Department of Health and Human Services October 2009 – Federal Register Recent Federal Regulation Documents

This document proposes to temporarily delay the effective date of the November 25, 2008 final rule entitled, ``Medicaid Program; Premiums and Cost Sharing'' and the December 3, 2008 final rule entitled, ``Medicaid Program; State Flexibility for Medicaid Benefit Packages.'' Upon the review and consideration of the new provisions of the American Recovery and Reinvestment Act of 2009, the Children's Health Insurance Program Reauthorization Act of 2009, and the public comments received during the reopened comment period, we believe that it is necessary to revise a substantial portion of the November 25, 2008 and the December 3, 2008 final rules. To allow time to make these revisions, the Department has determined that it needs several more months to revise the rule. Accordingly, we are asking for public comment on this proposal for delaying the effective date of the final rules until July 1, 2010.

The Secretary of the Department of Health and Human Services (HHS) adopts this interim final rule to conform the enforcement regulations promulgated under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) to the effective statutory revisions made pursuant to the Health Information Technology for Economic and Clinical Health Act (the HITECH Act), which was enacted as part of the American Recovery and Reinvestment Act of 2009 (ARRA). More specifically, this interim final rule amends HIPAA's enforcement regulations, as they relate to the imposition of civil money penalties, to incorporate the HITECH Act's categories of violations, tiered ranges of civil money penalty amounts, and revised limitations on the Secretary's authority to impose civil money penalties for established violations of HIPAA's Administrative Simplification rules (HIPAA rules). This interim final rule does not make amendments with respect to those enforcement provisions of the HITECH Act that are not yet effective under the applicable statutory provisions. Such amendments will be subject to forthcoming rulemaking(s).

HHS gives notice of a decision to designate a class of employees at the Lake Ontario Ordnance Works, Niagara Falls, New York, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On September 29, 2009, the Secretary of HHS designated the following class of employees as an addition to the SEC:

HHS gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees of Hooker Electrochemical Corporation, Niagara Falls, New York, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows:

The Centers for Disease Control and Prevention (``CDC'') proposes to establish total inward leakage (TIL) requirements for half- mask air-purifying particulate respirators approved by the National Institute for Occupational Safety and Health (``NIOSH'') of CDC. The proposed new requirements specify TIL minimum performance requirements and testing to be conducted by NIOSH and respirator manufacturers to demonstrate that these respirators, when selected and used correctly, provide effective respiratory protection to intended users against toxic dusts, mists, fumes, fibers, and biological and infectious aerosols (e.g. influenza A(H5N1), severe acute respiratory syndrome (SARS) coronavirus, and Mycobacterium tuberculosis).

The Food and Drug Administration (FDA) is amending its investigational new drug application (IND) regulations to add an

Under the provisions 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 Cancer Institute (NCI), 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.

The Food and Drug Administration (FDA) is announcing the availability of a draft revised guidance for industry and reviewers entitled ``SPL Standard for Content of Labeling Technical Qs & As.'' This draft guidance is intended to assist sponsors who submit the content of their product labeling to the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) using the Structured Product Labeling standard (SPL) in extensible markup language (XML). The draft guidance also provides information to CDER and CBER staff who review and manage that product information using electronic systems. This draft guidance is being revised to reflect technological changes and changes resulting from the requirement in the Food and Drug Administration Amendments Act of 2007 to submit drug establishment registration and drug listing information electronically.

A proposal by Dr. Harlan Caldwell at the Rocky Mountain Laboratories (RML) involving the deliberate transfer of a tetracycline resistance trait to non-ocular strains of Chlamydia trachomatis has been submitted to the NIH Office of Biotechnology Activities (OBA). The introduction of tetracycline resistance could compromise the ability to treat disease caused by Chlamydia trachomatis as doxycycline is currently used to treat disease caused by this organism. Under Section III-A-1 of the NIH Guidelines, if the deliberate transfer of a drug resistance trait to microorganisms could compromise the use of the drug to control disease in humans, veterinary medicine, or agriculture the experiment must be reviewed by the NIH Recombinant DNA Advisory Committee (RAC) and approved by the NIH Director.

The Food and Drug Administration is correcting a notice that appeared in the Federal Register of August 3, 2009 (74 FR 38451). The document announced the fiscal year 2010 fee rates for the Prescription Drug User Fee Act. The document was published with errors. This document corrects those errors.