Department of Health and Human Services December 13, 2007 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Elanco Animal Health. The supplemental NADA provides for an increased level of monensin in three-way combination Type C medicated feeds containing ractopamine, melengestrol, and monensin for heifers fed in confinement for slaughter.

In accordance with the requirements of the Privacy Act, the Centers for Disease Control and Prevention (CDC) is proposing to establish a new system of records (SOR), 09-20-0171, ``Quarantine and Traveler-Related Activities, Including Records for Contact Tracing Investigation and Notification Under 42 CFR Parts 70 and 71, HHS/CDC/ CCID.'' The purpose of the system is to maintain records on the conduct of activities (e.g., quarantine, isolation) that fulfill HHS's and CDC's statutory authority under sections 311 and 361-368 of the Public Health Service Act: To prevent the introduction, transmission and spread of serious communicable diseases from persons arriving into the United States from foreign countries or engaged in interstate or international movement. Identifiable records are collected when an individual known or suspected to have been exposed to such communicable diseases arrives in the U.S. from a foreign country or travels from one state or possession to another state or possession. These records are used to: (1) Document reports of illness on airplanes, maritime vessels, and at land-border crossings of persons that may pose a public health risk and who are arriving from foreign countries or traveling between states; (2) perform contact tracing investigations and notifications of passengers and crew when known or suspected exposures to serious communicable diseases occur on board a conveyance arriving in the United States from a foreign country or while traveling from one state or possession to another; (3) inform state or local public health authorities so that these authorities may act to protect public health or safety; and (4) take actions (e.g., quarantine or isolation) as necessary to prevent the introduction, transmission, and spread of serious communicable diseases from persons arriving into the United States from foreign countries or persons engaged in interstate or international movement. Additional background information about the new system is included in the SUPPLEMENTARY INFORMATION section below.

Pursuant to Public Law 92-463, notice is hereby given of a meeting of the NTP Board of Scientific Counselors Technical Reports Review Subcommittee (TRR Subcommittee). The primary agenda topic is the peer review of the findings and conclusions presented in seven draft NTP Technical Reports of rodent toxicology and carcinogenicity studies in conventional rats and mice, one draft NTP Technical Report on a study in Crl:SKH-1 hairless mice, and one draft NTP Toxicity Report (see Preliminary Agenda below). The TRR Subcommittee meeting is open to the public with time scheduled for oral public comment. The NTP also invites written comments on any draft report discussed at the meeting (see ``Request for Comments'' below). The TRR Subcommittee deliberations on the draft reports will be reported to the NTP Board of Scientific Counselors (BSC) at a future date.

The Department of Health and Human Services (HHS) gives notice of a decision to designate a class of employees at the Nuclear Materials and Equipment Corporation (NUMEC) in Apollo, Pennsylvania, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On November 29, 2007, the Secretary of HHS designated the following class of employees as an addition to the SEC: