Department of Health and Human Services 2009 – Federal Register Recent Federal Regulation Documents
Results 601 - 650 of 3,583
Medicare Program; Criteria for Medicare Coverage of Inpatient Hospital Rehabilitation Services
This notice rescinds HCFA Ruling 85-2, ``Medicare Criteria for Coverage of Inpatient Hospital Rehabilitation Services,'' 50 FR 31040 (July 31, 1985), as corrected at 50 FR 32643 (Aug. 13, 1985) which established the criteria for Medicare coverage of inpatient hospital rehabilitation services.
Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational Device Exemptions Reports and Records
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 Investigational Device Exemptions Reports and Records.
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry, FDA, and Foreign Governments: Fiscal Year 2010 Medical Device User Fee Small Business Qualification and Certification
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 FDA Forms 3602 and FDA Form 3602A which will allow domestic and foreign applicants to certify that they qualify as a ``small business'' and pay certain medical device user fees at reduced rates.
Agency Information Collection Activities; Proposed Collection; Comment Request; Recordkeeping and Reporting Requirements for Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing, Material From Cattle
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 information collection requirements of FDA's regulations that require records on FDA-regulated human food, including dietary supplements, and cosmetics that are manufactured from, processed with, or otherwise contain, material derived from cattle.
New Animal Drug Applications
The Food and Drug Administration (FDA) is proposing to amend the regulations regarding new animal drug applications (NADAs). Specifically, this proposed rule is being issued to provide that NADAs shall be submitted in the form and containing the information described, as appropriate for the particular submission. Currently, the regulation requires that all NADAs contain the same informational sections and does not explicitly provide the appropriate flexibility
New Animal Drug Applications
The Food and Drug Administration (FDA) is amending the regulations regarding new animal drug applications (NADAs). Specifically, this direct final rule is being issued to provide that NADAs shall be submitted in the described form, as appropriate for the particular submission. Currently, the regulation requires that all NADAs contain the same informational sections and does not explicitly
Medicare and Medicaid Programs; Conditional Approval of the Community Health Accreditation Program for Continued Deeming Authority for Hospices
This notice announces our decision to conditionally approve, with a 180-day probationary period, the Community Health Accreditation Program's (CHAP's) request for continued recognition as a national accreditation program for hospices seeking to participate in the Medicare or Medicaid programs.
Request for Notification From Industry Organizations Interested in Participating in Selection Process for Nonvoting Industry Representatives on Public Advisory Committees and Request for Nominations for Nonvoting Industry Representatives on Public Advisory Committees
The Food and Drug Administration (FDA) is requesting that any industry organizations interested in participating in the selection of nonvoting industry representatives to serve on its public advisory committees for the Center for Food Safety and Applied Nutrition (CFSAN) notify FDA in writing. FDA is also requesting nominations for nonvoting industry representatives to serve on CFSAN's Food Advisory Committee. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for current vacancies effective with this notice.
Agency Information Collection Activities; Proposed Collection; Comment Request; Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002
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 publication of the criteria FDA intends to use to accredit third parties to conduct inspections of eligible manufacturers of class II or class III medical devices.
Medicare Program; Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance Amounts for Calendar Year 2010
This notice announces the inpatient hospital deductible and the hospital and extended care services coinsurance amounts for services furnished in calendar year (CY) 2010 under Medicare's Hospital Insurance Program (Medicare Part A). The Medicare statute specifies the formulae used to determine these amounts. For CY 2010, the inpatient hospital deductible will be $1,100. The daily coinsurance amounts for CY 2010 will be(a) $275 for the 61st through 90th day of hospitalization in a benefit period; (b) $550 for lifetime reserve days; and (c) $137.50 for the 21st through 100th day of extended care services in a skilled nursing facility in a benefit period.
Medicare Program; Part A Premium for Calendar Year 2010 for the Uninsured Aged and for Certain Disabled Individuals Who Have Exhausted Other Entitlement
This annual notice announces Medicare's Hospital Insurance (Part A) premium for uninsured enrollees in calendar year (CY) 2010. This premium is paid by enrollees age 65 and over who are not otherwise eligible for benefits under Medicare Part A (hereafter known as the ``uninsured aged'') and by certain disabled individuals who have exhausted other entitlement. The monthly Part A premium for the 12 months beginning January 1, 2010 for these individuals will be $461. The reduced premium for certain other individuals as described in this notice will be $254.
Medicare Program; Medicare Part B Monthly Actuarial Rates, Premium Rate, and Annual Deductible Beginning January 1, 2010
This notice announces the monthly actuarial rates for aged (age 65 and over) and disabled (under age 65) beneficiaries enrolled in Part B of the Medicare Supplementary Medical Insurance (SMI) program beginning January 1, 2010. In addition, this notice announces the monthly premium for aged and disabled beneficiaries as well as the income-related monthly adjustment amounts to be paid by beneficiaries with modified adjusted gross income above certain threshold amounts. The monthly actuarial rates for 2010 are $221.00 for aged enrollees and $270.40 for disabled enrollees. The standard monthly Part B premium rate for 2010 is $110.50, which is equal to 50 percent of the monthly actuarial rate for aged enrollees or roughly 25 percent of the expected average total cost of Part B coverage for aged enrollees. (The 2009 standard premium rate was $96.40.) The Part B deductible for 2010 is $155.00 for all Part B beneficiaries. A beneficiary who has to pay an income-related monthly adjustment may have to pay a total monthly premium of roughly 35, 50, 65 or 80 percent of the total cost of Part B coverage.
Request for Comment: National Center for Complementary and Alternative Medicine Announcement of Strategic Planning Background Papers
The National Center for Complementary and Alternative Medicine (NCCAM) is developing its third strategic plan and invites the public to provide comments on three background papers which will support the development of this plan. The papers will cover three topics: Mission, priority setting, and communications and decisionmaking. They will be publicly available through the NCCAM Web site at from on or about October 19 through November 19, 2009. The public is invited to provide comments through the NCCAM Web site.
Medicare Program; Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs
We are proposing revisions to the Medicare Advantage (MA) program (Part C) and prescription drug benefit program (Part D) based on our continued experience in the administration of the Part C and D programs. The proposed revisions clarify various program participation requirements; specify changes to strengthen beneficiary protections; ensure that plan offerings to beneficiaries include meaningful differences; improve plan payment rules and processes; and implement new policy such as a Part D formulary policy.
Meeting of the National Vaccine Advisory Committee
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the National Vaccine Advisory Committee (NVAC) will hold a meeting via teleconference. The meeting is open to the public. Pre-registration is not required, however, individuals who wish to participate in the public comment session should either e-mail nvpo@hhs.gov or call 202- 690-5566 to register and RSVP.
Wallace E. Gonsalves, Jr., MD: Debarment Order
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the act) permanently debarring Wallace E. Gonsalves, Jr., MD, from providing services in any capacity to a person that has an approved or pending drug product application. We base this order on a finding that Dr. Gonsalves was convicted of a felony under Federal law for conduct relating to the regulation of a drug product under the act. After being given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation, Dr. Gonsalves failed to request a hearing. Dr. Gonsalves' failure to request a hearing constitutes a waiver of his right to a hearing concerning this action.
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Cardiac Allograft Gene Expression Profiling Test Systems
The Food and Drug Administration (FDA) is announcing the classification of cardiac allograft gene expression profiling test systems into class II (special controls). The special control that will apply to the device is the guidance document entitled ``Class II Special Controls Guidance Document: Cardiac Allograft Gene Expression Profiling Test Systems.'' FDA classified the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for this device.
Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Cardiac Allograft Gene Expression Profiling Test Systems; Availability
The Food and Drug Administration (FDA) is announcing the availability of the special controls guidance document entitled ``Class II Special Controls Guidance Document: Cardiac Allograft Gene Expression Profiling Test Systems.'' This guidance document describes a means by which cardiac allograft gene expression profiling test systems may comply with the requirement of special controls for class II devices. It includes recommendations for validation of performance characteristics and recommendations for product labeling. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule codifying the classification of cardiac allograft gene expression profiling test systems into class II (special controls), and establishing this guidance document as the special control for this device.
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