Department of Health and Human Services February 2006 – Federal Register Recent Federal Regulation Documents
Results 151 - 200 of 316
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.
Proposed Collection; Comment Request, Fogarty International Center CareerTrac
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the Fogarty International Center, the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Guidance for Industry: Considerations for Developmental Toxicity Studies for Preventive and Therapeutic Vaccines for Infectious Disease Indications; Availability
The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Considerations for Developmental Toxicity Studies for Preventive and Therapeutic Vaccines for Infectious Disease Indications,'' dated February 2006. The guidance is intended to provide sponsors with recommendations for the conduct of developmental toxicity studies for investigational preventive and therapeutic vaccines for infectious disease indications. The recommendations pertain to the assessment of the developmental toxicity potential of preventive and therapeutic vaccines for infectious diseases indicated for females of childbearing potential and pregnant individuals. This guidance document finalizes the draft guidance entitled ``Guidance for Industry: Considerations for Reproductive Toxicity Studies for Preventive Vaccines for Infectious Disease Indications,'' dated August 2000.
Emerging Clostridial Disease; Public Workshop
The Food and Drug Administration (FDA), on behalf of the Centers for Disease Control and Prevention (CDC) and the National Institute of Allergy and Infectious Diseases (NIAID) are announcing a public workshop entitled ``Emerging Clostridial Disease.'' This public workshop is intended to develop a draft research agenda to better understand the virulence, pathogenesis, host factors, and nonantimicrobial risk factors contributing to reports of morbidity and mortality associated with Clostridium sordellii (C. sordellii) and Clostridium difficile (C. difficile). Additionally, our goals are to identify research needs and priorities that will enable rapid progress as well as to develop and provide recommendations for detecting cases and conducting surveillance of diseases and organisms. DATES: The public workshop will be held on May 11, 2006, from 8:30 a.m. to 4:30 p.m. See section III of this document for information on how to register to attend or present at the workshop. You must register by close of business on April 15, 2006, to attend or participate. We are opening a docket to receive your written or electronic comments (see ADDRESSES). Written or electronic comments must be submitted to the docket by June 15, 2006.
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Pharmaceutical Development Study
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.
Healthy Start Program
The Conference Report (H.R. Rep. No. 109-337) accompanying the Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2006, indicates concurrence with the Senate report language regarding the recompetition of Healthy Start programs. Following the Senate Committee's recommendation in Senate Report 109-103, the Health Resources and Services Administration (HRSA) will give preference during the FY 2006 competition ``to current and former grantees with expiring or recently expired project periods. This should include grantees whose grant applications were approved but not funded during fiscal year 2005.''
Implantation or Injectable Dosage Form New Animal Drugs; Moxidectin Solution
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Fort Dodge Animal Health. The supplemental NADA provides for use of an injectable moxidectin solution in cattle for the treatment and control of an additional three species of internal parasites and an additional three life stages of previously- approved internal parasites.
Determination That PEPTAVLON (Pentagastrin) for Subcutaneous Injection, 0.25 Milligrams per Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that PEPTAVLON (pentagastrin) for subcutaneous injection, 0.25 milligrams (mg) per milliliter (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 pentagastrin for subcutaneous injection, 0.25 mg/mL.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; General Administrative Procedures: Citizen Petitions; Petition for Reconsideration or Stay of Action; Advisory Opinions
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.
Medicare Program; Provider Bad Debt Payment; Extension of Timeline for Publication of Final Rule
Section 1871(a)(3)(A) of the Social Security Act (the Act) requires us to publish a Medicare final rule no later than 3 years after the publication date of the proposed rule. This notice announces an extension of the timeline for publication of a Medicare final rule in accordance with section 1871(a)(3)(B) of the Act, which allows us to extend the timeline for publication of the ``Medicare Program; Provider Bad Debt Payment'' final rule under exceptional circumstances.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Financial Disclosure by Clinical Investigators
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use
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).
Draft Guidance for Industry and Food and Drug Administration Staff; Pharmacogenetic Tests and Genetic Tests for Heritable Markers; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Pharmacogenetic Tests and Genetic Tests for Heritable Markers.'' This draft guidance document is intended to provide guidance on preparing and reviewing premarket approval applications (PMAs) and 510(k) submissions for pharmacogenetic and other genetic tests, whether testing is for single markers or for multiple markers simultaneously (multiplex tests).
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