The Food and Drug Administration (FDA) is issuing regulations to permit FDA Center Directors to grant exceptions or alternatives to certain regulatory labeling requirements applicable to human drugs, biological products, or
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medical devices that are or will be included in the Strategic National Stockpile (SNS). Under this rule, the

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). At least one portion of the meeting will be closed to the public.

Name of Committee: Cellular, Tissue and Gene Therapies Advisory Committee.

General Function of the Committee: To provide advice and recommendations to the

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA) is announcing the availability for public comment of the draft information technology (IT) plan entitled ``Prescription Drug User Fee Act (PDUFA) IV Information Technology Plan.'' This plan is intended to provide regulated industry and other stakeholders with information on FDA's vision and plan for improving

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA) is amending the [[Page 72921]]
animal drug regulations to reflect a change of sponsor's name from Altana, Inc., to Nycomed US, Inc.

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of December 12, 2007 (72 FR 70599). The document announced that a proposed collection of information had been submitted to the Office of Management and Budget (OMB) for emergency processing under the Paperwork Reduction Act of 1995. The document was

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration is correcting a notice that appeared in the Federal Register of December 4, 2007 (72 FR 68166). The document announced that DSM Nutritional Products, Inc., has filed a petition proposing that the color additive regulations be amended to provide for the safe use of astaxanthin dimethyldisuccinate as a color additive

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA) is announcing a public workshop, cosponsored with the Infectious Diseases Society of America (IDSA), regarding scientific issues in clinical trial design for communityacquired pneumonia. This public workshop is intended to provide information for and to gain perspective from health care providers, academia,

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA) are announcing a public workshop entitled ``Maximizing the Public Health Benefit of Adverse Event Collection Throughout a Product's Marketed Life Cycle.'' The purpose of the public workshop is to

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.

Name of Committee: PulmonaryAllergy Drugs Advisory Committee.

General Function of the Committee: To provide advice and recommendations to the agency on FDA's regulatory issues.

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on its intent to reevaluate the scientific evidence for two previously authorized health claims (dietary lipids (fat) and cancer; soy protein and risk of coronary heart disease) and two qualified health claims that were the subject of letters of enforcement

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA) is issuing a final rule establishing new warning statements and other labeling information for all overthecounter (OTC) vaginal contraceptive drug products (also known as spermicides, hereinafter referred to as vaginal contraceptives or vaginal contraceptives/spermicides) containing nonoxynol 9 (N9). These

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the agency's Division of Dockets Management.

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.

Name of Committee: Cellular, Tissue and Gene Therapies Advisory Committee.

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General Function of the Committee: To provide advice and recommendations to the agency on

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.

Name of Committee: Psychopharmacologic Drugs Advisory Committee.

General Function of the Committee: To provide advice and recommendations to the agency on FDA's regulatory issues.

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA) is announcing a publication containing modifications the agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA recognized consensus standards). This publication, entitled ``Modifications to the List of Recognized Standards, Recognition List Number: 019'' (Recognition List

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 3: Test for Particulate Contamination: Subvisible Particles General Chapter.'' The draft guidance was prepared under the auspices of the International

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 2: Test for Extractable Volume of Parenteral Preparations General Chapter.'' The draft guidance was prepared under the auspices of the International

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry and FDA Review Staff: Collection of Platelets by Automated Methods,'' dated December 2007. The guidance document provides to blood establishments and FDA staff revised recommendations for the collection of Platelets by automated

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

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 Pennfield Oil Co. that provides for a zero day preslaughter withdrawal time following use of oxytetracycline in turkey and swine feed.

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

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 Elanco Animal Health. The supplemental NADA provides for an increased level of monensin in threeway combination Type C medicated feeds containing ractopamine, melengestrol, and monensin

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

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.

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA) is announcing an amendment to the notice of public workshop entitled ``Quality System Regulation Educational Forum on Design Controls.'' This workshop was announced in the Federal Register of October 11, 2007 (72 FR 57951). The amendment is made to reflect a change in the Location portion of the document.

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

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 emergency processing under the Paperwork Reduction Act of 1995 (the PRA). The proposed collection of information concerns the certification to accompany human drug, biological product,

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA) is announcing that, as required by the Federal Advisory Committee Act, the agency has filed with the Library of Congress the annual reports of those FDA advisory committees that held closed meetings during fiscal year 2007.

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

The Food and Drug Administration (FDA) is reopening until February 11, 2008, the comment period for the proposed rule published in the Federal Register of October 19, 2005 (70 FR 60751), (herein after referred to as the 2005 proposed rule). In that document, FDA proposed to amend its regulations to provide for the use of fluid ultrafiltered (UF)

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration