Department of Health and Human Services May 2010 – Federal Register Recent Federal Regulation Documents
Results 251 - 300 of 311
Office of Refugee Resettlement; Urgent Single Source Grant to Survivors of Torture International (SOTI)
Notice is hereby given that an urgent single-source award will be made to Survivors of Torture International (SOTI), San Diego, CA, to provide comprehensive rehabilitative services to incoming Iraqi and other survivors of torture, who are in need of specialized services, to regain their health and independence and rebuild productive lives. In addition to providing direct services, SOTI will train area providers to effectively serve this population and leverage resources within the community. SOTI will also focus on building and sustaining collaboration among other providers to serve this population.
Administration for Children and Families; Single-Source Program Expansion Supplement Grant
The Office of Refugee Resettlement (ORR) announces the award of a $150,000 single-source program expansion supplement to expand the provision of technical assistance to the Ethiopian Community Development Council, Inc. (ECDC), located in Arlington, VA.
Food Protection Workshop; Public Workshop
The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Southwest Regional Office (SWRO), in co-sponsorship with the University of Arkansas (UA) Institute of Food Science and Engineering, is announcing a public workshop entitled ``Food Protection Workshop.'' This public workshop is intended to provide information about food safety, food defense, the regulations authorized by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), and other related subjects to the Food Protection Plan as it relates to food establishments such as farms, manufacturers, processors, distributors, retailers, and restaurants.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not Individually Identifiable
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guidance on Informed Consent For In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not Individually Identifiable'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments and Listing of Ingredients in Tobacco Products
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 (the PRA).
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. The meeting is open to the public. Pre-registration is required for both public attendance and comment. Individuals who wish to attend the meeting and/or participate in the public comment session should either e-mail nvpo@hhs.gov or call 202-690-5566 to register.
Decision To Evaluate a Petition To Designate a Class of Employees From the Hanford Site, Richland, WA, To Be Included in the Special Exposure Cohort
HHS gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees from the Hanford site, Richland, Washington, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows:
Decision to Evaluate a Petition to Designate a Class of Employees From the Los Alamos National Laboratory, Los Alamos, NM, To Be Included in the Special Exposure Cohort
HHS gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees from the Los Alamos National Laboratory, Los Alamos, New Mexico, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows:
Decision to Evaluate a Petition to Designate a Class of Employees From BWX Technologies Inc., Lynchburg, VA, To Be Included in the Special Exposure Cohort
HHS gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees from BWX Technologies Inc., Lynchburg, Virginia, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows:
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Investigational Device Exemptions Reports and Records
The Food and Drug Administration (FDA) is announcing that a collection of information entitled `` Investigational Device Exemptions Reports and Records21 CFR Part 812'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Exception From General Requirements for Informed Consent
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.
Early Retiree Reinsurance Program
This interim final rule with comment period (IFC) implements the Early Retiree Reinsurance Program, which was established by section 1102 of the Patient Protection and Affordable Care Act (the Affordable Care Act). The Congress appropriated funding of $5 billion for the temporary program. Section 1102(a)(1) requires the Secretary to establish this temporary program not later than 90 days after enactment of the statute, which is June 21, 2010. The program ends no later than January 1, 2014. The program provides reimbursement to participating employment-based plans for a portion of the cost of health benefits for early retirees and their spouses, surviving spouses and dependents. The Secretary will reimburse plans for certain claims between $15,000 and $90,000 (with those amounts being indexed for plan years starting on or after October 1, 2011). The purpose of the reimbursement is to make health benefits more affordable for plan participants and sponsors so that health benefits are accessible to more Americans than they would otherwise be without this program.
Findings of Misconduct in Science
Notice is hereby given that on March 18, 2010, the Department of Health and Human Services (HHS) Debarring Official, on behalf of the Secretary of HHS, issued a final notice of debarment based on the misconduct in science findings of the Office of Research Integrity (ORI) in the following case:
Guidance for Industry on Documenting Statistical Analysis Programs and Data Files; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry 197 entitled ``Documenting Statistical Analysis Programs and Data Files.'' This guidance is provided to inform study statisticians of recommendations for documenting statistical analyses and data files submitted to the Center for Veterinary Medicine (CVM) for the evaluation of safety and effectiveness in new animal drug applications. These recommendations are intended to encompass the most complex data submissions to CVM, to reduce the number of revisions that may be required for CVM to effectively review statistical analyses and to simplify submission preparation by providing a uniform documentation system.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry, Food and Drug Administration, and Foreign Governments: Fiscal Year 2010 Medical Device User Fee Small Business Qualification and Certification
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guidance for Industry, FDA, and Foreign Governments: Fiscal Year 2010 Medical Device User Fee Small Business Qualification and Certification'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Administrative Detention and Banned Medical Devices
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Administrative Detention and Banned Medical Devices'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Medical Device User Fee Cover Sheet-Form FDA 3601
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Medical Device User Fee Cover SheetForm FDA 3601'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Notification
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 premarket notification.
Withdrawal of Approval of New Animal Drug Applications; Coumaphos; Novobiocin; Buquinolate and Lincomycin
The Food and Drug Administration (FDA) is withdrawing approval of three new animal drug applications (NADAs). In a final rule published elsewhere in this issue of the Federal Register, FDA is amending the animal drug regulations to remove portions reflecting approval of the single NADA of the three that is codified.
Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of a New Animal Drug Application; Buquinolate; Coumaphos
The Food and Drug Administration (FDA) is amending the animal drug regulations by removing those portions that reflect approval of two new animal drug applications (NADAs). In a notice published elsewhere in this issue of the Federal Register, FDA is withdrawing approval of these NADAs.
Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 023
The Food and Drug Administration (FDA) is announcing a publication containing modifications the agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA recognized consensus standards). This publication, entitled ``Modifications to the List of Recognized Standards, Recognition List Number: 023'' (Recognition List Number: 023), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.
Determination That BREVIBLOC (Esmolol Hydrochloride) Injection, 250 Milligrams/Milliliter, 10-Milliliter Ampule, Was Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that BREVIBLOC (esmolol hydrochloride (HCl)) Injection, 250 milligrams (mg)/ milliliter (mL), 10-mL ampule, was withdrawn from sale for reasons of safety or effectiveness. This determination means the agency will not accept or approve abbreviated new drug applications (ANDAs) for esmolol HCl injection, 250 mg/mL, 10-mL ampule.
Medicare and Medicaid Programs; Changes in Provider and Supplier Enrollment, Ordering and Referring, and Documentation Requirements; and Changes in Provider Agreements
This interim final rule with comment period implements several provisions set forth in the Patient Protection and Affordable Care Act (Affordable Care Act). It implements the provision which requires all providers of medical or other items or services and suppliers that qualify for a National Provider Identifier (NPI) to include their NPI on all applications to enroll in the Medicare and Medicaid programs and on all claims for payment submitted under the Medicare and Medicaid programs. This interim final rule with comment period also requires physicians and eligible professionals to order and refer covered items and services for Medicare beneficiaries to be enrolled in Medicare. In addition, it adds requirements for providers, physicians, and other suppliers participating in the Medicare program to provide documentation on referrals to programs at high risk of waste and abuse, to include durable medical equipment, prosthetics, orthotics and supplies (DMEPOS), home health services, and other items or services specified by the Secretary.
Health Care Reform Insurance Web Portal Requirements
The Patient Protection and Affordable Care Act (the Affordable Care Act) was enacted on March 23, 2010. It requires the establishment of an internet Web site (hereinafter referred to as a Web portal) through which individuals and small businesses can obtain information about the insurance coverage options that may be available to them in their State. The Department of Health and Human Services (HHS) is issuing this interim final rule in order to implement this mandate. This interim final rule adopts the categories of information that will be collected and displayed as Web portal content, and the data we will require from issuers and request from States, associations, and high risk pools in order to create this content.
Fiscal Year (FY) 2010 Funding Opportunity
This notice is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) intends to award approximately $620,000 for up to three years to the grantee of the Technical Assistance Center for Mental Health Promotion and Youth Violence Prevention. This is not a formal request for applications. Assistance will be provided only to the current grantee of the Technical Assistance Center for Mental Health Promotion and Youth Violence Prevention based on the receipt of a satisfactory application that is approved by an independent review group.
Medicare Program; Proposed Changes to the Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Proposed Fiscal Year 2011 Rates; Effective Date of Provider Agreements and Supplier Approvals; and Hospital Conditions of Participation for Rehabilitation and Respiratory Care Services Medicaid Program: Accreditation Requirements for Providers of Inpatient Psychiatric Services for Individuals Under Age 21
We are proposing to revise the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals to implement changes arising from our continuing experience with these systems. In addition, in the Addendum to this proposed rule, we describe the proposed changes to the amounts and factors used to determine the rates for Medicare acute care hospital inpatient services for operating costs and capital-related costs. These proposed changes would be applicable to discharges occurring on or after October 1, 2010. We also are setting forth the proposed update to the rate-of-increase limits for certain hospitals excluded from the IPPS that are paid on a reasonable cost basis subject to these limits. The proposed updated rate-of-increase limits would be effective for cost reporting periods beginning on or after October 1, 2010.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format
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.
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