Department of Health and Human Services December 3, 2008 – Federal Register Recent Federal Regulation Documents
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Draft Guidance for Industry on the Submission of Patent Information for Certain Old Antibiotics; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Submission of Patent Information for Certain Old Antibiotics.'' The draft guidance describes the agency's current thinking on the implementation of certain provisions of the Q1 Program Supplemental Funding Act (the Q1 Act) that concern old antibiotics and addresses which sponsors of new drug applications (NDAs) must submit patent information under the Q1 Act by December 5, 2008.
Medicare Program; Hospital Inpatient Prospective Payment Systems and Fiscal Year 2009 Rates: Fiscal Year 2009 Wage Index Changes Following Implementation of Section 124 of the Medicare Improvement for Patients and Providers Act of 2008
This notice contains fiscal year (FY) 2009 revised final wage indices and hospital reclassifications for 27 hospitals. These revised final wage indices and hospital reclassifications were made according to special procedural rules set forth in the FY 2009 hospital inpatient prospective payment systems final rule (73 FR 48588-9).
Medicaid Program; State Flexibility for Medicaid Benefit Packages
This final rule will 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. It also 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 recipients. In addition, this final rule responds to public comments on the February 22, 2008, proposed rule that pertain to the State Medicaid benefit package provisions.
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