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

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for a new animal drug application (NADA) for chloramphenicol capsules from Nylos Trading Co., Inc., to Pharmaceutical Ventures, Ltd.

The Department of Health and Human Services (HHS) notifies Federal agencies of the laboratories currently certified to meet the standards of Subpart C of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908), on September 30, 1997 (62 FR 51118), and on April 13, 2004 (69 FR 19644). A notice listing all currently certified laboratories is published in the Federal Register during the first week of each month. If any laboratory's certification is suspended or revoked, the laboratory will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end, and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at https:// workplace.samhsa.gov and https://www.drugfreeworkplace.gov.

In accordance with the requirements of the Privacy Act of 1974, we are proposing to modify or alter an existing SOR, titled ``Non-Medicare Beneficiary Workers' Compensation (WC) Set-aside File (WCSAF),'' System No. 09-70-0537, last published at 67 FR 36892 (May 28, 2002). We propose to expand the scope of this system to include non-Medicare beneficiaries whose applications for a WC Arrangement have not been approved (denied) as submitted. The disclosure provisions contained in published routine use number 2 and 3 are deemed to be duplicative of each other and as such require corrective action. This modified routine use will now be number 2 and will authorize disclosure to ``another Federal and/or state agency, agency of a state government, an agency established by state law, or its fiscal agent.'' We are modifying the language in the remaining routine uses to provide clarity to CMS's intention to disclose individual-specific information contained in this system. The routine uses will then be prioritized and reordered according to their usage. We will also take the opportunity to update any sections of the system that were affected by the recent reorganization and to update language in the administrative sections to correspond with language used in other CMS SORs. The primary purpose of the non-Medicare beneficiary WCSAF is to maintain a file of individuals who were injured while employed; are not currently Medicare beneficiaries; whose WC Settlement included a WC Medicare Set-aside Arrangement that is intended to pay for future medical expenses in place of future Medicare benefits; and was approved or not approved (denied) by CMS as submitted. The information retrieved from this system will be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor or consultant; (2) another Federal and/or state agency, agency of a state government, an agency established by state law, or its fiscal agent to contribute to the accuracy of CMS' proper payment of Medicare benefits, enable such agency to administer a Federal health benefits program, or enable such agency to fulfill a requirement of a Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds; (3) an individual or organization for research, evaluation or epidemiological projects related to the prevention of disease or disability, the restoration or maintenance of health, or for understanding and improving payment projects; (4) support constituent requests made to a Congressional representative; (5) support litigation involving the agency; and (6) combat fraud and abuse in health benefits programs funded in whole or in part by Federal funds. We have provided background information about the modified system in the Supplementary Information section, below. Although the Privacy Act requires only that the ``routine use'' portion of the system be published for comment, CMS invites comments on all portions of this notice. See Effective Date section for comment period.

The Food and Drug Administration (FDA) proposed to amend the biologics regulations and proposed to classify the bacterial vaccines and toxoids on the basis of findings and recommendations of the Panel on Review of Bacterial Vaccines and Toxoids (the Panel) on December 13, 1985. The Panel reviewed the safety, efficacy, and labeling of bacterial vaccines and toxoids with standards of potency, bacterial antitoxins, and immune globulins. After the initial final rule and final order was vacated by the U.S. District Court for the District of Columbia on October 27, 2004, FDA published a new proposed rule and proposed order on December 29, 2004 (69 FR 78281). The purpose of this final rule and final order is to amend the biologics regulations, issue a final order in response to the report and recommendations of the Panel; and, respond to comments on the previously published proposed rule and proposed order submitted to the Division of Dockets Management. This final rule and final order does not address Anthrax Vaccine Adsorbed (AVA). The final order concerning AVA is published elsewhere in this issue of the Federal Register. FDA is classifying these products as Category I (safe, effective, and not misbranded), Category II (unsafe, ineffective, or misbranded), or Category IIIB (off the market pending completion of studies permitting a determination of effectiveness).

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for four approved new animal drug applications (NADAs) for oral dosage forms and feed uses of tiamulin from Boehringer Ingelheim Vetmedica, Inc., to Novartis Animal Health US, Inc.

For more than a quarter century, the National Toxicology Program (NTP) testing program has provided extensive and useful scientific information for predicting human health hazards and protecting public health. The NTP periodically conducts reviews of animal models used in its bioassays to critically analyze their predictive power and determine whether the protocols for these studies should be altered. As part of this effort, the NTP is convening a workshop titled ``Hormonally-Induced Reproductive Tumors: Relevance of Rodent Bioassays.'' The 2\1/2\ day workshop will be held on May 22-24, 2006, at the Marriott Raleigh Crabtree Valley, 4500 Marriott Drive, Raleigh, NC 27612. The workshop's overall goal is to determine the adequacy and relevance to human disease outcome of rodent models for four types of hormonally-induced reproductive tumors (ovary, mammary gland, prostate, and testis). Other topics for discussion include proposed modes of action (for each tumor type and for hormonal tumors in general), dose response for tumor induction, predictiveness of rodent pre-neoplastic events for humans, the importance of the inclusion of an in utero exposure in the etiology of specific tumors, and the concept of ``additivity to background'' when normal hormones are present with homeostatic control mechanisms. The program will include plenary sessions as well as four breakout group sessions for in-depth discussions. This meeting is open to the public with time set aside for public comments. Attendance is limited by the space available to approximately 100 public attendees. Individuals may register to attend the workshop on a first-come, first-served basis per the procedures outlined below. A copy of the agenda and any additional information about the workshop, including background materials, public comments, and invited participants, will be posted on the NTP Web site when available (see NTP Web site https://ntp.niehs.nih.gov select ``Meetings and Workshops'').

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 National Toxicology Program (NTP) established the Nanotechnology Working Group (``the NWG'') to the NTP Board of Scientific Counselors in 2005 to enhance public and stakeholder input into the NTP nanotechnology research program. The second meeting of the NWG is scheduled for March 15, 2006 at the Holiday Inn-Rosslyn at Key Bridge (1900 N Fort Myer Drive, Arlington, VA 22209). This meeting is open to the public with time scheduled for oral public comment. The NTP also invites written comments on any topic discussed at the meeting. A copy of the agenda and any additional information about the meeting will be posted on the NTP website when available (see NTP Web site https://ntp.niehs.nih.gov select ``Meetings and Workshops'').

The Food and Drug Administration (FDA) is withdrawing approval of 15 new animal drug applications (NADAs) because the products are no longer manufactured or marketed. In a final rule published elsewhere in this issue of the Federal Register, FDA is amending the animal drug regulations to remove portions reflecting approval of the NADAs.

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 announcing that, as required by the Federal Advisory Committee Act, the agency has filed with the Library of Congress the annual reports of those FDA advisory committees that held closed meetings during fiscal year 2005.

The Food and Drug Administration (FDA) is announcing the availability of a guidance document entitled, ``Requesting an Extension to Use Existing Label Stock after the Trans Fat Labeling Effective Date of January 1, 2006.'' The trans fat final rule published in the Federal Register on July 11, 2003. This guidance document provides guidance to FDA and the food industry about when and how businesses may request the agency to consider enforcement discretion for the use, on products introduced into interstate commerce on or after the January 1, 2006, effective date, of some or all existing label stock that does not declare trans fat labeling in compliance with the final rule.