Department of Health and Human Services February 8, 2005 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``S8 Immunotoxicity Studies for Human Pharmaceuticals.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance describes a weight-of-evidence approach to determining whether additional immunotoxicity testing for nonbiological pharmaceuticals is appropriate when the findings from standard toxicity studies indicate signs of immunotoxicity. The draft guidance is intended to provide recommendations on nonclinical testing to identify compounds that have the potential to be immunosuppressive and guidance on a weight-of-evidence decision making approach for immunotoxicity testing.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Clinical Lactation StudiesStudy Design, Data Analysis, and Recommendations for Labeling.'' This guidance discusses agency recommendations on how and when to conduct clinical lactation studies and how to assess the influence of drugs or biologic products on lactation. The goals of this guidance are to provide the basic framework for designing, conducting, and analyzing clinical lactation studies and to stimulate further study and research to assist in rational therapeutics for lactating patients.

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.

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.

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.

The Food and Drug Administration (FDA) is announcing a public hearing to consider the process by which institutional review boards (IRBs) obtain and review information on adverse events that occur during the conduct of clinical investigations. FDA is increasingly aware of concerns within the IRB community that the process is burdensome, inefficient, and not as effective as it should be in providing IRBs the information they need to ensure that the rights and welfare of human subjects are protected during the course of a clinical study. The purpose of the hearing is to solicit information and views from interested persons on issues and concerns regarding the submission of adverse events to and their review by IRBs. FDA is seeking general information about the nature of the problem and possible solutions, responses to specific questions (see section III of this document), and any other pertinent information stakeholders would like to share. Date and Time: The public hearing will be held on March 21, 2005, from 9 a.m. to 5 p.m. Submit written or electronic notices of participation by 4:30 p.m. on March 4, 2005. Submit written and electronic comments by April 21, 2005. Location: The public hearing will be held at the Advisors and Consultants Staff Conference Room, 5630 Fishers Lane, Rockville, MD 20857. Addresses: Written or electronic notices of participation should be submitted to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, e-mail: FDADockets@oc.fda.gov; or on the Internet at https:// www.accessdata.fda.gov/scripts/oc/dockets/meetings/meetingdoc ket.cfm. Written or electronic comments should be submitted to https:// www.accessdata.fda.gov/scripts/oc/dockets/commentdocket.cfm or to the Division of Dockets Management (see Addresses above). Contacts: Nancy L. Stanisic, Center for Drug Evaluation and Research (HFD-1), Food and Drug Administration, 5600 Fishers Lane, rm. 9-64, Rockville, MD 20857, 301-827-1660, FAX: 301-443-9718, e-mail: stanisicn@cder.fda.gov. For Registration and/or to participate in the meeting: Because of limited seating, we recommend that persons interested in attending the meeting register at https://www.accessdata.fda.gov/scripts/oc/dockets/ meetings/meetingdocket.cfm. Registration will be accepted on a first- come, first-served basis. The procedures governing the hearing are found in part 15 (21 CFR part 15). If you wish to make an oral presentation during the open public comment period of the hearing, you must state your intention on your registration form (see Addresses). To participate, submit your name, title, business affiliation, address, telephone, fax number, and e-mail address. You should also submit a written statement at the time of registration for each discussion question you wish to address, the names and addresses of all individuals that plan to participate, and the approximate time requested to make your presentation. Individuals who have registered to make an oral presentation will be notified of the scheduled time for their presentation prior to the hearing. Depending on the number of presentations, FDA may need to limit the time allotted for each presentation. Presentations will be limited to the questions and subject matter identified in section III of this document. Presenters should submit two copies of each presentation given. All participants are encouraged to attend the entire day. If you need special accommodations due to a disability, please inform the registration contact person when you register.