Department of Health and Human Services May 3, 2006 – Federal Register Recent Federal Regulation Documents
Results 1 - 14 of 14
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 AGRYLIN (anagrelide), ARGATROBAN (argatroban), CLOLAR (clofarabine), and MERIDIA (sibutramine). These summaries are being made available consistent with 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.
Guidance for Industry on Using Electronic Means to Distribute Certain Product Information; Availability
The Food and Drug Administration (FDA) is announcing the availability of a final guidance for industry entitled ``Guidance for Industry: Using Electronic Means to Distribute Certain Product Information'' dated March 2006. The final guidance explains that persons can distribute certain product information, such as for recalls and product safety, by electronic means. We encourage the use of electronic communications for conveying all such important product safety information. We are making clear in this guidance that manufacturers and others may disseminate communications by electronic means, including e-mail or other electronic methods.
Revocation of Certification of a Laboratory Which No Longer Meets Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
The Department of Health and Human Services routinely publishes a list of laboratories in the Federal Register that are currently certified to meet standards of Subpart C of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908), on September 30, 1997 (62 FR 51118), and on April 13, 2004 (69 FR 19644). This notice informs the public that the following laboratory's certification was revoked effective February 8, 2006: Sciteck Clinical Laboratories, Inc., 317 Rutledge Road, Fletcher, North Carolina 28732. The letter describing the reasons for revoking Sciteck's certification is available on the Internet at https:// workplace.samhsa.gov.
Industry Exchange Workshop to Celebrate Food and Drug Administration Centennial: Past, Present, and Future of Regulated Food, Drugs, Nutritional Supplements, and Medical Devices; Public Workshop
The Food and Drug Administration (FDA) Philadelphia District, in cooperation with the Chemical Heritage Foundation (CHF), is announcing a workshop on past, current, and future issues and challenges in FDA regulation as part of the celebration of FDA's 100- year anniversary. Topics for discussion include: Turning points in FDA history; the impact of changes in science and technology on FDA regulation, regulation in the globalized economy, consumer access to information in the regulatory environment; and a risk-based approach to regulation as a model for the future. The purpose of this 1-day workshop for consumers, industry, academia, and regulators is to promote dialogue among regulators and these stakeholders. Date and Time: The public workshop will be held on Tuesday, May 16, 2006, from 9 a.m. to 5 p.m. Location: The public workshop will be held at the Chemical Heritage Foundation, 315 Chestnut St., Philadelphia, PA 19106, 215-873-8214, FAX: 215-629-5249. Contact: Marie Falcone, Food and Drug Administration, U.S. Customhouse, 200 Chestnut St., rm. 900, Philadelphia, PA 19106, 215- 717-3703, FAX: 215-597-5798, e-mail: Marie.Falcone@fda.hhs.gov. Registration: Send registration information (including name, title, firm name, address, telephone, fax number) and the registration fee of $20.00 payable to the Chemical Heritage Foundation, 315 Chestnut St., Philadelphia, PA 19106. To register via the Internet go to https:// www.chemheritage.org/events/fda/. (FDA has verified the Web site address, but is not responsible for subsequent changes to the Web site after this document publishes in the Federal Register.) The registrar will also accept payment by major credit cards. The registration fee for FDA Philadelphia District employees is waived. For more information on the meeting, or for questions about registration, contact the Chemical Heritage Foundation (CHF) at 215- 873-8214, FAX: 215-629-5249, or via e-mail: arthurd@chemheritage.org. Attendees are responsible for their own accommodations. The registration fee will be used to offset the expenses of hosting the conference, including meals, refreshments, meeting rooms, and materials. Space is limited, therefore interested parties are encouraged to register early. Limited onsite registration may be available. Please arrive early to ensure prompt registration. If you need special accommodations due to a disability, please contact Marie Falcone (see Contact) at least 7 days in advance of the workshop.
Memorandum of Understanding Between the Food and Drug Administration, United States Department of Health and Human Services, the Animal and Plant Health Inspection Service, the United States Department of Agriculture, and The National Institutes of Health, United States Department of Health and Human Services Concerning Laboratory Animal Welfare
The purpose of this Memorandum of Understanding (MOU) is to set forth an agreement between the Animal and Plant Health Inspection Service, U.S. Department of Agriculture, and the National Institutes of Health, U.S. Department of Health and Human Services concerning Laboratory Animal Welfare and FDA (collectively ``the Parties'', or individually as a ``Party'') regarding the framework for reciprocal cooperation which will assist each agency in meeting its responsibilities in promoting proper laboratory animal care and welfare. This MOU replaces 225-83-8400.
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