DOCSLIB.ORG

Enzacamene Order Based on This Proposed Order

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Enzacamene Order Based on This Proposed Order 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
Load more

Recommended publications
  • Senate Passage Media Clips Report September 19, 2014
    Senate Passage Media Clips Report September 19, 2014 1. The Hill, September 17, 2014, Senate passes bill to improve sunscreen. By Ramsey Cox 2. TIME, September 17, 2014, Senate Passes Bill for Better Sunscreen. By Alexandra Sifferlin 3. The Daily Caller, September 18, 2014, Senate Bill Passes To End FDA Stranglehold On Sunscreen Innovation. By Jonah Bennet 4. Skin, Inc. September 19, 2014, 2014 Sunscreen Innovation Act Unanimously Passes. 5. Inside Health (Subscription), September 18, 2014, Sunscreen Legislation Backers Seek Swift Enactment After Senate Clears Bill. By Stephanie Beasley 6. Politico Pulse (Subscription), September 18, 2014, Sunscreen bill heads to the House now. 7. Politico Pulse (Subscription), September 18, 2014, HELP approve sunscreen bill. 8. Office of Senator Kay Hagan, September 19, 2014, Bipartisan Sunscreen Innovation Act Cosponsored by Hagan Passes the Senate. 9. Northwest Georgia News, September 18, 2014, Isakson applauds Senate passage of bipartisan bill to help prevent skin cancer. 10. Primer{TBR}, September 18, 2014, Senate Passes Sunscreen Innovation Act to Improve Sunscreen. 11. Smithsonian, September 18, 2014, The US Is Trying to Expedite Sunscreen Innovation. By Rachel Nuwer 12. Cosmetics & Toiletries, September 18, 2014, Sunscreen Innovation Act Passes: What Does it Mean? By Rachel Grahenhofer 13. Office of Senator Mitch McConnell (Press Release), September 18, 2014, McConnell- Sponsored Sunscreen Innovation Act Passes Senate. 14. MarketPlace, September 18, 2014, Your sunscreen is way out of date. By Nancy Marshall-Genzer 37#32748001_v1 15. Earthy Essence, September 18, 2014, 2014 Sunscreen Innovation Act Unanimously Passes. 16. Melanoma Research Alliance, September 17, 2014, MRA Applauds Senate Passage of the Sunscreen Innovation Act.
    [Show full text]
  • GAO-18-61, SUNSCREEN: FDA Reviewed Applications For
    United States Government Accountability Office Report to Congressional Committees November 2017 SUNSCREEN FDA Reviewed Applications for Additional Active Ingredients and Determined More Data Needed GAO-18-61 November 2017 SUNSCREEN FDA Reviewed Applications for Additional Active Ingredients and Determined More Data Needed Highlights of GAO-18-61, a report to congressional committees Why GAO Did This Study What GAO Found Using sunscreen as directed with other The Food and Drug Administration (FDA), within the Department of Health and sun protective measures may help Human Services, implemented requirements for reviewing applications for reduce the risk of skin cancer—the sunscreen active ingredients within time frames set by the Sunscreen Innovation most common form of cancer in the Act, which was enacted in November 2014. For example, the agency issued a United States. In the United States, guidance document on safety and effectiveness testing in November 2016. sunscreen is considered an over-the- counter drug, which is a drug available As of August 2017, all applications for sunscreen active ingredients remain to consumers without a prescription. pending after the agency determined more safety and effectiveness data are Some sunscreen active ingredients not needed. By February 2015, FDA completed its initial review of the safety and currently marketed in the United States effectiveness data for each of the eight pending applications, as required by the have been available in products in act. FDA concluded that additional data are needed to determine that the other countries for more than a ingredients are generally recognized as safe and effective (GRASE), which is decade. Companies that manufacture needed so that products using the ingredients can subsequently be marketed in some of these ingredients have sought the United States without FDA’s premarket approval.
    [Show full text]
  • Pdf; Chi 2015 DPP Air in Cars.Pdf; Dodson 2014 DPP Dust CA.Pdf; Kasper-Sonnenberg 2014 Phth Metabolites.Pdf; EU Cosmetics Regs 2009.Pdf
    Bouge, Cathy (ECY) From: Nancy Uding <[email protected]> Sent: Friday, January 13, 2017 10:24 AM To: Steward, Kara (ECY) Cc: Erika Schreder Subject: Comments re. 2016 CSPA Rule Update - DPP Attachments: DPP 131-18-0 exposure.pdf; Chi 2015 DPP air in cars.pdf; Dodson 2014 DPP dust CA.pdf; Kasper-Sonnenberg 2014 phth metabolites.pdf; EU Cosmetics Regs 2009.pdf Please accept these comments from Toxic-Free Future concerning the exposure potential of DPP for consideration during the 2016 CSPA Rule update. Regards, Nancy Uding -- Nancy Uding Grants & Research Specialist Toxic-Free Future 206-632-1545 ext.123 http://toxicfreefuture.org 1 JES-00888; No of Pages 9 JOURNAL OF ENVIRONMENTAL SCIENCES XX (2016) XXX– XXX Available online at www.sciencedirect.com ScienceDirect www.elsevier.com/locate/jes Determination of 15 phthalate esters in air by gas-phase and particle-phase simultaneous sampling Chenchen Chi1, Meng Xia1, Chen Zhou1, Xueqing Wang1,2, Mili Weng1,3, Xueyou Shen1,4,⁎ 1. College of Environmental & Resource Sciences, Zhejiang University, Hangzhou 310058, China 2. Zhejiang National Radiation Environmental Technology Co., Ltd., Hangzhou 310011, China 3. School of Environmental and Resource Sciences, Zhejiang Agriculture and Forestry University, Hangzhou 310058, China 4. Zhejiang Provincial Key Laboratory of Organic Pollution Process and Control, Hangzhou 310058, China ARTICLE INFO ABSTRACT Article history: Based on previous research, the sampling and analysis methods for phthalate esters (PAEs) Received 24 December 2015 were improved by increasing the sampling flow of indoor air from 1 to 4 L/min, shortening the Revised 14 January 2016 sampling duration from 8 to 2 hr.
    [Show full text]
  • New Sunscreen Approval — Why So Complicated?
    Watch Pages New Sunscreen Approval — Why So Complicated? Topically-applied sunscreen product use is a billion-dollar These popular sunscreens have been submitted to the industry. The use of these products over the last 40 US Food and Drug Administration (FDA) over the last 15 years has changed dramatically from a “niche” market of years for approval. The FDA has approved none of these fair-skinned individuals who used small amounts on an products — which are regulated as drugs in the US — irregular basis to the current market of a large swath of despite years of use in Europe, Asia, or Latin America, the adult and paediatric population, fair-skinned or not, where they are regulated as cosmetics. The last over-the- over larger areas of their bodies on a much more regular counter (OTC) sunscreen approved by the FDA was in the basis — in some cases, daily. late 1990s. That said, the agency has not rejected these products either. Benefits of sunscreen use (SPF 15+) are widely accepted: sunburn prevention, skin-aging reduction, and, Instead, the products are in a nebulous regulatory of particular importance, skin cancer risk reduction. The area due to their classification and lack of criteria to benefits and increased usage have resulted in demand determine the type of clinical data needed to prove they for and development of a wide array of new sunscreen are “generally recognised as safe and effective” (GRASE), products over the last 20 years. These modern products an essential designation needed for OTC approval. This offer enhanced protection against the ultraviolet A (UVA) designation is usually granted, and the drug thereby rays that play a larger part in skin cancer than was once regulated, under what is called the OTC drug monograph believed, as well as the traditional protection against process.
    [Show full text]
  • REGULATION (EC) No 1223/2009 of the EUROPEAN PARLIAMENT and of the COUNCIL of 30 November 2009 on Cosmetic Products (Recast) (Text with EEA Relevance)
    9002.21.22 NE Official Journal of the European Union L 342/59 REGULATION (EC) No 1223/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 30 November 2009 on cosmetic products (recast) (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EURO­ (5) The environmental concerns that substances used in cos­ PEAN UNION, metic products may raise are considered through the appli­ cation of Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 con­ Having regard to the Treaty establishing the European Commu­ cerning the Registration, Evaluation, Authorisation and nity, and in particular Article 95 thereof, Restriction of Chemicals (REACH) and establishing a Euro­ pean Chemicals Agency (4), which enables the assessment of environmental safety in a cross-sectoral manner. Having regard to the proposal from the Commission, Having regard to the opinion of the European Economic and (6) This Regulation relates only to cosmetic products and not Social Committee (1), to medicinal products, medical devices or biocidal prod­ ucts. The delimitation follows in particular from the detailed definition of cosmetic products, which refers both Acting in accordance with the procedure laid down in Article 251 to their areas of application and to the purposes of their of the Treaty (2), use. Whereas: (7) The assessment of whether a product is a cosmetic prod­ uct has to be made on the basis of a case-by-case assess­ ment, taking into account all characteristics of the product. (1) Council Directive 76/768/EEC of 27 July 1976 on the Cosmetic products may include creams, emulsions, lotions, approximation of the laws of the Member States relating to gels and oils for the skin, face masks, tinted bases (liquids, cosmetic products (3) has been significantly amended on pastes, powders), make-up powders, after-bath powders, several occasions.
    [Show full text]
  • 2012/054071 Al
    (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date ft 26 April 2012 (26.04.2012) 2012/054071 Al (51) International Patent Classification: (81) Designated States (unless otherwise indicated, for every A61K 45/00 (2006.01) kind of national protection available): AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BR, BW, BY, BZ, (21) International Application Number: CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, DO, PCT/US20 11/001742 DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, (22) International Filing Date: HN, HR, HU, ID, IL, IN, IS, JP, KE, KG, KM, KN, KP, 12 October 201 1 (12.10.201 1) KR, KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, (25) Filing Language: English NO, NZ, OM, PE, PG, PH, PL, PT, QA, RO, RS, RU, (26) Publication Language: English RW, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, (30) Priority Data: ZM, ZW. 12/925,464 23 October 2010 (23.10.2010) US 13/233,012 14 September 201 1 (14.09.201 1) US (84) Designated States (unless otherwise indicated, for every kind of regional protection available): ARIPO (BW, GH, (72) Inventors; and GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, SZ, TZ, (71) Applicants : SCHLESSINGER, MD, Joel [US/US]; UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, MD, 632 N.
    [Show full text]
  • Investigation of Agonistic and Antagonistic Endocrine Activity During Full-Scale Ozonation of Waste Water
    Investigation of agonistic and antagonistic endocrine activity during full-scale ozonation of waste water Dissertation zur Erlangung des akademischen Grades eines Doktors der Naturwissenschaften – Dr. rer. nat. – vorgelegt von Fabian Itzel geboren in Moers Fakultät für Chemie der Universität Duisburg-Essen 2018 Die vorliegende Arbeit wurde im Zeitraum von September 2014 bis September 2018 im Arbeitskreis von Prof. Dr. Torsten C. Schmidt in der Fakultät für Chemie im Bereich Instrumentelle Analytische Chemie der Universität Duisburg-Essen durchgeführt. Tag der Disputation: 21.02.2019 Gutachter: Prof. Dr. Torsten C. Schmidt Prof. Dr. Elke Dopp Vorsitzender: Prof. Dr. Bettina Siebers I Summary The use of a wide variety of chemicals in our society, such as industrial chemicals, pharmaceuticals, personal care products, etc., leads to pollution of surface waters. Especially in densely populated urban areas such as the Ruhr catchment, sustainable water management poses a major challenge. Despite intensive use through various types of discharges (effluents of direct dischargers, municipal waste water treatment plants, industry, etc.), good water quality has always to be guaranteed in accordance to the European Water Framewor Directive. Endocrine disrupting chemicals can have an effect on aquatic organisms even at very low concentrations (pg/L range). In order to reduce the emission, ozonation was investigated as advanced waste water treatment for the elimination of organic trace compounds. An elimination performance of ≥ 80% for selected substances at specific ozone doses in the range of zspec. = 0.3 - 0.7 mgO3/mgDOC was achieved. Since 2015, estrogens are listed on the watch-list of the European Water Framework Directive with required detection limits in the pg/L range.
    [Show full text]
  • Perspective: Protect the USA From
    OUTLOOK MELANOMA PERSPECTIVE Protect the USA from UVA The United States does not have access to the latest sunscreens. The Sunscreen Innovation Act could set that right, says Michael J. Werner. ccording to the Skin Cancer Foundation, more than 3.5 mil- pending sunscreen ingredients, the FDA argued that the approval lion skin cancers and 76,000 melanomas are diagnosed each in a comparable jurisdiction, such as the EU, and experience of safe year in the United States, and, on average, one person dies marketing is insufficient to support the approval of a sunscreen ingre- Afrom melanoma every hour. As with most diseases, the best way to dient in the United States. Rather, the FDA would like companies to fight melanoma is to prevent it. Unfortunately, the latest sunscreen perform additional safety testing unique to the United States. This ingredients that can help to reduce the risk of melanoma and other might include studies of dermal safety, ‘bioavailability’, carcinogenicity, skin cancers have languished for decades awaiting approval from the developmental and reproductive toxicity, and toxicokinetics. The FDA US Food and Drug Administration (FDA). acknowledged that some of these tests would take at least two years. The ultraviolet (UV) filters in sunscreen work by absorbing, reflect- The FDA’s sluggish regulatory response prompted the forma- ing or scattering the UV light emitted by the Sun. UVA radiation, tion of the Public Access to Sunscreens (PASS) Coalition in March which represents roughly 90% of UV radiation, can accelerate skin 2013, for which I am a policy adviser. The coalition’s mission is to ageing, cause skin damage and create a risk of skin cancer by damaging work with the FDA, Congress, the White House, health providers DNA.
    [Show full text]
  • (12) United States Patent (10) Patent No.: US 8,158,152 B2 Palepu (45) Date of Patent: Apr
    US008158152B2 (12) United States Patent (10) Patent No.: US 8,158,152 B2 Palepu (45) Date of Patent: Apr. 17, 2012 (54) LYOPHILIZATION PROCESS AND 6,884,422 B1 4/2005 Liu et al. PRODUCTS OBTANED THEREBY 6,900, 184 B2 5/2005 Cohen et al. 2002fOO 10357 A1 1/2002 Stogniew etal. 2002/009 1270 A1 7, 2002 Wu et al. (75) Inventor: Nageswara R. Palepu. Mill Creek, WA 2002/0143038 A1 10/2002 Bandyopadhyay et al. (US) 2002fO155097 A1 10, 2002 Te 2003, OO68416 A1 4/2003 Burgess et al. 2003/0077321 A1 4/2003 Kiel et al. (73) Assignee: SciDose LLC, Amherst, MA (US) 2003, OO82236 A1 5/2003 Mathiowitz et al. 2003/0096378 A1 5/2003 Qiu et al. (*) Notice: Subject to any disclaimer, the term of this 2003/OO96797 A1 5/2003 Stogniew et al. patent is extended or adjusted under 35 2003.01.1331.6 A1 6/2003 Kaisheva et al. U.S.C. 154(b) by 1560 days. 2003. O191157 A1 10, 2003 Doen 2003/0202978 A1 10, 2003 Maa et al. 2003/0211042 A1 11/2003 Evans (21) Appl. No.: 11/282,507 2003/0229027 A1 12/2003 Eissens et al. 2004.0005351 A1 1/2004 Kwon (22) Filed: Nov. 18, 2005 2004/0042971 A1 3/2004 Truong-Le et al. 2004/0042972 A1 3/2004 Truong-Le et al. (65) Prior Publication Data 2004.0043042 A1 3/2004 Johnson et al. 2004/OO57927 A1 3/2004 Warne et al. US 2007/O116729 A1 May 24, 2007 2004, OO63792 A1 4/2004 Khera et al.
    [Show full text]
  • Federal Register/Vol. 84, No. 38/Tuesday, February 26, 2019
    6204 Federal Register / Vol. 84, No. 38 / Tuesday, February 26, 2019 / Proposed Rules DEPARTMENT OF HEALTH AND the public. Similarly, if your submission 1978–N–0018 (formerly Docket No. HUMAN SERVICES includes safety and effectiveness data or FDA–1978–N–0038) for ‘‘Sunscreen information marked as confidential by a Drug Products for Over-the-Counter Food and Drug Administration third party (such as a contract research Human Use.’’ Received comments, those organization or consultant), you should filed in a timely manner (see 21 CFR Parts 201, 310, 347, and 352 either include a statement that you are ADDRESSES), will be placed in the docket [Docket No. FDA–1978–N–0018] (Formerly authorized to make the information and, except for those submitted as Docket No. FDA–1978–N–0038) publicly available or include an ‘‘Confidential Submissions,’’ publicly authorization from the third party viewable at https://www.regulations.gov RIN 0910–AF43 permitting the information to be or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday Sunscreen Drug Products for Over-the- publicly disclosed. If you submit data through Friday. Counter Human Use without confidential markings in response to this document and such • Confidential Submissions—To AGENCY: Food and Drug Administration, data includes studies or other submit a comment with confidential HHS. information that were previously information that you do not wish to be made publicly available, submit your ACTION: Proposed rule. submitted confidentially (e.g., as part of a new drug application), FDA intends to comments only as a written/paper SUMMARY: The Food and Drug presume that you intend to make such submission.
    [Show full text]
  • Estudo Dos Extratos Apolares De Dichotomaria Marginata, Acanthophora Spicifera, Cladophora Prolifera, Lobophora Variegata; Identificação De Sesquiterpenos
    Angelica Nunes Garcia Macroalgas e poluentes marinhos: estudo dos extratos apolares de Dichotomaria marginata, Acanthophora spicifera, Cladophora prolifera, Lobophora variegata; identificação de sesquiterpenos em Dictyopteris delicatula Tese apresentada ao Instituto de Botânica da Secretaria do Meio Ambiente, como parte dos requisitos exigidos para a obtenção do título de DOUTOR em BIODIVERSIDADE VEGETAL E MEIO AMBIENTE, na Área de Concentração de Plantas Avasculares e Fungos em Análises Ambientais. São Paulo 2019 Angelica Nunes Garcia Macroalgas e poluentes marinhos: estudo dos extratos apolares de Dichotomaria marginata, Acanthophora spicifera, Cladophora prolifera, Lobophora variegata; identificação de sesquiterpenos em Dictyopteris delicatula Tese apresentada ao Instituto de Botânica da Secretaria do Meio Ambiente, como parte dos requisitos exigidos para a obtenção do título de DOUTOR em BIODIVERSIDADE VEGETAL E MEIO AMBIENTE, na Área de Concentração de Plantas Avasculares e Fungos em Análises Ambientais. Orientadora: Dra. Luciana Retz de Carvalho Ficha Catalográfica elaborada pelo NÚCLEO DE BIBLIOTECA E MEMÓRIA Garcia, Angelica Nunes G215m Macroalgas e poluentes marinhos: estudo dos extratos apolares de Dichotomaria marginata, Acanthophora spicifera, Cladophora prolifera, Lobophora variegata; identificação de sesquiterpenos em Dictyopteris deliculata / Angelica Nunes Garcia -- São Paulo, 2019. 171p.; il. Tese (Doutorado) -- Instituto de Botânica da Secretaria de Infraestrutura e Meio Ambiente, 2019. Bibliografia. 1. Bioindicadores de poluição. 2. Contaminantes aquáticos. 3. Metabolitos algais. I. Título. CDU: 582.26 Dedico este trabalho, em especial, ao meu filho Augusto, por ser uma fonte de inspiração e alegria, aos meus pais Roberto e Sonia e ao meu marido Rodrigo. O motivo pelo qual a vida acadêmica é tão atrativa é porque se resume em 99% de árduo trabalho e de somente 1% de mágica purpurina; mas esse 1% é muuuuito bommm!!!! “Autor desconhecido” AGRADECIMENTOS Agradeço em especial à minha orientadora-amiga Dra.
    [Show full text]
  • Towards Single System for Total Water Analysis. LC-MS/MS Screening of 325 PPCP Contaminants in Tap and Surface Water
    ThP082 Towards Single System for Total Water Analysis. LC-MS/MS screening of 325 PPCP Contaminants in Tap and Surface Water. Aurore JAFFUEL1, Mikael LEVI1, Jun WATANABE1. 1 SHIMADZU Corporation, MS Business Unit, Kyoto, Japan. PPCP compounds of Surface Water best LOQ in [50-100] ppt. 1. Overview 4.1. Best Low Limits of Quantification (LLOQ). 10,11-Dihydrocarbamazepine Ceftriaxone Etoposide Oxolinic acid 4-Hydroxy Diclofenac Chlorhexidine Fosamprenavir Oxytetracycline Low limits of quantification (LLOQ) were evaluated and selected from the best Allopurinol Cytarabine Maduramicin Prednisolone Single system LC-MS/MS multi-method approach for the development of an Azelnipidine Esmolol Methylparaben Rifampicine easy access automated exhaustive water analysis tool. analytical condition for each compound. In Tap Water: 6% of the compounds Doxycycline Ethylparaben Norfloxacine Triclosan presented a LLOQ within 50-100ppt (ng/L), 18% within 3-30ppt and 71% had a PPCP compounds of Surface Water best LOQ in [3-30] ppt. 17a-Estradiol Chlorpromazine Josamycin Pravastatine LLOQ of below or equal to 1ppt, showing the high sensitivity of the methods. From 17a-Ethinylestradiol Ciprofloxacine Ketoprofen Pristinamycin IIA 2. Introduction the 304 compounds, 95% could be analyzed by at least one of the four methods, Acetaminophen Clarithromycin Marbofloxacine Propylparaben demonstrating the wide coverage of this technique (Figure 1.). In Surface Water: Acetazolamide Clorsulon Medroxyprogesterone Ribavirin There is growing concern over the exposure of humans to their chemical waste, Acetylsulfamethoxazole Closantel Mestranol Rociletinib 6% of the compounds presented a LLOQ within 50-100ppt (ng/L), 24% within 3- Afatinib Crizotinib Metaflumizone Ronidazole flushed down everyday in the conventional wastewater network: pesticides, 30ppt and 61% below or equal to 1ppt.
    [Show full text]