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

Results 51 - 100 of 231
Medicare Program; Home Health Prospective Payment System Rate Update for Calendar Year 2009; Corrections
Document Number: E8-30453
Type: Notice
Date: 2008-12-22
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document corrects technical errors that appeared in the update notice published in the Federal Register on November 3, 2008, entitled ``Medicare Program; Home Health Prospective Payment System Rate Update for Calendar Year 2009.''
Medicare, Medicaid, and CLIA Programs; Clinical Laboratory Improvement Amendments of 1988 Exemption of Permit-Holding Laboratories in the State of New York
Document Number: E8-30452
Type: Notice
Date: 2008-12-22
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces that CMS has granted exemption from CLIA requirements to laboratories located within the State of New York that possess a valid permit under Article Five of Title V of the Public Health Law of the State of New York and its implementing regulations at 10 N.Y. Comp. Codes R. & Regs., Title V, Part 58.
Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Tissue Expander; Availability
Document Number: E8-30440
Type: Notice
Date: 2008-12-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Class II Special Controls Guidance Document: Tissue Expander.'' This draft guidance document describes a means by which the tissue expander device type may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a proposed rule to classify this device type into class II (special controls). This draft guidance is not final nor is it in effect at this time.
General and Plastic Surgery Devices: Proposed Classification for the Tissue Expander
Document Number: E8-30439
Type: Proposed Rule
Date: 2008-12-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is proposing to classify into class II (special controls) the tissue expander, as a device intended for temporary (less than 6 months) subdermal implantation to stretch the skin for surgical applications, specifically to develop surgical flaps and additional tissue coverage. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the draft guidance that FDA intends will serve as the special control if FDA classifies this device type into class II.
Notice of Draft Document Available for Public Comment
Document Number: E8-30382
Type: Notice
Date: 2008-12-22
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 availability of the following draft document available for public comment entitled ``Preventing Deaths and Injuries of Fire Fighters When Fighting Fires in Unoccupied Structures.'' The draft document and instructions for submitting comments can be found at http://www.cdc.gov/niosh/review/public/141/. Comments may be provided to the NIOSH Docket Number above.
Request for Public Comment: 30-Day Proposed Information Collection: Indian Health Service Background; Investigations of Individuals in Positions Involving Regular Contact With or Control Over Indian Children, OPM-306
Document Number: E8-30330
Type: Notice
Date: 2008-12-22
Agency: Department of Health and Human Services, Indian Health Service
In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 which requires 30 days for public comment on proposed information collection projects, the Indian Health Service (IHS) has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection project was previously published in the Federal Register (73 FR 23254) on September 24, 2008, and allowed 60 days for public comment. No public comment was received in response to the notice. The purpose of this notice is to allow 30 days for public comment to be submitted directly to OMB. Proposed Collection: Title: 0917-0028, ``IHS Background Investigations of Individuals in Positions Involving Regular Contact With or Control Over Indian Children, OPM-306. Type of Information Collection Request: Extension, without revision, of currently approved information collection, 0917-0028, ``IHS Background Investigations of Individuals in Positions Involving Regular Contact With or Control Over Indian Children, OPM-306.'' Form Number: OPM-306. Forms: Declaration for Federal Employment. Need and Use of Information Collection: This is a request for approval of information collection required by Section 408 of the Indian Child Protection and Family Violence Prevention Act, Pub. L. 101-630, 104 Stat. 4544, and 25 U.S.C. 3201-3211. The IRS is required to compile a list of all authorized positions within the IHS where the duties and responsibilities involve regular contact with, or control over, Indian children; and to conduct an investigation of the character of each individual who is employed, or is being considered for employment in a position having regular contact with, or control over, Indian children. Section 3207(b) of the Indian Child Protection and Family Violence Prevention Act was amended by Section 814 of U.S.C. 3031, the Native American Laws Technical Corrections Act of 2000, which requires that the regulations prescribing the minimum standards of character ensure that none of the individuals appointed to positions involving regular contact with, or control over, Indian children have been found guilty of, or entered a plea of nolo contendere or guilty to any felonious offense, or any of two or more misdemeanor offenses under Federal, State, or Tribal law involving crimes of violence; sexual assault, molestation, exploitation, contact or prostitution; crimes against persons; or offenses committed against children. In addition, 42 U.S.C. 13041 requires each agency of the Federal Government, and every facility operated by the Federal Government (or operated under contract with the Federal Government), that hires (or contracts for hire) individuals involved with children under the age of 18 or child care services to assure that all existing and newly hired employees undergo a criminal history background check. The background check is to be initiated through the personnel program of the applicable Federal agency. This section requires employment applications for individuals who are seeking work for an agency of the Federal Government, or for a facility or program operated by (or through contract with) the Federal Government, in positions involved with the provision to children under the age of 18 or child care services, to contain a question asking whether the individual has ever been arrested for or charged with a crime involving a child. Affected Public: Individuals and households. Type of Respondents: Individuals. The table below provides: Types of data collection instruments, estimated number of respondents, responses per respondent, average burden hour per response, and total annual burden hour(s).
Request for Public Comment: 30-Day Proposed Information Collection: Indian Health Service; HIV Knowledge/Attitudes/Practice Customer Survey
Document Number: E8-30329
Type: Notice
Date: 2008-12-22
Agency: Department of Health and Human Services, Indian Health Service
In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 which requires 30 days for public comment on proposed information collection projects, the Indian Health Service (IHS) has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection project was previously published in the Federal Register (73 FR 23254) on August 25, 2008 and allowed 60 days for public comment. No public comment was received in response to the notice. The purpose of this notice is to allow 30 days for public comment to be submitted directly to OMB. Proposed Collection: Title: 0917-NEW, ``Indian Health Service HIV Knowledge/Attitudes/Practice Customer Survey.'' Type of Information Collection Request: This is a one time survey to deliver the mission of the IRS and Centers for Disease Control (CDC) national guidelines collection, 0917-NEW, ``Indian Health Service HIV Knowledge/Attitudes/ Practice Customer Survey.'' Form Number(s): None. Need and Use of Information Collection: The IHS goal is to raise the health status of the American Indian and Alaska Native (AI/AN) people to the highest possible level by providing comprehensive health care and preventive health services. To support the IHS mission, the Division of Epidemiology and Disease Prevention (DEDP) and the Human Immunodeficiency Virus (HIV) Program collaborate to provide programmatic, technical, and financial assistance to IRS Areas and Service Units for improving prevention, detection, and treatment of infectious and chronic disease, specifically in this case, HIV and Sexually Transmitted Disease (STD). The ``HIV Knowledge/Attitudes/Practice Customer Survey'' (hereafter referred to as Customer Survey), will provide the information needed to understand the most effective and appropriate methods to complete these goals. With the information collected from patients, the DEDP and HIV programs will be able to offer recommendations to Service Units on how to best scale up screening for sensitive topics such as HIV and STDs in AllAN communities. Also, the information will give lETS the tools to assist the IHS Service Units with implementation of current national recommendations by CDC. At the moment, the DEDP and HIV programs are encouraging uptake of current CDC national recommendations; however, without this information, the DEDP and HIV programs are unable to maximize effectiveness, dispel myths, and identify misinformation. Voluntary customer surveys will be conducted through self- administered questionnaires, face-to-face interviews, and potentially electronic media. The information gathered will be used by DEDP and the HIV Program to identify how patients would prefer to be offered expanded testing in a way that is respectful, confidential, and effective. Affected Public: Individuals. Type of Respondents: IHS customers. The table below provides: Types of data collection instruments, estimated number of respondents, responses per respondent, average burden hour per response, and total annual burden hour(s).
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: E8-30328
Type: Notice
Date: 2008-12-22
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: E8-30326
Type: Notice
Date: 2008-12-22
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: E8-30325
Type: Notice
Date: 2008-12-22
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: E8-30324
Type: Notice
Date: 2008-12-22
Agency: Department of Health and Human Services, National Institutes of Health
Native American Research Centers for Health (NARCH) Grants
Document Number: E8-30300
Type: Notice
Date: 2008-12-22
Agency: Department of Health and Human Services, Indian Health Service
National Advisory Council on the National Health Service Corps; Notice of Meeting
Document Number: E8-30298
Type: Notice
Date: 2008-12-22
Agency: Department of Health and Human Services, Health Resources and Services Administration
Compliance Policy Guide; Radiofrequency Identification Feasibility Studies and Pilot Programs for Drugs; Notice to Extend Expiration Date
Document Number: E8-30297
Type: Notice
Date: 2008-12-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is extending the expiration date of compliance policy guide (CPG) Sec. 400.210 entitled ``Radiofrequency Identification (RFID) Feasibility Studies and Pilot Programs for Drugs'' to December 31, 2010.
National Toxicology Program (NTP); Office of Liaison, Policy and Review; Meeting of the NTP Board of Scientific Counselors
Document Number: E8-30288
Type: Notice
Date: 2008-12-22
Agency: Department of Health and Human Services
Pursuant to Public Law 92-463, notice is hereby given of a meeting of the NTP Board of Scientific Counselors (NTP BSC). The NTP BSC is a federally chartered, external advisory group composed of scientists from the public and private sectors that provides primary scientific oversight to the NTP and evaluates the scientific merit of the NTP's intramural and collaborative programs.
Agency Information Collection Activities: Proposed Collection: Comment Request
Document Number: E8-30286
Type: Notice
Date: 2008-12-22
Agency: Department of Health and Human Services
Agency Information Collection Activities: Proposed Collection: Comment Request
Document Number: E8-30284
Type: Notice
Date: 2008-12-22
Agency: Department of Health and Human Services, Health Resources and Services Administration
Agency Information Collection Request; 30-Day Public Comment Request
Document Number: E8-30274
Type: Notice
Date: 2008-12-22
Agency: Department of Health and Human Services
Submission for OMB Review; Comment Request
Document Number: E8-30172
Type: Notice
Date: 2008-12-22
Agency: Department of Health and Human Services, Administration for Children and Families
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: E8-30327
Type: Notice
Date: 2008-12-19
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Recall Authority
Document Number: E8-30280
Type: Notice
Date: 2008-12-19
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, 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 information collection requirements for medical device recall authority.
Agency Information Collection Activities; Proposed Collection; Comment Request; Voluntary Hazard Analysis and Critical Control Point Manuals for Operators and Regulators of Retail and Food Service Establishments
Document Number: E8-30278
Type: Notice
Date: 2008-12-19
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, 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 provisions of the agency's Voluntary Hazard Analysis and Critical Control Point Manuals for Operators and Regulators of Retail and Food Service Establishments.
Medicaid Program; Fiscal Year Disproportionate Share Hospital Allotments and Disproportionate Share Hospital Institutions for Mental Disease Limits
Document Number: E8-30267
Type: Notice
Date: 2008-12-19
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the final Federal share disproportionate share hospital (DSH) allotments for Federal fiscal year (FFY) 2007 and the preliminary Federal share DSH allotments for FFY 2009. This notice also announces the final FFY 2007 and the preliminary FFY 2009 limitations on aggregate DSH payments that States may make to institutions for mental disease and other mental health facilities. In addition, this notice includes background information describing the methodology for determining the amounts of States' FFY DSH allotments.
Medicare Program; Meeting of the Medicare Evidence Development & Coverage Advisory Committee-February 25, 2009
Document Number: E8-30162
Type: Notice
Date: 2008-12-19
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces that a public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) (``Committee'') will be held on Wednesday, February 25, 2009. The Committee generally provides advice and recommendations concerning the adequacy of scientific evidence needed to determine whether certain medical items and services can be covered under the Medicare statute. This meeting will focus on the requirements for evidence to determine if diagnostic use of genomic testing in beneficiaries with signs or symptoms of disease improves health outcomes in Medicare beneficiaries. The meeting will also discuss the various kinds of evidence that are useful to support requests for Medicare coverage in this field. This meeting is open to the public in accordance with the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)).
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: E8-30160
Type: Notice
Date: 2008-12-19
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Agency Information Collection Activities; Proposed Collection; Comment Request; Emergency Shortages Data Collection System (formerly “Emergency Medical Device Shortages Program Survey”)
Document Number: E8-30155
Type: Notice
Date: 2008-12-19
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, 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 Emergency Shortages Data Collection System.
Determination That RUBRAMIN PC (Cyanocobalamin) Injection and Ten Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: E8-30154
Type: Notice
Date: 2008-12-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined that the eleven drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to the drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.
Opportunity for Cosponsorship of the Integrated Medical, Public Health, Preparedness, and Response Training Summit
Document Number: E8-30151
Type: Notice
Date: 2008-12-19
Agency: Department of Health and Human Services
The Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response (ASPR) and Office of the Surgeon General (OSG) announce the opportunity for both private sector and non-profit entities to cosponsor an annual training summit. The focus of this training is medical and public health preparedness and response during disasters and emergencies. Potential cosponsors must have a mutual interest in the subject matter, the capability to provide logistical and educational support, and be willing to participate substantively in the cosponsored activity.
Notice of the Development of a Web-Based System Used To Request Meetings Regarding Medical Countermeasures to Naturally Occurring or Manmade Threats
Document Number: E8-30150
Type: Notice
Date: 2008-12-19
Agency: Department of Health and Human Services
The Department of Health and Human Services (HHS) is announcing the availability of a new Web-based system, MedicalCountermeasures.gov. MedicalCountermeasures.gov will enable external stakeholders to request meetings with personnel from the organizations that comprise the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) regarding medical countermeasures to threats to public health, either naturally occurring or manmade. The goal of these meetings is to provide an opportunity for stakeholders to share information regarding medical countermeasures. The system can be accessed from the Web site https://www.medicalcountermeasures.gov/ RequestMeeting.aspx. During the BioShield Stakeholders Workshop, HHS Secretary Michael O. Leavitt announced that HHS would develop a Web based system ``through which those in industry and the research and development community can reach the people they need in the federal government, whether they're looking at a basic level of research or are focused on end-stage development.'' In fulfillment of this promise, HHS has developed MedicalCountermeasures.gov. MedicalCountermeasures.gov enables external stakeholders to request a meeting with federal representatives from participating PHEMCE agencies regarding medical countermeasures they are developing for use in response to a public health emergency. The information will then be routed to personnel within the relevant PHEMCE agencies, which currently include: The National Institutes of Health (NIH), the Office of the Biomedical Advanced Research and Development Authority (BARDA), the Food and Drug Administration (FDA), and the Department of Veterans Affairs (VA). MedicalCountermeasures.gov also provides information on upcoming and past conferences; procurements and grants; regulatory information; and strategic plans from throughout the PHEMCE agencies.
Ensuring That Department of Health and Human Services Funds Do Not Support Coercive or Discriminatory Policies or Practices in Violation of Federal Law
Document Number: E8-30134
Type: Rule
Date: 2008-12-19
Agency: Department of Health and Human Services
The Department of Health and Human Services (HHS) is issuing a final rule to ensure that Department funds do not support morally coercive or discriminatory practices or policies in violation of federal law, pursuant to the Church Amendments (42 U.S.C. 300a-7), Public Health Service (PHS) Act Sec. 245 (42 U.S.C. 238n), and the Weldon Amendment (Consolidated Appropriations Act, 2008, Public Law 110-161, Div. G, Sec. 508(d), 121 Stat. 1844, 2209). This final rule defines certain key terms. In order to ensure that recipients of Department funds know about their legal obligations under these federal health care conscience protection laws, the Department is requiring written certification by certain recipients that they will comply with all three statutes, as applicable. Finally, this final rule assigns responsibility for complaint handling and investigation among the Department's Office for Civil Rights and Department program offices.
National Institute on Aging; Notice of Meeting
Document Number: E8-30123
Type: Notice
Date: 2008-12-19
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Biomedical Imaging and Bioengineering; Notice of Meeting
Document Number: E8-30122
Type: Notice
Date: 2008-12-19
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: E8-30121
Type: Notice
Date: 2008-12-19
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: E8-30120
Type: Notice
Date: 2008-12-19
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: E8-30119
Type: Notice
Date: 2008-12-19
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: E8-30118
Type: Notice
Date: 2008-12-19
Agency: Department of Health and Human Services, National Institutes of Health
Guidance for Industry on Diabetes Mellitus-Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes; Availability
Document Number: E8-30086
Type: Notice
Date: 2008-12-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Diabetes Mellitus Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes.'' This guidance makes recommendations about how to demonstrate that a new antidiabetic therapy to treat type 2 diabetes is not associated with an unacceptable increase in cardiovascular risk. We are issuing this guidance for immediate implementation to ensure that relevant issues related to minimizing cardiovascular risk are considered by all sponsors who have ongoing drug development programs for type 2 diabetes.
Medicare Program; First Semi-Annual Meeting of the Advisory Panel on Ambulatory Payment Classification Groups-February 18-20, 2009
Document Number: E8-30001
Type: Notice
Date: 2008-12-19
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the first semi-annual meeting of the Advisory Panel on Ambulatory Payment Classification (APC) Groups (the Panel) for 2009. The purpose of the Panel is to review the APC groups and their associated weights and to advise the Secretary of the Department of Health and Human Services (DHHS) (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) (the Administrator) concerning the clinical integrity of the APC groups and their associated weights. We will consider the Panel's advice as we prepare the proposed and final rules that would update the hospital Outpatient Prospective Payment System (OPPS) for CY 2010.
Medicaid Program; Disproportionate Share Hospital Payments
Document Number: E8-30000
Type: Rule
Date: 2008-12-19
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule sets forth the data elements necessary to comply with the requirements of Section 1923(j) of the Social Security Act (Act) related to auditing and reporting of disproportionate share hospital payments under State Medicaid programs. These requirements were added by Section 1001(d) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA).
Medicaid Program; State Option To Establish Non-Emergency Medical Transportation Program
Document Number: E8-29662
Type: Rule
Date: 2008-12-19
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule implements section 6083 of the Deficit Reduction Act of 2005, which provides States with additional State plan flexibility to establish a non-emergency medical transportation (NEMT) brokerage program, and to receive the Federal medical assistance percentage matching rate. This authority supplements the current authority that States have to provide NEMT to Medicaid beneficiaries who need access to medical care, but have no other means of transportation.
Deeming Notice for American Society for Histocompatibility and Immunogenetics (ASHI) as an Accrediting Organization Under the Clinical Laboratory Improvement Amendments of 1988
Document Number: E8-29659
Type: Notice
Date: 2008-12-19
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The American Society for Histocompatibility and Immunogenetics (ASHI) was granted deeming authority as an accrediting organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program on March 25, 2005. The deeming authority was granted for the CLIA specialty of Histocompatibility and the subspecialty ABO/Rh. In this notice, we approve and grant ASHI deeming authority for the additional CLIA subspecialty of General Immunology.
National Institute of Dental & Craniofacial Research; Notice of Closed Meeting
Document Number: E8-30097
Type: Notice
Date: 2008-12-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: E8-30096
Type: Notice
Date: 2008-12-18
Agency: Department of Health and Human Services, National Institutes of Health
Clinical Studies of Safety and Effectiveness of Orphan Products
Document Number: E8-30061
Type: Notice
Date: 2008-12-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration's (FDA) Office of Orphan Product Development (OPD) is providing notice of a funding opportunity announcement for Federal assistance. The goal of the OPD grant program is to support the clinical development of products for use in rare diseases or conditions where no current therapy exists or where the proposed product will be superior to the existing therapy. FDA provides grants for clinical studies on safety and/or effectiveness that will either result in, or substantially contribute to, market approval of these products.
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: E8-30029
Type: Notice
Date: 2008-12-18
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: E8-30028
Type: Notice
Date: 2008-12-18
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: E8-30026
Type: Notice
Date: 2008-12-18
Agency: Department of Health and Human Services, National Institutes of Health
National Toxicology Program (NTP); Office of Liaison, Policy and Review; Meeting of the NTP Board of Scientific Counselors Technical Reports Review Subcommittee
Document Number: E8-30024
Type: Notice
Date: 2008-12-18
Agency: Department of Health and Human Services
Pursuant to Public Law 92-463, notice is hereby given of a meeting of the NTP Board of Scientific Counselors (BSC) Technical Reports Review Subcommittee (TRR Subcommittee). The primary agenda topic is the peer review of the findings and conclusions presented in six draft NTP Technical Reports of rodent toxicology and carcinogenicity studies in conventional rats and mice. The TRR Subcommittee meeting is open to the public with time scheduled for oral public comment. The NTP also invites written comments on the draft reports (see ``Request for Comments'' below). The TRR Subcommittee deliberations on the draft reports will be reported to the NTP BSC at a future meeting.
National Library of Medicine; Notice of Closed Meeting
Document Number: E8-30010
Type: Notice
Date: 2008-12-18
Agency: Department of Health and Human Services, National Institutes of Health
National Library of Medicine; Notice of Closed Meeting
Document Number: E8-30008
Type: Notice
Date: 2008-12-18
Agency: Department of Health and Human Services, National Institutes of Health