The Federal Register

Proposed Information Collection Activity; Comment Request

Tue, Nov 28 2006 11:00:00 GMT

Proposed Projects:

Title: Annual MaintenanceofEffort (MOE) Report.

OMB No.: 09700248.

Description: The Administration for Children and Families (ACF) is requesting a threeyear extension of the ACF204 (Annual MOE Report). The report is used to collect descriptive program characteristics information on the programs operated by States and Territories in association with their Temporary Assistance for Needy Families (TANF) programs. All State and Territory expenditures claimed toward States' and Territories' MOE requirements must be appropriate, i.e., meet all applicable MOE requirements. The Annual MOE Report provides the ability to learn about and to monitor the nature of State and Territory expenditures used to meet State's and Territories' MOE requirements, and it is an important source of information about the different ways that States and Territories are using their resources to help families attain and maintain selfsufficiency. In addition, the report is used to obtain State

Oral Dosage Form New Animal Drugs; Neomycin

Tue, Nov 28 2006 11:00:00 GMT

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 Sparhawk Laboratories, Inc. The ANADA provides for use of neomycin sulfate oral solution in livestock for the treatment and control of bacterial enteritis.

Improving Patient Safety by Enhancing the Container Labeling for Parenteral Infusion Drug Products; Public Meeting

Tue, Nov 28 2006 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing a public meeting on improving patient safety by enhancing the container labeling for parenteral infusion drug products. This will be a 1day workshop involving FDA staff and representatives of the United States Pharmacopeia (USP) and the Institute for Safe Medication Practices (ISMP). The purpose of the meeting is to explore how labels on intravenous (IV) drug products could be designed to minimize medication errors. Design issues include placement, style and type of information, the need for standard expression of strength, quantity of information, and use of color on the label.

Draft Guidance for Industry and Food and Drug Administration Staff; Commercially Distributed Analyte Specific

Tue, Nov 28 2006 11:00:00 GMT

The Food and Drug Administration (FDA) is extending the comment period on the draft guidance entitled ``Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions.'' FDA announced the availability of this draft guidance in the Federal Register of September 7, 2006 (71 FR 52799). The initial comment period closes on December 6, 2006. To provide interested persons additional time to review and submit comments on the draft guidance, FDA has decided to extend the comment period.

Guidance for Industry: Gene Therapy Clinical Trials--Observing Subjects for Delayed Adverse Events; Availability

Tue, Nov 28 2006 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Gene Therapy Clinical TrialsObserving Subjects for Delayed Adverse Events,'' dated November 2006. The guidance document provides sponsors of gene therapy studies with recommendations regarding collection of data on delayed adverse events in subjects who have been exposed to investigational gene therapy products. The guidance announced in this notice finalizes the draft guidance entitled ``Guidance for Industry: Gene Therapy Clinical TrialsObserving Participants for Delayed Adverse Events,'' dated August 2005, and supplements the
recommendations for study subject longterm followup in the ``Guidance for Industry: Supplemental Guidance on Testing for Replication Competent Retrovirus in Retroviral Vector Based Gene Therapy Products and During Followup of Patients in Clinical Trials Using Retroviral Vectors'' (Retroviral Vector guidance), dated November 2006.

Draft Guidance for Industry, Clinical Laboratories, and Food and Drug Administration Staff on In Vitro Diagnostic

Tue, Nov 28 2006 11:00:00 GMT

The Food and Drug Administration (FDA) is extending the comment period on the ``Draft Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays.'' The agency announced the availability of this draft guidance in the Federal Register of September 7, 2006 (71 FR 52800). The initial comment period closes on December 6, 2006. To provide interested persons additional time to review and submit comments on the draft guidance, the agency has decided to extend the comment period.

Training Program for Regulatory Project Managers; Information Available to Industry

Tue, Nov 28 2006 11:00:00 GMT

The Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) is announcing the continuation of the Regulatory Project Management Site Tours and Regulatory Interaction Program (the Site Tours Program). The purpose of this notice is to invite pharmaceutical companies interested in participating in this program to contact CDER.

Office of the National Coordinator for Health Information Technology; American Health Information Community Meeting

Tue, Nov 28 2006 11:00:00 GMT

This notice announces the tenth meeting of the American Health Information Community in accordance with the Federal Advisory Committee Act (Pub. L. No. 92463, 5 U.S.C., App.) The American Health Information Community will advise the Secretary and recommend specific actions to achieve a common interoperability framework for health information technology (IT).

Advisory Committee on Infant Mortality; Notice of Meeting

Tue, Nov 28 2006 11:00:00 GMT

In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92463), notice is hereby given of the following meeting:

Name: Advisory Committee on Infant Mortality (ACIM).

Dates and Times: November 29, 2006, 9 a.m.5 p.m.; November 30, 2006, 8:30 a.m.3 p.m.

Place: Washington Marriott Hotel, 1221 22nd Street, NW., Washington, DC 20037, (202)8721500.

Status: The meeting is open to the public with attendance limited to space availability.

Purpose: The Committee provides advice and recommendations to the Secretary of Health and Human Services on the following issues: Department of Health and Human Services' programs that focus on reducing infant mortality and improving the health status of pregnant women and infants, factors affecting the continuum of care with respect to maternal and child health care, and outcomes following childbirth. It also includes strategies to coordinate the variety of Federal, State, local and private programs and efforts that are