Document 823Ed4B7bw2qxRv20Kq43wwLk

Frttral Regtutdr*'' Voi. 45, No. 179 / Friday. September 12. 1900 / Notices <0493 System Device* Parisian FDA adviiory Dated: September 1 ISPOl ooamitte*. which recommended JeaapbP.HUe. approval of the application. On |uly 28. I960. FDA approved Iho application by a tatter to the sponsor from the Acting Atsocio* CammttsioftorforRtfvlotery Affatn tm Ow. w-rtM PM ft-n-m eu tm\ Director of the Bureau of MedicaJ Device*. t1oDeedckel Mo. 00*4320) A summary of the safety and effectiveness date on which FDA1 a \ci Contaminant* Cooperative approval la based is on file in the office Agreement I the Hearing Clerk (address above) ind ie available upon request from that office. Requests should be identified with the neme of the device end the Hearing Clerk docket number found in brackets in the heeding of this noanev: Food end Drug Administration. action: Notice. _______________ ttmmunr The Food and Drag Administration announces its intent to award e Cooperative Agreement to the Health end Welfare. Canada. The Opportunity for Administrative Review purpose of the agreement ie to provide financial assistance to continue ita study Section 513(d)(3) of the Federal Food. Drug, end Cosmetic Act (the act) (21 UJ.C 360e(d)(3)J authorizes any interested person to petition under section 315(g) of the act (21 U.S.G 3t0e(g)] for administrative review of FDA's decision to approve this application. A petitioner may request either a formal hearing under Part 12 (21 C7R Part 12) of FDA's administrative priedcos and procedure* regulations or a review of the application end of FDA's octtoa by an independent advisory committee of experts. A petition must be la the form of a petition for raceaelderatloo of FDA action under 11033(b) (21CFR 1033(b)). A petitioner shall identify the fora of review requested (hearing or independent advisory committee) and shall submit of PCS toxicity in monkeys. The cost of this Cooperative Agreement will be J65.700 for the first year. It ie estimated that this agreement will extend for e total of 2 years. PO PURTWKU UWOmSATIOM contact: Sandra Cate. State Contracts and Assistance Agreements Section (HFA- . 513). Food end Drug Administration. 5600 Fishers Lane. Rockville. MD 20657. 301-443-6604. 6UM1 SMCMTSaT UWOmSATIONt This Cooperative Agreement ie awarded under section 301 of the Public Heclth Service Act (42 U.S.C 241). This study will provide information for evaluation of an international problem. La, the significance of the entry of environmental PCB*s into the food supply, end the occurrence of PCB'e in mother's milk. Since one of the with the petition supporting data and major areas of contamination is the information showing that there is e Croat Lakes, the cooperative nature of geaiint and substantial isstm of the study represents e significant move material fact far resolution through administrative review. After reviewing to tits pooling of adentlfie effort to tovaetijpte e serious problem that Is of the petition. FDA will decide whether to concern to both the United State* end grant or deny the petition and will publish the nodes of He dedakm in the radmal lighter. If FDA grants the petition. the notice will state the issue to be reviewed, the fora of review to be eeed. the persons who may participate In the review, the time end piece where the review will occur, end other details. Petitioners may. at any dam on or before October 14.I960. file with the Hearing Clerk (HFA-30S). Food and Drug Administration. Ra. 4-42.5M0 Ushers Lent. Rockville. MD 20457. four eoptee of each petition end supporting data and information, identified with the name of the device end the Hearing Clerk docket number found in brackets The work to be carried out by (be FDA contribution will directly support the maintenance of test animals and analytical work on tissues derived horn dm test animals. The animals will bo housed in the Ubortories of the Toxicology Research Division. Health Protection Brandi (HPB). in a section that has been specifically designed fro the maintenance of subhuman primates, to the recently completed New Research Center. The HPB hat had previous experience to the maintenance of primates as a remit of these extensive todies with other environmental contaminants such as lead end methylmercury. Thus the funds will be hi dm heeding of this document used for an integral pert of the HPB Received petitions may be seen la the tody, end can only be successfully ffiee above between a.tn. and 4 p.m* utilized if the whole project is controlled tooday through Friday. by the HBP. Dated: September 1IS64 foeapb P. (tile, AaMoe/ott CommmioMrfotRufuhtmy Affou% mDm.wnrnMMI-4BMw| OCPAATMCNT OP THCINTMtOII Bureau of Lend Management (CA 7061 will California; Proposed Continuation of Withdrawal and Opportunity far PuMto Hearing September 5. IMS As a result of the review made pursuant to Section 204(1) of the Federal Lend Policy end Management Act of irs (60 StaL 2754:43 UAC 1714). the Bureau of Lend Management. U.& Department of the Interior, proposes to continue the following Public Water Reserve withdrawal: Sa* Semardtoe Merita. CatMe T.iaSbRrt. Sec l nwwave Sec IS. Let 7. ' The area described egpegetes approximately 65.19 acres to Sen Diego County. California. This withdrawal wee created by Executive Order of December 31.1*12. which segregated the lend (ran settlement, nonmetolliforoua location, ale. or entry to order to preservo the public lends end the water thereon for general public uea and benefit No change to the aeygative effect of the withdrawal or the see of the lands ia proposed. For e period of 30 days from the date of publication of this notice Ml persona who wish to submit mmiaante suggestions. or objections to connection with the proposed withdrawn! continuation may prevent their views to writing to the undersigned authorized . officer of the Bureau of Land Management Notice is hereby given that an opportunity for a public bearing Is afforded to connection with toe proposed withdrawal coorimiatien. All interested persons who desire to be heard on the proposed continuation must submit a written request far hearing to the undersigned office*. If the State Director, in hie discretion, determine* that a public hearing ie justified, a notice will be published in the Federal Begiater giving the tune end Slace of such bearing. The public earing wtU be scheduled end conducted in accordance with BLM Manuel Section 2351,198. HONS 008640