Document mbyo0X0xRYQd9jbrKjqjZkGK4

14238 - m 24.874 toe denial order toned against die re spondent on February 31, 1973 <21 IB *306). W Datead: April IS, 1916. RtmElimt, Ander, Office o/ Export AdmMstrotioa. f PW..74 eoo ium --ie-74;e.*t am] COMPUTER SYSTEMS TECHNICAL ADVISORY COMMITTEE Pursuant to tbe provisions of toe IVderal Advisory Committee Act (Public law 93-43>, notice is hereby given that a meeting of the licensing Procedures Subgroup of toe Computer Systems Technical Advisory Committee win be held Monday, April 29. 1974. at 1:30 pm. In Conference Room A. Main Com merce Building. 14th and Constitution Avenue, Washington, D.C. Members advise toe Office of Export Administration. Bureau of East-West Trade, with respect to Questions involv ing technical matters, worldwide avail ability and actual utilisation of produc tion and technology, and licensing pro cedures which may affect the level of export controls applicable to computer systems, including technical data re lated thereto, and Including those whose export is subject to multilateral (COCOM) controls. Agenda items are as follows: 1. Opening remsrks by tbe Chairman. Computer Systems Technical Advisory Committee, 3. Appointment of subgroup chairman. 3. Presentation of papers or comments by tbe public. 4. Discussion of export Uoenslng proce dures relating to computer systama 5. Executive Session: Continuation of dlscusrlon of export licensing procedure*. The public will be permitted to attend the discussion of agenda items 1-4, and a limited number of seats will be avail able to the public lor these agenda Items. To the extent time permits, members of the public may present oral statements to the subgroup. Interested persons are also invited to file written statements with the sut group. With respect to agenda item 5, "Exec utive Session," the Assistant Secretary of Commerce for Administration, on De cember 20. 1073, determined, pursuant to section 10(d) of Public Lew 03-403, that this agenda item should be exempt from the provisions of sections 10 (a) (1) and u>*3). relating to open meetings and public participation therein, because tbe meeting trill be concerned with mat ters listed in 8 U.C. 552(b) (1). Further Information may be obtained from John L. Collins, chairman. Com puter Systems Technical Advisory Com mittee, IBM World Trade Corporation, isoi K Street NW,, Washington. D.C. 20000 (A/C3O2-g33-gO00>. Minutes of those portloneof the meet ing which are open to the public will be available 30 days from toe date of toe meeting upon written request ad* ____ to: Central Reference and ords Inspection Facility, DA. ant of Oorimwot. Washington, DjC. 10230. Sated: April IT. 1074. Rato H. Mxto. Director. Office of Export 44* aMitotlok, Bureau o/ EastWest Trade. Department ol |f* Poc-71 eoee filed 4-U-14;S:tS am] DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE tKAbA Ho. a-3aSV) AGRimONlCS CORF. Agritronlcs twine Premix T-t; Withdrawal of Approval of New Animal Drug Application Pursuant to provisions of toe Federal Food. Drug, and Cosmetic Act (sec. 812. 23 stat. 343-351; 21 UA.C. 380b) and wider authority delegated to toe Com missioner of Food and Drugs (21 CFR 2.120), the following notice I* Issued: Agritronlcs Corp.. 811 24to 8t_ Dea Moines, IA 50311. has requested that Its NADA (new animal drug application) No. 48-236V be withdrawn is accordance With (135.28(d) (21 CFR 135.23(d)) on toe grounds that the drug is not being marketed. Notice is given that approval of NADA No. 4S-236V for Agritronlcs Swine Premix T-8, which contains tylosin and sulfamethazine, la hereby withdrawn. Effective date. This notice shall be ef fective April 22.1874. Dated: April 18,1814. - Sam D. End, Associate Commisricmer lor Compliance. IP* Doe.74-9114 FU*d 4-14-74;S:4S sm) HUMAN DRUGS CONTAINING VINYL CHLORIDE OR PACKAGED IN POLY VINYL CHLORIDE CONTAINERS Notice to Drug Manufacturers, Peckers, - aria Distributors Elsewhere in this issue of the FmnAi Rzcrsixx (39 FR 14215) toe Camxnissitmer of Food end Drugs has proposed that all aerosol drug products containing vinyl chloride as a component, including propellant, are new drugs and subject to regulatory proceedings unless toe prod ucts are the subject of new drug appli cations approved pursuant to section 605 of the Federal Food, Drug, and Cosme tic Act. That proposal is based on scien tific data demonstrating that vinyl chlo ride is not generally recognized as safe and effective as a component. Including propellant, of a drug product. Tbe Food and Drug Administration is aware that vinyl chloride has been used as a propellant in aerosol drug prepara tions, but has no information that vinyl chloride is currently being used in the manufacture of drug products. There la ample evidence that vinyl chloride til In acute toxicity by an array of symptoms in cluding unconerJoninam as a result of high concentration inhalation. Cardiac effects, bene changes, and degenerattva changes in toe twain, liver, and kidneys have also been reposted in animats. In addition, toes* an toadies demonstrat ing toe oarrlncganlc effects in animals as a result of inhalattrm exposure to vinyl chloride, and It baa bean linked to liver cancer, in work- in the polymerization of the 'to polyvinyl chloride. Polyvinyl chloride, a polymeric resin produced by polymerisation of vinyl chloride, la wed in drug packaging materials Thera Is evidence of vinyl chloride migration when polyvinyl chlo ride Is need to paefcegtog material for products containtng alcohoL There have also been reports of toe possible migra tion of polyvinyl chloride container ingredients to non-alcoholic products as welL Because of this It la necessary to give special study to each packaging material to determine If it la safe for Ito IntsuAf^) on. For these reasons it is essential that ths Commissioner bare knowledge af every drug product currently marketed In the United States that contains vinyl chloride as an ingredient, and Informa tion regarding every marketed drug product packaged In a polyvinyl chloride container or In a container lined with polyvinyl chloride. Such information U necessary for determining if there is ade quate evidence whether drugs containing vinyl chloride or packaged In containers composed of, or lined with, polyvinyl chloride are safe and effective for their intended purposes and what action, if any, is required to protect toe public health. 8ection 510(j) (3) of toe act, as added by the Drug Listing Act of 1972, author izes the Commissioner to require each registrant under section 510 of the set to submit a list of each drug product which the registrant is manufacturing, preparing, propagating, compounding, or processing for commercial distribution and which contains a particular ingredi ent, when the Commissioner has made a finding that tbe submission of such a hst is necessary to cany out tbe pur poses of the act. Tar the reasons stated above tbe Commissioner so finds with regard to drugs nwnisimtif vinyl chlo ride. As packaging materials are an integral part of the drug product, the Commissioner also so finds with regard to drug products packaged In polyvinyl chloride contamers or In containers with polyvinyl chloride finer*. In addition to tbe required list of drugs containing vinyl chloride and a required list of drug products packaged to poly vinyl chloride container* or In containers with polyvinyl chloride linen, the Com missioner la requesting, but not requir ing, that certain other information be submitted. Tbe Ocmmtadaner acknowl edges that acme of toe Information being requested has also been requested in toe regulations Implementing toe Drug List ing Act of 1912, snd will be available SEDEXAl KOtSTn. VOL >4, NO. 7--MONDAY, ANUt It, 1V? OLI 1394 *****1 V t 1 t I t 3 * t C I i f c t fl V s t k a s C' It W o: k: *1 at m. Vi ei *: t! tr 14238 iraon that source. Howwrer.tt win greatly U. Hi_________ tbs eoropilatlon of this tolar* at tbs polyrtayl rssr s*&r Typ*fwmrtny ix tt is Included to this sub- Thereto** pursuant to the provisions tt the Psdenl Mod. Drug, and Coemetic ^Uaem. Ml. >10.701(a). 52 Stat. 1040- ee emnslml 1053. as amended. ISs! as amended: 21 U.S.C. Ml. MO. Tltis tntomttoft dMA to Department at fare Food aad Drug Bureau of Drugs. Drug listing *' at *%^kiew> Opss May totses*. MMa.a.,clo*d 85Ss 2s May IS altar IS a.a>.. itaaiil May S. Rabat 8. (BFD-t) Kwmady. Fh.D.. mrM-ixn woo S71<e>: M JJM.C. M2> and under au thority ilClsgiTtil to the Commissioner (21 CPR 2.130). each registrant under Motion 110 of the act is required to subalt to the Mod and Drug Administra tion a list of all human drugs which ere Peine manufactured, prepared, propa gated, compounded, or processed for commercial distribution and which con tain vinyl chloride whether or not the vinyl chloride is an active or inactive In gredient and a Ust or an human drug products packaged In polyvinyl chloride containers or in containers with poly vinyl chloride liners es follows: l, toeportlag dim sum. aflrtts**. aad isiisWstlwi number. j. ut ef drum containing vinyl chloride (by Wads name. If any. and astabUabsd nsmt. it any) and a Ust of drug products tor bleb polyvinyl chtorids is ussd ss a oonmm. or a eontalner liner (by trade name, It any. and eetablished name. It any) It Is requested but not required that the following Information also be sub mitted: Boekvllle, MD SMR1 bp May a. 1874. Dated: April U. 1874. Conmtukmtr of Mod mad Drugt. (fto Doe.T4-MU PBed -18-T4;8:4 MS] ADVISORY COMMITTEES Pursuant to the Federal Advisory Com mittee Act of October 8. 1871 (Public Xnw 83-463. M Stat. 770-776; 5 OA.C. App.). the Mod end Drug Administra tion announces the following public ad visory committee meeting* and other re quired information to accordance with provision* set forth to section 10(a) (l> and (3) of the act: Committea DaM.ttaa, pin a Tyfrifqnittnt fbbanLana. wRaaank.rmiDa-,wM-dm. v Purpose. Reviews and evaluates avail able data oonnarning the safety, effeeIlvenem. and reliability of dental devices currently to uee. Agenda. Open SMSton: comments and laaaentatlons by Interested persons; de fies rlessjftcaOcn; and device legisla tion. Closed asMton: Continuing review and classification of dental devices. Agenda Items are subfact to change as priorities dictate. During the open sessions shown above. Interested persons may present relevant Information or views orally to any com mittee for Its consideration. Information or view* submitted to any committee to writing before or during a meeting shall also be considered by the committee. A list of committee members and sum mary minutes of meetings may toe ob tained from the contact person for the committee both for meetings open to the public and those meetings Closed to S. Rational Drug Code (MDC) tf one has been amlgned. 4. A statement whether the drug Is mar keted over the counter or limited to pre scription distribution. 5. Bouts of administration. 6. amount ot vinyl chloride in average daily dme. t. Vend on BevMwsf lAenWatrcaraMlo iAnschtirMtMUOotaaatle Draw- May IwidS, as,, CenwrVaflclan Bid*..MBS ritan Lana, Roakrillr, Md. Opae May * * a^>. w t* aa.. aioaad May* SIMMS LleBa.,(MeioaaraadarM. ay A Room 1SB-SE, MOt Ftahan Lana, RoekrtUa. lid. ssm.Rn in sa the public to accordance with section 10(d) of the Federal Advisory Commit tee Act. Most Pood and Drug Administration advisory committees are created to ad vise the Commissioner of Pood and Drugs on pending regulatory matters. T. Quantity of drug dUWlbutad (number Recommendations made by the commit of dosage units) during previous IS months. Purpose. Reviews and evaluates avail tees on these matters are Intended to to A copy of the label and labeling. able information concerning safety and result to action under the Federal In addition to the information requested to Items 1 through 8 (excluding item 6) for drug products packaged in polyvinyl chloride containers or In containers with polyvinyl chloride linen it Is requested, but not required, that the following in formation be submitted. S. a statement of the vinyl chloride con tent in polyvinyl Chloride used for the manu facture of the drug container or oontatner lining. Include description of the method! and detraction systems used to determine effectiveness of active ingredients at cur rently marketed non-prescription drug products wwitaiwiny internal analgesic agents. Agenda. Open session: Comments and presentations by interested persons. Closed inssiirr* Continuing review of nonprescription internal analgesic drugs under Investigation. OomttMtw DaSwh.edaa*. TypaeraasMac Pood, Drug, and Cosmetic Act. and these committees thus necessarily participate with the Commissioner to exercising his law enforcement responsibilities. The Freedom of Information Act rec ognized that the premature disclosure of regulatory plans, or indeed internal discussions of alternative regulatory ap proaches to a specific problem, could have adverse effects upon both public and private interests. Congress recog nized that such plans, even when final this content. If this information Is not known, provide the name and address of the drug container or oonteiaar liner supplier and/or manufacturer. 10. Tha rate and level of extraction of vinyl chloride from the polyvinyl chloride eontetneri or container linen by the particu lar drug or toy any other aorta-action or solvent 1 Fatal ee OBrathrioa-waf BDMedrMtCas Motor Lain. Opaa * a.*., briimb. to M 1 altar Wa.B. lama B. Balt Las* Vrala (UFM-13Q, Ctty. L'laA WntmUM, wSrb'iBms. ised. may not be made fully available to advance of the effective date without damage to such interests, and therefore provided for thi type of discussion to remain confidential. Thus, law enforce ment activities have long been recog nized as a legitimate subject for confi ystema including data derived after periods dential consideration. of storage. Where such Information is not known, hut ie or may be available from the supplier or manufacturer of the eontalner r liner, provide the name and address of ueb supplier or manufacturer. Purpose. Review* aad evaluates avail able data concerning safety, effective ness, and reliability of orthopaedic de vices currently In use. These committees often must consider bade secrets and other confidential in formation submitted by particular man- ufacturen which the Pood and Drug . 11. The rate and level of absorption of Agenda. Open session: Comments and Administration by law may not disclose, vinyl chloride a* n Ingredient or of vinyl chloride extracted from a polyvinyl chloride container or liner by the drug contained on presentations by Interested person*. Closed session: Continuation of review of and which Congress has Included within the exemptions from the Freedom of cn average dally does. Where such informa previous classification results and iden Information Act Such information in tion is not known, but Is or may be available the supplier or manufacturer or the container or llnsr. provide the name and tification of specific areas for standards for those device# classified as requiring cludes safety and effectiveness Informa tion. product formulation, and manu Audroae ot sub supplier er manufacturer. standards. facturing methods and procedures, an hoots*, vol **. no. r*--Monday, assn, xt, ivy* OLI 1395 PROPOSED tun* 14215 ib) Technical services. (1) The builder-developer proposing a new subdivision which win have 10 or more dwelling rite* will secure the ttnhom of a site planner, architect, landscape architect, or engineer, reg* btered or otherwise certified a* qualified IB the state in which the subdivision to to be constructed, to provide complete toning, drawings, specifications, and aganMac on land, street, utility and grading development. (S> Complete technical services will be "***"** and paid lor by the builderdeveloper with his own funds. (S) At completion of construction (or when construction win be accomplished hi phsscs. at the end of each phase), the person who is qualified and registered or certified In the state in which the sub division is to be constructed end is pro viding supervisory services during the period of work shall notify the raA County Office In writing that an work has been completed in substantial conform ance with the approved plans and sped- need alnee that time. Only certain for mulations of FVC, however; are prior- sanctioned far nee In find packaging and therefore am exempt trem daastfleatlon as food additives and may be used with out pre-marketing dcamnei by the Food ms r>rue mm Early in 1973. the Food and Drug Ad ministration began receiving reports of p"-no* migration problems of ingredi ents of FVC bottles then being test mar keted tor distilled spirit*. As a meult of further analytical testing, the Oommls- atoner published the May 17, 1973 pro posal wherein be concluded that the urn of FVC for the packaging of alcoholic foods may cause each foods to be adulter ated. No FVC bottles have been need for such purposes since then After the pub lication of the proposal, the Commis sioner began Investigating adenUflc re port* regarding the possible migration of FVC container Ingredients to nonalco holic foods as well. Agency action on this nutter and on the earlier proposal is ex pected to be published shortly in the Fkdxxal Reams*. The Commissioner is ous drag fluids after they have been In contact with devices composed in whole or m part of polyvinyl chloride. (g) The effect on Mood and tissues of vinyl chloride extracted from devices composed In whole or In part of polyvinyl chloride inserted or implanted In the body. an in poserirtnn of such data are urgntty requested to submit it to the Food and Drug Administration In writing (preferably In qulntuplicate), if at all p--'on or before June 21, 1974. This data should be sent to the Hearing Clerk, Food and Drug Administration. Room -99, MOO Fishers Lane, Rockville, MD 30093. Received data may be seen in the Above office during working hours, Mon day through Friday. The Commissioner recently received a petition from the Health Research Group, 3000 P Street NW.. Washington. Dr. 30036, proposing to prohibit immedi ately the continued urn of vinyl chloride as a constituent or propellant of cosmetic aerosol products and of polyvinyl chlo ride as a container material for any cos * . * g. Amend f 1804.67 as follows: also considering the applicability of this metic product which can leach out de Information to various drug product* tectable amounts of vinyl chloride from packaged in FVC. and to various devices the polyvinyl chloride .container mate liaOMT Streets. composed in whole or In part of PVC rial. The petitioner contends that there (a) New subdivisions and expansion of existing subdivisions. (1) Streets must conform to master street plans, design standards and con traction specifications of the applicable public body, city, town, county or state and the requirements of the FHA. De velopments with more than 30 sites shall havs two accesses available, unless an exoeptlon is granted by the State Director. which may come in contact with drug fluids, or which may be Inserted or im planted In the human body. Because of the broad interest tn the subject of vinyl chloride by both the pub lic and the scientific community became of Its potential as a serious threat to the public health, the Commissioner has un dertaken an agency-wide effort to explore the problem In connection with those products within the jurisdiction of the Food and Drug Administration and to the appropriate regulatory ac is substantial evidence that vinyl chlo ride monomer is carcinogenic. A copy of the petition and letter of transmittal to the Commissioner are on file in the Office of the Hearing Clerk. The Commissioner has reviewed all cosmetic product Ingredient statements on file with the agency, representing ap proximately 90 percent of current market formulations, as of February l, 1974, and has ascertained that no Information ex ists In these flies Indicating use of vtayl chloride In oosmetic aerosol. products. (41 DSC. 1480's; delegation of authority by See. ft Agru 38 FR 14S44. 14S4S. 7 cm IAS; SeitoStW" of authority by the Aeet. See. for Bull Development. SS FB 14*44, 14863, 7 ora 1.70). Dated: April 15,1074. tions that should be taken to assure full protection of the public health. Repre sentatives of this agency arc also mem bers of a Federal inter-agency task force formed to gather data on the overall ef fect of vinyl chloride on the total en Furthermore, the Cosmetic, Toiletry and Fragrance Association, me. (CTFAi, has Informed the Food and Drug Adminis tration that the results of a recent tele phone poll, covering 26 companies in cluding the major aerosol hair spray Pun B. Elliott, Administrator, Farmers Home Administration. fFD Doe.14-4151 FUed 4-18-74:1:46 am] vironment and to initiate coordinated ac manufacturers, show that no company tion to this Impact. contacted has manufactured products In connection with this search for In containing vinyl chloride since June formation, the Commissioner Is particu ' 1973. In 1973, according to this Informa larly interested in receiving data in re tion. two companies produced vinyl chlo sponse to the following points relating to ride-containing products with a total DEPARTMENT OF HEALTH. EDUCATION, AND WELFARE the use of polyvinyl chloride In contain volume of approximately 1,625,000 units. ers for food and cosmetics, and in de The CTFA estimates that the percentage vices: of hair spray cans manufactured in 1973 Food and Drug Administration [ 21CFR Farts 310 and 700 ] (1) The extent of usage of polyvinyl which contained vinyl chloride is less chloride by type of container or container than 0.4 percent. A copy of the lnfor- Uner and type of product. . motion received from the CTFA is on VINYL CHLORIDE AS AN INGREDIENT OF (3) The vinyl chloride content In poly file in the Office of the Hearing Clerk. DRUG AND COSMETIC AEROSOL PROD vinyl chloride used to manufacture or There Is no known past or present UCTS line various food and oosmetic contain usage of vinyl chloride as a propellant Notice of Proposed Rule Making ers, Including description of the methods in food aerosol products. Any such use and extraction systems used to determine without a food additive regulation would h the Fbbsxal Rnnsm of May 17, this content. be a violation of the Federal Food, Drag, UTS <39 PR 12031), the Commissioner of (3) The rate end level of vinyl chloride and Oosmetic Act. Food and Drugs published a notice of extraction from the aforementioned con With regard to drug products, the Food proposed rulemaking for prior-sane- tainers or their linen by various foods and Drag Administration has recently tiansd polyvinyl chloride (FVC) resin. Polyvinyl chloride is a polymeric resin produced by polymerisation of vinyl chloride which was used as a component of food packaging materials prior to the passage of the Food Additive Amend ment* of IBM and which has been widely and cosmetics. Including data derived after periods of storage. (4) The rate and level of percutaneous absorption of vinyl chloride from cos metics and devices when in contact with the skin or mucous membrane. (A) The vinyl chloride content of vari reviewed its flies and conducted a sur vey of aD known drug manufacturers of aerosol protects to determine the extent to which vinyl chloride is used as a com ponent. iwfiiiiWng propellant, in such products. The only known use of vinyl chloride in drug products has been as a OOtSin, VOL *, NO. rs--MONDAY, AfBU tl, 1*74 OLI 1396 14g6 IHblUnt In aeroeol preparations. White made af any additional bo eapooed eould be i sJithe Information requested to the town If of the safe level survey ni not supplied by manufee- Two cosmetic with tuten, the review of the Mency flies end facturen that preliminary results of the survey tndl- April 2, 1974 and a drug chloride tohalatton can raault to eete that vinyl chloride Is not currently manufacturer, Idwttfled toxicity menlfacted by being need In aerosol drug products. search, began recall of There ere no approved new drug appli three eaieeal cations for vinyl chloride as s component April S. 1974, following of any drug. There Is evidence, however, enle effects to inhinli as a result of that manufacturers of some over-the- Therefore, tohalatton esposure to vtoyl chloride. counter drug products used vinyl chlo the PMaml Food. Furthermore, vinyl chloride has recently ride as a propellant until 1973. Act Caeca. M2. 505, Ml (a), 701(a): IS fMfutfioff To determine the full extent that vinyl Stat. 1060-1058, as ammidad; SI UAC. In tba chloride is used In drug products and to 352, 355,301(a). 371(a)) and under au polymerisation of vinyl chloride, It Is the determine If any additional action Is thority driagatod to the Oosnmlmloaar view of the CuwihiImImiiit that vinyl needed to protect the public, there Is of Food and Drugs (21 GFR 3.120). tt Is aUnrlda 4a a SStwif H-- *>- published elsewhere in this Issue of the proposed that Farta 310 and 700 to may render any eowneUe aeroeol prod- yrsnui Reams, a notice, pursuant to amended as follows: wet that contains B (132.7(a)(4) (21 CFR 132.7(a) (4)), Of 1. By adding a new 1310.506 to Bub- Injurious to user the regulations under the Drug Listing part K of Fait 310 to mad at followa: mette aerosol product containing vtoyl Act of 1972. requiring ell registrants to submit a list of all drug products mar keted containing the Ingredient vinyl 121<L506 the ml vtoyl ifclartle as -- ef chloride as an ingredient la deemed to be adulterated under section 601(a) of the Federal Food. Drug, and Osmetic Act. chloride or packaged In containers com <b> Any cosmetic aeroeol product con posed of or Used with polyvinyl chloride. (a) Vtoyl chloride has been used ae a taining vinyl chloride as an Ingredient Hie Commissioner has determined propellant fa aeroeol drug preparations. shipped within the Jurisdiction of the set that there axe sufficient scientific data on which to base a decision that: (1) vinyl chloride presents an unnecessary hazard to the public health when It Is used as an Ingredient hr cosmetic aerosol prod ucts and that such use should be banned, and (2) vinyl chloride, when used as an ingredient In drug aeroeol products. Is mi generally recognised as safe and ef- ^Atlve, is a new drug within the meaning section 201 (p) of the Federal Food, Drug and Cosmetic Act. and requires an approved new drug application as a con Evidence Indicates that vtoyl chloride Inhalation can result to acute toxicity manifested by dhxlnrss, headache, dis orientation, and unconsctonsnssr where inhaled at high concentrations. Cardiac effects, bone change^ and degenei alive changes In the brain, liver, and kidneys have been reported In studies also demonstrate carctoogenlc effects to niini || | mult of iwiwifMiw expo sure to vinyl chloride. Recently, vtoyl chloride has been linked to liver dlsrase, including liver cancer, to workers en Is subject to regulatory action. Interested persons may, on or before llay 22,1974. file with the Hearing Clerk. Fbod am Drug Administration, room 0-M, 5000 Fishers lane, Rockville, MD 20052, written comments (preferably to qulntupUcate) regarding this proposal. Comments may be accompanied by a memorandum or brief to thereof. Received comments may be i to the above office during working bourn, Monday through ftlday. dition of marketing. gaged to the polymerisation of vtoyl Dated: April 10.1974. There Is ample evidence that vinyl chloride. chloride Inhalation can result In acute (b) The Commissioner finds that there toxicity manifested by-aa army of symp Is a lack of general recognition by quali A. U. ScBumr. Commissioner of Food and Drugs. toms. Including unconsciousness as a re fied experts of the safety or effoettvenoas IP* Doc.74-0233 P1M 4-15-74:9:45 am] sult of high concentration of Inhalation. of aerosol drug preparations containing Cardiac effects, bone changes, and de vinyl chloride as an Ingredient, Includ generative changes In the brain, liver, ing propCDant. Therefore, any such prod and kidneys have also been reported In uct containing vinyl chloride is a new DEPARTMENT OF TRANSPORTATION animals. Reported studies also demon drug and a new drug application ap COAST BUAJtD strate carcinogenic effects In animals as proved under section 505 of the Federal a result of inhalation exposure to vinyl Food, Drug, and Cosmetic Act Is rechloride. Of most significance, however. aulred for marketing. [S3 GFR Fait 1171 [COD 14115) Is the fact that vinyl chloride has been linked to liver disease, including liver cancer, tn workers engaged In the poly merization of vinyl chloride to FVC. The scientific articles providing this evidence (c) A completed and signed "Notice of claimed Investigational Exemption for a New Drug4 (Farm FD-1571), as sat forth to I312J of this chapter. Is re quired to cover chnleal investigations NEW RIVER SOUND AND STRANAHAN RIVER. FLA. VTBpono unwonog* opanoPD Regulations are on file tn the Office of the Rearing designed to obtain evidence that such At the request of the Florida Yacht Clerk. In view of this evidence, the Com preparations are safe and effective for Club Council, the Coast Guard Is con missioner concludes that the banning of the purposes Intended. sidering revoking the regulations for the vinyl chloride as an Ingredient In drug (d) Any such drug within the juris East Las oias Boulevard drawbridge and cosmetic eerosol products is re diction of the act which is not to accord across the Atlantic Istr&coestal Water quired. These products an often used with this regulation Is subject to regula way tn Fort Lauderdale, Florida, to re in the confines of a small room where tory action. quire that the draw open on signal. Pres the level of vinyl chloride to which the Individual may be exposed, although usually only for a abort time, could be significantly In excess of the safe level established In connection with occupa tional exposure. 1 By adding a new 4 700.14 to Subpart B of Fart 700 to read as follows: (700.14 Use of vtoyl cUeride aa aa togradient, tnJadins prop*Ban* ef eeaedc acraaol parattk ent regulations allow closed periods from November 15 through Ifay 15 from 7 am. to 0 pm. during which the draw need only open on the hour and half hour. This change Is being considered for the fol " As a corollary to this conclusion, the (a) Vinyl chloride has been used aa an ia) The regulations presently in force ^Commissioner has requested all known Ingredient fa coamette aeroeol products were Issued on March 15. 1950 (15 FR ^Vranufacturers of such products with Inrludlng hair sprays. Where such aero 1401). and were amended on July 2.1953 ^Thipplies still on the market to recall sol products are used to the confines of (16 FR 3703), October 23. 1955 (20 FR these supplies from the market to the re a small room, as Is often the case, the gill). end October 30.1056 (21 FR 3084). tail kvri, and slmfler requests will be level of vtoyl chloride to which the todl- These regulations were lotted to < m**AL ttotsm. vol **, no. rs--monoay, am u. W4 OLI 1397