82 FR 32711 - Announcement of Intent To Establish the Tick-Borne Disease Working Group and Solicitation of Nominations for Appointment to the Working Group Membership

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 82, Issue 135 (July 17, 2017)

Page Range		32711-32712
FR Document		2017-14965

The U.S. Department of Health and Human Services (HHS) announces establishment of the Working Group. The Secretary of Health and Human Services is responsible for ensuring the conduct of and support for epidemiological, basic, translational, and clinical research related to vector-borne diseases, including tick-borne diseases. The Working Group will assist in this effort. The Working Group will consist of representatives of appropriate federal agencies and non-federal entities who represent diverse scientific disciplines and views. The Working Group will provide expertise and review all efforts within the Department of Health and Human Services related to all tick- borne diseases, to help ensure interagency coordination and minimize overlap, and to examine research priorities. This notice also will serve to announce that HHS is seeking nominations of individuals who are interested in being considered for appointment to the Working Group. Resumes or curricula vitae from qualified individuals who wish to be considered for appointment as a member of the Working Group are currently being accepted.

Federal Register, Volume 82 Issue 135 (Monday, July 17, 2017)

[Federal Register Volume 82, Number 135 (Monday, July 17, 2017)]
[Notices]
[Pages 32711-32712]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-14965]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Announcement of Intent To Establish the Tick-Borne Disease 
Working Group and Solicitation of Nominations for Appointment to the 
Working Group Membership

AGENCY: Office of the Assistant Secretary for Health, Office of the 
Secretary, U.S. Department of Health and Human Services.

ACTION: Notice.

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

SUMMARY: The U.S. Department of Health and Human Services (HHS) 
announces establishment of the Working Group. The Secretary of Health 
and Human Services is responsible for ensuring the conduct of and 
support for epidemiological, basic, translational, and clinical 
research related to vector-borne diseases, including tick-borne 
diseases.
    The Working Group will assist in this effort. The Working Group 
will consist of representatives of appropriate federal agencies and 
non-federal entities who represent diverse scientific disciplines and 
views. The Working Group will provide expertise and review all efforts 
within the Department of Health and Human Services related to all tick-
borne diseases, to help ensure interagency coordination and minimize 
overlap, and to examine research priorities.
    This notice also will serve to announce that HHS is seeking 
nominations of individuals who are interested in being considered for 
appointment to the Working Group. Resumes or curricula vitae from 
qualified individuals who wish to be considered for appointment as a 
member of the Working Group are currently being accepted.

DATES: Nominations must be received no later than close of business 
August 16, 2017.

ADDRESSES: All nominations should be sent to: CAPT Richard Henry, 
Office of HIV/AIDS and Infectious Disease Policy, Office of the 
Assistant Secretary for Health, U.S. Department of Health and Human 
Services, 330 C Street SW., Room L001 Switzer Building, Washington, DC 
20201.

FOR FURTHER INFORMATION CONTACT: CAPT Richard Henry, Office of HIV/AIDS 
and Infectious Disease Policy; Telephone: (202) 795-7615; Fax: (202) 
691-2101; Email address: [email protected]. When the charter for 
the Working Group has been filed with the appropriate Congressional 
committees and the Library of Congress, this document will be made 
available online. Web site information about activities of the Working 
Group will be provided when the URL has been identified. The charter 
will include detailed information about the purpose, function, and 
structure of the Working Group.

SUPPLEMENTARY INFORMATION: Section 2062 of the 21st Century Cures Act 
authorizes establishment of the Tick-Borne Disease Working Group 
(Working Group). The Working Group will be governed by provisions of 
the Federal Advisory Committee Act, Public Law 92-463, as amended (5 
U.S.C. App.), which sets forth standards for the formation and use of 
federal advisory committees.
    The 21st Century Cures Act is intended to advance the research and 
development of new therapies and diagnostics and make substantial 
federal investments in a wide range of health priorities.
    Under Section 2062 of the 21st Century Cures Act, it is mandated 
that the Secretary of Health and Human Services establish the Working 
Group. The Working Group will be comprised of representatives of 
appropriate federal agencies and non-federal entities. The Working 
Group membership will represent diverse scientific disciplines and 
views.
    The charter for the Working Group has been drafted. When the 
charter is approved, it will be filed with the appropriate 
Congressional committees and the Library of Congress; hard copies of 
this document will be made available upon request. The approved charter 
also will be accessible on line. The Working Group will be established 
as a non-discretionary federal advisory committee.
    Objectives and Scope of Activities. The Secretary of Health and 
Human Services is responsible for ensuring the conduct of and support 
for epidemiological, basic, translational, and clinical research 
related to vector-borne diseases, including tick-borne diseases. The 
Working Group will provide assistance for this effort. The Working 
Group membership will provide expertise and will review all efforts 
within the Department of Health and Human Services related to all tick-
borne diseases, to help ensure interagency coordination and minimize 
overlap, and to examine research priorities.
    Membership and Designation. The Working Group will consist of 14 
voting members who represent diverse scientific disciplines and views. 
The composition will include seven federal members and seven non-
federal public members. The federal members will consist of one or more 
representatives of each of the following: Office of the Assistant 
Secretary for Health, the Food and Drug Administration, the Centers for 
Disease Control and Prevention, and the National Institutes of Health. 
The non-federal public members will consist of representatives of the 
following categories: Physicians and other medical providers with 
experience in diagnosing and treating tick-borne diseases; scientists 
or researchers with expertise; patients and their family members; 
nonprofit organizations that advocate for patients with respect to 
tick-borne disease. Individuals who are appointed to represent federal 
entities will be classified as regular government employees. The non-
federal public members will be classified as special government 
employees. Invitations of membership will be extended to other agencies 
and offices of the Department of Health and Human Services and other 
individuals as determined by the Secretary to be appropriate and 
beneficial for accomplishing the mission of the Working Group.
    The federal members will be appointed to serve for the duration of 
time that the Working Group is authorized to operate. Participation of 
the appointed federal members will be at the discretion of their 
respective agency head. The non-federal public members will be invited 
to serve overlapping terms of up to four years. Any non-federal public 
member who is appointed to fill the vacancy of an unexpired term will 
be appointed to serve for the remainder of that term. A non-federal 
public member may serve after the expiration of their term until their 
successor has taken office, but no longer than 180 days. Terms of more 
than two years are contingent upon renewal of the charter of the 
Working Group.
    Pursuant to advance written agreement, non-federal public members 
of the Working Group will receive no stipend for the advisory service 
that they render as members of the Working Group. However, non-federal 
public members will receive per diem and reimbursement for travel 
expenses incurred in relation to performing duties for the Working 
Group, as authorized by law under 5 U.S.C. 5703 for persons who are 
employed intermittently to perform services for the federal

[[Page 32712]]

government and in accordance with federal travel regulations.
    Estimated Number and Frequency of Meetings. The Working Group will 
meet not less than twice a year. The meetings will be open to the 
public, except as determined otherwise by the Secretary, or another 
official to whom authority has been delegated, in accordance with the 
guidelines under Government in the Sunshine Act, 5 U.S.C. 552b(c).
    Nominations: Nominations, including self-nominations, of 
individuals who have the specified expertise and knowledge will be 
considered for appointment as public voting members of the Working 
Group. A nomination should include, at a minimum, the following for 
each nominee: (1) A letter of nomination that clearly states the name 
and affiliation of the nominee, the basis for the nomination, and a 
statement from the nominee that indicates that the individual is 
willing to serve as a member of the Working Group, if selected; (2) the 
nominator's name, address, and daytime telephone number, and the 
address, telephone number, and email address of the individual being 
nominated; and (3) a current copy of the nominee's curriculum vitae or 
resume, which should be limited to no more than 10 pages.
    Every effort will be made to ensure that the Working Group is a 
diverse group of individuals with representation from various 
geographic locations, racial and ethnic minorities, all genders, and 
persons living with disabilities.
    Individuals being considered for appointment as public voting 
members will be required to complete and submit a report of their 
financial holdings. An ethics review must be conducted to ensure that 
individuals appointed as public voting members of the Working Group are 
not involved in any activity that may pose a potential conflict of 
interest for the official duties that are to be performed. This is a 
federal ethics requirement that must be satisfied upon entering the 
position and annually throughout the established term of appointment on 
the Working Group.

    Dated: July 12, 2017.
Donald Wright,
Acting Assistant Secretary for Health.
[FR Doc. 2017-14965 Filed 7-14-17; 8:45 am]
 BILLING CODE 4150-28-P

32712 Federal Register / Vol. 82, No. 135 / Monday, July 17, 2017 / Notices

government and in accordance with DEPARTMENT OF HEALTH AND DEPARTMENT OF HEALTH AND
federal travel regulations. HUMAN SERVICES HUMAN SERVICES
Estimated Number and Frequency of
National Institutes of Health National Institutes of Health
Meetings. The Working Group will meet
not less than twice a year. The meetings Prospective Grant of Exclusive Patent
National Institute of Allergy and
will be open to the public, except as License: Development, Commercial
Infectious Diseases; Notice of Closed
determined otherwise by the Secretary, Application and Use of Fulvestrant in
Meeting
or another official to whom authority Combination Therapy for the
has been delegated, in accordance with Pursuant to section 10(d) of the Treatment of Cancers
the guidelines under Government in the Federal Advisory Committee Act, as AGENCY: National Institutes of Health,
Sunshine Act, 5 U.S.C. 552b(c). amended (5 U.S.C. App.), notice is HHS.
Nominations: Nominations, including hereby given of the following meeting. ACTION: Notice.
self-nominations, of individuals who The meeting will be closed to the
have the specified expertise and public in accordance with the SUMMARY: The National Cancer Institute,
knowledge will be considered for provisions set forth in sections an institute of the National Institutes of
appointment as public voting members Health, Department of Health and
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
of the Working Group. A nomination Human Services, is contemplating the
as amended. The grant applications and
should include, at a minimum, the grant of an Exclusive Commercialization
the discussions could disclose Patent License to practice the inventions
following for each nominee: (1) A letter confidential trade secrets or commercial
of nomination that clearly states the embodied in the U.S. Patents and Patent
property such as patentable material, Applications listed in the
name and affiliation of the nominee, the and personal information concerning
basis for the nomination, and a Supplementary Information section of
individuals associated with the grant this notice to NantBioScience, Inc.,
statement from the nominee that applications, the disclosure of which located in, California, USA.
indicates that the individual is willing would constitute a clearly unwarranted DATES: Only written comments and/or
to serve as a member of the Working invasion of personal privacy. applications for a license which are
Group, if selected; (2) the nominator’s
Name of Committee: National Institute of received by the National Cancer
name, address, and daytime telephone
Allergy and Infectious Diseases Special Institute’s Technology Transfer Center
number, and the address, telephone on or before August 1, 2017 will be
Emphasis Panel; NIAID Clinical Trial
number, and email address of the Planning Grant (R34). considered.
individual being nominated; and (3) a Date: July 31, 2017.
current copy of the nominee’s ADDRESSES: Requests for copies of the
Time: 2:00 p.m. to 4:00 p.m. patent application, inquiries, and
curriculum vitae or resume, which Agenda: To review and evaluate grant
should be limited to no more than 10 comments relating to the contemplated
applications. Exclusive Commercialization Patent
pages. Place: National Institutes of Health, 5601 License should be directed to: Sabarni
Every effort will be made to ensure Fishers Lane, Rockville, MD 20892 K. Chatterjee, Ph.D., M.B.A., Senior
that the Working Group is a diverse (Telephone Conference Call).
Licensing and Patenting Manager, NCI
group of individuals with representation Contact Person: Jay R. Radke, Ph.D., AIDS
Technology Transfer Center, 9609
from various geographic locations, racial Review Branch, Scientific Review Program,
Medical Center Drive, RM 1E530 MSC
Division of Extramural Activities, Room
and ethnic minorities, all genders, and 9702, Bethesda, MD 20892–9702 (for
#3G11B, National Institutes of Health, NIAID,
persons living with disabilities. business mail), Rockville, MD 20850–
5601 Fishers Lane MSC–9823, Bethesda, MD
Individuals being considered for 9702 Telephone: (240) 276–5530;
20892–9823, (240) 669–5046, jay.radke@
appointment as public voting members nih.gov.
Facsimile: (240) 276–5504 Email:
will be required to complete and submit sabarni.chatterjee@nih.gov.
This notice is being published less than 15
a report of their financial holdings. An SUPPLEMENTARY INFORMATION:
days prior to the meeting due to the urgent
ethics review must be conducted to need to meet timing limitations imposed by Intellectual Property
ensure that individuals appointed as the intramural research review cycle. • United States Provisional Patent
public voting members of the Working (Catalogue of Federal Domestic Assistance Application No. 62/290,117 filed
Group are not involved in any activity Program Nos. 93.855, Allergy, Immunology, February 02, 2016, and entitled
that may pose a potential conflict of and Transplantation Research; 93.856, ‘‘Fulvestrant Improves Immune-
interest for the official duties that are to Microbiology and Infectious Diseases mediated Cytotoxic Lysis of Cancer
be performed. This is a federal ethics Research, National Institutes of Health, HHS) Cells.’’ [HHS Reference No. E–066–
requirement that must be satisfied upon Dated: July 10, 2017. 2016/0–US–01];
entering the position and annually Natasha M. Copeland, • International PCT Application No.
throughout the established term of PCT/US2017/015829 filed January 31,
Program Analyst, Office of Federal Advisory
appointment on the Working Group. 2017, entitled ‘‘Fulvestrant Improves
Committee Policy.
Dated: July 12, 2017. Immune-mediated Cytotoxic Lysis of
[FR Doc. 2017–14857 Filed 7–14–17; 8:45 am]
asabaliauskas on DSKBBXCHB2PROD with NOTICES

Cancer Cells.’’ [HHS Reference No. E–
Donald Wright, BILLING CODE 4140–01–P 066–2016/0–PCT–02]; and U.S. and
Acting Assistant Secretary for Health. foreign patent applications claiming
[FR Doc. 2017–14965 Filed 7–14–17; 8:45 am] priority to the aforementioned
BILLING CODE 4150–28–P applications.
The patent rights in these inventions
have been assigned and/or exclusively
licensed to the government of the
United States of America.

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Document Created: 2017-07-15 03:46:06
Document Modified: 2017-07-15 03:46:06

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		Nominations must be received no later than close of business August 16, 2017.
Contact		CAPT Richard Henry, Office of HIV/AIDS and Infectious Disease Policy; Telephone: (202) 795-7615; Fax: (202)
FR Citation		82 FR 32711