Department of Health and Human Services March 15, 2005 – Federal Register Recent Federal Regulation Documents

The CERHR announces the availability of the final expert panel reports on amphetamines and on methylphenidate on March 21, 2005, from the CERHR Web site (https://cerhr.niehs.nih.gov) or in printed text from the CERHR (see FOR FURTHER INFORMATION CONTACT below). The CERHR invites the submission of public comments on these expert panel reports (see SUPPLEMENTARY INFORMATION below). The expert panel reports are evaluations on the reproductive and developmental toxicities of amphetamines and methylphenidate conducted by a 13-member expert panel composed of scientists from the Federal government, universities, and private companies. The CERHR previously solicited public comment on draft versions of each expert panel report (Federal Register volume 69, number 208, pages 62906-62907). Public deliberations by the panel took place on January 10-12, 2005, at the Holiday Inn Old Town Select Alexandria, Virginia to review and revise the draft expert panel reports and reach conclusions regarding whether exposure to amphetamines or methylphenidate is a hazard to human development or reproduction. The expert panel also identified data gaps and research needs. The final revisions on these reports have been reviewed for accuracy of content and presentation by the amphetamines and methylphenidate expert panel, NTP scientists, and CERHR personnel.

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.

In accordance with section 10(a) of the Federal Advisory Committee Act (FACA) (5 U.S.C. Appendix 2), this notice announces the first meeting of the Emergency Medical Treatment and Labor Act (EMTALA) Technical Advisory Group (TAG). The purpose of the EMTALA TAG is to review regulations affecting hospital and physician responsibilities under EMTALA to individuals who come to a hospital seeking examination or treatment for medical conditions. This notice also announces the newly appointed members of the EMTALA TAG. Interested parties are invited to this meeting to present their comments on the EMTALA regulations and implementation.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection requirements relating to the general licensing provisions regarding biologics license application, changes to an approved application, labeling, and revocation and suspension, and the use of Forms FDA 356h and 2567.