Department of Health and Human Services December 8, 2010 – Federal Register Recent Federal Regulation Documents
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Office of the Assistant Secretary for Planning and Evaluation; Medicare Program; Meeting of the Technical Advisory Panel on Medicare Trustee Reports
This notice announces a public meeting of the Technical Advisory Panel on Medicare Trustee Reports (Panel). Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)(1) and (a)(2)). The Panel will discuss the long- term rate of change in health spending and may make recommendations to the Medicare Trustees on how the Trustees might more accurately estimate health spending in the long run. The Panel's discussion is expected to be very technical in nature and will focus on the actuarial and economic assumptions and methods by which Trustees might more accurately measure health spending. Although panelists are not limited in the topics they may discuss, the Panel is not expected to discuss or recommend changes in current or future Medicare provider payment rates or coverage policy. Meeting Dates: December 13, 2010, 9:30 a.m. to 5 p.m. and December 14, 2010, 8:30 a.m.-1 p.m. e.t.
Oral Dosage Form New Animal Drugs; Tylosin
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 Huvepharma AD. The ANADA provides for use of tylosin tartrate soluble powder in drinking water of chickens, turkeys, swine, and honey bees for the treatment or control of various bacterial diseases.
Implantation or Injectable Dosage Form New Animal Drugs; Flunixin
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by Agri Laboratories, Ltd. The supplemental ANADA provides for use of flunixin meglumine solution by intravenous injection in lactating dairy cows for control of pyrexia associated with acute bovine mastitis.
Medicare Program; Renewal of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC)
This notice announces the renewal of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC).
Biologics Price Competition and Innovation Act of 2009; Meetings on User Fee Program for Biosimilar and Interchangeable Biological Product Applications; Request for Notification of Stakeholder Intention To Participate
The Food and Drug Administration (FDA) is issuing this notice to request that public stakeholders, including patient and consumer advocacy groups, health care professionals, and scientific and academic experts, notify FDA of their intent to participate in consultation meetings relating to the development of a user fee program for biosimilar and interchangeable biological product applications submitted under the Public Health Service Act (PHS Act). FDA is holding these consultation meetings to satisfy the requirement in the Patient Protection and Affordable Care Act that FDA consult with such public stakeholders regarding the development of recommendations to present to Congress with respect to the goals, and plans for meeting the goals, for the process for the review of biosimilar and interchangeable biological product applications for fiscal years (FYs) 2013 through 2017. To ensure continuity and to support the development of recommendations for establishing a user fee program for biosimilars and interchangeable products, the Agency requests stakeholder representation throughout this consultation process.
Mandatory Guidelines for Federal Workplace Drug Testing Programs
The recent revisions to the Department of Health and Human Services (HHS) Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines) which took effect on October 1, 2010 address the role and qualifications of Medical Review Officers (MROs) and HHS approval of entities that certify MROs. Subpart M-Medical Review Officer (MRO), Section 13.1(b), ``Who may serve as an MRO?'' states as follows: ``Nationally recognized entities that certify MROs or subspecialty boards for physicians performing a review of Federal employee drug testing results that seek approval by the Secretary must submit their qualifications and a sample examination. Based on an annual objective review of the qualifications and content of the examination, the Secretary shall publish a list in the Federal Register of those entities and boards that have been approved.'' HHS has completed its review of entities that train and certify MROs, in accordance with requests submitted by such entities to HHS. (1) The HHS Secretary approves the following MRO certifying entities that offer both MRO training and certification through examination:
Medicare Program; Home Health Prospective Payment System Rate Update for Calendar Year 2011; Changes in Certification Requirements for Home Health Agencies and Hospices; Correction
This document corrects a technical error in an amendatory instruction of the regulations text in the final rule that appeared in the November 17, 2010 Federal Register entitled ``Medicare Program; Home Health Prospective Payment System Rate Update for Calendar Year 2011; Changes in Certification Requirements for Home Health Agencies and Hospices'' final rule (75 FR 70372).
Food Labeling; Health Claim; Phytosterols and Risk of Coronary Heart Disease
The Food and Drug Administration (FDA) is proposing to amend the regulation authorizing a health claim on the relationship between plant sterol esters and plant stanol esters and reduced risk of coronary heart disease (CHD) for use on food labels and in food labeling. The agency is taking this action based on evidence previously considered by the agency, and FDA's own review of data on esterified and nonesterified plant sterols and stanols (collectively, phytosterols) \1\ published since the agency first authorized the health claim by regulation. FDA is also taking these actions, in part, in response to a health claim petition submitted by Unilever United States, Inc. The proposal would amend the authorized use of the claim by modifying the nature of the substances that may be the subject of the claim for conventional foods to include nonesterified, or free, phytosterols, by expanding the types of foods that may bear the claim to include a broader range of foods, by modifying the daily dietary intake of the substance specified in the claim as necessary for the claimed benefit, by adjusting the minimum amount of the substance required for a food to bear the claim, and by making other minor changes.
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