83 FR 24317 - Advisory Commission on Childhood Vaccines

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration

Federal Register Volume 83, Issue 102 (May 25, 2018)

Page Range		24317-24318
FR Document		2018-11298

In accordance with the Federal Advisory Committee Act, this notice announces that the Advisory Commission on Childhood Vaccines (ACCV) will hold a public meeting. This meeting will be open to the public.

Federal Register, Volume 83 Issue 102 (Friday, May 25, 2018)

[Federal Register Volume 83, Number 102 (Friday, May 25, 2018)]
[Notices]
[Pages 24317-24318]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-11298]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Service Administration


Advisory Commission on Childhood Vaccines

AGENCY: Health Resources and Service Administration (HRSA), Department 
of Health and Human Services (HHS).

ACTION: Notice of Advisory Committee meeting.

-----------------------------------------------------------------------

SUMMARY: In accordance with the Federal Advisory Committee Act, this 
notice announces that the Advisory Commission on Childhood Vaccines 
(ACCV) will hold a public meeting. This meeting will be open to the 
public.

DATES: Friday, June 15, 2018, from 10:00 a.m. to 2:00 p.m. ET.

ADDRESSES: The meeting is a teleconference and webinar. The conference 
call-in number is 1-800-988-0218; passcode: 9302948. The webinar link 
is https://hrsa.connectsolutions.com/accv/. Participants should call 
and connect 15 minutes prior to the meeting in order for logistics to 
be set up. If you have never attended an Adobe Connect meeting, please 
test your connection using the following URL: https://hrsa.connectsolutions.com/common/help/en/support/meeting_test.htm and 
get a quick overview by following URL: http://www.adobe.com/go/connectpro_overview.

FOR FURTHER INFORMATION CONTACT: Annie Herzog, Principal Staff Liaison, 
Division of Injury Compensation Programs (DICP), Healthcare Systems 
Bureau (HSB), HRSA, 5600 Fishers Lane, Room 08N146B, Rockville, 
Maryland 20857; phone: (301) 443-6593; or email: [email protected].

SUPPLEMENTARY INFORMATION: 
    Background: The ACCV advises the Secretary on the implementation of 
the Vaccine Injury Compensation Program (VICP). Other activities of the 
ACCV include: Recommending changes to the Vaccine Injury table, at its 
own initiative or as the result of the filing of a petition; advising 
the Secretary on implementing section 2127 of the Public Health Service 
Act (PHS Act) regarding

[[Page 24318]]

the need for childhood vaccination products that result in fewer or no 
significant adverse reactions; surveying federal, state, and local 
programs and activities related to gathering information on injuries 
associated with the administration of childhood vaccines, including the 
adverse reaction reporting requirements of section 2125 (b) of the PHS 
Act; advising the Secretary on the methods of obtaining, compiling, 
publishing, and using credible data related to the frequency and 
severity of adverse reactions associated with childhood vaccines; 
consulting on the development or revision of Vaccine Information 
Statements; and recommending to the Director of the National Vaccine 
Program research related to vaccine injuries which should be conducted 
to carry out the VICP.
    Agenda: During the June 15, 2018, meeting, agenda items may include 
updates from DICP, Department of Justice (DOJ), National Vaccine 
Program Office (NVPO), Immunization Safety Office (Centers for Disease 
Control and Prevention), National Institute of Allergy and Infectious 
Diseases (National Institutes of Health) and Center for Biologics, 
Evaluation and Research (Food and Drug Administration). Information 
about the ACCV, a roster of members, the meeting agenda, as well as 
past meeting summaries, is located on the ACCV website: http://www.hrsa.gov/advisorycommittees/childhoodvaccines/index.html. Agenda 
items are subject to change as priorities dictate.
    Public Participation: Members of the public will have the 
opportunity to provide comments. Oral comments will be honored in the 
order they are requested and may be limited as time allows. Requests to 
make oral comments or provide written comments to the ACCV should be 
sent to Annie Herzog by June 5, 2018. Individuals who plan to 
participate and need special assistance, such as sign language 
interpretation or other reasonable accommodations, should notify Annie 
Herzog, using the address and phone number above at least 10 days prior 
to the meeting.

Amy P. McNulty,
Acting Director, Division of the Executive Secretariat.
[FR Doc. 2018-11298 Filed 5-24-18; 8:45 am]
 BILLING CODE 4165-15-P

Federal Register / Vol. 83, No. 102 / Friday, May 25, 2018 / Notices 24317

communicating with us about the safety UCM350010.pdf) and may be used in ElectronicSubmissionsGateway/
evaluation. lieu of a cover letter for a New Protein default.htm), paper format, or as
Interested persons may use Form FDA Consultation (NPC). Form FDA 3666 electronic files on physical media with
3666 to transmit their submissions to prompts a submitter to include certain a paper signature page. FDA uses this
the Office of Food Additive Safety in the elements of a NPC in a standard format information to evaluate the food safety
Center for Food Safety and Applied and helps the respondent organize their of a specific new protein produced by
Nutrition. Form FDA 3666 is entitled submission to focus on the information a new plant variety.
‘‘Early Food Safety Evaluation of a New needed for our safety review. The form, Description of Respondents: The
Non-Pesticidal Protein Produced by a and elements that would be prepared as respondents to this collection of
New Plant Variety (New Protein attachments to the form, may be information are developers of new plant
Consultation)’’ (https://www.fda.gov/ submitted in electronic format via the varieties intended for food use.
downloads/AboutFDA/ Electronic Submission Gateway (https:// FDA estimates the burden of this
ReportsManualsForms/Forms/ www.fda.gov/ForIndustry/ collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Category FDA Form No. responses per burden per Total hours
respondents responses
respondent response

First four data components ...................... 3666 6 1 6 4 24
Two other data components .................... 3666 6 1 6 16 96

Total .................................................. ........................ ........................ ........................ ........................ ........................ 120
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Based on a review of the information publicly available databases. The other notice announces that the Advisory
collection since our last request for data component involves ‘‘wet’’ lab Commission on Childhood Vaccines
OMB approval, we have made no work to assess the new protein’s (ACCV) will hold a public meeting. This
adjustments to our burden estimate. The stability and the resistance of the meeting will be open to the public.
estimated number of annual responses protein to enzymatic degradation using DATES: Friday, June 15, 2018, from 10:00
and average burden per response are appropriate in vitro assays (protein a.m. to 2:00 p.m. ET.
based on our experience with early food digestibility study). The paperwork ADDRESSES: The meeting is a
safety evaluations. Completing an early burden of these two data components teleconference and webinar. The
food safety evaluation for a new protein consists of the time it takes the company conference call-in number is 1–800–
from a new plant variety is a one-time to assemble the information on these 988–0218; passcode: 9302948. The
burden (one evaluation per new two data components and include it in webinar link is https://
protein). Many developers of novel a NPC. We estimate that completing hrsa.connectsolutions.com/accv/.
plants may choose not to submit an these data components will take about Participants should call and connect 15
evaluation because the field testing of a 16 hours per NPC. We estimate the minutes prior to the meeting in order for
plant containing a new protein is reporting burden for the two other data logistics to be set up. If you have never
conducted in such a way (e.g., on such components to be 96 hours (16 hours × attended an Adobe Connect meeting,
a small scale, or in such isolated 6 responses). Thus, we estimate the total please test your connection using the
conditions, etc.) that cross-pollination annual burden for this collection of following URL: https://
with traditional crops or commingling information to be 120 hours. hrsa.connectsolutions.com/common/
of plant material is not likely to be an Dated: May 9, 2018. help/en/support/meeting_test.htm and
issue. Also, other developers may have Leslie Kux, get a quick overview by following URL:
previously communicated with us about http://www.adobe.com/go/connectpro_
Associate Commissioner for Policy.
the food safety of a new plant protein, overview.
[FR Doc. 2018–11281 Filed 5–24–18; 8:45 am]
for example, when the same protein was FOR FURTHER INFORMATION CONTACT:
BILLING CODE 4164–01–P
expressed in a different crop. Annie Herzog, Principal Staff Liaison,
We estimate the annual number of Division of Injury Compensation
NPCs submitted by developers will be DEPARTMENT OF HEALTH AND Programs (DICP), Healthcare Systems
six or fewer. The early food safety HUMAN SERVICES Bureau (HSB), HRSA, 5600 Fishers
evaluation for new proteins includes six Lane, Room 08N146B, Rockville,
main data components. Four of these Health Resources and Service Maryland 20857; phone: (301) 443–
data components are easily and quickly Administration 6593; or email: aherzog@hrsa.gov.
obtainable, having to do with the SUPPLEMENTARY INFORMATION:
identity and source of the protein. We Advisory Commission on Childhood Background: The ACCV advises the
estimate that completing these data Vaccines Secretary on the implementation of the
components will take about 4 hours per AGENCY: Health Resources and Service Vaccine Injury Compensation Program
amozie on DSK3GDR082PROD with NOTICES1

NPC. We estimate the reporting burden Administration (HRSA), Department of (VICP). Other activities of the ACCV
for the first four data components to be Health and Human Services (HHS). include: Recommending changes to the
24 hours (4 hours × 6 responses). Vaccine Injury table, at its own
ACTION: Notice of Advisory Committee
Two data components ask for original meeting. initiative or as the result of the filing of
data to be generated. One data a petition; advising the Secretary on
component consists of a bioinformatics SUMMARY: In accordance with the implementing section 2127 of the Public
analysis that can be performed using Federal Advisory Committee Act, this Health Service Act (PHS Act) regarding

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24318 Federal Register / Vol. 83, No. 102 / Friday, May 25, 2018 / Notices

the need for childhood vaccination DEPARTMENT OF HEALTH AND DEPARTMENT OF HEALTH AND
products that result in fewer or no HUMAN SERVICES HUMAN SERVICES
significant adverse reactions; surveying
federal, state, and local programs and National Institutes of Health National Institutes of Health
activities related to gathering
Clinical Center; Notice of Closed Prospective Grant of Exclusive
information on injuries associated with
Meeting License: Production of Monovalent
the administration of childhood
Live Attenuated Zika Vaccines and
vaccines, including the adverse reaction Multivalent Live Attenuated Flavivirus
Pursuant to section 10(d) of the
reporting requirements of section 2125 Vaccines
Federal Advisory Committee Act, as
(b) of the PHS Act; advising the
amended, notice is hereby given of a AGENCY: National Institute of Allergy
Secretary on the methods of obtaining,
meeting of the Board of Scientific and Infectious Diseases, National
compiling, publishing, and using
Counselors of the NIH Clinical Center. Institutes of Health, Public Health
credible data related to the frequency
and severity of adverse reactions The meeting will be closed to the Service, DHHS.
associated with childhood vaccines; public as indicated below in accordance ACTION: Notice.
consulting on the development or with the provisions set forth in section
revision of Vaccine Information 552b(c)(6), Title 5 U.S.C., as amended SUMMARY: The National Institute of
Statements; and recommending to the for the review, discussion, and Allergy and Infectious Diseases, an
Director of the National Vaccine evaluation of individual intramural institute of the National Institutes of
Program research related to vaccine programs and projects conducted by the Health, Department of Health and
CLINICAL CENTER, including Human Services, is contemplating the
injuries which should be conducted to
consideration of personnel grant of an Exclusive Commercialization
carry out the VICP.
qualifications and performance, and the Patent License to practice the inventions
Agenda: During the June 15, 2018, embodied in the Patents and Patent
competence of individual investigators,
meeting, agenda items may include Applications listed in the Summary
the disclosure of which would
updates from DICP, Department of Information section of this notice to to
constitute a clearly unwarranted
Justice (DOJ), National Vaccine Program Fundacao Butantan, having a place of
invasion of personal privacy.
Office (NVPO), Immunization Safety business in Sao Paulo, Brazil.
Office (Centers for Disease Control and Name of Committee: Board of Scientific DATES: Only written comments and/or
Prevention), National Institute of Counselors of the NIH Clinical Center Board application for a license which are
Allergy and Infectious Diseases meeting. received by the NIAID Technology
(National Institutes of Health) and Date: June 15, 2018. Transfer and Intellectual Property Office
Center for Biologics, Evaluation and Time: 8:00 a.m. to 4:00 p.m.
on or before June 25, 2018 will be
Agenda: To review and evaluate reports
Research (Food and Drug considered.
and responses to the following Clinic
Administration). Information about the ADDRESSES: Requests for a copy of the
Center’s Departments: Rehabilitation
ACCV, a roster of members, the meeting Medicine, Bioethics, Critical Care Medicine, patent application, inquiries, comments
agenda, as well as past meeting Imaging Sciences, Transfusion Medicine, and other materials relating to the
summaries, is located on the ACCV Laboratory Medicine, Nursing, and contemplated Exclusive
website: http://www.hrsa.gov/ Pediatrics. Commercialization Patent License
advisorycommittees/childhoodvaccines/ Place: National Institutes of Health, should be directed to: Peter Soukas,
index.html. Agenda items are subject to Building 10, 10 Center Drive, Bethesda, MD Technology Transfer and Patent
change as priorities dictate. 20892. Specialist, Technology Transfer and
Public Participation: Members of the Contact Person: John I. Gallin, M.D., Intellectual Property Office, National
public will have the opportunity to Associate Director for Clinical Research, Institute of Allergy and Infectious
provide comments. Oral comments will Office of Director, NIH Clinical Center, 1 Diseases, National Institutes of Health,
Center Drive, Room 201, Bethesda, MD 5601 Fishers Lane, Suite 6D, Rockville,
be honored in the order they are
20892, 301–827–5428. MD 20852–9804; Email: ps193c@
requested and may be limited as time
allows. Requests to make oral comments Any interested person may file written nih.gov; Telephone: (301) 496–2644;
or provide written comments to the comments with the committee by forwarding Facsimile: (240) 627–3117.
the statement to the Contact Person listed on SUPPLEMENTARY INFORMATION:
ACCV should be sent to Annie Herzog
this notice. The statement should include the
by June 5, 2018. Individuals who plan name, address, telephone number and when Intellectual Property
to participate and need special applicable, the business or professional
assistance, such as sign language U.S. Provisional Patent Application
affiliation of the interested person. Number 62/307,170, filed March 11,
interpretation or other reasonable
Dated: May 18, 2018. 2016 and entitled ‘‘Live Attenuated Zika
accommodations, should notify Annie
Michelle D. Trout, Virus Vaccines,’’ Whitehead et al., and
Herzog, using the address and phone PCT Patent Application Number PCT/
number above at least 10 days prior to Program Analyst, Office of Federal Advisory
Committee Policy.
US2017/0021989, filed March 11, 2017
the meeting. and entitled ‘‘Live Attenuated Zika
[FR Doc. 2018–11212 Filed 5–24–18; 8:45 am]
Amy P. McNulty, Virus Vaccines,’’ Whitehead et al. [HHS
amozie on DSK3GDR082PROD with NOTICES1

BILLING CODE 4140–01–P Reference E–118–2016/0]; and U.S. and
Acting Director, Division of the Executive
Secretariat. foreign patent applications claiming
[FR Doc. 2018–11298 Filed 5–24–18; 8:45 am]
priority to the aforementioned
applications.
BILLING CODE 4165–15–P
The patent rights in these inventions
have been assigned to the government of
the United States of America.

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Document Created: 2018-05-25 02:13:22
Document Modified: 2018-05-25 02:13:22

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 of Advisory Committee meeting.
Dates		Friday, June 15, 2018, from 10:00 a.m. to 2:00 p.m. ET.
Contact		Annie Herzog, Principal Staff Liaison, Division of Injury Compensation Programs (DICP), Healthcare Systems Bureau (HSB), HRSA, 5600 Fishers Lane, Room 08N146B, Rockville, Maryland 20857; phone: (301) 443-6593; or email: [email protected]
FR Citation		83 FR 24317

83 FR 24317 - Advisory Commission on Childhood Vaccines

DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth Resources and Services Administration

Federal Register Volume 83, Issue 102 (May 25, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration