National Toxicology Program (NTP); Center for the Evaluation of Risks to Human Reproduction (CERHR); Announcement of the Di(2-ethylhexyl)-phthalate Expert Panel Meeting and Availability of the Draft Expert Panel Report on Di(2-ethylhexyl)-phthalate; Request for Public Comment
The CERHR announces the availability of the draft expert panel report for di(2-ethylhexyl)-phthalate (DEHP) on August 15, 2005, from the CERHR Web site (http://cerhr.niehs.nih.gov) or in printed text from the CERHR (see ADDRESSES below). The CERHR invites the submission of public comments on sections 1-4 of the draft expert panel report (see SUPPLEMENTARY INFORMATION below). The expert panel will meet on October 10-12, 2005, at the Holiday Inn Old Town Select in Alexandria, Virginia to review and revise the draft expert panel report and reach conclusions regarding whether exposure to DEHP is a hazard to human development or reproduction. The expert panel will also identify data gaps and research needs. CERHR expert panel meetings are open to the public with time scheduled for oral public comment. Attendance is limited only by the available meeting room space. Following the expert panel meeting and completion of the expert panel report, the CERHR will post the report on its Web site and solicit public comment on it through a Federal Register notice.
Agency Information Collection Activities; Proposed Collection; Comment Request; Fourth National Survey of Older Americans Act Title III Service Recipients
The Administration on Aging (AoA) 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 information collection requirements contained in the annual consumer assessment survey which is used by AoA to measure program performance for programs funded under Title III of the Older Americans Act.
Thomas M. Rodgers, Jr.; Denial of Hearing; Debarment Order
The Food and Drug Administration (FDA) is denying Mr. Thomas M. Rodgers, Jr.'s request for a hearing and is issuing an order under the Federal Food, Drug, and Cosmetic Act (the act) debarring Mr. Thomas M. Rodgers, Jr., for 5 years from providing services in any capacity to a person that has an approved or pending drug product application including, but not limited to, a biologics license application. FDA bases this order on a finding that Mr. Rodgers was convicted of three misdemeanors under Federal law for conduct relating to the regulation of a drug product under the act, and that the type of conduct that served as the basis for the convictions undermines the process for the regulation of drugs. Mr. Rodgers failed to file with FDA information and analyses sufficient to create a basis for a hearing concerning this action. Therefore, FDA finds that there is no genuine and substantial issue of fact to grant a hearing on the debarment.
Proposed Vaccine Information Materials for Hepatitis A and Influenza Vaccines; Interim Vaccine Information Materials for Influenza Vaccines
Under the National Childhood Vaccine Injury Act (NCVIA) (42 U.S.C. 300aa-26), the CDC must develop vaccine information materials that all health care providers are required to give to patients/parents prior to administration of specific vaccines. CDC seeks written comment on proposed new vaccine information materials for hepatitis A and trivalent influenza vaccines. In addition, to ensure that influenza vaccine information materials are available at the beginning of the upcoming influenza vaccination season, this notice includes interim vaccine information materials covering influenza vaccines for use pending issuance of final influenza materials following completion of the formal NCVIA development process.
Determination of Regulatory Review Period for Purposes of Patent Extension; ZUBRIN
The Food and Drug Administration (FDA) has determined the regulatory review period for ZUBRIN and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that animal drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; ATS Open Pivot Bileaf Heart Valve
The Food and Drug Administration (FDA) has determined the regulatory review period for ATS Open Pivot Bileaf Heart Valve and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that medical device.
Summaries of Medical and Clinical Pharmacology Reviews of Pediatric Studies; Availability
The Food and Drug Administration (FDA) is announcing the availability of summaries of medical and clinical pharmacology reviews of pediatric studies submitted in supplements for ADDERALL XR (mixed salts of a single-entity amphetamine product), AVANDIA (rosiglitazone), AVAPRO (irbesartan), RAPAMUNE (sirolimus), and ZOFRAN (ondansetron). These summaries are being made available consistent with section 9 of the Best Pharmaceuticals for Children Act (BPCA). For all pediatric supplements submitted under the BPCA, the BPCA requires FDA to make available to the public a summary of the medical and clinical pharmacology reviews of the pediatric studies conducted for the supplement.
Draft Guidance for Industry on Nucleic Acid Testing for Human Immunodeficiency Virus Type 1 and Hepatitis C Virus: Testing, Product Disposition, and Donor Deferral and Reentry; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry,'' dated July 2005. The draft guidance document provides information for blood and plasma establishments, manufacturers, and testing laboratories that are implementing a licensed method for NAT on pooled or individual samples of human blood and blood component donations for HIV-1 ribonucleic acid (RNA) and HCV RNA. The draft guidance document is intended to encourage more effective testing of whole blood and blood component samples, and improved product and donor management based on the results of NAT and concurrent serologic testing for markers of HIV and HCV infection on donated whole blood and blood components.
National Toxicology Program (NTP); NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); Availability of Revised Analyses and Proposed Reference Substances for In Vitro Test Methods for Identifying Ocular Corrosives and Severe Irritants
NICEATM announces the availability of revised analyses for four in vitro test methods proposed for detecting ocular corrosives and severe irritants [the Bovine Corneal Opacity and Permeability (BCOP) assay, the Hen's Egg TestChorion Allantoic Membrane (HET-CAM), the Isolated Rabbit Eye (IRE) assay, and the Isolated Chicken Eye (ICE) assay]. A revised list of proposed reference substances for validation studies on in vitro test methods for identifying ocular corrosives and severe irritants is also available. The revised analyses and list of proposed reference substances are provided in an addendum that is applicable to each of four draft Background Review Documents (BRDs) that were released to the public on November 3, 2004. The NICEATM invites public comment on the information provided in this addendum. Copies of the draft BRDs and addendum may be obtained on the ICCVAM/ NICEATM Web site (http://iccvam.niehs.nih.gov see ``Reports & Background Documents''), or by contacting NICEATM at the address given below.