28780 Federal. Rogister_/ Vol. 54, No. 129 / Friday, July 7, 1989 / Rules and Regulations DEPARTMENT OF HEALTH AND Dockets Management Branch (HFA- a new Panel be convened with... HUMAN SERVICES, 208), Food and Drug Administration, Rm, ‘qualified experts 4-62, 5600 Fishers Lane, Rockwille, MD including nutritionists, herbalist, 21CFR Part 310 20887, efter deletion of a small amount sexologists, or physicians with expertise of trade secret information. in sex therapy. The comments {Dockt No, 6N-0419} ‘The agency's proposed regulation. in contended thal the Miscellaneous IN 0905-AA0E the form of a tentative final rule, for Internal Panel lacked expertise in the Aphrodisiac Drug Products for Over- the-Counter Human Use ‘AgENCY: Food and Drug Administration, ‘summany: The Food and Drag Administration (FDA) is issuing a final rule establishing that any aphrodisiac drug product for over-the-counter (OTC) ‘human use isnot generally recognized fs safe and effective and is misbranded. Aphrodisiac drug products claim to arouse or increase sexual desire (libido) ‘oF to improve sexual performance. FDA is issuing this final rule after considering public comments on the agency's proposed regulation, which was issued fn the form of a tentative final rule, and all new data and information on aphrodisiac drug products that have ‘come to the agency's attention. This final rule is part of the ongoing review of OTC drug products conducted by FDA. EFFECTIVE DATE: January 8, 1990. FOR FURTHER INFORMATION CONTACT: William E. Gilbertson, Center for Drug Evaluation and Research (HFD-210), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20887, 301~ 295-8000. ‘SUPPLEMENTARY INFORMATION: In the Federal Register of October 1, 1982 (37 FR 49572), FDA published, under § 330.10(¢)(6) (21 CFR 320.10(a)(6)), an advance notice of proposed rulemaking that would classify OTC aphrodisiac drug products as not generally recognized as safe and effective and as being misbranded and would declare these products to be new drugs within the meaning of section 201(p) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 821(p)). The notice was based on the recommendations of the Advisory Review Pare! on OTC. Miscellaneous Internal Drug Products (Miscellaneous Internal Panel], which ‘was the advisory review panel responsible for evaluating data on the active ingredients inthis drug clas. Interested persons were invited to submit comments by December 30, 1982. Reply comments in response to ‘comments filed in the initial coramient petiod could be submitted by January 51, 1983, in accordance with § 390,10(a)(10), the data and information considered by the Panel were put on display in the OTC aphrodisiac drug products was published in the Federal Register of January 15, 1985 (50 FR 2166), Interested persons wore invited to file by May 15, 1085, written comments, objections, or requests for oral hearing before the Commissioner of Food and Drugs regarding the proposal. Interested. Persons were invited to file comments ‘on the agency's economie impact determination by May 15, 1965. New data could have been submitted until January 15, 1986, and comments on the ‘until March 17, 1966. Final on occurs with the publication of this final rule on OTC aphrodisine drug produc TAD lscussed ioe pre regulation for OTC aphrodisiac drug products (60 FR 2108), the agency advised that the drug products covered by this regulation would be subject to the regulation effective 6 months after the date of publication of the final rule {in the Federal Register. On or after January 8, 1990, no OTC drug products that are subject to this final rule may be Initially introduced or initially delivered for introduction into interstate ‘commerce unless they are the subject of an approved new drug application (NDA). If, in the future, any ingredient is determined to be generally recognized as safe and offective for use in an OTC aphrodisiac drug product, the agency will promulgate an appropriate regulation at that time. In response to the proposed rule on OTC aphrodisiac drug products, $5 ‘consumers and 2 health care groups submitted comments. Requests for oral hearing before the Commissioner were also received on seven different issues. Copies of the comments and the hearing requests received are on public display in the Dockets Management Branch. ‘Additional information that has come to the agency's attention since publication of the proposed rule is also on public display in the Dockets Management Branch, ‘In proceeding with this final rule, the agency has considered all objections requests for oral hearings, and the ‘changes in the procedural regulations. The Agency's Conclus Comments 1, Numerous comments requested that the notice of proposed rulemaking for aphrodistac drug products for OTC use be withdrawn or, a8 an alternative, that ns on the folds relevant to the use of aphrodisiacs, and because the Panel did not consult a "biochemist, physician, psychologist, or other scientist with ‘successful clinical experience using nutritional aphrodisiacs,” it was in violation of FDA's own regulations under 21 CFR 330.10(a) which require at the Commissioner appoint “qualified experts” to the panel. The comments contended that the food supplement industry, food ‘manufacturers, and the public have been denied the benefits ofa full scientific be submitted in an appropriate citizen petition to establish a monograph. (See 21. CFR 1030) ‘The agency has carefully considered the data in the administrative record ‘and the arguments included in the ‘comments. The agency has determined that at present there is insufficient evidence to establish that any ingredient, including yohimbine, u OTC aphrodisinc dng products is generally recognized as safe an effective. Because these matters have been fully considered and because the agency concludes that a hearing on this issue is not likely to provide any additional useful information ot insight the agency concludes that a hearing is not warranted, References (2) Bruhl, D.B,, and C,H. Leslie, “Afrodex: Double-Blind Test in din al, “Double-Blind Trial of ‘Yohimbine in Treatment of Paychogenic Impotence,” The Lancet, 2421-423, 1987, ©) Miller, W. W.,"“Affodex in the ‘Treatment of Male Impotence: A Double-Blind Cross-Over Study," Current Therapeutic Research, 10:354- 360, 1968, (4) Margolis, R, et al, “Statistical ‘Summary of 10,000 Male Cases Using ‘Afrodex in the Troatment of Impotence,” Current Therapeutic Research, 13:816— 22, 1971. (6) Sobotka, J.J, “An Evaluation of ‘Alrodex in the Management of Male Impotency: A Double-Blind Crossover Study, (2) Reid, ixture of Nux Vomice, ‘Yohimbine, and Methyl Testosterone in the Treatment of Impotence," Current Therapeutic Research, 8:280-283, 1908, (7) Albert-Puleo, M, “Fennel and Anise as Estrogenic Agents," ournal of Ethnopharmacology, 2:387-944, 1990. (8) Clark, J.T, ER. Smith, and J. M, Davidson, “Enhancement of Sexual Motivation in Male Rats by Yohimbine,” Science, 25:847-849, 1964. (9) Slag, M. F, etal. "Impotence in ‘Medical Clinic Outpatients," The Journal of the American Medical ‘Association, 249:1736-1740, 1988. 5 Gus eames sooo publication of the final monogray Gelayed unl data fom studi reportedly ongoing, on yohimbine can be appropriately considered, ‘The comment w: 11985. The agency has received no ‘additional information on these or any other studies. The agency cannot further delay publication of this final rale to. await results of any reportedly ongoing studies, Such a delay would allow products that have not been shown to be safe and effective to remain in the ‘marketplace for a prolonged period of time and is not in the public interest Further, manufacturers have been alerted about the proposed port was published in the Federal Register on October 1, 1082 (47 FR 49972}. The agency reiterated the proposed nonmonograph Sat of pais ine nto ypoved rulemaking over 9 years ag0 in {ho Federal Rogistr of January 18,1003 (60 FR 2106). Thus, manufacturers have had ample opportunity to conduct clinical its and to submit the results tothe agency. “The agency points out that publication ot nal re doe ot reid manufacturer's esting an ingredient. New, relevant data can be submitted to28786 Federal Register / Voli 54, No. 129 / Friday, July 7, 1989 / Rules. and Regulations the agency at‘ later date as the subject, of an NDA that may provide for prescription ap OTC marketing status, (See 21 CFR Part 314) Asam alternative, ‘wheze there are adequate data establishing general recognition of safety and effectiveness, such data may. be submitted in an appropriate citizen petition to establish a monograph. (See ACER 1030}, a For the above reasons, the agency will not delay the final rule until publication of these studies, IL Tlie Agency's Final Conclusions.on ‘OTC Aphrodisiac Drug Products ‘The agency has determined that al: products that bear labeling claiming that they will arouse or increase sexual esr, or that they wil improve sexual performance, are aphrodisisc drug products. Moreover; the agency has Getermined that no aphrodisiac drug product hus been found to be generally recognized as safe and effective and-not risbranded for use in tre cual dysfunction: Therefore, all aphrodisiac ddrug products, including those containing such ingredients as anise, cantharides, dom qual, estrogens, fennel, ginseng, golden seal, gotu kola, Korean ginseng; licorice; mandrake, methyltestosterone, minerals, mx ‘vomica, Pega Palo, sarsaparilla, strychnine; testosterone, vitamins, yohimbine, yohimbine hydrochloride, ‘and yohimbinum, are-considered ‘onmonograph ingredients and risbranded under section 502 of the Federal Food, Drug, anc! Cosmetic Act (21 U.S.C. 352} and are now drugs under section 20%(p) of the act (21 U.S.C. '321{p)} for which an approved NDA. under section 505 of the act (21 USC. 355) and Part 314 ofthe regulations (21 CER Part $14) is required for marketing. In appropriate circumstances, a citizen petition to establish a monograph may bbe submitted under 21'CFR 10.30 in lieu of an NDA. Any such OTC drug product {initially Introduced or initially delivered {for introduction into interstate commerce after the effective date-of this final rule that is notin compliance with the regulation is subject to regulatory {In response to the agency's request for specific comment an the economic. ‘impact of this rulemaking (60 FR 2168), fone comment was received. (See ‘comment’ above) The agency has ‘examined the economic consequences of ‘this final rule in-conjunction with other rules resulting from the OTC drug: review. Ina notice published’ in the: Federal Register of Febrasry 8; 1983 (88 FR 5806) the agency announced! the availability of ax assessment of these economic impacts, The assessment determined that the combined impacts of all the rules resulting from the OTC ‘drug review do not constitute amajor rule according to the criteria established by Executive Order 12201. The agency therefore concludes that no one of these rules, including this final rule for OTC. aphrodisiac drug products, is a major rule, The economic assessment also concluded that the overall OTC drug roview was not likely to have @ significant economic impact on a substantial numbor of small entities as defined in the Regulatory Flexibility Act. Pub. L, 96-354. That assessment included a discretionary Regulatory Flexibility Analysis in the event that an. Individual rule might impose an unusual of disproportionate impact on small enias However this particular rulemaking for OFC aphrodisiac drug products is not expected to pose such an {mpact on small businesses. Therefore, the agency certifies that this final rule ‘will not have a significant economic {impact on a substantial number of small entities, "The agency has determined under 21 (CFR 25.24(0)(6) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. List of Subjocts in 21 CFR Part 210 Administrative practice and procedure, Drugs. Reporting and recordkeeping requirements. ‘Therefore, under the Federal Food, Drug. and Cosmetic Act and the ‘Administrative Procedure Act, Subchapter D of Chapter I of Title 21 of the Code of Federal Regulations is ‘amended In Part 310 to read as follows: PART 310—-NEW DRUGS 1. The authority citation for 21 CFR Part 310 continues to read as follows: Authority: Sees. 50, $02, 508, 505,702, 708, 708,52 Stat 2049-1089 as amended, 52 Stat 47085-1086 as amended, 67 Sia. 477 as amended, 52 Stat 1057-1059 (21 U.S.C. $51, 52, 49,355, 971, 374, 975); SUSC. 885; 20 CFR Savard 5:12 2, New §.310.528 is added to Subpart E to read as follows: 210528, Drug products containing active Ingredionts offered over-the-counter (OTC) {for use as.an aphrodisiac. (a) Any product that bears labeling claims that it will arouse or increase sexual desire, or that it will improve sexual performance; is am aphrodisiac ‘drug product. Anise, cantharides; don ‘qual. estrogens, fennel; ginsong, golden seal, gotu koa, Koroan ginseng, licrics, ‘mandrake, meibyltestosterone: minerals nx vomica, Rege Pal. sarsaperila, tinine, testosterone, vitamins. Yohimbine, yohimbine hydrochloride, ind yohimbinum have beer present as Jngredients in such drog product. “Androgens (eg. testosterone and hnetiyltestosterone) and estrogens are owerfal hormones when adminstered Internally and are not sae forse excont under the supervision of @ fhyolcian. There is wlack of adequate data to establish general recognition of theafoty and econo of any of these ingredients or any other ingredient, for OTC use aphrodisiac. Labeling claims for aphrodisiacs for OTC use are either false, misleading. or unsupported by Scientific data. Te following claims are txamples of some that have baen made foraphrodistac dug product for OTC tse: acts a9 an aphrodisiac" "arouses Drincroasos sexual deste and improves Sexual performances” “helps restore sexual vigor, potency. and Performance: "improves performance, Saying power, and sexual potency" and Sule ey and sexual poten Based on evidence curenty availabe, say OC drogprodct contain ingredients for vse as ax aphrodisiac cannot be generally secognized as safe find effective. {(b) Any OTC drug product that is tabelod tepresented, or prompted for tive apan aphrodisiae is regarded 03 & how dug within the meaning of section Zoli) ofthe Federal Food, Dros, and Conte At (he act for which an Spproved new drug appilcation under Section 505 of the act and Part S14 ofthis Sheptor is roquzed for marketing Inthe bsence ofan approved new dr “pplication, such prodac sels ‘branded under section 802 ofthe act. (6) Clinical investigations designed to obtain evidence that any drug product labeled, represented, or promoted for GTC use ab an ephrodisiees safe and effective forthe purpose intendad must Somply with the rguirements and procedures governing th use of {ovesigational new druge set forth im Parta12 ofthis chapter {4) After January 8,199, eny such OFC drug product intaly introduced or fntially delivered for introduction ito interstate commerce that not in Compliance with this section is subject {oregulatory action Dated March 20-1900 Frank Yours Commision of oa ont Drags: {PeDoe eb 1064 ed 7-0-0864 am} ne cone -oatFederal Register / Vol. 54, No. 194 / Friday, July 14, 1989 / Notices —————— yt to | Notices 29778 ote: fly 6,190, Steveo Newburg Rian, ‘Acting Diractornformation Management Dinston foe of Fate Subtonose {Doe 9-16649 Filed 7-13-6845 am (OPTS-50272; RRL-2616-31 ‘Toxic and Hazardous Substances; Test Market Exemption Applications AGENCY: Environmental Protection “Agency (EPA). ACTION: Notice. ‘Summany: EPA may upon application exempt any person from the remanufacturing notification Foquirements of section S{a) or (b) of the Toxic Substance Control Act (TSCA) to permit the person to manufacture or process a chemical for test marketing ‘purposes under section S(hj(t) of TSCA. Requirements for test market ‘exemption (TMB) applications, which ‘must either be approved or denied within 45 days of receipt are discussed in EPA's final rule published in the Foderal Register of May 13, 1983 (40 FR 21722), This notice, issued under section 5(h)(6) of TSCA, announces receipt of 2 ‘application{s) for exemption, provides. summary, and requests comments on the gppropratoens of ranting hie DATES: Written comments by: T 00-17, fly 22, 1989. ‘T 60-28, July 27, 1900. AboRess: Written comments, identified by the document control number “{OPTS-39272]" and the specific TME ‘number should be sent to: Document Processing Center (TS-700}, Office of ‘Toxic Substances, Environmental Protection Agency, 401 M Street SW., ‘Room 1-100, Washington, DC 20460 (202) 382-3582. FOR FURTHER INFORMATION CONTACT: Michael M. Stahl, Diteotor, TSCA Assistance Office (TS-790), Office of ‘Toxic Substances, Environmental Protection Agency, Room EB-44, 401 M Street SW.. Washington, DC 20400, (202) 584-1404, TDD (202) 854-0581, SUPPLEMENTARY INFORMATION: The following notice contains information extracted from the noneonfidential version of the submission provided by the manufacturer of the TME received by EPA. The complete nonconfidential document is available inthe Public Reading Room NE-GO04 at the above ‘address between 8:00 a.m. and 4:00 p.m., Monday through Friday, excluding legal holidays. Taes7 Close of Review Period. August 8, 1009. ‘Manufacturer. Confidential Chemical. (G) Crosslinked starch hydrolized acryloniteile copolymer. ‘Use/Import:(G) Oil fracturing fluid thickening agent. Prod. range: 250,000 g/yt rasa Close of Review Period. August 10, 1980, ‘Manufacturor: Confidential, ‘Chemical (G) Rosin, polymer with substituted phonols, formaldehyde, pentaerythritol and metal hydroxide, Use/Import. (G) Ink resin. Prod. range: Confidential. Prod. range: 250,000 kg/ yr Date: fly 6, 1906, Stoven Newburg Rian, Acting Dinector,Infermation Management Division, Office of Toxte Substances, {ER Doc. 09-16542 Filed 7-13-80, 64 um} (FRL-615-05 Sole Source Aquifer Designation for the Vinainaven Island Aquiter System, Maine AGENCY: U.S. Environmental Protection, Agency. ‘ACTION: Notice. ‘SUMMARY: In response to a petition from the State of Maine, notice is aiven that the Regional Administrator, Region I. of the U.S. Environmental Protection Agency (EPA) has determined that the Vinalhaven Island Aquifer System satisfies all determination criteria for designation as ‘sole source aqulfer, pursuant to section 1424(e} ofthe Safe Drinking Water Act. The following findings were made in accordance with the’ designation criteria: Vinathaven Island ‘Aquifer System is the principal source of drinking water for the residents of Vinalhaven Island: there are no viable altemative sources of sufficient supply: the boundaries of the designated area and project review area have been, ‘reviewed and approved by EPA; and, if ‘contamination were to occur, it would ose a significant public health hazard and a serious financial burden to the State of Maino. As a result ofthis action, all federal financially assisted projects, proposed for constriction ot ‘modification to take place on Vinalhaven Island will be subject to EPA review to minimize the risk of ‘ground water contamination from these Project DATES: This determination shall be promulgated for purposes of judicial Foview at 1:00 p.m. Eastern time two ‘weeks after the date of publication in the Poderal Register. Abbaesses: The data upon which these findings are based are available to the public and may be inspected daring normal business hours at the U.S. Environmental Protection Agency, Rogion I. JFK Federal Building, Water Management Division, WGP 2113, Boston, MA 02203. The designation petition submitted may also be inspected at the Maine State Planning Office in Augusta, Maine, FOR FURTHER INFORMATION CONTACT: Robert E. Mendoza, Chief of the Ground ‘Water Management Section, EPA Region I, JFK Federal Building, WGP- 2113, Boston, MA 02208, 617-865-3600. SUPPLEMENTARY INFORMATION: L Background Section 1424(0) ofthe Safe Drinking Water Act (42 U.S.C) a00f, 300h-3(e} Pub. L. 93-523) state H the Administrator determines, on his ows initiative or upon pettion, that an arva has 82 ‘aguifer whichis the sole or principal drinking ‘eater source for the area and which, if Contaminated, would crvate significant hhezard to pubic health he eal pblioh ‘notice ofthat determination in the Federal, Register. After the publication of sny such ‘notice, no commitment for federal fitancla {guarantee o otherwise) may be entered into {or any project which the Adminstrator determines may contaminate auch aquler {through a echargo zone so ae to cree significant hazard to public ‘commitment for Federal financial assistance ‘ay, if authorized under another proviion of law, be entered into to plan or design the project to aseure that will not 99 onteminate the aquifer On June 3, 1988, EPA received a petition from the State of Maine requesting the designation of the Vinalhaven Island Aquifer System sole source aquifer. EPA determined ‘that the petition fully satisfied the Completeness Determination Checklist. A public meeting was thea scheduled ‘and held on March 6, 1989 on Vinalhaven Island, Maine, in ‘accordance with ail applicable notification and procedural requirements. A one month comment period followed the meeting, TL Basis for Dotermination Among the factors considered by the Regional Administrator as part of the dotailed review and technical verification process for designating an ‘rea under section 1424{e) were:Federal Register {Vol 54, No. 194 / Friday, July 14, 1988 | Notices 28780 1. The Vinathaven Aquifer System is @ Interconnected bedrock aquifer which the population draws for their fresh ‘water needs. It serves as the principal Source of drinking water to all residents within the service area. 2, There exists no reasonable altemative drinking water source or combination of sources of sulficient ‘quantity to supply the designated 3 EPA has found that the State of ‘Maine has appropriately delineated the ‘boundaries of the aquifer recharge area, project designation area and project 4. Although the quality of the Island's ground water is considered adequate, it {8 vulnerable to contamination due to the laland’s goological characteristics ‘and possible land use activities. Because of thi, contaminants can be rapidly introduced into the aquifer system from many sources with minimal assimilation, Since the aquifer serves as the principal source of drinking water for the residents, a serious ‘contamination incident could pose & ‘significant public health hazard. IIL Description of the Vinalhaven islend ‘Aquifer Systom Designated Area and Project Review Area ‘The Vinalhaven Island fs «20 square miles ocean island looated in the sid ‘coastal region of Maine, approximately $0 miles east of Rockport, the nearest ‘mainland town. The aquifer system is ‘comprised of a interconnected bedrock ‘quifer The island's bedrock consists predominately of granite, gabbro, diorite {and pelite of Devonian age. The Island hhae relief of 218 foet, with a irregular topographic profile. ‘The designated area is defined as the surface area above the aquifer system ‘and its recharge area. For the Vinalhaven Island Aquiter System the boundary of the designated area coincides with the boundary of the ‘watershed basin, The watershed Doundary is the surface water divide ‘based on topography, which corresponds to the ground water divide, ‘The designated area, project review area and service area are conterminous, ‘encompassing all ofthe Island, IV. Information Utilized in Determination ‘The information utilized in this determination includes: the petition submitted to FPA Region I by the State fof Maine and letters of support received. ‘This information is available to the ‘public and may be inspected at the Baden listed above. \V. Project Review EPA Region Ii working withthe federal agencies most lkely to provide nance assistance to projects i the project review area, Interagency procedures and Memaranda of Tinderstending have been developed through which EPA wil be notified of proposed commitments by federal Egoncis to projects which could fontaminate the Vinalhoven island ‘Rauifor System, EPA will evaluate such projects and, where necessary, conduct Snincdepth review, including soliciting public comments when appropriate. Bhould the Regional Administrator Getermine that a project may gontaminate the aqufer through te fecharge zone 20 to create 8 gnifeant hazard to public health, no {Sommitmect for federal inanclal Sssistance may be entered into. However, a commitment fr federal nancial assistance may authorized Under another provision of law, be entered into (o plan or design the project oenture that twill ot contaminate the fouifer Included in the review of any federal financially aststed project wil be the coordination with state and local fgenciog and the project's developers. ‘Thetr comments wil be given ful consideration and EPA's reviw wil tempt to complement and support State and focal ground water protection ‘ensures. Although the projet review proceso cannot be delegeted, EPA will Fely to tho maximum extent possible on any existing o future state and/or local control measures to protect the quality St ground water in the Vinalhaven Island Aquifer System. VL Summary and Discussion of Public Comments ‘During the public meeting, a request for an extenston of the public comment peviod was made. It wae extended an Eadittonal two weeks and expired on ‘Aprile. 1960, One comment raised the ‘oncom thatthe State of Male, serving Ss the petitioner should have contacted the leland’s municipal officials eslier in the process. This concern was conveyed tortie appropriate state agency. Letiers In support of designation were submitted to EPA Paul Keough. ‘Roponol Adastra Date: May 83,290. [FR Dos. 8-16544 Fld 7-19-08 848 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ‘Advisory Committee; Notice of Meeting, ‘Agency: Food and Drug Administration. HHS. ‘ACTION: Notice. ‘uumany: This notice announces a forthcoming meeting of a public ‘advisory committee of the Food and Drug Administration (FDA), This notice also summarizes the procedures for the meetings and methods by which interested persons may participate in ‘open public hearings before FDA's ‘advisory committees. ‘Meeting: The following advisory committee meeting is smnounced: Pulmonary-Allergy Drags Advisory ‘Committee Date, time, and placa. july 91 and ‘Axgust 1, 1989, 8:30 a.m., Wilson Hall ‘Auditorium, National Institutes of ‘Health, Bldg, 1, 9000 Rockville Pike, ‘Bethesda, MD. Type of meeting and contact person. ‘Open public hearing, uly 31, 1880, 830 am, to 930 am. unless public participation does not last that long; pen committee discussion, 9:30 a.m. to Sip.ms open public hearing. August 1, ‘1429, 890 a.m, to 9:30 a.m. unless pubic ‘participation does not last that long: pen committee discussion, 9:30 a.m. to Sipum; Isaac F, Roubeln, Center for Drug Evaluation and Research (HD-8}, Food and Drag Administration, $000 Fishers Lane, Rockville, MD 20857, 901~443- 605. ‘General function of the committee. ‘The committee reviews and evaluates available data on the safety and effectiveness of marketed and investigational human drugs for use in the treatment of pulmonary disease and diseases with allergenic and/or mmunologic mechanisms. "Agenda—Open public hearing. Interested persons may present data, information, or views, orally or in writing, on issues pending before the ‘committee. Those desiring to make Formal presentations should notify the ‘contact person before July 15, 1908, and Ssubmita brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and fan indication of the approximate time required to make their comments. pea committee discussion. On july 960, the committee will discuss promethazine, On Augest 1, 1989, the29781 committee wil discus a status report fn surfactant replacement therapy and the guldelines forte evaluation of Depp dg “The agency Isaued a proposal in the Federal Register to allow over the- counter (OFC) marketing of promethazine in cough-eold products Comments have been received on this proposal concerning the advsebihty of Fritching the manketng of suck Product containing promethazine from { proscription basi tan OTC baw ‘The agency wishes to discus this osu isan apen public meeting of the Advisory eommitien “ee commits cision and conclusions regarding promethazine Ssrrochlortde wl be Considered fy the agency both ie: Reviewing the Ciict meshing sand abet of ‘ough-culd drug products containing promethazine hydrochloride and (2) Sid cough ellrgy.besechgdato and Eos, cough, ale an antissthmatic combination reg producto, ch « monograph i boing Eleveloped as part of the OTC drug review. The tentative final monograph (Droposed rule) for these products was Published in the Federal Register of ‘gust 12196689 FR 0828) The sary isnt aac of ny OT marketing of any combination product oataling promethazine hydrochloride Manufacturers of prescsption promethazine products bave voluntarily greed to withhold OTC marketing at Ns time, FDA public advisory committee snectinge may have at many as four feparable portion: (a) An open public hearing (2) an open committee discussion, (3) aelosed presentation of Sata, and () a closed comaitee Sciberation very advisory committee ‘meeting shalt have an open public heering potion. Whether or nti also Includes any ofthe other three potions will depend upon the speciio meeting Involved. There are no closed portions for the meetings announced inthis notice. The dates and times reserved for the open portions of each committee Decng alse shove open peblichearisg portion of ach meeting shall be atleast | hour long unless public participation does not last tat long. It Is emphasized however, thatthe 1 hour time lit for en ope public hearing representa minimum Fether than aaximum tine for public Participation, and an open public Reering may iat for whatover longer Beriod the committe chalzperson Setormines wil facitate the conta’ work Public bearings are subject to PDA's suldline (Subpart Cof 21 CFR Purt 10) ‘concerning the policy and procedures for electronic media coverage of FDA public administrative proceedings, Including hearings before public advisory committees under 21 CFR Part 14, Under 21 CER 10,206, representatives of the electronic media may be permitted, subject to certain limitations, to videotape, film, or otherwise record FDA's public administrative proceadings, including presentations by Participants Meetings of advisory committees shall be conducted, insofar accordance with the agenda published in this Federal Register notice. Changes in the agenda will be announced at the beginning of the open portion af a meeting. Any interested person who wishes to bbe assured of the right to make an oral presentation at the open public hearing portion of a meeting shal inform the contact person listed above, either ‘orally or in writing, prior to the meeting, Any person attending the hearing who does not in advance of the meeting request an opportunity to speak will be ‘allowed to make an oral presentation at the hearing’s conclusion, if time permits, at the chairperson's discretion. Persons interested in specific agenda items to be discussed in open session. ‘may ascertain from the contact person the approximate time of discussion. Details on the agenda, questions to be ‘addressed by the committes, and a ‘current list of committee members are ‘available from the contact person before ‘and after the meeting. Transcripts of the ‘pen portion of the meeting will be available from the Freedom of Information Office (HEI-35), Food and Drag Administration, Rm. 12A~16, 5500. Fishers Lane, Rookville, MD 20857, approximately 15 working days after the ‘meeting, at a cost of 10 cents per page. ‘The transcript may be viewed at the Dockets Management Branch (HFA~ 306}, Food and Drug Administration, Rm, 4-82, 5600 Fishers Lane, Rockuille, MD 20887, approximately 18 working days after the meoting, between the hours of 9 ‘am. and 4 pm. Monday through Friday, ‘Summary minutes of the open portion of the meeting will be available from the Freedom of Information Office (address shove) beginning approximately 90 daye after the meeting. ‘This notice is issued under section 10(@)(2) end (2) of the Federal Advisory Committee Act (Pub. L. 92-649, 66 Stat. 720-778 (6 US.C. App. I), and FDA‘ regulations (21 CFR Part 14) on advisory. committees. Date uly 10,1000, ‘Alan L Hosting, Acting Associate Commiesioner for Regulatory Affairs {FR Doe. 09-16702 Filed 7-12-68 214 pm) Public Heaith Service Health Resources and Services ‘Administration; Native Hawalian Health Gare Act of 1988; Delegation of Authority Notice is hereby given that i furtherance of the delegation of authority of June 14, 1960, from the Assistant Secretary for Health ta the Administrator, Health Resources and Services Administration, the Administrator has redelegeted all of the aathorities delegated to him under the Native Hawaiian Health Care Act of 11088, as amended hereafter, o the Director, Bureau of Health Care Delivery ‘and Assistance. Excluded was the authority to issue regulations and to submit reporis to the Congress. Redolegation These authorities may be redelegated. Effective Date ‘This delegation became effective on July 6, 1880. John EL Kelso, Acting Administator ate July 6 1089, (FR Doc. 69-10518 Filed 7-15-80; 64 oma} mG Cooe eee Social Security Administration Agency Forms Submitted to the Office. of Management and Buciget tor Clearance Bach Friday the Social Security ‘Administration publishes a list of information collection packages that have been submitted to the Office of ‘Management and Budget (OMB) for clearance in compliance with Pub. L. 96 511, The Paperwork Reduction Act. The following clearance packages have been submitted to OMB since the last list was, published in the Federal Register on June 30, 1980, (Call Reports Clearance Officer on (901) 265 4149 for copies of package) 1. Pain Instrument Development ‘Studies-—New—The information collected by these forms will be used by the Social Security Administration to develop and refine final information collection forms which will be used