Department of Health and Human Services April 2, 2007 – Federal Register Recent Federal Regulation Documents

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.

In compliance with the requirement of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI), the National Institutes of Health (NIH) request a review and approval of the information listed below. The proposed information collection was previously published in the Federal Register on October 26, 2006 on page 62597 and allowed 60 days for public comment. One public comment was received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised or implemented on or after October 1, 1995 unless it displays a currently valid OMB control number. Proposed Collection: Title: Health Information National Trends Survey 2007 (HINTS 2007). Type of Information Collection Request: NEW. Need and Use of Information Collection: Building on the first two rounds of HINTS data collection (HINTS 2003: OMB 0925-0507, Exp. Date: 8/31/03; and HINTS 2005: OMB 0925-0538, Exp. Date 11/30/2007), HINTS 2007 will continue to provide NCI with a comprehensive assessment of the American public's current access to, and use of, information about cancer, including cancer prevention, early detection, diagnosis, treatment, and prognosis. The content of the survey will focus on understanding the degree to which members of the general population understand vital cancer prevention messages. More importantly, this NCI survey will couple knowledge-related questions with inquiries into the communication channels through which understanding is being obtained. HINTS is intended to be the foundation of NCI's effort to build on the opportunities presented by a national shift in communication context (for example, the increase in information available on the Internet and the use of email as a method of communication), and by so doing, improve the nation's ability to reduce the national cancer burden. Data will be used (1) to understand individuals sources of and access to cancer-related information; (2) to measure progress in improving cancer knowledge and communication to the general public; (3) to develop appropriate messages for the public about cancer prevention, detection, diagnosis, treatment, and survivorship; and (4) to identify research gaps and guide decisions about NCI's research efforts in health promotion and health communication. Frequency of Response: One time. Affected Public: Individuals. Type of Respondents: U.S. Adults. The annual reporting burden is as follows: Estimated Number of Respondents: 11,670; Estimated Number of Responses per Respondent: 1.36; Average Burden Hours per Response: .24; and Estimated Total Annual Burden Hours Requested: 3,739. The annualized cost to respondents is estimated at: $59,824. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.

The Food and Drug Administration (FDA) has determined the regulatory review period for KEPIVANCE and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human biological product.

Briefly provide a statement of the proposed demonstration project indicating that it is a prevention demonstration project and whether it is for a local or statewide project; type of organization applying (school, state agency, voluntary agency, etc.); geographic area to be served (urban, rural, suburban); description of target population to be served; brief description of the proposed prevention demonstration project; and brief description of the evaluation-intensive design. Description of Applicant Organization (1-2 pages): Describe the decision-making authority and structure (e.g. relationship to the Board of Directors and organizational chart), its resources, experience, existing program units and/or those to be established if funding is obtained. This description should cover personnel, time and facilities and contain evidence of the organization's capacity to provide the rapid and effective use of resources needed to conduct the project, collect necessary data and evaluate it. It is recommended that applicants place an organizational chart in the Appendices. Need Statement (3 pages): Describe the need for prevention services in the proposed target area by describing the geographic area to be served. Document the incidence of adolescent pregnancy, sexually transmitted infections, a description of socio-economic conditions including income levels, existing services and unmet needs in the proposed service area. If the proposed population has unique challenges and barriers, these should be addressed as well. Rationale (2-4 pages): Describe the rationale for use of the proposed approach based upon previous practice and review of the literature and/or evaluation findings. This section should include discussion of previous youth service experience and how lessons learned from this experience helped develop the rationale for the proposed demonstration model. All previous AFL grantees should clearly describe their program and evaluation experience as it relates to past AFL funding. Program Outcome Objectives (4 pages): Provide a goal and 4-6 outcome objectives that clearly state expected results or benefits of the demonstration project. Two of the outcome objectives must address the required OAPP cross-site performance measures. Objectives should be specific, measurable, achievable, realistic, and time-framed. Please see ``Evaluation'' section for more information. Prevention Services Demonstration Model (8-10 pages): Thoroughly describe proposed program intervention activities and services as they relate to the outcome objectives by describing the project logic model. This section should include a description of all proposed curricula, types of supportive asset building and youth development activities and services proposed as part of the model, and a description of the parental involvement component. It should also include a clear plan for recruitment and retention of program participants, including parents. This description should clearly relate to program objectives and should address intensity of services (dosage). All components of the intervention must be consistent with the A-H definition of abstinence education. How the project will address the issue of sexual exploitation and coercion should also be included. Workplan and Timetable (1 page): Provide a year long detailed work plan and timetable for the first year. Within this plan include each program activity associated with the project and the proposed time frame for the start and completion of each activity. A separate and more generalized work plan should be included in the appendices for the 2nd and 3rd year of program implementation. Numbers and Types of Participants (2 pages): Provide estimates of who the project will serve and how many will be participating in the proposed demonstration project. Please describe how many participants are expected to participate during the first year and break out the types of participants into categories (e.g. pre-adolescents, adolescents and parents), including the race and ethnicity of participants to be served. Documentation of Community Support and Commitment (1-2 pages): Provide documentation of the support from other community agencies. If a community agency is partnering with the applicant to implement the proposed prevention demonstration project, a letter of commitment detailing the level of effort and commitment to this effort must be included. Continuation Funding (1 page): Describe the plan regarding continuation of services at the termination of this Federal funding opportunity. The OAPP cannot guarantee that funding will be available annually or at the end of the five-year grant cycle. Evaluation Plan (15-20 pages): Provide a clear and fully developed evaluation plan in accordance with the criteria laid out under the ``Evaluation'' section of this announcement. Include a letter of commitment and curriculum vitae from the independent evaluator in the appendices, how the AFL prevention core instruments will be included in the evaluation plan, and the understanding of the proposed project, if funded by OAPP, will participate in a formal cross site evaluation of the AFL program. Applicants are encouraged to identify anticipated problems with the evaluation and recommended solutions. Inclusion of a proposed 2-year follow-up based on randomized assignment will greatly strengthen an applicant's evaluation plan. Appendices: Include: (1) Articles of incorporation and mission statement for private nonprofit organizations; (2) Resumes of key staff and detailed position descriptions; (3) A program logic model that ties project objectives and intervention activities and services to expected results; (4) A description of how the A-H criteria are addressed in the project curricula and supportive activities and services in chart format (see ``A-H Compliance Strategies'' chart in the application kit for a suggested format); (5) A description of how the project will obtain parental consent including a copy of the proposed parental consent form, if developed; (6) Letters of commitment from partnering agencies; (7) Letters of support from other community agencies; (8) A letter of commitment and/or a memorandum of understanding with the independent evaluator affiliated with a college or university located in the applicant's State that includes willingness to participate and their role(s) described; (9) A copy of the curriculum vitae of the independent evaluator; (10) Copies of the table of contents of the proposed curricula, plus a list of any other instructional materials that will be an integral part of the proposed project; and (11) the workplan and timetable for years 2 and 3 of the proposed project. Please note, applicants must be familiar with Title XX in its entirety to ensure that they have complied with all applicable requirements. In addition, applicants must incorporate the definition of ``abstinence education,'' as set out in section 510(b)(2) of Title V of the Social Security Act, as amended, and ensure program activities and services are consistent and supportive of this language. A copy of both sets of legislation is included in the application kit. A Dun and Bradstreet Universal Numbering System (DUNS) number is required for all applications for Federal assistance. Organizations should verify that they have a DUNS number or take the steps necessary to obtain one. Instructions for obtaining a DUNS number are included in the application package, and may be downloaded from the OPA Web site (opa.osophs.dhhs.gov/duns.html).