policy Requirements 3. Reporting Requirements Section VII. Agency Contacts Section VIII. Other Information 1. Healthy People 2010 2. Definitions Section I. Funding Opportunity Description 1. Purpose The purpose of the AI/AN Health Disparities Program is to improve the effectiveness of efforts to eliminate health disparities for American Indian and Alaska Native communities through increased access and utilization of data and data-related activities. Through this FY 2007 announcement, the OMH is promoting utilization of epidemiological data to identify high priority health status objectives and to make recommendations relative to the services and/or activities required to address those objectives. Support will also be provided to projects that include the development of alliances and partnerships to improve coordination of and access to quality health services, and/or the development of programs designed to increase the representation of the American Indians/Alaska Natives in the healthcare workforce (including research positions). 2. OMH Expectations It is intended that the AI/AN Health Disparities Program will result in: Enhanced data collection/utilization to identify highest priority health status objectives and services needed to achieve such objectives; and Development of alliances and partnerships which improve coordination/alignment of health and human services; and/or Provision of technical training in public health practices and prevention oriented research to create public health career pathways for tribal members. 3. Applicant Project Results Applicants must identify at least 3 of the 4 following anticipated project results that are consistent with the AI/AN Health Disparities Program overall and OMH expectations: Increased awareness of health disparities; Strengthening of leadership at all levels for addressing health disparities; Improved cultural and linguistic competency; and/or Improved coordination and utilization of research and outcome evaluations. The outcomes of these projects will be used to develop other national efforts to address health disparities among American Indian and Alaska Native populations. 4. Project Requirements Each applicant under the AI/AN Health Disparities Program must implement activities designed to enhance effective data collection and management methods to create better understanding and development of the link between public health problems, behavior, socioeconomic conditions, and geography. Applicants must also propose to conduct activities related to at least one of the following: Establishment of partnerships and development of systems to improve coordination and continuity of access to quality health and human services; or Development of methods to establish career pathways for AI/AN health care professionals, paraprofessionals, and researchers. Section II. Award Information *Estimated Funds Available for Competition:* $1,000,000 in FY 2007. *Anticipated Number of Awards:* 4. *Range of Awards:* $175,000 to $250,000 per year. *Anticipated Start Date:* September 1, 2007. *Period of Performance:* 5 Years (September 1, 2007 to August 31, 2012). *Budget Period Length:* 12 months. *Type of Award:* Grant. *Type of Application Accepted:* New. Section III. Eligibility Information 1. Eligible Applicants To qualify for funding, an applicant must be one of the 12 established Tribal Epidemiologic Centers currently supported by the Indian Health Service. The organization submitting the application will: Serve as the lead agency for the project, responsible for its implementation and management; and Serve as the fiscal agent for the Federal grant awarded. OMH encourages TECs to work collaboratively on this project. Applications from a group or consortium of TECs must identify one of its members as the lead agency for the project. To demonstrate coordination between the TEC and participating Tribes, letters of support and collaboration from the participating Tribes should be included with the application. 2. Cost Sharing or Matching Matching funds are not required for the AI/AN Health Disparities Program. 3. Other If funding is requested in an amount greater than the ceiling of the award range, the application will be considered non-responsive and will not be entered into the review process. The application will be returned with notification that it did not meet the submission requirements. Applications that are not complete or that do not conform to or address the criteria of this announcement will be considered non-responsive and will not be entered into the review process. The application will be returned with notification that it did not meet the submission requirements. An organization may submit no more than one application to the AI/AN Health Disparities Program. Organizations submitting more than one proposal for this grant program will be deemed ineligible. The multiple proposals from the same organization will be returned without comment. Organizations are not eligible to receive funding from more than one OMH grant program to carry out the same project and/or activities. Section IV. Application and Submission Information 1. Address To Request Application Kit Application kits for the AI/AN Health Disparities Program may be obtained by accessing Grants.gov at *http://www.grants.gov* or the GrantSolutions system at *http://www.grantsolutions.gov.* To obtain a hard copy of the application kit for this grant program, contact WilDon Solutions at 1-888-203-6161. Applicants may also fax a written request to WilDon Solutions at
(703)351-1138 or e-mail the request to *OPHSgrantinfo@teamwildon.com.* Applications must be prepared using Form OPHS-1, which can be obtained at the Web sites noted above. 2. Content and Form of Application Submission A. Application and Submission Applicants must use Grant Application Form OPHS-1 and complete the Face Page/Cover Page (SF 424), Checklist, and Budget Information Forms for Non-Construction Programs (SF 424A). In addition, the application must contain a project narrative. The project narrative (including summary and appendices) is limited to 75 pages double-spaced. The narrative description of the project must contain the following, in the order presented: Table of Contents. Project Summary: Describe key aspects of the Background, Objectives, Program Plan, and Evaluation Plan. The summary is limited to 3 pages. Background: *Statement of Need:* Describe and document, with data, demographic information of the targeted local geographic area(s) that are to be included in the project, the significance and prevalence of health problems or issues, gaps in services affecting the local targeted communities. Describe demographics of the local American Indian and Alaska Native populations expected to be affected by the project. *Experience:* Discuss the applicant organization's background and experience in managing projects/activities, especially those targeting the population to be served. Indicate where the project will be administered within the applicant organization's structure and the reporting channels. Provide a chart of the proposed project's organizational structure, showing who will report to whom. *Objectives:* Provide objectives stated in measurable terms including baseline data, improvement targets, and time frames for achievement for the five-year project period. *Program Plan:* Provide a plan which clearly describes how the project will be carried out. Describe specific activities and strategies planned to achieve each objective. For each activity, describe how, when, where, by whom, and for whom the activity will be conducted. Describe methods to be employed to enhance data access, collection and utilization. Describe any special studies to be conducted that will inform and enhance the ability of the TECs to collect and manage data more effectively, to better understand and develop the link between public health problems and behavior, and to help guide health policy and action for prioritizing health status objectives and monitor progress toward meeting those objectives. Describe the role of each participating Tribe, tribal organization, and/or other partner involved in project activities. Provide a description of the proposed program staff, including résumés and job descriptions for key staff, qualifications and responsibilities of each staff member, and percent of time each will commit to the project. Provide a description of duties for any proposed consultants. Describe any products to be developed by the project. Provide a time line for each of the five years of the project. *Evaluation Plan:* Delineate how program activities will be evaluated. The evaluation plan must clearly articulate how the project will be evaluated to determine if the intended results have been achieved. The evaluation plan must describe, for all funded activities: Intended results (i.e., impacts and outcomes); How impacts and outcomes will be measured (i.e., what indicators or measures will be used to monitor and measure progress toward achieving project results); Methods for collecting and analyzing data on measures; Evaluation methods that will be used to assess impacts and outcomes; Evaluation expertise that will be available for this purpose; How results are expected to contribute to the objectives of the Program as a whole, and Healthy People 2010 goals and objectives; and The potential for replicating the evaluation methods for similar efforts. Discuss plans and describe the vehicle (e.g., manual, CD) that will be used to document the steps which others may follow to replicate the proposed project in similar communities. Describe plans for disseminating project results. Appendices: —Submit letters of support from collaborating tribal partners and other collaborating organizations (if applicable). —Include other relevant information in this section. In addition to the project narrative, the application must contain a detailed budget justification which includes a narrative explanation and indicates the computation of expenditures for each year for which grant support is requested. The budget request must include funds for key project staff to attend an annual OMH grantee meeting. (The budget justification does not count toward the page limitation.) B. Data Universal Numbering System Number
(DUNS)Applications must have a Dun & Bradstreet (D&B) Data Universal Numbering System number as the universal identifier when applying for Federal grants. The D&B number can be obtained by calling
(866)705-5711 or through the Web site at *http://www.dnb.com/us/.* 3. Submission Dates and Times To be considered for review, applications must be received by the Office of Public Health and Science (OPHS), Office of Grants Management, c/o WilDon Solutions, by 5 p.m. Eastern Time on August 6, 2007. Applications will be considered as meeting the deadline if they are received on or before the deadline date. The application due date requirement in this announcement supercedes the instructions in the OPHS-1 form. Submission Mechanisms OPHS provides multiple mechanisms for the submission of applications, as described in the following sections. Applicants will receive notification via mail from the OPHS Office of Grants Management confirming the receipt of applications submitted using any of these mechanisms. Applications submitted to the OPHS Office of Grants Management after the deadlines described below will not be accepted for review. Applications which do not conform to the requirements of the grant announcement will not be accepted for review and will be returned to the applicant. While applications are accepted in hard copy, the use of the electronic application submission capabilities provided by the Grants.gov and GrantSolutions.gov systems is strongly encouraged. Applications may only be submitted electronically via the electronic submission mechanisms specified below. Any applications submitted via any other means of electronic communication, including facsimile or electronic mail, will not be accepted for review. In order to apply for new funding opportunities which are open to the public for competition, you may access the Grants.gov Web site portal. All OPHS funding opportunities and application kits are made available on Grants.gov. If your organization has/had a grantee business relationship with a grant program serviced by the OPHS Office of Grants Management, and you are applying as part of ongoing grantee related activities, please access GrantSolutions.gov. Electronic grant application submissions must be submitted no later than 5 p.m. Eastern Time on the deadline date specified in the DATES section of the announcement using one of the electronic submission mechanisms specified below. All required hardcopy original signatures and mail-in items must be received by the OPHS Office of Grants Management, c/o WilDon Solutions, no later than 5 p.m. Eastern Time on the next business day after the deadline date specified in the DATES section of the announcement. Applications will not be considered valid until all electronic application components, hardcopy original signatures, and mail-in items are received by the OPHS Office of Grants Management according to the deadlines specified above. Application submissions that do not adhere to the due date requirements will be considered late and will be deemed ineligible. Applicants are encouraged to initiate electronic applications early in the application development process, and to submit early on the due date or before. This will aid in addressing any problems with submissions prior to the application deadline. Electronic Submissions via the Grants.gov Web site Portal The Grants.gov Web site Portal provides organizations with the ability to submit applications for OPHS grant opportunities. Organizations must successfully complete the necessary registration processes in order to submit an application. Information about this system is available on the Grants.gov Web site, *http://www.grants.gov.* In addition to electronically submitted materials, applicants may be required to submit hard copy signatures for certain Program related forms, or original materials as required by the announcement. It is imperative that the applicant review both the grant announcement, as well as the application guidance provided within the Grants.gov application package, to determine such requirements. Any required hard copy materials, or documents that require a signature, must be submitted separately via mail to the OPHS Office of Grants Management, and, if required, must contain the original signature of an individual authorized to act for the applicant agency and the obligations imposed by the terms and conditions of the grant award. When submitting the required forms, do not send the entire application. Complete hard copy applications submitted after the electronic submission will not be considered for review. Electronic applications submitted via the Grants.gov Web site Portal must contain all completed online forms required by the application kit, the Program Narrative, Budget Narrative, and any appendices or exhibits. All required mail-in items must be received by the due date requirements specified above. Mail-In items may only include publications, resumes, or organizational documentation. When submitting the required forms, do not send the entire application. Complete hard copy applications submitted after the electronic submission will not be considered for review. Upon completion of a successful electronic application submission via the Grants.gov Web site Portal, the applicant will be provided with a confirmation page from Grants.gov indicating the date and time (Eastern Time) of the electronic application submission, as well as the Grants.gov Receipt Number. It is critical that the applicant print and retain this confirmation for their records, as well as a copy of the entire application package. All applications submitted via the Grants.gov Web site Portal will be validated by Grants.gov. Any applications deemed “Invalid” by the Grants.gov Web site Portal will not be transferred to the GrantSolutions system, and OPHS has no responsibility for any application that is not validated and transferred to OPHS from the Grants.gov Web site Portal. Grants.gov will notify the applicant regarding the application validation status. Once the application is successfully validated by the Grants.gov Web site Portal, applicants should immediately mail all required hard copy materials to the OPHS Office of Grants Management to be received by the deadlines specified above. It is critical that the applicant clearly identify the Organization name and Grants.gov Application Receipt Number on all hard copy materials. Once the application is validated by Grants.gov, it will be electronically transferred to the GrantSolutions system for processing. Upon receipt of both the electronic application from the Grants.gov Web site Portal, and the required hardcopy mail-in items, applicants will receive notification via mail from the OPHS Office of Grants Management confirming the receipt of the application submitted using the Grants.gov Web site Portal. Applicants should contact Grants.gov regarding any questions or concerns regarding the electronic application process conducted through the Grants.gov Web site Portal. Electronic Submissions via the GrantSolutions System OPHS is a managing partner of the GrantSolutions.gov system. GrantSolutions is a full life-cycle grants management system managed by the Administration for Children and Families, Department of Health and Human Services (HHS), and is designated by the Office of Management and Budget
(OMB)as one of the three Government-wide grants management systems under the Grants Management Line of Business initiative (GMLoB). OPHS uses GrantSolutions for the electronic processing of all grant applications, as well as the electronic management of its entire Grant portfolio. When submitting applications via the GrantSolutions system, applicants are required to submit a hard copy of the application face page (Standard Form 424) with the original signature of an individual authorized to act for the applicant agency and assume the obligations imposed by the terms and conditions of the grant award. If required, applicants will also need to submit a hard copy of the Standard Form LLL and/or certain Program related forms (e.g., Program Certifications) with the original signature of an individual authorized to act for the applicant agency. When submitting the required forms, do not send the entire application. Complete hard copy applications submitted after the electronic submission will not be considered for review. Electronic applications submitted via the GrantSolutions system must contain all completed online forms required by the application kit, the Program Narrative, Budget Narrative, and any appendices or exhibits. The applicant may identify specific mail-in items to be sent to the Office of Grants Management separate from the electronic submission; however these mail-in items must be entered on the GrantSolutions Application Checklist at the time of electronic submission, and must be received by the due date requirements specified above. Mail-In items may only include publications, resumes, or organizational documentation. When submitting the required forms, do not send the entire application. Complete hard copy applications submitted after the electronic submission will not be considered for review. Upon completion of a successful electronic application submission, the GrantSolutions system will provide the applicant with a confirmation page indicating the date and time (Eastern Time) of the electronic application submission. This confirmation page will also provide a listing of all items that constitute the final application submission including all electronic application components, required hardcopy original signatures, and mail-in items, as well as the mailing address of the OPHS Office of Grants Management where all required hard copy materials must be submitted. As items are received by the OPHS Office of Grants Management, the electronic application status will be updated to reflect the receipt of mail-in items. It is recommended that the applicant monitor the status of their application in the GrantSolutions system to ensure that all signatures and mail-in items are received. Mailed or Hand-Delivered Hard Copy Applications Applicants who submit applications in hard copy (via mail or hand-delivered) are required to submit an original and two copies of the application. The original application must be signed by an individual authorized to act for the applicant agency or organization and to assume for the organization the obligations imposed by the terms and conditions of the grant award. Mailed or hand-delivered applications will be considered as meeting the deadline if they are received by the OPHS Office of Grant Management on or before 5 p.m. Eastern Time on the deadline date specified in the DATES section of the announcement. The application deadline date requirement specified in this announcement supersedes the instructions in the OPHS-1. Applications that do not meet the deadline will be returned to the applicant unread. 4. Intergovernmental Review The Executive Order 12372 “Intergovernmental Review of Federal Programs” does not apply to this program. The Public Health System Impact Statement (PHSIS) does not apply to this program. 5. Funding Restrictions Budget Request If funding is requested in an amount greater than the ceiling of the award range, the application will be considered non-responsive and will not be entered into the review process. The application will be returned with notification that it did not meet the submission requirements. Grant funds may be used to cover costs of: Personnel Consultants Equipment Supplies (including screening and outreach supplies) Grant-related travel (domestic only), including attendance at an annual OMH grantee meeting Other grant-related costs Grant funds may not be used for: Building alterations or renovations Construction Fund-raising activities Job training Medical care, treatment or therapy Political education and lobbying Research studies involving human subjects Vocational rehabilitation. Guidance for completing the budget can be found in the Program Guidelines, which are included with the complete application kit. Section V. Application Review Information 1. Criteria The technical review of the AI/AN Health Disparities Program applications will consider the following four generic factors listed, in descending order of weight. A. Factor 1: Program Plan (40%) Appropriateness and merit of proposed approach and specific activities for each objective. Logic and sequencing of the planned approaches as they relate to the statement of need and to the objectives. • Qualifications and appropriateness of proposed staff or requirements for “to be hired” staff and consultants. Proposed staff level of effort. Appropriateness of defined roles including staff reporting channels and that of any proposed consultants. B. Factor 2: Evaluation Plan (25%) The degree to which intended results are appropriate for the objectives of the AI/AN Health Disparities Program overall, stated objectives of the proposed project and proposed activities. Appropriateness of the proposed methods for data collection (including demographic data to be collected on project participants), analysis, and reporting. Suitability of process, outcome, and impact measures. Clarity of the intent and plans to assess and document progress toward achieving objectives, planned activities, and intended outcomes. Potential for the proposed project to impact the health status of the target population(s) relative to the health areas addressed. Soundness of the plan to document the project for replicability in similar communities. Soundness of the plan to disseminate project results. Potential for replicating the evaluation methods for similar efforts by this or other applications. C. Factor 3: Background (20%) Demonstrated knowledge of the problem at the local level. Significance and prevalence of targeted health issues in the proposed community and target population(s). Extent to which the applicant demonstrates access to the target population(s), and whether it is well positioned and accepted within the community(ies) to be served. Extent and documented outcome of past efforts and activities with the target population. Applicant's capability to manage and evaluate the project as determined by: The applicant organization's experience in managing project/activities involving evidence-based data and data-related activities (including special studies that informs decision-making applying evidence-based methods). The applicant organization's experience in managing project activities involving the target population. The applicant's organizational structure and proposed project organizational structure. Demonstrate clear lines of authority of the applicant and partner organizations. D. Factor 4: Objectives (15%) Merit of the objectives. Relevance to Healthy People 2010 and National Partnership for Action objectives. Relevance to the AI/AN Health Disparities Program purpose and expectations, and to the stated problem to be addressed by the proposed project. Degree to which the objectives are stated in measurable terms. Attainability of the objectives in the stated time frames. 2. Review and Selection Process Accepted AI/AN Health Disparities Program applications will be reviewed for technical merit in accordance with Public Health Service
(PHS)policies. Applications will be evaluated by an Objective Review Committee (ORC). Committee members are chosen for their expertise in minority health and health disparities, and their understanding of the unique health problems and related issues confronted by the racial and ethnic minority populations in the United States. Funding decisions will be determined by the Deputy Assistant Secretary for Minority Health who will take under consideration: The recommendations and ratings of the ORC; and Geographic distribution. 3. Anticipated Award Date September 1, 2007. Section VI. Award Administration Information 1. Award Notices Successful applicants will receive a notification letter from the Deputy Assistant Secretary for Minority Health and a Notice of Grant Award (NGA), signed by the OPHS Grants Management Officer. The NGA shall be the only binding, authorizing document between the recipient and the Office of Minority Health. Unsuccessful applicants will receive notification from OPHS. 2. Administrative and National Policy Requirements In accepting this award, the grantee stipulates that the award and any activities thereunder are subject to all provisions of 45 CFR parts 74 and 92, currently in effect or implemented during the period of the grant. The DHHS Appropriations Act requires that, when issuing statements, press releases, requests for proposals, bid solicitations, and other documents describing projects or programs funded in whole or in part with Federal money, all grantees shall clearly state the percentage and dollar amount of the total costs of the program or project which will be financed with Federal money and the percentage and dollar amount of the total costs of the project or program that will be financed by non-governmental sources. 3. Reporting Requirements A successful applicant under this notice will submit:
(1)Semi-annual progress reports;
(2)an annual Financial Status Report; and
(3)a final progress report and Financial Status Report in the format established by the OMH, in accordance with provisions of the general regulations which apply under “Monitoring and Reporting Program Performance,” 45 CFR Part 74.51-74.52, with the exception of State and local governments to which 45 CFR part 92, Subpart C reporting requirements apply. Uniform Data Set: The Uniform Data Set
(UDS)is a Web-based system used by OMH grantees to electronically report progress data to OMH. It allows OMH to more clearly and systematically link grant activities to OMH-wide goals and objectives, and document programming impacts and results. All OMH grantees are required to report program information via the UDS ( *http://www.dsgonline.com/omh/uds* ). Training will be provided to all new grantees on the use of the UDS system during the annual grantee meeting. Grantees will be informed of the progress report due dates and means of submission. Instructions and report format will be provided prior to the required due date. The Annual Financial Status Report is due no later than 90 days after the close of each budget period. The final progress report and Financial Status Report are due 90 days after the end of the project period. Instructions and due dates will be provided prior to required submission. Section VII. Agency Contacts For application kits, submission of applications, and information on budget and business aspects of the application, please contact: WilDon Solutions, Office of Grants Management Operations Center, 1515 Wilson Blvd., Third Floor Suite 310, Arlington, VA 22209 at 1-888-203-6161, e-mail *OPHSgrantinfo@teamwildon.com,* or fax 703-351-1138. For questions related to the AI/AN Health Disparities Grant Program or assistance in preparing a grant proposal, contact Ms. Sonsiere Cobb-Souza, Director, Division of Program Operations, Office of Minority Health, Tower Building, Suite 600, 1101 Wootton Parkway, Rockville, MD 20852. Ms. Cobb-Souza can be reached by telephone at
(240)453-8444 or by e-mail at *sonsiere.cobb-souza@hhs.gov.* For additional technical assistance, contact the OMH Regional Minority Health Consultant for your region listed in your grant application kit. For health information, call the Office of Minority Health Resource Center (OMHRC) at 1-800-444-6472. Section VIII. Other Information 1. Healthy People 2010 The PHS is committed to achieving the health promotion and disease prevention objectives of Healthy People 2010, a PHS-led national activity announced in January 2000 to eliminate health disparities and improve years and quality of life. More information may be found on the Healthy People 2010 Web site: *http://www.healthypeople.gov/* and copies of the documents may be downloaded. Copies of the Healthy People 2010: Volumes I and II can be purchased by calling
(202)512-1800 (cost $70 for a printed version; $20 for CD-ROM). Another reference is the Healthy People 2010 Final Review—2001. For one free copy of the Healthy People 2010, contact: The National Center for Health Statistics, Division of Data Services, 3311 Toledo Road, Hyattsville, MD 20782, or by telephone at
(301)458-4636. Ask for HHS Publication No.
(PHS)99-1256. This document may also be downloaded from: *http://www.healthypeople.gov.* 2. Definitions For purposes of this announcement, the following definitions apply: *Minority Populations* —American Indian or Alaska Native, Asian, Black or African American, Hispanic or Latino, and Native Hawaiian or Other Pacific Islander. (42 U.S.C. 300u-6, section 1707 of the Public Health Service Act, as amended). *Tribal Epidemiology Centers* —Entities whose mission includes enhancing the health and wellness of American Indian and Alaska Native communities; the implementation and enhancement of data systems; disease surveillance, bioterrorism and disease outbreak protocols; guidance of public health policy; and facilitation of disease control and prevention programs. *Tribal Organizations* —Tribal organizations that may partner with TECs include Federally Recognized Indian Tribes, Tribally sanctioned non-profit tribal organizations or eligible consortium of Tribes. Dated: June 20, 2007. Garth N. Graham, Deputy Assistant Secretary for Minority Health. [FR Doc. E7-13080 Filed 7-5-07; 8:45 am] BILLING CODE 4150-29-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-07-0636] Proposed Data Collections Submitted for Public Comment and Recommendations In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention
(CDC)will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 404-639-5760 or send comments to Maryam I. Daneshvar, Acting, CDC Assistant Reports Clearance Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail to *omb@cdc.gov.* Comments are invited on:
(a)Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility;
(b)the accuracy of the agency's estimate of the burden of the proposed collection of information;
(c)ways to enhance the quality, utility, and clarity of the information to be collected; and
(d)ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Written comments should be received within 60 days of this notice. Proposed Project State-based Evaluation of the Alert Notification Component of CDC's Epidemic Information Exchange (Epi-X) Secure Public Health Communications Network (OMB No. 0920-0636)—3-year Extension—National Center for Health Marketing (NCHM), Centers for Disease Control and Prevention (CDC). Background and Brief Description A central component of the CDC's mission is to strengthen the nation's public health infrastructure by coordinating public health surveillance at CDC and providing domestic and international support through scientific communications and terrorism preparedness and emergency response. The Epidemic Information Exchange (Epi-X) provides CDC and its state and local partners and collaborators with a secure public health communications network intended for routine and emergent information exchange in a secure environment. Great attention has been focused on improving secure public health communications networks for the dissemination of critical disease outbreak and/or bioterrorism-related events, which may have multi-jurisdictional involvement and cause disease and death within a short time-frame. The purpose of the information gathered during this notification proficiency testing exercise is to evaluate the extent to which new registrants and currently authorized users of the Epidemic Information Exchange (Epi-X) are able to utilize alert notification functionality to minimize or prevent unnecessary injury or disease-related morbidity and mortality through the use of secure communications and rapid notification systems. In this case, notification alerts would be sent to targeted public health professionals through a “barrage” of office cell phone, home telephone, and pager calls to rapidly inform key health authorities from multidisciplinary backgrounds and multiple jurisdictions of evolving and critical public health information, and assist with the decision-making process. Presently, the necessity of this evaluation process is timely because of ongoing terrorism threats and acts perpetrated worldwide. The survey information will be gathered through an online questionnaire format, and help evaluate user comprehension and facility solely with the targeted notification and rapid alerting functionalities of Epi-X. The questionnaire will consist of both closed- and open-ended items, and will be administered through Zoomerang, an online questionnaire program, or as a last resort, by telephone. Approximately 1,000 Epi-X users from every state of the union will be asked to volunteer input (in a 5-10 question format) about their experiences using the alert notification functionalities of the Epi-X communications system. There will be no cost to respondents, whose participation will be strictly voluntary. Estimated Annualized Burden Hours Respondents Number of respondents Number of responses per respondent Average burden per response (in hours) Total burden (in hours) Public Health Professionals 1,000 1 10/60 167 Dated: June 29, 2007. Maryam I. Daneshvar, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. [FR Doc. E7-13086 Filed 7-5-07; 8:45 am] BILLING CODE 4163-18-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Cooperative Agreement to Support the Joint Institute for Food Safety and Applied Nutrition AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)is announcing its intention to receive and consider a single source application for the award of a cooperative agreement in fiscal year 2007
(FY)to the University of Maryland, College Park
(UMCP)to support the Joint Institute for Food Safety and Applied Nutrition (JIFSAN). This award will strengthen existing programs and allow expansion of JIFSAN's education, outreach and applied research programs and external partnerships that have already been established. DATES: Applications are due within 30 days after the publication of the funding opportunity in the **Federal Register** . FOR FURTHER INFORMATION CONTACT: Gladys M. Bohler, Office of Acquisition and Grants Services, Food and Drug Administration, 5630 Fishers Lane, rm. 2105, Rockville, MD 20857, 301-827-7168, or e-mail: gladys.melendez-bohler@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Funding Opportunity Description Funding Opportunity Number; Notice of Intent to Renew a Cooperative Agreement; RFA-FD-07-001 CFSAN Catalog of Federal Domestic Assistance Number: 93.103 An estimated amount of support in FY07 will be for up to $2.0 million (direct plus indirect cost) the total amount being subject to annual budget appropriations, with an additional 4 years of support. JIFSAN is located on the University of Maryland Campus in College Park, MD. Competition is limited to UMCP because of the unique partnership between FDA and UMCP. The cooperative agreement will continue to allow for a more efficient use of research, scientific, education, and outreach resources which enhance overall public health by expanding and improving food safety and nutrition as well as other program areas that impact on public health policy. II. Eligibility Information FDA believes UMCP is uniquely qualified to fulfill the objectives of the proposed cooperative agreement. UMCP is in close proximity to the FDA's Center for Food Safety and Applied Nutrition (CFSAN) and the Center for Veterinary Medicine offices and laboratories in Prince Georges County, MD. UMCP has vast resources which complement and greatly expand FDA's research, scientific, education and outreach resources. As the UMCP and FDA are both located within the greater Washington, DC area increased interactions with the USDA Beltsville Agricultural Research Center and other world class research and medical institutions are possible. UMCP is the Washington region's most comprehensive research institution, with numerous academic programs relevant to FDA's mission and the resources to support CFSAN's areas of interest, including: microbiology, chemistry, food science, animal health sciences, agriculture, public policy, risk assessment, computational science, economics, and survey methodology. UMCP serves as a primary center for graduate study and research and provides undergraduate and graduate instruction across a broad spectrum of academic disciplines. The University extends its intellectual resources to the community through innovative projects designed to serve individuals, governments and the private sector throughout the State of Maryland, the nation, and the international community. The University has developed core facilities to provide effective use of state-of-the-art scientific instrumentation with high acquisition, installation, and maintenance costs to conduct research at the forefront of science. An electron microscopy facility jointly supported by FDA and the University opened in 2000. CFSAN has moved its nuclear magnetic resonance
(NMR)instrumentation and personnel to the University's NMR facility in the Chemistry building. These instrumentation centers complement CFSAN's resources and expertise.The University has developed *http://www.FoodRisk.org* (formerly the Risk Analysis Clearinghouse) which is the only web-based information resource specializing in food safety risk analysis, including risk assessment, risk management, and risk communication. Users include government officials from around the world seeking the latest risk assessment, or training and workshop opportunities. The Web site for FoodRisk.org contains:
(1)Data and tools for researchers seeking to fill data gaps, build models, and develop expertise;
(2)specialized data, peer networks, and access to modeling tools for risk assessors and project managers; and
(3)the latest risk assessments, and information on workshops and training opportunities for interested individuals from around the world. The Web site for FoodRisk.org also operates the Food and Agricultural Organization/World Health Organization (FAO/WHO) Acrylamide in Food Network, the internationally sanctioned repository for information about the safety and prevention of acrylamide in food. The University through JIFSAN has developed a broad range of international agreements with:
(1)The Ministry of Science and Technology Thailand;
(2)the Korea Food and Drug Administration (KFDA);
(3)the Central Science Laboratory, Department for Environment Food and Rural Affairs in York, UK; and
(4)the Department of Natural Resources and Environment in Victoria Australia. Additionally JIFSAN has been designated a Pan American Health Organization/World Health Organization (PAHO/WHO) Collaborating Center for Food Safety Risk Analysis. These agreements enable UMCP and JIFSAN to:
(1)Further promote international scientific, education, outreach and cooperative research activities; and
(2)deepen the understanding of the scientific, economic and social issues/needs within the respective countries. Acknowledging the importance of an interdisciplinary approach to knowledge, the University maintains organized research units outside the usual academic department structures. Through collaborative projects, FDA has access to additional University resources that include:
(1)The Center for Risk Communication Research where cooperative projects related to risk communication studies have been and will continue to be developed;
(2)The Center for Food Systems Security and Safety, within the College of Agriculture and Natural Resources, providing opportunities for the development of multidisciplinary food safety research using an integrated food systems approach; and
(3)The Maryland NanoCenter established as a partnership among the A. James Clark School of Engineering, the College of Computer, Math, and Physical Sciences (CMPS), and the College of Chemical and Life Sciences provides access to major nano-research, equipment and informational seminars that could foster trans-disciplinary collaboration among a critical mass of researchers spanning the sciences and engineering. As UMCP is part of the University System of Maryland (comprised of eleven universities, two research institutions and two regional higher education centers) additional education, research and outreach expertise through affiliated campuses/faculty may be accessed to build additional relationships that advance our mutual goals. Collaboration between the public and the private sectors has proven to be an efficient means for both FDA and the University to remain current with scientific and technical advances associated with FDA regulated products (i.e., foods, cosmetics and animal drugs and feed additives). The degree to which we nurture, develop and build on these collaborations directly impacts our ability to enhance public health. The information and expertise obtained through this partnership between FDA and UMCP can be leveraged by all segments of the food safety and nutrition community, as well as by public health organizations, other Federal agencies, and academic institutions in the performance of their roles. As of October 1, 2003, applicants are required to have a DUNS number to apply for a grant or cooperative agreement from the Federal government. The DUNS number is a 9-digit identification number, which uniquely identifies business entities. Obtaining a DUNS number is easy and there is no charge. To obtain a DUNS number, call 1-866-705-5711. Be certain that you identify yourself as a Federal grant applicant when you contact Dun and Bradstreet. III. Application and Submission FDA will accept the application for this program electronically via http://www.grants.gov. The applicant is encouraged to apply electronically by visiting the Web site http://www.grants.gov and following instructions under “Apply for Grants.” The required application, SF 424 (Research & Related) (also referred to as the “SF424 (R&R)”), can be completed and submitted online. The package should be labeled “Response to RFA-FD-07 001”. If you experience technical difficulties with your online submission you should contact Gladys M. Bohler by telephone 301-827-7168 or by e-mail: *gladys.melendez-bohler@fda.hhs.gov* . Information about submitting an application electronically can be found on the *http://www.grants.gov* Web site. In order to apply electronically, the applicant must have a DUNS number and register in the central contractor registration
(CCR)database. A. Dun and Bradstreet Number
(DUNS)As of October 1, 2003, applicants are required to have a DUNS number to apply for a grant or cooperative agreement from the Federal government. The DUNS number is a 9-digit identification number, which uniquely identifies business entities. Obtaining a DUNS number is easy and there is no charge. To obtain a DUNS number, call 1-866-705-5711. Be certain that you identify yourself as a Federal grant applicant when you contact Dun and Bradstreet. B. Central Contractor Registration Applicants must register with the CCR database. This database is a government-wide warehouse of commercial and financial information for all organizations conducting business with the Federal Government. The preferred method for completing a registration is through the World Wide Web at *http://www.ccr.gov* . This Web site provides a CCR handbook with detailed information on data you will need prior to beginning the online pre-registration, as well as steps to walk you through the registration process. You must have a DUNS number to begin your registration. For foreign entities the Web site is *http://www.grants.gov/RequestaDUNS.gov* .In order to access grants.gov an applicant will be required to register with the Credential Provider. Information about this is available at *https://apply.grants.gov/OrcRegister* . A copy of the complete RFA can also be viewed on FDA's Center for Food Safety and Applied Nutrition Web site at *http://www.cfsan.fda.gov/list.html* . (FDA has verified the Web site and its address but we are not responsible for changes subsequent to the Web site or its address after this document publishes in the **Federal Register** ). IV. Agency Contacts For issues regarding the programmatic aspects of this document, contact Christine L. Hileman, Center for Food Safety and Applied Nutrition (HFS-006), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1674, or e-mail: *christine.hileman@fda.hhs.gov* . For issues regarding the administrative and financial management aspects of this document contact, Gladys Melendez-Bohler at 301-827-7168 or by e-mail: *gladys.melendez-bohler@fda.hhs.gov* . Dated: June 26, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-13046 Filed 7-5-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007N-0238] Medical Devices: The Mammography Quality Standards Act of 1992 and Subsequent Mammography Quality Standards Reauthorization Act and Amendments; Inspection Fees AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)is announcing the increased fees the agency will assess for inspections of mammography facilities starting October 1, 2007. The Mammography Quality Standards Act of 1992 (the MQSA) requires FDA to assess and collect fees from mammography facilities to cover the costs of annual inspections required by the MQSA. Because these costs have increased, FDA is raising the fees to ensure the program is able to meet its objective of ensuring that high quality mammography remains available to women. This document explains which facilities are subject to payment of inspection fees, provides information on the costs included in developing inspection fees, and provides information on the inspection billing and collection processes. DATES: Effective October 1, 2007, for all inspections conducted under section 354(g) of the Public Health Service Act (PHS Act) (42 U.S.C. 263b(g)). Submit written or electronic comments by October 1, 2007. ADDRESSES: Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to *http://www.fda.gov/dockets/ecomments* . Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Helen J. Barr, Center for Devices and Radiological Health (HFZ-240), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, 240-276-3332, FAX: 240-276-3272. SUPPLEMENTARY INFORMATION: I. Background The MQSA requires all mammography facilities, other than facilities of the Department of Veterans Affairs, to be accredited by an approved accreditation body and certified by the Secretary of Health and Human Services, as meeting quality standards (section 354(b) and
(d)of the PHS Act). The MQSA requires FDA to establish and operate the following:
(1)A Federal certification and inspection program for mammography facilities,
(2)regulations and standards for accreditation bodies, and
(3)standards for equipment, personnel, quality assurance, and recordkeeping and reporting by mammography facilities (section 354(c), (e), (f), and
(g)of the PHS Act). The MQSA requires annual facility inspections to determine compliance with the quality standards (section 354(g) of the PHS Act). Section 354(r) of the PHS Act requires FDA to assess and collect fees for inspections of mammography facilities, other than governmental entities as determined by FDA, to cover the costs of inspections. An updated resource review has demonstrated that the recoverable costs of the MQSA inspection program have increased since the last notice on fees in 2003 (68 FR 5289, September 4, 2003). In addition, the annual amount of fees collected under the current fee schedule has been well below the level authorized by Congress. FDA needs to be able to collect the full cost of mammography inspections to ensure it has the resources to ensure high quality mammography remains available to women. Accordingly, the fees have been recalculated so that the aggregate amount of fees collected will equal the aggregate recoverable costs of the inspections conducted, as mandated by the MQSA. Therefore, FDA is providing notice of the increased fees to be assessed starting on October 1, 2007, and additional information relating to those fees. II. Inspections Under the Mammography Quality Standards Act of 1992 Section 354(g)(1) of the PHS Act requires FDA, States as Certifier
(SAC)States, or a State or local agency acting on behalf of the FDA, to conduct an annual inspection of each mammography facility. The purpose of the annual inspection is to determine facility compliance with quality standards established under the MQSA. Inspectors who have met Federal training requirements and who are qualified by FDA will conduct inspections. Under ordinary circumstances, inspections will be conducted during the regular business hours of the facility or at a mutually agreed time. FDA normally will provide 5 working days advance notice of each annual inspection. If a significant deficiency is identified during an inspection, FDA will provide information on necessary corrective action and, in appropriate cases, will schedule a followup inspection after the facility has had a reasonable time to correct the deficiency. FDA normally will provide 5 working days advance notice of each followup inspection. FDA may make unannounced inspections or may provide shorter notice if prompt action is necessary to protect the public health (see section 354(g)(4) of the PHS Act). III. Costs Included in the Fees to Be Assessed Beginning on October 1, 2007 Section 354(r) of the PHS Act requires FDA to assess and collect fees from persons who own or lease mammography facilities, or their agents, to cover the costs of inspections conducted by FDA, SAC States, or a State or local agency acting on behalf of FDA. Section 354(r) of the PHS Act limits FDA's discretion in setting inspection fees in three ways:
(1)Fees must be set so that, for a given fiscal year (FY), the aggregate amount of fees collected will equal the aggregate costs of inspections conducted;
(2)a facility's liability for fees must be reasonably based on the proportion of the inspection costs that relate to the facility; and
(3)governmental entities, as determined by FDA, are exempt from payment of fees. FDA has determined that the following categories of costs are recoverable under section 354(r) of the PHS Act and has included them in the fees to be assessed beginning on October 1, 2007. These categories represent the same costs that have been assessed in fees since the beginning of the inspection program. Facilities are not being assessed for any new costs associated with inspections. Cost categories are as follows:
(1)Personnel costs of annual and followup inspections of mammography facilities, including administration and support;
(2)purchase of equipment, calibration of instruments used in the inspections, and modification and maintenance of training facilities and laboratories to support the MQSA operations;
(3)design, programming, and maintenance of data systems necessary to schedule and track inspections and to collect data during inspections;
(4)training and qualification of inspectors (both FDA and State inspectors);
(5)costs of billing facilities for fees due for annual and followup inspections and collecting facility payments;
(6)tracking, coordination, and direction of inspections; and
(7)overhead and support attributable to facility inspections. Because most equipment used for inspections is durable and can be used for a period of years, it is not appropriate to recover the full costs of such expenditures in the year of purchase. To do so would result in the MQSA inspection fee varying widely from one year to the next. Instead, FDA recovers these costs over the useful life of the asset. The recoverable portions of all fixed costs of the inspection program and appropriate variable costs are recovered in the annual inspection fee. This fee will vary depending on how many mammography units are used by a facility. All mammography facilities, except governmental entities, are subject to an inspection fee. If the annual inspection of a facility identifies a deficiency that necessitates a followup inspection, the facility will be assessed an additional fee to recover the costs of that additional inspection (unless it is a governmental entity). Facilities that do not require a followup inspection are not subject to this fee. IV. Inspection Fees to be Assessed Beginning on October 1, 2007 FDA reviewed the past methodologies for calculating the inspection fee, which accounted for differences in facility size. The same method was adopted for calculating the fees FDA will assess beginning on October 1, 2007 (Ref. 1). A facility's inspection fee will be based on the number of mammography units used by the facility. The total recoverable aggregate cost of the MQSA inspection program is estimated to be $15.77 million in FY 2008. This is below the $16.4 million authorized by Congress for collections in FY 2004, the last time fees were increased, and well below the $18.4 million authority requested from Congress for MQSA user fee collections in FY 2008. To recover the costs of the inspection program, the facility portion of the fee is $1,900 and each unit portion is $250. The cost of each additional unit must be added to the facility portion of the fee to determine the total inspection fee. This new fee of $2,150 for a facility with one unit replaces the current fee of $1,749 for a facility with one unit. FDA will assess the following fees, beginning on October 1, 2007, for facility inspections, as shown in table 1 of this document: **Table 1.—Annual Inspection Fee by Number of Units** Number of Units Fee 1 $2,150 2 $2,400 3 $2,650 4 $2,900 5 $3,150 6 $3,400 7 $3,650 8 $3,900 9 $4,150 10 $4,400 Followup Inspection Fee $1,144 FDA will continue to charge separately for annual and followup inspections. FDA believes it is more appropriate and equitable for the costs of followup inspections to be borne entirely by the facilities that require such inspections. FDA has again chosen to adopt a flat fee for followup inspections over an hourly rate that would vary the fee by the length of the inspection. This approach eliminates concerns about variations among inspectors and differential treatment of facilities. The fee schedule is subject to change each year to ensure that the aggregate amount of fees collected during any year equals the aggregate amount of costs for that year's facility inspections. FDA will monitor the adequacy of the fee on an annual basis to account for any major programmatic and budget changes. FDA continues to use a uniform national fee structure. The methodology adopted by FDA to determine inspection fees does not pass on the costs of inspecting governmental entities to other facilities. The entire cost of inspecting governmental entities has been and will continue to be borne by appropriated funds. V. Facilities Subject to Payment of Inspection Fees Under the MQSA, all mammography facilities, except governmental entities as determined by FDA, are subject to payment of inspection fees (see section 354(r) of the PHS Act). FDA will continue to use the definition that was previously developed and applied to determine whether a facility qualifies as a governmental entity for the purpose of determining whether a facility is exempt from payment of inspection fees under section 354(r) of the PHS Act. A facility may qualify as a governmental entity in two ways. First, a facility may qualify if any Federal department, State, district, territory, possession, Federally-recognized Indian tribe, city, county, town, village, municipal corporation, or similar political organization does the following:
(1)Operates the facility;
(2)pays the entire salary of all onsite personnel for the facility;
(3)owns, rents, or leases all of the facility's mammography equipment; and
(4)has the ultimate authority to make day-to-day decisions concerning the management and operation of the facility. Second, a facility may qualify as a governmental entity if the facility provides services under the Breast and Cervical Cancer Mortality Prevention Act of 1990, ( *http://apps.nccd.cdc.gov/cancercontacts/nbccedp/contacts.asp* ) and at least 50 percent of the mammography screening examinations provided during the preceding 12 months were funded under that statute. (FDA has verified the Web site address, but FDA is not responsible for any subsequent changes to the Web site after this document publishes in the ** Federal Register. ** ) Facilities providing mammography services using grants under other statutes will not qualify as government entities. FDA does not recognize, as a governmental entity, a facility providing Medicare/Medicaid services unless that facility qualifies as a governmental entity as described in the previous paragraph. VI. Billing and Collection Procedures Within 30 days following inspection, FDA mails a bill and a “Governmental Entity Declaration” form (Form 3422) to the inspected facility. Facilities who believe they meet the governmental entity criteria complete the form and return it in lieu of the inspection fee payment. The bill sets forth the type of inspection conducted (annual or followup), the fee to be paid, and the date payment is due (30 days after billing date). Inspection fees are billed to and collected from the party that operates the facility. If the facility is owned or controlled by an entity other than the operator, it is up to the parties to establish, through contract or otherwise, how the costs of facility inspections will be allocated. If full payment is not received by the due date, a second bill is sent. At that time, interest begins to accrue at the prevailing rate set by the Department of the Treasury, a 6 percent late payment penalty is assessed in accordance with 45 CFR 30.13, and a $20 administrative fee is assessed for each 30-day period that a balance remains due. If payment is not received within 30 days of a third and final bill, FDA may initiate action to collect unpaid balances (with interest and penalties), including the use of collection agencies, the reporting of delinquencies to commercial credit reporting agencies, and forwarding delinquent accounts to the Department of the Treasury. Any questions or concerns about the billing and collection procedures may be addressed to Billing Inquiries c/o Mammography Quality Assurance Program, P.O. Box 6057, Columbia, MD 21045, 1-800-838-7715. VII. Request for Comments Although the MQSA does not require FDA to solicit comments on fee exemption, assessment, and collection, FDA is inviting comments from interested persons in order to have the benefit of additional views and information, as the agency continues to evaluate its fee assessment procedures. Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. VIII. References The following reference is on display in the Division of Dockets Management (see ADDRESSES ) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday. 1. U.S. Food and Drug Administration, MQSA Inspection Fees: Methodology and Fees for Fiscal Year 2008. Dated: June 27, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-13044 Filed 7-5-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing AGENCY: National Institutes of Health, Public Health Service, HHS. ACTION: Notice. SUMMARY: The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing. ADDRESSES: Licensing information and copies of the U.S. patent applications listed below may be obtained by writing to the indicated licensing contact at the Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-3804; telephone: 301/496-7057; fax: 301/402-0220. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications. Potential Serum Bio-Markers for Alpha-Fetoprotein
(AFP)Negative Hepatocellular Carcinoma Description of Technology: This technology relates to improved methods of detecting hepatocellular carcinoma
(HCC)by using new biomarkers. The overexpression of Gpc3, Mdk, SerpinI1, PEG-10 and QP-C correlates with the presence of HCC, even in small tumors. By comparing the expression levels of at least three of these markers in subject samples with their expression levels in control samples, the presence of HCC can be diagnosed. The method can also be used to monitor the progression, and regression of HCC. HCC is a common and aggressive cancer with a high mortality rate. The high mortality rate stems from an inability to diagnose the cancer at an early stage in patients, due to the lack of available biomarkers for HCC. Currently, HCC is diagnosed by measuring the levels of serum alpha-fetoprotein (AFP); however, AFP is not always present in HCC tumors, especially small tumors. Applications: Protein markers useful for screening HCC more accurately and with increased sensitivity; The proteins can also serve as prognostic and therapeutic response biomarkers. Advantages: Highly sensitive, secretory markers that can be easily identified in patient serum; Markers can identify HCC in patients with small tumors that would previously go undetected. Benefits: HCC affects 20,000 people in U.S. or over half a million worldwide every year and 90% of them die of the disease. Improving the quality of life and duration of life for people suffering from this disease will depend a lot on early detection of the disease and this technology can contribute significantly to that social cause. Furthermore, the cancer diagnostic market is estimated to grow to almost $10 billion dollars in the next 5 years. Inventors: *Xin Wei Wang*
(NCI)et al. U.S. Patent Status: Pending PCT Application PCT/US2006/042591, published as WO 2007/053659 (HHS Reference No. E-333-2005/0-PCT-02). Licensing Contact: David A. Lambertson, PhD; Phone:
(301)435-4632; Fax:
(301)402-0220; E-mail: *lambertsond@mail.nih.gov.* Collaborative Research Opportunity: The National Cancer Institute, Laboratory of Human Carcinogenesis, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize new biomarkers for hepatocellular carcinoma (HCC). Please contact John D. Hewes, PhD at 301-435-3121 or *hewesj@mail.nih.gov* for more information. Modification of Recombinant Anti-Tumor RNase (rapLR1) for Optimal Use in the Large Scale Manufacture of Stable and Potent RapLR1-Antibody Conjugates Description of Technology: This technology involves modified rapLR1 molecules having an improved capacity for conjugation to targeting moieties. Previously, techniques for attaching wild-type rapLR1 to a targeting moiety required an excess of RNase, leading to high production costs. The inventors have now mutated specific amino acids in rapLR1 to allow a more efficient (and therefore less costly) conjugation reaction. Members of the ribonuclease A (RNase A) superfamily, such as rapLR1, have the ability to efficiently kill a wide range of cancer cells. Ligand binding moieties such as antibodies or peptides can be used to target RNases to a particular cell or cell type that expresses a marker, e.g., a marker that is associated with cancer. The current invention provides rapLR1 molecules that have been genetically modified to contain a cysteine at a specific location that does not interfere with the enzymatic activity of the molecule. The inserted cysteine provides the advantage of a site-directed and specific attachment of rapLR1 to targeting moieties, which results in more efficient production of the therapeutic. This significantly reduces the cost of bringing rapLR1-related cancer therapeutics to market. Applications: Targeted anti-cancer therapy molecules; Targeting moiety can be interchanged based on target cancer cells; Targeting any disease in which the cell is transformed and presents unique levels of cell surface markers. Advantages: RapLR1 delivery, specificity and toxicity to cancer cells is increased by conjugation to a targeting moiety; Modified rapLR1 increases conjugation efficiency, making the preparation of the anti-cancer agents more cost effective without sacrificing specificity. Benefits: Cancer is the second leading cause of death in the United States, with approximately 600,000 cancer-related deaths occurring in 2006 alone. Because rapLR1 can be used to treat a number of different cancers (depending on the targeting moiety), there is a powerful social benefit from this technology: Improving the duration and quality of life of a wide range of cancer patients. Furthermore, the cancer therapeutic market is expected to reach $27 billion by 2009. Because rapLR1 can now be efficiently conjugated to targeting moieties, there is an opportunity to occupy a significant niche in that predicted market, with lower cost to the licensee. Inventors: Dianne L. Newton et al. (NCI). U.S. Patent Status: Pending PCT Application PCT/US2006/038180, published as WO 2007/041361 (HHS Reference No. E-265-2005/0-PCT-02). Licensing Contact: David A. Lambertson, PhD; Phone:
(301)435-4632; Fax:
(301)402-0220; E-mail: *lambertsond@mail.nih.gov.* Methods for Expression and Purification of Immunotoxins Description of Technology: The invention concerns immunotoxins and methods of making the immunotoxins. Targeting of the immunotoxins occurs via an antibody that is specific to T cells. This allows the specific ablation of malignant T cells and resting T cells. The transient ablation of resting T cells can “reset” the immune system by accentuating tolerizing responses. As a result, the immunotoxin can be used to treat autoimmune disease, malignant T cell-related cancers, and graft-versus-host disease. The toxin portion of the immunotoxin is engineered to maintain bioactivity when produced in yeast, specifically *Pichia pastoris* . This system allows the production of dimeric antibody fragments with increased binding affinity and potency. Applications: Immunotoxins produced by this method can be used for the treatment of autoimmune diseases such as multiple sclerosis, lupus, type I diabetes, aplastic anemia; Immunotoxins produced by this method can be used for treatment of T-cell leukemias and lymphomas such as cutaneous T cell leukemia/lymphoma (CTCL); Immunotoxins produced by this method can be used for increasing immune tolerance in patients requiring transplants/grafts. Advantages: Method produces GMP quality immunotoxin and can be scaled up to industry scales; Modified toxin moiety has reduced glycosylation in this system, resulting in a more effective and efficient immunotoxin; Immunotoxin doesn't produce the deleterious side-effects seen with other methods of treating autoimmune disease, malignant T cell leukemia/lymphoma and graft-versus-host disease. Benefits: New methods and compositions with limited side-effects have the potential to revolutionize treatment of autoimmune disease; provides an opportunity to capture a significant market share for the millions of people who suffer from an autoimmune disease. Inventors: *David Neville* et al.
(NIMH)Patent Status: U.S. Patent Application No. 10/566,886 filed 01 Feb 2006, which published as U.S. 2006/0216782 on 28 Sep 2006 (HHS Reference No. E-043-1997/2-US-03); U.S. Patent No. 6,632,928 issued 14 Oct 2003 (HHS Reference No. E-044-1997/0-US-07); U.S. Patent Application No. 10/435,567 filed 09 May 2003, which published as 2003/0185825 on 02 Oct 2003 (HHS Reference No. E-044-1997/0-US-08); U.S. Patent Application No. 10/296,085 filed 18 Nov 2002, which published as 2004/0127682 on 01 Jul 2004 (HHS Reference No. E-044-1997/1-US-06); Foreign rights are also available. Licensing Status: Available for exclusive or non-exclusive licensing. Licensing Contact: David A. Lambertson, PhD; 301/435-4632; *lambertsond@mail.nih.gov. * Collaborative Research Opportunity: The National Institute of Mental Health, Laboratory of Molecular Biology, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize methods of expression and purification of immunotoxins. Please contact David Neville at *davidn@mail.nih.gov* for more information. Dated: June 28, 2007. Steven M. Ferguson, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E7-13128 Filed 7-5-07; 8:45 am] BILLING CODE 4140-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institutes of Neurological Disorders and Stroke; Notice of Closed Meetings 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 meetings. The meetings will be closed to the public in accordance with the provisions set forth in section 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 Institutes of Neurological Disorders and Stroke Special Emphasis Panel, Texas-SNRP. *Date:* July 16-17, 2007. *Time:* 8 a.m. to 1 p.m. *Agenda:* To review and evaluate grant applications. *Place:* Marriott San Antonio Riverwalk, 711 East River Walk, San Antonio, TX 78205. *Contact Person:* Philip F. Wiethorn, Scientific Review Administrator, DHHS/NIH/NINDS/DER/SRB, 6001 Executive Boulevard; MSC 9529, Neuroscience Center; Room 3203, Bethesda, MD 20892-9529,
(301)496-5388, *wiethorp@ninds.nih.gov.* This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. *Name of Committee:* National Institutes of Neurological Disorders and Stroke Special Emphasis Panel, Neurofibromatosis/Tuberous Sclerosis. *Date:* July 24, 2007. *Time:* 11 a.m. to 5 p.m. *Agenda:* To review and evaluate grant applications. *Place:* National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852 (Telephone Conference Call). *Contact Person:* Shantadurga Rajaram, PHD, Scientific Review Administrator, Scientific Review Branch, NIH/NINDS/Neuroscience Center, 6001 Executive Blvd., Suite 3208, Msc 9529, Bethesda, MD 20852,
(301)435-6033, *rajarams@mail.nih.gov.* The notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. (Catalogue of Federal Domestic Assistance Program Nos. 93.853, Clinical Research Related to Neurological Disorders; 93.854, Biological Basis Research in the Neurocsciences, National Institutes of Health, HHS) Dated: June 29, 2007. Anna Snouffer, Acting Director, Office of Federal Advisory Committee Policy. [FR Doc. 07-3292 Filed 7-5-07; 8:45 am]
Connectionstraces to 5
3 references not yet in our index
- 45 CFR 74.51-74
- 45 CFR 92
- 45 CFR 30.13
Citation graph
cites case law
Notices
Notice
Cite45 CFR 74.51-74
Cite45 CFR 92
Cite45 CFR 30.13
Cites 8Cited by 0 across 0 sources