Department of Health and Human Services June 6, 2011 – Federal Register Recent Federal Regulation Documents
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Reducing Regulatory Burden; Retrospective Review Under Executive Order 13563
In accordance with Executive Order 13563, ``Improving Regulation and Regulatory Review,'' the Department of Health and Human Services (HHS) seeks public comment from interested parties on its Preliminary Plan for Retrospective Review of Existing Regulations. The purpose of the Preliminary Plan is to identify a preliminary list of regulations that are appropriate candidates for review over the next two years and establish an ongoing process of retrospective review of existing regulations by which HHS can determine whether any should be modified, streamlined, expanded, or repealed. HHS anticipates that such reviews will make its regulatory program more effective and flexible and reduce unnecessary burdens on the regulated communities.
BASF Corp.; Filing of Food Additive Petition (Animal Use); Methyl Esters of Conjugated Linoleic Acid; Silicon Dioxide
The Food and Drug Administration (FDA) is announcing that BASF Corp. has filed a petition proposing that the food additive regulations be amended to provide for the safe use of methyl esters of conjugated linoleic acid (CLA) as a source of fatty acids in lactating dairy cow diets and for use of silicon dioxide as a carrier for the methyl esters of CLA.
Collaboration in Regulatory Science and Capacity To Advance Global Access to Safe Vaccines and Biologicals
The Food and Drug Administration (FDA) announces its intention to accept and consider a single source application for award of a cooperative agreement to the World Health Organization (WHO) in support of collaboration in regulatory science and capacity of National Regulatory Authorities (NRAs) to advance global access to safe and effective vaccines and other biologicals that meet international standards. The goal of FDA's Center for Biologics Evaluation and Research (FDA/CBER) is to enhance technical collaboration and cooperation between FDA, WHO, and its Member States.
Determination That ORLAAM (Levomethadyl Acetate Hydrochloride) Oral Solution, 10 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that ORLAAM (levomethadyl acetate hydrochloride (HCl)) oral solution, 10 milligrams (mg)/milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for levomethadyl acetate HCl oral solution, 10 mg/mL, if all other legal and regulatory requirements are met.
Draft Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by Clinical Investigators; Correction
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of May 24, 2011 (76 FR 30175). The document announced the availability of a draft guidance entitled `` Draft Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by Clinical Investigators.''The document was published with an incorrect docket number. This document corrects that error.
Medicaid Program; Payment Adjustment for Provider-Preventable Conditions Including Health Care-Acquired Conditions
This final rule will implement section 2702 of the Patient Protection and Affordable Care Act which directs the Secretary of Health and Human Services to issue Medicaid regulations effective as of July 1, 2011 prohibiting Federal payments to States under section 1903 of the Social Security Act for any amounts expended for providing medical assistance for health care-acquired conditions specified in the regulation. It will also authorize States to identify other provider- preventable conditions for which Medicaid payment will be prohibited.
Agency Information Collection Activities: Proposed Collection; Reports and Records Under Prescription Drug Marketing Act of 1987
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the reporting and recordkeeping requirements contained in the regulations implementing the Prescription Drug Marketing Act of 1987 (PDMA).
Medicare Program; Five-Year Review of Work Relative Value Units Under the Physician Fee Schedule
This proposed notice sets forth proposed revisions to work relative value units (RVUs) and corresponding changes to the practice expense and malpractice RVUs affecting payment for physicians' services. The statute requires that we review RVUs no less often than every 5 years. This is our Fourth Five-Year Review of Work RVUs since we implemented the physician fee schedule (PFS) on January 1, 1992. These revisions to work RVUs are proposed to be effective for services furnished beginning January 1, 2012. These revisions reflect changes in medical practice and coding that affect the relative amount of physician work required to perform each service as required by the statute. The Fourth Five-Year Review of Work includes services that were submitted through public comment and by the Medicare contractor medical directors (CMDs), as well as a number of potentially misvalued codes identified by CMS (that is, Harvard valued codes and codes with Site-of-Service anomalies).
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