Department of Health and Human Services March 2013 – Federal Register Recent Federal Regulation Documents

Results 151 - 200 of 347
Agency Information Collection Activities; Proposed Collection; Comment Request
Document Number: 2013-06217
Type: Notice
Date: 2013-03-20
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed changes to the currently approved information collection project: ``Medical Expenditure Panel Survey Insurance Component.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on December 26th, 2012 and allowed 60 days for public comment. Two comments were received. The purpose of this notice is to allow an additional 30 days for public comment.
Patient Safety Organizations: Voluntary Relinquishment From Universal Safety Solution PSO
Document Number: 2013-06216
Type: Notice
Date: 2013-03-20
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act), Public Law 109-41, 42 U.S.C. 299b-21b-26, provides for the formation of Patient Safety Organizations (PSOs), which collect, aggregate, and analyze confidential information regarding the quality and safety of health care delivery. The Patient Safety and Quality Improvement Final Rule (Patient Safety Rule), 42 CFR part 3, authorizes AHRQ, on behalf of the Secretary of HHS, to list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found no longer to meet the requirements of the Patient Safety Act and Patient Safety Rule, or when a PSO chooses to voluntarily relinquish its status as a PSO for any reason. AHRQ has accepted a notification of voluntary relinquishment from Universal Safety Solution PSO of its status as a PSO, and has delisted the PSO accordingly.
Patient Safety Organizations: Voluntary Relinquishment From QAISys, Inc.
Document Number: 2013-06215
Type: Notice
Date: 2013-03-20
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act), Public Law 109-41, 42 U.S.C. 299b-21 b-26, provides for the formation of Patient Safety Organizations (PSOs), which collect, aggregate, and analyze confidential information regarding the quality and safety of health care delivery. The Patient Safety and Quality Improvement Final Rule (Patient Safety Rule), 42 CFR part 3, authorizes AHRQ, on behalf of the Secretary of HHS, to list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found no longer to meet the requirements of the Patient Safety Act and Patient Safety Rule, or when a PSO chooses to voluntarily relinquish its status as a PSO for any reason. AHRQ has accepted a notification of voluntary relinquishment from QAISys, Inc. of its status as a PSO, and has delisted the PSO accordingly.
Tobacco Product Manufacturing Practice; Establishment of a Public Docket
Document Number: 2013-06288
Type: Proposed Rule
Date: 2013-03-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is establishing a public docket to obtain input on recommendations for regulations on good manufacturing practice for tobacco products that were submitted to FDA by a group of 13 tobacco companies (tobacco companies' recommendations). FDA is establishing this docket to provide an opportunity for all interested parties to comment on the tobacco companies' recommendations and to share information that will improve FDA's understanding of the tobacco industry and its manufacturing operations.
Agency Information Collection Activities; Proposed Collection; Public Comment Request
Document Number: 2013-06281
Type: Notice
Date: 2013-03-19
Agency: Department of Health and Human Services, Office of the Secretary
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit a new Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Medicare and Medicaid Programs; Requirements for Long-Term Care (LTC) Facilities; Notice of Facility Closure
Document Number: 2013-06276
Type: Rule
Date: 2013-03-19
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This rule adopts, with technical changes, the interim rule that published February 18, 2011. That interim rule revised the requirements that a long-term care (LTC) facility must meet in order to qualify to participate as a skilled nursing facility (SNF) in the Medicare program, or a nursing facility (NF) in the Medicaid program. The requirements implemented section 6113 of the Patient Protection and Affordable Care Act to ensure that, among other things, in the case of an LTC facility closure, individuals serving as administrators of a SNF or NF provide written notification of the impending closure and a plan for the relocation of residents at least 60 days prior to the impending closure or, if the Secretary terminates the facility's participation in Medicare or Medicaid, not later than the date the Secretary determines appropriate.
Office of the Director, National Institutes of Health; Notice of Closed Meeting
Document Number: 2013-06249
Type: Notice
Date: 2013-03-19
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2013-06248
Type: Notice
Date: 2013-03-19
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review Notice of Closed Meeting
Document Number: 2013-06247
Type: Notice
Date: 2013-03-19
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2013-06246
Type: Notice
Date: 2013-03-19
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meetings
Document Number: 2013-06245
Type: Notice
Date: 2013-03-19
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Meeting
Document Number: 2013-06244
Type: Notice
Date: 2013-03-19
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meeting
Document Number: 2013-06243
Type: Notice
Date: 2013-03-19
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-06242
Type: Notice
Date: 2013-03-19
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2013-06241
Type: Notice
Date: 2013-03-19
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2013-06240
Type: Notice
Date: 2013-03-19
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Assistant Secretary for Financial Resources, Office of Grants and Acquisition Policy and Accountability, Division of Acquisition; Public Availability of the Department of Health and Human Services FY 2011 Service Contract Inventory; Correction
Document Number: 2013-06218
Type: Notice
Date: 2013-03-19
Agency: Department of Health and Human Services
This document makes changes to the notice published in the February 28, 2013 Federal Register entitled ``Office of the Assistant Secretary for Financial Resources, Office of Grants and Acquisition Policy and Accountability, Division of Acquisition; Public Availability of the Department of Health and Human Services FY 2011 Service Contract Inventory.'' The following should be changed: The notice provided an incorrect URL address: http://www.hhs.gov/grants/ servicecontractsfy11.html. The correct URL address is as follows: http://www.hhs.gov/grants/servicecontracts/index.html. The FY 2011 needs to be changed to FY 2012 in the TITLE, ACTION, and SUMMARY sections. This document makes these technical corrections.
General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
Document Number: 2013-06167
Type: Notice
Date: 2013-03-18
Agency: Food and Drug Administration, Department of Health and Human Services
Shu Bei Yuan: Debarment Order
Document Number: 2013-06165
Type: Notice
Date: 2013-03-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Shu Bei Yuan for a period of 5 years from importing articles of food or offering such articles for importation into the United States. FDA bases this order on a finding that Ms. Yuan was convicted of one felony count under Federal law for conduct relating to the importation into the United States of an article of food. Ms. Yuan was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. As of December 31, 2012 (30 days after receipt of the notice), Ms. Yuan had not responded. Ms. Yuan's failure to respond constitutes a waiver of her right to a hearing concerning this action.
Medicare Program; Part B Inpatient Billing in Hospitals
Document Number: 2013-06163
Type: Proposed Rule
Date: 2013-03-18
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The proposed rule would revise Medicare Part B billing policies when a Part A claim for an hospital inpatient admission is denied as not medically reasonable and necessary.
Medicare Program; Medicare Hospital Insurance (Part A) and Medicare Supplementary Medical Insurance (Part B)
Document Number: 2013-06159
Type: Rule
Date: 2013-03-18
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces a CMS Ruling that establishes a policy that revises the current policy on Part B billing following the denial of a Part A inpatient hospital claim by a Medicare review contractor on the basis that the inpatient admission was determined not reasonable and necessary. This revised policy is intended as an interim measure until CMS can finalize a policy to address the issues raised by the Administrative Law Judge and Medicare Appeals Council decisions going forward. To that end, elsewhere in this issue of the Federal Register, we published a proposed rule entitled, ``Medicare Program; Part B Inpatient Billing in Hospitals,'' to propose a permanent policy that would apply on a prospective basis.
International Conference on Harmonisation; Proposed Change to Rodent Carcinogenicity Testing of Pharmaceuticals; Request for Comments
Document Number: 2013-06145
Type: Notice
Date: 2013-03-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is considering a proposed change to the International Conference on Harmonisation (ICH) Sl guidance on rodent carcinogenicity testing. The goal of this potential change is to introduce a more comprehensive and integrated approach to address the risk of human carcinogenicity of small molecule pharmaceuticals, and to define conditions under which 2- year rodent carcinogenicity studies add value to that assessment. The basis of this proposed change is the retrospective analyses of several datasets that reflect three decades of experience with such studies. The datasets suggest that knowledge of certain pharmacologic and toxicologic data can sometimes provide sufficient information to anticipate the outcome of 2-year rodent studies and their potential value in predicting the risk of human carcinogenicity of a given pharmaceutical. FDA is requesting public comment regarding a proposed change in approach to carcinogenicity assessment, on the prospective evaluation period intended to test this new approach, and on the proposed weight-of-evidence factors for carcinogenicity assessment.
Impax Laboratories, Inc.; Withdrawal of Approval of Bupropion Hydrochloride Extended-Release Tablets, 300 Milligrams
Document Number: 2013-06144
Type: Notice
Date: 2013-03-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is withdrawing approval of Bupropion Hydrochloride (HCl) Extended-Release Tablets, 300 Milligrams (mg) (Bupropion HCl Extended-Release Tablets 300 mg), under Abbreviated New Drug Application (ANDA) 77-415, held by Impax Laboratories, Inc. (Impax), 30831 Huntwood Ave., Hayward, CA 94544, and marketed under the name BUDEPRION XL. Impax has voluntarily requested that approval for this product be withdrawn and waived its opportunity for a hearing.
Center for Drug Evaluation and Research Medical Policy Council; Request for Comments
Document Number: 2013-06142
Type: Notice
Date: 2013-03-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the establishment of a docket to receive suggestions, recommendations, and comments for topics from interested parties, including academic institutions, regulated industry, patient representatives, and other interested organizations, on medical policy issues that may be considered by the CDER Medical Policy Council (Council) in FDA's Center for Drug Evaluation and Research (CDER). These comments will help the Agency identify and address medical policy issues that need clarification through guidance, notice and comment procedures, or other means.
Agency Information Collection Activities; Proposed Collection; Comment Request; Draft Guidance for Industry and FDA Staff; Total Product Life Cycle: Infusion Pump-Premarket Notification [510(k)] Submissions
Document Number: 2013-06128
Type: Notice
Date: 2013-03-18
Agency: Food and Drug Administration, Department of Health and Human Services
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 ``Guidance for Industry and FDA Staff; Total Product Life Cycle: Infusion PumpPremarket Notification [510(k)] Submissions.''
Agency Information Collection Activities; Proposed Collection; Comment Request; Requirements Under the Comprehensive Smokeless Tobacco Health Education Act of 1986, as Amended by the Family Smoking Prevention and Tobacco Control Act
Document Number: 2013-06127
Type: Notice
Date: 2013-03-18
Agency: Food and Drug Administration, Department of Health and Human Services
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 submission of rotational plans for health warning label statements for smokeless tobacco products.
Government-Owned Inventions; Availability for Licensing
Document Number: 2013-06070
Type: Notice
Date: 2013-03-18
Agency: Department of Health and Human Services, 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.
Prospective Grant of Start-Up Option Exclusive License: The Development of Liposomal Therapeutic Agents for the Treatment of Human Epithelial Cancers and Liposarcomas
Document Number: 2013-06069
Type: Notice
Date: 2013-03-18
Agency: Department of Health and Human Services, National Institutes of Health
This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant to ZoneOne Pharma, Inc., of an exclusive evaluation option license to practice the inventions embodied in the following US Patent (and all foreign counterparts): Serial No. 6,890,917 entitled, ``Geldanamycin Derivative and Method of Treating Cancer Using Same'' [HHS Ref. E-050-2000/0-US- 15]. The patent rights in this invention have been assigned to the Government of the United States of America. The prospective exclusive evaluation option license territory may be worldwide, and the field of use may be limited to:
Office of the Assistant Secretary for Planning and Evaluation; Advisory Council on Alzheimer's Research, Care, and Services
Document Number: 2013-06065
Type: Notice
Date: 2013-03-15
Agency: Department of Health and Human Services
HHS is soliciting nominations for a new, non-Federal member of the Advisory Council on Alzheimer's Research, Care, and Services to fill the position of representative of a voluntary health association as described in Public Law 111-375 (42 U.S.C. 11225). Nominations should include the nominee's contact information (current mailing address, email address, and telephone number) and current curriculum vitae or resume.
Delegation of Authority
Document Number: 2013-06057
Type: Notice
Date: 2013-03-15
Agency: Department of Health and Human Services, Administration for Children and Families
Authorities under the Developmental Disabilities Assistance and Bill of Rights Act of 2000 are being delegated from the Assistant Secretary, Administration for Children and Families, to the Administrator, Administration for Community Living (ACL). This action is necessary to complete the transition of the Administration on Intellectual and Developmental Disabilities to the Administration for Community Living from the Administration for Children and Families, consistent with the Federal Register notice of reorganization as last amended, 77 FR 23250-23260, April 18, 2012.
Delegation of Authority
Document Number: 2013-06056
Type: Notice
Date: 2013-03-15
Agency: Department of Health and Human Services, Administration for Children and Families
The delegation of authorities for Title II, Subpart D, Parts 2 and 5 of the Help America Vote Act are being delegated from the Assistant Secretary, Administration for Children and Families, to the Administrator, Administration for Community Living (ACL). This action is necessary to complete the transition of the Administration on Intellectual and Developmental Disabilities to the Administration for Community Living from the Administration for Children and Families, consistent with the Federal Register notice of reorganization as last amended, 77 FR 23250-23260, April 18, 2012.
Statement of Organization, Functions and Delegations of Authority
Document Number: 2013-06043
Type: Notice
Date: 2013-03-15
Agency: Department of Health and Human Services, Health Resources and Services Administration
Secretary's Advisory Committee on Heritable Disorders in Newborns and Children; Notice of Meeting
Document Number: 2013-06042
Type: Notice
Date: 2013-03-15
Agency: Department of Health and Human Services, Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2013-06038
Type: Notice
Date: 2013-03-15
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Institutional Review Boards; Correcting Amendments
Document Number: 2013-06030
Type: Rule
Date: 2013-03-15
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending its regulations regarding institutional review boards to address a minor correction to the regulatory text and to update contact information. This action is editorial in nature and is intended to provide accuracy and clarity to the Agency's regulations.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2013-06029
Type: Notice
Date: 2013-03-15
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Establishing and Maintaining a List of U.S. Dairy Product Manufacturers/Processors With Interest in Exporting to Chile
Document Number: 2013-06017
Type: Notice
Date: 2013-03-15
Agency: Food and Drug Administration, Department of Health and Human Services
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 OMB Review; Comment Request
Document Number: 2013-06004
Type: Notice
Date: 2013-03-15
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Prospective Grant of Exclusive License: Chimeric West Nile/Dengue Viruses
Document Number: 2013-05990
Type: Notice
Date: 2013-03-15
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
This is a notice in accordance with 35 U.S.C. 209(e) and 37 CFR 404.7(a)(1)(i) that the Technology Transfer Office, Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS), is thinking about giving an exclusive license, in the field of use of in vitro diagnostics for dengue virus infection, to practice the inventions listed in the patent applications referred to below to CTK Biotech Inc., having a place of business in San Diego, California. The patent rights in these inventions have been assigned to the government of the United States of America. The patent applications(s) to be licensed are:
Notice of Hearing: Reconsideration of Disapproval of Florida State Plan Amendments (SPA) 12-015
Document Number: 2013-05978
Type: Notice
Date: 2013-03-15
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces an administrative hearing to be held on April 30, 2013, at the CMS Atlanta Regional Office, Atlanta Federal Center, 3rd Floor, 61 Forsyth Street SW., Suite 3B52, Atlanta, Georgia 30303-8909, to reconsider CMS' decision to disapprove Florida SPA 12- 015.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Interstate Shellfish Dealer's Certificate
Document Number: 2013-05970
Type: Notice
Date: 2013-03-15
Agency: Food and Drug Administration, Department of Health and Human Services
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.
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2013-05969
Type: Notice
Date: 2013-03-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2013-05968
Type: Notice
Date: 2013-03-15
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Information Collection Activity; Comment Request
Document Number: 2013-05935
Type: Notice
Date: 2013-03-15
Agency: Department of Health and Human Services, Administration for Children and Families
Amendment to Information Collection Activity; Comment Request
Document Number: 2013-05772
Type: Notice
Date: 2013-03-15
Agency: Department of Health and Human Services, Administration for Children and Families
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2013-05850
Type: Notice
Date: 2013-03-14
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2013-05849
Type: Notice
Date: 2013-03-14
Agency: Department of Health and Human Services, National Institutes of Health