Notices. Notice

1,452 words·~7 min read·/register/2008/01/11/08-64·

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BILLING CODE 4184-01-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007F-0478] Kemira Oyi; Filing of Food Additive Petition (Animal Use); Partially Ammoniated Formic Acid AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration

(FDA)is announcing that Kemira Oyi has filed a petition proposing that the food additive regulations be amended to provide for the safe use of partially ammoniated formic acid as a pH control agent in swine feed. DATES: Submit written or electronic comments on the petitioner's environmental assessment by March 11, 2008. ADDRESSES: You may submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to: *http://www.fda.gov/dockets/ecomments* . FOR FURTHER INFORMATION CONTACT: Isabel W. Pocurull, Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240 453-6853, email: *isabel.pocurull@fda.hhs.gov* . SUPPLEMENTARY INFORMATION: Under the Federal Food, Drug, and Cosmetic Act (section 409(b)(5) (21 U.S.C. 348(b)(5))), notice is given that a food additive petition (FAP 2258) has been filed by Kristi O. Smedley, Center for Regulatory Services, Inc., 5200 Wolf Run Shoals Rd., Woodbridge, VA 22192-5755, United States agent for Kemira Oyi, Porkkalantatu 3, PO Box 330, 001000 Helsinki, Finland. The petition proposes to amend the food additive regulations in part 573—Food Additives Permitted in Feed and Drinking Water of Animals (21 CFR part 573) to provide for the safe use of partially ammoniated formic acid as a pH control agent in swine feed when used at levels up to 1.2 percent of the feed. The potential environmental impact of this action is being reviewed. To encourage public participation consistent with regulations issued under the National Environmental Policy Act (40 CFR 1501.4(b)), the agency is placing the environmental assessment submitted with the petition that is the subject of this notice on public display at the Division of Dockets Management (see ADDRESSES ) for public review and comment. Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. FDA will also place on public display any amendments to, or comments on, the petitioner's environmental assessment without further announcement in the **Federal Register** . If, based on its review, the agency finds that an environmental impact statement is not required and this petition results in a regulation, the notice of availability of the agency's finding of no significant impact and the evidence supporting that finding will be published with the regulation in the **Federal Register** in accordance with 21 CFR 25.51(b). Dated: December 31, 2007. Bernadette Dunham, Deputy Director, Center for Veterinary Medicine. [FR Doc. E8-316 Filed 1-10-08; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Anti-Infective Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. 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* : Anti-Infective Drugs Advisory Committee. *General Function of the Committee* : To provide advice and recommendations to the agency on FDA's regulatory issues. *Date and Time* : The meeting will be held on February 27 and 28, 2008, from 8 a.m. to 5 p.m. *Location* : Crowne Plaza Silver Spring, The Ballrooms, 8777 Georgia Ave., Silver Spring, MD, 301-589-0800. *Contact Person* : Sohail Mosaddegh, Center for Drug Evaluation and Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857, 301-827-7001, FAX: 301-827-6776, e-mail: *sohail.mosaddegh@fda.hhs.gov* , or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512530. Please call the Information Line for up-to-date information on this meeting. A notice in the **Federal Register** about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency's Web site and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting. *Agenda* : On February 27, 2008, the committee will discuss new drug application

(NDA)022-110, telavancin powder for reconstitution and intravenous administration, Theravance, Inc., proposed for the treatment of complicated skin and skin structure infection. On February 28, 2008, the committee will discuss NDA 022-132, ceftobiprole medocaril (500 milligrams), lyophilized powder for reconstitution and intravenous administration, Johnson and Johnson Pharmaceutical Research and Development, LLC, proposed for the treatment of complicated skin and skin structure infection. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at *http://www.fda.gov/ohrms/dockets/ac/acmenu.htm* , click on the year 2008 and scroll down to the appropriate advisory committee link. *Procedure* : Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before February 12, 2008. Oral presentations from the public will be scheduled between approximately 11 a.m. and 12 noon. Those desiring to make formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before February 4, 2008. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by February 5, 2008. Persons attending FDA's advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Sohail Mosaddegh at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at *http://www.fda.gov/oc/advisory/default.htm* for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: January 7, 2008. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E8-343 Filed 1-10-08; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. *Name of Committee:* National Cancer Institute Initial Review Group, Subcommittee J—Population and Patient-Oriented Training. *Date:* February 13, 2008. *Time:* 7:45 a.m. to 6 p.m. *Agenda:* To review and evaluate grant applications. *Place:* The Westin Arlington Gateway, 801 North Glebe Road, Arlington, VA 22203. *Contact Person:* Ilda M. McKenna, PhD, Scientific Review Administrator, Research Training Review Branch, Division of Extramural Activities, National Cancer Institute, 6116 Executive Boulevard, Room 8111, Bethesda, MD 20892, 301-496-7481, *mckennai@mail.nih.gov.* (Catalogue of Federal Domestic Assistance Program Nos. 93.392, Cancer Construction; 93.393, Cancer Cause and Prevention Research; 93.394, Cancer Detection and Diagnosis Research; 93.395, Cancer Treatment Research; 93.396, Cancer Biology Research; 93.397, Cancer Centers Support; 93.398, Cancer Research Manpower; 93.399, Cancer Control, National Institutes of Health, HHS) Dated: January 4, 2008. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 08-64 Filed 1-10-08; 8:45 am]

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