Document BRRZGQ3p9eRNR9Dn6MGLDBEdw

' /\ 7\ c^fi^r^oc/uctl and 3tetmea INC. AP00025802 MANUFACTURING CHEMISTS ASSOCIATION 1825 CONNECTICUT AVENUE. N. W. WASHINGTON, 0. C. 20009 - FOR RELEASE--------------------------------------------------------------------------------- CONTACT: For Immediate Release Richard F. Blewitt (202) 483-6126, ext. 282 WASHINGTON, D. C., April IS -- The Manufacturing Chemists Association (MCA) announced today preliminary indications that vinyl chloride exposure has produced angiosarcoma -- a liver cancer -- in mice at several exposure levels. Industrial Bio-Test Laboratories, Inc., who are conducting tiie MCA-administercd vinyl chloride animal exposure study, informed MCA that their work -- although very preliminary at this point -- tends to confirm the findings of Professor Cesare Malloni, an Italian scientist who found that vinyl chloride exposure in rats caused cancer. MCA ii.unndiatp.ly notified the Occupational Safety and Health Administration, the National Institute for Occupational Safety and Health and the Environmental Protection Agency of the preliminary test results. In the MCA-administcrcd study, rats, hamsters and mice are being exposed seven hours a day, five days a week, to 2500 parts per million (ppm), 200 ppm and 50 ppm. After seven months Ol exposure, angiosarcoma las boon observed in mico at all levels, but not in rats or hams tors. (more) AP00025803 Page 2 of 2 Professor Maltoni reported at tho OSIIA hearings on vinyl chloride February 15 that he had observed the liver cancer in rats exposed four hours a day, five cays a week, tti 250 ppm for up to 12 months. However, he did not find tho cancer in testing at the 50 ppm level. The animal exposure study is continuing. Another MCAadministered study on the chemical, documenting the health experience of present and former employees who have worked with the material, the results of which also will be released, is expected to be completed in the near future. Further vinyl chloride testing is under consideration. ### MCA-3839 AP00025804 PROPOSED RULES (b) Technical services. used since that time. Only certain for (1) The builder-developer proposing mulations of PVC, however, arc prior- a new subdivision which will have 10 sanctioned for use In food packaging and or more dwelling sites will secure the there fore arc exempt from classification services of a site planner, architect, as food additives and may be used with landscape architect, or engineer, reg out pre-marketing clearance by tho Food istered or otherwise certified as qualified and Drug Administration. in the state in which the subdivision Early in 1973, the Food and Drug Ad is to be constructed, to provide complete ministration began receiving reports of planning, drawings, specifications, and possible migration problems of ingredi supervision on land, street, utility and ents of PVC bottles then being test mar grading development. keted for distilled spirits. As a result of (2) Complete technical services will further analytical testing, the Commis be obtained end paid lor by the builder- sioner published tho May 17, 1973 pro developer with Iris own funds. posal wherein he concluded that tho use (3) At completion of construction (or of PVC for the packaging of alcoholic when construction will be accomplished foods may cause such foods to be adulter to phases, at the end of each phase), the ated. No PVC bottles have been used for person who is qualified and registered or such purposes since then. After the pub certified in the stato in which the sub lication of the proposal, tho Commis division is to be constructed and' is pro sioner began investigating scientific re viding supervisory services during the ports regarding the possible migration of period of work shall notify tho PHA PVC container ingredients to nonalco County Office in writing that all work has holic foods as well. Agency action on tills been completed in substantial conform ance with the approved plans and speci fications. a 2. Amend i 1804.67 as follows: matter nnd on the earlier proposal is ex pected to be published shortly in the Federal Register. The Commissioner Is also considering the applicability of this Information to various drug products packaged in PVC. and to various devices 1C01.67 Streets. (a) New subdivisions and expansion of existing subdivisions. Cl) Streets must conform to master street plans, design standards and con duction specifications of the applicable public body, city, town, county or state and tho requirements of the PHA. De velopments with more than 20 sites shall have two accesses available, unless an exception is granted by the State Director. composed in whole or in part of PVC 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 in the subject of vinyl cliloride by both the pub lic and the scientific community because 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 * fashion the appropriate regulatory ac (42 XJS.C. USO'tf; delegation or authority by tions that should be taken to assure full See. or Anri., 38 Fit 14044, 14048. 7 CFR 3-23: delegation of fvutViority by the Asst. See. for RurAl Development. 38 KR 14944. 14958, 7 CFR 2.70). protection of the public health. Repre sentatives of this agency are also mem bers of a Federal inter-agency task force formed to gather data on the overall ef Dated: April 15, 1074. fect of vinyl chloride on the total cn- Frank B. Elliott, Administrator, Farmers Home Administration. |n> Doc.74-9152 Filed 4-19-74:8:45 am] . vlronmcnt and to initiate coordinated ac tion to minimize this impact. In connection with this search for In formation. the Commissioner Is particu larly Interested In receiving data In re sponse to tho following points relating to DEPARTMENT OF HEALTH, the use of polyvinyl cliloride in contain ers for food and cosmetics, and in de EDUCATION, AND WELFARE vices: Food end Drug Administration [ 21 CFR Parts 310 and 700 ] U) The extent of usage of polyvinyl chloride by type of container or container liner and type of product. VINYL CHLORIDE AS AN INGREDIENT OF (2) Tire vinyl chloride content in poly DRUG AND COSMETIC AEROSOL PROD vinyl chloride used to manufacture or UCTS line various food and cosmetic contain Notice of Proposed Rule Making ers, Including description of tho methods and extraction systems used to determine In Ihe Federal Register of May 17, tills content. 1073 (38 PR 12031), the Commissioner of (3) Tho rate and level of vinyl chloride Food and Drugs published a notice of extraction from the aforementioned con proposed rulemaking for prior-snne- tainers or their liners by various foods tioned polyvinyl cliloride (PVC) resin. and cosmetics, including data derived Polyvinyl chloride is a polymeric resin after periods of storage. produced by polymerization of vinyl (4) The rate and level of percutaneous chloride which was used ax a component absorption of vinyl chloride from cos of food packaging materials prior to tho metics nnd devices when in contact with passage of tho Feed Additive Amend tho skin or mucous niembmno. ments of 1938 and which has been widely (5) Tho vinyl chloride content of vori- ous drug- fluids after they have boon in contact with devices compared in whole or in part of polyvinyl chloride. (6) The effect on blood and tissues of vinyl chloride extracted from devices composed in whole or in part of polyvinyl chlorido Inserted or implanted In the body. All persons in possession of such data arc urgently requested to submit it to the Food nnd Drug Administration in writing (preferably in quintupllcatc), if at all possible on or before June 21, 1974. This data should be sent to the Hearing Clerk, Food and Drug Administration, Room 0-36, 5600 Fishers Lane, Rockville, MD 20352. Received data may bo seen in Lite above office during working hours, Mon day through Friday. The Commissioner recently received a petition from tho Health Research Group, 2000 P Street NW,, Washington. D.C. 20036, proposing to prohibit immedi ately the continued use of vinyl chloridv as a constituent or propellant of cosmct :c aerosol products and of polyvinyl chlo ride as a container material for any cos metic product which can leach out de tectable amounts of vinyl-chloride from the polyvinyl chlorido container mate rial. The petitioner contends that there 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 tagredic-nt statements on file with the agency, representing ap proximately 50 percent of current market formulations, as of February 1,1974, and has ascertained that no information ex ists in these files indicating use of vinyl chloride In cosmetic aerosol products. Furthermore, the Cosmetic, Toiletry and Fragrance Association, Inc. (CTFA), 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 manufacturers, show that no coi, contacted has manufactured containing vinyl chloride store 1973. In 1973, according to this Inn . .ra tion, two companies produced vinyl chlo ride-containing products with a total volume of approximately 1,825,000 units. The CTFA estimates that the percentage of lialr spray cans manufactured to 1073 which contained vinyl chlorido is Jess than 0.4 percent. A copy of the infor mation received from the CTFA is on file In the Office of tho Hearing Clerk. There is no known past or present usage of vinyl chloride as a propellant in food aerosol products. Any such use without a food additive regulation would be n violation of the Federal Food, Drug, and Cosmetic Act. With rcgai-d to drug products, the Food and Drug Administration lias recently reviewed Its files and conducted ^ sur vey of all known drug manufacturers o,f aerosol products to dolcrmtoc tho extent to which vinyl chloride Is used as a com ponent, including propellant, In such products. Tho only known use of vinyl chloride in drug products has been as a FEDERAL REGISTER, VOL 34, NO. 76--MONDAY, AFRIl 22, 1974 AP00025805 i <_;u rr.cro;:D j>ro;vl!.v.:t i:i ncro.iol prcjur.itinns. While made of any additional such manufac all the itiranii.'.iiup roqu..\lvd in Hie turers If and ns tiny .arc loomed. survey v.t--. not supplied by rnunulac- Two cosmetic aero o! hair spray manu `turcrs.Uic review of the agency files and facturers commenced such recalls as of preliminary results of the survey Indi cate that vinyl clilorldo is not currently being used In aerosol drug products. There arc no approved new drug appli April 2, 1074 and a drug and cosmetle manufacturer, identified after a file search, began recall of seven drug and threo cosmetic aerosol products as of cations for vinyl chloride as a component April S. 1374, fsllotr-ng an April 4, 1374 of any drug. There is evidence, however, request. that manufacturers of some over-thecounter drug products used vinyl chloridc as a propellant until 1073, To determine the full extent that vinyl Therefore, pursuant to provisions of the Federal Food, Drug, and Cosmetic Act (sc-cs. 502, 505, C01(a>, 701(a); 51 Stat. 1050-1055, as amended; 21 U.S.C. chloride Is used In drug products and to determine If any additional action Is needed to protect the public, there is published elsewhere in tlJs issue of the I'lDiiRAt Rncisrzii, a notice, pursuant to 1132.7(a) (4) (21 CFR 132.7(a) )). of the retaliations under the Drue Listing Act of 1372, requiring all registrants to submit a list of all drug products mar keted containing the ingredient vinyl chloride or packaged in containers com 352. 355. 361(a). 271(a)) and under au thority delegated to the Commissioner of Food and Drugs (21 CFR 2.130), It Is proposed that Parts 310 and 708 bo amended as follows: 1. By adding a new i 310.506 to.Sub part of Fart 310 to read as follows; $ 310.335 Use of vinyl chloride a* an ingredient, including propellant, of aerosol drug products, posed of or iiv.cd with polyvinyl chloride. (a) Vinyl chloride has been used os a The Commissioner has determined propellant in aerosol drug preparations. that there ere sufficient scientific data on Evidence Indicates that vinyl chloride which to base c decision licit: (1) vinyl Inhalation can result In acute toxicity chloride presents an unnecessary hazard manifested by dizziness, headache, dis to the public health when It Is used as orientation. and unconsciousness where an ingredient In cosmetic aerosol prod inhaled at high concentrations. Cardiac ucts and that such use should be banned, effects, bone changes, and degenerative and (2) vinyl .chloride, when used as an changes in tho brain, liver, and kidneys Ingredient in drug aerosol products. Is have been reported in animals. Studies not generally recognised as safe and ef also demonstrate carcinogenic effects In fective, Is a new drug within the meaning animals as a result of Inhalation expo of section 201(p> of the Federal Food, sure to vinyl chloride. Recently, vinyl Drug and Cosmetic Act. end requires an chloride has been linked to liver disease, approved new drug application as a con Including liver cancer, in workers en dition of marketing. gaged la the polymerization of vinyl There is ample evidence that vinyl chloride. chloride inhalation can result in acute (b> The Commissioner finds that there toxicity manifested by an array of symp is a lack of general recognition by quali toms, Including unconsciousness as a re fied experts of the safety or effectiveness sult of high concentration of inhalation. of aerosol drug preparations containing Cardiac effects, bone changes, and de vinyl chloride ns an Ingredient, includ generative changes in the brain, liver, ing propellant. Therefore, any such prod and kidneys have also been reported in uct containing vinyl chloride Is a new animals. Reported studies also demon drug and a new drug application ap 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 re chloride. Of most significance, however. quired lor marketing. Is the fact that vinyl chloride has been (c) A completed and signed "Notice linked to liver disease. Including liver of Claimed Invcstlgutlonal Exemption cancer, in workers engaged In tlio poly for a New Drug" (Form FD-1571). as set merization of vinyl chloride to PVC. The forth in I 312.1 of this chapter, 1s re scientific articles providing tills evidence quired to cover clinical investigations arc on file in the Oillcc of the Hearing designed to obtain evidence that such Clerk. In view of this evidence, the Com preparations are safe and effective for missioner concludes that the banning of the purposes Intended. vinyl chloride as nn Ingredient in drug <d) Any such drug within the Juris and cosmetic aerosol products Is re diction of the act which is not In accord quired. These products are often used with this regulation is subject to regula in the confines of a small room where tory action. . tho level of vinyl chloride to which the Individual may bo exposed, although usually only for a short time, could bo significantly in excess of the safe level established In connection with occupa tional exposure. 2. By adding a new i 700.14 to Subpart II of Part TOO to read as follows: 700.11 Use of vinyl chloride as an lagrrdlcnt. including propcllunt of cos metic aerosol products. As a corollary to this conclusion, the fa) Vinyl chloride has been used as nn Commissioner has requested all known Ingredient in cosmetic aerosol products manufacturers of such products with including heir sprays. Where such aero supplies still on the market to recall sol products arc used in the confines of theso supplies from the market to the re a small room, as is often the caso, tho tail level, and similar requests will bo level of vinyl clilorldo to which the Indi vidual may la; cxpor.ed ecr.kl be sicr.ir.c.-uitly in cures of the r.ate level c:'...bllshcd in connection with occupational exposure. Evidence Indicates that vin;,l chloride inhalation can remit hr acute toxicity manifested by dizziness, head ache, disorientation, and unconscious ness where inhaled lit high concentra tions. Studies also demonstrate carcino genic effects In animals as a result of Inhalation exposure to vinyl chloride. Furthermore, vinyl chloride has recently been linked to liver disease, including liver cancer. In workers engaged in the polymerization of vinyl chloride. It Is the view of the Commissioner that vinyl chloride is a deleterious substance which may render any cosmetic aerosol prod uct that contains it as an ingredient injurious to users. Accordingly, any cos metic aerosol product containing vinyl chlorido as an ingredient is deemed to be adulterated under section CO 1(a) of the Federal Food. Drug, and Cosmetic Act. (b) Any cosmetic aerosol product con taining vinyl chloride as an Ingredient shipped within the jurisdiction of the act is subject to regulatory action. Interested persons may, on or before May 22, 1374, file with the Hearing Clerk, Food and Drug Administration, room 6-36, 5600 Fishers Lane, Rockville, MD 20352, written comments (preferably lit quintupllcate) regarding this proposal. Comments may be accompanied by a memorandum or brief in support thereof. Received comments may be seen In the above office during working hours, Monday through Friday. Dated: April 16,1974. A. M. Schmidt, Commissioner o! Foal ar.d Drugs. (TR Doc.74-3233 riled 4-15-74;S:i3 amj DEPARTMENT CF TRANSPORTATION COAST GUARS [33 CFR Pert 117] (COD 74115] NEW RIVER SCUMS AND STRAKAHAN RIVER, FLA. Proposed Drawbridge Operation Regulations At the request of the Florida Yacht Club Council, the Coast Guard is con sidering revoking the regulations for the East Las Olas Boulevard drawbridge across tho Atlantic Intraroast.-J Water way in Fort Lauderdale, Florida, to re quire that the draw open on signal. Pres ent regulations allow closed periods from November 13 through May 15 from 7 a.m. to 6 p.m. during which tho draw need only open on the hour and half hour. This change is being considered for the fol lowing reasons: (a) The regulations presently In forco were issued on March 15, 1553 (15 l'R 1461), and were amended on July 2.1013 08 FR S7B2), October 23. 1555 (20 FR 3113),and October 20,1950 (21 FRC0S4). These regulations were issued to ease vc- FE0ERAI REGISTER, VOL 39, NO. 71--MONDAY, A2R11 II, 197* AP00025806 NOTICES the denial order issued against the re dressed to: Central Reference and Rec halation can result in acute toxicity spondent on February 28, 1972 <37 FR ords Inspection Facility. U.S. Depart manifested by an array of symptoms in 5300. ment of Conunerce, Washington. D.C. cluding unconsciousness as a result of Dated: April 12.197G. Rader H. Meyer. Director. Office 0/ Expert Adminisfroliop. 30230. Dated: April 17,1374. ItAuea It. J.ItYEn, Director, Office o) Export Ad high concentration inhalation. Cardisc effects, bone changes, and degenerative chances in tho bruin, liver, and kidneys have also been reported in animals. In addition, there arc studies dcmoix-krai- [Fit Doc.70-0000 Filed 4-10-74:8:45 am) ministration, Bureau o/ BastWest Trade, Department of ing the carcinogenic cheats in animals as a result of inhalation exposure to \ in;, i COMPUTER SYSTEMS TECHNICAL ADVISORY COMMITTEE Commerce. ira Dac.74-M59 Filed 4-lS-74;8:45 am] chloride, and it has Leen linked to liver disease. Including Uvor cancer, In work ers engaged in the polymerization of the Notice of Meeting Pursuant to the provisions of tits Fed eral Advisory Committee Act (Public Law 92-403). notice is hereby civen that a meeting of the Licensing Procedures Subgroup of the Computer Systems Technical Advisory Committee will he held Monday. April 29, 1974, at 1:30 p.m. in Conference Hoorn A, Main Com merce Building, 14th and Constitution Avenue, Washington. "D.C. Members advise the Office or Export Administration. Bureau of East-West Trade, with respect to Questions involv ing technical matters, worldwide avail ability and actual utilisation cf produc tion and technology, and liccnzinj pro cedures which stay affect the level of export controls applicable to computer systems, including technical data re lated thereto, and including those whore export Is subject to multiluieral (COCOM) controls. Agenda items arc- as follows: DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE monomer to polyvinyl chloride. Polyvinyl chloride, a polymeric re.,In produced by polymerization of vinyl Food end Drug Administration [NADAXo. 48-23CV] chloride, is used in drug packaging materials. There is evidence of viny'l chloride migration when polyvinyl chlo AGfllTRONICS COR?. ride is used in packaging material tor. Aqrit.-onics Swine Freml* T-S; Withdrawal of Approval of New Animal Drug Application Pursuant to provisions of the Federal Food. Drug, and Cosmetic Act (see. 512, E2 Stat. 343-351; 21 U.S.C. 3G0b) and under authority delegated to the Com missioner of Food and Drugs <21 CFIt 2.129). the following notice is Issued: products containing alcohol. There hve also been reports of tire possible migra tion of polyvinyl chloride container ingredients to non-alcoholic products as well. Because of this it is necessary to give special study Id such packaging material to determine if it i; safe for Hs intended use. For these reasons it is eutcutUl that Asritronlcs Corp., 211 21lh St, Dcs the Commie:,Ior.or have knowledge of Moines. LA 50311. has requested that Us every drug product currently maikefod NADA (new animal drug application) in the United states that contains vinyl No. 40-230V be withdrawn is accordance chloride as an ingredient, arid informa with 5 135.20(d) (21 CFR 135.20(d)) on tion regarding every marketed drug the grounds that the drug Is not being product packaged In a polyvinyl cldorido marketed. Notice is given that approval container or In a container lined with of NADA No. 4B-23GV for Agrilronics polyvinyl cliloridc. Such information is Swine Premix T-S, which contains ty- . necessary for determining if there it ade 1, OpeMv.g remark* by the ChMrmr.n, losin and sulfamethazine, Is hereby quate evidence whether drugs containing Computer Systems Technical Advisory Committee. a. Appointment of oubr.roup chr.irmr.n. 3. Precaution of papers or comments by the public. 4. Discussion of export licensing proce dures relating to computer systems. 5. Executive Session: Continuation of <f1* cuttlovA* X export uconcuig proc*a\iTc. Hie public will bo permitted to attend the discussion of agenda Items 1-4, end a limited number of seats will be avail able to the public for 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 subcroup. With respect to agenda item 5, ''Exec utive Session." the Assistant Secretary of Conunerce for Administration, on De cember 20, 1873, determined, pursuant to section 10(d) of Public Law 92-4C3, that this agenda item should be exempt from toe provisions of sections 10 (a) (1) and (a)(3), relating to open meetings and public participation therein, because the meeting will bo concerned with mat ters listed in 5 D.S.C. 552(b) (1). Further information may be obtained from John L. Collins, Chairman, Com puter Systems Technical Advisory Com withdrawn. Effective date. This notice shall be ef fective April 22, 1974. Dated: April 15.1974. ' Sam D. Fixe, Associate Commissioner Jot Compliance. |FR Doc.74-8114 Filed 4-19-74;8:43 am] HUMAN' DRUGS CONTAINING VINYL CHLORIDE Cft PACKAGED IN POLY VINYL CHLORIDE CONTAINERS Notice to Drug Manufacturers, Peckers, and Distributors Elsewhere In tills issue of the Federal Reoisver (39 FR 14215) the Commis sioner of Food and Drugs has proposed that all aerosol drug products containing vinyl chloride as a component, including propellant, are now drugs and subject to regulatory proceedings-unless the prod ucts are the subject of new drug npplicntlons approved pursuant to section 505 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 eufe and effective as a component, including propellant, of a drug product. vinyl chloride or packaged in containers composed of, or llnod with, polyvinyl chloride arc safe and effective for their intended purposes and what action, ii any, is required to protect'the public health. Section 510(j)<3) of the act, as added by the Di-US' nistins Act or 1&72. author izes the Commissioner to require each registrant under section 510 of the act to submit a list of each drug product which the registrant Is manufacturing, preparing, propagating, compounding, or processing for commercial distribution and wiilch contains a particular ingredi ent, when the Commissioner has r.-.ude a finding that the submission of such a list is necessary to carry out the pur poses of tire act. For the reasons slated above the Commissioner so finds will; regard to druss containing vinyl chlo ride. As packaging materials are an integral part of tho drug product, the Commissioner also so finds with regard to drug products packaged in polyvinyl chloride containers or in containers with polyvinyl chloride iir.ers. In addition to the required list of drugs containing vinyl chloride ar.d a required list of drug products packaged in poly vinyl chloride coutair.cvs or in containers with polyvinyl chloride liners, the Com mittee, IBM World Trade CoriXJration. The Food and Drug Administration Is missioner is requesting, but not roquir-- 1C01 K Street N\V,, Washington, D.C. aware that vinyl chloride lias been used ilia, that certain other information be 20006 IA/C 202-823-C0001. os a propellant in aerosol drug prepara submit'cd. Tire Commissioner rickno.'.'.- Minutes of those portions of tlic meet tions. but lias no Information that vinyl edges that some of ihe Information balr.g ing which arc open to the public will chloride Is currently being used in the requested has also been requestea in the be uvailnblo 20 days from the dato of manufacture of drug products. There is regulations implementing the Drug List the meeting upon written request ad-. ample evidence that vinyl chloride in- ing Act of 1972, and will be available FEDERAL RCOIS7ER, VOL It, NO. Ft--MONDAY, APRIL 23, 1974 AP00025807 Noncr.; from that source. 1 iowcvcr, it will greatly simplify the compilation o[ tint; infor mation IT ft is included in this sub mission. Therefore, pursuant to the provisions of the Federal Food. Drue, end Cosmetic Act (see.). 201. 310, 701(a), 52 Slat. 10101012, as amended, 1033, ns amended, 1005, as amended; 21 U.S.C. 321, 3C0, 371(a); 42 U.S.C. 202) and under au thority delegated to the Commissioner (21 Ci'Tt 2.123). each renislraut under section 510 of llie act Is required to sub mit to the Food and Dims Administra tion a list of nil human drugs which nro being 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 list of all human -drug products packaged in polyvinyl chloride containers or in containers with poly vinyl chloride liners as follows: 1. Reporting firm name, address, end registration number. 2. List or drag. containing vinyl chloride (by tr;.tle name. IX any, and established name, H any) tnd a list of drug products for which polyvir.yl chloride is used t.i a con tainer or a container liner (by trade uomo, if any, and established nacre, if any). It is requested but not required that the following information also be sub mitted : 3. National Drug Code (NDC) if one ha* been assigned. 4. A *l:.tement whether the drui; is r;ftr- kelcd ever the counter or limited to pre scription. distribution. 5. Route of adminiHcnvlion. 8. Amount of vinyl chloride In average dally dore. 7. Quantity of drug distributed (number of dosage unl'.-.J during previous 12 mouths. 8. A copy of the label and labeling. In addition to the information requested la item* 1 through 8 (excluding item 0) for cU*usr products packaged in polyvinyl Chloride containers or iu containers with polyvinyl chloride liners it Is requested, but not required, that the following in formation bo submitted. 9. A statement of the vinyl chloride content In polyvinyl chloride used for the manu facture of tho drug container or container lining. Include description of tho methods and extraction systems used to determine this content. If this Information Is not known, provide the name and address of the drug container or container liner supplier and/or manufacturer. 10. The rate and level of extraction of vinyl chloride from the polyvinyl chloride containers or container Uners by tbo particu lar drug or by any other extraction or col vent systems, Including date derived after periods of storage. Where such information lx not known, but Is or may bo available from the supplier or manufacturer cf tbo container or liner, provide tho name and address of such supplier or mamu'aclvror. 11.. The rato and level of absorption of vinyl chlorJdo os an ingrcdlout or of vinyl chloride extracted from a polyvinyl cl.Iorlcto container or liner by the drug contained on au average daily flora. Where such luform.vtloii l not known, but is or may bo available from tho supplier or manufacturer of the container or liner, provide tho n;uno and addrou of such supplier or manufacturer. 12. Name ami art.Ircu of Iho manufacturer oC Vila j.olyvlnyl chlurtbo riwln, where i;uch Information is known. ThL; information shall bo submitted to; Dopailment of Health, Education, anti Wet- faro rood and Drug Administration Bureau ot Drugs, Drug Listing stair (1IFD-7) &C00 i-V.hcrs Lnuo liOokrllio, X:D 23822 by May 22, 1371. Datod: April 15,1974. A. M. Schmidt, Commissioner o/ Food and Drugs. (I'R Doc.74-9231 Filed 4-l!i-74;B:4S ami ADVISORY COMMITTEES Notice of Meetings Pursuant to the Federal Advisory Com mittee Act of October G, 1972 (Public Law 92-463, 8G Slat. 770-773; 5 U.S.C. App.). the Food and Drug Administra tion announces the following public ad visory committee meetings and other re quired information in accordanco with provisions set forth in section 10(a) (1) and (2) of the net; CutniuiUcc ntiMio Pate, lime, Type of ri.eetint anil <onl:*t H-r^on 1. cm May 9 itid 9.9 Open Majr 8,9 a.m. Kevifft'of Coufs-r- to 10 a.m., clos'd luti'riifil mm* rioom 0, May b. utter Hi Anal'-v-iC I'arXhiAti A.tiu, clo.TO'i Muy 9. iiicl'i'llnS Tv'ti (Vttmmr. Alttirlicu* Hoorn 1011-0% initio Dnijs. villi* Md. !///> l'io.ieM l.:ie, Unckvt'.Ic, Mil, 2G>*J,SM-ilS^oCO. Purpose. Reviews and evaluates avail able Information concerning safety nnd effectiveness of active ingredients of cur rently marketed nan-prescription drug products containing internal analgesic agents. Agenda. Open session: Comments and presentations by interested persons. Closed session: Continuing review of nonprcscrlptlon interna] analgesic drugs under investigation. PblllQ Dot*. Um#, t-taco Type of meeting and . cooUa jsor/M 2, rr.iul on livview ot OrtlfVjr.ulip LV-vUci May 11.9 a.m., Ii'.|.il Vl.li M.tur J. ts.ll Lllk* City, l-'tall. Open 9 a.m, to 10 a.m., eiucd nit--r 10 a.in. J in.r* K. Vejlft (UKM-rJO). 5KiXoekFvIMillokt, rMfd.r.tuo, :<uc2,3ui-ifriuoL Purpose. Reviews and evaluates avail able data concerning safety, effective ness, and reliability of orthopaedic de vices currently In use. Agenda. Open session: Comments and presentations by interested persons. Closed session: Continuation of review of previous classification results and Iden tification of specific areas for standards for tho.c devices classified as requiring standards. t7prmijtU-> tliutl* Pot. . l-Uo futi. urvl .8 Panel on Keview of 1 Mlt.J l>avkas. May and ?3, 9 iun., Airrr* ifin ln-i.t.,1 A.aji;,LJ,tt Open M,,y 72, 9 a m. in 10 w M ijr /- ! a.m.. e'f*fd y...f **. KmnMy. !;. IV, (ii r.M-u) ;-.*j J*i.dn r Lat \ Kfvkvl.lo. M l. 2uvVJ. igl-tlS-J .r.J. Purjjose. Reviews and evaluates avail able data concerning the safety, cffecitivcncss. and reliability of dental devices currently In use. Agenda. Open session: Comments and presentations by interested persons; de vice classification; and device legisla tion. Closed session: Continuing review and classification of dental devices. Agerida items are subject 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 views submitted to any esmmltlee in writing before or during a meeting shall also bo considered by tho committee. A list of committee members and sum mary minutes of meetings may be ob tained from the contact person for the committee both for meetings open to the public and those meetings closed to tho public in accordance with section 10(d) of the Federal Advisory Commit tee Act. Most Food and Drug Administration advisory committees are created to ad vise the Commissioner of Food r.r.d Drugs on pending regulator}' matte:-.;. Recommendations made by the commit tees on these matters are Intended to result In action under the Federal Food, Drug, and Cosmetic Act, and these committees thus necessarily participate with tlia Commissioner in 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 reccgnizod that such 'plans, over, wh.cn final ized. may not be mude fully available in advance of the effective dale without damage to such interests, and therefore provided for this type of discussion to remain confidential. Thus, law enforce ment activities have long been recog nized as a legitimate subject for confi dential consideration. These committees often must consider trade secrets and other confidential in formation submitted by particular man ufacturers which the Food r.r.d Drug Administration by law may not disclose, and which Congress has included wltlju the exemptions from the Freedom of Information Act. Such information in cludes safety and effectiveness informa tion, product formulation, and manu facturing methods and procedures, all FSDEKAl KEOISrf*, VOL 39, NO. 7--MONDAY, APIIL 22, 1974 AP00025808