10026 Federal Register / Vol. 80, No. 37 / Wednesday, February 25, 2015 / Proposed Rules TABLE 11a—UNIQUE PERSONS OVER PERCENTAGES OF PROPOSED POSITION LIMIT LEVELS, JANUARY 1, 2013, TO DECEMBER 31, 2014—Continued Unique persons over level Commodity type/core referenced futures contract Percent of Spot month level (physical- Spot month Single month All months delivery) (cash-settled) 80 49 63 7 9 100 31 44 (*) 6 500 — 5 — — NYMEX RBOB Gasoline (RB) ............................................. 60 97 57 26 30 80 67 52 15 17 100 36 37 11 12 500 — (*) — — Metals COMEX Copper (HG) .......................................................... 60 12 — 61 62 80 9 — 37 40 100 4 — 29 30 COMEX Gold (GC) .............................................................. 60 13 — 22 24 80 9 — 14 14 100 5 — 10 11 COMEX Silver (SI) ............................................................... 60 9 — 34 32 80 4 — 20 21 100 (*) — 16 16 NYMEX Palladium (PA) ....................................................... 60 9 — 12 13 80 5 — 9 5 100 (*) — 4 4 NYMEX Platinum (PL) ......................................................... 60 11 — 29 29 80 7 — 18 18 100 (*) — 9 9 Legend: * means fewer than 4 unique owners exceeded the level. — means no unique owner exceeded the level. NA means not applicable.14 Both comment periods will reopen on DEPARTMENT OF HEALTH AND because the currently available data are February 26, 2015, and will close on HUMAN SERVICES insufficient to classify it as GRASE and March 28, 2015. not misbranded, and additional Food and Drug Administration information is needed to allow us to Issued in Washington, DC, on February 19, determine otherwise. 2015, by the Commission. 21 CFR Part 310 Christopher J. Kirkpatrick, DATES: Submit either electronic or [Docket Nos. FDA–2003–N–0196 (Formerly written comments on this proposed Secretary of the Commission. 2003N–0233), FDA–1978–N–0018 (Formerly order by April 13, 2015. Sponsors may Note: The following appendix will not 1978N–0038 and 78N–0038), and FDA–1996– submit written requests for a meeting N–0006 (Formerly 96N–0277)] appear in the Code of Federal Regulations. with FDA to discuss this proposed order Over-the-Counter Sunscreen Drug by March 27, 2015. See section VI for Appendix to Position Limits for Products—Regulatory Status of the proposed effective date of a final Derivatives and Aggregation of Enzacamene order based on this proposed order. Positions Reopening of Comment ADDRESSES: You may submit comments Periods—Commission Voting Summary AGENCY: Food and Drug Administration, by any of the following methods: HHS. On this matter, Chairman Massad and ACTION: Proposed order; request for Electronic Submissions Commissioners Wetjen, Bowen, and comments. Submit electronic comments in the Giancarlo voted in the affirmative. No following way: Commissioner voted in the negative. SUMMARY: The Food and Drug Administration (FDA or the Agency) is • Federal eRulemaking Portal: http:// [FR Doc. 2015–03834 Filed 2–24–15; 8:45 am] issuing a proposed sunscreen order www.regulations.gov. Follow the BILLING CODE 6351–01–P (proposed order) under the Federal instructions for submitting comments. Food, Drug, and Cosmetic Act (the Written Submissions FD&C Act), as amended by the Sunscreen Innovation Act (SIA). The Submit written submissions in the proposed order announces FDA’s following ways: tentative determination that • Mail/Hand delivery/Courier (for 14 Table notes: (1) Aggregation exemptions were not used in computing the counts of unique enzacamene is not generally recognized paper submissions): Division of Dockets persons; (2) the position data was for futures, as safe and effective (GRASE) and is Management (HFA–305), Food and Drug futures options and swaps that are significant price misbranded when used in over-the- Administration, 5630 Fishers Lane, Rm. discovery contracts (SPDCs). counter (OTC) sunscreen products 1061, Rockville, MD 20852. VerDate Sep<11>2014 15:09 Feb 24, 2015 Jkt 235001 PO 00000 Frm 00019 Fmt 4702 Sfmt 4702 E:\FR\FM\25FEP1.SGM 25FEP1 wreier-aviles on DSK5TPTVN1PROD with PROPOSALS Federal Register / Vol. 80, No. 37 / Wednesday, February 25, 2015 / Proposed Rules 10027 Instructions: All submissions received to be marketed in the United States received, and for which a TEA feedback must clearly identify the specific active without an approved new drug letter had not yet been issued (section ingredient (enzacamene) and the Docket application (NDA) or abbreviated new 586C(b)(4) of the FD&C Act (21 U.S.C. Nos. FDA–2003–N–0196, FDA–1978–N– drug application (ANDA). Because this 360fff–3(b)(4)), as amended by the SIA). 0018, and FDA–1996–N–0006 for this proposed order specifically addresses an Other provisions of the SIA that are not rulemaking. All comments received may OTC sunscreen active ingredient discussed in this proposed order be posted without change to http:// (enzacamene), the remainder of this address procedures applicable to other www.regulations.gov, including any discussion will refer only to ‘‘active pending and future sunscreen active personal information provided. For ingredients.’’ ingredient GRASE determinations, additional information on submitting Critical steps in a proceeding under pending and future GRASE comments, see the ‘‘Comments’’ heading the TEA regulation include the determinations for OTC products other of the SUPPLEMENTARY INFORMATION following: (1) FDA’s determination that than sunscreens, issuance of specified section of this document. an active ingredient had been marketed guidances and reports, and completion Docket: For access to the docket to for the proposed OTC use for a material of pending sunscreen rulemakings, read background documents or time and to a material extent (eligibility among others. comments received, go to http:// determination), and public call for A proposed sunscreen order under the www.regulations.gov and insert the submission of safety and efficacy data, SIA is an order containing FDA’s docket numbers, found in brackets in followed by; (2) review of safety and tentative determination proposing that a the heading of this document, into the efficacy data submitted by the sponsor nonprescription sunscreen active ‘‘Search’’ box and follow the prompts or other interested parties; and (3) ingredient or combination of and/or go to the Division of Dockets FDA’s initial determination that the data ingredients: (1) Is GRASE and is not Management, 5630 Fishers Lane, Rm. show the active ingredient to be either misbranded when marketed in 1061, Rockville, MD 20852. GRASE or not GRASE for OTC use accordance with the proposed order; (2) Submit requests for a meeting with under the applicable monograph is not GRASE and is misbranded; or (3) FDA to discuss this proposed order to conditions (including any new is not GRASE and is misbranded Kristen Hardin (see FOR FURTHER conditions rising from FDA’s review) because the data are insufficient to INFORMATION CONTACT). (GRASE determination). Under the TEA classify the active ingredient or FOR FURTHER INFORMATION CONTACT: regulation, FDA’s GRASE combination of ingredients as GRASE Kristen Hardin, Division of determinations are effectuated through and not misbranded, and additional Nonprescription Drug Products, Center notice and comment rulemaking to information is necessary to allow FDA for Drug Evaluation and Research, Food amend or establish the appropriate to determine otherwise (section 586(7) and Drug Administration, 10903 New monograph. of the FD&C Act, as amended by the Hampshire Ave., Bldg. 22, Rm. 5491, The TEA process in FDA regulations SIA). Publication of a proposed Silver Spring, MD 20993–0002, 240– was supplemented by Congress’s sunscreen order triggers several 402–4246. enactment of the SIA. Among other timelines under the SIA, including a 45- SUPPLEMENTARY INFORMATION: amendments it makes to the FD&C Act, day public comment period, and a 30- the SIA creates new procedures I. Regulatory Background day period in which a sponsor may specifically for reviewing the safety and request a meeting with FDA to discuss A. Regulatory and Statutory Framework effectiveness of nonprescription the proposed order. sunscreen active ingredients, including The data and information addressed those, such as enzacamene, that were B. FDA’s Review of Enzacamene in this proposed order were originally the subject of pending TEA proceedings Buchanan Ingersoll submitted a TEA submitted for review under FDA’s Time at the time the SIA was enacted. Like and Extent Application (TEA) in 2002 on behalf of Merck KGaA under the TEA regulation, the SIA calls for an § 330.14(c) seeking OTC monograph regulation, § 330.14 (21 CFR 330.14), a initial eligibility determination phase process that has since been status for the sunscreen active for nonprescription sunscreen active ingredient enzacamene (also known as supplemented with new statutory ingredients, followed by submissions of procedures established in the SIA (Pub. 4-Methylbenzylidene Camphor (4-MBC) safety and efficacy data and a GRASE or Eusolex 6300) at concentrations up to L. 113–195), enacted November 26, determination phase. However, the SIA 2014. The discussion that follows 4 percent for use in OTC sunscreen requires FDA to make proposed and products (enzacamene TEA) (Note 1). briefly describes and compares the pre- final GRASE determinations for and post-SIA processes as they apply to FDA issued a TEA notice of eligibility nonprescription sunscreen active for enzacamene on July 11, 2003 (68 FR the regulatory status of enzacamene. ingredients in the