Department of Health and Human Services August 2005 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing that CIBA Vision Corp. has filed three petitions proposing that the color additive regulations be amended to provide for the safe use of Color Index (C.I.) Pigment Violet 19, C.I. Pigment Yellow 154, and C.I. Pigment Red 122 as color additives in contact lenses.

The Food and Drug Administration (FDA) is requesting nominations for voting consumer representatives to serve on the National Mammography Quality Assurance Advisory Committee (NMQAAC) in the Center for Devices and Radiological Health (CDRH). FDA has a special interest in ensuring that women, minority groups, and individuals with disabilities are adequately represented on advisory committees and, therefore, encourages nominations of qualified candidates from these groups.

The Food and Drug Administration (FDA) is reopening until September 23, 2005, the comment period for the May 23, 2005, public meeting on the therapeutic equivalence of levothyroxine sodium drug products that was announced in the Federal Register of April 20, 2005 (70 FR 20574). The public meeting included FDA staff and representatives of three medical societies: The American Thyroid Association (ATA), the Endocrine Society, and the American Association of Clinical Endocrinologists (AACE). FDA is taking this action in response to a request for an extension.

The Health Resources and Services Administration (HRSA) is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (``the Program''), as required by Section 2112(b)(2) of the Public Health Service (PHS) Act, as amended. While the Secretary of Health and Human Services is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.

The Food and Drug Administration (FDA) is announcing a series of public meetings entitled ``Vision 2006A Conversation With the American Public,'' in three cities. This forum will be an open format in which consumers can interact directly with the agency's leadership to discuss what is on the public's mind. It will also be an opportunity for the agency to update the public on current agency programs, engage the public in discussion, and obtain consumer input on specific issues. We may use the public input we receive to evaluate and to propose modifications, if necessary, to our programs and activities.

The Food and Drug Administration (FDA) is amending its regulation regarding the intrastate and interstate distribution of turtles to reflect a change in responsibility for administering the provisions of the regulations from FDA's Center for Food Safety and Applied Nutrition (CFSAN) to FDA's Center for Veterinary Medicine (CVM). FDA is taking this action to enable the agency to more effectively administer the provisions of this regulation.

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, regarding the opportunity for public comment on proposed data collection projects, the National institute on Alcohol Abuse and Alcoholism (NIAAA), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: Field Test of the Discovering the Science of Alcohol Curriculum. Type of Information Collection Request: New. Need and Use of Information Collection: The Discovering the Science of Alcohol curriculum (DSA) was developed with a Phase II SBIR grant to bring accurate, research-based information to high school students in biology and science classrooms. The curriculum includes standards-based content objectives and assessment activities. Curriculum materials include a teacher's guide and website. The field test is necessary to estimate the DSA curriculum's effectiveness in conveying information to students and teachers. Specifically, the field study is designed to enable NIAAA to determine whether teachers and students who complete the DSA curriculum demonstrate significantly greater knowledge of the topics covered in the curriculum than teachers and students who do not use the DSA curriculum. In addition, the study is designed to enable NIAAA to determine whether the students who are exposed to the curriculum components self-report different beliefs, attitudes, and intentions regarding alcohol use than their counterparts who are not exposed to the curriculum at their schools. Participating in this field test will be an experimental group of 30 high school biology classrooms with a total of approximately 400 to 500 students and a control group of 30 high school biology classrooms with approximately 400 to 500 students. Teachers and students from grades 9, 10, 11, and 12 will comprise both groups. The field test will include two surveys: (1) An online, computerized survey that measures teachers' knowledge of the DSA curriculum components and teacher satisfaction with the DSA curriculum components. (2) For students, an anonymous, online, computerized survey that measures three factors: (a) student knowledge of the DSA components, (b) student attitudes, beliefs, and intentions, and (c) student satisfaction with the DSA curriculum components. Frequency of response: Once per respondent. Affected Public: Individuals. Type of Respondents: Biology/Science teachers and high school students. The reporting burden is as follows: Estimated Number of Respondents: It is estimated that we will be able to recruit approximately 60 teachers and approximately 1000 students. Estimated Number of Responses per Respondent: One response per respondent. Average Burden Hours per Response: 15 minutes per individual in the control group and 30 minutes per individual in the experimental group, for a total respondent burden of 662.5 hours. Estimated Total Annual Burden Hours Requested: 662.5 hours. Estimated Costs to Respondents: Assuming an hourly rate of $22 for teachers, we estimate the total costs to be $825. There are no Capital Costs to report. There are no Operating or Maintenance costs to report. Request for Comments: Written comments and suggestions from the public and affected agencies are invited on the following points: (1) Whether the data collection is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. For further information contact: To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact Jason Lazarow, M.Ed., NIH/NIAAA/ORTC/HSEB, 5635 Fishers Lane, Room 3101, MSC 9304, Bethesda, MD 20892-9304, or e-mail your request to: jlazarow@mail.nih.gov. Mr. Lazarow can be contacted by telephone at 301-435-8043. Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication.

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.

This final rule will update the prospective payment rates for inpatient rehabilitation facilities for Federal fiscal year 2006 as required under section 1886(j)(3)(C) of the Social Security Act (the Act). Section 1886(j)(5) of the Act requires the Secretary to publish the classification and weighting factors for the inpatient rehabilitation facilities case-mix groups and a description of the methodology and data used in computing the prospective payment rates for that fiscal year. In addition, we are implementing new policies and are changing existing policies regarding the prospective payment system within the authority granted under section 1886(j) of the Act.

The Advisory Committee on Blood Safety and Availability will meet to review progress and solicit additional comments from the Committee regarding numerous recommendations made over the past year. Specifically, the Committee will hear updates of previous recommendations. In addition, the Committee will be asked to continue its deliberation on strategies for vigilant detection and management of emerging or re-emerging infectious diseases, since it is a necessary first step toward the goal of reducing the risk of transfusion- transmitted diseases as well as disease transmission through other vital products such as bone marrow, progenitor cells, tissues, and organs.

The Food and Drug Administration (FDA) is announcing the withdrawal of a draft guidance for industry entitled ``Conjugated Estrogens, USP-LC-MS Method for Both Qualitative Chemical Characterization and Documentation of Qualitative Pharmaceutical Equivalence.'' FDA is withdrawing the draft guidance because the published methodology limits the submission of scientifically valid information to the agency that may be based on different methodologies. FDA does not want to dictate the scientific approach for developing adequate methods.