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2782 NOTICES 2. Partially controlled or uncontrolled VXf. If the submission la by a manu 0. Carboo disulfide. studio*. 3. Documented care report*. 4. Pertinent marketing experience* tnat may Influenoe a determination as to facturer. a statement signed by the per son responsible for such submission, that to the best of his knowledge It Includes unfavorable Information, as well as any 7. cnjoroOeoMo*. 5. a.e-dlnltropbenot 0. Ethyl benzene 10. infrared radiation 11. Iron and iron compounds the safety of each individual active com favorable Information, known to him 13. Magnesite ponent. pertinent to an evaluation of the safety, 19. Magnesium and magnesium compounds 5. Pertinent medical and sclentlflo effectiveness, and labeling of such a 14. Methyl 3-butyl ketone literature. S. Combinations of the Individual ac tive components. 1. Controlled studies. 2. Partially controlled or uncontrolled product. Thus. If any type of sclentlflo 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 16. Nickel carnonyt 16. Ozone IT. Pfioepaorue penu-chloride is. Phosphorus p*DU>iuifl6 19. Phosphorus trichloride 30. Tut and tin oompounda studies. submitted, such as consumer surveys or 21. 1.1.2-trlchlorootbsne 3. Documented case reports. marketing results. 33. Vibration 4. Pertinent marketing experiences In order to avoid duplication. Inter 33. Vinyl chloride that may Influence a determination as to the safety of combinations of the individ ual active components. 5. Pertinent medical and scientific literature. ested persons should not In their sub missions Include published literature listed in the FDA literature search. An abstract of all such literature will be provided to the panel. Dpon request, the Tho Information and data collected for each agent will be analyzed and eval uated relative to the note areas listed below: 1. Establishment of safe occupational C. Finished drug product. 1. controlled studies. 2. Partially controlled or uncontrolled studies. panel will be provided with the complete article. Interested persons may, of course, refer to such literature in their submissions by citation. environment levels for such agents. In cluding levels foracute and chronic ex posure to airborne concentrations of the chemicad substances, as well as safe work 3. Documented case reports. Submissions or requests for copies of practices concerning direct contact with 4. Pertinent marketing experiences the bibliography of the FDA literature such substances or physical agents. that may influence a determination as to search should be forwarded to: 2. Establishment of biologic standards; the safety of the finished product. 5. Pertinent medical and scientific lit Food sad Drug Administration. Bureau of l.e.. the levels of such substances, meta Drugs. OTC Drug Products evaluation Staff bolites. or other effects of exposure which erature. (BD-100), MOO PIstur* Lane, RockvUlt, may be present within man without his V. Efficacy data. MD 30683. suffering 111 effects, taking Into consider A. Individual active components. 1. Controlled studies. 2. Partially controlled or uncontrolled studies. 3. Documented case reports. Submission of data must be on or be fore April 2,1913. (Federal Food. Drug, and Cosmetic Act, lee. 101; 31 VAC. 971) 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 that may Influence a determination on the efficacy of each individual active component. 3. Pertinent medical and scientific lit Dated: January 23,1913. Sak D. Fine. Attociaie Commissioner for Compliance. nervous system, and (b) the analytical methods for determining the amount of the substance which may be present within man. 3. Engineering controls. Including ven erature. (PN Doc.79-1701 Piled 1-30-71:9:48 anti 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 Service* 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 that may influence a determination on the efficacy of combinations of the in dividual active components. 5. Pertinent medical and scientific lit erature. C. Finished drug product. 1. Controlled studies. Request for Information on Certain Chemical and Physical Agents Section 20(a) (3) of the Occupational Safety and Health Act of 1910 (29 U.8.C. 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 should be required. 8. Methodology. Including Instrumen tation, for air sampling and sample analysts of chemical substances and lor quantitation of physical agents. 6. The need for medical examinations for workers exposed to such substances, the frequency of such examinations, and the specific diagnostic tests which should be used, and the rationale for their 2. Partially controUcd or uncontrolled and substances which will describe ex selection. studies. posure levels that are safe for various 7. Work practice* or procedures which 3. Documented case reports. periods of employment. Bectlga 22(c) of may be instituted for control of the work 4. Pertinent marketing experiences the Act authorizes the National Institute place environment In norma] operations, that may influence e determination on the efficacy of the finished drug product. 8. Pertinent medical and scientific lit erature. VI. A summary of the data and views setting forth the medical rationale and J purpose (or lack thereof) for the drug and Its Ingredients and the sclentlflo beisls (or lack thereof) for the conclusion that the drug and its ingredients have been proven safe and effective for the Intended use. If there Is an absence of controlled studies In the material sub mitted, an explanation as to why such studies axe not considered necessary 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 tute is currently collecting information and data on a number of chemical and physical agents Including: 1. Acrolein. 2. Acrylonitrile. 3. Aluminum. 4. Ammonium nitrate. 8. Barotrauma (Inducing decompression table* and etendsrde for dlvere and tunnel and those which may be instituted when environmental levels are temporarily ex ceeded. or where peak concentrations of chemical substances In man are reached. 8. The type* 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 scientific literature" In any of the nine must be included. workers). area* listed, or In other areas which the tooAocez J FfOitAl MOIUH, VOl. 91. NO. 19--TUtSOAT, JANUARY 90, 1973 BFG40513 NONCES 278.1 priori considers relevant to the estab- Usnment of a safe 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 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 the provuionj of Public Law 92-463. sec tion 10(a)(2i. Items for discussion are subject :o change due to priorities as directed by the President of the United States, or the Secretary of Health, education, and rector for Research and Standards De velopment. National Institute for Occu pational Safety and Health. Room 10-28. 5600 Fishers Lane, Rockville, MD 20852. within 60 days after publication of thla 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 Welfare. A roster of members may be obtained from the contact person listed above. Dated. January 23, 1973. notice. ing portion of the meeting will be for the Axdaiw J. Cardinal. All Information received concerning any agent will be available for public In spection after the development of the re spective research analysts report or cri teria document. Dated: January 23. 1973. 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 92-483. section 10(a)12). Acting Associate Administrator lor Management, Health Services and Mental Health Administration. [FR Doc.73-1690 Plied 1-29-73:8:48 am| Marcus M. Kit. Offlte of the Secretary Director. National Institute /or Occupational Safety and Health. int Doc.73-1689 Plied 1-39-73:8:45 am] NATIONAL ADVISORY COMMITTEES Notice of Meeting* 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. Commute* oaroe Date, Ufa*, pleoe Type of mealing hf>4j/Of concoct persoa M*t<*rna) *n/1 i hitit Health ^vrvice He* v rch lirwnu Ravii-w Com- Ftb 1-2. t m.. Con* frrpitrw Huom It I'lfttAWO nut*., frtuo Kisitrm Lrro, Rockville. Md. CIo*m1. Contort * Hurta Wuckrrnoh, lluom WA-tt. I'lwktevn Bid*., 5*40 Ktjhers Lon#, flock TH!. MJ.. Ct dot -- CoRunlttM Type ol meeting 00/80 Date, tl/Bfl, place and/or contact persoa NIMH Continual. cations Advisory Committee. Fepb.m7.-.1C, o3o* frrvnoe Room 14-10J. Park* lawn Bid*., 5600 Fishers Lent. Rock* villa. Md. Open. Confect Mr. Edwin M. Long. Room IV105. Pe/klewn Bldg., 5600 Ftihers MLailn..e.CoR*otc kntie. 501--UVJTM. Purpose. Advises, consults with, and makes recommendations to the Director, National Institute ol Mental Health, on matters of general policy concerning tha fields of mental health, scientific and public Information, communications, and pubUc 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. HEALTH SERVICES ANO MENTAL HEALTH ADMINISTRATION Statement of Organization, Functions, and Delegations of Authority Part 3 (Health Sendees and Menu) 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, a* follows: In Chapter 3A-00 (Office of the Admin istrator). section 3A17 entitled "Offlce of Information (3A17)" Is being amended In order to change the name of the offlce. broaden Its activities, and transfer to It the printing and distribution functions from the Office of Procurement and Ma teriel Management (3A190S). The above changes require a complete replacement of section 3A17, as follows: Office ol Communications and Public Affairs (3Ai7>. Plana, directs, and co ordinates the scientific communications, 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 will 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 Type of meeting iiiiiii* Pair, lime, pleoe end/or contact (cam National Ad* risdfy Court* cil on HrklOrtki Mr.llClil t'n^fatnj. Fob 7-f % 30 a.m.. C*en. f.ffnc* Room Hmim O H, VttrkUwn iiitifteoa Fishen Lino, Rockville, Md. Parttally o(M to the public. Cloud tor front review. Contact Mr. Kenneth Bourn, Room tl*!*. Perktewn BWIf., tMX Flshtrv Iim, KockriUo, Md., CodeJOl--MVUU. Purpose. The Council advise* and as sists the Secretary In the preparation of CommlUr-* Type of meeting Mini* Oe(e. time. piece and/or eootect parvou Ra*earth Scientist Development Review Committee. Feb. 2J-74. 9 am. Center for Advanced Study in the Behavioral }<cicttCM, Pete AIM. CeUf. Clewed. Contact Or. Mary R. Haworth. Root* 12 **4. Pafklawn 111.ht . 5600 Fishers Lane. Rockville. Md.. Code Ml --0-047. 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 career* 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 technical Information, and health tnfor- matton/educatlon activities of the Health Sendees and Mental Health Ad ministration. Specifically: (11 Deter mines policies related to external and Internal public affair* 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 nil HSMHA scientific and technical infor mation program*. Including clearing houses. libraries, and specialized Infor mation center*: <3> 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 article*, news features, exhibits, etc.) to ensure that Informa tion/education projects are supportive of program guidelines for major com regulations for. and as to policy matter* trator. Health Service* and Mental munications activities, and provides ad arising with rsapect to, ths admlnlstra- Health Administration, pursuant to ministrative management support to glOIIAl IfCISTtt, VOL 31, NO. 19--UHSOAT. JANUAIY 30, 1973 I i zoo6o?sz U*MasM*af> idli'Jktti EFG40512 : * . ii7