Department of Health and Human Services June 7, 2005 – Federal Register Recent Federal Regulation Documents

Using the ANA Project Abstract form (OMB Control Number 0980-0204, exp. 10/31/06), the applicant must include: The name of the applicant, the project title, the Federal amount requested, the amount of matching funds to be provided, length of time required to accomplish the project, the goal of the project, a list of the project objectives (not activities), the estimated number of people to be served and the expected outcomes of the project. In addition to the Project Abstract form, the applicant will provide an introductory summary narrative that includes: An overview of the project, a description of the community to be served, the location of the identified community, a declarative statement identifying the need for the project, and a brief overview of the project's objectives, strategy and community or organizational impact. Application Format: Applicants are required to submit applications in a standard format, following the ANA requirements on application length, font, numbering, line spacing, etc. Please refer to Section IV Part 2, ``Content and Form of Application Submission'' for detailed formatting instructions. 2. Review and Selection Process No grant award will be made under this announcement on the basis of an incomplete application. Initial Screening: Each application submitted under an ANA program announcement will undergo a pre-review screening to determine: (a) Timelinessthe application was received by 4:30 p.m. eastern time on the closing date; (b) the funding request does not exceed the upper value of the dollar range specified; (c) the applicant has submitted a current signed and dated resolution from the governing body; and, (d) if the applicant is not a Tribe or Alaska Native Village government, the applicant has submitted proof of a majority of the board of directors is representative of the community to be served. An application that does not meet one of the above elements will be determined to be incomplete and excluded from the competitive review process. Applicants with incomplete applications will be notified by mail within 30 business days from the closing date of this program announcement. ANA staff cannot respond to requests for information regarding funding decisions prior to the official applicant notification. After the Commissioner has made decisions on all applications, unsuccessful applicants will be notified in writing within 90 days. The notification will include the reviewer comments. Applicants are not ranked based on general financial need. Applicants who are initially excluded from competition because of ineligibility may appeal the agency's decision. Applicants may also appeal an ANA decision that an applicant's proposed activities are ineligible for funding consideration. The appeals process is stated in the final rule published in the Federal Register on August 19, 1996 (61 FR 42817 and 45 CFR part 1336, subpart C). Competitive Review Process: Applications that pass the initial ANA screening process will be analyzed, evaluated and rated by an independent review panel on the basis of the Evaluation Criteria. The evaluation criteria were designed to analyze and assess the quality of a proposed community-based project, the likelihood of its success, and the ability of ANA to monitor and evaluate community impact and long- term results. The evaluation criteria and analysis are closely related and are wholly considered in judging the overall quality of an application. In addition, the evaluation criteria standardizes the review of each application and distributes the number of points more equitably. Applications will be evaluated in accordance with the program announcement criteria and ANA's program areas of interest. A determination will be made as to whether the project is an effective use of Federal funds. Application Review Criteria: Applicants will be reviewed based on the following criteria and points: ANA's criteria categories are Introduction and Project Summary/Application Format; Need for Assistance; Project Approach; Organizational Capacity; Project Impact/ Evaluation; and Budget and Budget Narrative/Cost Effectiveness. Application Consideration: The Commissioner's funding decision is based on an analysis of the application by the review panel, panel review scores and recommendations; an analysis by ANA staff; review of previous ANA grantee's past performance; comments from State and Federal agencies having contract and grant performance related information; and other interested parties. The Commissioner makes grant awards consistent with the purpose of the Native American Programs Act (NAPA), all relevant statutory and regulatory requirements, this program announcement, and the availability of appropriated funds. The Commissioner reserves the right to award more, or less, than the funds described or under such circumstances as may be deemed to be in the best interest of the Federal government. Applicants may be required to reduce the scope of projects based on the amount of approved award. Federal. Since ACF will be using non-Federal reviewers in the process, applicants have the option of omitting from the application copies (not the original) of specific salary rates or amounts for individuals specified in the application budget and Social Security numbers, if otherwise required for individuals. The copies may include summary salary information. Approved but Unfunded Applications. Applications that are approved but unfunded may be held over for funding in the next funding cycle, pending the availability of funds, for a period not to exceed one year. 3. Anticipated Announcement and Award Dates Approximately 120 days after the application due date, the successful applicants will be notified by mail through the issuance of a Financial Assistance Award document which will set forth the amount of funds granted, the terms and conditions of the grant, the effective date of the grant, the budget period for which initial support will be given, the non-Federal share to be provided and the total project period for which support is contemplated. The Financial Assistance Award will be signed by the Grants Officer and sent to the applicant's Authorizing Official. Applications not funded in this competition will be notified in writing.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Bar Code Label RequirementsQuestions and Answers.'' FDA regulations require certain human drug and biological products to have on their labels a linear bar code that identifies the drug's National Drug Code (NDC) number. We have received several inquiries about how the requirements apply to specific products or circumstances. The purpose of the draft guidance is to respond to the questions.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Department of Health and Human Services (``HHS'') gives notice of a decision to designate a class of employees at the Iowa Army Ammunition Plant (IAAP), in Burlington, Iowa as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On May 20, 2005, the Secretary of HHS designated the following class of employees as an addition to the SEC:

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.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.