83 FR 21785 - Meeting of the National Vaccine Advisory Committee

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 83, Issue 91 (May 10, 2018)

Page Range		21785-21786
FR Document		2018-09947

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that a meeting is scheduled to be held of the National Vaccine Advisory Committee (NVAC). The meeting will be open to the public via teleconference; a public comment session will be held during the meeting.

Federal Register, Volume 83 Issue 91 (Thursday, May 10, 2018)

[Federal Register Volume 83, Number 91 (Thursday, May 10, 2018)]
[Notices]
[Pages 21785-21786]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-09947]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Meeting of the National Vaccine Advisory Committee

AGENCY: National Vaccine Program Office, Office of the Assistant 
Secretary for Health, Office of the Secretary, Department of Health and 
Human Services.

ACTION: Notice.

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SUMMARY: As stipulated by the Federal Advisory Committee Act, the 
Department of Health and Human Services (HHS) is hereby giving notice 
that a meeting is scheduled to be held of the National Vaccine Advisory 
Committee (NVAC). The meeting will be open to the public via 
teleconference; a public comment session will be held during the 
meeting.

DATES: The meeting will be held on June 25, 2018, from 2:00 p.m. to 
4:30 p.m. EST. The confirmed meeting times and agenda will be posted on 
the NVAC website at http://www.hhs.gov/nvpo/nvac/meetings/index.html as 
soon as they become available.

ADDRESSES: Instructions regarding attending this meeting will be posted 
one week prior to the meeting at: http://www.hhs.gov/nvpo/nvac/meetings/index.html. Pre-registration is required for members of the 
public who wish to attend the meeting and who wish to participate in 
the public comment session. Individuals who wish to attend the meeting 
and/or participate in the public comment session should register at 
http://www.hhs.gov/nvpo/nvac/meetings/index.html.

FOR FURTHER INFORMATION CONTACT: Captain Angela Shen, National Vaccine 
Program Office, U.S. Department of Health and Human Services, Room 
715H, Hubert H. Humphrey Building, 200 Independence Avenue SW, 
Washington, DC 20201. Phone: (202) 690-5566; email: nvac@hhs.gov.

SUPPLEMENTARY INFORMATION: Pursuant to Section 2101 of the Public 
Health Service Act (42 U.S.C. 300aa-1), the Secretary of HHS was 
mandated to establish the National Vaccine Program to achieve optimal 
prevention of human infectious diseases through immunization and to 
achieve optimal prevention against adverse reactions to vaccines. The 
NVAC was established to provide advice and make recommendations to the 
Director of the National Vaccine Program on matters related to the 
Program's responsibilities. The Assistant Secretary for Health serves 
as Director of the National Vaccine Program.
    The public meeting will include a presentation from the HPV 
Implementation Working Group on its findings and draft recommendations 
for strengthening the effectiveness of national, state, and local 
efforts to improve HPV coverage rates. The presentation will be 
followed by Committee deliberation and a vote. The public meeting will 
also include a presentation on the recent HHS report, ``Encouraging 
Vaccine Innovation: Promoting the Development of Vaccines that Minimize 
the Burden of Infectious Diseases in the 21st Century,'' which was 
submitted to Congress in accordance with provisions in the 21st Century 
Cures Act. All agenda items are tentative and subject to change. 
Information on the final meeting agenda will be posted prior to the 
meeting on the NVAC website: http://www.hhs.gov/nvpo/nvac/index.html.
    Members of the public will have the opportunity to provide comments 
at the NVAC meeting during the public comment periods designated on the 
agenda. Public comments made during the meeting will be limited to 
three minutes per person to ensure time is allotted for all those 
wishing to speak. Individuals are also welcome to submit their written 
comments. Written comments should not exceed three pages in length. 
Individuals submitting written comments should email their comments to 
the National Vaccine Program Office (nvac@hhs.gov) at least five 
business days prior to the meeting.


[[Page 21786]]


    Dated: May 7, 2018.
Roula Sweis,
Deputy Director, National Vaccine Program Office.
[FR Doc. 2018-09947 Filed 5-9-18; 8:45 am]
 BILLING CODE 4150-44-P

Federal Register / Vol. 83, No. 91 / Thursday, May 10, 2018 / Notices 21785

Treatment.’’ The purpose of this draft II. The Paperwork Reduction Act of at http://www.hhs.gov/nvpo/nvac/
guidance is to assist sponsors in the 1995 meetings/index.html.
development of new drugs for the This guidance refers to previously FOR FURTHER INFORMATION CONTACT:
treatment of uncomplicated urinary approved collections of information that Captain Angela Shen, National Vaccine
tract infections. are subject to review by the Office of Program Office, U.S. Department of
This draft guidance defines Management and Budget (OMB) under Health and Human Services, Room
enrollment criteria for uncomplicated the Paperwork Reduction Act of 1995 715H, Hubert H. Humphrey Building,
urinary tract infection trials and (44 U.S.C. 3501–3520). The collections 200 Independence Avenue SW,
provides options for clinical trials of information in 21 CFR parts 312 and Washington, DC 20201. Phone: (202)
designed to demonstrate efficacy. An 314 have been approved under OMB 690–5566; email: nvac@hhs.gov.
appendix to this draft guidance control numbers 0910–0014 and 0910–
0001, respectively. SUPPLEMENTARY INFORMATION: Pursuant
describes the justification for the to Section 2101 of the Public Health
noninferiority margin to be used for the III. Electronic Access Service Act (42 U.S.C. 300aa–1), the
option of active-controlled trials Persons with access to the internet Secretary of HHS was mandated to
designed to demonstrate noninferiority. may obtain the draft guidance at either establish the National Vaccine Program
In addition, this draft guidance reflects https://www.fda.gov/Drugs/ to achieve optimal prevention of human
recent developments in scientific GuidanceComplianceRegulatory infectious diseases through
information that pertain to drugs being Information/Guidances/default.htm or immunization and to achieve optimal
developed for the treatment of https://www.regulations.gov. prevention against adverse reactions to
uncomplicated urinary tract infections. Dated: May 4, 2018. vaccines. The NVAC was established to
Issuance of this draft guidance fulfills Leslie Kux, provide advice and make
a portion of the requirements of Title recommendations to the Director of the
Associate Commissioner for Policy.
VIII, section 804, of the Food and Drug National Vaccine Program on matters
[FR Doc. 2018–09929 Filed 5–9–18; 8:45 am]
Administration Safety and Innovation related to the Program’s responsibilities.
BILLING CODE 4164–01–P
Act (Pub. L. 112–144), which requires The Assistant Secretary for Health
FDA to review and, as appropriate, serves as Director of the National
revise not fewer than three guidance DEPARTMENT OF HEALTH AND Vaccine Program.
documents per year for the conduct of HUMAN SERVICES The public meeting will include a
clinical trials with respect to presentation from the HPV
antibacterial and antifungal drugs. In Meeting of the National Vaccine Implementation Working Group on its
1998, FDA published a draft guidance Advisory Committee findings and draft recommendations for
entitled ‘‘Uncomplicated Urinary Tract AGENCY: National Vaccine Program strengthening the effectiveness of
Infections—Developing Antimicrobial Office, Office of the Assistant Secretary national, state, and local efforts to
Drugs for Treatment’’ (the 1998 draft for Health, Office of the Secretary, improve HPV coverage rates. The
guidance). In a Federal Register notice Department of Health and Human presentation will be followed by
dated August 7, 2013 (78 FR 48175), Services. Committee deliberation and a vote. The
FDA announced an initiative in the public meeting will also include a
ACTION: Notice.
Center for Drug Evaluation and Research presentation on the recent HHS report,
involving the review of draft guidance SUMMARY: As stipulated by the Federal ‘‘Encouraging Vaccine Innovation:
documents issued before 2010 to Advisory Committee Act, the Promoting the Development of Vaccines
Department of Health and Human that Minimize the Burden of Infectious
determine their status and to decide
Services (HHS) is hereby giving notice Diseases in the 21st Century,’’ which
whether those guidances should be
that a meeting is scheduled to be held was submitted to Congress in
withdrawn, revised, or finalized with
of the National Vaccine Advisory accordance with provisions in the 21st
only minor changes. In the same August
Committee (NVAC). The meeting will be Century Cures Act. All agenda items are
7, 2013, Federal Register notice, FDA tentative and subject to change.
open to the public via teleconference; a
announced that the 1998 draft guidance, Information on the final meeting agenda
public comment session will be held
as well as other draft guidances, was will be posted prior to the meeting on
during the meeting.
being withdrawn (78 FR 48175). FDA is the NVAC website: http://www.hhs.gov/
DATES: The meeting will be held on June
now issuing a new draft guidance that nvpo/nvac/index.html.
revises the recommendations in the 25, 2018, from 2:00 p.m. to 4:30 p.m.
EST. The confirmed meeting times and Members of the public will have the
1998 draft guidance.
agenda will be posted on the NVAC opportunity to provide comments at the
This draft guidance is being issued website at http://www.hhs.gov/nvpo/ NVAC meeting during the public
consistent with FDA’s good guidance nvac/meetings/index.html as soon as comment periods designated on the
practices regulation (21 CFR 10.115). they become available. agenda. Public comments made during
The draft guidance, when finalized, will ADDRESSES: Instructions regarding the meeting will be limited to three
represent the current thinking of FDA attending this meeting will be posted minutes per person to ensure time is
on developing drugs for the treatment of one week prior to the meeting at: http:// allotted for all those wishing to speak.
uncomplicated urinary tract infections. www.hhs.gov/nvpo/nvac/meetings/ Individuals are also welcome to submit
daltland on DSKBBV9HB2PROD with NOTICES

It does not establish any rights for any index.html. Pre-registration is required their written comments. Written
person and is not binding on FDA or the for members of the public who wish to comments should not exceed three
public. You can use an alternative attend the meeting and who wish to pages in length. Individuals submitting
approach if it satisfies the requirements participate in the public comment written comments should email their
of the applicable statutes and session. Individuals who wish to attend comments to the National Vaccine
regulations. This guidance is not subject the meeting and/or participate in the Program Office (nvac@hhs.gov) at least
to Executive Order 12866. public comment session should register five business days prior to the meeting.

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21786 Federal Register / Vol. 83, No. 91 / Thursday, May 10, 2018 / Notices

Dated: May 7, 2018. Intertek USA, Inc., has been approved to provisions of 19 CFR 151.12 and 19 CFR
Roula Sweis, gauge and accredited to test petroleum 151.13. Intertek USA, Inc., is approved
Deputy Director, National Vaccine Program and petroleum products for customs for the following gauging procedures for
Office. purposes for the next three years as of petroleum and certain petroleum
[FR Doc. 2018–09947 Filed 5–9–18; 8:45 am] June 13, 2017. products set forth by the American
BILLING CODE 4150–44–P DATES: The accreditation and approval Petroleum Institute (API):
of Intertek USA, Inc., as commercial
gauger and laboratory became effective API
Chap- Title
DEPARTMENT OF HOMELAND on June 13, 2017. The next triennial ters
SECURITY inspection date will be scheduled for
June 2020. 3 ....... Tank gauging.
U.S. Customs and Border Protection FOR FURTHER INFORMATION CONTACT: Mr. 5 ....... Metering.
Stephen Cassata, Laboratories and 7 ....... Temperature Determination.
Accreditation and Approval of Intertek 8 ....... Sampling.
Scientific Services, U.S. Customs and 11 ..... Volume Correction Factors.
USA, Inc., as a Commercial Gauger Border Protection, 1300 Pennsylvania
and Laboratory 12 ..... Calculations.
Avenue NW, Suite 1500N, Washington, 17 ..... Maritime Measurements.
AGENCY: U.S. Customs and Border DC 20229, tel. 202–344–1060.
Protection, Department of Homeland SUPPLEMENTARY INFORMATION: Notice is Intertek USA, Inc., is accredited for
Security. hereby given pursuant to 19 CFR 151.12 the following laboratory analysis
ACTION: Notice of accreditation and and 19 CFR 151.13, that Intertek USA, procedures and methods for petroleum
approval of Intertek USA, Inc., as a Inc., 149 Pintail St., St. Rose, LA 70087, and certain petroleum products set forth
commercial gauger and laboratory. has been approved to gauge and by the U.S. Customs and Border
accredited to test petroleum and Protection Laboratory Methods (CBPL)
SUMMARY: Notice is hereby given, petroleum products for customs and American Society for Testing and
pursuant to CBP regulations, that purposes, in accordance with the Materials (ASTM):

CBPL No. ASTM Title

27–03 .............. ASTM D–4006 Standard test method for water in crude oil by distillation.
27–04 .............. ASTM D–95 Standard test method for water in petroleum products and bituminous materials by distillation.
27–05 .............. ASTM D–4928 Standard Test Method for Water in Crude Oils by Coulometric Karl Fischer Titration.
27–06 .............. ASTM D–473 Standard test method for sediment in crude oils and fuel oils by the extraction method.
27–08 .............. ASTM D–86 Standard Test Method for Distillation of Petroleum Products.
27–11 .............. ASTM D–445 Standard test method for kinematic viscosity of transparent and opaque liquids (and calculations of dynamic
viscosity).
27–13 .............. ASTM D–4294 Standard test method for sulfur in petroleum and petroleum products by energy-dispersive x-ray fluorescence
spectrometry.
27–14 .............. ASTM D–2622 Standard Test Method for Sulfur in Petroleum Products (X-Ray Spectrographic Methods).
27–46 .............. ASTM D–5002 Standard Test Method for Density and Relative Density of Crude Oils by Digital Density Analyzer.
27–48 .............. ASTM D–4052 Standard test method for density and relative density of liquids by digital density meter.
27–50 .............. ASTM D–93 Standard Test Methods for Flash-Point by Pensky-Martens Closed Cup Tester.
27–54 .............. ASTM D–1796 Standard test method for water and sediment in fuel oils by the centrifuge method (Laboratory procedure).
27–58 .............. ASTM D–5191 Standard Test Method For Vapor Pressure of Petroleum Products (Mini Method).

Anyone wishing to employ this entity Dated: May 2, 2018. SUMMARY: Notice is hereby given,
to conduct laboratory analyses and Dave Fluty, pursuant to CBP regulations, that
gauger services should request and Executive Director, Laboratories and AmSpec LLC (Ferndale, WA) has been
receive written assurances from the Scientific Services Directorate. approved to gauge petroleum and
entity that it is accredited or approved [FR Doc. 2018–10020 Filed 5–9–18; 8:45 am] certain petroleum products and
by the U.S. Customs and Border BILLING CODE 9111–14–P accredited to test petroleum and certain
Protection to conduct the specific test or petroleum products for customs
gauger service requested. Alternatively, purposes for the next three years as of
inquiries regarding the specific test or DEPARTMENT OF HOMELAND August 24, 2017.
gauger service this entity is accredited SECURITY
DATES: AmSpec LLC (Ferndale, WA)
or approved to perform may be directed U.S. Customs and Border Protection was approved and accredited as a
to the U.S. Customs and Border
commercial gauger and laboratory as of
Protection by calling (202) 344–1060. Accreditation and Approval of AmSpec August 24, 2017. The next triennial
The inquiry may also be sent to LLC (Ferndale, WA) as a Commercial inspection date will be scheduled for
cbp.labhq@dhs.gov. Please reference the Gauger and Laboratory August 2020.
website listed below for a complete
AGENCY: U.S. Customs and Border
daltland on DSKBBV9HB2PROD with NOTICES

listing of CBP approved gaugers and FOR FURTHER INFORMATION CONTACT:
accredited laboratories: http:// Protection, Department of Homeland Christopher J. Mocella, Laboratories and
www.cbp.gov/about/labs-scientific/ Security. Scientific Services Directorate, U.S.
commercial-gaugers-and-laboratories. ACTION: Notice of accreditation and Customs and Border Protection, 1300
approval of AmSpec LLC (Ferndale, Pennsylvania Avenue NW, Suite 1500N,
WA) as a commercial gauger and Washington, DC 20229, tel. 202–344–
laboratory. 1060.

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Document Created: 2018-11-02 09:47:19
Document Modified: 2018-11-02 09:47:19

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.
Dates		The meeting will be held on June 25, 2018, from 2:00 p.m. to 4:30 p.m. EST. The confirmed meeting times and agenda will be posted on the NVAC website at http://www.hhs.gov/nvpo/nvac/meetings/index.html as soon as they become available.
Contact		Captain Angela Shen, National Vaccine Program Office, U.S. Department of Health and Human Services, Room 715H, Hubert H. Humphrey Building, 200 Independence Avenue SW, Washington, DC 20201. Phone: (202) 690-5566; email: [email protected]
FR Citation		83 FR 21785