(8) Poison ity, poison oak, or poison sumac dermatitiz An allergic wane dlormatiis (usualy an intensely lenieg skin rash) due to exposure to ante of the genus Rus (poison Ivy: poison ook, Polson sumac), which contata uusivola potent skinseneitzing soeat, 3, Section 347,10 is amended by adding new paragrapha (0) () (0, (gi aide hema adding new paragraphs (1) and (1) to read av follows: $347.10 kin protectant active Ingredients. (0)-{5) (Reserved (1) Colloidal oatmeat. (0) Sodium bicarbonate, 1 to 100 pervent. 4. Soction 347.50 is amended by adding an introductory text paregeaph, by revising paragraph (a), by adding now paragraph (b)(4), by revising Paragraphs (c)(1), (c}(2), and (e}3}, by ‘adding new paragraph {c}(9), and by ‘eviing paragraph (@) to read ao $347.50 Labeling of ekin protectant drug products, Pave more than one labled use. When ict eg, (2) "Skin protectant." (@) For products containing ony Angrodient in § 47.10 (8), (c) a), (), (), (mi. “Poison ivy, oak, sumac drying’ (insert dosage form, eg. “cream,” lotion,” or “ointment™ (8) For products containing any ‘ingredient in § 947.10 1), () (a) (4), (0, (2). (9, or (uj. "Poison vy oak, sumac treatment.” won (4) For products containing aay ingredient in § 347.10 (1) and (4) “Provides temporary skin protection and relioves minor iritation and itching due to poison ivy, poison oak, poison sumag ‘and inseet bites." (9) “Avoid contact withthe eyes." (2) “Ifcondition worsens or dows not {improve within? days, consulta doctor” (9) For products containieg any ingredient in § 94710 a). (D5 (01 (9), (o), (ah. (0.0) 09.08). tm) and “Por extersal use only> (9) For products containing colloidal oatmeal identified in $947.10) when labeled forse os a soak ino tub, Take special care o avoid slipping when gelling into and out of the tab {4) Directions. The labeling ofthe Product contains the followin formation ender the head Directions”: ae (0) For products containing an fngredient in §947 20 (ah. (8 (0 (2, (fyi). (8 0,0) (8). DoF (nh. Apply liberally as often as necessary, (2) For products containing cooidat 2atmneal identified in $947 100) Adults tnd children 2 years of ago and oven For use as.a soak ina tah: Turn wb wast water faveet onto fll ores then slowly sprinkle 1 cupful of colloidal oatmeal directly under th fave nto the tab Before entering the tu assay colloidal oatmeal that may have seed to the bottom ofthe tub. Soak the alfected ares for 35 to 20 minutes as needed. Do not rub aren dry, but instead Dat dry o that a thn ayer ofthe colloidal oatmea! wil be eft on the skin, Soak once or twice daly, or as directed by your doctor. Children under 2 youre, of age: Consult a doctor {9) For products containing sodium bicarbonate identified in $395 tofu) Adults and children 2 yours of ape ond over Topical dosage ig 1 to 100 poseost sodium bicarbonate. (@ Forse as paste, Add sufficient water tothe sodiam bicarbonate ta form 4 paste and apply to tho affected sree of the skin as needed. Children undor 2 years of age: Consilta doctor (i) Far so as a 00k in a tub Dissolve to 2 cupfls ofthis product in atub of warm water and soak for a0 te 40 minutos us needed. Do not rob doy. but instead pat dry eo that atin lance ofthe sodium bicarbonate will be let on the skin. Children under 2 years ef ago Consult 2 doctor il, For use a8 a wet dressing. Ada soditin bicarbonate to water to make a solution. Use w container in which pou Gan saturate w cloth, Saturate s closes Soft white cloth each asa diaper on torn sheet) inthe solution, gently squeeze, and apply loosely to iy alfected area. Saturate the cots in the solution every 15 to 30 minutes and apply to the affected area. Repeat as often as necessary, Discard remaining solution after use, Dated: August 25, 1080, Frank E. Young, Commissioner of Food and Drugs {FR Doo. 09-292n2 Filed 10-2-09; 848 am} ee 21CFR Part 340 (Docket No. 78N-201P} FIN 0905-AAOS. External Analgesic Drug Products for ‘Over-the-Counter Human Use; Proposed Rulemaking for Polson Ivy, Poison Oak, Poison Sumac, and Insect Bites Drug Products ‘AGENCY: Food and Drug Administration, tice of proposed rulemaking ‘SumuanY: The Food and Drug ‘Administration (FDA) is issuing a notice of proposed rulemaking amending the tentative final monograph {proposed rule) for over-the-counter (OTC) external analgesic drug products. The Proposed rulemaking would establish Conditions under which OTC extersal analgesic drug products for the treatment of the symptoms of poison ivy, poison oak, poison sumacy and insect bites are generally recognized as safe and effective and not misbranded. FDA, {s issuing this notice of proposed rulemaking after considering the statements on OTC drug products for poison ivy, poison oak, and polson ‘sumac, and for use as insect bite novtralizers of the Advisory Review Panel on OTC Miscellaneous External Drug Products, public comments on on advance notice of proposed rulemaking that was based on those statements, and public comments on the notice of FR 5852) The agency's propos, conceming the use of ther OT drug Droducts fer the treatment andjor prevention of poison Ivy, pelson oak fnd poison sumac and for the treatment and/or neutralisation of inset bites are being published elsewhere io this tue, of the Fdoral Rogstor. Tee propocale fre part ofthe ongolng review of OT og products conducted by FDA DATES: Whitton comment, cbjections, or fess for fl eat one roposed rulemaking betorethe Commissioner of Foe and Drop byOctober 3, 1989 / Proposed Rules 40819 January 31, 1990. The agency is allowing a period of 120 days for comments and Objections instead of the normal 00 days forthe following reasons: (1) The concurrent publication of two rulemakings regarding OTC drug products for poison ivy, poison oak, poison sumac, and insect bites and (2) this document contains the first published evaluation of several submissions of data on OTC drug products for the treatment of symptoms bf these conditions that were made to, but not reviewed by, the Advisory Review Panel on OTC Miscellaneous External Drug Products (Miscellaneous External Panel). New data by October 3, +1680, Comments on the new data by December 3, 2990, Written comments on the agency's economic impact determination by January 31, 1990. ‘AvonEss: Written comments, objections, new data, of requests for oral hearing to the Dockets Management Branch (HFA~ 305), Food and Drug Administration, Rr. 4-62, 5600 Fishers Lane, Rockville, MD 20087. FOR FURTHER INFORMATION CONTACT: William E, Gilbertson, Center for Drug Evaluation and Rosearch (HFD-210), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301— 295-8000, SUPPLEMENTARY INFORMATION: Inthe Federal Register of September 7, 1962, EDA published, under § 890.10(2)(6) (21, CER 830.10(a)(6)). advance notices of proposed rulemalking and reopened the Ruministrative reeards for OTC extemal ‘analgesic drug products (47 FR 30412}, fend skin protectant drug products (47 FR 30496), The notices were published to allow for consideration of statements on OTC drug products forthe prevention of poison ivy, poison oak, poison sumac, tnd for use as insect bite neutralizers. ‘Tho statements were prepared by the Miscellaneous External Panel, which ‘was the advisory review panel responsible for evaluating data on the ‘active ingredients used for these ‘conditions, Interested persons were Invited to submit comments by December 6, 1982. Reply comments in response fo comments filed in the initial ‘comment period could be submitted by January 5, 1983, in the Fedoral Register of December 28, 1962 (47 FR 57738), in response to & request for an extension of ime, the Comment period and reply comment period for OTC external analgesic drug products were extended to February 4, ‘Yoga, and to March 7, 1983, respectively. Tn accordance with § 390.10(8}(10), the data and information considered by the Panel were put on public display in the Dockets Management Branch (address above), after deletion of a small amount of trade secret information. (One trade association and five drug ‘manufacturers submitted comments concerning the use of external analgesic, ‘tug products for poison ivy, poisen oak, jon sumac, and insect bites (poison Ivy-oak-sumac and insect bites). Some of these comments were submitted to both the extemal analgesic and skin protectant rulemakings. In those cases ‘where the same comments were ‘submitted to both rulemakings, th Comments will be addsessed only in the ‘appropriate amendment to either the proposed rule for OTC external [Snalgesic drug products or for OTC skin protectant drug products published Elsewhere is this sue of the Federal Register. Copies of the comments received are on public display in the Dockets Management Branch. “The Panel provided general statements on OTC drug products for ‘he prevention of polson ivy, poison oak, poison sumac, and for use as insect bite heutzalizers, However, the Panel did not review all of the submitted individual ingredients nor develop labeling for drug products for these indications. Also, the Panel reviewed only ingredients with labeling claims for prevention of poison ivy, poison oak, or poison sumac, oF for treatment of insect bites by neutralization or inactivation of insect ‘venom, However, many submissions to the Panel were for drug products used to treat the symptoms (ic. itching, minor irritations) of poison ivy-oak-sumac and Insect bites by the mechanism of depressing or stimulating cuianeous sensory receptors. Additionally, a umber of external analgeste drag products labeled for the treatment of olson ivy-oak-sumac and insect bites twere not submitted to the Miscellaneous ‘External Panel, Therefore, the agency is ‘expanding the scope of this segment of the external analgesic rulemaking to include sll OTC extemal analges products labeled for any of thes In this document, the agency ing drug producto for th bf poison Ivy-oak-sumac and insect bites When the mechanism of action involves the depression or stimulation of cutaneous sensory receptors. inthe skin protectant rulemaking (published Elsewhere in this iseue of the Federal Register, the agency is addressing the ‘sims for the treatment and/or ‘prevention of poison ivy, poison oak, fnd poison sumac and for the treatm tend/or neutralization of insect bites ‘when the mechanism of action for these Claus involves the ingrediont’s ability fo neutralize or inactivate insect venom ot the ingredient’s ablity to provide a ‘mechanism barrio to protect the exposed skin surfaces from harmful or ‘annoying stimuli In the Federal Register of February 8, 4983 (48 FR 5852), the agency published € tentative final monograph (proposed tule] for OTC extemal analgesic drug products, The agency issued this notice bfter considering the report and recommendations of the Advisory Review Panel on OTC Topical ‘Analgeste, Anticheumatic, Otic, Burn, ‘and Sunburn Prevention and Treatment Drug Products (Topical Analgesic Panel) ‘and public comments on an advance notice of proposed rulemaking that was ‘based on those recommendations. Interested persons were invited to submit comments by April 11, 1989; new Gata by February 8, 1964, and comments fon new data by April 9, 1984. In response to that notice, one manufacturer's association and five drug manufacturers submitted comments concerning the uee of extorna! snalgesic {ngredients for the treatment of poison ivy-oak-sumac and insect bites. The agency is also addressing these ‘Comments in this notice of proposed rulemaking, Copies of the comments received are on public display in the ‘Dockets Management Branch (address above). In this notice of proposed rulemaking. FDA responds to public comment and further discusses its position on OTC external analgesic drug products for the freatment of poison ivy-oak-sumac and insect bites. Final agency action on this ‘matter will occur with the publication at fa future date ofa final rule relating to (OTC external analgesic drug preducts for the treatment of these conditions. ‘The OTC drug procedural regulations (21 CER 320.10) now provide that any testing necessary to resolve the safety or effectiveness issues that formerly resulted in a Category Il classification, fend submission to FDA of the results of that testing ot any other data, must be one during the OTC drug rulemaking process before the establishment of @ final monograph. Accordingly, FDA, no longer use the terms "Category I {generally recognized as safe and effective and not misbranded). “Category Il” (not generally recognized as gefe and effective or misbranded), fand "Category III” (available data are inoulficient to classify as safe and tffective, and further testing is required) ft the final monograph stage, but will tse instead the terms "monograph ‘oonditions” (old Category I) an “nonmonograph conditions” (old Categories Il and I}. This document retains the concepts of Categories I I,40820 Foderal Register / Vc No. 190 / Tue: October 3, 1989 / Proposed Rules ‘and I stage. ‘The agency advises that the conditions under which the drug products that are subject to this monograph would be generally. eoognized as safe and effective and not tisbranded (monograph conditions) will be effective 12 months after the date of ublication of the final monograph in the Federal Register. On or after that date, ‘no OTC drug product that is subject to the monograph and that cont ‘nonmonograph condition, condition that would cause the drug to be not generally recognized as safe and cffoctive or to be misbranded, may be initially introduced or intially delivered {for introduction into interstate commerce unless it ie the subject of an ‘approved application. Further, {drug product subject to this monograph that is repackaged or relabeled after the elfective date of the monograph must be ‘in compliance with the monograph regardless of the date the product was initially introduced or initially delivered for introduction into interstate ‘commerce. Manufacturers are ‘encouraged to comply voluntarily with ‘the monograph at the earliest possible final monograph the agency determines that ny labeling for a condition included fy tho final monograph should be implemented ifa safety problem identified for a particular nonmonograph Condition, a shorter deadline may be set {for removal ofthat condition from OTC. drug products, All “OTC Volumes” cited throughout this document refer to the submissions made by interested persons pursuant (0 the call-for-data notices published in the Federal Register on December 12,1972 (87 FR 26490), Novernber 16, 1973 (08 FR 51697), and August 27, 1975 (40 FR 36176), orto additional information that thas come to the agency's attention since Publication of the advance notices of roposed rulamaking. The volumes are on public display in the Dockets, Management Branch (address above), 1. The Agency's Tentative Conclusions ‘on the Comments, ‘The agency has reviewed the comments submitted to this rulemaking, As noted above, most of the comments ‘were also submitted to the shin protectant rulemaking. Several of those comments are general in scope and will be addressed in this rulemaking for extemal analgesic drug products, Any of these general comments that are ‘applicable to the akin protectant es Soeecemin Soe podedmerime,,, published in th feral Register on can cunanes, dosteae tem eae, Saeco, a a ote ero ‘appear in the specific wording established under the OTC drug ‘monograph or other regulation where exact language has been established and identified by quotation marks, e., 21 GFR 201.69 oF 330.1(2. The proposed rule in this document is subject to the labeling provisions of § 2301(¢)(2). 3. Two comments in response to the tentative final monograph for OTC external analgesic drug products (48 FR 15652) requested that specific indications for rashes caused by poison ivy be added to the monograph. One comment stated that the phrase “and rashes due to poison ivy, poison oak, or poison sumac’ should be added to the indication “for the temporary relief of ftching associated with sunburn, insect bites, or minor skin irritations.” The ‘comment requested that the agency revise this indication for extemal analgesic ingredients identified in $948.10 (a), (b), and (c) to read “For the temporary relief of" (select one of the following: hing.” or “pain ‘and itching”) whick may be followed by: “associated with” (select one or more of the following: “minor burns,” “sunburn, pes,” “insect bites’ “minor skin irritations,” oF “rashes due to poison ivy, poison oak, or poison sumac’), The comment used th example of Category I combination products containing an external ‘analgesic (antihistamine) and a skin protectant to eupport ite request. The ‘comment noted that the agency proposed the indication "Dries the ‘oozing and weeping of poison ivy. poison oak, and poison sumac" in the skin protectant tentative final monograph (February 15, 1963; 48 FR {820 at 6532). According to the comment, the purpose of e combination product ‘containing a topfeal antihistamine ard & skin protectant is both to help d poison ivy, poison oak, or poison sumac lesions and to relieve the iteh associated ‘with these conditions. The comment largued thet not permitting an indication for the elief of itch associated with rashes due to poison ivy, poison oak, and poison sumac in the external ‘analgesic monograph is not only inconsistent with the allowed combination but also misleading and ‘would cause confusion to consumers. ‘The second comment stated that the proposed indication for extemal analgesic ingredients identified in $45.20 (a), (b), and (o) of the tentative final monogreph is too restrletive for the broad range of uses for these products ‘The comment proposed the following as fan example of a truthful statement that is an appropriete indication for extornal analgesic drug products: “For the