Department of Health and Human Services July 2011 – Federal Register Recent Federal Regulation Documents
Results 201 - 288 of 288
Draft Guidance for Industry and Food and Drug Administration Staff; Enforcement Policy for Premarket Notification Requirements for Certain In Vitro Diagnostic and Radiology Devices; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Enforcement Policy for Premarket Notification Requirements for Certain In Vitro Diagnostic and Radiology Devices.'' This document describes FDA's intent with regard to enforcement of premarket notification (510(k)) requirements for certain in vitro diagnostic and radiology devices under the regulations. This draft guidance is not final nor is it in effect at this time.
Medicare Program; Home Health Prospective Payment System Rate Update for Calendar Year 2012
This proposed rule would update the Home Health Prospective Payment System (HH PPS) rates, including: The national standardized 60- day episode rates, the national per-visit rates, the low utilization payment amount (LUPA), and outlier payments under the Medicare prospective payment system for home health agencies effective January 1, 2012.
Medicaid Program; Face-to-Face Requirements for Home Health Services; Policy Changes and Clarifications Related to Home Health
This proposed rule would revise the Medicaid home health service definition as required by section 6407 of the Affordable Care Act to add a requirement that physicians document the existence of a face-to-face encounter (including through the use of telehealth) with the Medicaid eligible individual within reasonable timeframes. This proposal would align the timeframes with similar regulatory requirements for Medicare home health services in accordance with section 6407 of the Affordable Care Act and reflects CMS' commitment to the general principles of the President's Executive Order 13563 released January 18, 2011, entitled ``Improving Regulation and Regulatory Review.'' In addition, this rule proposes to amend home health services regulations to clarify the definitions of included medical supplies, equipment and appliances, and clarify that States may not limit home health services to services delivered in the home, or to services furnished to individuals who are homebound.
Meeting of the National Advisory Council for Healthcare Research and Quality
In accordance with section 10(a) of the Federal Advisory Committee Act, 5 U.S.C. App. 2, this notice announces a meeting of the National Advisory Council for Healthcare Research and Quality.
New Animal Drugs; Change of Sponsor's Name and Address
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor's name from Alpharma, LLC, to Alpharma, LLC, a wholly owned subsidiary of Pfizer, Inc. The sponsor's mailing address will also be changed.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Additional Criteria and Procedures for Classifying Over-the-Counter Drugs as Generally Recognized as Safe and Effective and Not Misbranded
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Additional Criteria and Procedures for Classifying Over-the-Counter Drugs as Generally Recognized as Safe and Effective and Not Misbranded'' 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; Voluntary Cosmetic Registration Program
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Voluntary Cosmetic Registration Program'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
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.
National Institutes of Health
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.
New Proposed Collection; Comment Request; Study Logistic Formative Research Methodology Studies for the National Children's Study
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institute of Child Health and Human Development (NIHCD), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. This proposed information collection was previously published in the Federal Register on April 27, 2011, pages 23605-23606, and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment.
Agency Information Collection Activities; Proposed Collection; Comment Request; Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms
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 information collection requirements for the labeling of natural rubber latex condoms.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic Records; Electronic Signatures
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.
Oral Dosage Form New Animal Drugs; Change of Sponsor
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for a new animal drug application (NADA) from Virbac AH, Inc., to Cross Vetpharm Group Ltd.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Revised Draft Guidance for Industry on User Fee Waivers, Reductions, and Refunds for Drug and Biological Products; Availability
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).
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Applications for Food and Drug Administration Approval to Market a New Drug; Postmarketing Reports; Reporting Information About Authorized Generic Drugs
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Exports: Notification and Recordkeeping Requirements
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.
Medicare Program; Changes to the End-Stage Renal Disease Prospective Payment System for CY 2012, End-Stage Renal Disease Quality Incentive Program for PY 2013 and PY 2014; Ambulance Fee Schedule; and Durable Medical Equipment
This proposed rule would update and make certain revisions to the End-Stage Renal Disease (ESRD) prospective payment system (PPS) for calendar year (CY) 2012. This proposed rule would also set forth proposed requirements for the ESRD quality incentive program (QIP) for payment years (PYs) 2013 and 2014. In addition, this proposed rule would revise the ambulance fee schedule regulations to conform with statutory changes. Finally, this proposed rule would revise the definition of durable medical equipment (DME) by adding a 3-year minimum lifetime criterion that must be met by an item or device in order to be considered durable for the purpose of classifying the item under the Medicare benefit category for DME. (See the Table of Contents for a listing of the specific issues addressed in this proposed rule.)
Administrative Simplification: Adoption of Operating Rules for Eligibility for a Health Plan and Health Care Claim Status Transactions
Section 1104 of the Administrative Simplification provisions of the Patient Protection and Affordable Care Act (hereafter referred to as the Affordable Care Act) establishes new requirements for administrative transactions that will improve the utility of the existing HIPAA transactions and reduce administrative costs. Specifically, in section 1104(b)(2) of the Affordable Care Act, Congress required the adoption of operating rules for the health care industry and directed the Secretary of Health and Human Services to ``adopt a single set of operating rules for each transaction * * * with the goal of creating as much uniformity in the implementation of the electronic standards as possible.'' This interim final rule with comment period adopts operating rules for two Health Insurance Portability and Accountability Act of 1996 (HIPAA) transactions: eligibility for a health plan and health care claim status. This rule also defines the term ``operating rules'' and explains the role of operating rules in relation to the adopted transaction standards. In general, transaction standards adopted under HIPAA enable electronic data interchange through a common interchange structure, thus minimizing the industry's reliance on multiple formats. Operating rules, in turn, attempt to define the rights and responsibilities of all parties, security requirements, transmission formats, response times, liabilities, exception processing, error resolution and more, in order to facilitate successful interoperability between data systems of different entities.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance for Industry, Third Parties and Food and Drug Administration Staff; Medical Device ISO 13485:2003 Voluntary Audit Report Submission Program
The Food and Drug Administration (FDA) is announcing that a
Announcement of a Grant Award
The Administration for Children and Families (ACF), Office of
Design of Clinical Trials for Systemic Antibacterial Drugs for the Treatment of Acute Otitis Media; Public Workshop
The Food and Drug Administration (FDA) is announcing a public
Agency Information Collection Activities: Proposed Collection; Comment Request
This notice announces the intention of the Agency for
Regulatory Agenda
The following Agenda presents the results of the statutorily
New Animal Drugs; Change of Sponsor's Address
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of address for Huvepharma AD, a sponsor of approved new animal drug applications.
Request for Notification From Industry Organizations Interested in Participating in the Selection Process for a Nonvoting Industry Representative and Request for Nominations for a Nonvoting Industry Representative on an FDA Advisory Committee
The Food and Drug Administration (FDA) is requesting that any industry organizations interested in participating in the selection of a nonvoting industry representative to serve on its Cellular, Tissue, and Gene Therapies Advisory Committee notify FDA in writing. FDA is also requesting nominations for nonvoting industry representatives to serve its Cellular, Tissue, and Gene Therapies Advisory Committee. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nomination will be accepted for current vacancies effective with this notice.
Tobacco Products, Exemptions From Substantial Equivalence Requirements
The Food and Drug Administration (FDA) is issuing this final rule to establish procedures for requesting an exemption from the substantial equivalence requirements of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). The final rule describes the process and statutory criteria for requesting an exemption and explains how FDA reviews requests for exemptions. This regulation satisfies the requirement in the Tobacco Control Act that FDA issue regulations implementing the exemption provision.
Medicare Program; Hospital Inpatient Value-Based Purchasing Program; Correction
This document corrects technical errors that appeared in the final rule published in the Federal Register on May 6, 2011 (76 FR 26490) entitled ``Medicare Program; Hospital Inpatient Value-Based Purchasing Program.''
Meeting of the Advisory Committee on Minority Health
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (DHHS) is hereby giving notice that the Advisory Committee on Minority Health (ACMH) will hold a meeting. This meeting is open to the public. Preregistration is required for both public attendance and comment. Any individual who wishes to attend the meeting and/or participate in the public comment session should e-mail acmh@osophs.dhhs.gov.
Medicare Program; Section 3113: The Treatment of Certain Complex Diagnostic Laboratory Tests Demonstration
This notice informs interested parties of an opportunity to participate in the Treatment of Certain Complex Diagnostic Laboratory Tests Demonstration. The Demonstration is mandated by section 3113 of the Affordable Care Act. This notice also serves to notify interested parties that they must obtain a temporary code from CMS for tests currently billed using a ``not otherwise classified (NOC)'' code but that would otherwise meet the criteria set forth in section 3113 for being a complex diagnostic laboratory test under the Demonstration. The statute requires a Report to Congress that includes an assessment of the impact of the Demonstration on access to care, quality of care, health outcomes, and expenditures.
Negotiated Rulemaking Committee on Designation of Medically Underserved Populations and Health Professional Shortage Areas; Notice of Meeting
In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), notice is hereby given of the following meeting of the Negotiated Rulemaking Committee on Designation of Medically Underserved Populations and Health Professional Shortage Areas.
Draft Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications and Related Issues; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.'' The draft guidance, when finalized, will assist industry in deciding when a premarket safety notification for a dietary supplement containing a new dietary ingredient (NDI) is necessary and in preparing premarket safety notifications (also referred to as ``NDI notifications'').
Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of Comparative Direct-to-Consumer Advertising
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 Experimental Study of Comparative Direct-to-Consumer (DTC) Advertising. This study is designed to explore how consumers understand and interpret DTC ads that explicitly compare the efficacy, dosing, and risks, among other items, of two similar drugs whether comparisons are named or unnamed.
Food and Drug Administration (FDA) and Marine Environmental Sciences Consortium/Dauphin Island Sea Lab Collaboration (U19)
The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of a cooperative agreement between the Center for Food Safety and Applied Nutrition (CFSAN) and the Marine Environmental Sciences Consortium/Dauphin Island Sea Lab (DISL). The goal of the DISL is marine science education, basic and applied marine science research, coastal zone management policy, and educating the general public.
Submission for OMB Review; Comment Request; Food Reporting Comparison Study (FORCS) and Food and Eating Assessment Study (FEAST) (NCI)
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Cancer Institute (NCI), the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on April 15, 2011 (76 FR 21383). One public comment was received on April 15 requesting a copy of the data collection package. The submission was sent to the requestor on April 21. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Proposed Collection: Title: Food Reporting Comparison Study (FORCS) and Food and Eating Assessment Study (FEAST) (NCI). Type of Information Collection Request: Extension. Need and Use of Information Collection: The title of this collection was previously, ``24-Hour Dietary Recall Method Comparison and the National Cancer Institute (NCI) Observational Feeding Studies.'' The objective of the two studies is to compare the performance of the newly developed computerized Automated Self- Administered 24-Hour Recall (ASA24) approach to collecting 24-hour recall (24HR) data with the current standard, the interviewer- administered Automated Multiple Pass Method (AMPM). The ultimate goal is to determine to what extent the new automated instrument can be used instead of the more expensive interviewer-administered instrument in the collection of dietary intake data. Frequency of Response: Twice. Affected Public: Individuals. Type of Respondents: For the FORCS study, approximately 1,200 adult members from three health maintenance organization plans (in Minnesota, California, and Michigan) between ages 20 and 70 years. For the FEAST study, approximately 90 adult residents from the Washington, DC metropolitan area between ages 20 and 70 years. The annual reporting burden is estimated at 866 hours (see table below). This amounts to an estimated 2598 burden hours over the 3-year data collection period with a total cost to the respondents $54,293. There are no Capital costs, Operating costs, and/or Maintenance costs to report.
New Proposed Collection; Comment Request; Neuropsychosocial Measures Formative Research Methodology Studies for the National Children's Study
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institute of Child Health and Human Development (NICHD), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. This proposed information collection was previously published in the Federal Register on May 2, 2011, pages 24497-24498, and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Experimental Study of Format Variations in the Brief Summary of Direct-to-Consumer Print Advertisements
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.
World Trade Center Health Program Requirements for the Addition of New WTC-Related Health Conditions
Title I of the James Zadroga Health and Compensation Act of 2010 amended the Public Health Service Act (PHS Act) to establish the World Trade Center (WTC) Health Program. Sections 3311, 3312, and 3321 of Title XXXIII of the PHS Act require that the WTC Program Administrator develop regulations to implement portions of the WTC Health Program established within the Department of Health and Human Services (HHS). The WTC Health Program, which will be administered in part by the Director of the National Institute for Occupational Safety and Health (NIOSH), within the Centers for Disease Control and Prevention (CDC), will provide medical monitoring and treatment to eligible firefighters and related personnel, law enforcement officers, and rescue, recovery and cleanup workers who responded to the September 11, 2001, terrorist attacks in New York City, Shanksville, PA, and at the Pentagon, and to eligible survivors of the New York City attacks. The proposed rule establishes the processes by which the WTC Program Administrator may add a new condition to the list of WTC-related health conditions through rulemaking, including a process for considering petitions by interested parties to add a new condition.
Oral Dosage Form New Animal Drugs; Amprolium
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 Cross Vetpharm Group Ltd. The ANADA provides for the use of amprolium soluble powder as an aid in the treatment and prevention of coccidiosis in calves.
World Trade Center Health Program Requirements for Enrollment, Appeals, Certification of Health Conditions, and Reimbursement
Title I of the James Zadroga Health and Compensation Act of 2010 amended the Public Health Service Act (PHS Act) by adding Title XXXIII, which establishes the World Trade Center (WTC) Health Program. Sections 3311, 3312, and 3321 of Title XXXIII of the PHS Act require that the WTC Program Administrator develop regulations to implement portions of the WTC Health Program established within the Department of Health and Human Services (HHS). The WTC Health Program, which will be administered in part by the Director of the National Institute for Occupational Safety and Health (NIOSH), within the Centers for Disease Control and Prevention (CDC), will provide medical monitoring and treatment to eligible firefighters and related personnel, law enforcement officers, and rescue, recovery and cleanup workers who responded to the September 11, 2001, terrorist attacks in New York City, Shanksville, PA, and at the Pentagon, and to eligible survivors of the New York City attacks. This interim final rule establishes the processes by which eligible responders and survivors may apply for enrollment in the WTC Health Program, obtain health monitoring and treatment for WTC-related health conditions, and appeal enrollment and treatment decisions. This interim final rule also establishes a process for the certification of health conditions, and reimbursement rates for providers who provide initial health evaluations, treatment, and health monitoring.
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