43210 Federal Register / Vol. 78, No. 139 / Friday, July 19, 2013 / Notices held on October 25, 2012. In selecting 3.1. Do your symptoms come and go? Patients who are interested in the disease areas, FDA carefully If so, do you know of anything that presenting comments as part of the considered the public comments makes your symptoms better? Worse? initial panel discussions will be asked received and the perspectives of its Topic 2: Patients’ perspectives on to indicate in their registration which review divisions. By the end of FY 2015, current approaches to treating topic(s) they wish to address. They will FDA will initiate another public process narcolepsy: also be asked to send a brief summary for determining the disease areas for FY 1. What are you currently doing to of responses to the topic questions to 2016–2017. More information, including help treat your condition or its [email protected]. Panelists the list of disease areas and a general symptoms? (Examples may include will be notified of their selection soon schedule of meetings, is posted on FDA-approved medicines, over-the- after the close of registration on FDA’s Web site at http://www.fda.gov/ counter products, and other therapies September 13, 2013. FDA will try to ForIndustry/UserFees/ including non-drug therapies such as accommodate all patients and patient PrescriptionDrugUserFee/ lifestyle modifications.) stakeholders who wish to speak, either ucm326192.htm. 1.1. What specific symptoms do your through the panel discussion or therapies address? audience participation; however, the II. Public Meeting Information 1.2. How has your treatment regimen duration of comments may be limited by A. Purpose and Scope of the Meeting changed over time, and why? time constraints. 2. How well does your current As part of Patient-Focused Drug Interested members of the public, treatment regimen treat the most including those who attend the meeting Development, FDA will gather patient significant symptoms of your disease? and patient stakeholder input on in person or through the webcast, are 2.1. How well do these therapies invited to provide electronic or written symptoms of narcolepsy that matter improve your ability to do specific most to patients and on current responses to the questions pertaining to activities that are important to you in Topics 1 and 2 to the public docket (see approaches to treating narcolepsy. your daily life? Narcolepsy is a chronic disorder of the ADDRESSES). Comments may be 2.2. How well have these therapies submitted until November 25, 2013. central nervous system caused by the worked for you as your condition has brain’s inability to control sleep-wake changed over time? Dated: July 15, 2013. cycles and is characterized by excessive 3. What are the most significant Leslie Kux, daytime sleepiness, cataplexy, downsides to your current therapies, Assistant Commissioner for Policy. hallucination, and disturbed nocturnal and how do they affect your daily life? [FR Doc. 2013–17327 Filed 7–18–13; 8:45 am] sleep. Although there is no cure for (Examples of downsides may include BILLING CODE 4160–01–P narcolepsy, medications and lifestyle bothersome side effects, inconvenient modifications can help patients manage dosing schedules, access issues, etc.) their symptoms. FDA is interested in 4. Assuming there is no complete cure DEPARTMENT OF HEALTH AND obtaining a better understanding of for your condition, what specific things HUMAN SERVICES patients’ perspectives on the severity of would you look for in an ideal therapy the disease and assessments of available for your condition? Food and Drug Administration therapies. [Docket No. FDA–2013–N–0845] The questions that will be asked of B. Meeting Attendance and/or patients and patient stakeholders at the Participation Bracco Diagnostics et al.; Withdrawal meeting are listed in this section, If you wish to attend this meeting, of Approval of 52 New Drug organized by topic. For each topic, a visit http://patientfocused Applications and 77 Abbreviated New brief patient panel discussion will begin narcolepsy.eventbrite.com. Please Drug Applications the dialogue, followed by a facilitated register by September 13, 2013. Those AGENCY: discussion inviting comments from who are unable to attend the meeting in Food and Drug Administration, other patient and patient stakeholder person can register to view a live HHS. participants. In addition to input webcast of the meeting. You will be ACTION: Notice. generated through this public meeting, asked to indicate in your registration SUMMARY: The Food and Drug FDA is interested in receiving patient whether you plan to attend in person or Administration (FDA) is withdrawing input addressing these questions via the webcast. Your registration approval of 52 new drug applications through the public docket (see should also contain your complete (NDAs) and 77 abbreviated new drug ADDRESSES). contact information, including name, applications (ANDAs) from multiple Topic 1: Disease symptoms and daily title, affiliation, address, email address, applicants. The holders of the impacts that matter most to patients: and phone number. applications notified the Agency in 1. Of all the symptoms that you Seating will be limited, so early writing that the drug products were no experience because of your condition, registration is recommended. longer marketed and requested that the which one to three symptoms have the Registration is free and will be on a first- approval of the applications be most significant impact on your life? come, first-served basis. However, FDA withdrawn. (Examples may include excessive may limit the number of participants daytime sleepiness, cataplexy, etc.) from each organization based on space DATES: Effective August 19, 2013. 2. Are there specific activities that are limitations. Registrants will receive FOR FURTHER INFORMATION CONTACT: important to you but that you cannot do confirmation once they have been Florine P. Purdie, Center for Drug at all or as fully as you would like accepted. Onsite registration on the day Evaluation and Research, Food and because of your condition? (Examples of of the meeting will be based on space Drug Administration, 10903 New activities may include sleeping through availability. If you need special Hampshire Ave., Bldg. 51, Rm. 6366, the night, work and school performance, accommodations because of disability, Silver Spring, MD 20993–0002, 301– etc.) please contact Pujita Vaidya (see FOR 796–3601. 3. How have your symptoms changed FURTHER INFORMATION CONTACT) at least 7 SUPPLEMENTARY INFORMATION: The over time? days before the meeting. holders of the applications listed in VerDate Mar<15>2010 15:33 Jul 18, 2013 Jkt 229001 PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 E:\FR\FM\19JYN1.SGM 19JYN1 emcdonald on DSK67QTVN1PROD with NOTICES Federal Register / Vol. 78, No. 139 / Friday, July 19, 2013 / Notices 43211 table 1 in this document have informed applications under the process in Withdrawal of approval of an FDA that these drug products are no § 314.150(c) (21 CFR 314.150(c)). The application or abbreviated application longer marketed and have requested that applicants have also, by their requests, under § 314.150(c) is without prejudice FDA withdraw approval of the waived their opportunity for a hearing. to refiling. TABLE 1 Application No. Drug Applicant NDA 011620 ............... Cardiografin (diatrizoate meglumine USP, 85%) Injection .. Bracco Diagnostics, 107 College Rd. East, Princeton, NJ 08540. NDA 012828 ............... Travase (sutilains) Ointment ................................................ Abbott Laboratories, PA 77/Bldg. AP30–1E, 200 Abbott Park Rd., Abbott Park, IL 60064–6157. NDA 014215 ............... Celestone (betamethasone) Oral Solution .......................... Merck Sharp & Dohme Corp., One Merck Dr., P.O. Box 100, Whitehouse Station, NJ 08889. NDA 014685 ............... Aventyl (nortriptyline hydrochloride (HCl) Oral Solution, 10 Ranbaxy Inc., U.S. Agent for Ranbaxy Laboratories Lim- milligrams (mg)/5 milliliters (mL). ited, 600 College Rd. East, Princeton, NJ 08540. NDA 014860............... Aralen Phosphate (chloroquine phosphate) with pri- Sanofi-Aventis U.S., LLC, 55 Corporate Dr., Bridgewater, maquine phosphate Tablets. NJ 08807–0890. NDA 016017 ............... Cloroquine-Primaquine (chloroquine phosphate and pri- Do. maquine phosphate) Tablets. NDA 016019 ............... Questran Resin (cholestyramine resin) ............................... Bristol-Myers Squibb Co., P.O. Box 4000, Princeton, NJ 08543–4000. NDA 016640 ............... Questran Powder (cholestyramine for oral suspension) ..... Do. NDA 016721 ............... Dalmane (flurazepam HCl) Capsules .................................. Valeant Pharmaceuticals North America, LLC, 700 Route 202/206 North, Bridgewater, NJ 08807. NDA 016732 ............... Talwin 50 (pentazocine HCl USP), Tablets, 50 mg ............ Sanofi-Aventis U.S., LLC. NDA 016891 ............... Talwin Compound (pentazocine HCl USP and aspirin Do. USP), Equivalent to (EQ) 12.5 mg (base) and 325 mg. NDA 016927 ............... Demulen 1/50–21 (ethynodiol diacetate/ethinyl estradiol) G.D. Searle, LLC, c/o Pfizer Inc., 235 East 42nd St., New Tablets. York, NY 10017. NDA 016936 ............... Demulen 1/50–28 (ethynodiol diacetate/ethinyl estradiol) Do. Tablets. NDA 017557 ............... Danocrine (danazol) Capsules ............................................ Sanofi-Aventis U.S., LLC. NDA 017633 ............... Glycine Irrigation USP, 1.5% ..............................................