Document a4g2VB4ZZE3GjbdNx61RXLzG9

MANUFACTURING CHEMISTS ASSOCIATION 1825 CONNECTICUT AVENUE. N. W. WASHINGTON, D. C. 20009 -- FOR RELEASE------------------------------------------------------------------------------- CONTACT: For Immediate Release Richard F. Blewitt (202) 433-6126, ext. 282 WASHINGTON, D. C., April 15 -- 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 the MCA-administcred vinyl chloride animal exposure study, informed MCA that their work -- although very preliminary at this point -- tends to confirm the findings of professor Cesare .Maltoni, an Italian scientist who found that vinyl chloride exposure in rats caused cancer. MCA iwinediately 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-administered 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 been observed in mice at all levels, but not in rats or hamsters. (more) OCC 1555 Page 2 of 2 Professor Maltoni reported at the 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, to 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 wo.rked 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, # # b' MCA-3S39 OCC 1556 PROPOSED RULES 1121.1 (b) Technical services, * (1) The builder-developer proposing a new subdivision which will have 10 or more dwelling sites will secure the services ol a site planner, architect, landscape architect, or engineer, reg istered or otherwise certified as qualified in the state in which the subdivision is to be constructed, to provide complete planning, drawings, specifications, and super-vision on land, street, utility and grading development. (21 Complete technical services will be obtained and paid for by the builderdeveloper with his own funds. (3) At completion of construction (or when construction will be accomplished in phases, 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 and is pro viding supervisory services during the period of wort shall notify the FHA County Office in writing that all wort has been completed in substantial conform ance with the approved plans and speci fications. * * 2. Amend S 1804.67 as follows: 1804.67 Streets. (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 20 sites shall have two accesses available, unless an exception is granted by the State Director. *** (42 U.S.C. 1480's; delegation of authority by Sec. of Agri., 38 FR 14944, 14948, 7 CFR 2.23; delegation of authority by the Asst. Sec, for Rural Development, 38 FB 14944, 14952, 7 CFR 2.70). Dated; April 15, 1974. Frank B. Elliott, Administrator, Farmers Home Administration, (FD Doc:74-9152 Filed 4-19-74;8:4fi am) DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE Food and Drug Administration [ 21 CFR Parts 310 and 700 ] VINYL CHLORIDE AS AN INGREDIENT OF DRUG AND COSMETIC AEROSOL PROD UCTS Notice of Proposed Rule Making In the Federal Register of May 17, 1973 (38 FR 12931), the Commissioner of Food and Drugs published a notice of proposed rulemaking for prior-sanc tioned polyvinyl chloride (PVC) resin. Polyvinyl chloride is a polymeric resin produced by polymerization of vinyl chloride which was used as a component of food packaging materials prior to the passage of the Food Additive Amend ments of 1958 and which has been widely used since that time. Only certain for mulations of PVC, however, are priorsanctioncd for use in food packaging and therefore are exempt from classification as food additives and may be used with out pre-marketing clearance by the Food and Drug Administration. Early in 1973, the Food and Drug Ad ministration began receiving reports of possible migration problems of ingredi ents of PVC bottles then being test mar keted for distilled spirits. As a result of further analytical testing, the Commis sioner published the May 17, 1973 pro posal wherein he concluded that the use of PVC for the packaging of alcoholic foods may cause such foods to be adulter ated. No PVC bottles have been used for such purposes since then. After the pub lication of the proposal, the Commis sioner began investigating scientific re ports regarding the possible migration of PVC container ingredients to nonalco holic foods as well. Agency action on this matter and 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 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 chloride 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 tions that should be taken to assure full 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 fect of vinyl chloride on the total en vironment 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 the following points relating to the use of polyvinyl chloride in contain ers for food and cosmetics, and in de vices: (1) The extent of usage of polyvinyl chloride by type of container or container liner and type of product. (2) The vinyl chloride content in poly vinyl chloride used to manufacture or line various food and cosmetic contain ers, including description of the methods and extraction systems used to determine this content. (3) The rate and level of vinyl chloride extraction from the aforementioned con tainers or their liners by various foods 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. (5> The vinyl chloride content of vari ous drug'fluids after they have been :n contact with devices composed in whole or in part of polyvinyl chloride. (6) The effect on blood and tissue^ of vinyl chloride extracted from devices composed in whole or m part of polyvinyl chloride inserted or implanted in the body. All persons in possession of such data are urgently requested to submit it to the Food and Drug Administration m writing (preferably in qmntuplicate), if at all possible on or before June 21. 1974. This data should be sent to theHeanng Clerk, Food and Drug Administration, Room 6-36, 5600 Fishers Lane, Rockville, MD 20852. 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, 2000 P Street NW., Washington. D.C. 20036, proposing to prohibit immedi ately the continued use of vinyl chloride as a constituent or propellant of cosmetic aerosol products and of polyvinyl chlo ride as a container material for any cos metic product which can leach out ce- tectable amounts of vinyl chloride from the polyvinyl chloride 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 Ingredient 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 s::r:\ manufacturers, show that no cm.:, .. contacted has manufactured i>. . containing vinyl chloride sir., r . .> 1973. In 1973, according to this iiiu. .na tion, two companies produced vinyl chlo ride-containing products with a total volume of approximately 1,625,000 units. The CTFA estimates that the percentage of hair spray cans manufactured in 1973 which contained vinyl chloride is less than 0.4 percent. A copy of the infor mation received from the CTFA is on file in the Office of the 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 a violation of the Federal Food, Drug, and Cosmetic Act. With regard to drug products, the Food and Drug Administration has recently reviewed its files and conducted a sur vey of all known drug manufacturers of aerosol products to determine the extent to which vinyl chloride is used as a com ponent, including propellant, in such products. The only known use of vinyl chloride in drug products has been as a FEDERAL REGISTER, VOL 39, NO. 78--MONDAY, APRIL 22, 1974 CC is;7 14216 PROPOSED RULES propellant In aerosol preparations. While all the Information requested in the survey was not supplied by manufac turers, the review of the agency files and preliminary results of the survey Indi cate that vinyl chloride is not currently being used in aerosol drug products. There are no approved new drug appli cations for vinyl chloride as a component of any drug. There is evidence, however, that manufacturers of some over-thecounter drug products used vinyl chlo ride as a propellant until 1373. To determine the full extent that vinyl chloride is used in drug products and to determine if any additional action is needed to protect the public, there is published elsewhere in this issue of the Federal Recister, a notice, pursuant to 132.7(a) (-1) (21 CFR 132.7(a)(4)), of the regulations under the Drug Listing Act of 1972, requiring all registrants to submit a list of all drug products mar keted containing the ingredient vinyl chloride or packaged in containers com posed of or lined with polyvinyl chloride. The Commissioner has determined that there are 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 in cosmetic aerosol prod ucts and that such use should be banned, and (2) vinyl.chloride, when used as an ingredient in drug aerosol products, is not generally recognized as safe and ef fective, is a new drug within the meaning of section 201 (p) of the Federal Food, Drug and Cosmetic Act, and requires an approved new drug application as a con dition of marketing. There is ample evidence that vinyl chloride inhalation can result in acute toxicity manifested by an array of symp toms, including unconsciousness as a re sult of high concentration of inhalation. Cardiac effects, bone changes, and de generative changes in the brain, liver, and kidneys have also been reported in animals. Reported studies also demon strate carcinogenic effects in animals as a result of inhalation exposure to vinyl chloride. Of most significance, however, is the fact that vinyl chloride has been linked to liver disease. Including liver cancer, in workers engaged in the poly merization of vinyl chloride to PVC. The scientific articles providing this evidence are on file In the Office of the Hearing Clerk. In view of this evidence, the Com missioner concludes that the banning of vinyl chloride as an Ingredient in drug and cosmetic aerosol products Is re quired. These products are often used in the confines of a small room where the level of vinyl chloride to which the Individual may be exposed, although usually only for a short time, could be significantly in excess of the safe level established in connection with occupa tional exposure. As a corollary to this conclusion, the Commissioner has requested all known manufacturers of such products with supplies still on the market to recall these supplies from the market to the re tail level, and similar requests will be made of any additional such manufac turers if and as they are located. Two cosmetic aerosol hair spray manu facturers commenced such recalls as of April 2. 1974 and a drug and cosmetic manufacturer, Identified after a fife search, began recall of seven drug and threo cosmetic aerosol products as of April 8, 1974, following an April 4. 1974 request. Therefore, pursuant to provisions of the Federal Food, Drug, and Cosmetic Act (secs. 502, 505, 601(a), 701(a); 52 Stat. 1050-1055, as amended; 21 UE.C. 352, 355, 361(a), 371(a)) and under au thority delegated to the Commissioner of Food and Drugs (21 CFR 2.120), It is proposed that Parts 310 and 700 be amended as follows: 1. By adding a new f 310.506 to.Sub part E of Part 310 to read as follows: 310.506 Use of vinyl chloride a* an ingredient, including propellant, of aerosol drug products. fa) Vinyl chloride has been used os a propellant in aerosol drug preparations. Evidence indicates that vinyl chloride inhalation can result in acute toxicity manifested by dizziness, headache, dis orientation, and unconsciousness where inhaled at high concentrations. Cardiac effects, bone changes, and degenerative changes in the brain, liver, and kidneys have been reported in animals. Studies also demonstrate carcinogenic effects in animals as a result of inhalation expo sure to vinyl chloride. Recently, vinyl chloride has been linked to liver disease, including liver cancer, in workers en gaged in the polymerization of vinyl chloride. (b) The Commissioner finds that there is a lack of general recognition by quali fied experts of the safety or effectiveness of aerosol drug preparations containing vinyl chloride as an Ingredient, Includ ing propellant. Therefore, any such prod uct containing vinyl chloride is a new drug and a new drug application ap proved under section 505 of the Federal Food, Drug, and Cosmetic Act Is re quired for marketing. (c) A completed and signed "Notice of Claimed Investigational Exemption for a New Drug" (Form FD-1571), as set forth in } 312.1 of this chapter, Is re quired to cover clinical investigations designed to obtain evidence that such preparations are safe and effective for the purposes Intended. (d) Any such drug within the juris diction of the act which is not in accord with this regulation is subject to regula tory action. 2. By adding a new 5 700.14 to Subpart B of Part 700 to read as follows: 700.14 Use of vinyl chloride aa an 1- grcdicnl, including propellant of cos metic aerosol products. (a) Vinyl chloride has been used as an Ingredient in cosmetic aerosol products including hair sprays. Where such aero sol products are used in the confines of a small room, as is often the case, the level of vinyl chloride to which the Indi vidual may be exposed could bo signifi cantly In excess of the safe level estab lished in connection with occupational exposure. Evidence Indicates that vinyl chloride inhalation can result in acute toxicity manifested by dizziness, head ache, disorientation, and unconscious ness where inhaled at high concentra tions. Studies also demonstrate carcino genic effects in animals as a result cf 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 chloride 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 22,1974, file with the Hearing Clerk, Food and Drug Administration, room 6-86, 5600 Fishers Lane, Rockville, MD 20852, written comments (preferably in quintuplicate) 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 of Food, and Drugs. (FR Doc.74-9232 Piled 4-19-74,3:43 am] DEPARTMENT CF TRANSPORTATION COAST GUARD [ 33 CFH Part 117 ] icon 74115] NEW RIVER SOUND AND STP.ANAHAN 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 the Atlantic Intracoastal Water way in Fort Lauderdale. Florida, to re quire that the draw open on signal. Pres ent regulations allow closed periods from November 15 through May 15 from 7 a.m. to 6 pan. during which the draw need only open on the hour and half hour, Tbia change is being considered for the fol lowing reasons: (a) The regulations presently in force were issued on March 15, 1950 (15 FR 1461), and were amended on July 2,1953 (18 FR 3782). October 23, 1955 (20 FR 8110), and October 20,1956 (21 FF. 8034). These regulations were issued to ease vo- FEDERAL REGISTER, VOL 39. NO. 78--MONDAY, APRIL 22, 1974 OCC 1558 1-123S NOTICES the denial order issued against the re spondent on February 28, 1972 (37 FR 5300). Dated: April 12,1976. Rauer H. Meyer, Director, Office of Export Administration. [Kit Doc.74-9080 Piled 4-19-74;8;45 am] COMPUTER SYSTEMS TECHNICAL AOVISORY COMMITTEE Notice of Meeting Pursuant to the provisions of the Fed eral Advisory Committee Act (Public Law 92-453), notice is hereby given that a meeting of the Licensing Procedures Subgroup of the Computer Systems Technical Advisory Committee will be held Monday, April 29, 1974, at 1:30 p.m. in Conference Room A, Main Com merce Building, 14th and Constitution Avenue. Washington. 'D.C, Members advise the Office of Export Administration, Bureau of East-West Trade, with respect to questions involv ing technical matters, worldwide avail ability and actual utilization 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 remarks by the Chairman, Computer Systems Technical Advisory Committee. 2. Appointment of subgroup chairman. 3. Presentation of papers or comments by the public. 4. Discussion of export licensing proce dures relating to computer systems. 5. Executive Session: Continuation of dis cussion' of export licensing procedures. 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 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 Ale written statements with the subgroup. With respect to agenda item 5, "Exec utive Session," the Assistant Secretary of Commerce for Administration, on De cember 20, 1973, determined, pursuant to section 10(d) of Public Law 92--4G3, that this agenda item should be exempt from the provisions of sections 10 (a) (1) and (a)(3), relating to open meetings and public participation therein, because the meeting will be concerned with mat ters listed in 5 U.S.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, 1C01 K Street NW,, Washington, D.C. 20000 (A/C 202-833-6000). Minutes of those portions of the meet ing which are open to the public will be available 30 days from the date of the meeting upon written request ad dressed to: Central Reference and Rec ords Inspection Facility, U.S. Depart ment of Commerce, Washington, D.C. 20230. Dated: April 17,1974. Rauer H. Meyer, Director, Office of Export Ad ministration, Bureau of EasiWest Trade, Department of Commerce. [F3 Doc.74-9099 Filed 4-19-74,8:49 am) DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE Food and Drug Administration [NADA No. 4S-23GV] AGRITRONICS CORF. Agrilronics Swine Premix T-S; Withdrawal of Approval of New Animal Drug Application Pursuant to provisions of the Federal Food, Drug, and Cosmetic Act (sec, 512, 2 Sic.:. 343-351; 21 U.S.C. 360b) and under authority delegated to the Com missioner of Food and Drugs (21 CFR 2.120), the following notice is issued; Agritronics Corp., Oil 24th St,, Des Moines, IA 50311, has requested that its NADA (new animal drug application) No, 4S-236V be withdrawn Is accordance with 5 135.23(d) (21 CFR 135.28(d)) on the grounds that the drug is not being marketed. Notice is given that approval of NADA No. 48-236V for Agritronics Swine Premix T-3, which contains tylosin and sulfamethazine, is hereby withdrawn. Effective date. This notice shall be ef fective April 22,1974. Dated: April 15,1974. Sam D. Fine, Associate Commissioner for Compliance. [PR DOC.74-B114 Filed 4-19-74,8:45 amj HUMAN DRUGS CONTAINING VINYL CHLORIDE OR PACKAGED IN POLY VINYL CHLORIDE CONTAINERS Notico to Drug Manufacturers, Packers, and Distributors Elsewhere in this issue of the Federal Register (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 new drugs and subject to regulatory proceedings-unless the prod ucts are the subject of new drug appli cations 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 sale and effective as a component, including propellant, of a drug product. The Food and Drug Administration is aware that vinyl chloride has been, used as a propellant in aerosol drug prepara tions, but lias no information that vinyl chloride is currently being used in the manufacture of drug products. There is ample evidence that vinyl chloride in halation can result in acute to\-.c:iy manifested by an array of symptoms in cluding unconsciousness as a result of high concentration inhalation. Carch.-.e effects, bone changes, and degenm-aute changes in the brain, liver, and kidnev., have also been reported in animal.,, in addition, there are studies demonstrat ing the carcinogenic effects in animals as a result of inlndation exposure to \ m.;. 1 chloride, and it has been linked to liter disease, including liver cancer, in work ers engaged in the polymerization of the monomer to polyvinyl chloride. Polyvinyl chloride, a polymeric re.-in produced by polymerization of vinyl chloride, is used hi drug packs-;.ng materials. There is evidence oi tmyl chloride migration when pci;,-vinyl chlo ride is used in packaging mate; ltd tor products containing alconol. There hi-,e also been reports of the pcoiible migra tion of poly-vinyl chloride container ingredients to non-alcoholic products as well. Because cf this it is necessary to give special study to such packaging material to determine if it is safe for its intended use. For these reasons it is essential that the Commissioner have knowledge c: every drug product currently masketed in the United States that contains vm>l 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 is necessary for determining if there ir ade quate evidence whether drugs containing vinyl chloride or packaged ni containers composed of, or lined with, polyvmt! chloride are safe and effective for then- intended purposes and vriiut act.cm, any, is required to protect the puohc health. Section 510(j)(3) of the- act, as added by the Drug Listing Act of 1972, author izes the Commissioner to require each registrant under section 510 of rhe act 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 the submission of such a list is necessary to carry out the pur poses of the act. For the reasons stated above the Commissioner so finds with regard to drugs containing vinyl chioride. As packaging materials are an integral part of the drug prcducL, the Commissioner also so find., with regard to drug products packaged in polyvinyl chloride containers or in containers with polyvinyl chloride liners. In addition to the required list of drugs containing vinyl chloride and a re;;u.rtd list of drug products packaged m poly vinyl chloride containers or in containers with polyvinyl chloride liners, the Com missioner is requesting, but not requir ing, that certain other information be submitted. The Commissioner acknowl edges that some of the information being requested has also been recuosten m the regulations implementing the Drug lust ing Act of 1972, and will be at affable FEDERAL REGISTER, VOL, 39, NO. 78--MONDAY, APRIL 22, 1974 OCC 1559 NOTICES ' 112 i',0 from that source. However, it will greatly 12. Name and nddress of tho manufacturer simplify the compilation of tins infor of the polyvinyl chloride resin, where such mation if it Is included m this sub Information Is known. Committee came Date, time, place Tyj-o of r.fsoth.s ContlCt PofaoQ mission. This information shall be submitted Therefore, pursuant to the provisions of the Federal Food. Drug, and Cosmetic Act (secs. 201, 510, 701(a), 52 Stat. 10401042, as amended, 1053, as amended, 1055, as amended; 21 U.S.C. 321, 3G0, 371(a) ; 42 U.S.C. 262) and under au thority delegated to the Commissioner (21 CFR 2.120), each registrant uyder section 510 of the act is required to sub mit to the Food and Drug Administra tion a list of all human drugs which are 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, addies; and registration number. 2. List of drugs containing vinyl chloride (by trade name, if any, and established name. If any) and a list of drug products for which polyvinyl chloride is used as a con tainer or a container liner (by trade name, if any, and established name. If any). to: Department of Health, Education, rind WeiflLCO Food and Drug Administration Bureau of Druj;3t Drue; Listing Stall (IlrD-7) 5G0Q Fi*.Ucts Lane RockMUe, MD 20852 by May 22, 1974, Dated: April 15, 1974. A. M. Schmidt, Commissioner of Food and Drags. [PR Doc.74-9231 Filed 4-19-74:8:45 amj ADVISORY COMMITTEES Notice of Meetings Pursuant to the Federal Advisory Com mittee Act of October 6, 1972 (Public Law 92-463, 86 Stat. 770-776; 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 accordance with provisions set forth in section 10(a) (1) and (2) of the act: 8. Panel on Review of Dent J Devices. Mny 22 and 23. tj a.m,. Arncrirnn Dentr.l Ap^/cialion 13UL'.. Chi cago, IU. Open May 72. 0 t to 10 ft.in , clu^bi M vy 1 h.'t-T l i a m , cloc-d M.,y 23, Ilol-crt S, Kennedy, (Mi.11 (JIJ'M-I-W :,.xo Fi-dii r Lftr.c, Rockville. Md 2\fc*%&2p 301-113-2370. Purpose. Reviews and evaluates avail able data concerning the safety, effec tiveness, and reliability of dental devices currently in use. Agenda. Open session: Comments and presentations by interested persons: de vice classification; :.:.d device legisla tion. Closed session: continuing review and classification of dental devices. Ageiida 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 committee in writing before or during a meeting shall also be considered by the committee. A list of committee members and sum It is requested but not required that the following information also be sub mitted: 3. National Drug Code (NDC) If one has been assigned. 4. A statement whether the drug Is mar keted over the counter or limited to pre scription distribution. 5. Route of administration. 6. Amount of vinyl chloride to average dally dose. CollllulLtife name Date, thno, pluco Typo of mooting and contact peran I. Panel oa Icovirw of luten.&l AnalsvMC including Aniirheu* mu lie Drug*. May 3 and 0, 0 Open May 8, 9 e.m. a,,ni,f Confor- to 10 a.m.* closed ' cnee Room C, May 8. after 10 Parkkw n ft.m., closed May 9. Bids,. :*600 Lre Geismnr, Flint rs Lane, Room l6(J-03, KockvilK .ViOO Fishers Laue, Md. Rockville, Md- 20S33, 301-143-4900- 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 the 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 ar.i Dings on pending regulatory matters. 7. Quantity of drug distributed (number of dosage units) during previous 12 months. 8. A copy of the label and labeling. In addition to the information requested in items 1 through 8 (excluding item 6) for drug products packaged in polyvinyl chloride containers or in containers with polyvinyl chloride liners it is requested, but not required, that the following in formation be submitted. 9. A statement of the vinyl chloride con tent In polyvinyl chloride used for tho manu facture of the drug container or container lining. Include description of the methods and extraction systems used to determine this content. If this information Is not Purpose. Reviews and evaluates avail able information concerning safety and effectiveness of active ingredients of cur rently marketed non-prescription drug products containing Internal analgesic agents. Agenda. Open session: Comments and presentations by interested persons. Closed session: Continuing review of nonprescription internal analgesic drugs under investigation. Committee name Date, time, . place Type of meeting and contact porsoa 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 the 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 recog nized that such plans, even when final ized. may not be made fully available 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 liners by the particu lar drug or by any other extraction or colvent systems. Including data derived after periods 2. Fnnol on liovicw of Ortho* pruiilKDevices Mav 11,9 a.m,, Hotel uuu Motor Lg&g. tsilt Lake City, Open 9 .m. to 19 a.m,, closed after 10 3-m. James R. Veale (Ill`M-120). ftkio Fishers Lane, Rockville, Md. 20852, 301-443-3550. in advance of the effective date 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. of storage. Where such information is not Purpose. Reviews and evaluates avail These committees often mutt consider known, but is or may be available from the supplier or manufacturer of the container or liner, provide the name and address of such supplier or manufacturer. able data concerning safety, effective ness, and reliability of orthopaedic de vices currently in use. trade secrets and other confident.al in formation submitted by particular man ufacturers which the Food and Drug 11. The rate and level of absorption of Agenda. Open session: Comments and Administration by law may not disclose, vinyl chlorldo as an ingredient or of vinyl chloride extracted from a polyvinyl chloride container or liner by the drug contained on presentations by interested persons. Closed session: Continuation of review of and which Congress has included within the exemptions from the Freedom of an average dally dose. Where such informa previous classification results and iden Information Act. Such information in tion Is not known, but is or may be avallablo from the supplier or manufacturer of the container or Uner. provide the name and tification of specific areas for standards for those devices classified as requiring cludes safety and effectiveness informa tion. product formulation, and manu address of such supplier or manufacturer. standards. facturing methods and procedures, all FEDERAL REGISTER, VOL 39, NO. 73--MONDAY, APRIL 22, 1974 OCC 1560