Department of Health and Human Services April 2010 – Federal Register Recent Federal Regulation Documents

This rule revises the final rule published on December 3, 2008 to implement provisions of section 6044 of the Deficit Reduction Act of 2005, which amends the Social Security Act by adding a new section 1937 related to the coverage of medical assistance under approved State plans. That rule provides States increased flexibility under an approved State plan to define the scope of covered medical assistance by offering coverage of benchmark or benchmark-equivalent benefit packages to certain Medicaid-eligible individuals. In addition, this final rule responds to public comments on the February 22, 2008 proposed rule and comments received in response to rules published subsequently that delayed the effective date of the December 3, 2008 final rule until July 1, 2010.

The Department of Health and Human Services (HHS) is changing the effective date of the Revisions to the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines) from May 1, 2010, to October 1, 2010. The purpose of this notice is to notify participants in Federal and federally-regulated workplace drug testing programs as soon as possible that they will not be expected to implement the revisions to the Mandatory Guidelines on May 1, 2010, so that they do not unnecessarily expend resources to comply on May 1, or risk compliance problems by prematurely implementing new provisions.

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 issuing an advance notice of proposed rulemaking (ANPRM) to request data and information on the food transportation industry and its practices. FDA also is requesting data and information on the contamination of transported foods and any associated outbreaks. FDA is taking this action as part of its implementation of the Sanitary Food Transportation Act of 2005 (2005 SFTA), which requires the Secretary of Health and Human Services (HHS) to issue regulations setting forth sanitary transportation practices to be followed by shippers, carriers by motor vehicle or rail vehicle, receivers, and others engaged in food transport. This action is also part of a larger agency effort to focus on prevention of food safety problems throughout the food chain. The regulations would

The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry'' dated May 2010. The guidance document provides recommendations to blood and plasma establishments, manufacturers, and testing laboratories that are implementing a licensed method for Human Immunodeficiency Virus Type 1 (HIV-1) Nucleic Acid Test (NAT) and Hepatitis C Virus (HCV) NAT, on testing individual samples or pooled samples from donors of human blood and blood components for HIV-1 ribonucleic acid (RNA) and HCV RNA. This guidance also contains recommendations regarding product disposition and donor management based on the results of NAT and serologic testing for markers of HIV-1 and HCV infection on samples, collected at the time of donation, from donors of human blood and blood components. The guidance announced in this notice finalizes the draft guidance of the same title, dated July 2005. This guidance also supersedes the recommendations for reentry of donors deferred because of anti-HIV-1 test results, HIV-1 p24 antigen test results, and anti-HCV test results that were provided in the FDA memoranda entitled ``Revised Recommendations for the Prevention of Human Immunodeficiency Virus (HIV-1) Transmission by Blood and Blood Products,'' April 23, 1992; ``Revised Recommendations for Testing Whole Blood, Blood Components, Source Plasma and Source Leukocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV),'' August 5, 1993; ``Recommendations for Donor Screening with a Licensed Test for HIV-1 Antigen,'' August 8, 1995.

HRSA will be awarding non-competitive Part D funds to the Mecklenburg County Health Department in order to ensure continuity of critical HIV medical care and treatment services, and to avoid a disruption of HIV clinical care and support services to women, infants, children, and youth in the Charlotte, North Carolina and surrounding counties. HRSA will also be awarding non-competitive Part D Funds to Duke University in order to ensure continuity of critical HIV medical care and treatment services, and to avoid a disruption of HIV clinical care and support services to women, infants, children, and youth in the central North Carolina area.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Draft Guidance for Industry and FDA Staff; User Fees for 513(g) Requests for Information.'' This draft guidance describes the user fees associated with 513(g) requests for information.

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 amending the animal drug regulations to reflect approval of an original abbreviated new animal drug application (ANADA) filed by Modern Veterinary Therapeutics, LLC. The ANADA provides for use of an injectable solution of butorphanol tartrate in cats for the relief of pain.

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institute on Aging (NIA), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

HHS gives notice of a decision to designate a class of employees at Westinghouse Electric Corp., Bloomfield, New Jersey, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On April 5, 2010, the Secretary of HHS designated the following class of employees as an addition to the SEC:

HHS gives notice of a decision to designate a class of employees at the Lawrence Livermore National Laboratory in Livermore, California, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On April 5, 2010, the Secretary of HHS designated the following class of employees as an addition to the SEC:

HHS gives notice of a decision to designate a class of employees of Area IV of the Santa Susana Field Laboratory as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On April 5, 2010, the Secretary of HHS designated the following class of employees as an addition to the SEC: