Department of Health and Human Services March 3, 2011 – Federal Register Recent Federal Regulation Documents

National Institute on Aging; Notice of Closed Meeting
Document Number: 2011-4826
Type: Notice
Date: 2011-03-03
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Research Resources; Notice of Closed Meetings
Document Number: 2011-4825
Type: Notice
Date: 2011-03-03
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2011-4824
Type: Notice
Date: 2011-03-03
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2011-4823
Type: Notice
Date: 2011-03-03
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: 2011-4784
Type: Notice
Date: 2011-03-03
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: 2011-4783
Type: Notice
Date: 2011-03-03
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2011-4782
Type: Notice
Date: 2011-03-03
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 2011-4781
Type: Notice
Date: 2011-03-03
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meeting
Document Number: 2011-4780
Type: Notice
Date: 2011-03-03
Agency: Department of Health and Human Services, National Institutes of Health
Albert Poet: Debarment Order
Document Number: 2011-4778
Type: Notice
Date: 2011-03-03
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 Albert Poet, 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. Poet was convicted of felonies under Federal law for conduct relating to the regulation of a drug product under the FD&C Act. Dr. Poet was given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Dr. Poet failed to respond. Dr. Poet's failure to respond constitutes a waiver of his right to a hearing concerning this action.
National Cancer Institute; Notice of Closed Meetings
Document Number: 2011-4777
Type: Notice
Date: 2011-03-03
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Amended Notice of Meeting
Document Number: 2011-4775
Type: Notice
Date: 2011-03-03
Agency: Department of Health and Human Services, National Institutes of Health
Advisory Committee on Organ Transplantation; Notice of Meeting
Document Number: 2011-4755
Type: Notice
Date: 2011-03-03
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 of February 9, 2011 (76 FR 7223-7224) announcing an Advisory Committee on Organ Transplantation meeting on March 8, 2011. The type of meeting, time and place have been changed.
Medicare, Medicaid, and Children's Health Insurance Programs; Renewal, Expansion, and Renaming of the Advisory Panel on Outreach and Education (APOE) and Request for Nominations
Document Number: 2011-4754
Type: Notice
Date: 2011-03-03
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces that the charter of the Advisory Panel on Medicare Education (APME), as renamed the Advisory Panel on Outreach and Education (APOE), has been renewed and the scope of the charter has been expanded. It also requests nominations for individuals to serve on the APOE.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Radioactive Drug Research Committees
Document Number: 2011-4741
Type: Notice
Date: 2011-03-03
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; Proposed Collection; Comment Request; Infant Formula Label Statements Experimental Study
Document Number: 2011-4740
Type: Notice
Date: 2011-03-03
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 ``Infant Formula Label Statements Experimental Study.''
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Expanded Access to Investigational Drugs for Treatment Use
Document Number: 2011-4739
Type: Notice
Date: 2011-03-03
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Expanded Access to Investigational Drugs for Treatment Use'' 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; Testing Communications on Medical Devices and Radiation-Emitting Products
Document Number: 2011-4738
Type: Notice
Date: 2011-03-03
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Testing Communications on Medical Devices and Radiation-Emitting Products'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Drugs for Human Use; Unapproved and Misbranded Oral Drugs Labeled for Prescription Use and Offered for Relief of Symptoms of Cold, Cough, or Allergy; Enforcement Action Dates
Document Number: 2011-4703
Type: Notice
Date: 2011-03-03
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing its intention to take enforcement action against unapproved and misbranded oral drug products that are labeled for prescription use and offered for relief of symptoms of cold, cough, or allergy and persons who manufacture or cause the manufacture of such products. These drug products are marketed without approved applications, and many are inappropriately labeled for use in infants and young children. These drug products must obtain FDA approval of a new drug application (NDA) or an abbreviated new drug application (ANDA), or comply with an FDA over-the-counter (OTC) drug final monograph, before marketing.
Drugs for Human Use; Drug Efficacy Study Implementation; Oral Prescription Drugs Offered for Relief of Symptoms of Cough, Cold, or Allergy; Withdrawal of Hearing Requests; Final Resolution of Dockets
Document Number: 2011-4702
Type: Notice
Date: 2011-03-03
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that all outstanding hearing requests pertaining to oral prescription drugs offered for relief of symptoms of cough, cold, or allergy, Docket Nos. FDA-1981-N-0077 (formerly 81N-0393), FDA-1981-N-0248 (formerly 81N- 0396), FDA-1982-N-0046 (formerly 82N-0095), FDA-1982-N-0264 (formerly 82N-0096), and FDA-1983-N-0137 (formerly 83N-0095), have been withdrawn. Therefore, shipment in interstate commerce of the products identified in those dockets, or any identical, related, or similar (IRS) product that is not the subject of an approved new drug application (NDA) or abbreviated new drug application (ANDA) (other than an over-the-counter (OTC) product that complies with an applicable OTC monograph), is unlawful as of the effective date of this notice.
Current List of Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
Document Number: 2011-4620
Type: Notice
Date: 2011-03-03
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
The Department of Health and Human Services (HHS) notifies Federal agencies of the Laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908); September 30, 1997 (62 FR 51118); April 13, 2004 (69 FR 19644); November 25, 2008 (73 FR 71858); December 10, 2008 (73 FR 75122); and on April 30, 2010 (75 FR 22809). A notice listing all currently certified Laboratories and Instrumented Initial Testing Facilities (IITF) is published in the Federal Register during the first week of each month. If any Laboratory/IITF's certification is suspended or revoked, the Laboratory/IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any Laboratory/IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at https:// www.workplace.samhsa.gov and https://www.drugfreeworkplace.gov.
Temperature-Indicating Devices; Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers
Document Number: 2011-4475
Type: Rule
Date: 2011-03-03
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending its regulations for thermally processed low-acid foods packaged in hermetically sealed containers to allow for use of other temperature- indicating devices, in addition to mercury-in-glass thermometers, during processing. This final rule also establishes recordkeeping requirements relating to temperature-indicating devices and reference devices maintained by the processor and allows for the use of advanced technology for measuring and recording temperatures during processing. Finally, this final rule includes metric equivalents of avoirdupois (U.S.) measurements where appropriate. This final rule will allow low- acid canned food processors to transition from mercury-in-glass thermometers to alternative temperature-indicating devices. Use of temperature-indicating devices that do not contain mercury will eliminate concerns about potential contamination of the food or the processing environment from broken mercury-in-glass thermometers. Elsewhere in this issue of the Federal Register, FDA is publishing a 30-day notice announcing that it has submitted the information collection provisions of this final rule to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (the PRA). The notice also invites the public to submit comments on the information provisions to OMB. Prior to the effective date of this final rule, FDA will publish a notice in the Federal Register announcing OMB's decision to approve, modify, or disapprove the information collection provisions of the final rule.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Canning Establishment Registration, Process Filing, and Recordkeeping for Acidified Foods and Thermally Processed Low-Acid Foods in Hermetically Sealed Containers
Document Number: 2011-4474
Type: Notice
Date: 2011-03-03
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).
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