Document wKKvGa0Y1gZYy1g3M7MNxNDnQ

14*4 RUIH AND REGULATIONS fpftparad by diluting 0 8 milliliter of 12S the standard between the wavelength* 38411). the Commissioner of Food and hydrochloric cM to 100 milliliters with of 300 and 200 nanometers. Determine Drugs reorgsntaed and republlsiied cer muon alcohol). Trait i portton of tho the absorbance of each solution at the tain sectiona of the general regtristtans tkoiTllltn standard In the time man maxima, at approximately 230 nanom under Subchapter A end the general feed ner. Uatnc i mltable spectrophotometer eters. The spectrum of the samples regulations under HnhrhaiT(Ri B into equipped with a l.0-centimeter quirts should compare qualitatively with that Subchapter E Animal Drugs, fnh. cell sad 0.1N methanoUc acid ae a blank, of the tlcarclllln working standard. and Related Products. As part of this re can the absorption spectrum of the Determine the percent tkarcUUn as organisation and republic*tion. 1108.38 methanoUc solution of the sample and follows: Temporary tolerwne** for pofveAJOrt- Permit itrnrcIlUn. Ahwirhwiw a) Winnie vreWM in miMmma X of atwniwm X Pwwtry a) rfntulnrrl in nHrmgrsww pit nuiiianm y to M\*wb*me1 M&mlwti X Wi*ht in miUtsmni H of winpi* whan: ParcmI motature In the aamplr b. By adding new i 440.290 to Subpart g 440.210 BcMsylpcnictlloyl-polylyaine C, to raid aa follows: injection. noted biphenyls (PCtTs) <21 CFR 10838 < formerly J 123.10. prior to lecodlBcattaP published elsewhere in this issue of the FrstRAL Rsstem)) was repubttahed us Subchapter E as new 1908.38. while being retained in Subchapter B htraaes of its provisions for feed for human use. | 440.290 Sterile ticarrillin wdiiim. <&> Arquirrmeot* for certification-- ft lias come to the attention of the The requirements for certification and the teat* and methods of assay for sterile UcardUln sodium packaged for dispen sing are described in i 440 00a. Because the conditions prerequisite to providing for certification of this drag have been compiled with and the matter is noncontrovental. notice and public procedure and delayed effective date are not prerequisites to this promulgation. Effective date-. This order shall be ef (1) Standards of identity, strength, quality, and purity. BenxyJpentcilloylpolylyslne inlection is an aqueous solu tion of benxylpenlcilloyl-polylysJne. It contains one or more suitable and harmleu buffets. Its benzyipenicllloyl content is satisfactory If it is not leu than 5.4x10'* N and not more than 7.0X10** M. except that for the issuance of a cer tificate for a batch, the benxylpenieittoyl content must be not leu than 4.4X10 * Jf. It Is sterile. It is nonpyrogenlc It Commissioner that certain <rf the tem porary tolerances for PCB's in foads m-1 tended for human use were Inadvertently republished in I 908.30 when that regu- I lation was Issued flipfibir 10. 197g. Therefore the Comwhslnner la mmrftag f 508.30 as set forth below to ttaott lie provisions to animal fead and ratated products as was origtaollv intended. Temporary tolerance* for FCB*S m food intended for human use win continue to appear in f 108.30. fective March 19. 1977. (Sec. 807. 99 8Ut. 493. as emended (21 U.8.C. 3971.) Dated: March. 10, 1877. passu the safety tut Us oh is not leu than 6.5 and not more than 8 5. The benzyipenicllloyl-polylysln* concentrate used conforms to the standards pre scribed by I 440 10(a) (1). Therefore under the Federal Food. Drug, and Cosmetic Act 'sees. SOT'S). 400. 409. 701. 92 SUk 1946 as amended. 1048. 1095-1084 as amended by 70 Scat. 919 and 72 SUt. 948. 72 Stat. 1T8*-I7g8 Mast A. McEnnnrs, as amended <21 UB.C- 34<a>. 348. 348, 4Mortal* Director for Regulatory Affairs. Bureautxf Drugs. [PH Dm.77-7817 Plied 3-14-77:9:48 am] | Docket Mo. TOMimi Effective date: This amendment shall become effective Apru 14,1977. (gee. 807. 99 8*M. 4S3 u unvnded (31 U S C 387).) Dated: March 10.1977. 371) and under authority delegated to the Commisdoner '21 CPlt 9.1*. 9 50838 la revised by detetlra paragraphs *aM|). <2). <3). (4). (7) and'9) and by redesig nating paragraphs <a)<5>. <g). and 'V) as paragraphs (a)(1). <2>. and '3> re PART 440--PENICILLIN ANTIBIOTIC OHIMS snbdpsnlditoy#oMy9bM Injection; Mtaimom Shaif-Ufo Potency The Food and Drug Administration la Mart a. McEmxrt. Assistant Director for Regulatory Affairs, Bureau of Drugs. (PR Doe.77-7818 711*4 *-14-77:8:48 sm| spectively. to rand ae follows: 508.30 Temporary totevanre* for palydlwbrtd Hybinyli (POT*). (a) Polychlorinated Mphenyle fFCffD are toxic, industrial ehemleala. Beeaaaw amending the antibiotic drug regulations of their widespread. uncontrolled indus to provide for a minimum shelf-life trial applications PCB's have beromw a potency for benxylpenleiaoyi-polyfrslne MLATXD RUOOMCTS persistent and ubtquitguscontaaainaiit in tniection; effective April 14. 1877. [Docket Mo. 77-00e3[ the environment. Ae a result retrain The commlsaianer of Food and Drug* propoaed. In the Tucul Raozam of July 1. 1878 (41 PR 27083). that 1440.210(a) (1) (21 CfK 440.220(a) (in bo amended PART 909--UNAVOIDABLE CONTAMI NANTS IN ANIMAL FOOO AND FOOb PACKAGING MATERIAL foods and animal feed*, printtaafiy inane of animal and marine origin, contain PCB's as unavoidable, environmental contaminants. PCB's am transmitted ea to clarify that the minimum potency PtayeMutaetod BsMwyinFCl'in the food portion imeak milk, and eggs' throughout the storage period of the AGENCY: Pood and Drug nfiRsnltr*- of food producing snlmals tngexuaa FCB drug product is 5.4x10=Jf, which la tion, HEW. contaminated animal feed. In addition, a equivalent to 90 percent of the labeled content of the drug product The maxi ACTION: Final rule. significant percantata of paper toad packaging raatertai* contain PCB's which mum potency limit that la allowable for the issuance of a certificate is also speci fied in 1440.210<a>U>. and this limit would also spply for the maximum shelf- life potency. Sixty days were allowed for public comment on the propoaaL Bo com ments were received. Therefore, the Com- SUMMARY: This regulation amends | 909.30 Temporary tolerances tor poly chlorinated biphenyls (PCB's) (21 CFR 508.304 to limit its provisions to animal feeds and related products. DATES: Effective date: March 15. 1977. may migrate to the packaged food. The source of PCB's in paper food-packaging materials is primarily of certain type* of carbonless copy paper (containing 3 to 5 percent PCB's) In waste paoer storks used for manufacturing recycled paper. Therefore temporary talerant-- for res misstaner finds that the amendment FOR FURTHER INFORMATION CON idues of PCB's as unavetdabie environ ihould be adopted as proposed. Therefore, under the Federal Food. Drug, and Cosmetic Act (sec. 907.59 But. 483 ss amended <31 UB.C. 397)) and TACT: Robert S. Brigham. Bureau of Veteri nary Medicine <HPV-23S>. Food and mental or industrial contaminant* are established for a sufficient period of mne following the effective tele ef this para graph to permit the summation ef soeh under authority delegated to the Com Drug Administration. Department of contaminants at the earths! praciwbta missioner <21 CFR 5.1) (raeodlflcatlon Health. Education, and Welfare, 9400 time. For the purpats of this paragraph, published in the Fcmml Racism of June 15. 1879 <41 PR 24283)). Part 440 is amended In 1440.210 by revising para graph <ai <1) to read ao follows: The originator of these procedures la Fishers Lane. Rockville. MD 20857, (301) 443-4243. SUPPLEMENTARY INFORMATION: In a regulation published in the Fipcral the term "polychlorinated biphenyls (PCB's)'' is applicable to mixturm of chlorinated biphenyl eseerpoond*. irre spective of which mixture of PCB's h Carol toull. National Park Service. Rsozstbr of September 10, 1974 (41 FR present as the residue. The temporary NOtAAl ISWSTtX, VOk 42, NO. 30--TUtSDAY, MARCH IS, 1W HONS 011208 RULES AND REGULATIONS (b) Working standard stock solutions AnUbtoUs Drying emdlliora (method number m lined in mc. aaa) Dtltunt Initial (sotwii rent listed In see. oa 101(a)) Final eoneen. tration units or milUcnnis par mifiiUter Rtomts time under reffigtruon Standard reports* line ctmcentrstMMU Diluent Final concen tration*. units or mirrugmn* Of sntlMotia activity per mitlllur 1 *., 4.00. J.0O, 8.24. 741 mug. I PART 440--PCNICIU1N ANTIBIOTIC DRUGS 2. Part 440 Is amended ai follows; a. By adding new f 440.90a to Subpart A. to read ae follow*: (440.90a Sterile itearciM* 4ho4ia. (a) Requirements for certification (1) Standard* of Identity, strength, quality, and purity. Sterile tlcarclUln dlsodlum l* 8-(<carboxy-3-thienylaeetyl> ] amino] - 3.3-dlmethyl 7-oxo-4-thi*-lazablcyelol 3.10]heptane - 2 - carboxylic acid dleodium salt It 1* *o purified and dried that: (U it contain* not leea than 900 mi crosram* of tlcarclUln per milligram on an anhydrous basis. If it la packaged for dispensing, it* ttcarcfflln content la not less than 90 percent and not more than 119 percent of the number of milligram* of tlcarclUln that It la represented to contain. (11) ItlaaterUa. dll) It l* oonpyrogenie. (1*) It paeeeeUM safety teat (v) Its moisture content la not more than 0.0 percent <vt> Us pH in an aqueous solution containing 10 milligrams of tlcarclUln per milllllter (or if packaged for dispensing after reconstitution as directed in the labeling) Is not leee than 0.0 and not more than 0.0. (vU) It glees a positive Identity test for tlcarclUln. (vtil) its tlcarclUln content Is not loss than 90 percent and not more than 94 percent on an anhydrous basis. (2) Labeting. it ahaU be labeled in ac cordance with the requirements of I 493-5 of th*s chapter. (3) Requests for certification; samplei. In addition to complying with the requirements of 1431.1 of this chapter, each such rsquast Naan contain: (I) Results of teats and essays on the batch for potency, sterility, pyrogens, safety, moisture. pH. identity, and ticarclllln contest. (II) 8amplee required: (a) If It is packaged for repacking or for use In the manufacture of another drag. . (1) For all tests except sterility: 10 packages, each containing approxi mately 900 milligrams; and 8 packages, each containing approximately l gram. (2) For sterility tasting: 20 packages, each containing approximately 300 milli grams. <b> Ifltls packaged for dispensing: (/) For aU tests except sterility: A minimum of 15 immediate contamers. (2) For sterility testing: 20 immediate containers, collected et regular intervals throughout each Ailing operation. (b) Testa and methods of assay--(1) Potency, Proceed as directed in f 43S.109 of this chapter, preparing the sample for sway as follows: Dissolve an ac curately weighed sample In sufficient to percent potassium phosphate buffer. pH 8.0 (solution 1), to give a stock solution of convenient concentration: and also, If It Is packaged for dispensing, recon stitute as directed in the labeling. Then using a suitable hypodermic needle and syringe, remove aU the withdrawable contents if tt la represented as a single dose container: or If the labeling speci fies the amount of potency In a given volume of the reeultant preparation, remove an accurately measured repre sentative portion from each container. If it Is a single dose container, use a separate needle and syringe for each container. Dilute with sufficient solution 1 to give a stock solution of convenient concentration. Further dilute en aliquot of the stock solution with solution I to the reference concentration of 5.0 micro grams of tlcarclUln per milliliter (esti mated). (2) Sterility. Proceed as directed in 1438.20 of this chapter, using the method described in paragraph (e)(1) of that section. (3i Pyrogens. Proceed as directed In I 436.32(b) of this chapter, using a solu tion containing 100 milligrams of tlcarclllln per milliliter. (4) Safety. Proceed as directed in 1436.33 of this chapter. (5) Moisture. Proceed ss directed In | 436.201 of this chapter. (6) pH. Proceed as directed In I 436.202 of this chapter, using an aqueous solu tion containing 10 milligrams of tlcareilUn per milliliter (or If packaged for dispensing, use a solution prepared as directed tor reconstitution In the label ing). (7) Identity and ticarcilUn content. Transfer an accurately weighed portion of approximately 40 milligrams of the sample to a 100-mtUlUter volumetric flask. Dissolve and dilute to volume with distilled water. Transfer 5.0 milliliters of tills solution to another 100-mlUlltter volumetric flask and dilute to volume with 0.1JV methanoiic hydrochloric add nosiUL HOfsrta. voc 43. ho. SO--TUISOAT, MAACM 13. IFT HONS 011209 tataacn laa naldun at n aa aa s^SSfSaS *: WWMIWIB, fa* *1^t^rtrSDtaMlMlM otoSoMBto aTmSSTi^iuSflJS WUS AND HOUIAHONS 1|MS -- tanaan, ynmtmt iam- ^ ,, m (| rrsr.sTr DMadr MMiMm. M tokm*E ' Mnrm S***nuNmlbMiiM HuntrfiftiMlnlim yw ------ ---- rTl_j_j_ <<(Fm DM.TT-nia fw B-t4-*Tt: dm) to nSSto^MMnM^^PtoSlVHB^ Utoatod for load pnittotoy aafeto _ -~ __dtoaSTo?mmTEbL SL77^ <J) U fftfto pto hum to vm* Ito*-*' w mm mm mam hhiiri ---fii- t^it wftfc jSg^ - parttMWt matoftet intmtod far or wad [P*ni 7w wiu) M ^ intotiHr tZ ^LJiTT MM MM ftod and aizr onto* FMT ffl POM ABOflWB . KAPA* wd - ""iTiSnu"??^ m >iiNiiinmi m.^ *ffy"'?T * ** **** *Dd MV UBX7T' tad ohleh u UMmU to BNntM * tttODD. TV lM,kb^ (fc M(l). W | J. l(l), SJrJgT.rJ.: J-** *** -- fC%>*'yWLantad-AnalrmaJ *2":TnnpjriranoUv^m- """ MllDMip laa taaahlartaatn mlri fytiltt, anndm aa m*aaa<c. <l) twk.PH>wllirMmaN MaoniT:Aiartri(D>MM *. *** * --> tm Hata taaaM|kM M HI HMM am- <UNNirtMSMMPClMD " TM" agd t aMnHHlBr adi a MM IB tbli aaotlon 1 aaatala Ma bn l--inrpiaaMiaUM inita !> laai Natfc (. tba tafta CNa*. IM and Dta dd- Miiaw a HOa Una im aa* amnnltim, tan 4-aa. MO# Man ma naalaMana or [imw thacaaC tea --- Wll * <** n aanta* lana DOIDMNI. tanaft aaiytatra uNaaa la la . * 1 tan , ia. at. tan. ha madtatalataa tana* aotataa. fin tmnHm g?f**7 - ""* DWN'NWalalaltamill taa am m mm aaa apm 1**-A. . I"' " " marnua* ___________ liana* a tana, mnna *f taa - kaaaa.Manm and Cotar Adtfltta. IDNHI. a- (a) laiaaaawMninatak- nan o< tan. tad and Dm *dadn- <!) Hama an nmat nataparary iiiaian Htoamn. maamam afaaltft. Mu- ,___ lam aiiaimaa *r I anJa(a| (i ar --aa noon, and wauam. laa c at. SW. nmaanaamadtaa: n m mi inaaaa mimai naaad waniaaiaa. ne. saaaa.aaa IT naa. . ara* ana* a. .. w al*ma liaiiaiaBMaMCMMnai: !2"Jto** Sn^Taant i**>.ro*T ^ " *"" lamnan j-- nan nnannaan Ha daman taw aada an aaank- m^u-. atete* Vhfa aga^dta ^ ItaSSiuim ___ _ _____ -___ XMttd. liMrchf. ifTi. oitaalaataanl ` ` diim aiaaa <a 1* mad ntalnaa Ob Mini T, ifTI, tta 1--mnaa Cmtaa flM( Ml OM OMM IMm fltoirt tf a*l*lar Ha LtaM n Qtata Or- Ml* Btotao for M * IDA* Miftr m It itnr im M Him rwM ___ _ Inn______ laana mm in oan Banpa n. '"' * * * * taa: HHaantatan* MltolMUl,llw. MNKi).MtoW(atVAeMi{u) ) . Arttor I--ritoPiwjliiigir f omm. IFM ^.TT-meFAto m. i isunt (n cm mum> o MhMU. UTT. MCMvftof Iwli. ^ >qa% MMMnWto * MfMT t MUM to MM PMM *- smm mm ia itn. ------------ " II r I rTnj*jTjTjL. nm--mn-alm n--mn*mnm-- ^ [ ItoTT-MI IM tm\ itoMtoMMtm ' tw.itonMM.ivn. . nurr nwi niinpM i iP.BM, _ MM MOwptoMCM iSfaki teMIDtoaM-fltotl.. ... MUl A to VMMlMVtotoMMfa IFABiiiW-TMIM ^WTT.tJI Ml IRmiltMVM totoiMlir n. im itoJiV iirwMrt --------- to to--MM to MMtov Mr UataraAaadanrMoalaanaaa.. - pamt m mm HI--HI, owuto lpaaaiia at Ipaaai n Itatalani ?anaa aadaanta aWaa^^amfat r| IHkUMH pnlada lar *!* .............. . w aHpanaaliana Ian for dan <n < *".. ***** Tla tad aad Oaaa adnlamwllaa noaairi (MM IM OTPpfaMMtel MM- MMll ttto WM *r, mm (J* in HONS 011210 140M RUUS AND REGULATIONS bacterial elated with ______________ir, caused by susceptible ill imlw The approval la " March 10,1977. Hm conaMoscr la 1000.110a (21 CPR 500.110a) to reflect TWo2< Heuoint end Urban Deuejepment CHAPTVR VIII--LOW INCOME HOU04NS. OCPMVTMKNT 00 HOUOINO AND URBAN QEVCLOPMCMT lDocket No. a-n-ase r on March 10. 1*77. However. with the Dtreetor, office of TkchmcM Support, HDD Central Office. 401 IN stmt. 8W* Roam 9IIN waehtagtan. D.C. 35410, and a copy should be sent la this approval. In accordance with | 014.11(e) <9> <U> the HDD Ana offise. I North DccrUeea <21 CFR 514.1K*) (2MU) > 4>f tha animal drug regulation* a summary of Um aXety and sffsetivensss data and Infor mation submitted to aupport the ap proval of IMa application la relaaaad pub licly. Th# auamary la available for pub lic examination at tha office of the Rear ing Clerk. Rm. MS, 5000 Plahera Lane. Rockville. MD ZOOS'!, between the houre of 0 a.m. and 4 p m., Monday through mday. (Ow. 519 (U and (a). 99 Mat. 941. 990-961 (91 v.ac. MO (t) add 40). and under au thority dsHgaMd to the coaivthtkmsr (91 Of* 9.1) (raaodUeetloa published la the yvaaaaa Usama of June l>. 1*79 <41 PR Appendix A Prototype Coot Uiwtia tar Low income Housing In the FfeoetAL Rgemrsa issued June 9. 1970, (41 Fit 23303), prototype per unit cost schedules were published pursuant to section 0<b> of the United States Houslnf Act of 1937. Subsequently, con sideration was given to factual coat data and other information received from the Chicago Area Office Field Btaff which showed that the coat limits imposed by the schedule now in effect are unrealisti cally low. The publishing of these revteed prototype per unit cost schedule! will permit housing to be built that other the National Fnvtrnnwisiifal Fahey Act of (fit, baa been made to sirorilaars with HUD pcoreduree. A copy of Drte Finding of feoppOcabiter wtB be avail* able for public tnapaclten during rsgnlai business hours in the Office of Urn Mm Docket Clerk. Office of the Betracery. Room 20141. nspenmni of itctrtng ami Urban Development. 401 7th Street. SW.. Washington, D.C. Accordingly, the prototype par unit cost schedule, pursuant to 24 CFR tot 841 is amended cetohews: part 900 la amended In 1500.110a by revising paragraph* ia)(l> and (c)(1) (1) and (U> to read ee follows: | 550.110* CMoremphenfcoJ tablets. wise could not, with cast limits that are now In effect The cost data and other information submitted Indicated that the prototype per unit coat schedule for Chi cago should be revised and retained 1. At 41 FR 23339. substitute the for Chicago, shown so the table set forth hereinafter entitled "Prototype Per Unit Cost Schedule Rsglcn V " (a) Ktv*ir*mtnu for certi/lctftfcm-- (1) Stmmdord* of identity, strength. util ity. end purify, chloramphenicol tableto are eompoeed of ehJorampbentedl with or without one or more u)table diluents, under the City of Chicago designation. The contiguous areas currently Included under the Chicago designation will re main unchanged and are republished 2. At 41 PS 33330, odd the prototype per unit cost schedule for Aurora, shown on the table set forth hereinafter entitled 'Prototype Per Unit Cast Schedule-- lubricants. binders. cotarings. and eoat- with the designation of Aurora. Region V." inc mhetenrn lach tablet contains 100. 2S0, or 000 milligrams or l gram of chlor amphenicol. Its potency h eattefaetcry If It la not leaa than 00 percent and net more than 120 percent of the number of mfltScrama of chloramphenicol that It la icpmcntcrt to contain. Tablets shall dMBtetrate within l hour. The ehtoramphwdtel used conforms to the standards iirMnrrhnl by it&s.ioiaxi) of this chapter. (e> Condition* of merkettno--U)<1) SpeciAcatimw. Chloramphenicol tableta Prototype cost limits were previously published as an appendix to 24 CFR Fart 270. Effective February 7. 1977. this appendix baa been redesignated Appen dix A. "Fiulotnw Cast Limits tor LowIncome Housing,'' to 24 CFR Part 041. This change was made in connection with publication of the Anal regulations for the Public Rousing Program--Devel opment Phase, 94 CFR Fart 941- Seetkm 9(b) of the U-B. Rousing Act provides that prototype costs be effective (See. 7(4). Department at HDD Art. u mr 393S44M Neve.--it is heresy nrtUtad tbu rmnomle sad taBMtmery tapes*et tae sewaomenc to Art Ctl have Seen earehdiy eeeiaUM la MeerdMOT Htu gasruttve Oder S#. 11191. Effective dote: ThN amrudmem is f(. fcctive on March if, 1977. Acting Deputy itsshteuf .Secre tary /or Housing. Fedrrel Hoestog ComMiuioner. oonform to the certification requirements of parecraph (a) of tbit section. PrunrorvF* !* 1Jirr Notrarf.* (U) Sponsor. No. 017030 t& 1010.000 (O of this chapter for 100 mUBgram tab let; No- 000010 in I 010.000(c) of this chapter for 200.200. or 500 mttUtraa or Effective date: This regulation be effeailve March 10. 1977. (gsa. 919(1) sad (a), etsa 54T. (it 7M teoaii) aa (a))) Dated: March 10,1977. Pud J. Ewans, m II tan US !iSis,ns is.ns ilm ians ii is 3s ii txus SSmac SBmen aisa fins....11----------- JZ-....71____ is 1 |PR DesTMatl Died 9-14-77:9:49 saJ (PR Doc-TT-TStt Med 9-U-77;9:40 sm) 90999AL Mdlim VOL *9, MO. SO--TU9I0AV. MA9CH 19. 1*77 MOMS 011211