57000 Federal Register / Vol. 80, No. 182 / Monday, September 21, 2015 / Notices

DEPARTMENT OF HEALTH AND Guide Sec. 100.101 Crotalaria spp. The draft CPG, when finalized, will HUMAN SERVICES Seeds in Grain.’’ We previously represent our current thinking on provided guidance on Crotalaria Crotalaria spp. seeds in grains. It does Food and Drug Administration spectabilis and Crotalaria striata seeds not create or confer any rights for or on [Docket No. FDA–2015–D–2994] in grains in a CPG entitled ‘‘Compliance any person and does not operate to bind Policy Guide 7126.15 Crotalaria Seeds FDA or the public. An alternate Draft Compliance Policy Guide in Grains and Feeds’’ (CPG 7126.15), approach may be used if such approach Crotalaria spp. Seeds in Grains; which we issued on December 1, 1980. satisfies the requirements of the Availability We revoked CPG 7126.15 on July 22, applicable statutes and regulations. 1994, because at the time we deemed II. Comments AGENCY: Food and Drug Administration, the CPG to be no longer relevant (59 FR HHS. 37498). However, because Crotalaria Interested persons may submit to the ACTION: Notice. plants persist in the agricultural Division of Dockets Management (see environment and still present a ADDRESSES) either electronic or written SUMMARY: The Food and Drug potential public health risk, we comments regarding the draft CPG. It is Administration (FDA or we) is continue to monitor grains for the only necessary to send one set of announcing the availability of a draft presence of Crotalaria spp. seeds. comments. Identify comments with the Compliance Policy Guide (CPG) entitled We are making available the draft CPG docket number found in brackets in the ‘‘Compliance Policy Guide Sec. 100.101 because the revocation of CPG 7126.15 heading of this document. Received Crotalaria spp. Seeds in Grains’’ (the in 1994 inadvertently affected comments may be seen in the Division draft CPG). The draft CPG, when interactions between FDA and the U.S. of Dockets Management between 9 a.m. finalized, will provide guidance for FDA Department of Agriculture’s (USDA’s) and 4 p.m., Monday through Friday and staff on our regulatory action guidance Federal Grain Inspection Service (FGIS). may be posted to the docket at http:// criteria for Crotalaria species (spp.) Under a Memorandum of www.regulations.gov. seeds in grains. Understanding between FDA and USDA III. Electronic Access DATES: Although you can comment on (MOU 225–80–2000; http:// any CPG at any time (see 21 CFR www.fda.gov/AboutFDA/ Persons with access to the Internet 10.115(g)(5)), to ensure that we consider PartnershipsCollaborations/ may obtain the draft CPG from FDA’s your comment on the draft CPG before MemorandaofUnderstandingMOUs/ Office of Regulatory Affairs Compliance we begin work on the final version of DomesticMOUs/ucm116312.htm), FGIS Policy Guide Revision/Update History the CPG, submit written or electronic reports to FDA’s district offices the page. It may be accessed at http:// comments on the draft CPG by results of FGIS’s analysis that may be www.fda.gov/ICECI/ November 20, 2015. actionable under the Federal Food, ComplianceManuals/ CompliancePolicyGuidanceManual/ ADDRESSES: Submit electronic Drug, and Cosmetic Act (the FD&C Act). default.htm or http:// comments on the draft CPG to http:// FGIS has been using the CPG 7126.15 www.regulations.gov. Always access an www.regulations.gov. Submit written criteria for reporting their analytical FDA guidance document by using comments on the draft CPG to the results relating to Crotalaria in grain to FDA’s Web site listed previously to find Division of Dockets Management (HFA– FDA. CPG 7126.25 established a regulatory the most current version of the 305), Food and Drug Administration, action criterion of ‘‘an average of at least guidance. 5630 Fishers Lane, Rm. 1061, Rockville, one whole seed of Crotalaria spectabilis MD 20852. Submit written requests for Dated: September 15, 2015. and/or Crotalaria striata per pound’’ of single copies of the draft CPG to the Leslie Kux, grain. In developing the draft CPG, we Office of Policy and Risk Management, Associate Commissioner for Policy. converted the unit of weight from Office of Regulatory Affairs, Office of pounds to kilograms because metric [FR Doc. 2015–23619 Filed 9–18–15; 8:45 am] Global Regulatory Operations and units of measurement (e.g., kilograms) BILLING CODE 4164–01–P Policy, Food and Drug Administration, are generally used for scientific 12420 Parklawn Dr., Rockville, MD calculations. The conversion from DEPARTMENT OF HEALTH AND 20857. Send two self-addressed ‘‘seeds per pound’’ to ‘‘seeds per HUMAN SERVICES adhesive labels to assist that office in kilogram’’ resulted in 2.2 seeds per processing your request, or fax your kilogram. Because the analytical method Food and Drug Administration request to 240–632–6861. See the is based on determining whole seeds, SUPPLEMENTARY INFORMATION section for we rounded 2.2 to the nearest number [Docket No. FDA–2007–D–0369] electronic access to the draft CPG. of whole seeds (i.e., 2 whole seeds). The FOR FURTHER INFORMATION CONTACT: draft CPG also refers to Crotalaria spp. Product-Specific Bioequivalence George C. Ziobro, Center for Food Safety seeds in grain instead of Crotalaria Recommendations; Draft and Revised and Applied Nutrition (HFS–316), Food spectabilis and Crotalaria striata Draft Guidances for Industry; and Drug Administration, 5100 Paint because it is impracticable to Availability Branch Pkwy., College Park, MD 20740, distinguish between Crotalaria seeds AGENCY: Food and Drug Administration, 240–402–1700; or Amber M. McCoig, based on species. Thus, the draft CPG HHS. Center for Veterinary Medicine (HFV– states that FDA may regard grain that ACTION: Notice. 230), Food and Drug Administration, contains more than two whole 7519 Standish Place, Rockville, MD Crotalaria spp. seeds per one kilogram SUMMARY: The Food and Drug 20855, 240–402–5556. of grain to be adulterated within the Administration (FDA or Agency) is SUPPLEMENTARY INFORMATION: meaning of section 402(a)(1) of the announcing the availability of FD&C Act (21 U.S.C. 342(a)(1)). additional draft and revised draft I. Background The draft CPG is being made available product-specific bioequivalence (BE) We are announcing the availability of consistent with FDA’s good guidance recommendations. The a draft CPG entitled ‘‘Compliance Policy practices regulation (21 CFR 10.115). recommendations provide product-

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specific guidance on the design of BE RegulatoryInformation/Guidances/ TABLE 1—NEW DRAFT PRODUCT-SPE- studies to support abbreviated new drug default.htm. CIFIC BE RECOMMENDATIONS FOR applications (ANDAs). In the Federal As described in that guidance, FDA DRUG PRODUCTS—Continued Register of June 11, 2010, FDA adopted this process as a means to announced the availability of a guidance develop and disseminate product- Ponatinib hydrochloride Rivaroxaban for industry entitled ‘‘Bioequivalence specific BE recommendations and Ruxolitinib phosphate Recommendations for Specific provide a meaningful opportunity for Suvorexant Products’’ that explained the process the public to consider and comment on Tasimelteon Tedizolid phosphate that would be used to make product- those recommendations. Under that Tramadol hydrochloride specific BE recommendations available process, draft recommendations are Trimipramine maleate to the public on FDA’s Web site. The BE posted on FDA’s Web site and recommendations identified in this announced periodically in the Federal III. Drug Products for Which Revised notice were developed using the process Register. The public is encouraged to Draft Product-Specific BE described in that guidance. submit comments on those Recommendations are Available recommendations within 60 days of DATES: Although you can comment on FDA is announcing the availability of their announcement in the Federal any guidance at any time (see 21 CFR a revised draft guidance for industry on Register. FDA considers any comments 10.115(g)(5)), to ensure that the Agency product-specific BE recommendations received and either publishes final considers your comments on these draft for drug products containing the recommendations or publishes revised and revised draft guidances before it following active ingredients: begins work on the final versions of the draft recommendations for comment. guidances, submit either electronic or Recommendations were last announced TABLE 2—REVISED DRAFT PRODUCT- in the Federal Register on June 30, 2015 written comments on the draft and SPECIFIC BE RECOMMENDATIONS (80 FR 37273). This notice announces revised draft product-specific BE FOR DRUG PRODUCTS recommendations listed in this notice draft product-specific by November 20, 2015. recommendations, either new or Acitretin revised, that are posted on FDA’s Web Amantadine hydrochloride ADDRESSES: Submit written requests for site. Benzonatate single copies of the individual BE Carbamazepine guidances to the Division of Drug II. Drug Products for Which New Draft Colesevelam hydrochloride Product-Specific BE Recommendations Cyclophosphamide Information, Center for Drug Evaluation Dabigatran etexilate mesylate and Research, Food and Drug are Available Dasatinib Administration, 10001 New Hampshire FDA is announcing the availability of Desvenlafaxine succinate Ave., Hillandale Bldg., 4th Floor, Silver Esomeprazole magnesium a new draft guidance for industry on Estradiol Spring, MD 20993–0002. Send one self- product-specific BE recommendations Ethinyl estradiol; Norethindrone addressed adhesive label to assist that for drug products containing the Gabapentin office in processing your requests. See following active ingredients: Isotretinoin the SUPPLEMENTARY INFORMATION section Minocycline hydrochloride Naltrexone for electronic access to the draft TABLE 1—NEW DRAFT PRODUCT-SPE- Sevelamer carbonate guidance recommendations. CIFIC BE RECOMMENDATIONS FOR Sirolimus Submit electronic comments on the DRUG PRODUCTS draft product-specific BE For a complete history of previously recommendations to http:// Aclidinium bromide published Federal Register notices www.regulations.gov. Submit written Acyclovir related to product-specific BE comments to the Division of Dockets Aminocaproic acid recommendations, go to http:// Apremilast www.regulations.gov and enter Docket Management (HFA–305), Food and Drug Benazepril hydrochloride; Hydrochlorothiazide Administration, 5630 Fishers Lane, Rm. Brimonidine tartrate No. FDA–2007–D–0369. 1061, Rockville, MD 20852. Carbidopa; Levodopa These draft and revised draft Ceritinib guidances are being issued consistent FOR FURTHER INFORMATION CONTACT: Clobetasol propionate with FDA’s good guidance practices Xiaoqiu Tang, Center for Drug Clomipramine hydrochloride regulation (21 CFR 10.115). These Clonidine hydrochloride Evaluation and Research, Food and guidances represent the Agency’s Drug Administration, 10903 New Cobicistat Cysteamine bitartrate current thinking on product-specific Hampshire Ave., Bldg. 75, Rm. 4730, Dapagliflozin propanediol; Metformin hydrochloride design of BE studies to support ANDAs. Silver Spring, MD 20993–0002, 301– Dasabuvir sodium; Ombitasvir; Paritaprevir; They do not establish any rights for 796–5850. Ritonavir Desvenlafaxine fumarate anyone and are not binding on FDA or SUPPLEMENTARY INFORMATION: Eslicarbazepine acetate the public. You may use an alternative Esomeprazole magnesium I. Background approach if it satisfies the requirements Ferric citrate of the applicable statutes and Fluticasone propionate (multiple reference listed In the Federal Register of June 11, drugs) regulations. 2010 (75 FR 33311), FDA announced the Formoterol fumarate availability of a guidance for industry Idelalisib IV. Comments entitled ‘‘Bioequivalence Ledipasvir; Sofosbuvir Interested persons may submit either Levocarnitine electronic comments on any of the Recommendations for Specific Loperamide hydrochloride; Simethicone Products’’ that explained the process Mometasone furoate monohydrate specific BE recommendations posted on that would be used to make product- Naltrexone HCL; Bupropion HCL FDA’s Web site to http:// specific BE recommendations available Netupitant; Palonosetron hydrochloride www.regulations.gov or written Nintedanib esylate comments to the Division of Dockets to the public on FDA’s Web site at Nortriptyline hydrochloride http://www.fda.gov/Drugs/ Pirfenidone Management (see ADDRESSES). It is only GuidanceCompliance Pomalidomide necessary to send one set of comments.

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Identify comments with the docket OMB control number 0910–0721. The Representative nominations may be number found in brackets in the approval expires on August 31, 2018. A submitted electronically by accessing heading of this document. The copy of the supporting statement for this the FDA Advisory Committee guidances, notices, and received information collection is available on Membership Nomination Portal: https:// comments may be seen in the Division the Internet at http://www.reginfo.gov/ www.accessdata.fda.gov/scripts/ of Dockets Management between 9 a.m. public/do/PRAMain. FACTRSPortal/FACTRS/index.cfm, by and 4 p.m., Monday through Friday, and Dated: September 11, 2015. mail to Advisory Committee Oversight will be posted to the docket at http:// Leslie Kux, and Management Staff, Food and Drug www.regulations.gov. Administration, 10903 New Hampshire Associate Commissioner for Policy. Ave., Bldg. 32, Rm. 5103, Silver Spring, V. Electronic Access [FR Doc. 2015–23566 Filed 9–18–15; 8:45 am] MD 20993–0002, or FAX: 301–847– Persons with access to the Internet BILLING CODE 4164–01–P 8640. Information about becoming a may obtain the document at either member of an FDA advisory committee http://www.fda.gov/Drugs/ can also be obtained by visiting FDA’s DEPARTMENT OF HEALTH AND GuidanceCompliance Web site at HUMAN SERVICES RegulatoryInformation/Guidances/ http://www.fda.gov/ default.htm or http:// Food and Drug Administration AdvisoryCommittees/default.htm. www.regulations.gov. FOR FURTHER INFORMATION CONTACT: For Dated: September 15, 2015. [Docket No. FDA–2015–N–3224] questions relating to participation in the Leslie Kux, Request for Nominations of Individuals selection process: Kimberly Hamilton, Associate Commissioner for Policy. and Consumer Organizations for the Advisory Committee Oversight and [FR Doc. 2015–23571 Filed 9–18–15; 8:45 am] Patient Engagement Advisory Management Staff, Food and Drug BILLING CODE 4164–01–P Committee Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5117, Silver Spring, AGENCY: Food and Drug Administration, MD 20993–0002, 301–796–6319, DEPARTMENT OF HEALTH AND HHS. [email protected]. HUMAN SERVICES ACTION: Notice. For questions relating to the Committee: Letise Williams, Center for Food and Drug Administration SUMMARY: The Food and Drug Devices and Radiological Health, Food Administration (FDA) is requesting that [Docket No. FDA–2009–N–0025] and Drug Administration, 10903 New any consumer organizations interested Hampshire Ave., Bldg. 66, Rm. 5441, Agency Information Collection in participating in the selection of a Silver Spring, MD 20993–0002, 301– Activities; Announcement of Office of voting consumer representative to serve 796–8398, [email protected]. Management and Budget Approval; on the Patient Engagement Advisory SUPPLEMENTARY INFORMATION: FDA is Animal Food Labeling; Declaration of Committee (the Committee) notify FDA requesting nominations for a voting Certifiable Color Additives in writing. FDA is also requesting consumer representative on the nominations for a voting consumer Committee. AGENCY: Food and Drug Administration, representative to serve on the Elsewhere in this issue of the Federal HHS. Committee. Nominees recommended to Register, FDA is publishing separate ACTION: Notice. serve as a voting consumer documents regarding: representative may either be self- 1. Patient Engagement Advisory SUMMARY: The Food and Drug nominated or may be nominated by a Administration (FDA) is announcing Committee; Notice of Establishment. consumer organization. Nominations 2. Request for Nominations for Voting that a collection of information entitled will be accepted for the current vacancy ‘‘Animal Food Labeling; Declaration of Members for the Patient Engagement effective with this notice. Advisory Committee. Certifiable Color Additives’’ has been FDA seeks to include the views of approved by the Office of Management 3. Request for Nominations of women and men, members of all racial Individuals and Industry Organizations and Budget (OMB) under the Paperwork and ethnic groups, and individuals with Reduction Act of 1995. for the Patient Engagement Advisory and without disabilities on its advisory Committee. FOR FURTHER INFORMATION CONTACT: FDA committees and, therefore encourages PRA Staff, Office of Operations, Food nominations of appropriately qualified I. General Description of the and Drug Administration, 8455 candidates from these groups. Committee’s Duties Colesville Rd., COLE–14526, Silver DATES: Any consumer organization The Committee provides advice on Spring, MD 20993–0002, PRAStaff@ interested in participating in the complex issues relating to medical fda.hhs.gov. selection of an appropriate voting devices, the regulation of devices, and SUPPLEMENTARY INFORMATION: On July member to represent consumer interests their use by patients. Agency guidance 16, 2015, the Agency submitted a on the Committee may send a letter or and policies, clinical trial or registry proposed collection of information email stating that interest to FDA by design, patient preference study design, entitled ‘‘Animal Food Labeling; October 21, 2015. Concurrently, benefit-risk determinations, device Declaration of Certifiable Color nomination materials for prospective labeling, unmet clinical needs, available Additives’’ to OMB for review and candidates should be sent to FDA by alternatives, patient reported outcomes clearance under 44 U.S.C. 3507. An October 21, 2015. and device-related quality of life or Agency may not conduct or sponsor, ADDRESSES: All statements of interest health status issues are among the topics and a person is not required to respond from consumer organizations interested that may be considered by the to, a collection of information unless it in participating in the selection process Committee. Members are knowledgeable displays a currently valid OMB control should be sent electronically to in areas such as clinical research, number. OMB has now approved the Kimberly Hamilton (see FOR FURTHER primary care patient experience, health information collection and has assigned INFORMATION CONTACT). All Consumer care needs of patient groups in the

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