Department of Health and Human Services March 2007 – Federal Register Recent Federal Regulation Documents
Results 251 - 300 of 358
New Animal Drugs for Use in Animal Feeds; Melengestrol, Ractopamine, and Monensin
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Ivy Laboratories, Division of Ivy Animal Health, Inc. The ANADA provides for use of single-ingredient Type A medicated articles containing melengestrol, ractopamine, and monensin to make three-way combination drug Type C medicated feeds for heifers fed in confinement for slaughter.
Salary Offset
The Department of Health and Human Services (HHS) adds specific rules concerning involuntary salary offset by adding a new part 33 to title 45 CFR. The rule implements 5 U.S.C. 5514, as amended by the salary offset provisions of the Debt Collection Improvement Act of 1996 (DCIA), as implemented by the Office of Personnel Management at 5 CFR part 550, subpart K. Involuntary salary offset was previously included in the Department's more general claims collection regulations at 45 CFR part 30.
Claims Collection
This final rule amends the Department of Health and Human Services' (HHS) regulations to implement the provisions of the Debt Collection Improvement Act of 1996 (DCIA), as implemented by the Department of Justice (Justice) and the Department of the Treasury (Treasury) as the Federal Claims Collection Standards (FCCS). This final rule implements the final rule promulgated by Justice and Treasury, and amends the process by which HHS can administratively collect, offset, compromise, suspend and terminate collection activity for civil claims for money, funds, or property, and the rules and process by which HHS can refer civil claims to Treasury, Treasury- designated debt collection centers, or Justice for collection by further administrative action or litigation, as applicable.
National Practitioner Data Bank; Announcement of Proactive Disclosure Service (PDS) Opening Date and User Fees
The Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS), is announcing the implementation of a Proactive Disclosure Service (PDS) Prototype. The PDS is being offered as an alternative to the periodic querying of the National Practitioner Data Bank (NPDB). It was developed in response to the growing interest of healthcare entities in on-going monitoring of practitioner credentials. Authorized Data Bank entities can choose to enroll all of their practitioners in PDS or enroll some practitioners while continuing to periodically query on others using the regular query methods. The query fee for periodic queries remains $4.75 per name. Entities with PDS enrolled practitioners will be notified within one business day of the NPDB's receipt of a report on any of their enrollees. While entities can expect to receive reports sooner with PDS, the format of and the information contained in a report, as well as the information required to be reported will remain the same. Initially, the PDS is being offered as a prototype. The annual subscription fee, during the prototype period, is $3.25 per practitioner. This rate is subject to change after the prototype period is complete.
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products
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; Experimental Study of Possible Footnotes and Cueing Schemes to Help Consumers Interpret Quantitative Trans Fat Disclosure on the Nutrition Facts Panel
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Guidance on Drug Safety Information-Food and Drug Administration's Communication to the Public; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance titled ``Drug Safety InformationFDA's Communication to the Public.'' This guidance describes FDA's current approach to communicating important drug safety information, including emerging drug safety information, to the public and the factors that influence when such information is communicated. This guidance was developed in connection with FDA's Drug Safety Initiative. This guidance is the final version and supersedes the previously issued draft guidance titled ``FDA's Drug Watch for Emerging Drug Safety Information'' (70 FR 24606, May 10, 2005).
Secretary's Advisory Committee on Human Research Protections
Pursuant to section 10(a) of the Federal Advisory Committee Act, U.S.C. Appendix 2, notice is hereby given that the Secretary's Advisory Committee on Human Research Protections (SACHRP), will hold its twelfth meeting. The meeting will be open to the public.
Dandruff, Seborrheic Dermatitis, and Psoriasis Drug Products Containing Coal Tar and Menthol for Over-the-Counter Human Use; Amendment to the Monograph
The Food and Drug Administration (FDA) is issuing a final rule amending the final monograph (FM) for over-the-counter (OTC) dandruff, seborrheic dermatitis, and psoriasis drug products to include the combination of 1.8 percent coal tar solution and 1.5 percent menthol in a shampoo drug product to control dandruff. FDA did not receive any comments or data in response to its previously proposed rule to include this combination. This final rule is part of FDA's ongoing review of OTC drug products.
Guidance for Industry on Orally Inhaled and Intranasal Corticosteroids: Evaluation of the Effects on Growth in Children; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Orally Inhaled and Intranasal Corticosteroids: Evaluation of the Effects on Growth in Children.'' This guidance provides recommendations regarding the design, conduct, and evaluation of clinical trials to assess the effects of orally inhaled and intranasal corticosteroids on growth in children. For this class of drug products, measurement of growth is considered a sensitive surrogate of, and an important sentinel for, the potential to cause systemic effects. Growth studies designed and carried out following the recommendations in this guidance can provide adequate and well-controlled data that are consistent among drug products and can be included in product labeling. This guidance finalizes the draft guidance published on November 6, 2001.
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.
Advisory Committee: Change of Name and Function
The Food and Drug Administration (FDA) is amending the standing advisory committees' regulations to change the name and function of the Advisory Committee for Pharmaceutical Science. This action is being taken to reflect changes made to the charter for this advisory committee.
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