Office of Tribal Self-Governance; Negotiation Cooperative Agreement; Correction of Due Date, 19788 [2018-09506]

Download as PDF 19788 Federal Register / Vol. 83, No. 87 / Friday, May 4, 2018 / Notices 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. Application No. Drug Applicant ANDA 040259 ......... Hydrocortisone Acetate Cream USP, 2.5% .......................... ANDA 040457 ......... Pyridostigmine Bromide Tablets USP, 60 milligrams (mg) ... ANDA 061806 ......... Cloxapen (cloxacillin sodium) Capsules, Equivalent to (EQ) 250 mg base and EQ 500 mg base. Vancomycin Hydrochloride (HCl) Capsules USP, EQ 125 mg base and EQ 250 mg base. Calcitriol Injection, 1 microgram (mcg)/milliliter (mL) and 2 mcg/mL. Rimantadine HCl Tablets USP, 100 mg ................................ Glyburide and Metformin HCl Tablets USP, 1.25 mg/250 mg, 2.5 mg/500 mg, and 5 mg/500 mg. Fluconazole in Sodium Chloride 0.9% Injection, 200 mg/ 100 mL and 400 mg/200 mL. Ferndale Laboratories, Inc., 780 West Eight Mile Rd., Ferndale, MI 48220. Impax Laboratories, Inc., 30831 Huntwood Ave., Hayward, CA 94544. GlaxoSmithKline, LLC, 5 Crescent Dr., Philadelphia, PA 19112. Fresenius Kabi USA, LLC, Three Corporate Dr., Lake Zurich, IL 60047. Do. ANDA 065453 ......... ANDA 075836 ......... ANDA 075916 ......... ANDA 076731 ......... ANDA 076889 ......... ANDA 088572 ......... Impax Laboratories, Inc. Do. Mylan Laboratories, Ltd., c/o Mylan Pharmaceuticals, Inc., 781 Chestnut Ridge Rd., P.O. Box 4310, Morgantown, WV 26504. Abbott Laboratories, One Abbott Park Rd., Abbott Park, IL 60064. Pediatric LTA Kit (lidocaine HCl) Solution, 2% ..................... Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of June 4, 2018. 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 June 4, 2018 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. Dated: May 1, 2018. Leslie Kux, Associate Commissioner for Policy. Application Due Date has been modified. Paul Gettys, Grant Systems Coordinator, 5600 Fishers Lane, Mail Stop: 09E70, Rockville, MD 20857, Phone: (301) 443– 2114; or the Division of Grants Management main line (301) 443–5204, or Fax: (301)–594–0899. FOR FURTHER INFORMATION CONTACT: Correction In the FR notice of April 17, 2018, (FR 2018–07941), the correction is: Key Dates: Under the heading Key Dates, the Application Due Date should read as: • Application Due Date: June 18, 2018 The other dates in the Key Dates section remain as originally published. Dated: April 27, 2018. Michael D. Weahkee, RADM, Assistant Surgeon General, U.S. Public Health Service, Acting Director, Indian Health Service. [FR Doc. 2018–09534 Filed 5–3–18; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES [FR Doc. 2018–09506 Filed 5–3–18; 8:45 am] BILLING CODE 4160–16–P Indian Health Service amozie on DSK3GDR082PROD with NOTICES ACTION: Dated: April 27, 2018. Michael D. Weahkee, Assistant Surgeon General, U.S. Public Health Service, Acting Director, Indian Health Service. The Indian Health Service published a notice in the Federal Register (FR) on April 17, 2018, for the Negotiation Cooperative Agreement, Funding Announcement Number: HHS– 2018–IHS–TSGN–0001. The SUMMARY: Jkt 244001 BILLING CODE 4165–16–P Indian Health Service Notice; Correction of due date. 18:16 May 03, 2018 In the FR notice of April 17, 2018, (FR 83 FR 16885), the correction is: Key Dates: Under the heading Key Dates, the Application Due Date should read as: • Application Due Date: June 18, 2018 The other dates in the Key Dates section remain as originally published. [FR Doc. 2018–09507 Filed 5–3–18; 8:45 am] Indian Health Service, HHS. VerDate Sep<11>2014 Correction DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of Tribal Self-Governance; Negotiation Cooperative Agreement; Correction of Due Date AGENCY: Register on April 17, 2018, for the Planning Cooperative Agreement, Funding Announcement Number: HHS– 2018–IHS–TSGP–0001. The Application Due Date has been modified. FOR FURTHER INFORMATION CONTACT: Paul Gettys, Grant Systems Coordinator, 5600 Fishers Lane, Mail Stop: 09E70, Rockville, MD 20857, Phone: (301) 443– 2114; or the Division of Grants Management main line (301) 443–5204, or Fax: (301) 594–0899. DEPARTMENT OF HEALTH AND HUMAN SERVICES Planning Cooperative Agreement; Correction of Due Date National Institutes of Health Office of Tribal SelfGovernance, Indian Health Service, HHS. ACTION: Notice; correction of due date. AGENCY: The Indian Health Service published a notice in the Federal SUMMARY: PO 00000 Frm 00109 Fmt 4703 Sfmt 4703 National Institute on Aging; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. E:\FR\FM\04MYN1.SGM 04MYN1

Agencies

[Federal Register Volume 83, Number 87 (Friday, May 4, 2018)]
[Notices]
[Page 19788]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-09506]


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 DEPARTMENT OF HEALTH AND HUMAN SERVICES

Indian Health Service


Office of Tribal Self-Governance; Negotiation Cooperative 
Agreement; Correction of Due Date

AGENCY: Indian Health Service, HHS.

ACTION: Notice; Correction of due date.

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SUMMARY: The Indian Health Service published a notice in the Federal 
Register (FR) on April 17, 2018, for the Negotiation Cooperative 
Agreement, Funding Announcement Number: HHS-2018-IHS-TSGN-0001. The 
Application Due Date has been modified.

FOR FURTHER INFORMATION CONTACT: Paul Gettys, Grant Systems 
Coordinator, 5600 Fishers Lane, Mail Stop: 09E70, Rockville, MD 20857, 
Phone: (301) 443-2114; or the Division of Grants Management main line 
(301) 443-5204, or Fax: (301)-594-0899.

Correction

    In the FR notice of April 17, 2018, (FR 2018-07941), the correction 
is:
    Key Dates:
    Under the heading Key Dates, the Application Due Date should read 
as:
     Application Due Date: June 18, 2018
    The other dates in the Key Dates section remain as originally 
published.

    Dated: April 27, 2018.
Michael D. Weahkee,
RADM, Assistant Surgeon General, U.S. Public Health Service, Acting 
Director, Indian Health Service.
[FR Doc. 2018-09506 Filed 5-3-18; 8:45 am]
 BILLING CODE 4160-16-P

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