Agency Emergency Processing Under the Office of Management and Budget Review; Submission for Office of Management and Budget Review; Comment Request; Food and Drug Administration Food Safety Modernization Act: Economic Hardship Fee Reduction Guidance
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 (PRA). The proposed collection of information concerns a guidance document that outlines the criteria and the process through which firms may request a reduction of fees based on severe economic hardship of the FDA Food Safety Modernization Act (FSMA) reinspection and recall user fees that are mandated by the Federal Food, Drug, and Cosmetic Act (the FD&C Act).
Medicare Program; Renaming and Other Changes to the Advisory Panel on Hospital Outpatient Payment Charter (Formerly the Advisory Panel on Ambulatory Payment Classification Groups) and Request for Nominations
This notice announces the name change of the Advisory Panel on Ambulatory Payment Classification Groups to the Advisory Panel on Hospital Outpatient Payment (HOP) (the Panel). In addition, it announces the renewal and amendments to the charter including changing the scope of the Panel to include supervision of outpatient hospital services, changing the Panel membership to include Critical Access Hospitals (CAH), and the solicitation of six nominations for individuals to serve on the Panel in 2012.
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Office of the Assistant Secretary for Planning and Evaluation; Medicare Program; Meeting of the Technical Advisory Panel on Medicare Trustee Reports
This notice announces public meetings of the Technical Advisory Panel on Medicare Trustee Reports (Panel). Notice of these meetings 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 range (75 year) projection methods and assumptions in projecting Medicare health expenditures and projecting National Health Expenditures 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 project 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.
Animal Drugs, Feeds, and Related Products; Eprinomectin; N-Methyl-2-Pyrrolidone
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original new animal drug application (NADA) filed by Merial Ltd. The NADA provides for the veterinary prescription use of eprinomectin by injection for the treatment and control of internal and external parasites of cattle on pasture with persistent effectiveness. The current tolerance for the marker residue for total residues of eprinomectin in edible tissues of cattle is being lowered. The method of detection for residues of the carcinogenic excipient n-methyl-2- pyrrolidone (NMP) in edible tissues of cattle is also being codified.
Ophthalmic and Topical Dosage Form New Animal Drugs; Eprinomectin
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Merial Ltd. The supplemental NADA provides for addition of a warning statement against the use of eprinomectin topical solution in preruminating calves intended for veal.
Agency Information Collection Activities; Proposed Collection; Comment Request; Draft Guidance for Tobacco Retailers on Tobacco Retailer Training Programs
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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of the draft guidance entitled ``Tobacco Retailer Training Programs.''
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Adverse Experience Reporting for Licensed Biological Products; and General Records
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Adverse Experience Reporting for Licensed Biological Products; and General Records'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Permanent Certification Program for Health Information Technology; Revisions to ONC-Approved Accreditor Processes
Under the authority granted to the National Coordinator for Health Information Technology by section 3001(c)(5) of the Public Health Service Act (PHSA) as added by the Health Information Technology for Economic and Clinical Health (HITECH) Act, this final rule establishes a process for addressing instances where the ONC-Approved Accreditor (ONC-AA) engages in improper conduct or does not perform its responsibilities under the permanent certification program. This rule also addresses the status of ONC-Authorized Certification Bodies (ONC- ACBs) in instances where there may be a change in the accreditation organization serving as the ONC-AA and clarifies the responsibilities of the new ONC-AA.