Department of Health and Human Services 2008 – Federal Register Recent Federal Regulation Documents

Results 251 - 300 of 3,343
Federal Financial Participation in State Assistance Expenditures; Federal Matching Shares for Medicaid, the State Children's Health Insurance Program, and Aid to Needy Aged, Blind, or Disabled Persons for October 1, 2009 Through September 30, 2010
Document Number: E8-28233
Type: Notice
Date: 2008-11-26
Agency: Office of the Secretary, Department of Health and Human Services
The Federal Medical Assistance Percentages and Enhanced Federal Medical Assistance Percentages for Fiscal Year 2010 have been calculated pursuant to the Social Security Act (the Act). These percentages will be effective from October 1, 2009 through September 30, 2010. This notice announces the calculated ``Federal Medical Assistance Percentages'' and ``Enhanced Federal Medical Assistance Percentages'' that The U.S. Department of Health and Human Services (HHS) will use in determining the amount of Federal matching for State medical assistance (Medicaid) and State Children's Health Insurance Program (SCHIP) expenditures, and Temporary Assistance for Needy Families (TANF) Contingency Funds, the Federal share of Child Support Enforcement collections, Child Care Mandatory and Matching Funds of the Child Care and Development Fund, Foster Care Title IV-E Maintenance payments, and Adoption Assistance payments. The table gives figures for each of the 50 States, the District of Columbia, Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Commonwealth of the Northern Mariana Islands. Programs under title XIX of the Act exist in each jurisdiction. Programs under titles I, X, and XIV operate only in Guam and the Virgin Islands, while a program under title XVI (Aid to the Aged, Blind, or Disabled) operates only in Puerto Rico. Programs under title XXI began operating in fiscal year 1998. The percentages in this notice apply to State expenditures for most medical services and medical insurance services, and assistance payments for certain social services. The statute provides separately for Federal matching of administrative costs. Sections 1905(b) and 1101(a)(8)(B) of the Act require the Secretary, HHS to publish the Federal Medical Assistance Percentages each year. The Secretary is to calculate the percentages, using formulas in sections 1905(b) and 1101(a)(8)(B), from the Department of Commerce's statistics of average income per person in each State and for the Nation as a whole. The percentages are within the upper and lower limits given in section 1905(b) of the Act. The percentages to be applied to the District of Columbia, Puerto Rico, the Virgin Islands, Guam, American Samoa, and the Northern Mariana Islands are specified in statute, and thus are not based on the statutory formula that determines the percentages for the 50 States. The ``Federal Medical Assistance Percentages'' are for Medicaid. Section 1905(b) of the Act specifies the formula for calculating Federal Medical Assistance Percentages as follows:
Draft Guidance for Industry: Small Entities Compliance Guide for Renderers-Substances Prohibited From Use in Animal Food or Feed; Availability
Document Number: E8-28189
Type: Notice
Date: 2008-11-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry 195, entitled ``Draft Guidance for Industry: Small Entities Compliance Guide for RenderersSubstances Prohibited From Use in Animal Food or Feed.'' This small entities compliance guide aids renderers in complying with the requirements of the final rule published in the Federal Register of April 25, 2008 (73 FR 22720). FDA's goal is to strengthen existing safeguards to prevent the spread of bovine spongiform encephalopathy (BSE) in U.S. cattle and to reduce the risk of human exposure to the BSE agent.
Sex Differences in the Cardiovascular Device Trials; Public Workshop
Document Number: E8-28169
Type: Notice
Date: 2008-11-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing a public workshop entitled ``Sex Differences in the Cardiovascular Device Trials.'' FDA is co-sponsoring the conference with the Advanced Medical Technology Association (AdvaMed). The purpose of the workshop is to facilitate discussion between FDA and other interested parties on the study and analysis of sex and gender differences in cardiovascular medical device trials, in anticipation of issuance of draft guidance on this subject.
Request for Nominations of Candidates To Serve on the Advisory Committee on Immunization Practices (ACIP)
Document Number: E8-28154
Type: Notice
Date: 2008-11-26
Agency: Department of Health and Human Services, Centers for Disease Control and Prevention (cdc), Centers for Disease Control and Prevention
Fees for Sanitation Inspections of Cruise Ships
Document Number: E8-28153
Type: Notice
Date: 2008-11-26
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
This notice announces fees for vessel sanitation inspections for fiscal year 2009 (October 1, 2008, through September 30, 2009).
Notice of Public Meeting
Document Number: E8-28152
Type: Notice
Date: 2008-11-26
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the following public meeting: ``Partnerships to Advance the National Occupational Research Agenda (NORA).'' Public Meeting Time and Date: 10 a.m.-4 p.m. EST, January 22, 2009. Place: Patriots Plaza, 395 E Street, SW., Conference Room 9000, Washington, DC 20201. Purpose of Meeting: The National Occupational Research Agenda (NORA) has been structured to engage partners with each other and/or with NIOSH to advance NORA priorities. The NORA Liaison Committee continues to be an opportunity for representatives from organizations with national scope to learn about NORA progress and to suggest possible partnerships based on their organization's mission and contacts. This opportunity is now structured as a public meeting via the internet to attract participation by a larger number of organizations and to further enhance the success of NORA. Some of the types of organizations of national scope that are especially encouraged to participate are employers, unions, trade associations, labor associations, professional associations, and foundations. Others are welcome. This meeting will include updates from NIOSH leadership on NORA as well as updates from approximately half of the Sector Councils on their progress, priorities, and implementation plans to date, including the Agriculture, Forestry and Fishing Sector; Healthcare and Social Assistance Sector; Mining Sector; MiningOil and Gas Extraction Sub- Sector; and Transportation, Warehousing and Utilities Sector. After each update, there will be time to discuss partnership opportunities. Status: The meeting is open to the public, limited only by the capacities of the conference call and conference room facilities. There is limited space available in the meeting room (capacity 34). Therefore, information to allow participation in the meeting through the internet (to see the slides) and a teleconference call (capacity 50) will be provided to registered participants. Participants are encouraged to consider attending by this method. Each participant is requested to register for the free meeting by sending an e-mail to noracoordinator@cdc.gov containing the participant's name, organization name, contact telephone number on the day of the meeting, and preference for participation by Web meeting (requirements include: computer, internet connection, and telephone, preferably with ``mute'' capability) or in person. An e-mail confirming registration will include the details needed to participate in the Web meeting. Non-US citizens are encouraged to participate in the Web meeting. Non-US citizens registering to attend in person after January 8 will not have time to comply with security procedures. Background: NORA is a partnership program to stimulate innovative research in occupational safety and health leading to improved workplace practices. Unveiled in 1996, NORA has become a research framework for the nation. Diverse parties collaborate to identify the most critical issues in workplace safety and health. Partners then work together to develop goals and objectives for addressing those needs and to move the research results into practice. The NIOSH role is facilitator of the process. For more information about NORA, see http:/ /www.cdc.gov/niosh/nora/about.html. Since 2006, NORA has been structured according to industrial sectors. Eight sector groups have been defined using the North American Industrial Classification System (NAICS). After receiving public input through the Web and town hall meetings, NORA Sector Councils have been working to define sector-specific strategic plans for conducting research and moving the results into widespread practice. During 2008, most of these Councils have posted draft strategic plans for public comment. One has posted its finalized National Sector Agenda after considering comments on its draft. For more information, see the link above and choose ``Sector-based Approach,'' ``NORA Sector Councils,'' ``Sector Agendas'' and ``Comment on Draft Sector Agendas'' from the right-side menu. Contact Person for Technical Information: Sidney C. Soderholm, Ph.D., NORA Coordinator, e-mail noracoordinator@cdc.gov, telephone (202) 245-0665.
Diseases Transmitted Through the Food Supply Correction
Document Number: E8-28151
Type: Notice
Date: 2008-11-26
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
New Animal Drugs; Cephalosporin Drugs; Extralabel Animal Drug Use; Revocation of Order of Prohibition; Withdrawal
Document Number: E8-28093
Type: Rule
Date: 2008-11-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is revoking the order prohibiting the extralabel use of cephalosporin antimicrobial drugs in food-producing animals. FDA received many substantive comments on the order of prohibition. The agency is taking this action so that it may fully consider these comments.
Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study: Toll-Free Number for Consumer Reporting of Drug Product Side Effects in Direct-to-Consumer Television Advertisements for Prescription Drugs
Document Number: E8-28065
Type: Notice
Date: 2008-11-26
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 a 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 a study examining the impact on consumer comprehension of inclusion of a toll-free number to report side effects in direct-to-consumer (DTC) prescription drug television advertisements.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prescription Drug Product Labeling: Medication Guide Requirements
Document Number: E8-28064
Type: Notice
Date: 2008-11-26
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).
National Vaccine Injury Compensation Program; List of Petitions Received
Document Number: E8-28058
Type: Notice
Date: 2008-11-26
Agency: Department of Health and Human Services, Health Resources and Services Administration
The Health Resources and Services Administration (HRSA) is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (``the Program''), as required by Section 2112(b)(2) of the Public Health Service (PHS) Act, as amended. While the Secretary of Health and Human Services is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
Agency Information Collection Activities: Proposed Collection: Comment Request
Document Number: E8-28048
Type: Notice
Date: 2008-11-26
Agency: Department of Health and Human Services, Health Resources and Services Administration
National Institute of Mental Health; Notice of Closed Meetings
Document Number: E8-28047
Type: Notice
Date: 2008-11-26
Agency: Department of Health and Human Services, National Institutes of Health
Public Consultation Meeting of the Trans-Federal Task Force on Optimizing Biosafety and Biocontainment Oversight
Document Number: E8-28013
Type: Notice
Date: 2008-11-25
Agency: Department of Health and Human Services
The U.S. Department of Health and Human Services is hereby giving notice that the Trans-Federal Task Force on Biosafety and Biocontainment Oversight will be holding a public consultation meeting. The meeting is open to the public.
Compliance Policy Guide Sec. 540.700 Processed and/or Blended Seafood Products (CPG 7108.16); Availability
Document Number: E8-27969
Type: Notice
Date: 2008-11-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of revised Compliance Policy Guide Sec. 540.700 Processed and/or Blended Seafood Products (CPG 7108.16) (the CPG). The CPG provides guidance for FDA staff on FDA's labeling requirements for processed and blended seafood products.
Medicaid Program; Premiums and Cost Sharing
Document Number: E8-27717
Type: Rule
Date: 2008-11-25
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule implements and interprets the provisions of sections 6041, 6042, and 6043 of the Deficit Reduction Act of 2005 (DRA), and section 405(a)(1) of the Tax Relief and Health Care Act of 2006 (TRHCA). The DRA was amended by the TRHCA which revised sections 6041, 6042, and 6043 of the DRA including limitations on cost sharing for individuals with family incomes at or below 100 percent of the federal poverty line. These sections amended the Social Security Act (the Act) by adding a new section 1916A to provide State Medicaid agencies with increased flexibility to impose premium and cost sharing requirements on certain Medicaid recipients. This flexibility supplements the existing authority States have to impose premiums and cost sharing under section 1916 of the Act. The DRA provisions also specifically address cost sharing for non-preferred drugs and non- emergency care furnished in a hospital emergency department.
Mandatory Guidelines for Federal Workplace Drug Testing Programs
Document Number: E8-26726
Type: Notice
Date: 2008-11-25
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
This Final Notice of Revisions to the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Revisions to Mandatory Guidelines) addresses collection and testing of urine specimens, the requirements for the certification of Instrumented Initial Test Facilities (IITFs), and the role of and standards for collectors and Medical Review Officers (MROs). Additional notices of Proposed Revisions to the Mandatory Guidelines addressing the use of point of collection testing (POCT), oral fluid testing, sweat patch testing, hair testing, and associated issues will be published at a later date. With regard to the use of alternative specimens including hair, oral fluid, and sweat patch specimens in Federal Workplace Drug Testing Programs, significant issues have been raised by Federal agencies during the review process which require further examination, and may require additional study and analysis. As part of the review process for these alternative tests, the Department of Health and Human Services (``HHS'' or ``Department'') plans to issue a notice in the Federal Register requesting information and assistance from the general public to provide or identify data and research findings that address specific areas of interest.
Draft Guidance for Industry on the Contents of a Complete Submission for the Evaluation of Proprietary Names; Availability
Document Number: E8-27896
Type: Notice
Date: 2008-11-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Contents of a Complete Submission for the Evaluation of Proprietary Names.'' This draft guidance provides recommendations to industry regarding the submission of a complete package that FDA intends to use to assess the safety of proposed proprietary drug and biological product names and other factors that, in association with the name, can contribute to medication errors. In addition, FDA intends to use this information in the assessment of promotional aspects of proposed proprietary names.
Meeting of the Advisory Committee on Blood Safety and Availability
Document Number: E8-27852
Type: Notice
Date: 2008-11-24
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the Advisory Committee on Blood Safety and Availability (ACBSA) will hold a meeting. The meeting will be open to the public on both Tuesday December 16 and Wednesday December 17, 2008.
Solicitation of Nominations for Membership on the Secretary's Advisory Committee on Human Research Protections
Document Number: E8-27851
Type: Notice
Date: 2008-11-24
Agency: Department of Health and Human Services
The Office for Human Research Protections (OHRP), a program office in the Office of Public Health and Science, Department of Health and Human Services (HHS), is seeking nominations of qualified candidates to be considered for appointment as members of the Secretary's Advisory Committee on Human Research Protections (SACHRP). SACHRP provides advice and recommendations to the Secretary, HHS, and the Assistant Secretary for Health on matters pertaining to the continuance and improvement of functions within the authority of HHS directed toward protections for human subjects in research. SACHRP was established by the Secretary, HHS, on October 1, 2002. OHRP is seeking nominations of qualified candidates to fill two positions on the Committee membership that will be vacated in June of 2009.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: E8-27838
Type: Notice
Date: 2008-11-24
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Medicaid Program; State Allotments for Payment of Medicare Part B Premiums for Qualifying Individuals: Federal Fiscal Year 2008 and Federal Fiscal Year 2009
Document Number: E8-27810
Type: Rule
Date: 2008-11-24
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This interim final rule with comment period makes technical changes to the existing methodology and process used to compute and issue each State's preliminary and final allotments available to pay the Medicare Part B premiums for qualifying individuals (QIs). The technical revisions conform the existing regulations to reflect continued funding of this program. Additionally, this rule contains charts providing the States' final QI allotments for the Federal fiscal year (FY) 2008 and preliminary QI allotments for FY 2009, determined in accordance with the methodology set forth in the October 2006 final rule, and reflecting funding for the QI program made available under recent legislation.
Roy Page, M.D.; Debarment Order
Document Number: E8-27803
Type: Notice
Date: 2008-11-24
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 act) permanently debarring Dr. Roy Page from providing services in any capacity to a person that has an approved or pending drug product application including, but not limited to, a biologics license application. FDA bases this order on a finding that Dr. Page was convicted of a felony under Federal law for conduct relating to the development or approval, including the process for development or approval, of a drug product under the act. After being given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation, Dr. Page failed to request a hearing. Dr. Page's failure to request a hearing constitutes a waiver of his right to a hearing concerning this action.
George Kindness; Debarment Order
Document Number: E8-27802
Type: Notice
Date: 2008-11-24
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 act) permanently debarring Mr. George Kindness from providing services in any capacity to a person that has an approved or pending drug product application including, but not limited to, a biologics license application. FDA bases this order on a finding that Mr. Kindness was convicted of a felony under Federal law for conduct relating to the development or approval, including the process for development or approval, of a drug product under the act. After being given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation, Mr. Kindness failed to request a hearing. Mr. Kindness's failure to request a hearing constitutes a waiver of his right to a hearing concerning this action.
Agency Information Collection Activities; Proposed Collection; Comment Request; Mental Models Study of Health Care Providers' Understanding of Prescription Drug Effectiveness
Document Number: E8-27801
Type: Notice
Date: 2008-11-24
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 the information collection provisions of the Mental Models Study of Health Care Providers' Understanding of Prescription Drug Effectiveness. Together with other information being collected, the results from this study will be used to help inform FDA about how health care providers conceptualize the drug effectiveness portion of the risk/benefit tradeoff and how that conceptualization differs from how agency experts think about drug effectiveness. The information gathered in this study will be used to focus and strengthen future planned quantitative research. It will also contribute to FDA's ability to communicate drug effectiveness information to health care providers in labeling and other communications.
National Cancer Institute; Notice of Meeting
Document Number: E8-27800
Type: Notice
Date: 2008-11-24
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meeting
Document Number: E8-27799
Type: Notice
Date: 2008-11-24
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings
Document Number: E8-27798
Type: Notice
Date: 2008-11-24
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: E8-27796
Type: Notice
Date: 2008-11-24
Agency: Department of Health and Human Services, National Institutes of Health
Submission for OMB Review; Comment Request; The National Diabetes Education Program Comprehensive Evaluation Plan
Document Number: E8-27793
Type: Notice
Date: 2008-11-24
Agency: Department of Health and Human Services, National Institutes of Health
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request to review and approval of the information listed below. The proposed information collection was previously published in the Federal Register on September 8, 2008, pages 52052-52053 and allowed 60 days for public comment. The National Institutes of Health received one comment that was determined to be not relevant to the specific questions stated in the notice. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, the collection of information that has been extended, revised, or implemented unless it displays a currently valid OMB control number. Proposed Collection: Title: The National Diabetes Educations Program Comprehensive Evaluation Plan. Type of Information Collection Request: Extension of a currently approved collection (0925- 0552). Need and Use of Information Collection: The National Diabetes Education Program (NDEP) is a partnership of the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) and more than 200 public and private organizations. The long-term goals of the NDEP are to improve the treatment and health outcomes of people with diabetes, to promote early diagnosis, and, ultimately, to prevent the onset of diabetes. The NDEP objectives are: (1) To increase awareness of the seriousness of diabetes, its risk factors, and strategies for preventing diabetes and its complications among people at risk for diabetes; (2) to improve understanding about diabetes and its control and to promote better self-management behaviors among people with diabetes; (3) to improve health care providers' understanding of diabetes and its control and to promote an integrated approach to care; (4) to promote health care policies that improve the quality of and access to diabetes care. Multiple strategies have been devised to address the NDEP objectives. These have been described in the NDEP Strategic Plan and include: (1) Creating partnerships with other organizations concerned about diabetes; (2) developing and implementing awareness and education activities with special emphasis on reaching the racial and ethnic populations disproportionately affected by diabetes; (3) identifying, developing, and disseminating educational tools and resources for the program's diverse audiences; (4) promoting policies and activities to improve the quality of and access to diabetes care. The NDEP evaluation will document the extent to which the NDEP program has been implemented, and how successful it has been in meeting program objectives. The evaluation relies heavily on data gathered from existing national surveys such as National Health and Nutrition Examination Survey (NHANES), the National Health Interview Survey (NHIS), the Behavioral Risk Factor Surveillance System (BRFSS), among others for this information. This generic clearance request is for the collection of additional primary data from NDEP target audiences on some key process and impact measures that are necessary to effectively evaluate the program. Approval is requested for a survey of audiences targeted by the National Diabetes Education Program including people at risk for diabetes, people with diabetes and their families and the public. Frequency of Response: On occasion. Affected Public: Individuals or households. Type of Respondents: Adults. The annual reporting burden is as follows: Estimated Number of Respondents: 3759, Estimated Number of Responses per Respondent: 1; Average Burden Hours Per Response: .153; and Estimated Total Annual Burden Hours Requested: 575. There are no Capital Costs, Operating or Maintenance Costs to report.
National Institute of Child Health and Human Development Submission for OMB Review; Comment Request; Health Behaviors in School-Age Children
Document Number: E8-27792
Type: Notice
Date: 2008-11-24
Agency: Department of Health and Human Services, National Institutes of Health
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Child Health and Human Development (NICHD), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This extension of data collection was previously published in the Federal Register on September 12, 2008, Volume 73, Number 128, pages 53030- 53031 and allowed 60 days for public comment. One public comment was received asking for a copy of the data collection plans for the proposed collection. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.
Office of Dietary Supplements 2010-2014 Strategic Plan
Document Number: E8-27791
Type: Notice
Date: 2008-11-24
Agency: Department of Health and Human Services, National Institutes of Health
The Office of Dietary Supplements (ODS) at the National Institutes of Health (NIH) has initiated a strategic planning process that will culminate in the ODS Strategic Plan for 2010-2014. To assist with this process, the ODS requests input from research communities academic, government, and industryand from other interested parties. The overall purpose of the strategic planning effort is to identify both new opportunities and emerging needs for incorporation in the programmatic efforts of the Office. A background paper has been prepared, A Report to the Public, that summarizes progress in four key areas of ODS activity. The background paper and related information are available on the ODS Web site at http://ods.od.nih.gov/strategicplan. Public comment can be sent directly to ODS or through the public Webinars ODS will hold on January 29, 2009, February 3, 2009, February 11, 2009, and February 19, 2009. The section on Public Participation (below) gives details for the Webinars.
National Toxicology Program (NTP); NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); Availability of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) Test Method Evaluation Report: Validation Status of Five In Vitro
Document Number: E8-27790
Type: Notice
Date: 2008-11-24
Agency: Department of Health and Human Services
NICEATM announces availability of the ICCVAM Test Method Evaluation Report: Validation Status of Five In Vitro Test Methods Proposed for Assessing Potential Pyrogenicity of Pharmaceuticals and Other Products (NIH Publication 08-6392). The test method evaluation report (TMER) describes five in vitro pyrogen test methods that can be used for detecting Gram-negative endotoxin in human parenteral pharmaceuticals. The report includes ICCVAM's (a) Recommendations on uses and limitations for each test method, (b) recommendations for standardized protocols, (c) recommendations for future studies, and (d) recommendations for the development of performance standards. ICCVAM concludes that none of these test methods can be considered as a complete replacement for the rabbit pyrogen test (RPT) for all testing situations for the detection of Gram-negative endotoxin. However, ICCVAM recommends that they can be considered for use on a case-by-case basis to detect Gram-negative endotoxin in human parenteral drugs, subject to product-specific validation to demonstrate equivalence to the RPT, in accordance with applicable U.S. Food and Drug Administration regulations. When used in this manner, these methods can reduce the number of animals needed for pyrogenicity testing. The report also recommends that these and other in vitro alternative test methods be considered prior to in vivo pyrogenicity testing, where determined appropriate for a specific testing situation. NICEATM also announces availability of the final ICCVAM Background Review Document: Validation Status of Five In Vitro Test Methods Proposed for Assessing Potential Pyrogenicity of Pharmaceuticals and Other Products (NIH Publication 08-6391). The final background review document (BRD) provides the data and analyses used to assess the current validation status of these five in vitro test methods. The ICCVAM TMER and supporting BRDs have been forwarded to U.S. Federal agencies for regulatory and other acceptance consideration, where applicable. Responses received will be posted on the NICEATM- ICCVAM Web site.
Center for Scientific Review; Notice of Closed Meetings
Document Number: E8-27786
Type: Notice
Date: 2008-11-24
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: E8-27785
Type: Notice
Date: 2008-11-24
Agency: Department of Health and Human Services, National Institutes of Health
Statement of Organization, Functions and Delegations of Authority
Document Number: E8-27776
Type: Notice
Date: 2008-11-24
Agency: Department of Health and Human Services, Health Resources and Services Administration
Agency Recordkeeping/Reporting Requirements Under Emergency Review by the Office of Management and Budget (OMB)
Document Number: E8-27668
Type: Notice
Date: 2008-11-24
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Determination That NUBAIN (Nalbuphine Hydrochloride) Injection, 10 and 20 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: E8-27714
Type: Notice
Date: 2008-11-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing its determination that NUBAIN (nalbuphine hydrochloride) injection, 10 and 20 milligrams/milliliter (mg/ml), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for nalbuphine hydrochloride injection, 10 and 20 mg/ml, if all other legal and regulatory requirements are met.
Oncologic Drugs Advisory Committee; Notice of Meeting
Document Number: E8-27713
Type: Notice
Date: 2008-11-21
Agency: Food and Drug Administration, Department of Health and Human Services
Medicare Program; Revisions to the Medicare Advantage and Prescription Drug Benefit Programs; Correcting Amendment
Document Number: E8-27712
Type: Rule
Date: 2008-11-21
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
In the September 18, 2008 issue of the Federal Register (73 FR 54226), we published an interim final rule with comment period that revises the regulations governing the Medicare Advantage (MA) program (Part C), prescription drug benefit program (Part D) and section 1876 cost plans. The interim final rule makes conforming changes to the MA regulations to reflect new statutory requirements regarding special needs plans (SNP), private-fee-for-service plans (PFFS), regional preferred provider organizations (RPPO) plans, Medicare medical savings accounts (MSA) plans, and new statutory provisions governing cost- sharing for dual-eligible enrollees in the MA program prescription drug pricing, coverage, and payment processes in the Part D program. In addition, the interim final rule sets forth new requirements governing the marketing of Part C and Part D plans which by statute must be in place at a date specified by the Secretary, but no later than November 15, 2008. Both the conforming changes to the regulations to reflect new statutory provisions and the new marketing requirements are based on provisions in the Medicare Improvements for Patients and Providers Act (MIPPA), which became law on July 15, 2008. This correcting amendment corrects technical and typographical errors identified in the September 18, 2008 interim final rule.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: E8-27711
Type: Notice
Date: 2008-11-21
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Privacy Act of 1974; Report of Amended or Altered System; Medical, Health and Billing Records System
Document Number: E8-27708
Type: Notice
Date: 2008-11-21
Agency: Department of Health and Human Services, Indian Health Service
Pursuant to the provisions of the Privacy Act of 1974, as amended, 5 U.S.C. 552a(e)(4), the IHS has amended and is publishing the proposed alteration of a system of records, System No. 09-17-0001, ``Medical, Health and Billing Records.'' The amended and altered system of records makes only administrative edits and revisions as necessary.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: E8-27696
Type: Notice
Date: 2008-11-21
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: E8-27530
Type: Notice
Date: 2008-11-21
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: E8-27529
Type: Notice
Date: 2008-11-21
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: E8-27528
Type: Notice
Date: 2008-11-21
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: E8-27523
Type: Notice
Date: 2008-11-21
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
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: ``Improving implementation of the U.S. Preventive Services Task Force recommendation for prophylactic aspirin use among adults at risk for cardiovascular disease.'' 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.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: E8-27522
Type: Notice
Date: 2008-11-21
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
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: ``Conducting Measurement Activities in Support of the AHRQ Health IT Initiative.'' 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 September 19th, 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.