Department of Health and Human Services 2009 – Federal Register Recent Federal Regulation Documents
Results 551 - 600 of 3,583
Prescription Drug User Fee Rates for Fiscal Year 2010; Correction
The Food and Drug Administration is correcting a notice that appeared in the Federal Register of August 3, 2009 (74 FR 38451). The document announced the fiscal year 2010 fee rates for the Prescription Drug User Fee Act. The document was published with errors. This document corrects those errors.
Saccharomyces boulardii Eligibility for Consideration To Be Added to the Over-the-Counter Drug Monograph for Antidiarrheal Drug Products; Request for Safety and Effectiveness Data; Withdrawal
We (Food and Drug Administration (FDA)) are withdrawing a notice of eligibility and call-for-data for safety and effectiveness information. The original notice published in the Federal Register of August 23, 2004 (69 FR 51852). In that notice, we announced that Saccharomyces boulardii (S. boulardii) was eligible for consideration to be added to the over-the-counter (OTC) monograph for antidiarrheal drug products.
Announcement of Final Priority Data Needs for Six Priority Hazardous Substances
This notice announces the final priority data needs for six priority hazardous substances (see Table 1) as part of the continuing development and implementation of the ATSDR Substance-Specific Applied Research Program (SSARP). This notice also serves as a continuous call for voluntary research proposals.
Agency Information Collection Activities; Proposed Collection; Comment Request; Antimicrobial Animal Drug Distribution Reports Under Section 105 of the Animal Drug User Fee Amendments of 2008
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 including each proposed extension of a collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on reporting and recordkeeping requirements for antimicrobial animal drug distribution as required by Section 105 of the Animal Drug User Fee Amendments of 2008 (ADUFA).
Privacy Act of 1974; Report of an Altered System of Records
In accordance with the requirements of the Privacy Act of 1974, the Health Resources and Services Administration (HRSA) is proposing to: change the security classification of the system from low to moderate; add an additional system location, to reflect the creation of a system contingency site; delete language from authorized users of the system; add information on physical safeguards pertaining to system security; delete the use of a receptionist controlled area from the physical safeguards for the system; change the room number for the system manager; change the legal authority cited for maintenance of system information; add a new routine use to Information Center (IC) Integrated Clearinghouse System (ICS), 09-15-0067, last published at 72 Federal Register 44846-44847 (August 9, 2007). The HRSA Office of Communications is responsible for the HRSA IC/ICS System of Records (SOR), which is an existing Agency SOR.
Guidance for Industry on Investigator Responsibilities-Protecting the Rights, Safety, and Welfare of Study Subjects; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Investigator ResponsibilitiesProtecting the Rights, Safety, and Welfare of Study Subjects.'' This guidance is intended to assist investigators in meeting their responsibilities with respect to protecting human subjects and ensuring the integrity of data in the conduct of clinical investigations. The guidance also clarifies FDA's expectations concerning the investigator's responsibility for supervising a clinical study in which some study tasks are delegated to employees of the investigator or to outside parties.
Agency Information Collection Activities; Proposed Collection; Comment Request; Tobacco Product Standard for Flavored Cigarettes
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 proposed extension of an existing collection of information pertaining to the tobacco product standard for flavored cigarettes under the Family Smoking Prevention and Tobacco Control Act (FSPTCA).
National Toxicology Program (NTP); Office of Liaison, Policy and Review; Meeting of the NTP Board of Scientific Counselors
Pursuant to Public Law 92-463, notice is hereby given of a meeting of the NTP Board of Scientific Counselors (BSC). The 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 Director and evaluates the scientific merit of the NTP's intramural and collaborative programs.
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