Federal Register/Vol. 85, No. 224/Thursday, November 19, 2020/Notices PRODUCTS—Continued

73726 Federal Register / Vol. 85, No. 224 / Thursday, November 19, 2020 / Notices information on the cover sheet and not guidances are posted on FDA’s website TABLE 2—REVISED DRAFT PRODUCT- in the body of your comments and you and announced periodically in the SPECIFIC GUIDANCES FOR DRUG must identify this information as Federal Register. The public is PRODUCTS—Continued ‘‘confidential.’’ Any information marked encouraged to submit comments on as ‘‘confidential’’ will not be disclosed those recommendations within 60 days Active ingredient(s) except in accordance with 21 CFR 10.20 of their announcement in the Federal and other applicable disclosure law. For Register. FDA considers any comments Fluphenazine hydrochloride more information about FDA’s posting received and either publishes final Hydrocortisone acetate of comments to public dockets, see 80 guidances or publishes revised draft Isotretinoin (multiple referenced listed drugs) Levorphanol tartrate FR 56469, September 18, 2015, or access guidances for comment. Guidances were Lomitapide mesylate the information at: https:// last announced in the Federal Register Methylphenidate hydrochloride www.govinfo.gov/content/pkg/FR-2015- on August 26, 2020. This notice Pimavanserin tartrate 09-18/pdf/2015-23389.pdf. announces draft product-specific Propranolol hydrochloride (multiple ref- Docket: For access to the docket to guidances, either new or revised, that erenced listed drugs) read background documents or the are posted on FDA’s website. Tofacitinib citrate electronic and written/paper comments II. Drug Products For Which New Draft received, go to https:// For a complete history of previously Product-Specific Guidances Are www.regulations.gov and insert the published Federal Register notices Available docket number, found in brackets in the related to product-specific guidances, go heading of this document, into the FDA is announcing the availability of to https://www.regulations.gov and ‘‘Search’’ box and follow the prompts new draft product-specific guidances for enter Docket No. FDA–2007–D–0369. and/or go to the Dockets Management industry for drug products containing These draft guidances are being Staff, 5630 Fishers Lane, Rm. 1061, the following active ingredients: issued consistent with FDA’s good Rockville, MD 20852, 240–402–7500. guidance practices regulation (21 CFR You may submit comments on any TABLE 1—NEW DRAFT PRODUCT-SPE- 10.115). These draft guidances, when guidance at any time (see 21 CFR CIFIC GUIDANCES FOR DRUG PROD- finalized, will represent the current 10.115(g)(5)). UCTS thinking of FDA on, among other things, Submit written requests for single the product-specific design of BE copies of the draft guidances to the Active ingredient(s) studies to support ANDAs. They do not Division of Drug Information, Center for establish any rights for any person and Drug Evaluation and Research, Food Ceritinib are not binding on FDA or the public. Clobazam and Drug Administration, 10001 New You can use an alternative approach if Crofelemer it satisfies the requirements of the Hampshire Ave., Hillandale Building, Diazepam 4th Floor, Silver Spring, MD 20993– Epinephrine applicable statutes and regulations. 0002. Send one self-addressed adhesive Fluorodopa F–18 IV. Paperwork Reduction Act of 1995 label to assist that office in processing Lefamulin acetate FDA tentatively concludes that this your requests. See the SUPPLEMENTARY Naloxone hydrochloride; Oxycodone hydro- draft guidance contains no collection of INFORMATION section for electronic chloride Pretomanid information. Therefore, clearance by the access to the draft guidance documents. Prochlorperazine maleate Office of Management and Budget under FOR FURTHER INFORMATION CONTACT: Tafamidis the Paperwork Reduction Act of 1995 is Mara Miller, Center for Drug Evaluation Tafamidis meglumine not required. and Research, Food and Drug Vancomycin hydrochloride Administration, 10903 New Hampshire V. Electronic Access Ave., Bldg. 75, Rm. 4709C, Silver III. Drug Products For Which Revised Persons with access to the internet Spring, MD 20993–0002, 301–796–0683. Draft Product-Specific Guidances Are may obtain the draft guidances at either SUPPLEMENTARY INFORMATION: Available https://www.fda.gov/drugs/guidancecompliance-regulatory-information/ I. Background FDA is announcing the availability of revised draft product-specific guidances guidances-drugs or https:// In the Federal Register of June 11, for industry for drug products www.regulations.gov. 2010 (75 FR 33311), FDA announced the containing the following active Dated: November 13, 2020. availability of a guidance for industry ingredients: Lauren K. Roth, entitled ‘‘Bioequivalence Acting Principal Associate Commissioner for Recommendations for Specific TABLE 2—REVISED DRAFT PRODUCT- Policy. Products’’ that explained the process SPECIFIC GUIDANCES FOR DRUG [FR Doc. 2020–25602 Filed 11–18–20; 8:45 am] that would be used to make product- PRODUCTS specific guidances available to the BILLING CODE 4164–01–P public on FDA’s website at https:// Active ingredient(s) www.fda.gov/Drugs/ DEPARTMENT OF HEALTH AND GuidanceCompliance Azelaic acid HUMAN SERVICES RegulatoryInformation/Guidances/ Budesonide default.htm. Bupropion hydrochloride; Naltrexone hydro- Food and Drug Administration As described in that guidance, FDA chloride Calcipotriene [Docket No. FDA–2020–N–1394] adopted this process as a means to Clobetasol propionate develop and disseminate product- Desonide Richard M. Simon: Final Debarment specific guidances and provide a Erythromycin ethylsuccinate (multiple ref- Order meaningful opportunity for the public to erenced listed drugs) consider and comment on those Erythromycin ethylsuccinate; Sulfisoxazole AGENCY: Food and Drug Administration, guidances. Under that process, draft acetyl HHS. VerDate Sep<11>2014 19:40 Nov 18, 2020 Jkt 253001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 E:\FR\FM\19NON1.SGM 19NON1 Federal Register / Vol. 85, No. 224 / Thursday, November 19, 2020 / Notices 73727 ACTION: Notice. management positions, including been convicted of a felony under Regional Sales Manager for the Federal law for conduct otherwise SUMMARY: The Food and Drug Southeast Region and Vice President of relating to the regulation of a drug Administration (FDA or Agency) is Sales, of Insys Therapeutics Inc. (Insys), product under the FD&C Act. issuing an order under the Federal a Delaware Corporation, with As a result of the foregoing finding, Food, Drug, and Cosmetic Act (FD&C headquarters in Chandler, Arizona. Mr. Simon, is permanently debarred Act) permanently debarring Richard M. Insys developed and owned a drug Simon from providing services in any called SUBSYS, a liquid formulation of from providing services in any capacity capacity to a person that has an fentanyl to be applied under the tongue. to a person with an approved or approved or pending drug product FDA approved SUBSYS for the pending drug product application, application. FDA bases this order on a management of breakthrough pain in effective (see DATES) (see section finding that Richard M. Simon was adult cancer patients who are already 306(a)(2)(B) and (c)(2)(A)(ii) of the FD&C convicted of a felony under Federal law receiving and are already tolerant to Act). Any person with an approved or for conduct that relates to the regulation opioid therapy for their underlying pending drug product application who of a drug product under the FD&C Act. persistent cancer pain. From early 2012 knowingly employs or retains as a Mr. Simon was given notice of the and continuing through 2015, Mr. consultant or contractor, or otherwise proposed permanent debarment and an Simon participated in a conspiracy uses the services of Mr. Simon, in any opportunity to request a hearing to show whereby employees of Insys bribed capacity, during his debarment, will be why he should not be debarred. As of medical practitioners in various states to subject to civil money penalties (section August 6, 2020 (30 days after receipt of get those practitioners to increase 307(a)(6) of the FD&C Act (21 U.S.C. the notice), Mr. Simon had not prescribing SUBSYS to their patients, 335b(a)(6))). If Mr. Simon provides responded. Mr. Simon’s failure to many of whom did not have cancer. Mr. services in any capacity to a person with respond and request a hearing Simon, along with his co-conspirators, an approved or pending drug product constitutes a waiver of his right to a measured the effect of these bribes on application during his period of hearing concerning this action. each practitioner’s prescribing habits debarment, he will be subject to civil and on the revenue that each bribed DATES: This order is applicable money penalties (section 307(a)(7) of the practitioner generated for Insys. Mr. November 19, 2020. FD&C Act). In addition, FDA will not ADDRESSES: Submit applications for Simon, along with his co-conspirators, reduced or eliminated bribes paid to accept or review any abbreviated new special termination of debarment to the drug application from Mr. Simon during Dockets Management Staff (HFA–305), those practitioners who failed to meet the minimum prescription requirements his period of debarment, other than in Food and Drug Administration, 5630 connection with an audit under section Fishers Lane, Rm. 1061, Rockville, MD or failed to generate enough revenue to 306(c)(1)(B) of the FD&C Act. Note that, 20852, 240–402–7500. justify additional bribes. As a result of this conviction, FDA for purposes of section 306 of the FD&C FOR FURTHER INFORMATION CONTACT: sent Mr. Simon by certified mail on Act, a ‘‘drug product’’ is defined as a Jaime Espinosa, (ELEM–4029) Division August 3, 2020, a notice proposing to drug subject to regulation under section of Enforcement, Office of Strategic permanently debar him from providing 505, 512, or 802 of the FD&C Act (21 Planning and Operational Policy, Office services in any capacity to a person that U.S.C. 355, 360b, or 382) or under of Regulatory Affairs, Food and Drug has an approved or pending drug section 351 of the Public Health Service Administration, 12420 Parklawn Dr., product application.

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