Document O3Ky4ybv5VJ1RX1bO9xLnxekp

JOSEPH E KELLER JEROME n HECKMAN CHARLES M, MEEHAN WILLIAM H BOBGHESAXI, JR ROBERT R TIEEXAX WAYNE V BLACK DAVID L HILL MARTIN W BERCOV1CI PETER M NEMKOV JOSEPH E. HADLEY CAROLE C. HARRIS PETER THOMAS SMITH MICHAEL F MORROSE LARRY S SOLOMON LAW OFFICES Keli.ee a.vd Heckmax 1150 lrTM STREET, X, W. SUITE lOOO WASHINGTON, D. C . 20036 August 20, 1976 No. 25 TELEPHONE 02 200OO CABLi: ADDHess KELMAN" TO: All Members of PVC/VCM Mailing List Letter Highlight The National Institute of Occu pational Safety and Health is re investigating the health aspects of vinyl chloride to bring its criteria document up to date. Ladies and Gentlemen We are taking advantage of the attached mailing to distribute to you a copy of the Notice that appeared in the July 29, 1976 edition of the Federal Register regarding the National Institute of Occupational Safety and Health's (NIOSH) request for additional information on vinyl chloride. though the Notice only requests the submission oi new information regarding vinyl chloride so that the criteria document can be updated, we have just learned that NIOSH is actually going beyond the mere request for infor mation" and i5 SendincTTnvestiqators into plants as well. Ultimately, "all "the "Information ft''accumulates" will be used to determine whether the Vinyl Chloride Standard should be revised. Obviously, this is" another area that we must follow closely Cordially yours GENCO16825 Enclosure I olSSG NOTICES employment. Section 22(c) of the Act, authorizes the Motional Institute for Occupational Safety and Health (NIOSH) to develop recommended oc cupational safety and health standards (criteria documents) and to perform all functions of the Sccefary of Health, Education, and Welfare, unuer sections 20 and 21 of the Act. Since 1972, NIOSH has developed and forwarded to the Assistant Secretary for Labor criteria documents on more than 30 subjects. Published and unpublished information relating to many of the criteria docu ments which were published during 19721974 has increased at such a rate that NIOSH must now consider an update of the following 13 criteria documents: Criteria Documents: Hot Environments-------Caron Monoxide________ Noise.................................. Uptraviolet Radiation. Inorganic Lead..__ .... Coke Ovens_____________ Toluene 1733-00010 Inorganic Mercury.------ -- Viny; Cblorlde_________ Sulfuric ACld__________ Ammonia ______________ Cotton Dust___________ Silica__ _____________ CPO Number 1733-00010 1733-00006 1733-0000" -1733-00012 1733-00013 1733-00015 1733-00022 (Not .tvailable front GPO) 1733-00034 1733-00030 1733-00044 (Not available from GPO) Each criteria document includes among other items an evaluation of available information relative to the areas listed below. Any person having new information or data in any of the areas-listed below, or in other areas considered relevant to the establishment of a safe and health ful occupational environment involving these agents is requested to submit such infoimation. with accompanying docu mentation to the Director, Division of Criteria Documentation and Standards Deveiapment, (Federal Register Notice No. 61, NIOSH, 5G00 Fishers Lane, Park Building, Room 3-18, Rockville, AID 20852, within 30 days. 1. Establishment of safe occupational environmental levels for such agents in cluding levels for acute and chronic exposure to airborne concentrations of the chemical agents as well as safe prac tices concerning direct contact with such agents. 2. Establishment of biologic stand ards, l.e., the levels of such agents, me tabolites, or other effects of exposure which may be present within man with out his suffering ill effects taking into consideration (a) the correlation of airbomo concentrations of, and extent of exposure to, such substances with ef fects on specific b.ologic systems of man such as the circulatory, respiratory, uri nary'. and nervotts system, and (b) the analytical methods for determining the amount of the substance which may be present with.n man. 3. Engineering controls, including ven tilation, environmental temperature, hu midity, and housekeeping and sanitation procedures, with attention to the tech nological feasibility of such controls. 4. Specifications for the conditions under which personal protective devices should be required. 5. Methods, including instruments, for/ air sampling acid sample analysis of-tin chemical agents and methods of mea-l suring levels of exposure to the physical) agents. 6. The need for medical examinations for workers exposed to such agents, the frequency of such examinations, and the specific diagnostic tests which should bo used and the rationale of their selection. 7. Work practices or procedures which may be instituted for control of the work place environment in normal operations and those which may be instituted when occupational environmental levels are temporarily exceeded or where peak con centrations of chemical agents m man are reached, 8. Hie types of records concerning oc cupational exposure to such agents that employers should be required to main tain. 9. Warning devices and labels winch should be required for the prevention of occupational diseases and hazar-u caused by sucli agents. All information received concerning these substances, except that informa tion which is trade secret and protectee, by Section 15 of the Act, will be avail able for public inspection at the fore going address. ^ Dated: July 20, 1976. Edward J. Baier, Acting Director, National Insti tute lor Occupational Safety and Health. IFF. Doc.76-21906 Filed 7-28-76,8.45 air., ' Food and Drug Administration [Docket No. 76N-021D; DESI 9295J BUCLIZINE hydrochloride fcr ORAL ADMINISTRATION Drugs for Human Use: Drug Efficacy Study Implementation; Followup Notice and Opportunity for Hearing In' a notice (DESI 9295; Docket No. FDC-D-302 mow Docket No. 7GN-0249)) published in the Federal Register of March 9, 1971 (36 FR 4558), as amended by a notice published in the Federal Register , of March 13, 1975 (40 FA. 11794), the Feed and Drug Administra tion announced its conclusions that the drug products described below are effective for the management of nausea, vomiting, and dizziness associated with motion sickness; (2) lacking substantial evidence of effectiveness for the follow ing claims; ''Conditions in which emo tional stress Is a complicating or causa tive factor such as essential hyperten sion, sterility, hyperkinesia, palpitation, cramps, hyperhidrosis, tremor, headache, and insomnia"; "Additional antihistaminic, antir.ausea.nt, antimotion sick ness, and hypotensive properties make it a unique compound in tire field of nonphcnothiazine tranquilizers"; and for the relief of bronchial asthma; and (3) pos sibly effective for Its other labeled indi cations, including vertigo. The March 9. 1971 notice also offered an opportunity for a hearing concerning the indications concluded at that time to lack substantial evidence nf t ffectiveness. No person has submitted any data in support of the pos sibly effee';-. o indications, and those in dications ,,:e .low reciassified as lacking substantial _, dance of effectiveness Th.s notice offer.. ..n opportunity for .-. near ing concerning those in '.ications and -c:.-. forth tile -'or.nincr.s :_r marcc'. t, . drug products for tile indic.u.. for whlcn they continue to be regained a,-, effective. Persons who wish to request a i caring may do so on or before August 20, 1976. The notic' that follows does not per tain to th.. indications stated in the .March 9, 1971 notice tc lack suoMt-ntia! evidence of effective:', ---s. No person reUiested a hearing concerning them, anc r.ey arc r.o longer allowable in k.cch.r.c ny such product labeled for those indi cations is subject to regulatory action. 1. NDA 9-205; Vibazine Hydr., hcr.dj Tablets coma. 'Aug buclizme hydros.Aor.c.e, previously ir. eted bv Pfizer L.-Aocramm-,- ">i\lsion o' r, Ir.c., 235 E <2C : . Nv.. y./r.:. NY . . - NDA Em : u-S 7a-.. - co..- ......ng bv hvaro . .ride; Btu.ir: ?;-,a. . -.'.ceutica:- aioii cl 1. C. I.. U.u . SUiie- iic., P.O. 151, 3411 S.lverside in. , Wii- ntngton. DL ;9897. 3. NDA II- ~b: Soltra:. Tablets co:u;a oucllzlne hvcroehlorlde; previously marketed by Stuart Ph .rv-taoeutler.'.s. In a not.ee published in the Fedl-*,. (Register of February 2, 1973 .38 FI. 3208), the approval of NDA 11-278 for Softran Tablets was withdrawn or. tin ground of failure to submit requ.red re ports under section 505(j) of the Feder... Food, Drug u..d Cosmetic Act 121 U.S C 555<j)). A: me time that notice vis pub lish; d, no imal conclusions con. .ir.g .u possibly effective indications had bee.; reached. Those conclusions h/'-e now ..een reached, and the purpose ... ./.elud ing Softran tbuelizine hydrochloride Tablets (NDA 11-378; m this notice l-. to inform all interested persons of such, conclusions and offer from the opportu nity to request a hearing concerning ab issues relating to its legal status Such drugs are regarded as m d.: (21 U.S.C. 321(p)). Suppleme;.-. : drug applications are required ' the labc-h:..'. m and to update , . approved ..p ...cations providing .... drugs. An .. v/oved new drug appheat-o. is a lequui- nt for marketing ii dru,, products. In addition to tire holder is i of the nc-v drug application^) specifically named aoove, thin notice applies to ail person5 who manufacture or distribute a dm: product, not the subject of an approved new drug application, that is identical, related, or similar' to a ding produM named above, as defined in 21 CFR 310.8 It Is the responsibility of every dru; man ufacturer or distributor1 to retie.'- tins notice to deumnne whether it covers a: ; drug product he manufactures or distrib utes. Any person may request an opuiion of the applicability of tins r.ot:c< to a specific drug product he manufac tures or distributes that may be Identi cal, related, or similar to a drug predur named hi this notice by writing to Liu Food and Drug Administration, Bureau of Drugs, Division of Drug Labeling Co:n- FEDERAL REGISTER, VOL 41, NO. 147--THURSDAY, JULY 29, 1976 GENC016826 NOTICES 315SS Monday, August 23 & *6 ..m______ 8 '5 6.111______ 8:45 a.m______ 10:15 a.m............ 10:30 a.m______ 10:45 a.m______ 11 aan__________ 11:45 a.m______ 12:15 pun---------- 1 30 p.tn_______ 3:16 p.m______ 2:45 p.m______ 3:15 p.m______ 3:30 p.m______ 4:30 pan............ Call to order and an nouncements. Approval of minutes. Progress re port on CZM program. Issues and concerns of the A!.r, coastal program. A ; .i.el dihCusaion. Eco nomic dependence on the coast. Native inter ests and concerns. Committee's Discussion of above topics. Brief recess Continuation of panel Resource management/ fish and game. Alaska CZM Program--A review of Its progress to date and Its response to Issues and concerns raised above. Committee's discussion of above topics. Oral statements (if any) by Interested persons. Lunch. OCS impacts on Alaska A panel discussion. OCS policy development, community impacts study methods. Indus trial problems and work ing arrangements with State. Committee discussion of above topics. Continuation of panel. Federal planning for lease sales, baseline studies. The impact of Yakutat. Brief recess. Committee's recommenda tions. Adjourn. Tuesday, August 24 11:10 a.m_______ 10.su a.m______ 11:30 a.m______ 5 p.m__________ 7:25 p.m______ 8:05 p.m--------- Leave Juneau via Alaska airlines flight 03. Arrive YaXutat. Onsite inspection of City of Yakutat. Meetings with local officials re garding OCS Impacts. Adjourn. Return to Juneau via Alaska airlines 66. Arrive Juneau. Please contact executive secretary to receive addi tional information on on site visit. Dr. Rtonard Keating, 202/634^4245 Wednesday, August 25 9 &.m___ _______ Call to order. 9:15 &.nu-- * 10 a.m__________ 10:30 a.m______ 10:45 a.m______ 11:15 a.m______ 12 n.............. ........ 1:30 p.m____ Legislative issues related to Alaska coastal man agement. A panel dis cussion. 'l iie Tanker Bin. State-local relationships. CZM legislative imu* tlves. Committee discussion of above topics. Brief recess. ConL.nuaiUe. of panel. Forest practices. Legis lative needs from the ad ministration's view. Committee's discussion of above topics. Lunch. D-2 Lands: Implications for coastal management. Wednesday, August 25--continued 2 p.m.................. 2:30 p.m______ 3 p.m__________ 3:15 p.m______ 4:30 p.m_______ Committee's discussion of above topic, Report on interstate co ordination for OCS is sues (Pacific). Brief recess. Committee's recommenda tions. Adjourn. Thursday, August 26 9 am__________ 9:15 a.m______ 10 a.m_________ ions a.m______ 10:45 a.m______ 11:30 a.m______ 1 p.m,---------- -- 2:30 p.m______ 3 p m__________ 3:15 p.m______ 4 p.m__________ 4:30 pm______ 7:45 p.m______ 7:10p.m---------- Coll to order. Committee's recommenda tions of substantive poli cies for evaluation of CZM. Brief recess Continuation of above topic. Discussion of GAO final re port. Lunch. Review of national legisla tion amending the CZM Act, A panel discussion. OCZM report on 546 imple mentation at the na tional level. Brief recess. Committee's recommenda tions. Discussion of agenda, time and place of next meeti ng. Adjourn. Leave Juneau viaAlaska airlines 67. Arrive Anchorage. Friday, August 27 7:45 R.m______ Leave Anchorage via Alaska aeronautical flight 109. 8:l5a.m---------- Arrive Kenal. A M-------------------- Inspections. Meetings with local officials. P.M Kachcmak Bay--A case study of State decision making and public atti tude -- Frank Tuppcr, Kachemak Bay Defense Fund. Beaufort Sea Lease Sale-- A case study No. 2 of State decision making-- Pat Dobey, Department of Natural Resources. 6 p.m..,------ ... Leave Kenal via Alaska aeronautical 134. 6:30 p.m---------- Arrive Anchorage. Please contact Exo\.:ive Secretary to receive m.ditional-info. mation regarding onsite visit- Dr. Richard Keating. 202634-1245. Dated: July 22,1976. T. P, Gleiter. Assistant Administrator for Administration, National Oce anic and Atmospheric Admin istration. 1FR Doc.76-21973 Filed 7-28-76:8:45 ami DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE Alcohol, Drug Abuse, and Mental Health Administration NATIONAL ADVISORY MENTAL HEALTH COUNCIL Meeting In accordance with Section 10(a) 12) of the Federal Advisory Committee Act .5 U.S.C. Appei.v...x I), announcement is made of the following National Advisory body scheduled to assemble during the month of September 1976: National Advisot' ' vTU, Health Council September 8-10: i* j Conference Room 14-10$, I'urAl&wn Building. Rockville, Maryland Operv: September 8 Closed; Otherwise Contact: Mrs. Zellft Diggs, Room 11-1G1, Parklawn Building 5600 Fishers Lane, Rockville,Maryland 20852, 30l~443"*333 Purpose: The National Advisory Men tal Health Council advises the Secretary. Department of Health, Education, and Welfare, the Administrator, Alcohol. Drug Abuse, and Mental Health Admin istration, and the Director, National I. stitute of Mental Health, regarding policies and programs of the Department in the field of mental health. The council reviews applications for grants-in-aid relsi.ng to rcseam:. training, and serv ice- .. the helc .nentai health and makes recommend;.' .ons to the Secretary with respect to ap;,. oval of applications for, and the amount of. these grants. Agenda: On September 8, the meeting will be open for discussion of NIMH pol icy issues. These will include current administrative, legislative and program developments. Otherwise, the Counc : will conduct a final review of grant ap plications for Federal assistance and this session will not be open to the pub lic, in accordance with the determina tion by the Administrator. Alcohoi, Drug Abuse, and Mental Health Admin istration, pursuant, to the provisions se: forth in Section 552(b)(5) and 552 bn (G), Title 5, U.S, Code, and Section 10id, of Public Law 92-462 id U.S.C. Appendix I). Substantive information may be ob tained from the contact person listed abov,-. The NIMH Information Officer who will furnish summaries of the meeting and rosters of the ommittee members is Mr, Edwin Long, Deputy Director, Di vision of Scientific and Publ-c Informa tion, NIMH, Room 15-105. Parklawn BuiL 5600 Fi , Lane, Rockville. Mar;,:...... 20352, 3...- . 3-2JoO D.t. / uiv 23, i./.c Carolyn T. Evans, Committee Management Officer, Alcohol, Drug Abuse, and Mental Health Administra tion. IFP Doc.76-21567 Filed 7-28-76,3.45 am] Center for Disease Conti oi OCC A TiCNAL SArETY AND HEALTH R." vitforlnfo. ,. non on Certain Chemical/P. sical Agents Set Lion 20ia)(3) o. the Occupational Safety ana Health Act of 1&70 I '29 U.S.C. 6G0ta. ! 1 provides that the Secretary of Health, Lt...cation, and Welfare, on the basis of ii.formation available to him, shall nuvelop criteria dealing with toxic materials which will describe exposure levels that are safe for various periods of FEDERAL REGISTER, VOL 41, NO. 147--THURSDAY, JULY 29, 1976 GENC016827