83 FR 14017 - Meeting of the National Vaccine Advisory Committee

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 83, Issue 63 (April 2, 2018)

Page Range		14017-14018
FR Document		2018-06663

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services 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 63 (Monday, April 2, 2018)

[Federal Register Volume 83, Number 63 (Monday, April 2, 2018)]
[Notices]
[Pages 14017-14018]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-06663]


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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 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 May 3, 2018, from 10:30 a.m. to 
12:30 p.m. ET. 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: 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 Health and 
Human Services 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 be dedicated to the deliberation of 
the draft recommendations written by

[[Page 14018]]

the HPV Implementation work group. 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.

    Dated: March 27, 2018.
Roula Sweis,
Deputy Director, National Vaccine Program Office.
[FR Doc. 2018-06663 Filed 3-30-18; 8:45 am]
 BILLING CODE 4150-44-P

Federal Register / Vol. 83, No. 63 / Monday, April 2, 2018 / Notices 14017

Application No. Drug Applicant

NDA 020716 ........................ Vicoprofen (hydrocodone bitartrate and ibuprofen) Tab- AbbVie Inc., 1 North Waukegan Rd., North Chicago, IL
lets, 7.5 milligrams (mg)/200 mg. 60064.
NDA 021692 ........................ Ultram ER (tramadol HCl) Extended-Release Tablets, Valeant Pharmaceuticals North America LLC, 400 Som-
100 mg, 200 mg, and 300 mg. erset Corporate Blvd., Bridgewater, NJ 08807.
NDA 207621 ........................ Troxyca ER (oxycodone HCl and naltrexone HCl) Ex- Pfizer Inc., 235 East 42nd St., New York, NY 10017.
tended-Release Capsules, 10 mg/1.2 mg, 20 mg/2.4
mg, 30 mg/3.6 mg, 40 mg/4.8 mg, 60 mg/7.2 mg,
and 80 mg/9.6 mg.
NDA 207975 ........................ Vantrela ER (hydrocodone bitartrate) Extended-Release Teva Branded Pharmaceutical Products R&D, Inc., 41
Tablets, 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg. Moores Rd., P.O. Box 4011, Frazer, PA 19355.

Therefore, approval of the ADDRESSES: This meeting will be held at Services is hereby giving notice that a
applications listed in the table, and all The Saratoga Hilton. The address for the meeting is scheduled to be held of the
amendments and supplements thereto, meeting is 534 Broadway Saratoga National Vaccine Advisory Committee
is hereby withdrawn as of May 2, 2018. Springs, NY 12866–2209, (855) 605– (NVAC). The meeting will be open to
Introduction or delivery for introduction 0316. the public via teleconference; a public
into interstate commerce of products FOR FURTHER INFORMATION CONTACT: comment session will be held during
without approved new drug Steve Hirsch, MSLS, Administrative the meeting.
applications violates section 301(a) and Coordinator, NACRHHS, HRSA, DATES: The meeting will be held on May
(d) of the Federal Food, Drug, and 17W29–C, 5600 Fishers Lane, Rockville, 3, 2018, from 10:30 a.m. to 12:30 p.m.
Cosmetic Act (21 U.S.C. 331(a) and (d)). MD 20857, Telephone (301) 443–0835, ET. The confirmed meeting times and
Drug products that are listed in the table Fax (301) 443–2803. agenda will be posted on the NVAC
that are in inventory on May 2, 2018 SUPPLEMENTARY INFORMATION: website at http://www.hhs.gov/nvpo/
may continue to be dispensed until the NACRHHS provides counsel and nvac/meetings/index.html as soon as
inventories have been depleted or the recommendations to the Secretary with they become available.
drug products have reached their respect to the delivery, research, ADDRESSES: Instructions regarding
expiration dates or otherwise become development, and administration of attending this meeting will be posted
violative, whichever occurs first. health and human services in rural one week prior to the meeting at: http://
Dated: March 21, 2018. areas. During the meeting the www.hhs.gov/nvpo/nvac/meetings/
Leslie Kux, Committee will examine the issues of index.html. Pre-registration is required
Associate Commissioner for Policy. Assessing and Mitigating the Effect of for members of the public who wish to
[FR Doc. 2018–06579 Filed 3–30–18; 8:45 am] Adverse Childhood Experiences and attend the meeting and who wish to
BILLING CODE 4164–01–P
Health Insurance Markets in Rural participate in the public comment
Areas; conduct site visits to the session. Individuals who wish to attend
Adirondack Health Institute in Glens the meeting and/or participate in the
DEPARTMENT OF HEALTH AND Falls, New York and St. Vincent de Paul public comment session should register
HUMAN SERVICES Catholic Church in Cobleskill, New at http://www.hhs.gov/nvpo/nvac/
York, to visit the Head Start Program; meetings/index.html.
Health Resources and Services and summarize key findings and FOR FURTHER INFORMATION CONTACT:
Administration develop a work plan for the next National Vaccine Program Office, U.S.
quarter. Members of the public will also Department of Health and Human
National Advisory Committee on Rural have the opportunity to provide Services, Room 715H, Hubert H.
Health and Human Services comments. Humphrey Building, 200 Independence
AGENCY: Health Resources and Service Amy P. McNulty, Avenue SW, Washington, DC 20201.
Administration (HRSA), Department of Acting Director, Division of the Executive
Phone: (202) 690–5566; email: nvac@
Health and Human Services (HHS). Secretariat. hhs.gov.
ACTION: Notice of meeting. [FR Doc. 2018–06651 Filed 3–30–18; 8:45 am] SUPPLEMENTARY INFORMATION: Pursuant
BILLING CODE 4165–15–P to Section 2101 of the Public Health
SUMMARY: In accordance with the Service Act (42 U.S.C. 300aa–1), the
Federal Advisory Committee Act, notice Secretary of Health and Human Services
is hereby given that a meeting is DEPARTMENT OF HEALTH AND was mandated to establish the National
scheduled for the National Advisory HUMAN SERVICES Vaccine Program to achieve optimal
Committee on Rural Health and Human prevention of human infectious diseases
Services (NACRHHS). This meeting will Meeting of the National Vaccine through immunization and to achieve
be open to the public. Information about Advisory Committee optimal prevention against adverse
the NACRHHS and the agenda for this reactions to vaccines. The NVAC was
AGENCY: National Vaccine Program
meeting can be obtained by accessing established to provide advice and make
Office, Office of the Assistant Secretary
the NACRHHS website at http:// recommendations to the Director of the
for Health, Office of the Secretary,
daltland on DSKBBV9HB2PROD with NOTICES

www.hrsa.gov/advisorycommittees/ National Vaccine Program on matters
Department of Health and Human
rural/. related to the Program’s responsibilities.
Services.
DATES: The meeting will be held on ACTION: Notice. The Assistant Secretary for Health
April 16, 2018, from 8:45 a.m.–5:00 p.m. serves as Director of the National
EDT, April 17, 2018, from 8:30 a.m.– SUMMARY: As stipulated by the Federal Vaccine Program. The public meeting
5:15 p.m. EDT, and April 18, 2018, from Advisory Committee Act, the will be dedicated to the deliberation of
8:30 a.m.–11:00 a.m. EDT. Department of Health and Human the draft recommendations written by

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14018 Federal Register / Vol. 83, No. 63 / Monday, April 2, 2018 / Notices

the HPV Implementation work group. SUMMARY: In compliance with the whether the information will have
All agenda items are tentative and requirement of the Paperwork practical utility; (2) The accuracy of the
subject to change. Information on the Reduction Act of 1995 to provide agency’s estimate of the burden of the
final meeting agenda will be posted opportunity for public comment on proposed collection of information,
prior to the meeting on the NVAC proposed data collection projects, the including the validity of the
website: http://www.hhs.gov/nvpo/ National Institutes of Health (NIH), methodology and assumptions used; (3)
nvac/index.html. Office of the Director (OD) will publish Ways to enhance the quality, utility, and
Members of the public will have the periodic summaries of proposed clarity of the information to be
opportunity to provide comments at the projects to be submitted to the Office of collected; and (4) Ways to minimize the
NVAC meeting during the public Management and Budget (OMB) for burden of the collection of information
comment periods designated on the review and approval. on those who are to respond, including
agenda. Public comments made during DATES: Comments regarding this the use of appropriate automated,
the meeting will be limited to three information collection are best assured electronic, mechanical, or other
minutes per person to ensure time is of having their full effect if received technological collection techniques or
allotted for all those wishing to speak. within 60 days of the date of this other forms of information technology.
Individuals are also welcome to submit publication.
their written comments. Written Proposed Collection Title: The
comments should not exceed three FOR FURTHER INFORMATION CONTACT: To Genetic Testing Registry, 0925–0651,
pages in length. Individuals submitting obtain a copy of the data collection Expiration Date 07/31/2018—
written comments should email their plans and instruments, submit EXTENSION, Office of the Director
comments to the National Vaccine comments in writing, or request more (OD), National Institutes of Health
Program Office (nvac@hhs.gov) at least information on the proposed project, (NIH).
five business days prior to the meeting. contact: Dr. Dina Paltoo, Director,
Division of Scientific Data Sharing Need and Use of Information
Dated: March 27, 2018. Collection: Clinical laboratory tests are
Policy, Office of Science Policy, NIH,
Roula Sweis, 6705 Rockledge Dr., Suite 750, available for more than 10,000 genetic
Deputy Director, National Vaccine Program Bethesda, MD 20892, or call nontoll— conditions. The Genetic Testing Registry
Office. free number (301) 496–9838, or Email (GTR) provides a centralized, online
[FR Doc. 2018–06663 Filed 3–30–18; 8:45 am] your request, including your address to: location for test developers,
BILLING CODE 4150–44–P SciencePolicy@mail.nih.gov. Formal manufacturers, and researchers to
requests for additional plans and voluntarily submit detailed information
instruments must be requested in about the availability and scientific
DEPARTMENT OF HEALTH AND writing. basis of their genetic tests. The GTR is
HUMAN SERVICES of value to clinicians by providing
SUPPLEMENTARY INFORMATION: Section
information about the accuracy,
National Institutes of Health 3506(c)(2)(A) of the Paperwork
validity, and usefulness of genetic tests.
Reduction Act of 1995 requires: Written
Proposed Collection; 60-Day Comment comments and/or suggestions from the The GTR also highlights evidence gaps
Request; The Genetic Testing Registry public and affected agencies are invited where additional research is needed.
to address one or more of the following OMB approval is requested for 3
AGENCY: National Institutes of Health,
Department of Health and Human points: (1) Whether the proposed years. There are no costs to respondents
Services. collection of information is necessary other than their time. The total
for the proper performance of the estimated annualized burden hours are
ACTION: Notice.
function of the agency, including 4,198.

ESTIMATED ANNUALIZED BURDEN HOURS
Average Total
Number of
Number of time per annual
Type of respondent Form name responses per
respondents response burden
respondent (in hours) hours

Laboratory Personnel Using Bulk Submission ........ Minimal Fields ......................... 313 25 18/60 2,348
Optional Fields ........................ 313 25 6/60 783
Laboratory Personnel Not Using Bulk Submission .. Minimal Fields ......................... 64 25 30/60 800
Optional Fields ........................ 64 25 10/60 267

Total .................................................................. ................................................. 377 18,850 .................... 4198

Dated: March 24, 2018. DEPARTMENT OF HEALTH AND amended, notice is hereby given of the
Lawrence A. Tabak, HUMAN SERVICES following meeting.
Deputy Director, National Institutes of Health. The meeting will be closed to the
National Institutes of Health public in accordance with the
daltland on DSKBBV9HB2PROD with NOTICES

[FR Doc. 2018–06572 Filed 3–30–18; 8:45 am]
provisions set forth in sections
BILLING CODE 4140–01–P
National Eye Institute; Notice of Closed 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
Meeting as amended. The grant applications and
the discussions could disclose
Pursuant to section 10(d) of the confidential trade secrets or commercial
Federal Advisory Committee Act, as property such as patentable material,
and personal information concerning

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Document Created: 2018-11-01 09:08:52
Document Modified: 2018-11-01 09:08:52

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 May 3, 2018, from 10:30 a.m. to 12:30 p.m. ET. 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		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 14017