Department of Health and Human Services October 2012 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Stephen C. Delaney, Jr. for a period of 5 years from importing articles of food or offering such articles for importation into the United States. FDA bases this order on a finding that Mr. Delaney was convicted of one felony count under Federal law for conduct relating to the importation into the United States of an article of food. Mr. Delaney was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. As of August 10, 2012 (30 days after receipt of the notice), Mr. Delaney had not responded. Mr. Delaney's failure to respond constitutes a waiver of his right to a hearing concerning this action.

In accordance with section 10(a) of the Federal Advisory Committee Act, 5 U.S.C. App. 2, this notice announces a meeting of the National Advisory Council for Healthcare Research and Quality.

In accordance with the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, the Centers for Disease Control and Prevention (CDC) located within the Department of Health and Human Services (HHS) has reviewed the list of biological agents and toxins that have the potential to pose a severe threat to public health and safety and is republishing that list. As a result of our review, we have added Chapare virus, Lujo virus, and SARS-associated coronavirus (SARS-CoV) to the list of HHS select agents and toxins. We have also removed from the list of HHS and overlap select agents and toxins, or excluded from compliance with part 73, the agents and toxins described in the Executive Summary. Further, in accordance with Executive Order 13546, ``Optimizing the Security of Biological Select Agents and Toxins in the United States,'' HHS/CDC has designated those select agents and toxins that present the greatest risk of deliberate misuse with the most significant potential for mass casualties or devastating effects to the economy, critical infrastructure; or public confidence as ``Tier 1'' agents; established new security requirements for entities possessing Tier 1 agents, including the requirement to conduct pre- access assessments and on-going monitoring of personnel with access to Tier 1 agents and toxins; and made revisions to the regulations to clarify regulatory language concerning security, training, biosafety, and incident response. In a companion document published in this issue of the Federal Register, the United States Department of Agriculture (USDA) has made parallel regulatory changes.

This notice with comment period announces a hospital's request for a waiver from the requirement to have an agreement with its designated Organ Procurement Organization (OPO). The request was made in accordance with section 1138(a)(2) of the Social Security Act (the Act). In addition, this notice requests comments from OPOs and the general public for our consideration in determining whether we should grant the requested waiver.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) during August 2012 and to reflect a change of sponsor's address for Baxter Healthcare Corp. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.

HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from the Winchester Engineering and Analytical Center Site, in Winchester, Massachusetts, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On August 23, 2012, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:

HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from the Clarksville Modification Center Site, Ft. Campbell, in Clarksville, Tennessee, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On August 23, 2012, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:

The Food and Drug Administration (FDA) is withdrawing approval of a new animal drug application (NADA) and three abbreviated new animal drug applications (ANADAs) at the sponsors' request because the products are no longer manufactured or marketed.

This document corrects technical errors in the final rule that appeared in the August 31, 2012 Federal Register entitled ``Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Fiscal Year 2013 Rates; Hospitals' Resident Caps for Graduate Medical Education Payment Purposes; Quality Reporting Requirements for Specific Providers and for Ambulatory Surgical Centers.''

The Food and Drug Administration's (FDA) Center for Drug Evaluation and Research/Office of Medical Policy and the Duke University Office of Continuing Medical Education are cosponsoring a 3- day training course for clinical investigators on scientific, ethical, and regulatory aspects of clinical trials. This training course is intended to provide clinical investigators with expertise in the design, conduct, and analysis of clinical trials; improve the quality of clinical trials; and enhance the safety of trial participants. Senior FDA staff will communicate directly with clinical investigators on issues of greatest importance for successful clinical research. Date and Time: The training course will be held on November 13 and 14, 2012, from 8 a.m. to 5 p.m., and on November 15, 2012, from 8 a.m. to 4 p.m. Location: The course will be held at the Holiday Inn College Park, 10000 Baltimore Ave., College Park, MD 20740. Contact Person: Connie Wisner, Office of Medical Policy, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6360, Silver Spring, MD 20993, 301-796- 8509. Registration: Register by October 22, 2012. The registration fee is $400 per person. The fee includes course materials and onsite lunch. Early registration is recommended because seating is limited. There will be no onsite registration. Register online for the training course at the registration Web site: https://evm.auxserv.duke.edu/iebms/reg/regp1 form.aspx?oc=10&ct=DCRIINVEST&eventid=46475 or download a full-size copy of the registration form and mail a check and completed form to: Duke University Conference and Event Services, FDA Investigator Course Box 90841, 101 Bryan Center, Durham, NC 27708. You will receive an email that confirms your registration. (FDA has verified the Web site address, but FDA is not responsible for subsequent changes to the Web site after this document publishes in the Federal Register.) Attendees are responsible for their own accommodations. A block of rooms has been reserved under ``FDA Clinical Investigator Course'' at the Holiday Inn College Park at a reduced conference rate. Reservations for these accommodations can be made online using the course registration Web site mentioned previously. Click on ``registration form.'' You will see a direct link to the hotel. Registration materials, payment procedures, accommodation information, and a detailed description of the course can be found at the registration/information Web site mentioned previously. If you need special accommodations due to a disability, please contact Connie Wisner at least 7 days in advance. Persons attending the course are advised that FDA is not responsible for providing access to electrical outlets.

The Department of Health and Human Services (HHS) notifies Federal agencies of the Laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards 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); September 30, 1997 (62 FR 51118); April 13, 2004 (69 FR 19644); November 25, 2008 (73 FR 71858); December 10, 2008 (73 FR 75122); and on April 30, 2010 (75 FR 22809). A notice listing all currently certified Laboratories and Instrumented Initial Testing Facilities (IITF) is published in the Federal Register during the first week of each month. If any Laboratory/IITF's certification is suspended or revoked, the Laboratory/IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any Laboratory/IITF 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:// www.workplace.samhsa.gov and https://www.drugfreeworkplace.gov.

The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft guidance for industry entitled ``Initial Completeness Assessments for Type II API DMFs Under GDUFA.'' Under the Generic Drug User Fee Amendments of 2012 (GDUFA), holders of certain drug master files, namely, Type II active pharmaceutical ingredient (API) drug master files (DMFs) that are referenced in generic drug applications, or in amendments or prior approval supplements to these applications, will be required to undergo an initial completeness assessment in accordance with FDA criteria. This guidance is intended to clarify the criteria FDA will use in the initial completeness assessment.