83 FR 19788 - Planning Cooperative Agreement; Correction of Due Date
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Indian Health Service Federal Register Volume 83, Issue 87 (May 4, 2018)
Indian Health Service
Federal Register Volume 83, Issue 87 (May 4, 2018)
| Page Range | 19788-19788 | |
| FR Document | 2018-09507 |
[Federal Register Volume 83, Number 87 (Friday, May 4, 2018)] [Notices] [Page 19788] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-09507] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Indian Health Service Planning Cooperative Agreement; Correction of Due Date AGENCY: Office of Tribal Self-Governance, Indian Health Service, HHS. ACTION: Notice; correction of due date. ----------------------------------------------------------------------- SUMMARY: The Indian Health Service published a notice in the Federal 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. Correction 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. Dated: April 27, 2018. Michael D. Weahkee, Assistant Surgeon General, U.S. Public Health Service, Acting Director, Indian Health Service. [FR Doc. 2018-09507 Filed 5-3-18; 8:45 am] BILLING CODE 4165-16-P
![19788 Federal Register / Vol. 83, No. 87 / Friday, May 4, 2018 / Notices
have requested that FDA withdraw also, by their requests, waived their § 314.150(c) is without prejudice to
approval of the applications under the opportunity for a hearing. Withdrawal refiling.
process described in § 314.150(c) (21 of approval of an application or
CFR 314.150(c)). The applicants have abbreviated application under
Application No. Drug Applicant
ANDA 040259 ......... Hydrocortisone Acetate Cream USP, 2.5% .......................... Ferndale Laboratories, Inc., 780 West Eight Mile Rd., Fern-
dale, MI 48220.
ANDA 040457 ......... Pyridostigmine Bromide Tablets USP, 60 milligrams (mg) ... Impax Laboratories, Inc., 30831 Huntwood Ave., Hayward,
CA 94544.
ANDA 061806 ......... Cloxapen (cloxacillin sodium) Capsules, Equivalent to (EQ) GlaxoSmithKline, LLC, 5 Crescent Dr., Philadelphia, PA
250 mg base and EQ 500 mg base. 19112.
ANDA 065453 ......... Vancomycin Hydrochloride (HCl) Capsules USP, EQ 125 Fresenius Kabi USA, LLC, Three Corporate Dr., Lake Zu-
mg base and EQ 250 mg base. rich, IL 60047.
ANDA 075836 ......... Calcitriol Injection, 1 microgram (mcg)/milliliter (mL) and 2 Do.
mcg/mL.
ANDA 075916 ......... Rimantadine HCl Tablets USP, 100 mg ................................ Impax Laboratories, Inc.
ANDA 076731 ......... Glyburide and Metformin HCl Tablets USP, 1.25 mg/250 Do.
mg, 2.5 mg/500 mg, and 5 mg/500 mg.
ANDA 076889 ......... Fluconazole in Sodium Chloride 0.9% Injection, 200 mg/ Mylan Laboratories, Ltd., c/o Mylan Pharmaceuticals, Inc.,
100 mL and 400 mg/200 mL. 781 Chestnut Ridge Rd., P.O. Box 4310, Morgantown,
WV 26504.
ANDA 088572 ......... Pediatric LTA Kit (lidocaine HCl) Solution, 2% ..................... Abbott Laboratories, One Abbott Park Rd., Abbott Park, IL
60064.
Therefore, approval of the Application Due Date has been Register on April 17, 2018, for the
applications listed in the table, and all modified. Planning Cooperative Agreement,
amendments and supplements thereto, FOR FURTHER INFORMATION CONTACT: Paul Funding Announcement Number: HHS–
is hereby withdrawn as of June 4, 2018. Gettys, Grant Systems Coordinator, 5600 2018–IHS–TSGP–0001. The Application
Introduction or delivery for introduction Fishers Lane, Mail Stop: 09E70, Due Date has been modified.
into interstate commerce of products Rockville, MD 20857, Phone: (301) 443– FOR FURTHER INFORMATION CONTACT: Paul
without approved new drug 2114; or the Division of Grants Gettys, Grant Systems Coordinator, 5600
applications violates section 301(a) and Management main line (301) 443–5204, Fishers Lane, Mail Stop: 09E70,
(d) of the Federal Food, Drug, and or Fax: (301)–594–0899. Rockville, MD 20857, Phone: (301) 443–
Cosmetic Act (21 U.S.C. 331(a) and (d)). 2114; or the Division of Grants
Drug products that are listed in the table Correction Management main line (301) 443–5204,
that are in inventory on June 4, 2018 In the FR notice of April 17, 2018, (FR or Fax: (301) 594–0899.
may continue to be dispensed until the 2018–07941), the correction is:
inventories have been depleted or the Key Dates: Correction
drug products have reached their Under the heading Key Dates, the In the FR notice of April 17, 2018, (FR
expiration dates or otherwise become Application Due Date should read as: 83 FR 16885), the correction is:
violative, whichever occurs first. • Application Due Date: June 18, Key Dates:
2018 Under the heading Key Dates, the
Dated: May 1, 2018.
The other dates in the Key Dates Application Due Date should read as:
Leslie Kux, section remain as originally published.
Associate Commissioner for Policy.
• Application Due Date: June 18, 2018
Dated: April 27, 2018. The other dates in the Key Dates
[FR Doc. 2018–09534 Filed 5–3–18; 8:45 am]
Michael D. Weahkee, section remain as originally published.
BILLING CODE 4164–01–P
RADM, Assistant Surgeon General, U.S.
Dated: April 27, 2018.
Public Health Service, Acting Director, Indian
Health Service. Michael D. Weahkee,
DEPARTMENT OF HEALTH AND [FR Doc. 2018–09506 Filed 5–3–18; 8:45 am] Assistant Surgeon General, U.S. Public Health
HUMAN SERVICES Service, Acting Director, Indian Health
BILLING CODE 4160–16–P
Service.
Indian Health Service [FR Doc. 2018–09507 Filed 5–3–18; 8:45 am]
Office of Tribal Self-Governance; DEPARTMENT OF HEALTH AND BILLING CODE 4165–16–P
Negotiation Cooperative Agreement; HUMAN SERVICES
Correction of Due Date Indian Health Service DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY: Indian Health Service, HHS. Planning Cooperative Agreement;
ACTION: Notice; Correction of due date. Correction of Due Date National Institutes of Health
amozie on DSK3GDR082PROD with NOTICES
AGENCY: Office of Tribal Self- National Institute on Aging; Notice of
SUMMARY: The Indian Health Service Governance, Indian Health Service, Closed Meeting
published a notice in the Federal HHS.
Register (FR) on April 17, 2018, for the ACTION: Notice; correction of due date. Pursuant to section 10(d) of the
Negotiation Cooperative Agreement, Federal Advisory Committee Act, as
Funding Announcement Number: HHS– SUMMARY: The Indian Health Service amended, notice is hereby given of the
2018–IHS–TSGN–0001. The published a notice in the Federal following meeting.
VerDate Sep<11>2014 18:16 May 03, 2018 Jkt 244001 PO 00000 Frm 00109 Fmt 4703 Sfmt 4703 E:\FR\FM\04MYN1.SGM 04MYN1](https://thefederalregister.org/doc/83_FR_19875/page/1.svg)
Document Created: 2018-11-02 09:52:11
Document Modified: 2018-11-02 09:52:11
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice; correction of due date. | |
| Dates | June 18, 2018 | |
| 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. | |
| FR Citation | 83 FR 19788 |
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