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10828 as this article is intended to be used. 1s being manufactured in the United States. Reasons: The foreign article provides an optical matching system with the capability to locate a. desired site 1n a prior thick section and then precisely aUne its image upon the remaining block face to guide further appropriate trim- ming. The Department of Health, Educa- tion. and Welfare (HEW) advised in its memorandum dated April 12, 1973. that the capability described above is per- tinent to th.e applicant's use in stud~es ot skeletal muscle after experimental ma- nipulation and staining. HEW also ad- vises that It knows of no domestic in- strument or apparatus of equivalent scientific value to the foreign article for such purposes as this article is intended to be used. The Department of Commerce knows of no other instrument or apparatus of equivalent scientific value to the foreign artJr.le, for such purposes as this article is intended to be used. which is being manufactured in the United States. B. BLANKENHEIMER, Acting Director, Office of Import Programs. [FR Doc.73-8551 Flled 5-1-73;8:45 a.m.] DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE Food and Drug Administration [DES! 1730: Docket No. FDC-D-534; NDA 1-730. etc.] CERTAIN DRUGS CONTAINING AMOBAR. BITAL AND D10XYLlNE PHOSPHATE, PHENOBARBITAL AND THEOBROMINE CALCIUM SALICYLATE; OR BUTABAR- BITAL AND HYOROCHLOROTHIAZIDE, WITH AND WITHOUT RESERPINE Notice of Withdrawal of Approval of Those New Drug Applications for Which No Hearing Was Requested On December 23, 1972, thel'e was pub- lished in the FEDERAL REGISTER (37 FR 28433) a notice of opportunity for hear. ing (DESI 1730) in which the Commis- sioner of Food and Drugs proposed to issue an order nnder sedion 505(e) of the Federal Food, Drug. and Cosmetic Act (21 U.S.C. 355(e)) withdrawing approval of the new drug applications for the sub- ject drugs. The basis of the proposed withdrawal of approval was the lack of substantial evidence that these fixed combination drugs will have the effects that they purport or are represented to have under the conditions of use pre- scribed, recommended, or suggested in the labeling and that each component of such drugs contributes to the total effects claimed. On January 16, 1973, McNeil Labora- tories, Inc., holder of NDA 13-313 for Butiserpazide-25 and Butiserpazide-50 Prestabs, an'd NDA 13-312 for Butizide- 25 and Butizide-50 Prestabs. elected to avail itself of the opportunity for a hearing. This request is under review and will be the subject .of a future publica- tion in the FEDERAL REGISTER. None of the holders of the following new drug applications or any other In. terested person have filed a written ap- NOTICES pearance of election as provided by said notice. The faUure to file such an ap- pearance constitutes an elect10nby such perSOIlB not to avail themselves of the opportunity for a hearing: 1. NDA 1-730; Phenobarb Theocaldn Tablets containing phenobarbital and theobromine calcium salicylate; Knoll Pharmaceutical Co., 377 Crane Street. Orange, N.J. 07031. 2. NDA 9-047; Paveril Phosphate and Amy tal Tablets containing dioxyline phosphate and amobarbital; Eli Lilly & Co., P.O. Box 618, Indianapolis, Ind. 46206. All identical, related, or similar products, not the subject of an approved new drug application, are covered by the new drug applications reviewed and are subject to this notice: see 21 CFR 130.40 (37 FR 23185. Oct. 31, 1972). Any per- son who wishes to determine whether a specific product is covered by this notice should write to the Food and Drug Ad- ministration, Bureau of Drugs, Omce of Compliance (BD-300). 5600 Fishers Lane, Rockville, Md. 20852. The Commissioner of Food and Drugs, pursuant to the provisions of the Fed. eral Food, Drug, and Cosmetic Act .(sec. 505,52 Stat. 1053, as amended: 21'U.S.C. 355), and the Administrative Procedure Act (5 U.S.C. 554), and Wlder authority delegated to him (21 CFR 2.120), finds that on the basis of new information before him with respect to the drugs, evaluated together with the evidence available to him when the applications were approved, there is a lack of sub- stantial evidence that the drugs wlll have the effects they purport or are repre. sented to have under the conditions of use prescribed, recommended, or sug- gested in the labeling thercof. Therefore, pursuant to the foregoing findings, approval of NDA 1-730 and NDA 9-047 and all amendments and supplements applying thereto is with- drawn effective on May 2. 1973. Ship- ment in interstate commerce of the above-listed drug products or of any identical, related., or simUar product, not the subject of an approved new drug ap- pllcation, is henceforth wllawful, Dated.April 24, 1973. SAM D. FINE, Associate Commissioner 5l!or Compliance. IFR Doc.73-8521 Filed 5-1-73:8:45 am] CERTAIN IDESI53161 PEN ICILLlN-CONT AINING DRUGS rheal infections issued in March 1972 by the U,S. Public Health Service, the Com- mt.ssloner of Food and Drugs finds it ap- propriate to amend the announcemen t ot July 29, 1970, as It pertains to the fol- lowing aqueous procaine penicUIin G preparations for injection: 1. Abbocillin-DC Aqueous Injection and Procaine PeniCillin G Suspension (NDA 60-098) ; Abbott Laboratories, 14th and Sheridan Road, North Chicago, TIt. 60064. 2. DuracilIin A.S. Aqueous Injection (NDA 60-093); Eli Lilly & Co., P,O. Box 618. Indianapolis, Ind. 46206. 3 a. Procaine Penicillin G in Aqueous Suspension (NDA 60-099) ; and b. Procaine Penicillin G for Aqueous Injection (NDA 60-286); Ptlzer Labora- tories Division, Pfizer, Inc., 235 East 42d Street, New York, N.Y. 10017. 4 a. Procaine Penicillin G for Aqueous Injection (NDA 60-356) : and b. Procaine PeniCillin G Injection in Aqueous Suspension (NDA 60-357); formerly marketed by philadelphia Laboratories, 9815 Roosevelt Boulevard, Philadelphia, Pa. 19114. 5 a. Procaine Penicillin G Powder for Aqueous Injection (NDA 90-455) ; and b. Procaine PeniCillin G in Aqueous Suspension (NDA 60-420); formerly marketed by Pure Laboratories. Inc., 50 Intervale Road, Parsfppany, N.J. 07054. 6. Procaine PenicilIin G in Aqueous Suspension (NDA 60-102): Roehr Prod. uets Co., Inc., 2010 New Daytona Road, Deland, Fla. 32720. 7 a. CrystlcilIin Aqueous Injection (NDA 60-100) : and b. Pentids-P Aqueous Injection (NDA. 60-100): E. R. Squibb &: Sow. Inc., Georges Road, New Brunswick, N.J. 08903. 6. Diurna.l - PeniCillin Reactimixed Aqueous Injection (NDA 60-094); the Upjohn Co., 7171 Portage Road, Kalama- zoo, Mich. 49002. 9. Wycillin Aqueous Injection (NDA 60-10U; Wyeth Laboratories Inc., P.O. Box 6299, Philadelphia, Pa.19101. The recommended dosage for gonor. rheal infections <uncomplicated) for procaine penicillin G aqueous is amended to read as follows: Gonorrheal infections (nncomplica- ted) . Men or women-4.8 million units in- tramuscularly divided into at least two doses and injected at different sites at one visit, together with 1 gram of oral probenecid, preferably given at least 30 minutes prior to the injection. NOT:B:.-GonorrheaJ. endocarditis slWu1d be trea.ted Intensively with aqueous peritcUl1n O. (., " ,- Drugs for Human Use; Drug Efficacy Study Implementation; Amendment of An. This notice is issued pursuant to pro- nouncement visioIlS of the Federal Food, Drug, and The Food and Drug Administration Cosmetic Act (sees. 502, 507, 52 Stat. pUblished an announcement in the FED- 1050-1051, as amended, 59. 'Stat. 463, s..s ERAL REGISTER of July 29, 1970 (35 FR amended.; 21 U.S.C. 352, 357) and under 12144), regarding the emcacy of certain a.uthority delegated to the Commissioner of Food and Drugs (21 CFR 2.120). penicillin-containing drugs. A folIowup notice was published. in, the.FEDI:RAL REG- Dated Apri124',1973. ISTER of March 30, 1972 (37 FR 6511), SAM. D. FINE, concenling certain of those drugs. Associate Commissioner Based upon the recommended treat-. lor Compliance. ment schedule for uncomplicated gonor- IFR Doc.73-85HI Flled 5-1-73:8:45 amI FEDERAL REGISTER, VOL. 38, NO. 84-WED!'IESDAY, MAY 2, 1973 7'