Department of Health and Human Services August 28, 2007 – Federal Register Recent Federal Regulation Documents

The Department of Health and Human Services (HHS) gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees at the Mound Plant, Dayton, Ohio, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: Mound Plant. Location: Dayton, Ohio. Job Titles and/or Job Duties: All workers. Period of Employment: February 1, 1949 through the present.

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 National Institute of Allergy and Infectious Diseases (NIAID), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: Pretesting of NIAID's HIV Vaccine Research Communications Messages. Type of Information Collection Request: NEW. Need and Use of Information Collection: This is a request for clearance to pretest messages, materials and program activities produced for the NIAID HIV Vaccine Research Education Initiative (NHVREI). The primary objectives of the pretests are to (1) Assess audience knowledge, attitudes, behaviors and other characteristics for the planning/development of health messages, education products, communication strategies, and public information programs; and (2) pretest these health messages, products, strategies, and program components while they are in developmental form to assess audience comprehension, reactions, and perceptions. The information obtained from audience research and pretesting results in more effective messages, materials, and programmatic strategies. By maximizing the effectiveness of these messages and strategies for reaching targeted audiences, the frequency with which publications, products, and programs need to be modified is reduced. Frequency of Response: On occasion. Affected Public: Individuals. Type of Respondents: Adults at risk for HIV/AIDS, particularly those who are Black/African-American, Hispanic/Latino, or men who have sex with men; healthcare providers; representatives of organizations disseminating HIV-related messages or materials. The annual reporting burden is shown in the table below. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.

The Food and Drug Administration (FDA) is amending the animal drug regulations by removing those portions that reflect approval of a new animal drug application (NADA) for a bacitracin zinc Type A medicated article. In a notice published elsewhere in this issue of the Federal Register, FDA is withdrawing approval of this NADA.

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(I), that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of an exclusive license to practice the inventions embodied in: PCT Application No. PCT/US2006/031208 (E-258-2005/0-PCT-02) filed August 10, 2006 claiming priority to U.S. Provisional Application No. 60/ 707,518 (E-258-2005/0-US-01), titled ``Method for Determining the Redox Status of a Tissue'' (Inventors: Dr James Mitchell et al.) to Mitos Pharmaceutical, Inc. (hereafter Mitos), having a place of business in Newport Beach, California. The patent rights in these inventions have been assigned to the United States of America.

The select agents and toxins listed in 42 CFR part 73 include those regulated only by the U.S. Department of Health and Human Services (HHS) (42 CFR 73.3), as well as those overlap select agents and toxins regulated by both HHS and the U.S. Department of Agriculture (USDA) (42 CFR 73.4). In response to USDA's proposal to no longer regulate ten select agents and toxins currently listed as ``overlap'' agents and toxins, we are proposing to move those ten select agents and toxins from the overlap select agents and toxins section to the HHS select agents and toxins section.