Department of Health and Human Services June 2008 – Federal Register Recent Federal Regulation Documents
Results 51 - 100 of 304
Office of Refugee Resettlement; Unaccompanied Alien Children Shelter Care Facilities
This notice announces that the Administration for Children and Families (ACF), Office of Refugee Resettlement intends to award ten unaccompanied alien shelter care providers in the amount of $2,521,320. This funding will support services through September 30, 2008.
Guidance for Industry: Microbiological Considerations for Antimicrobial Food Additive Submissions; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Guidance for Industry: Microbiological Considerations for Antimicrobial Food Additive Submissions.'' The guidance explains FDA's current thinking on a number of microbiological issues unique to the preparation of premarket submissions for antimicrobial food additives.
Oral Dosage Form New Animal Drugs; Sulfachlorpyridazine Powder
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Fort Dodge Animal Health, A Division of Wyeth Holdings Corp. The supplemental NADA provides for a revised food safety warning statement for oral use of sulfachlorpyridazine in the milk or milk replacer of ruminating calves.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Infant Formula Recall Regulations
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.
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.
Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practices and Related Regulations for Blood and Blood Components; and Requirements for Donor Testing, Donor Notification, and “Lookback”
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 requirements relating to FDA's regulation of current good manufacturing practice and related regulations for blood and blood components; and requirements for donor testing, donor notification, and ``lookback.''
Agency Information Collection Activities: Proposed Collection; Comment Request
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 information collection project: ``Assessing the Impact of the Patient Safety Improvement Corps (PSIC) Training Program.'' In accordance with the Paperwork Reduction Act of 1995, 44 U.S.C. 3506(c)(2)(A), AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on April 16th, 2008 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.
Determination of Regulatory Review Period for Purposes of Patent Extension; ERAXIS
The Food and Drug Administration (FDA) has determined the regulatory review period for ERAXIS and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.
Medical Devices; Change of Name; Technical Amendment
The Food and Drug Administration (FDA) is amending its regulations to implement a nomenclature change and to ensure accuracy and clarity in the agency's regulations.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Temporary Marketing Permit Applications
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.
New Animal Drugs; Change of Sponsor's Drug Labeler Code
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor's drug labeler code for ADM Alliance Nutrition, Inc. This action is being taken to improve the accuracy of the regulations.
Notice Regarding Revisions to the Laboratory Protocol To Measure the Quantity of Nicotine Contained in Smokeless Tobacco Products Manufactured, Imported, or Packaged in the United States
The uniform protocol for the analysis of nicotine, total moisture, and pH in smokeless tobacco products, originally published in the Federal Register in 1999 (64 FR 14086), ``Notice Regarding Requirement for Annual Submission of the Quantity of Nicotine Contained in Smokeless Tobacco Products Manufactured, Imported, or Packaged in the United States,'' and revised in the Federal Register on March 14, 2008 (73 FR 13903), implements the requirement of the Comprehensive Smokeless Tobacco Health Education Act (CSTHEA) of 1986 (15 U.S.C. 4401 et seq., Pub. L. 99-252) that each entity manufacturing, packaging, or importing smokeless tobacco products shall annually provide the Secretary of Health and Human Services (HHS) with a specification of the quantity of nicotine contained in each smokeless tobacco product. CDC is re-publishing the notice published in the Federal Register on March 14, 2008 (73 FR 13903) concerning the revision of the protocol for analysis of nicotine in smokeless tobacco products (hereinafter referred to as ``Protocol'') to (1) make a technical change to correct the date when the first report of information under the revised Protocol is due; (2) solicit public comments concerning a change in the Protocol that increased the volume of water in the pH determination from 10 mL to 20 mL, and (3) solicit public comments concerning the addition of the following commercial smokeless tobacco product categories: Dry snuff portion packs, snus, snus portion packs, and pellet or compressed. The Protocol as published in the Federal Register on March 14, 2008 (73 FR 13903), remains in effect with the technical correction to the date described below. Technical change: The language in the March 14, 2008 notice stated that ``The first report of information is due June 30, 2008, with subsequent submissions due by March 31 of each year.'' The first report date of information should be 2009 so that the sentence correctly reads: ``The first report of information is due June 30, 2009, with subsequent submissions due by March 31 of each year.''
Meeting of the Secretary's Advisory Committee on Human Research Protections
Pursuant to Section 10(a) of the Federal Advisory Committee Act, U.S.C. Appendix 2, notice is hereby given that the Secretary's Advisory Committee on Human Research Protections (SACHRP) will hold its sixteenth meeting. The meeting will be open to the public.
Reimbursement of Travel and Subsistence Expenses Toward Living Organ Donation Eligibility Guidelines
This notice finalizes an amendment to the eligibility guidelines proposed on March 5, 2008, in the Federal Register (73 FR 11930). The purpose of this notice was to solicit comments on the amendment to the Program Eligibility Guidelines proposed by HRSA concerning the Reimbursement of Travel and Subsistence Expenses Program.
Notice of Intent To Prepare an Environmental Impact Statement for the Transport of Laboratory Personnel Exposed to Infectious Agents From Fort Detrick, Frederick, MD to the National Institutes of Health Clinical Center, Bethesda, MD
In accordance with the National Environmental Policy Act, 42 U.S.C. 4321-4347, the NIH is issuing this notice to advise the public that an environmental impact statement will be prepared for the transport of laboratory personnel exposed to infectious agents from Fort Detrick, Frederick, Maryland to the National Institutes of Health Clinical Center, Bethesda, Maryland.
Notice of Public Comment on Tribal Consultation Sessions To Be Held on July 21, July 23, and July 31, 2008
Pursuant to the Improving Head Start for School Readiness Act of 2007, Public Law 110-134, notice is hereby given of three one-day Tribal Consultation Sessions to be held between the Department of Health and Human Services, Administration for Children and Families, Office of Head Start leadership and the leadership of Tribal governments operating Head Start (including Early Head Start) programs. The purpose of these Consultation Sessions is to discuss ways to better meet the needs of Indian, including Alaska Native, children and their families, taking into consideration funding allocations, distribution formulas, and other issues affecting the delivery of Head Start services in their geographic locations [42.U.S.C. 9835, Section 640(l)(4)]. Dates & Locations: July 21, 2008Kansas City, Missouri. July 23, 2008Denver, Colorado. July 31, 2008Seattle, Washington.
Danisco USA, Inc.; Withdrawal of Food Additive Petition
The Food and Drug Administration (FDA) is announcing the withdrawal, without prejudice to a future filing, of a food additive petition (FAP 6A3958) proposing that the food additive regulations be amended to provide for the safe use of alitame as a sweetening agent or flavoring in food.
Office of the National Coordinator for Health Information Technology; American Health Information Community Personalized Healthcare Workgroup Meeting
This notice announces the 17th meeting of the American Health Information Community Personalized Healthcare Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.).
Office of the National Coordinator for Health Information Technology; American Health Information Community Chronic Care Workgroup Meeting
This notice announces the 26th meeting of the American Health Information Community Chronic Care Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.).
Office of the National Coordinator for Health Information Technology; American Health Information Community Confidentiality, Privacy, & Security Workgroup Meeting
This notice announces the 21st meeting of the American Health Information Community Confidentiality, Privacy, & Security Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.).
Office of the National Coordinator for Health Information Technology; American Health Information Community Population Health and Clinical Care Connections Workgroup Meeting
This notice announces the 28th meeting of the American Health Information Community Population Health and Clinical Care Connections Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.).
Office of the National Coordinator for Health Information Technology; American Health Information Community Electronic Health Records Workgroup Meeting
This notice announces the 24th meeting of the American Health Information Community Electronic Health Records Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.).
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