Department of Health and Human Services 2008 – Federal Register Recent Federal Regulation Documents
Results 201 - 250 of 3,343
Draft Guidance for Industry on the Submission of Patent Information for Certain Old Antibiotics; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Submission of Patent Information for Certain Old Antibiotics.'' The draft guidance describes the agency's current thinking on the implementation of certain provisions of the Q1 Program Supplemental Funding Act (the Q1 Act) that concern old antibiotics and addresses which sponsors of new drug applications (NDAs) must submit patent information under the Q1 Act by December 5, 2008.
Medicare Program; Hospital Inpatient Prospective Payment Systems and Fiscal Year 2009 Rates: Fiscal Year 2009 Wage Index Changes Following Implementation of Section 124 of the Medicare Improvement for Patients and Providers Act of 2008
This notice contains fiscal year (FY) 2009 revised final wage indices and hospital reclassifications for 27 hospitals. These revised final wage indices and hospital reclassifications were made according to special procedural rules set forth in the FY 2009 hospital inpatient prospective payment systems final rule (73 FR 48588-9).
Medicaid Program; State Flexibility for Medicaid Benefit Packages
This final rule will implement provisions of section 6044 of the Deficit Reduction Act of 2005, which amends the Social Security Act by adding a new section 1937 related to the coverage of medical assistance under approved State plans. It also provides States increased flexibility under an approved State plan to define the scope of covered medical assistance by offering coverage of benchmark or benchmark-equivalent benefit packages to certain Medicaid recipients. In addition, this final rule responds to public comments on the February 22, 2008, proposed rule that pertain to the State Medicaid benefit package provisions.
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.
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.
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:// www.workplace.samhsa.gov and https://www.drugfreeworkplace.gov.
Proposed Substances To Be Evaluated for Set 23 Toxicological Profiles
This notice announces the list of proposed substances that will be evaluated for CERCLA Set 23 toxicological profile development. ATSDR's Division of Toxicology and Environmental Medicine is soliciting public nominations from the list of proposed substances to be evaluated for toxicological profile development. ATSDR also will consider the evaluation of any additional substances that may have public health implications.
Guidance for Sponsors, Clinical Investigators, and IRBs; Data Retention When Subjects Withdraw From FDA-Regulated Clinical Trials; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials.'' This guidance clarifies FDA's position that it is critical that data be retained from trial participants who decide to discontinue participation in a clinical study of an investigational product, who are withdrawn by their legally authorized representative, as applicable, or who were discontinued from participation by the clinical investigator. The guidance will be of interest especially to sponsors, clinical investigators, and members of investigational review boards (IRBs).
New Animal Drugs; Ractopamine
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by Elanco Animal Health. The NADA provides for use of ractopamine hydrochloride Type A medicated articles to make Type B and Type C medicated feeds used for increased rate of weight gain and improved feed efficiency in finishing turkeys.
Draft Guidance on Important Considerations for When Participation of Human Subjects in Research Is Discontinued
The Office for Human Research Protections (OHRP), Office of Public Health and Science, is announcing the availability of a draft guidance document entitled, ``Guidance on Important Considerations for When Participation of Human Subjects in Research is Discontinued,'' and is seeking comment on the draft guidance. The draft guidance document, when finalized, would provide OHRP's first formal guidance on this topic. The draft document, which is available on the OHRP Web site at https://www.hhs.gov/ohrp/requests/, is intended primarily for institutional review boards (IRBs), investigators, and funding agencies that may be responsible for the review or oversight of human subject research conducted or supported by the Department of Health and Human Services (HHS). OHRP will consider comments received before issuing the final guidance document.
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: ``Colorado Regional Health Information Exchange (CORHIO) Point of Care Exchange System Evaluation: Point of Care Questionnaires and Focus Groups.'' 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.
Medicare Program; Announcement of Meeting of the Advisory Panel on Medicare Education, January 13, 2009
In accordance with the Federal Advisory Committee Act, this notice announces a meeting of Advisory Panel on Medicare Education (the Panel). The Panel advises and makes recommendations to the Secretary of Health and Human Services and the Administrator of the Centers for Medicare & Medicaid Services on the effectiveness of consumer education strategies concerning the Medicare program. This meeting is open to the public.
Availability of an Update to the ATSDR Policy Guideline for Dioxins and Dioxin-Like Compounds in Residential Soil; Correction
Correction: This notice was published in the Federal Register on October 15, 2008, Volume 73, Number 200, page 61133. The original version of the ATSDR Dioxin Soil Policy that was posted on the ATSDR Web site at: https://www.atsdr.cdc.gov/substances/dioxin/policy prior to November 3, 2008, has been updated to include some minor edits to the policy. These updates are now available at the ATSDR Web site for your review.
Announcement of Seventh and Eighth Meetings of the Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2020
The U.S. Department of Health and Human Services (HHS) announces the seventh and eighth meetings of the Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2020 (Committee). These meetings will be open to the public. The Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2020 will address issues regarding the development and implementation of the nation's health promotion and disease prevention objectives for 2020 and activities to improve the health status of and reduce health risks for Americans by the year 2020. The Committee will provide to the Secretary of Health and Human Services advice and consultation for developing and implementing the next iteration of national health promotion and disease prevention goals and objectives and provide recommendations for initiatives to occur during the initial implementation phase of the goals and objectives. HHS will use the recommendations to inform the development of the national health promotion and disease prevention objectives for 2020 and the process for implementing the objectives. The intent is to develop and launch objectives designed to improve the health status and reduce health risks for Americans by the year 2020.
National Institute for Occupational Safety and Health; Decision To Evaluate a Petition To Designate a Class of Employees for the Standard Oil Development Company, Linden, NJ, To Be Iincluded in the Special Exposure Cohort
The Department of Health and Human Services (HHS) gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees for the Standard Oil Development Company, Linden, New Jersey, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: Standard Oil Development Company. Location: Linden, New Jersey. Job Titles and/or Job Duties: All employees. Period of Employment: August 1, 1942 through December 31, 1963.
Decision To Evaluate a Petition To Designate a Class of Employees for the United Nuclear Corp., Hematite, MO, To Be Included in the Special Exposure Cohort
The Department of Health and Human Services (HHS) gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees for the United Nuclear Corp., Hematite, Missouri, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: United Nuclear Corp. Location: Hematite, Missouri. Job Titles and/or Job Duties: All site employees. Period of Employment: January 1, 1958 through December 31, 1969, and from January 1, 1970 through July 31, 2006 (residual radiation period).
Medicare Program; Town Hall Meeting on the Fiscal Year 2010 Applications for New Medical Services and Technologies Add-on Payments Under the Hospital Inpatient Prospective Payment Systems, February 17, 2009
This notice announces a Town Hall meeting in accordance with section 1886(d)(5)(K)(viii) of the Social Security Act (the Act) to discuss fiscal year (FY) 2010 applications for add-on payments for new medical services and technologies under the hospital inpatient prospective payment systems. Interested parties are invited to this meeting to present their comments, recommendations, and data regarding whether the FY 2010 new medical services and technologies applications meet the substantial clinical improvement criterion.
Medicare Program; Rechartering of the Advisory Panel on Ambulatory Payment Classification Groups
This notice announces the Rechartering of the Advisory Panel on Ambulatory Payment Classification (APC) Groups (the Panel) by the Secretary, DHHS (the Secretary) for a 2-year period with the new charter effective through November 21, 2010.
Medicare and Medicaid Programs; Application by the Joint Commission for Continued Deeming Authority for Hospices
This proposed notice with comment period acknowledges the receipt of a deeming application from the Joint Commission for continued recognition as a national accrediting organization for hospices that wish to participate in the Medicare or Medicaid programs. Section 1865(b)(3)(A) of the Act, recodified under the Medicare Improvement for Patients and Providers Act of 2008 (Pub. L. 110-275, July 15, 2008) (MIPPA) as section 1865(a)(3)(A) requires that within 60 days of receipt of an organization's complete application, we publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.
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