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Federal Register/Vol. 84, No. 175/Tuesday, September 10, 2019 Federal Register / Vol. 84, No. 175 / Tuesday, September 10, 2019 / Notices 47521 FR 56469, September 18, 2015, or access causes in whom childbearing is III. Petitions the information at: https://www.gpo.gov/ complete. Subsequent to this approval, Anyone with knowledge that any of fdsys/pkg/FR-2015-09-18/pdf/2015- the USPTO received a patent term the dates as published are incorrect may 23389.pdf. restoration application for AEGEA submit either electronic or written Docket: For access to the docket to VAPOR SYSTEM (U.S. Patent No. comments and, under 21 CFR 60.24, ask read background documents or the 8,574,226) from Tsunami MedTech, for a redetermination (see DATES). electronic and written/paper comments LLC, and the USPTO requested FDA’s Furthermore, as specified in § 60.30 (21 received, go to https:// assistance in determining this patent’s CFR 60.30), any interested person may www.regulations.gov and insert the eligibility for patent term restoration. In petition FDA for a determination docket number, found in brackets in the a letter dated April 4, 2018, FDA regarding whether the applicant for heading of this document, into the advised the USPTO that this medical extension acted with due diligence ‘‘Search’’ box and follow the prompts device had undergone a regulatory during the regulatory review period. To and/or go to the Dockets Management review period and that the approval of meet its burden, the petition must Staff, 5630 Fishers Lane, Rm. 1061, AEGEA VAPOR SYSTEM represented comply with all the requirements of Rockville, MD 20852. the first permitted commercial § 60.30, including but not limited to: FOR FURTHER INFORMATION CONTACT: marketing or use of the product. Must be timely (see DATES), must be Beverly Friedman, Office of Regulatory Thereafter, the USPTO requested that filed in accordance with § 10.20, must Policy, Food and Drug Administration, FDA determine the product’s regulatory contain sufficient facts to merit an FDA 10903 New Hampshire Ave., Bldg. 51, review period. investigation, and must certify that a Rm. 6250, Silver Spring, MD 20993, II. Determination of Regulatory Review true and complete copy of the petition 301–796–3600. Period has been served upon the patent SUPPLEMENTARY INFORMATION: applicant. (See H. Rept. 857, part 1, 98th FDA has determined that the Cong., 2d sess., pp. 41–42, 1984.) I. Background applicable regulatory review period for Petitions should be in the format The Drug Price Competition and AEGEA VAPOR SYSTEM is 1,381 days. specified in 21 CFR 10.30. Patent Term Restoration Act of 1984 Of this time, 1,148 days occurred during Submit petitions electronically to (Pub. L. 98–417) and the Generic the testing phase of the regulatory https://www.regulations.gov at Docket Animal Drug and Patent Term review period, while 233 days occurred No. FDA–2013–S–0610. Submit written Restoration Act (Pub. L. 100–670) during the approval phase. These petitions (two copies are required) to the generally provide that a patent may be periods of time were derived from the Dockets Management Staff (HFA–305), extended for a period of up to 5 years following dates: Food and Drug Administration, 5630 so long as the patented item (human 1. The date an exemption for this Fishers Lane, Rm. 1061, Rockville, MD drug product, animal drug product, device, under section 520(g) of the 20852. Federal Food, Drug, and Cosmetic Act medical device, food additive, or color Dated: September 4, 2019. additive) was subject to regulatory (FD&C Act) (21 U.S.C. 360j(g)), became Lowell J. Schiller, review by FDA before the item was effective: September 4, 2013. FDA has marketed. Under these acts, a product’s verified the applicant’s claim that the Principal Associate Commissioner for Policy. regulatory review period forms the basis date the investigational device [FR Doc. 2019–19496 Filed 9–9–19; 8:45 am] for determining the amount of extension exemption (IDE) for human tests to BILLING CODE 4164–01–P an applicant may receive. begin, as required under section 520(g) A regulatory review period consists of of the FD&C Act, became effective two periods of time: A testing phase and September 4, 2013. DEPARTMENT OF HEALTH AND an approval phase. For medical devices, 2. The date an application was HUMAN SERVICES initially submitted with respect to the the testing phase begins with a clinical Food and Drug Administration investigation of the device and runs device under section 515 of the FD&C until the approval phase begins. The Act (21 U.S.C. 360e): October 25, 2016. [Docket No. FDA–2019–N–3968] approval phase starts with the initial The applicant claims December 17, submission of an application to market 2015, as the date the premarket approval International Drug Scheduling; the device and continues until application (PMA) for AEGEA VAPOR Convention on Psychotropic permission to market the device is SYSTEM (PMA P160047) was initially Substances; Single Convention on granted. Although only a portion of a submitted. However, FDA records Narcotic Drugs; APINACA; AB– regulatory review period may count indicate that PMA P160047 was FUBINACA; 5F–AMB; 5F–MDMB–PICA; toward the actual amount of extension submitted as a complete application on 4–F–MDMB–BINACA; 4–CMC; N- that the Director of USPTO may award October 25, 2016. ethylhexedrone; alpha-PHP; DOC; (half the testing phase must be 3. The date the application was Crotonyl Fentanyl; Valeryl Fentanyl; subtracted as well as any time that may approved: June 14, 2017. FDA has Flualprazolam; Etizolam; and 8 have occurred before the patent was verified the applicant’s claim that PMA Additional Preparations Listed in issued), FDA’s determination of the P160047 was approved on June 14, Schedule III of the 1961 Single length of a regulatory review period for 2017. Convention on Narcotic Drugs; a medical device will include all of the This determination of the regulatory Request for Comments testing phase and approval phase as review period establishes the maximum AGENCY: Food and Drug Administration, specified in 35 U.S.C. 156(g)(3)(B). potential length of a patent extension. HHS. FDA has approved for marketing the However, the USPTO applies several ACTION: Notice; request for comments. medical device AEGEA VAPOR statutory limitations in its calculations SYSTEM. AEGEA VAPOR SYSTEM is of the actual period for patent extension. SUMMARY: The Food and Drug indicated for ablation of the endometrial In its application for patent extension, Administration (FDA) is requesting lining of the uterus in premenopausal this applicant seeks 931 days of patent interested persons to submit comments women with menorrhagia due to benign term extension. concerning abuse potential, actual VerDate Sep<11>2014 16:56 Sep 09, 2019 Jkt 247001 PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 E:\FR\FM\10SEN1.SGM 10SEN1 khammond on DSKBBV9HB2PROD with NOTICES 47522 Federal Register / Vol. 84, No. 175 / Tuesday, September 10, 2019 / Notices abuse, medical usefulness, trafficking, Management Staff (HFA–305), Food and must identify this information as and impact of scheduling changes on Drug Administration, 5630 Fishers ‘‘confidential.’’ Any information marked availability for medical use of 21 drug Lane, Rm. 1061, Rockville, MD 20852. as ‘‘confidential’’ will not be disclosed substances. These comments will be • For written/paper comments except in accordance with 21 CFR 10.20 considered in preparing a response from submitted to the Dockets Management and other applicable disclosure law. For the United States to the World Health Staff, FDA will post your comment, as more information about FDA’s posting Organization (WHO) regarding the abuse well as any attachments, except for of comments to public dockets, see 80 liability and diversion of these drugs. information submitted, marked and FR 56469, September 18, 2015, or access WHO will use this information to identified, as confidential, if submitted the information at: https://www.gpo.gov/ consider whether to recommend that as detailed in ‘‘Instructions.’’ fdsys/pkg/FR-2015-09-18/pdf/2015- certain international restrictions be Instructions: All submissions received 23389.pdf. placed on these drugs. This notice must include the Docket No. FDA– Docket: For access to the docket to requesting comments is required by the 2019–N–3968 for ‘‘International Drug read background documents or the Scheduling; Convention on Controlled Substances Act (the CSA). electronic and written/paper comments Psychotropic Substances; Single DATES: Submit either electronic or received, go to https:// Convention on Narcotic Drugs; written comments by October 4, 2019. www.regulations.gov and insert the APINACA (AKB–48); AB–FUBINACA; ADDRESSES: You may submit comments docket number, found in brackets in the 5F–AMB (5F–AMB–PINACA, 5F– as follows. Please note that late, heading of this document, into the MMB–PINACA); 5F–MDMB–PICA (5F– untimely filed comments will not be ‘‘Search’’ box and follow the prompts MDMB–2201); 4–F–MDMB–BINACA considered. Electronic comments must and/or go to the Dockets Management (4F–ADB); 4–CMC (4- be submitted on or before (October 4, Staff, 5630 Fishers Lane, Rm. 1061, chloromethcathinone; clefedrone); N- 2019. The https://www.regulations.gov Rockville, MD 20852. electronic filing system will accept ethylhexedrone (NEH, hexen, ethyl- FOR FURTHER INFORMATION CONTACT: comments until 11:59 p.m. Eastern Time hex); alpha-PHP (PV–7, a- James R. Hunter, Center for Drug at the end of October 4, 2019. Comments pyrrolidinohexanophenone); DOC (2,5- Evaluation and Research, Controlled received by mail/hand delivery/courier dimethoxy-4-chloroamfetamine); (for written/paper submissions) will be Crotonyl Fentanyl; Valeryl Fentanyl; Substance Staff, Food and Drug considered timely if they are Flualprazolam; Etizolam; Preparations Administration, 10903 New Hampshire postmarked or the delivery service listed in Schedule III of the 1961 Single Ave., Bldg.
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