83 FR 53069 - National Heart, Lung, and Blood Institute Notice of Closed Meetings
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 83, Issue 203 (October 19, 2018)
National Institutes of Health
Federal Register Volume 83, Issue 203 (October 19, 2018)
| Page Range | 53069-53070 | |
| FR Document | 2018-22760 |
[Federal Register Volume 83, Number 203 (Friday, October 19, 2018)] [Notices] [Pages 53069-53070] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-22760] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Heart, Lung, and Blood Institute Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Heart, Lung, and Blood Institute Special Emphasis Panel; [[Page 53070]] Using Stem Cells to Better Understand Heart Failure. Date: November 2, 2018. Time: 8:00 a.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: Hilton Crystal City Hilton Crystal City, 2399 Jefferson Davis Hwy., Arlington, VA 22202. Contact Person: David A. Wilson, Ph.D., Scientific Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, 6701 Rockledge Drive, Room 7204, Bethesda, MD 20892-7924, 301-435-0299, [email protected]. Name of Committee: National Heart, Lung, and Blood Institute Special Emphasis Panel; Bold New Bioengineering Methods and Approaches for Heart, Lung, Blood and Sleep Disorders and Diseases (R21). Date: November 2, 2018. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Westin Grand, 2350 M Street NW, Washington, DC 20037. Contact Person: Susan Wohler Sunnarborg, Ph.D., Scientific Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, 6701 Rockledge Drive, Room 7182, Bethesda, MD 20892, [email protected]. (Catalogue of Federal Domestic Assistance Program Nos. 93.233, National Center for Sleep Disorders Research; 93.837, Heart and Vascular Diseases Research; 93.838, Lung Diseases Research; 93.839, Blood Diseases and Resources Research, National Institutes of Health, HHS) Dated: October 15, 2018. Ronald J. Livingston, Jr., Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2018-22760 Filed 10-18-18; 8:45 am] BILLING CODE 4140-01-P
![Federal Register / Vol. 83, No. 203 / Friday, October 19, 2018 / Notices 53069
Application No. Drug Applicant
NDA 006002 ...... Aralen Hydrochloride (chloroquine hydrochloride Sanofi-Aventis, U.S., LLC, 55 Corporate Dr., Bridgewater, NJ 08807.
(HCl)) Injection, Equivalent to (EQ) 40 milli-
gram (mg) base/milliliter (mL); Aralen
(chloroquine phosphate) Tablets, EQ 300 mg
base.
NDA 008107 ...... Leucovorin calcium for Injection USP, EQ 60 mg Hospira Inc., Subsidiary of Pfizer Inc., 235 East 42nd St., New York, NY
base/vial for solution, oral; EQ 3 mg base/mL 10017.
injection; EQ 50 mg base/vial injection; EQ
100 mg base/vial injection; EQ 350 mg base/
vial injection.
NDA 009321 ...... Cholografin Meglumine (iodipamide meglumine) Bracco Diagnostics, Inc., 259 Prospect Plains Rd., Monroe Township, NJ
Injection, 10.3% and 52% (cholografin sodium, 08831.
20%).
NDA 017566 ...... Brevicon (ethinyl estradiol; norethindrone) Tab- Allergan Pharmaceuticals International, Ltd., c/o Allergan Sales, LLC,
lets, 0.035 mg/0.5 mg (21-Day Regimen). 2525 Dupont Dr., Irvine, CA 92612.
NDA 018181 ...... Mycelex (clotrimazole) Topical Solution, 1% ....... Bayer HealthCare LLC, 100 Bayer Blvd., 100 Bayer Rd., Pittsburgh, PA
15205.
NDA 018182 ...... Mycelex-7 (clotrimazole) Tablets, 100 mg ........... Do.
NDA 018183 ...... Mycelex (clotrimazole) Topical Cream, 1% .......... Do.
NDA 018230 ...... Mycelex-7 (clotrimazole) Topical Vaginal Cream, Do.
1%.
NDA 018856 ...... D-Xylose (xylose) Powder, 25 grams (g)/bottle ... Lyne Laboratories, 10 Burke Dr., Brockton, MA 02301.
NDA 018874 ...... Calcijex (calcitriol) Injection, 0.001 mg/mL and AbbVie, Inc., 1 North Waukegan Rd., North Chicago, IL 60064.
0.002 mg/mL.
NDA 020214 ...... Zemuron (rocronium bromide) Injection, 50 mg/5 Organon USA Inc., Subsidiary of Merck & Co., Inc., 2000 Galloping Hill
mL (10 mg/mL); 10 mg/mL (10 mg/mL); 100 Rd., Kenilworth, NJ 07033.
mg/10 mL (10 mg/mL).
NDA 020389 ...... Mycelex-7 Combination Pack (clotrimazole) Top- Bayer HealthCare LLC.
ical Vaginal Cream and Tablets, 1%, 100 mg.
NDA 020528 ...... Mavik (trandolapril) Tablets, 1 mg, 2 mg, and 4 AbbVie, Inc.
mg.
NDA 020738 ...... Teveten (eprosartan mesylate) Tablets, 300 mg, Do.
400 mg, and 600 mg.
NDA 020863 ...... Pletal (cilostazol) Tablets, 50 mg and 100 mg .... Otsuka Pharmaceutical Development and Commercialization, Subsidiary
of Otsuka Pharmaceutical Company, Ltd., 2440 Research Blvd., Rock-
ville, MD 20850.
NDA 021268 ...... Teveten HCT (eprosartan mesylate and AbbVie, Inc.
hydrochlorothiazide) Tablets, 600/12.5 mg and
600/25 mg.
NDA 021410 ...... Avandamet (rosiglitazone maleate and metformin GlaxoSmithKline, 1250 South Collegeville Rd., Collegeville, PA 19426.
hydrochloride (HCl)) Tablets, 500 mg EQ 1 mg
base; 500 mg EQ 2 mg base; 500 mg EQ 4
mg base; 1 g EQ 2 mg base; 1 g EQ 4 mg
base.
NDA 021511 ...... Copegus (ribavirin) Tablets, 200 mg and 400 mg Hoffmann La-Roche, Inc., Subsidiary of Genentech, Inc., 1 DNA Way,
South San Francisco, CA 94080.
NDA 021700 ...... Avandaryl (glimepiride and rosiglitazone male- SB Pharmco Puerto Rico Inc., Subsidiary of GlaxoSmithKline, 1250
ate) Tablets, 1 mg/4 mg; 2 mg/4 mg; 2 mg/8 South Collegeville Rd., Collegeville, PA 19426.
mg; 4 mg/4 mg; 4 mg/8 mg.
NDA 205123 ...... Olysio (simeprevir sodium) Capsules, EQ 150 Janssen Pharmaceuticals, Inc., 1000 U.S. Rte. 202 South, Raritan, NJ
mg base. 08869.
Therefore, approval of the Dated: October 15, 2018. amended, notice is hereby given of the
applications listed in the table, and all Leslie Kux, following meetings.
amendments and supplements thereto, Associate Commissioner for Policy. The meetings will be closed to the
is hereby withdrawn as of November 19, [FR Doc. 2018–22805 Filed 10–18–18; 8:45 am] public in accordance with the
2018. Introduction or delivery for BILLING CODE 4164–01–P provisions set forth in sections
introduction into interstate commerce of 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
products without approved new drug as amended. The grant applications and
applications violates section 301(a) and DEPARTMENT OF HEALTH AND the discussions could disclose
(d) of the Federal Food, Drug, and HUMAN SERVICES confidential trade secrets or commercial
Cosmetic Act (21 U.S.C. 331(a) and (d)). property such as patentable material,
amozie on DSK3GDR082PROD with NOTICES1
Drug products that are listed in the table National Institutes of Health and personal information concerning
that are in inventory on November 19, individuals associated with the grant
2018 may continue to be dispensed National Heart, Lung, and Blood applications, the disclosure of which
until the inventories have been depleted Institute Notice of Closed Meetings would constitute a clearly unwarranted
or the drug products have reached their invasion of personal privacy.
expiration dates or otherwise become Pursuant to section 10(d) of the
Federal Advisory Committee Act, as Name of Committee: National Heart, Lung,
violative, whichever occurs first. and Blood Institute Special Emphasis Panel;
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![53070 Federal Register / Vol. 83, No. 203 / Friday, October 19, 2018 / Notices
Using Stem Cells to Better Understand Heart Wednesday, November 7, 2018, from 8 the ‘‘Search’’ box, press Enter, and then
Failure. a.m. to 1 p.m. These meetings may close click on the item you wish to view.
Date: November 2, 2018. early if all business is finished. FOR FURTHER INFORMATION CONTACT: Mr.
Time: 8:00 a.m. to 4:00 p.m. Comments and supporting
Agenda: To review and evaluate grant Ryan Owens, Alternate Designated
applications.
documentation. To ensure your Federal Officer of the National Maritime
Place: Hilton Crystal City Hilton Crystal comments are reviewed by Committee Security Advisory Committee, 2703
City, 2399 Jefferson Davis Hwy., Arlington, members before the meetings, submit Martin Luther King Jr. Avenue SE,
VA 22202. your written comments no later than Washington, DC 20593, Stop 7581,
Contact Person: David A. Wilson, Ph.D., November 1, 2018. Washington, DC 20593–7581; telephone
Scientific Review Officer, Office of Scientific ADDRESSES: The meeting will be held at 202–372–1108 or email ryan.f.owens@
Review/DERA, National Heart, Lung, and the Double Tree Hilton Hotel by uscg.mil.
Blood Institute, 6701 Rockledge Drive, Room
7204, Bethesda, MD 20892–7924, 301–435–
Houston Hobby Airport, 8181 Airport SUPPLEMENTARY INFORMATION: Notice of
0299, wilsonda2@nhlbi.nih.gov. Boulevard, Houston, TX 77061, this meeting is in compliance with the
Name of Committee: National Heart, Lung,
HoustonHobbyAirport.DoubleTree.com. Federal Advisory Committee Act, Title
and Blood Institute Special Emphasis Panel; This meeting will be broadcast via a 5, United States Code, Appendix. The
Bold New Bioengineering Methods and web enabled interactive online format National Maritime Security Advisory
Approaches for Heart, Lung, Blood and Sleep and teleconference line. To participate Committee operates under the authority
Disorders and Diseases (R21). via teleconference, contact the of 46 U.S.C. 70112.
Date: November 2, 2018. individual listed in the FOR FURTHER The National Maritime Security
Time: 8:00 a.m. to 5:00 p.m. INFORMATION CONTACT section no later Advisory Committee provides advice,
Agenda: To review and evaluate grant than November 1, 2018. Additionally, if
applications.
consults with, and makes
you would like to participate in this recommendations to the Secretary of
Place: Westin Grand, 2350 M Street NW,
Washington, DC 20037.
meeting via the online web format, Homeland Security, via the
Contact Person: Susan Wohler Sunnarborg, please log onto https://share.dhs.gov/ Commandant of the Coast Guard, on
Ph.D., Scientific Review Officer, Office of nmsac/ and follow the online matters relating to national maritime
Scientific Review/DERA, National Heart, instructions to register for this meeting. security.
Lung, and Blood Institute, 6701 Rockledge If you encounter technical difficulties,
Drive, Room 7182, Bethesda, MD 20892, contact Mr. Ryan Owens at 202–302– Agenda
susan.sunnarborg@nih.gov. 6565. Day 1
(Catalogue of Federal Domestic Assistance For information on facilities or
Program Nos. 93.233, National Center for The Committee will meet to review,
services for individuals with
Sleep Disorders Research; 93.837, Heart and discuss and formulate recommendations
disabilities, or to request special
Vascular Diseases Research; 93.838, Lung on the following issues:
assistance at the meetings, contact the
Diseases Research; 93.839, Blood Diseases (1) Cyber Security Update. Members
individual listed in FOR FURTHER
and Resources Research, National Institutes will receive an update from the U.S.
of Health, HHS) INFORMATION CONTACT below as soon as
Coast Guard concerning the draft Cyber
possible.
Dated: October 15, 2018. Security Navigation and Vessel
Written comments must be submitted
Ronald J. Livingston, Jr., Inspection Circular and other Cyber
using the Federal eRulemaking Portal:
Program Analyst, Office of Federal Advisory Security matters related to the Marine
http://www.regulations.gov. If you
Committee Policy. Transportation System.
encounter technical difficulties, contact (2) Unmanned Aircraft Systems. The
[FR Doc. 2018–22760 Filed 10–18–18; 8:45 am] the individual in the FOR FURTHER Committee will receive an update from
BILLING CODE 4140–01–P INFORMATION CONTACT section of this
the U.S. Coast Guard concerning the
document. threat of Unmanned Aircraft Systems
Instructions: You are free to submit and the efforts of the U.S. Coast Guard
DEPARTMENT OF HOMELAND comments at any time, including orally to provide guidance to the maritime
SECURITY at the meetings, but if you want industry in addressing the concern these
Committee members to review your aircraft pose to critical infrastructure.
Coast Guard comment before the meetings, please (3) Port of Houston Maritime Security
submit your comments no later than Review. The Committee will receive a
[Docket No. USCG–2018–0877]
November 1, 2018. We are particularly brief on the current state of maritime
National Maritime Security Advisory interested in comments on the issues in security at the Port of Houston.
Committee; Meeting the ‘‘Agenda’’ section below. You must (4) Public Comment period.
include ‘‘Department of Homeland
AGENCY: U.S. Coast Guard, Department Security’’ and the docket number Day 2
of Homeland Security. [USCG–2018–0877]. Comments received The Committee will meet to review,
ACTION: Notice of Federal Advisory will be posted without alteration at discuss and formulate recommendations
Committee meeting. http://www.regulations.gov including on the following issues:
any personal information provided. For (1) Member Report. The Committee
SUMMARY: The National Maritime more information about privacy and the members will each provide an update
Security Advisory Committee will meet docket, review the Privacy and Security on the security developments in each of
in Houston, Texas, to review and Notice for the Federal Docket the respective member’s representative
amozie on DSK3GDR082PROD with NOTICES1
discuss various issues relating to Management System at https:// segment.
national maritime security. All meetings regulations.gov/privacyNotice. (2) Customs-Trade Partnership
will be open to the public. Docket Search: For access to the Against Terrorism. The Committee will
DATES: docket or to read documents or receive an update on efforts of from
Meetings. The Committee will meet comments related to this notice, go to Customs and Border Protection to revise
on Tuesday, November 6, 2018, from http://www.regulations.gov, and use the security requirements of the
12:00 noon to 5 p.m. and on docket number ‘‘USCG–2018–0877’’ in program.
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Document Created: 2018-10-19 01:26:16
Document Modified: 2018-10-19 01:26:16
| 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 | |
| Dates | November 2, 2018. | |
| FR Citation | 83 FR 53069 |
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