Department of Health and Human Services September 2008 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is removing its regulation that established restrictions on the capture, transport, sale, barter, exchange, distribution, and release of African rodents, prairie dogs, and certain other animals. We are removing the restrictions because we believe they are no longer needed to prevent the further introduction, transmission, or spread of monkeypox, a communicable and potentially fatal disease, in the United States.

The RoC Office invites public comment on the recommendation from an expert panel on the listing status for styrene in the 12th RoC and the scientific justification for the recommendation. The recommendation and scientific justification for styrene is available electronically in Part B of the Expert Panel Report (https:// ntp.niehs.nih.gov/go/29682, see Expert Panel Report Part B) or in printed text from the RoC Office (see FOR FURTHER INFORMATION CONTACT below). The RoC Office convened an eleven-member expert panel of scientists from the public and private sectors on July 21-22, 2008. The panel was asked (1) to apply the RoC listing criteria to the relevant scientific evidence and make a recommendation regarding listing status (i.e., known to be a human carcinogen, reasonably anticipated to be a human carcinogen, or not to list) for styrene in the 12th RoC and (2) to provide the scientific justification for the recommendation.

The Food and Drug Administration (FDA) is amending certain of its regulations on current good manufacturing practice (CGMP) requirements for finished pharmaceuticals as the culmination of the first phase of an incremental approach to modifying the CGMP regulations for these products. This rule revises CGMP requirements primarily concerning aseptic processing, verification of performance of operations by a second individual, and the use of asbestos filters. We are amending the regulations to modernize or clarify some of the requirements as well as to harmonize them with other FDA regulations and international CGMP standards.

This notice announces the meeting date for the 24th meeting of the American Health Information Community in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.) The American Health Information Community will advise the Secretary and recommend specific actions to achieve a common interoperability framework for health information technology (IT). Meeting Date: September 23, 2008, from 8:30 a.m. to 3 p.m. (Eastern).

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 worldwide exclusive license to practice the invention embodied in:

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 Diabetes and Digestive and Kidney Diseases (NIDDK), 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: The National Diabetes Education Program Comprehensive Evaluation Plan. Type of Information Collection Request: Extension of a currently approved collection (0925-0552). Need and Use of Information Collection: The National Diabetes Education Program (NDEP) is a partnership of the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) and more than 200 public and private organizations. The long-term goals of the NDEP are to: Improve the treatment and health outcomes of people with diabetes, promote early diagnosis, and, ultimately, prevent the onset of diabetes. The NDEP objectives are: (1) To increase awareness of the seriousness of diabetes, its risk factors, and strategies for preventing diabetes and its complications among people at risk for diabetes; (2) to improve understanding about diabetes and its control and to promote better self-management behaviors among people with diabetes; (3) to improve health care providers' understanding of diabetes and its control and to promote an integrated approach to care; (4) to promote health care policies that improve the quality of and access to diabetes care. Multiple strategies have been devised to address the NDEP objectives. These have been described in the NDEP Strategic Plan and include: (1) Creating partnerships with other organizations concerned about diabetes; (2) developing and implementing awareness and education activities with special emphasis on reaching the racial and ethnic populations disproportionately affected by diabetes; (3) identifying, developing, and disseminating educational tools and resources for the program's diverse audiences; (4) promoting policies and activities to improve the quality of and access to diabetes care. The NDEP evaluation will document the extent to which the NDEP program has been implemented, and how successful it has been in meeting program objectives. The evaluation relies heavily on data gathered from existing national surveys such as National Health and Nutrition Examination Survey (NHANES), the National Health Interview Survey (NHIS), the Behavioral Risk Factor Surveillance System (BRFSS), among others for this information. This generic clearance request is for the collection of additional primary data from NDEP target audiences on some key process and impact measures that are necessary to effectively evaluate the program. Approval is requested for a survey of audiences targeted by the National Diabetes Education Program including people at risk for diabetes, people with diabetes and their families and the public. Frequency of Response: On occasion. Affected Public: Individuals or households. Type of Respondents: Adults. The annual reporting burden is as follows: Estimated Number of Respondents: 3759, Estimated Number of Responses per Respondent: 1; Average Burden Hours per Response: .153; and Estimated Total Annual Burden Hours Requested: 575. There are no Capital, Operating or Maintenance Costs to report.

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 Food and Drug Administration (FDA) is requesting comments concerning abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use of 10 drug substances. These comments will be considered in preparing the United States' response to the World Health Organization (WHO) regarding the abuse liability and diversion of these drugs. WHO will use this information to consider whether to recommend that certain international restrictions be placed on these drugs. This notice requesting comments is required by the Controlled Substances Act (CSA).

This notice announces the establishment of the National Commission on Children and Disasters, a Secretary's Advisory Committee. The Consolidated Appropriations Act, 2008 (Pub. L. 110-161), Division G, Title VI, directs the establishment of the National Commission on Children and Disasters. The Commission shall conduct a comprehensive study to examine and assess the needs of children as they relate to preparation for, response to, and recovery from all hazards, building upon the evaluation of other entities and avoiding unnecessary duplication by reviewing the findings, conclusions, and recommendations of these entities, and shall then submit a report to the President and Congress on the Commission's specific findings, conclusions, and recommendations to address the needs of children as they relate to major disasters and emergencies.

The National Health and Nutrition Examination Survey (NHANES) is a program of periodic surveys conducted by the National Center for Health Statistics (NCHS) of the Centers for Disease Control and Prevention (CDC). Examination surveys conducted since 1960 by NCHS, have provided national estimates of health and nutritional status of the United States civilian non-institutionalized population. To add to the large amount of information collected for the purpose of describing the health of the population in the most recent survey, serum, urine and limited plasma samples were collected and stored for future research projects. Specimens are currently available from NHANES III (conducted from 1988-1994) and from NHANES 1999+. In 1999, NHANES became a continuous survey with data release every two years. Specimens are available from two year survey cycles after the demographic file has been released to the public. Participants in the survey that began in 1999 signed a separate consent document agreeing to specimen storage allowing their biologic specimens to be used for approved research projects. Specimens are stored in two Specimen Banks. Surplus samples that were initially used for laboratory assays included in the surveys, have since been stored at -70[deg] C and have been through at least two freeze-thaw cycles. They are stored at a commercial repository under contract to NCHS. In addition, on average, six vials of sera were also stored in vapor-phase liquid nitrogen at the CDC and ATSTR Specimen Packaging, Inventory and Repository (CASPIR) Repository in Lawrenceville, GA. These specimens have not undergone a freeze-thaw cycle. The CASPIR Repository is considered a long-term repository for the NHANES specimens. NCHS is making both of these collections available for research proposals. The research proposals that can use the surplused specimens will receive higher priority. Proposals that request the specimens in CASPIR need to justify the use of the unthawed specimens. The purpose of this notice is to request comments on this program and the proposed cost schedule. After consideration of comments submitted, CDC will finalize and publish the cost schedule and accept proposals for use of the NHANES stored biologic samples. Please go to https://www.cdc.gov/nchs/about/major/nhanes/serum1b.htm for final proposal guidelines. All interested researchers are encouraged to submit proposals. No funding is provided as part of this solicitation. Samples will not be provided to those projects requiring funding until the project has received funds. Approved projects that do not obtain funding will be canceled. A more complete description of this program follows.

This notice announces the 29th meeting of the American Health Information Community Consumer Empowerment Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).

This notice announces the 26th meeting of the American Health Information Community Chronic Care Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.)

This notice announces the 25th meeting of the American Health Information Community Electronic Health Records Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.)