73178 Federal Register / Vol. 70, No. 236 / Friday, December 9, 2005 / Proposed Rules

chapter II, subchapter C, part 341 of the For the Board: 305), Food and Drug Administration, Code of Federal Regulations as follows: Beatrice Ezerski, 5630 Fishers Lane, rm. 1061, Rockville, Secretary to the Board. MD 20852. PART 341—STATUTORY LIEN WHERE [FR Doc. 05–23606 Filed 12–8–05; 8:45 am] To ensure more timely processing of SICKNESS BENEFITS PAID BILLING CODE 7905–01–P comments, FDA is no longer accepting comments submitted to the agency by e- 1. The authority citation for part 341 mail. FDA encourages you to continue continues to read as follows: DEPARTMENT OF HEALTH AND to submit electronic comments by using Authority: 45 U.S.C. 362(o). HUMAN SERVICES the Federal eRulemaking Portal or the agency Web site, as described in the 2. Revise § 341.6(a) introductory text Food and Drug Administration Electronic Submissions portion of this to read as follows: paragraph. § 341.6 Report of settlement or judgment. 21 CFR Parts 310 and 358 Instructions: All submissions received (a) When a person or company makes [Docket No. 2005N–0448] must include the agency name and a settlement or must satisfy a final RIN 0910–AF49 Docket No. 2005N–0448. All comments judgment based on an for which received may be posted without change the employee received sickness benefits, , Seborrheic , and to http://www.fda.gov/ohrms/dockets/ the person or company shall notify the Drug Products Containing default.htm, including any personal Board of the settlement or final and for Over-the- information provided. For additional judgment. That notice shall be in Counter Human Use; Proposed information on submitting comments, writing and submitted within five days Amendment to the Monograph see the ‘‘Comments’’ heading of the of the settlement or final judgment. A SUPPLEMENTARY INFORMATION section of AGENCY: railroad employer may fulfill the written Food and Drug Administration, this document. notice requirement by sending an HHS. Docket: For access to the docket to electronic message in the manner ACTION: Proposed rule. read background documents or prescribed by the agency. That comments received, go to http:// SUMMARY: The Food and Drug notification shall contain: www.fda.gov/dockets/default.htm and Administration (FDA) is issuing a insert the docket number, found in * * * * * proposed rule to amend the final brackets in the heading of this 3. Amend § 341.8 as follows: monograph (FM) for over-the-counter document, into the ‘‘Search’’ box and (OTC) dandruff, seborrheic dermatitis, a. Add a new sentence to the end of follow the prompts and/or go to the and psoriasis drug products to include paragraph (a); Division of Dockets Management, 5630 the combination of 1.8 percent coal tar b. Revise paragraph (b); and Fishers Lane, rm. 1061, Rockville, MD solution and 1.5 percent menthol in a 20852. c. Amend paragraph (c) by removing drug product to control the phrase ‘‘Division of Claims dandruff. FDA is issuing this proposed FOR FURTHER INFORMATION CONTACT: Operations’’ and adding the phrase rule after considering information Michael L. Koenig, Center for Drug ‘‘Sickness and Unemployment Benefits submitted in a citizen petition. This Evaluation and Research (HFD–560), Section’’ in its place. proposal is part of FDA’s ongoing Food and Drug Administration, 5600 The additions and revisions read as review of OTC drug products. Fishers Lane, Rockville, MD 20857, follows: DATES: Submit written or electronic 301–827–2222. comments by March 9, 2006. See section SUPPLEMENTARY INFORMATION: § 341.8 Termination of sickness benefits due to a settlement. IX of this document for the proposed I. Background effective date of any final rule that may (a) * * * A railroad employer may publish based on this proposal. In the Federal Register of December 4, file the required report by sending an ADDRESSES: You may submit comments, 1979 (44 FR 69768), FDA published an electronic message in the manner identified by Docket No. 2005N–0448 advance notice of proposed rulemaking prescribed by the agency. and RIN 0910–AF49, by any of the (ANPR) to establish a monograph for (b) A report of settlement shall be following methods: OTC external drug products. made to the Sickness and The ANPR includes the Electronic Submissions Unemployment Benefits Section and recommendations of the Advisory shall include the information required Submit electronic comments in the Review Panel on OTC Topical in § 341.6. Where the report is an oral following ways: Analgesic, Antirheumatic, Otic, , report, and the informant is neither the • Federal eRulemaking Portal: http:// and Prevention and Treatment employee nor his or her representative, www.regulations.gov. Follow the Drug Products (the Topical Analgesic the informant shall be told that written instructions for submitting comments. Panel). The Topical Analgesic Panel confirmation containing the information • Agency Web site: http:// concluded that menthol is safe and called for by § 341.6 must be submitted www.fda.gov/dockets/ecomments. effective for use as an OTC external to the Board within 5 days from the date Follow the instructions for submitting (anti-) ingredient in of the oral report. A railroad employer comments on the agency Web site. concentrations of 1.0 percent or less and as a topical counterirritant in may fulfill the written report Written Submissions requirement by sending an electronic concentrations exceeding 1.25 percent message in the manner prescribed by Submit written submissions in the up to 16 percent. In the Federal Register the agency. following ways: of February 8, 1983 (48 FR 5852), FDA’s • FAX: 301–827–6870. proposed monograph, or tentative final * * * * * • Mail/Hand delivery/Courier [For monograph (TFM), for OTC external Dated: November 30, 2005. paper, disk, or CD–ROM submissions]: analgesic drug products included By authority of the Board. Division of Dockets Management (HFA– menthol as an antipruritic ingredient at

VerDate Aug<31>2005 17:03 Dec 08, 2005 Jkt 208001 PO 00000 Frm 00012 Fmt 4702 Sfmt 4702 E:\FR\FM\09DEP1.SGM 09DEP1 Federal Register / Vol. 70, No. 236 / Friday, December 9, 2005 / Proposed Rules 73179

concentrations from 0.1 percent to 1.0 shampoo drug product to relieve scalp FDA is proposing that labeling for this percent. itching associated with dandruff. The combination in proposed § 358.760 be In the Federal Register of December 3, petitioner subsequently clarified that as follows: 1982 (47 FR 54646), FDA published an the coal tar concentration of 9 percent • Statement of identity: ‘‘dandruff/ ANPR to establish a monograph for OTC was actually 9 percent, on a volume-to- anti-itch shampoo’’ or ‘‘antidandruff/ dandruff, seborrheic dermatitis, and volume basis, of a 20 percent coal tar anti-itch shampoo’’ (proposed psoriasis drug products. The ANPR solution, on a weight-to-volume basis. § 358.760(a)(1)) includes the recommendations of the Thus, the final concentration of the coal • Indication: ‘‘[bullet] [select one of Advisory Review Panel on OTC tar solution used in the study was 1.8 the following: ‘for relief of’ or ‘controls’] Miscellaneous External Drug Products percent on a weight-to-volume basis the symptoms of dandruff [bullet] (the Miscellaneous External Panel) (Ref. 3). The petition includes results of [select one of the following: ‘additional’ concerning OTC drug products for the a three-arm clinical study evaluating the or ‘extra’] relief of itching due to control of dandruff, seborrheic effectiveness of the ingredients in dandruff’’ (proposed § 358.760(b)(1) and dermatitis, and psoriasis. The (b)(2)) combination compared to 1.8 percent • Miscellaneous External Panel coal tar alone and 1.5 percent menthol Warnings: those listed in recommended coal tar preparations as alone. Both menthol alone and the § 358.750(c)(1) and (c)(2) (proposed safe and effective for use as combination of coal tar and menthol § 358.760(c)) • Directions: ‘‘[bullet] wet hair for controlling dandruff. The provided additional itch relief at 5, 15, [bullet] apply shampoo and work into a Miscellaneous External Panel also and 30 minutes over coal tar alone, and lather [bullet] rinse thoroughly [bullet] concluded that menthol is safe at the difference in itch relief was for best results, use at least twice a week concentrations of 0.04 to 1.5 percent, statistically significant (p ≤ 0.05). The or as directed by a doctor’’ (proposed but that there were insufficient study did not examine relief of scaling effectiveness data to include it in the § 358.760(d)(1)) (i.e., control of dandruff). FDA FDA believes the proposed labeling monograph for controlling dandruff. tentatively concludes that this study The Miscellaneous External Panel for coal tar-menthol combination drug supports the combination of 1.8 percent products reflects the scientific data, further noted that the temporary relief of coal tar solution and 1.5 percent itching does not amount to control of which demonstrate the combination menthol in a shampoo to provide more provides additional itch relief over coal dandruff. or additional relief of itching associated In the Federal Register of July 30, tar alone. FDA proposes a statement of with dandruff over 1.8 percent coal tar identity for this product that reflects the 1986 (51 FR 27346), FDA published its alone. FDA’s detailed comments and TFM for OTC dandruff, seborrheic antidandruff action of coal tar as well as evaluation of the study are on file in the the anti-itch action of menthol. When dermatitis, and psoriasis drug products. Division of Dockets Management (Ref. No new information was submitted for comparing coal tar products labeled as 4). menthol. Therefore, menthol was not ‘‘dandruff shampoo’’ with combination included in the TFM. III. FDA’s Proposal coal tar-menthol products labeled as In the Federal Register of December 4, ‘‘dandruff/anti-itch shampoo,’’ 1991 (56 FR 63554), FDA issued an FM Based on the study submitted in the consumers will be informed that the for OTC dandruff, seborrheic dermatitis, petition and FDA’s previous conclusion combination products contain menthol and psoriasis drug products in part 358, that coal tar is GRASE for the control of for more itch relief than provided by subpart H (21 CFR part 358, subpart H). dandruff, FDA believes the combination coal tar alone. The FM included discussion of a study of 1.8 percent coal tar and 1.5 percent FDA also proposes to include this comparing a shampoo product menthol in a shampoo is GRASE to additional anti-itch action under the containing the combination of 9 percent control dandruff and relieve itching ‘‘Uses’’ heading in the Drug Facts coal tar solution and 1.5 percent associated with dandruff. FDA proposes labeling. FDA is proposing a similar menthol versus a shampoo containing to include this new combination in indication statement for coal tar- only the coal tar for relieving scalp § 358.720 and remove the combination menthol combination products as that itching associated with dandruff (Ref. from § 310.545(d)(3). Because data on a included in the dandruff monograph for 1). FDA determined that the study had range of concentrations for coal tar and other coal tar products (§ 358.750(b)). In a number of major flaws and did not menthol have not been submitted, FDA addition, FDA proposes a second demonstrate that the combination is proposing to amend the FM to indication statement for coal tar- product offers any advantage over the include only the concentration of each menthol combination products only: product containing only coal tar (56 FR active ingredient used in the study. ‘‘[bullet] [select one of the following: 63554 at 63562 to 63564). Therefore, Although the 1.5 percent concentration ‘additional’ or ‘extra’] relief of itching FDA concluded that the coal tar- for menthol exceeds the 1.0 percent due to dandruff’’. This indication menthol combination is not generally maximum currently proposed for the reflects the data from the submitted recognized as safe and effective ingredient as an antipruritic (see study (Ref. 2) by informing consumers (GRASE) for the control of dandruff and proposed § 348.10(b)(6), 48 FR 5852 at that the combination product provides placed this combination in a list of 5867), this use of menthol is different, more itch relief than coal tar alone. active ingredients found not to be because the product will be applied to Because the warnings for menthol in GRASE (21 CFR 310.545(d)(3)). hair that has been thoroughly wetted the proposed rule for OTC external and subsequently rinsed. Furthermore, analgesic drug products (48 FR 5852 at II. FDA’s Tentative Conclusions on the the menthol is likely diluted to below 5868) are similar to those for coal tar in Petition 1.0 percent concentration immediately. the dandruff monograph (§ 358.750(c)(1) In 1993, FDA received a petition (Ref. FDA is not proposing menthol as a and (c)(2)), FDA proposes the same 2) to amend the FM for OTC dandruff, single active ingredient for the control warnings for the combination as for coal seborrheic dermatitis, and psoriasis or relief of symptoms of dandruff tar alone. The directions proposed for drug products to include the because FDA has not received any data the combination product specify that combination of 9 percent coal tar demonstrating that menthol alone is the product be a shampoo applied to solution and 1.5 percent menthol in a GRASE for this indication. wetted hair and thoroughly removed

VerDate Aug<31>2005 17:03 Dec 08, 2005 Jkt 208001 PO 00000 Frm 00013 Fmt 4702 Sfmt 4702 E:\FR\FM\09DEP1.SGM 09DEP1 73180 Federal Register / Vol. 70, No. 236 / Friday, December 9, 2005 / Proposed Rules

from the scalp after brief exposure. FDA The purpose of this proposed rule is VII. Federalism is not proposing to include formulations to allow an additional combination of FDA has analyzed this proposed rule that are applied and left on the or active ingredients for OTC antidandruff in accordance with the principles set scalp (e.g., creams, ointments, lotions, drug products. Manufacturers can forth in Executive Order 13132. FDA or hairgrooms) because FDA has only reformulate their OTC antidandruff drug has determined that the proposed rule reviewed safety and effectiveness data products that contain coal tar to include does not contain policies that have for coal tar-menthol combination drug the combination or can manufacture a substantial direct effects on the States, products in a shampoo. new combination product containing on the relationship between the IV. Analysis of Impacts coal tar and menthol. Reformulating or National Government and the States, or manufacturing a new combination on the distribution of power and FDA has examined the impacts of the product might result in additional proposed rule under Executive Order responsibilities among the various product sales but, in either case, is levels of government. Accordingly, FDA 12866 and the Regulatory Flexibility Act completely optional. Thus, this (5 U.S.C. 601–612), and the Unfunded tentatively concludes that the proposed proposed rule will not impose a rule does not contain policies that have Mandates Reform Act of 1995 (Public significant economic burden on affected Law 104–4). Executive Order 12866 federalism implications as defined in entities. Therefore, FDA certifies that the Executive order and, consequently, directs agencies to assess all costs and this proposed rule will not have a benefits of available regulatory a federalism summary impact statement significant economic impact on a has not been prepared. alternatives and, when regulation is substantial number of small entities. No necessary, to select regulatory further analysis is required under the VIII. Request for Comment approaches that maximize net benefits Regulatory Flexibility Act (5 U.S.C. Interested persons may submit to the (including potential economic, 605(b)). environmental, public health and safety, Division of Dockets Management (see FDA invites public comment ADDRESSES and other advantages; distributive ) written or electronic regarding any substantial or significant impacts; and equity). Under the comments regarding this proposal and Regulatory Flexibility Act, if a rule may economic impact that this proposed rule on FDA’s economic impact have a significant economic impact on would have on manufacturers of OTC determination. Submit a single copy of a substantial number of small entities, drug products for the control of electronic comments or two paper an agency must analyze regulatory dandruff. Types of impact may include, copies of any mailed comments, except options that would minimize any but are not limited to, costs associated that individuals may submit one paper significant impact of the rule on small with manufacturing, labeling, or copy. Comments are to be identified entities. repackaging. Comments regarding the with the docket number found in Section 202(a) of the Unfunded impact of this proposed rule should be brackets in the heading of this Mandates Reform Act of 1995 requires accompanied by appropriate document. Received comments may be that agencies prepare a written documentation. FDA is providing a seen in the Division of Dockets statement, which includes an period of 90 days, from the date of Management between 9 a.m. and 4 p.m., assessment of costs and benefits, before publication of this proposed rule in the Monday through Friday. Federal Register, to develop and submit proposing ‘‘any rule that includes any IX. Proposed Effective Date Federal mandate that may result in the comments on this subject. FDA will expenditure by State, local, and tribal evaluate any comments and supporting FDA is proposing that any final rule governments, in the aggregate, or by the data that are received and will reassess that may issue based on this proposal private sector, of $100 million or more the economic impact of this proposed become effective 30 days after its date (adjusted annually for inflation) in any rule in the preamble to the final rule. of publication in the Federal Register. one year.’’ V. Paperwork Reduction Act of 1995 X. References FDA tentatively concludes that this proposed rule is consistent with the FDA tentatively concludes that the The following references are on principles set out in Executive Order labeling requirements proposed in this display in the Division of Dockets 12866 and in these two statutes. This document are not subject to review by Management (see ADDRESSES) under proposed rule is not a significant the Office of Management and Budget Docket No. 1982N–0214 and may be regulatory action as defined by the because they do not constitute a seen by interested persons between 9 Executive order and so is not subject to ‘‘collection of information’’ under the a.m. and 4 p.m., Monday through review under the Executive order. As Paperwork Reduction Act of 1995 (44 Friday. discussed in this section of the U.S.C. 3501 et seq.). Rather, the 1. Comment No. RPT. document, FDA has tentatively proposed labeling statements are a 2. Comment No. PR 1. determined that this proposed rule will ‘‘public disclosure of information 3. Comment No. LET 13. not have significant economic impact on originally supplied by the Federal 4. Comment No. LET 14. a substantial number of small entities Government to the recipient for the List of Subjects under the Regulatory Flexibility Act. purpose of disclosure to the public’’ (5 The Unfunded Mandates Reform Act CFR 1320.3(c)(2)). 21 CFR Part 310 does not require FDA to prepare a Administrative practice and VI. Environmental Impact statement of costs and benefits for this procedure, Drugs, Labeling, Medical proposed rule because the proposed rule FDA has determined under 21 CFR devices, Reporting and recordkeeping is not expected to result in any 1-year 25.31(a) that this action is of a type that requirements. expenditure that would meet or exceed does not individually or cumulatively 21 CFR Part 358 $100 million adjusted for inflation. The have a significant effect on the human current threshold after adjustment for environment. Therefore, neither an Labeling, Over-the-counter drugs. inflation is about $115 million, using environmental assessment nor an Therefore, under the Federal Food, the most current (2003) Implicit Price environmental impact statement is Drug, and Cosmetic Act and under Deflator for the Gross Domestic Product. required. authority delegated to the Commissioner

VerDate Aug<31>2005 17:03 Dec 08, 2005 Jkt 208001 PO 00000 Frm 00014 Fmt 4702 Sfmt 4702 E:\FR\FM\09DEP1.SGM 09DEP1 Federal Register / Vol. 70, No. 236 / Friday, December 9, 2005 / Proposed Rules 73181

of Food and Drugs, it is proposed that respectively, applicable to each (c) Warnings. The labeling of the 21 CFR parts 310 and 358 be amended ingredient in the product may be product states, under the heading as follows: combined to eliminate duplicative ‘‘Warnings,’’ the warning(s) listed in words or phrases so that the resulting § 358.750(c)(1) and (c)(2). PART 310—NEW DRUGS information is clear and understandable. (d) Directions. The labeling of the 1. The authority citation for 21 CFR (a) Statement of identity. For a product states, under the heading part 310 continues to read as follows: combination drug product that has an ‘‘Directions,’’ directions that conform to established name, the labeling of the the directions established for each Authority: 21 U.S.C. 321, 331, 351, 352, product states the established name of ingredient in the directions sections of 353, 355, 360b–360f, 360j, 361(a), 371, 374, the combination drug product, followed the applicable OTC drug monographs, 375, 379e; 42 U.S.C. 216, 241, 242(a), 262, 263b–263n. by the statement of identity for each unless otherwise stated in this 2. Section 310.545 is amended by ingredient in the combination, as paragraph (d). When the time intervals revising paragraph (d)(3) to read as established in the statement of identity or age limitations for administration of follows: sections of the applicable OTC drug the individual ingredients differ, the monographs. directions for the combination product § 310.545 Drug products containing may not contain any dosage that certain active ingredients offered over-the- (1) Combinations of control of exceeds those established for any counter (OTC) for certain uses. dandruff and external analgesic active individual ingredient in the applicable * * * * * ingredients in § 358.720(b). The label OTC drug monograph(s), and may not (d) * * * states ‘‘dandruff/anti-itch shampoo’’ or provide for use by any age group lower (3) December 4, 1992, for products ‘‘antidandruff/anti-itch shampoo’’. than the highest minimum age limit subject to paragraph (a)(7) of this section (2) [Reserved] established for any individual that contain menthol as an antipruritic (b) Indications. The labeling of the ingredient. in combination with the antidandruff product states, under the heading ingredient coal tar identified in ‘‘Uses,’’ one or more of the phrases (1) Combinations of control of § 358.710(a)(1) of this chapter. This listed in this paragraph (b), as dandruff and external analgesic active section does not apply to products appropriate. Other truthful and ingredients in § 358.720(b). The labeling allowed by § 358.720(b) of this chapter nonmisleading statements, describing states ‘‘[bullet] wet hair [bullet] apply after January 9, 2006. only the uses that have been established shampoo and work into a lather [bullet] * * * * * and listed in this paragraph (b), may rinse thoroughly [bullet] for best results, also be used, as provided in § 330.1(c)(2) use at least twice a week or as directed PART 358—MISCELLANEOUS of this chapter, subject to the provisions by a doctor’’. EXTERNAL DRUG PRODUCTS FOR of section 502 of the Federal Food, Drug, (2) [Reserved] OVER-THE-COUNTER HUMAN USE and Cosmetic Act (the act) relating to Dated: December 5, 2005. misbranding and the prohibition in 3. The authority citation for 21 CFR section 301(d) of the act against the Jeffrey Shuren, part 358 continues to read as follows: introduction or delivery for introduction Assistant Commissioner for Policy. Authority: 21 U.S.C. 321, 351, 352, 353, into interstate commerce of unapproved [FR Doc. 05–23839 Filed 12–8–05; 8:45 am] 355, 360, 371. new drugs in violation of section 505(a) BILLING CODE 4160–01–S 4. Section 358.720 is revised to read of the act. as follows: (1) Combinations of control of § 358.720 Permitted combinations of dandruff and external analgesic active DEPARTMENT OF DEFENSE active ingredients. ingredients in § 358.720(b). The labeling Department of the Army (a) Combination of active ingredients states ‘‘[bullet] [select one of the following: ‘for relief of’ or ‘controls’] the for the control of dandruff. Salicylic 32 CFR Part 635 acid identified in § 358.710(a)(4) may be symptoms of dandruff [bullet] [select combined with sulfur identified in one of the following: ‘additional’ or RIN 0702–AA52–U § 358.710(a)(6) provided each ingredient ‘extra’] relief of itching due to is present within the established dandruff’’. Law Enforcement Reporting concentration and the product is labeled (2) The following terms or phrases AGENCY: Department of the Army, DoD. according to § 358.750. ACTION: Proposed rule. (b) Combination of control of dandruff may be used in place of or in addition to the words ‘‘for relief of’’ or ‘‘controls’’ and external analgesic active SUMMARY: The Department of the Army ingredients. Coal tar identified in in the indications in paragraph (b)(1) of this section: ‘‘fights,’’ ‘‘reduces,’’ ‘‘helps proposes to amend its regulation § 358.710(a)(1) may be used at a concerning law enforcement reporting, concentration of 1.8 percent coal tar eliminate,’’ ‘‘helps stop,’’ ‘‘controls recurrence of,’’ ‘‘fights recurrence of,’’ to implement portions of section solution, on a weight-to-volume basis, 577(b)(5) of the Ronald W. Reagan in combination with menthol, 1.5 ‘‘helps prevent recurrence of,’’ ‘‘reduces recurrence of,’’ ‘‘helps eliminate National Defense Authorization Act for percent, in a shampoo formulation Fiscal Year 2005, October 28, 2004, Pub. provided the product is labeled recurrence of,’’ ‘‘helps stop recurrence of’’. L. 108–375, pertaining to reporting of according to § 358.760. sexual assaults. This revision also 5. New § 358.760 is added to subpart (3) The following terms may be used implements Department of Defense H to read as follows: in place of the words ‘‘the symptoms of’’ policy concerning sexual assault. § 358.760 Labeling of permitted in the indication in paragraph (b)(1) of DATES: Comments submitted to the combinations of active ingredients for the this section: ‘‘scalp’’ (select one or more address below on or before January 9, control of dandruff. of the following: ‘‘itching,’’ ‘‘,’’ 2006 will be considered. The statement of identity, indications, ‘‘redness,’’ ‘‘flaking,’’ ‘‘scaling’’) ADDRESSES: You may submit comments, warnings, and directions for use, ‘‘associated with’’. identified by ‘‘32 CFR Part 635 and RIN

VerDate Aug<31>2005 17:03 Dec 08, 2005 Jkt 208001 PO 00000 Frm 00015 Fmt 4702 Sfmt 4702 E:\FR\FM\09DEP1.SGM 09DEP1