Department of Health and Human Services May 2011 – Federal Register Recent Federal Regulation Documents

Medicare Program; Notification of Closure of St. Vincent's Medical Center
Document Number: 2011-13478
Type: Notice
Date: 2011-05-31
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the closure of St. Vincent's Medical Center and the initiation of an application process for hospitals to apply to the Centers for Medicare & Medicaid Services (CMS) to receive St. Vincent's Medical Center's full time equivalent (FTE) resident cap slots.
Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals
Document Number: 2011-13441
Type: Notice
Date: 2011-05-31
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 the information collection provisions of FDA's Current Good Manufacturing Practice (CGMP) Regulations for Finished Pharmaceuticals.
Cooperative Arrangement Between the United States Food and Drug Administration and the Inter-American Institute for Cooperation in Agriculture
Document Number: 2011-13440
Type: Notice
Date: 2011-05-31
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is providing notice of a cooperative arrangement between FDA and the Inter-American Institute for Cooperation in Agriculture. The purpose of the arrangement is to provide a framework between the two Agencies to facilitate the exchange of information and the development of projects of mutual interest.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2011-13421
Type: Notice
Date: 2011-05-31
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Determination of Regulatory Review Period for Purposes of Patent Extension; ACTEMRA
Document Number: 2011-13388
Type: Notice
Date: 2011-05-31
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for ACTEMRA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of Patents and Trademarks, Department of Commerce, for the extension of patents which claim that human biological product.
Permanent Certification Program for Health Information Technology; Revisions to ONC-Approved Accreditor Processes
Document Number: 2011-13372
Type: Proposed Rule
Date: 2011-05-31
Agency: Department of Health and Human Services, Office of the Secretary
Under the authority granted to the National Coordinator for Health Information Technology (the National Coordinator) 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 rule proposes 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 proposes to address 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.
Public Health Service Act (PHS); Delegation of Authority
Document Number: 2011-13371
Type: Notice
Date: 2011-05-31
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Office of the Director Amended Notice of Meeting
Document Number: 2011-13353
Type: Notice
Date: 2011-05-31
Agency: Department of Health and Human Services, National Institutes of Health
President's Committee for People With Intellectual Disabilities; Notice of Correction of Room for Meeting
Document Number: 2011-13337
Type: Notice
Date: 2011-05-31
Agency: Department of Health and Human Services, Administration for Children and Families
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2011-13333
Type: Notice
Date: 2011-05-31
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2011-13330
Type: Notice
Date: 2011-05-31
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2011-13328
Type: Notice
Date: 2011-05-31
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Submission for OMB Review; Comment Request
Document Number: 2011-13300
Type: Notice
Date: 2011-05-31
Agency: Department of Health and Human Services, Administration for Children and Families
HIPAA Privacy Rule Accounting of Disclosures Under the Health Information Technology for Economic and Clinical Health Act
Document Number: 2011-13297
Type: Proposed Rule
Date: 2011-05-31
Agency: Department of Health and Human Services, Office of the Secretary
The Department of Health and Human Services (HHS or ``the Department'') is issuing this notice of proposed rulemaking to modify the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule's standard for accounting of disclosures of protected health information. The purpose of these modifications is, in part, to implement the statutory requirement under the Health Information Technology for Economic and Clinical Health Act (``the HITECH Act'' or ``the Act'') to require covered entities and business associates to account for disclosures of protected health information to carry out treatment, payment, and health care operations if such disclosures are through an electronic health record. Pursuant to both the HITECH Act and its more general authority under HIPAA, the Department proposes to expand the accounting provision to provide individuals with the right to receive an access report indicating who has accessed electronic protected health information in a designated record set. Under its more general authority under HIPAA, the Department also proposes changes to the existing accounting requirements to improve their workability and effectiveness.
Privacy Act of 1974; System of Records
Document Number: 2011-13470
Type: Notice
Date: 2011-05-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Department of Health and Human Services (HHS) proposes to alter System of Records, 09-20-0147, ``Occupational Health Epidemiological Studies and EEOICPA Program Records, HHS/CDC/NIOSH'' In accordance with the requirements of the Privacy Act, the Centers for Disease Control and Prevention (CDC) is publishing notice of the amendment of the categories of individuals covered by the system of records; the categories of records; the authorities; and the purposes for maintenance of the system of records. In addition, we are proposing to add new routine uses. The purpose of these modifications is to provide notice that the National Institute for Occupational Safety and Health (NIOSH) is complying with the Privacy Act in executing its responsibilities under the James Zadroga 9/11 Health and Compensation Act of 2010 found at Title XXXIII of the Public Health Service Act, 42 U.S.C. 300mm300mm-61 (Title XXXIII). To reflect these changes, NIOSH is also revising the name of the system of records to ``Occupational Health Epidemiological Studies, EEOICPA Program Records and WTC Health Program Records, HHS/CDC/NIOSH.'' The entire resulting system of records notice, as amended, appears below.
Submission for OMB Review; Comment Request
Document Number: 2011-13259
Type: Notice
Date: 2011-05-27
Agency: Department of Health and Human Services, Administration for Children and Families
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2011-13257
Type: Notice
Date: 2011-05-27
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Proposed Information Collection Activity; Comment Request
Document Number: 2011-13216
Type: Notice
Date: 2011-05-27
Agency: Department of Health and Human Services, Administration for Children and Families
Agency Information Collection Activities: Proposed Collection: Comment Request
Document Number: 2011-13212
Type: Notice
Date: 2011-05-27
Agency: Department of Health and Human Services, Health Resources and Services Administration
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2011-13209
Type: Notice
Date: 2011-05-27
Agency: Department of Health and Human Services, Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection: Comment Request
Document Number: 2011-13206
Type: Notice
Date: 2011-05-27
Agency: Department of Health and Human Services, Health Resources and Services Administration
Advisory Commission on Childhood Vaccines; Notice of Meeting
Document Number: 2011-13205
Type: Notice
Date: 2011-05-27
Agency: Department of Health and Human Services, Health Resources and Services Administration
The Health Resources and Services Administration published a notice in the Federal Register, 76 FR 27651 (May 12, 2011), announcing the meeting of the Advisory Commission on Childhood Vaccines, June 9- 10, 2011, in the Parklawn Building (and via audio conference call), Conference Rooms G & H, 5600 Fishers Lane, Rockville, MD 20857.
Advisory Committee on Training in Primary Care Medicine and Dentistry; Notice of Meeting
Document Number: 2011-13203
Type: Notice
Date: 2011-05-27
Agency: Department of Health and Human Services, Health Resources and Services Administration
Council on Graduate Medical Education; Notice of Meeting
Document Number: 2011-13199
Type: Notice
Date: 2011-05-27
Agency: Department of Health and Human Services, Health Resources and Services Administration
Stephen Lee Seldon: Debarment Order
Document Number: 2011-13198
Type: Notice
Date: 2011-05-27
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) permanently debarring Stephen Lee Seldon, M.D. 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. Seldon was convicted of felonies under Federal law for conduct relating to the regulation of a drug product under the FD&C Act. Dr. Seldon was given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Dr. Seldon failed to respond. Dr. Seldon's failure to respond constitutes a waiver of his right to a hearing concerning this action.
Adrien E. Aiache: Debarment Order
Document Number: 2011-13196
Type: Notice
Date: 2011-05-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) (the Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Adrien Aiache, M.D. for 5 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on findings that Dr. Aiache was convicted of a misdemeanor under Federal law for conduct relating to the regulation of a drug product under the FD&C Act and that the type of conduct underlying the conviction undermines the process for the regulation of drugs. Dr. Aiache was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Dr. Aiache failed to respond. Dr. Aiache's failure to respond constitutes a waiver of his right to a hearing concerning this action.
Part C Early Intervention Services Grant Under the Ryan White HIV/AIDS Program
Document Number: 2011-13194
Type: Notice
Date: 2011-05-27
Agency: Department of Health and Human Services, Health Resources and Services Administration
HRSA will award non-competitively Ryan White HIV/AIDS Program, Part C funds to the Tutwiler Clinic, Tutwiler, Mississippi, to support comprehensive primary care services for persons living with HIV/AIDS, including primary medical care, laboratory testing, oral health care, outpatient mental health and substance abuse treatment, specialty and subspecialty care, referrals for health and support services and adherence monitoring/education services in order to ensure continuity of critical HIV medical care and treatment services, and to avoid a disruption of HIV clinical care to clients in Marks, Mississippi, and the surrounding counties.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2011-13039
Type: Notice
Date: 2011-05-27
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Meeting of the Presidential Advisory Council on HIV/AIDS; Correction
Document Number: 2011-12936
Type: Notice
Date: 2011-05-27
Agency: Department of Health and Human Services
The Department of Health and Human Services published a notice in the Federal Register of May 11, 2011 to announce a meeting of the Presidential Advisory Council on HIV/AIDS that will be held on Thursday, May 26, 2011, and Friday, May 27, 2011. The meeting is to be held from 10 a.m. to approximately 5 p.m. on May 26, 2011, and from 9 a.m. to approximately 3 p.m. on May 27, 2011. The meeting is scheduled to be held in the Department of Health and Human Services; Room 705A Hubert H. Humphrey Building; 200 Independence Avenue, SW.; Washington, DC 20201. The meeting dates have been changed.
National Institute of Environmental Health Sciences; Amended Notice of Meetings
Document Number: 2011-13123
Type: Notice
Date: 2011-05-26
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Environmental Health Sciences; Amended Notice of Meeting
Document Number: 2011-13122
Type: Notice
Date: 2011-05-26
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: 2011-13121
Type: Notice
Date: 2011-05-26
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: 2011-13120
Type: Notice
Date: 2011-05-26
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: 2011-13115
Type: Notice
Date: 2011-05-26
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2011-13110
Type: Notice
Date: 2011-05-26
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2011-13108
Type: Notice
Date: 2011-05-26
Agency: Department of Health and Human Services, National Institutes of Health
Government-Owned Inventions; Availability for Licensing
Document Number: 2011-13084
Type: Notice
Date: 2011-05-26
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.
Notice of Interest Rate on Overdue Debts
Document Number: 2011-13083
Type: Notice
Date: 2011-05-26
Agency: Department of Health and Human Services, Office of the Secretary
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2011-13082
Type: Notice
Date: 2011-05-26
Agency: Department of Health and Human Services, National Institutes of Health
Meeting of the National Vaccine Advisory Committee
Document Number: 2011-13081
Type: Notice
Date: 2011-05-26
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (DHHS) 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 register at https://www.hhs.gov/nvpo/nvac, e-mail nvpo@hhs.gov or call 202-690-5566 and provide name, organization and e-mail address.
Meeting of the National Vaccine Advisory Committee; Vaccine Safety Working Group
Document Number: 2011-13080
Type: Notice
Date: 2011-05-26
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (DHHS) is hereby giving notice that the Vaccine Safety Working Group (VSWG) of the National Vaccine Advisory Committee (NVAC) will hold a meeting. The meeting is open to the public. Pre-registration is required for public attendance. Individuals who wish to attend the meeting should register at https:// www.hhs.gov/nvpo/nvac, e- mail nvpo@hhs.gov or call 202-690-5566 and provide name, organization and e-mail address.
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2011-13079
Type: Notice
Date: 2011-05-26
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Complementary & Alternative Medicine; Notice of Closed Meeting
Document Number: 2011-13078
Type: Notice
Date: 2011-05-26
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: 2011-13074
Type: Notice
Date: 2011-05-26
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: 2011-13070
Type: Notice
Date: 2011-05-26
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Meeting
Document Number: 2011-13069
Type: Notice
Date: 2011-05-26
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study on Consumer Responses to Whole Grain Labeling Statements on Food Packages
Document Number: 2011-13060
Type: Notice
Date: 2011-05-26
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 a study entitled: ``Experimental Study on Consumer Responses to Whole Grain Labeling Statements on Food Packages.''
Food and Drug Administration Food Safety Modernization Act: Focus on Inspections and Compliance
Document Number: 2011-13059
Type: Notice
Date: 2011-05-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing a public meeting entitled ``FDA Food Safety Modernization Act: Focus on Inspections and Compliance.'' The purpose of the public meeting is to provide interested persons an opportunity to discuss implementation of inspections and compliance under the recently enacted FDA Food Safety Modernization Act (FSMA). More specifically, the public will have an opportunity to provide information and share views that will inform FDA's FSMA implementation strategies relative to enforcement authorities; frequency and targeting of facility inspections; manner of inspection in a preventive controls environment; and improving the reportable food registry (RFR).
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Draft Guidance for Industry and Food and Drug Administration Staff: Food and Drug Administration and Industry Procedures for Section 513(g) Requests for Information Under the Federal Food, Drug, and Cosmetic Act
Document Number: 2011-13058
Type: Notice
Date: 2011-05-26
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 (the PRA).
Breast and Cervical Cancer Early Detection and Control Advisory Committee (BCCEDCAC)
Document Number: 2011-13047
Type: Notice
Date: 2011-05-26
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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