Document NNyv65354Dj1Gv00YQyRbVgJR

22566 ______________Federal Register / Vol. 51, No. 119 / Friday, June 20, 1986 / Notices ADDRESS: Requests for a copy of the constructive notice to all interested both petitions should be identified with petitions and written comments persons that they may be affected by the both docket numbers. The petitions and regarding the petitions to the Dockets petition and gives them an opportunity received comments may be seen in the Management Branch (HFA-305), Food to submit their comments on the petition Dockets Management Branch between 9 and Drug Administration,-Rm. 4-62, 5600 to the agency. Persons potentially aim. and 4 p.m.. Monday through Friday. Fisher Lane, Rockville, MD 20B57. affected include holders of approved Requests for a single copy of cither or FOR FURTHER INFORMATION CONTACT: ANDA's or approved paper NDA's the both petitions should contain the Carol A. Kimbrough, Center for Drugs effective-dates of which might be appropriate docket number or numbers and Biologies (HFN-364), Food and Drug changed by a decision to grant the and be sent to the Dockets Management Administration, 5600 Fishers Lane, petition, persons who have pending Branch. Rockville, MD 20857, 301-295-8046. SUPPLEMENTARY INFORMATION: On September 24.1984, the President signed into law the Drug Price Competition and Patent Term Restoration Act of 1984. This statute amends the Federal Food. Drug, and Cosmetic Act (the act) by authorizing the agency to accept abbreviated new drug applications (ANDA's) for most previously approved new drug products. This legislation also provides for extending the term of a ANDA's or paper NDA's or who contemplate submitting such applications that, when approved, would have effective dates that will be determined by the decision on the petition or, in some cases, persons whose right to submit such applications, may be affected. Where a petition seeks a change in a decision to grant exclusivity, the applicant granted exclusivity has an obvious interest in the issue. Dated: June 10.1906. John M. Taylor, Acting Associate Commissionerfor Regulatory Affairs. |FR Doc. 80-13950 Filed 6-19-86: 8:45 am) BILUNO C0OE 4IS0-0I-U [Docket No. B6F-0171I Reynolds Metals Co.; Filing of Food -Additive Petition patent which claims a product, use, or method of manufacture that was subject to a regulatory review period in In accordance with FDA's policy, the agency is announcing the filing of two petitions in which Xttrium Laboratories AGENCY: Food and Drug Administration. ACTION: Notice. accordance with the act. Further, the legislation' provides for periods of exclusive marketing ("exclusivity'-) of certain new drug products approved in an application (or a supplement to an application) submitted under section 505(b) of the act (21 U.S.C. 355(b)). An ANDA or paper new drug application (NDA) for such a drug may not be submitted, under some provisions or made effective, under other provisions, until the period of exclusivity ends. The new drug products that have been granted periods of exclusivity under one of the several exclusivity provisions of the 1984 legislation are identified in the volume entitled "Approved Drug Products with Therapeutic Equivalence Evaluations" (the list) and its monthly supplements. For each such drug seeks exclusivity for certain topical antimicrobial cleansing agents. Petition 8SP-01D6 requests exclusivity for an aerosol product and a solution product, each containing 4 percent chlorhexidine gluconate. Petition 86-0204 requests exclusivity for two solution products, one containing 2 percent chlorhexidine gluconate and the other containing 2.5 percent chlorhexidine gluconate. In each petition, Xttrium states that the glove juice studies and health care hand washing studies it was required to conduct were new clinical investigations meeting all the requirements for 3-year exclusivity under section 505(j)(4)[D)(iii) of the act. FDA is reviewing the merits of these petitions and, by this notice, is giving anyone who may be affected by these SUMMARY: The Food and Drug Administration (FDA) is announcing that Reynolds Metals Co. has filed a petition proposing that the food additive regulations by amended to provide for the safe use of o/pho-tridecyl-omegohydroxypoly(oxyethylene) phosphate: o/pho-butyl-omego-hydroxypoly (oxyethylene)poly(oxypropylene), minimum molecular weight 1,000; and o/pho-lauroyl-omegohydroxypoly(oxyethylene) in the' manufacture of metallic articles intended to contact food. FOR FURTHER INFORMATION CONTACT. Vir Anand, Center for Food Safety and Applied Nutrition (HFF-335). Food and Drug Administration, 200 C St. SW,, Washington, DC 20204, 202-472-5690. product, the period of exclusivity is petitions an opportunity to submit SUPPLEMENTARY INFORMATION: Under shown. Further, the list shows those comments within 30 days. the Federal Food, Drug, and Cosmetic /> 'll ! products that are covered by a patent and when the patent expires. Interested persons may, on or before July 21,1986, submit to the Dockets Act (sec. 409(b)(5), 72 Slat. 1786 (21 U.S.C. 348(b)(5))). notice i9 given that a The agency believes that all patent Management Branch (address above) petition (FAP 8B3931) has been filed by and exclusivity information appearing in written comments on the petitions. Reynolds Metals Co.. 2101 Rcymet Rd., the list is correct, and expects that such These cpmments will be considered in Richmond, VA 23237, proposing that information appearing in any future supplements to the list will also be correct. However, interested persons preparing an agency response to the petitions. Two copies of any comments are to be submitted for each petition to 178.3910 Surface lubricants used in the manufacture ofmetallic articles (21 CFR 178.3910) be amended to provide for the may disagree with the agency's findings which comments are addressed, except safe use of a/pho-lridccyl-omego- and believe that FDA has excluded that individuals may submit one copy. hydroxypoly (oxyethylene) phosphate: patent or exclusivity information that Comments on the petition regarding the aipha-butyi-omega- should have been included, or included 4-percent chlorhexidine gluconate hydroxypoly(oxyethylene)- patent or exclusivity information that should have been excluded. products should be identified with docket number 86P-018B as shown in poly(oxypropylene), minimum molecular weight 1,000; and c/pho-lauroyl-omego- Accordingly. FDA has established a brackets in the heading of this hydroxypoly(oxyelhylene) in the policy that, whenever an interested document. Comments on the petition manufacture of metallic articles person submits a citizen petition ' regarding the 2- and 2.5-percent intended to contact food. requesting such inclusion or exclusion, chlorhexidine products should be The potential environmental impact of the agency will publish a notice in the Federal Register of the availability of the petition. This publication is identified with docket number 86P-0204 as shown in brackets in the heading of this document. Comments addressed to thi3 action is being reviewed. If the agency finds that an environmental impact statement is not required and m GLEASON-000831