Department of Health and Human Services 2006 – Federal Register Recent Federal Regulation Documents
Results 651 - 700 of 3,314
Genes and Environment Initiative (GEI)-Exposure Biology Program; GEI-Exposure Biology RFA Application Information Meeting
An Application Information Meeting, hosted by the National Institute of Environmental Health Sciences (NIEHS), the National Cancer Institute (NCI), the National Heart, Lung, and Blood Institute (NHLBI), and the National Institute on Drug Abuse (NIDA), will be held on October 20, 2006, on the NIEHS campus in Research Triangle Park, North Carolina. The meeting will include an overview of the Exposure Biology Program, presentations on the five funding opportunities, an overview of the cooperative agreement mechanism and Grants Management and Review issues, and a question and answer session addressing RFA-related questions.
Privacy Act of 1974; Report of a Modified or Altered System of Records
In accordance with the Privacy Act of 1974, we are proposing to modify or alter an existing SOR, ``Medicare Managed Care Beneficiary Reconsideration (RECON) System,'' System No. 09-70-4003, last published at 67 Federal Register 48179 (July 23, 2002). We propose to assign a new CMS identification number to this system to simplify the obsolete and confusing numbering system originally designed to identify the Bureau, Office, or Center within CMS that maintained the system of records. The new assigned identifying number for this system should read: System No. 09-70-0533. We propose to modify existing routine use number 1 that permits disclosure to agency contractors and consultants to include disclosure to CMS grantees who perform a task for the agency. CMS grantees, charged with completing projects or activities that require CMS data to carry out that activity, are classified separate from CMS contractors and/or consultants. The modified routine use will remain as routine use number 1. We will delete routine use number 5 authorizing disclosure to support constituent requests made to a congressional representative. If an authorization for the disclosure has been obtained from the data subject, then no routine use is needed. The Privacy Act allows for disclosures with the ``prior written consent'' of the data subject. We will broaden the scope of routine uses number 7 and 8, authorizing disclosures to combat fraud and abuse in the Medicare and Medicaid programs to include combating ``waste'' which refers to specific beneficiary/recipient practices that result in unnecessary cost to all Federally-funded health benefit programs We are modifying the language in the remaining routine uses to provide a proper explanation as to the need for the routine use and to provide clarity to CMS' intention to disclose individual-specific information contained in this system. The routine uses will then be prioritized and reordered according to their usage. We will also take the opportunity to update any sections of the system that were affected by the recent reorganization or the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Public Law 108-173) provisions and to update language in the administrative sections to correspond with language used in other CMS SORs. The primary purpose of this modified system is to collect and maintain information necessary to process requests for reconsideration of service requests or claims by or on behalf of Medicare managed care enrollees, promote the effectiveness and integrity of the Medicare managed care program, and reply to future correspondence related to the case. The information retrieved from this system of records will also be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor or consultant; (2) assist another Federal or state agency; (3) assist third party contacts; (4) assist Quality Improvement Organizations; (5) support litigation involving the agency; and (6) combat fraud, waste, and abuse in Federally-funded health benefit programs. We have provided background information about the modified system in the SUPPLEMENTARY INFORMATION section below. Although the Privacy Act requires only that CMS provide an opportunity for interested persons to comment on the modified or altered routine uses, CMS invites comments on all portions of this notice. See ``Effective Dates'' section for comment period.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Labeling; Trans Fatty Acids in Nutrition Labeling
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.
Guidance for Industry on Investigating Out-of-Specification Test Results for Pharmaceutical Production; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Investigating Out- of-Specification (OOS) Test Results for Pharmaceutical Production.'' This guidance provides information for the pharmaceutical industry on how to evaluate laboratory test results that fall outside of specification limits. The guidance is intended to provide clear and consistent communication of regulatory expectations and to promote voluntary compliance with current FDA requirements.
Office of the National Coordinator for Health Information Technology, American Health Information Community Meeting
This notice announces the ninth meeting of the American Health Information Community in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.) The American Health Information Community will advise the Secretary and recommend specific actions to achieve a common interoperability framework for health information technology (IT).
Recordkeeping Requirements for Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing, Material From Cattle
The Food and Drug Administration (FDA) is requiring that manufacturers and processors of human food and cosmetics that are manufactured from, processed with, or otherwise contain, material from cattle establish and maintain records sufficient to demonstrate that the human food or cosmetic is not manufactured from, processed with, or does not otherwise contain, prohibited cattle materials. These recordkeeping requirements provide documentation for the provisions in FDA's interim final rule entitled ``Use of Materials Derived From Cattle in Human Food and Cosmetics.'' FDA is requiring recordkeeping because manufacturers and processors of human food and cosmetics need records to ensure that their products do not contain prohibited cattle materials, and records are necessary to help FDA ensure compliance with the requirements of the interim final rule.
Redetermination of Regulatory Review Period for Purposes of Patent Extension; BONIVA; Correction
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of June 22, 2006 (71 FR 35918). The document announced that FDA had determined the regulatory review period for BONIVA. The notice provided that on or before August 21, 2006, anyone with knowledge that any of the dates as published are incorrect may submit a request for a redetermination of the regulatory review period. A request for revision of the regulatory review period was filed for the product on July 25, 2006. FDA reviewed its records and found that the effective date of the investigational new drug application (IND) was incorrect because of a clerical error. Therefore, FDA is republishing a determination of the regulatory review period to reflect the corrected effective date for the IND. FDA has made a determination of the regulatory review period 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.
Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
The Department of Health and Human Services (HHS) notifies Federal agencies of the laboratories currently certified to meet the standards of Subpart C 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), on September 30, 1997 (62 FR 51118), and on April 13, 2004 (69 FR 19644). A notice listing all currently certified laboratories is published in the Federal Register during the first week of each month. If any laboratory's certification is suspended or revoked, the laboratory will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory 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:// workplace.samhsa.gov and https://www.drugfreeworkplace.gov.
Request for Nominations for Voting Members on Public Advisory Panels or Committees
The Food and Drug Administration (FDA) is requesting nominations for voting members to serve on the Device Good Manufacturing Practice Advisory Committee, certain device panels of the Medical Devices Advisory Committee, the National Mammography Quality Assurance Advisory Committee, and the Technical Electronic Products Radiation Safety Standards Committee in the Center for Devices and Radiological Health. Nominations will be accepted for current vacancies and those that will or may occur through August 31, 2007. FDA has a special interest in ensuring that women, minority groups, and individuals with disabilities are adequately represented on advisory committees and, therefore, encourages nominations of qualified candidates from these groups.
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) allow the proposed information collection project: ``Assessment of Unreimbursed Care among Community Primary Care Physicians.'' In accordance with the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)), AHRQ invites the public to comment on this proposed information collection.
Notice of 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 acmb@osophs.dhhs.gov.
Medicare Program; Hospital Inpatient Prospective Payment Systems and Fiscal Year 2007 Rates: Final Fiscal Year 2007 Wage Indices and Payment Rates After Application of Revised Occupational Mix Adjustment to Wage Index
This notice contains tables listing the final occupational mix adjusted wage indices, hospital reclassifications, payment rates, impacts, and other related tables as a result of the application of the occupational mix adjustment to 100 percent of the wage index effective for fiscal year (FY) 2007.
Oral Dosage Form New Animal Drugs; Omeprazole
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 Merial Ltd. The supplemental NADA provides for administration of omeprazole paste to horses for 8 or 28 days for the prevention of gastric ulcers.
Office of the National Coordinator for Health Information Technology; American Health Information Community Biosurveillance Workgroup Meeting
This notice announces the tenth meeting of the American Health Information Community Biosurveillance Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-4363, 5 U.S.C., App.).
Notice of Hearing: Reconsideration of Disapproval of Oregon State Plan Amendment 05-003
This notice announces an administrative hearing to be held on December 8, 2006, at 2201 6th Street, Suite 1101, Seattle, Washington 98121, to reconsider CMS' decision to disapprove Oregon State plan amendment 05-003. Closing Date: Requests to participate in the hearing as a party must be received by the presiding officer by October 23, 2006.
Fogarty International Center (FIC) 2007-2011 Strategic Plan
The FIC is initiating a strategic planning process to culminate in the FIC Strategic Plan 2007-2011. To anticipate and set priorities for global health research and research training, FIC requests input from scientists, the general public, and interested parties. The goal of this strategic planning process is to identify current and future needs and directions for global health research. The existing FIC strategic plan can be viewed at https://www.fic/nih.gov/ about/plan/StrategicPlan.pdf.
Prospective Grant of an Exclusive License: Development and Commercialization of Therapeutic Products for Autoimmune Diseases Including Rheumatoid Arthritis (RA), Inflammatory Bowel Disease (IBD) and Psoriasis
This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), announces that the Department of Health and Human Services is contemplating the grant of an exclusive license to practice the inventions embodied in United States Patent Application Number 60/ 181,909 entitled ``Identification of a Novel Domain in the Tumor Necrosis Factor Receptor Family that Mediates Pre-ligand Receptor Assembly and Function'' filed February 11, 2000 (HHS Ref. No. E-095- 2000/0-US-01); U.S. Patent Application No. PCT/US01/04125 entitled ``Identification of a Novel Domain in the Tumor Necrosis Factor Receptor Family that Mediates Pre-ligand Receptor Assembly and Function'' filed February 9, 2001, 2000 (HHS Ref. No. E-095-2000/0-PCT- 02); U.S. Patent Application No. 10/203,495, filed August 9, 2002, entitled ``Identification of Novel Domain in the Tumor Necrosis Factor Receptor Family that Mediates Pre-ligand Receptor Assembly and Function'' (E- 095-2000/0-US-03); U.S. Patent Application No. 60/694,015 entitled ``Amelioration of Inflammatory Arthritis Targeting the Pre-ligand Assembly Domain (PLAD) of Tumor Necrosis Factor Receptors'' filed June 24, 2005 [E-095-2000/2-US-01]; U.S. Patent Application No. 60/717,589 entitled ``Amelioration of Inflammatory Arthritis Targeting the Pre- ligand Assembly Domain (PLAD) of Tumor Necrosis Factor Receptors'' filed September 16, 2005 [E-095-2000/3-US-01]; U.S. PCT Application entitled ``A Potential Novel Therapeutic Protein Molecule of Inflammatory Arthritis Targeting the Pre-ligand Assembly Domain (PLAD) of Tumor Necrosis Factor Receptor Type 1'' filed February 9, 2001 [E- 095-2000/4-PCT-01]; European Patent Application No. 01910476.9 entitled ``Identification of Novel Domain in the Tumor Necrosis Factor Receptor Family that Mediates Pre-ligand Receptor Assembly and Function'' filed February 9, 2001 [E-095-2000/0-EP-06]; Australian Patent Application No. 2001238076 entitled ``Identification of Novel Domain in the Tumor Necrosis Factor Receptor Family that Mediates Pre-ligand Receptor Assembly and Function'' issued on February 9, 2001 [E-095-2000/0-AU- 04]; and Canadian Patent Application No. 2399388 entitled ``Identification of Novel Domain in the Tumor Necrosis Factor Receptor Family that Mediates Pre-ligand Receptor Assembly and Function'' filed February 9, 2001, [E-095-2000/0-CA-05] to Domantis, Inc. The prospective exclusive license territory may be worldwide and the field of use may be limited to therapeutic applications for autoimmune diseases including rheumatoid arthritis (RA) inflammatory bowel disease (IBD) and psoriasis as covered under the agreement and based upon the Patent Rights.
Request for Nominations for Nonvoting Members Representing Industry Interests on Public Advisory Panels or Committees
The Food and Drug Administration (FDA) is requesting nominations for nonvoting industry representatives to serve on the National Mammography Quality Assurance Advisory Committee (NMQAAC) and certain device panels of the Medical Devices Advisory Committee in the Center for Devices and Radiological Health.
Guidance for Industry on Bar Code Label Requirements-Questions and Answers; Availability
The Food and Drug Administration (FDA) is announcing the availability of additional questions and answers that are being incorporated into the final guidance document entitled ``Guidance for Industry: Bar Code Label RequirementsQuestions and Answers.'' This final guidance is dated October 2006. The additional questions and answers relate to blood and blood components intended for transfusion and requirements that their container labels bear certain machine- readable information. These requirements were part of the final rule on bar code label requirements for human drugs published on February 26, 2004.
Head Start Program
This rule finalizes the provisions of the proposed rule published on May 30, 2006 and responds to public comments received as a result of the proposed rule. This final rule authorizes approval of annual waivers, under certain circumstances, from two provisions in the current Head Start transportation regulation (45 CFR part 1310): the requirement that each child be seated in a child restraint system while the vehicle is in motion, and the requirement that each bus have at least one bus monitor on board at all times. Waivers would be granted when the Head Start or Early Head Start grantee demonstrates that compliance with the requirement(s) for which the waiver is being sought will result in a significant disruption to the Head Start program or the Early Head Start program and that waiving the requirement(s) is in the best interest of the children involved. The rule also revises the definition of child restraint system in the regulation to remove the reference to weight which now conflicts with Federal Motor Vehicle Safety Standards. The regulation also reflects new effective dates for Sec. 1310.12(a) and 1310.22(a) on the required use of school buses or allowable alternate vehicles and the required availability of such vehicles adapted for use of children with disabilities, as the result of enactment of Section 224 of Public Law 109-149 and Section 7012 of Public Law 109-234.
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