Department of Health and Human Services March 8, 2011 – Federal Register Recent Federal Regulation Documents

This notice announces the change of location of the March 14, 2011, public meeting of the Consumer Operated and Oriented Plan (CO-OP) Advisory Board that was published in the March 2, 2011 Federal Register (76 FR 1184 through 1185). In accordance with the Federal Advisory Committee Act, the meeting is open to the public.

The Director of the National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) serves as the World Trade Center (WTC) Program Administrator for certain functions related to the WTC Health Program established by the James Zadroga 9/11 Health and Compensation Act (Pub. L. 111-347). In accordance with Section 3312(a)(5)(A) of that Act, the WTC Program Administrator is conducting a review of all available scientific and medical evidence to determine if, based on the scientific evidence, cancer or a certain type of cancer should be added to the applicable list of health conditions covered by the World Trade Center Health Program. The WTC Program Administrator is requesting information on the following: (1) Relevant reports, publications, and case information of scientific and medical findings where exposure to airborne toxins, any other hazard, or any other adverse condition resulting from the September 11, 2001 terrorist attacks, is substantially likely to be a significant factor in aggravating, contributing to, or causing cancer or a type of cancer; (2) clinical findings from the Clinical Centers of Excellence providing monitoring and treatment services to WTC responders (i.e., those persons who performed rescue, recovery, clean- up and remediation work on the WTC disaster sites) and community members directly exposed to the dust cloud on 9/11/01; and (3) input on the scientific criteria to be used by experts to evaluate the weight of the medical and scientific evidence regarding such potential health conditions.

The Food and Drug Administration (FDA) is confirming the effective date of April 14, 2011, for the final rule that appeared in the Federal Register of November 30, 2010 (75 FR 73951). The direct final rule amends certain general regulations of FDA to include tobacco products, where appropriate, in light of FDA's authority to regulate these products under the Family Smoking Prevention and Tobacco Control Act, by revising the Agency's regulations to require tobacco products to be subject to the same general requirements that apply to other FDA- regulated products. This document confirms the effective date of the direct final rule.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Elanco Animal Health. The NADA provides for veterinary prescription use of chewable tablets containing spinosad and milbemycin oxime in dogs for the treatment and prevention of flea infestations and for the prevention and control of various internal parasites.