Source: https://regulations.justia.com/regulations/fedreg/2019/06/11/2019-12298.html
Timestamp: 2019-06-19 07:39:39
Document Index: 286723015

Matched Legal Cases: ['§ 10', '§ 60', '§ 60', '§ 10', 'art 1', '§ 314', '§ 314']

Determination of Regulatory Review Period for Purposes of Patent Extension; BAXDELA IV INJECTION-NDA 208611, 27126-27128 [2019-12298] :: Food And Drug Administration :: Department Of Health And Human Services :: Regulation Tracker :: Justia
Justia Regulation Tracker Department Of Health And Human Services Food And Drug Administration Determination of Regulatory Review Period for Purposes of Patent Extension; BAXDELA IV INJECTION-NDA 208611, 27126-27128 [2019-12298]
Determination of Regulatory Review Period for Purposes of Patent Extension; BAXDELA IV INJECTION-NDA 208611, 27126-27128 [2019-12298]
Download as PDF 27126 Federal Register / Vol. 84, No. 112 / Tuesday, June 11, 2019 / Notices EXHIBIT A.2—ESTIMATED ANNUALIZED COST BURDEN—Continued Number of respondents Form name Total burden hours Average hourly wage rate * Total cost burden b. Other Health Practitioners .................................................................... 5. EHR data (Cohorts 1, 2, and 3) .................................................................. 6. EHR data (Cohort 4) ................................................................................... 60 334 167 120 4,008 2,505 b 27.87 b 27.87 3,344 111,703 69,814 Total .......................................................................................................... 14,022 27,064 ........................ 1,311,096 b 27.87 * National Compensation Survey: Occupational wages in the United States May 2016 ‘‘U.S. Department of Labor, Bureau of Labor Statistics:’’ http://www.bls.gov/oes/current/oes_stru.htm. a Based on the mean wages for 29–1069 Physicians and Surgeons, All Other. b Based on the mean wages for 29–9099 Miscellaneous Health Practitioners and Technical Workers: Healthcare Practitioners and Technical Workers, All Other. Request for Comments Virginia L. Mackay-Smith, Associate Director. [FR Doc. 2019–12306 Filed 6–10–19; 8:45 am] BILLING CODE 4160–90–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration khammond on DSKBBV9HB2PROD with NOTICES [Docket Nos. FDA–2017–E–6741 and FDA– 2018–E–0046] Determination of Regulatory Review Period for Purposes of Patent Extension; BAXDELA IV INJECTION— NDA 208611 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. VerDate Sep<11>2014 17:36 Jun 10, 2019 The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for BAXDELA IV INJECTION under new drug application (NDA) 208611 and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product. DATES: Anyone with knowledge that any of the dates as published (see the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by August 12, 2019. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by December 9, 2019. See ‘‘Petitions’’ in the SUPPLEMENTARY INFORMATION section for more information. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before August 12, 2019. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of August 12, 2019. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. SUMMARY: In accordance with the Paperwork Reduction Act, comments on AHRQ’s information collection are requested with regard to any of the following: (a) Whether the proposed collection of information is necessary for the proper performance of AHRQ’s health care research and health care information dissemination functions, including whether the information will have practical utility; (b) the accuracy of AHRQ’s estimate of burden (including hours and costs) of the proposed collection(s) of information; (c) ways to enhance the quality, utility and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information upon the respondents, including the use of automated collection techniques or other forms of information technology. Comments submitted in response to this notice will be summarized and included in the Agency’s subsequent request for OMB approval of the proposed information collection. All comments will become a matter of public record. Jkt 247001 Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket Nos. FDA– 2017–E–6741 and FDA–2018–E–0046 for ‘‘Determination of Regulatory Review Period for Purposes of Patent Extension; BAXDELA IV INJECTION.’’ Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 E:\FR\FM\11JNN1.SGM 11JNN1 Federal Register / Vol. 84, No. 112 / Tuesday, June 11, 2019 / Notices khammond on DSKBBV9HB2PROD with NOTICES a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with § 10.20 (21 CFR 10.20) and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301–796–3600. SUPPLEMENTARY INFORMATION: medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product’s regulatory review period forms the basis for determining the amount of extension an applicant may receive. A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA’s determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B). FDA has approved NDA 208611 for marketing the human drug product, BAXDELA IV INJECTION (delafloxacin meglumine) indicated in adults for the treatment of acute bacterial skin and skin structure infections caused by designated susceptible bacteria. Subsequent to the approval, the USPTO received patent term restoration applications for BAXDELA (U.S. Patent Nos. 7,728,143 and 8,252,813) from Melinta Therapeutics, Inc., and the USPTO requested FDA’s assistance in determining the patents’ eligibility for patent term restoration. In a letter dated February 2, 2018, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approvals of BAXDELA TABLETS and BAXDELA IV INJECTION represent the first permitted commercial marketing or use of the products. Thereafter, the USPTO requested that FDA determine the products’ regulatory review period. I. Background II. Determination of Regulatory Review Period The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98–417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100–670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, FDA has determined that the applicable regulatory review period for BAXDELA IV INJECTION is 5,813 days. Of this time, 5,569 days occurred during the testing phase of the regulatory review period, while 244 days occurred during the approval phase. These periods of time were derived from the following dates: VerDate Sep<11>2014 17:36 Jun 10, 2019 Jkt 247001 PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 27127 1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective: July 22, 2001. Melinta claims that April 19, 2007, is the date an IND application became effective for this product. However, FDA records indicate that the IND effective date was July 22, 2001, which was 30 days after FDA receipt of Melinta’s first IND for the active ingredient. 2. The date the application (NDA 208611) was initially submitted with respect to the human drug product under section 505 of the FD&C Act: October 19, 2016. FDA has verified the applicant’s claim that the NDA 208611 for BAXDELA IV INJECTION was submitted on October 19, 2016. 3. The date the application was approved: June 19, 2017. FDA has verified the applicant’s claim that NDA 208611 was approved on June 19, 2017. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its applications for patent extension, this applicant seeks 1,307 or 1,001 days of patent term extension. III. Petitions Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as specified in § 60.30 (21 CFR 60.30), any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must comply with all the requirements of § 60.30, including but not limited to: Must be timely (see DATES), must be filed in accordance with § 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41–42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Submit petitions electronically to https://www.regulations.gov at Docket No. FDA–2013–S–0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. E:\FR\FM\11JNN1.SGM 11JNN1 27128 Federal Register / Vol. 84, No. 112 / Tuesday, June 11, 2019 / Notices Dated: June 6, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. Notice. Food and Drug Administration The Food and Drug Administration (FDA or Agency) is withdrawing approval of six abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn. [Docket No. FDA–2019–N–1740] DATES: [FR Doc. 2019–12298 Filed 6–10–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Novartis Pharmaceuticals Corp., et al.; Withdrawal of Approval of Six Abbreviated New Drug Applications AGENCY: Food and Drug Administration, HHS. Application No. SUMMARY: Approval is withdrawn as of July 11, 2019. FOR FURTHER INFORMATION CONTACT: Trang Tran, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1671, Silver Spring, The applicants listed in the table have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications under the process described in § 314.150(c) (21 CFR 314.150(c)). The applicants have also, by their requests, waived their opportunity for a hearing. Withdrawal of approval of an application or abbreviated application under § 314.150(c) is without prejudice to refiling. SUPPLEMENTARY INFORMATION: Applicant ANDA 070185 ......... Fluor-Op (fluorometholone) Ophthalmic Suspension, 0.1% ANDA 070858 ......... Trazodone Hydrochloride Tablets USP, 100 milligrams (mg) ANDA 076023 ......... ANDA 078167 ......... ANDA 088726 ......... Hydrocodone Bitartrate and Ibuprofen Tablets, 7.5 mg/200 mg. Paclitaxel Injection USP, 6 mg/milliliter ................................. Chlorpropamide Tablets USP, 250 mg ................................. ANDA 089852 ......... Chlorzoxazone Tablets USP, 250 mg ................................... Dated: June 6, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–12287 Filed 6–10–19; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 MD 20993–0002, 240–402–7945, Trang.Tran@fda.hhs.gov. Drug Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of July 11, 2019. Approval of each entire application is withdrawn, including any strengths or products inadvertently missing from the table. Introduction or delivery for introduction into interstate commerce of products without approved new drug applications violates section 301(a) and (d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(a) and (d)). Drug products that are listed in the table that are in inventory on July 11, 2019 may continue to be dispensed until the inventories have been depleted or the drug products have reached their expiration dates or otherwise become violative, whichever occurs first. khammond on DSKBBV9HB2PROD with NOTICES ACTION: 17:36 Jun 10, 2019 Jkt 247001 Novartis Pharmaceuticals Corp., One Health Plaza, East Hanover, NJ 07936. Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044. Teva Pharmaceuticals USA, Inc., 400 Interpace Pkwy., Bldg. A, Parsippany, NJ 07054. Sandoz, Inc., 100 College Rd. West, Princeton, NJ 08540. Aurolife Pharma, LLC, 279 Princeton Hightstown Rd., East Windsor, NJ 08520. Do. DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA–2018–E–0068; FDA– 2018–E–0069; FDA–2018–E–0070; FDA– 2018–E–0071; and FDA–2018–E–0072] Determination of Regulatory Review Period for Purposes of Patent Extension; KISQALI AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for KISQALI and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of patents which claims that human drug product. DATES: Anyone with knowledge that any of the dates as published (see the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by August 12, 2019. Furthermore, any interested person may SUMMARY: PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by December 9, 2019. See ‘‘Petitions’’ in the SUPPLEMENTARY INFORMATION section for more information. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before August 12, 2019. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of August 12, 2019. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any E:\FR\FM\11JNN1.SGM 11JNN1
[Pages 27126-27128]
[FR Doc No: 2019-12298]
Extension; BAXDELA IV INJECTION--NDA 208611
determined the regulatory review period for BAXDELA IV INJECTION under
new drug application (NDA) 208611 and is publishing this notice of that
determination as required by law. FDA has made the determination
because of the submission of applications to the Director of the U.S.
Patent and Trademark Office (USPTO), Department of Commerce, for the
electronic or written comments and ask for a redetermination by August
12, 2019. Furthermore, any interested person may petition FDA for a
due diligence during the regulatory review period by December 9, 2019.
must be submitted on or before August 12, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of August 12, 2019. Comments
FDA-2017-E-6741 and FDA-2018-E-0046 for ``Determination of Regulatory
Review Period for Purposes of Patent Extension; BAXDELA IV INJECTION.''
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9
[[Page 27127]]
FDA has approved NDA 208611 for marketing the human drug product,
BAXDELA IV INJECTION (delafloxacin meglumine) indicated in adults for
caused by designated susceptible bacteria. Subsequent to the approval,
the USPTO received patent term restoration applications for BAXDELA
(U.S. Patent Nos. 7,728,143 and 8,252,813) from Melinta Therapeutics,
Inc., and the USPTO requested FDA's assistance in determining the
patents' eligibility for patent term restoration. In a letter dated
February 2, 2018, FDA advised the USPTO that this human drug product
had undergone a regulatory review period and that the approvals of
BAXDELA TABLETS and BAXDELA IV INJECTION represent the first permitted
commercial marketing or use of the products. Thereafter, the USPTO
requested that FDA determine the products' regulatory review period.
BAXDELA IV INJECTION is 5,813 days. Of this time, 5,569 days occurred
during the testing phase of the regulatory review period, while 244
July 22, 2001. Melinta claims that April 19, 2007, is the date an IND
application became effective for this product. However, FDA records
indicate that the IND effective date was July 22, 2001, which was 30
days after FDA receipt of Melinta's first IND for the active
2. The date the application (NDA 208611) was initially submitted
with respect to the human drug product under section 505 of the FD&C
Act: October 19, 2016. FDA has verified the applicant's claim that the
NDA 208611 for BAXDELA IV INJECTION was submitted on October 19, 2016.
3. The date the application was approved: June 19, 2017. FDA has
verified the applicant's claim that NDA 208611 was approved on June 19,
this applicant seeks 1,307 or 1,001 days of patent term extension.
[[Page 27128]]