Document MoJBkVxOwN49MopNabjwaOOX7

JOSEPH E. KELLER JEROME H. HECKMAN CHARLES M. MEEHAN WILLIAM H. BOHOHESANL JR. ROBERT R TIERNAN WAYNE V BLACK DAVID L. HILL MARTIN W. BERCOVICI LELAND J- BLAIR PETER M, KEMKOV LAW OFFICES Relleh and Heckman 1130 177* STBEET, N. W. SUITE lOOO Washington, d.c. 2003 February 6, 1973 FEB 9 1373 TELEPHONE sob arjb-sioo CABLE ADDHESS"KELNAN" TO: All Members of the SPI Food, Drug and Cosmetics Packaging Materials Committee RE: Occupational Safety and Health; Request for Information on Chemical Agents Gentlemen: The January 30 issue of the Federal Register included a request for information on certain chemical and physical agents in connection with enforcement of the Occupational Safety and Health Act of 1970. We are enclosing a copy of this Notice for your consider ation. You will note that information that is not in the published literature is requested on a number of chemicals, some of which are of direct concern to our industry. For that reason, we are circulating this Notice so that any of you who possess such information and wish to submit it because you deem it to be in your company's interest to do so, will be informed of this opportunity. The information and documentation should be submitted by Friday, March 30 although later submis sions will undoubtedly be accepted. If you have any questions about any aspect of this Notice, please do not hesitate to contact us. Enclosure ASI-PR 0001684 2782 HOTICfS 2. Partially controlled or uncontrolled VIL If the submission is by a manu fl. Carbon disulfide. studies. facturer, a statement signed by the per -> 7. Chlorobenzene. 3. Documented case reports. 4. Pertinent marketing experiences that may influence a determination as to the safety of each individual active com ponent. 5. Pertinent medical and scientific son responsible for such submission, that to the best of his knowledge it Includes unfavorable information, as well as any favorable information, known to him pertinent to an evaluation of the safety, effectiveness, and labeling of such a 8. 2,4-dinltrophenol 9. Ethyl benzene 10. Infrared radiation 11. Iron and iron compounds 12. Magnesite 13. Magnesium and magnesium compounds 14. Methyl 2-butyl ketone literature. B. Combinations of the individual ac tive components. 1. Controlled studies. 2. Partially controlled or uncontrolled studies. 3. Documented case reports. product. Thus, if any type of scientific data is submitted, a balanced submission of favorable and unfavorable data must be submitted. The same would be true of any other pertinent data or information submitted, such as consumer surveys or , marketing results. 15. Nickel carbonyl 16. Ozone 17. Phosphorus penta-chloride 18. Phosphorus penta-sulflde 19. Phosphorus trichloride 20. Tin and tin compounds 21. 1,1,2-trichloroethane 22. Vibration 4. Pertinent marketing experiences In order to avoid duplication, inter ^-23. Vinyl chloride that may influence a determination as to ested persons should not in their sub the safety of combinations of the individ missions include published literature ual active components. listed in the FDA literature search. An 5. Pertinent medical and scientific abstract of all such literature will be literature. provided to the panel. Upon request, the C. Finished drug product. panel will be provided with the complete 1. Controlled studies, article. Interested persons may, of 2. Partially controlled or uncontrolled course, refer to such literature in their studies. submissions by citation. 3. Documented case reports. Submissions or requests for copies of 4. Pertinent marketing experiences the bibliography of the FDA literature that may influence a determination as to search should be forwarded to: the safety of the finished product. 5. Pertinent medical and scientific lit erature. Food and Drug Administration, Bureau of Drugs. OTC Drug Products Evaluation Staff (BD-109), 8600 FlsUers Lane, Rockville, V. Efficacy data. UP 20852. A. Individual active components. 1. Controlled studies. 2. -.Partially controlled or uncontrolled Submission of data must be on or be fore April 2,1973. studies. (Federal Food. Drug, and Cosmetic Act, sec. 3. Documented case reports. 701; 21 UJB.C. 371) The information and data collected for each agent will be analyzed and eval uated relative to the nine areas listed below: 1. Establishment of safe occupational environment levels for such agents, in cluding levels for acute and chronic ex posure to airborne concentrations of the ' chemical substances, as well as safe work practices concerning direct contact with such substances or physical agents. 2. Establishment of biologic standards! Le., the levels of such substances, meta bolites, or other effects of exposure which may be present within man without his suffering ill effects, taking into consider ation (a) the correlation of airborne concentrations of and extent of exposure to such substances with effects on spe cific biologic systems of man, such as the circulatory, respiratory, excretory, and - 4. Pertinent marketing experiences Dated: January 23,1973. nervous system, and (b) the analytical that may influence a determination on the efficacy of each individual active component. 5. Pertinent medical and scientific lit Sam D. Fine, Associate Commissioner for Compliance. methods-for determining the amount of the substance which may be present within man. 3. Engineering controls, including ven erature. [FR Doc.73-1707 Filed 1-29-73; 8:45 am] tilation, physical factors, and house B. Combinations of the individual ac keeping and sanitation procedures, with tive components. 1. Controlled studies. 2. Partially controlled or uncontrolled Health Services and Mental Health Administration attention to the technological feasibility of such controls. 4. Specifications for the conditions - studies. OCCUPATIONAL SAFETY AND HEALTH under which personal protective devices 3. Documented case reports. 4. Pertinent marketing experiences Request for Information on Certain Chemical and physical Agents should be required. 5. Methodology, Including instrumen that may influence a determination on tation, for air sampling and sample the efficacy of combinations of the in dividual active components. Section 20(a) (3) of the Occupational Safety and Health Act of 1970 (29 U.S.C. analysis of chemical substances and for qnantitation of physical agents. 5. Pertinent medical and scientific lit erature. C. Finished drug product, 1. Controlled studies. 2. Partially controlled or uncontrolled 669(a)(3)) provides that the Secretary of Health, Education, and Welfare, on the basis of Information available to him, shall develop criteria dealing with toxic materials and harmful physical agents and substances which will describe ex 6. The need for medical examinations foe workers exposed to such substances, the frequency of such examinations, and the specific diagnostic tests which should be used, and the rationale for their sdection. studies. posure levels that are safe for various 3. Documented case reports. periods of employment. Section 22(c) of 4. Pertinent marketing experiences that may influence a determination on the efficacy of the finished drug product. 5. Pertinent medical and scientific lit erature. VI. A summary of the data and views setting forth the medical rationale and the Act authorizes the National Institute for Occupational Safety and Health to develop recommended occupational safety and health standards and to per form all functions of the Secretary of Health, Education, and Welfare, under sections 20 and 21 of the Act. The insti purpose (or lack thereof) for the drug tute is currently collecting information and its ingredients and the scientific and data on a number of chemical and basis (or lack thereof) for the conclusion physical agents including: that the drug and its ingredients have been proven safe and effective for the Intended use. If there is an absence of 1. Acrolein. 2. Acrylonitrile. 3. Aluminum. controlled studies in the material sub --^4, Ammonium nitrate. mitted, an explanation as to why such 5. Barotrauma (Including decompression 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 environmental levels are temporarily ex ceeded, or where peak concentrations of chemical substances in man are reached. . The types of records concerning oc cupational exposure to such agents that employers should be required to main tain. 9. Warning devices and labels which should be required for the prevention of occupational diseases and hazards caused by exposure to such agents. Any person having information or data which Is not readily available in "open studies arc not considered necessary tables and standards for. divers and tunnel scfcntific literature" In any of the nine must be included. workers). anas listed, or in other areas which the FEDERAL REGISTER, VOL 38, NO. 19--TUESDAY, JANUARY 30l 1973 ASI-PR 0001685 NOTICES 2783 nerson considers relevant to the cstabUslunent ot a sale and healthful occu pational environment involving the agents set forth above, is invited to sub mit such Information, with accompany ing documentation, to the Assistant Di rector for Research and Standards De velopment. National Institute for Occu pational Safety and Health, Room 10-28, 5500 Fishers Lane, Rockville, MD 20852, tt-itiiin 60 days after publication of this notice. All information received concerning any agent will be available for public in spection after the development of the re spective research analysis report or cri teria document Dated: January 23, 1973. Marcus M. Key, Director, National Institute for Occupational Safety and Health. |FR Doc.73-1689 Filed 1-29-73:8:45 am] NATIONAL ADVISORY COMMITTEES Notice of Meetings The Acting Administrator, Health Services and Mental Health Adminis tration, announces the meeting dates and other required information for the fol lowing national advisory bodies sched uled to assemble the month of February 1973. Committee name Dote, time, place Type of meeting and/or contact person Maternal and Child Health Service Kesd.trch (.rants Re view OoMimilU'e. Feb. 1-2, 9 a.m., Con ference Boom H, Parklawa Bldg,. fir,oo Fishers Lane, Rockville, Md. Closed. Contact Qloria Wackera&h, Room 12A-11, Parklawu Bid;,, WOO Fishers Lane, Rockville, Md., Code 30l--443-2100. ' Purpose. The Committee is charged with the review of all research grant ap plications in the program areas adminis tered by the Maternal and Child Health Service. Agenda. The Committee will be per forming review of grant applications for Federal assistance and wili not be open to the public in accordance with the de termination by the Acting Administrator, Health Services and Mental Health Ad ministration, pursuant to the provisions of Public Law 92-463, section 10(a) (2), Committee 1121110 Date, time, place Type of meeting and/or contact person National Adcviilsoonry CounIteKional Medical I'rotfraioa. Feb. 7-S. S 30 a.m.. Conference Room Room G/tt, Parklawn Bldg., WOO Fishers Lane, MRodc. kville, Partially open to the public. Closed for grant review. Contact Mr; Kenneth Baum. Room 11-10, Parklttwn Bldg., 5600 Fishers Lone, Rockville, Md., Code 301--443-1514. Purpose. The Council advises and as sists the Secretary in the preparation ot regulations for, and as to policy matters arising with respect to, the administra tion of this program. Reviews applica tions for grants under title IX, and rec ommends to the Secretary with respect to approval of applications for and the amounts of grants under this title. Agenda. The Council will hear reports and other business discussed by the Di rector, Regional Medical Programs Serv ice, regarding the administration of this program, and this portion of the meeting shall be open to the public. The remain ing portion of the meeting will be for the review of grant applications, and will not be open to the public in accordance with the determination by the Acting Admin istrator, Health Services and Mental Health Administration, pursuant to the provisions of Public Law 92-463, section 10(a)(2). Committee Type of meeting TlftTTIft Date, time, place and/or contact person NIMH Communi cations Advisory Committee. Feb. 7-3, 2 p.m., Con ference Room 14-103. Parklawn Bldg., 5000 Fishers Lane, Rock ville, Md. Open, Contact Mr. Edwin M. Long, Room 15-105, Parklawn Bldg., 5600 Fishers Lane, Rockville, Md., Code 301-443-3783. Purpose. Advises, consults with, and makes recommendations to the Director, National Institute of Mental Health, on matters of general policy concerning the fields of mental health, scientific and public information, communications, and public health education. Agenda. Agenda items will include a report on staff activities and considera tion of special projects. The Committee will discuss the Child Mental Health In formation Interchange, the Tenth Anni versary of Community Mental Health Centers, and the Future Role of the Com mittee. Committee Type of meeting name Date, tlma, plats and/or contact person Research Feb. 22-24,3 Closed. Contact Scientist a.m.. Center Dr. Mary R. Development for Advanced Haworth, Room Review Study in the . 12-04, Farklawn Committee. Behavioral Bldg., 5600 Sciences, Palo Fishers Lane, Alto, Calif. Rockville, Md., Code 301-443-4347. Purpose. Reviews applications for the Research Scientist Development Awards for support of additional training or ex perience of behavioral scientists to de velop their full capacities for careers de voted to research, and the Research Scientist Awards. Makes recommenda tions on these programs to the Division, of Manpower and Training Programs, National Institute of Mental Health, and the National Advisory Mental Health Council. Agenda. The Committee will be per forming review of grant applications for Federal assistance and will not be open to the public, in accordance with the determination by the Acting Adminis trator, Health Services and Mental Health Administration, pursuant to the provisions of Public Law 92-463 sec tion 10(a)(2). Items for discussion are subject to change due to priorities as directed by the President of the United States, or the Secretary of Health, Education, and Welfare, A roster of members may be obtained from the contact person listed above. Dated: January 23,1973. Andrew J. Cardinal, Acting Associate Administrator for Management, Health Services and Mental Health Administration. [FR Doc.73--1690 Filed 1-29-73:8:45 am] Office of the Secretary HEALTH SERVICES AND MENTAL HEALTH ADMINISTRATION Statement of Organization, Functions, and Delegations of Authority Part 3 (Health Services and Mental Health Administration) of the statement of organization, functions, and delega tions of authority for the Department of Health, Education, and Welfare (33 FR 15953, October 30, 1968), as amended, is hereby amended with regard to section 3-20, organization and functions, as follows: In Chapter 3A-00 (Office of the Admin istrator), section 3A17 entitled "Office of Information (3A17)" is being amended in order to change the name of the office, broaden its activities, and transfer to it the printing and distribution functions from the Office of Procurement and Ma teriel Management (3A1905). The above changes require a complete replacement of section 3A17, as follows: Office of Communications and Public Affairs (3AI7), Plans, directs, and co ordinates the scientific communications, technical information, and health infor mation/education activities, of the Health Services and Mental Health Ad ministration. Specifically: (1) Deter mines policies related to external and internal public affairs and communica tions activities; (2) plans and carries out all such activities for the guidance of communications and public affairs activities throughout the Administra tion; (3) identifies program areas and population groups requiring^special em phasis in health education and provides guidance, assistance, and support to such special efforts; (4) coordinates all HSMHA scientific and technical infor mation programs. Including clearing houses, libraries, and specialized infor mation centers; (5) establishes operating procedures for the orderly and expedi tious processing and dissemination of information/education materials; (6) performs a concept-review and evalua tion function of all such materials (films, radio and television materials, publica tions, magazine articles, news features, exhibits, etc.) to ensure that Informa tion/education projects are supportive of program guidelines for major com munications activities, and provides ad ministrative management support to FEDERAL REGISTER, VOL. 38, NO. 19--TUESDAY, JANUARY 30, 1973 ASI-PR 0001686