Department of Health and Human Services July 2009 – Federal Register Recent Federal Regulation Documents
Results 101 - 150 of 344
Availability of Draft Toxicological Profile for Perfluoroalkyls
This notice announces the availability of the draft toxicological profile for perfluoroalkyls, prepared by ATSDR, for review and comment.
Agency Information Collection Activities; Submission for OMB Review; Comment Request; SMP (Formerly Senior Medicare Patrol) Program Outcome Measurement
The Administration on Aging (AoA) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Notice of Development of Set 23 Toxicological Profiles
This notice announces the development of Set 23 Toxicological Profiles. Set 23 Toxicological Profiles consists of three new drafts and two updated drafts. These profiles will be available to the public on or about October 17, 2009. Electronic access to these documents will be available at the ATSDR Web site: https://www.atsdr.cdc.gov/ toxpro2.html.
Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications
The Food and Drug Administration (FDA) is amending the animal drug regulations by removing those portions that reflect approval of two new animal drug applications (NADAs) and an abbreviated new animal drug application (ANADA). In a notice published elsewhere in this issue of the Federal Register, FDA is withdrawing approval of these NADAs and ANADA.
Withdrawal of Approval of New Animal Drug Applications; Ketamine; S-Methoprene; Nitazoxanide
The Food and Drug Administration (FDA) is withdrawing approval of two new animal drug applications (NADAs) and an abbreviated new animal drug application (ANADA) listed in table 1 of this document. In a final rule published elsewhere in this issue of the Federal Register, FDA is amending the animal drug regulations to remove portions reflecting approval of these NADAs and ANADA.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prescription Drug Marketing Act of 1987
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).
New Animal Drugs; Change of Sponsor
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for three new animal drug applications (NADAs) and one abbreviated new animal drug application (ANADA) from Virbac AH, Inc., to Cross Vetpharm Group Ltd.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Food Contact Substances Notification System
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Food Contact Substances Notification System'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Export of Food and Drug Administration Regulated Products: Export Certificates
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Export of Food and Drug Administration Regulated Products: Export Certificates'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Notice of Participation
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Notice of Participation'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
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: Proposed Collection; Comment Request
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: ``Study of Factors Influencing Consumer Choices Among Health Plans and Clinicians.'' In accordance with the Paperwork Reduction Act of 1995, Public Law 104-13 (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 3rd, 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. This notice differs from the 60 day notice in the following ways: (1) The number of responses has been decreased from 6,000 to 4,950, (2) the burden hours are decreased from 838 to 709, and (3) the descriptions of each experimental arm in the sections: Clinician Choice Experimental Design and Health Plan Choice Experimental Design were removed.
Agency Information Collection Activities: Proposed Collection; Comment Request
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: ``Health Literacy Item Set Supplemental to CAHPS Hospital SurveyPretest of Proposed Questions and Methodology.'' In accordance with the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)), AHRQ invites the public to comment on this proposed information collection.
National Health and Nutrition Examination Survey (NHANES) Stored Biologic Specimens: Guidelines for Proposals to Use Samples and Proposed Cost Schedule
The National Health and Nutrition Examination Survey (NHANES) is a program of periodic surveys conducted by the National Center for Health Statistics (NCHS) of the Centers for Disease Control and Prevention (CDC). Examination surveys conducted since 1960 by NCHS, have provided national estimates of health and nutritional status of the United States civilian non-institutionalized population. To add to the large amount of information collected for the purpose of describing the health of the population in the most recent survey, serum, urine and limited plasma samples were collected and stored for future research projects. Specimens are currently available from NHANES III (conducted from 1988-1994) and from NHANES 1999-2008. In 1999, NHANES became a continuous survey with data release every two years. Specimens are available from two year survey cycles after the demographic file has been released to the public. Participants in the survey that began in 1999 signed a separate consent document agreeing to specimen storage allowing their biologic specimens to be used for approved research projects.
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Draft Guidance for Industry on Bracketing and Matrixing Designs for Stability Testing of New Veterinary Drug Substances and Medicinal Products (VICH GL45); Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry (198) entitled ``Draft Guidance for Industry on Bracketing and Matrixing Designs For Stability Testing of New Veterinary Drug Substances and Medicinal Products,'' VICH GL45. This draft guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This draft guidance is an annex to a VICH guidance entitled ``Stability Testing of New Veterinary Drug Substances and Medicinal Products (Revision),'' VICH GL3(R), that published in the Federal Register of November 23, 2007 (72 FR 65751). This draft VICH guidance document is intended to provide guidance on the application of reduced designs (i.e., bracketing and matrixing) for stability studies conducted in accordance with the principles outlined in VICH GL3(R).
Ajinomoto Co., Inc.; Filing of Food Additive Petition
The Food and Drug Administration (FDA) is announcing that Ajinomoto Co., Inc., has filed a petition proposing that the food additive regulations be amended to provide for the safe use of N-[N-[3- (3-hydroxy-4-methoxyphenyl) propyl-[alpha]-aspartyl]-L-phenylalanine 1- methyl ester, monohydrate (CAS Reg. No. 714229-20-6) for use as a non- nutritive sweetener in tabletop applications and powdered beverage mixes. Ajinomoto Co., Inc., also proposes that this additive be identified as advantame.
Advisory Committee; Risk Communication Advisory Committee; Termination and Recharter
The Food and Drug Administration (FDA) is announcing the termination and the recharter of the Risk Communication Advisory Committee (the committee). These actions are needed to implement the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Food and Drug Administration Amendments Act of 2007, to change the committee from a discretionary to a statutory committee. This document also amends the agency's regulations which list advisory committees to reflect that the Risk Communication Advisory Committee has been rechartered and to revise the function statement.
Submission for OMB Review; Comment Request; CareerTrac
Under the provisions of section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Fogarty International Center (FIC) and National Institute of Environmental Health Sciences (NIEHS), 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 proposed information collection was previously published in the Federal Register on May 12, 2009, page 22172, and allowed 60-days for public comment. No comments were received from this notification regarding the cost and hour burden estimates. The purpose of this announcement is to allow an additional 30 days for public comment.
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