81 FR 74456 - Renewal of Charters for Certain Federal Advisory Committees

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 81, Issue 207 (October 26, 2016)

Page Range		74456-74458
FR Document		2016-25916

As stipulated by the Federal Advisory Committee Act, as amended (5 U.S.C. App), the U.S. Department of Health and Human Services is hereby announcing that the charters have been renewed for the following federal advisory committees for which Office of the Assistant Secretary for Health provides management support: Chronic Fatigue Syndrome Advisory Committee (CFSAC); President's Council on Fitness, Sports, and Nutrition (PCFSN; the Council); Secretary's Advisory Committee on Human Research Protections (SACHRP); and Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA). Functioning as federal advisory committees, these committees are governed by the provisions of the Federal Advisory Committee Act (FACA). Under FACA, it is stipulated that the charter for a federal advisory committee must be renewed every two years in order for the committee to continue to operate.

Federal Register, Volume 81 Issue 207 (Wednesday, October 26, 2016)

[Federal Register Volume 81, Number 207 (Wednesday, October 26, 2016)]
[Notices]
[Pages 74456-74458]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2016-25916]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Renewal of Charters for Certain Federal Advisory Committees

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

ACTION: Notice.

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

SUMMARY: As stipulated by the Federal Advisory Committee Act, as
amended (5 U.S.C. App), the U.S. Department of Health and Human
Services is hereby announcing that the charters have been renewed for
the following federal advisory committees for which Office of

[[Page 74457]]

the Assistant Secretary for Health provides management support: Chronic
Fatigue Syndrome Advisory Committee (CFSAC); President's Council on
Fitness, Sports, and Nutrition (PCFSN; the Council); Secretary's
Advisory Committee on Human Research Protections (SACHRP); and Advisory
Committee on Blood and Tissue Safety and Availability (ACBTSA).
Functioning as federal advisory committees, these committees are
governed by the provisions of the Federal Advisory Committee Act
(FACA). Under FACA, it is stipulated that the charter for a federal
advisory committee must be renewed every two years in order for the
committee to continue to operate.

FOR FURTHER INFORMATION CONTACT: Olga B. Nelson, Committee Management
Officer, Office of the Assistant Secretary for Health; U.S. Department
of Health and Human Services; 200 Independence Avenue SW., Room 714B;
Washington, DC 20201; (202) 690-5205.

SUPPLEMENTARY INFORMATION: CFSAC was established on September 5, 2002
as a discretionary federal advisory committee. The Committee provides
science-based advice and recommendations to the Secretary of Health and
Human Services, through the Assistant Secretary for Health, on a broad
range of issues and topics pertaining to myalgic encephalomyelitis/
chronic fatigue syndrome (ME/CFS), including (1) opportunities to
improve knowledge and research about the epidemiology, etiologies,
biomarkers and risk factors for ME/CFS; (2) research on the diagnosis,
treatment, and management of ME/CFS and potential impact of treatment
options; (3) strategies to inform the public, health care
professionals, and the biomedical academic and research communities
about ME/CFS advances; (4) partnerships to improve the quality of life
of ME/CFS patients; and (5) strategies to insure that input from ME/CFS
patients and care givers is incorporated into HHS policy and research.
The new charter includes the following amendments: (1) The language
in the Description of Duties has been simplified. A fifth duty has been
added to emphasize the importance of getting stakeholder input on HHS
policy and research concerning ME/CFS; (2) authority has been given to
the Assistant Secretary for Health (ASH) as an official to whom the
Committee will report. Extending this authority to include the ASH
gives clear responsibility to the ASH for better monitoring and
implementation of the recommendations that are approved by the
Secretary; and (3) the Committee structure has been changed to (a)
increase the number of voting public members to 13 to give patients
and/or caretakers of ME/CFS more representation on the Committee. This
amendment has been made to the charter to respond to recent concerns
that had been expressed by CFS advocates, (b) remove the Centers for
Medicare and Medicaid Services (CMS) as a non-voting ex-officio member.
A determination was made that there is not much for CMS to contribute
to or to seek advice from CFSAC. It would be more beneficial to have
CMS involved in the Committee's deliberative process if diagnostics or
treatments are developed for ME/CFS. This activity is not projected to
take place during the two-year period that the new charter will be in
effect, and (c) expand the Committee structure to add two new ex-
officio positions for the Department of Veterans Affairs (VA) and the
Department of Defense (DoD). Expanding the Committee structure to
include these two government agencies will provide valuable information
on services available to patients with ME/CFS and research being
conducted on illnesses with similar symptoms to ME/CFS.
On September 5, 2016, the Secretary of Health and Human Services
approved for the CFSAC charter with the proposed amendments to be
renewed. The new charter has been made effective; the charter was filed
with the appropriate Congressional committees and the Library of
Congress on September 5, 2016. Renewal of the CFSAC charter provides
authorization for the Committee to continue to operate until September
5, 2018. A copy of the Committee charter is available on the CFSAC Web
site at http://www.hhs.gov/advcomcfs.
The PCFSN is a non-discretionary federal advisory committee. The
PCFSN was established under Executive Order 13545, dated June 22, 2010.
This authorizing directive was issued to amend the purpose, function,
and name of the Council, which formerly operated as the President's
Council on Physical Fitness and Sports (PCPFS). The scope of the
Council was changed to include nutrition to bring attention to the
importance of good nutritional habits with regular physical activity
for maintaining a healthy lifestyle. The PCFSN is the only federal
advisory committee that is focused solely on the promotion of physical
activity, fitness, sports, and nutrition. Since the PCFSN was
established by Presidential directive, appropriate action had to be
taken by the President or agency head to authorize continuation of the
PCFSN. The President issued Executive Order 13708, dated September 30,
2015. Under the authority given in this directive, the Council can
continue to operate until September 30, 2017.
No amendments were recommended for the PCFSN charter. The charter
was approved by the Secretary of Health and Human Services on September
8, 2016, and it was filed with the appropriate Congressional committees
and the Library of Congress on September 10, 2016. A copy of the
Council charter is available on the PCFSN Web site at http://fitness.gov.
SACHRP is a discretionary federal advisory committee. SACHRP
provides advice to the Secretary, through the Assistant Secretary for
Health, on matters pertaining to the continuance and improvement of
functions within the authority of the Department of Health and Human
Services concerning protections for human subjects in research.
There was one amendment recommended and approved for the SACHRP
charter. The charter stipulated that appointment of the Designated
Federal Officer (DFO) was restricted to the Director of the Office for
Human Research Protections. This restriction has been removed to allow
for other senior level program and management OHRP staff to be
considered for appointment as the DFO. On September 30, 2016, the
Secretary of Health and Human Services approved for the SACHRP charter
to be renewed. The new charter was filed with the appropriate
Congressional committees and the Library of Congress on October 1,
2016. SACHRP is authorized to continue to operate until October 1,
2018. A copy of the charter is available on the Committee Web site at
http://www.hhs.gov/ohrp/sachrp/.
The ACBTSA is a discretionary federal advisory committee. The
Committee provides advice to the Secretary, through the Assistant
Secretary for Health, on a range of policy issues related to the safety
of blood, blood products, organs and tissues. For organs and blood stem
cells, the Committee's work is limited to policy issues related to
donor derived infectious disease complications of transplantation
around the safety and availability of the blood supply and blood
products.
There were two minor amendments recommended and approved for the
ACBTSA charter. The charter has been amended to include the option for
a Vice Chair and/or Co-Chairs to be

[[Page 74458]]

appointed for the Committee leadership. The Committee structure has
been expanded to include ex-officio representation from the Department
of Veterans Affairs (VA). The VA has the largest conglomerate of
hospitals in the United States. The agency has responsibility for the
largest patient population that uses the largest quantity of blood and
tissue products in the United States. Therefore, it was determined that
involvement of the VA would be beneficial to the ACBTSA for ensuring
that the Committee properly addresses current issues and concerns
regarding blood and tissue safety and availability.
On October 5, 2016, the new charter for the ACBTSA was approved by
the Secretary of Health and Human Services, and it was filed with the
appropriate Congressional committees and the Library of Congress on
October 9, 2016. ACBTSA is authorized to operate until October 9, 2018.
A copy of the charter can be obtained on the ACBTSA Web site at http://www.hhs.gov/ash/bloodsafety.
Copies of the charters for the designated committees also can be
obtained by accessing the FACA database that is maintained by the
Committee Management Secretariat under the General Services
Administration. The Web site address for the FACA database is http://facadatabase.gov/.

Dated: October 20, 2016.
Karen B. DeSalvo,
Acting Assistant Secretary for Health.
[FR Doc. 2016-25916 Filed 10-25-16; 8:45 am]
BILLING CODE 4150-28-P

74456 Federal Register / Vol. 81, No. 207 / Wednesday, October 26, 2016 / Notices

revision of Vaccine Information using the following URL: https:// and severity of adverse reactions
Statements; and recommending to the hrsa.connectsolutions.com/accv/ (copy associated with childhood vaccines;
Director of the National Vaccine and paste the link into your browser if consulting on the development or
Program research related to vaccine it does not work directly, and enter as revision of Vaccine Information
injuries which should be conducted to a guest). Participants should call and Statements; and recommending to the
carry out the VICP. connect 15 minutes prior to the meeting Director of the National Vaccine
On July 21, 2016, the ACCV charter in order for logistics to be set up. If you Program research related to vaccine
was renewed. Renewal of the ACCV have never attended an Adobe Connect injuries which should be conducted to
charter gives authorization for the meeting, please test your connection carry out VICP.
Commission to operate until July 21, using the following URL: https:// The agenda items for the December
2018. hrsa.connectsolutions.com/common/ 2016 meeting will include, but are not
A copy of the ACCV charter is help/en/support/meeting_test.htm and limited to, updates from the Division of
available on the ACCV Web site at get a quick overview by following URL: Injury Compensation Programs (DICP),
http://www.hrsa.gov/ http://www.adobe.com/go/connectpro_ Department of Justice (DOJ), National
advisorycommittees/childhoodvaccines/ overview. Vaccine Program Office (NVPO),
index.html. A copy of the charter also Immunization Safety Office (Centers for
FOR FURTHER INFORMATION CONTACT:
can be obtained by accessing the FACA Disease Control and Prevention),
Anyone requesting information
database that is maintained by the National Institute of Allergy and
regarding the ACCV should contact
Committee Management Secretariat Infectious Diseases (National Institutes
Annie Herzog, Program Analyst,
under the General Services Division of Injury Compensation of Health) and Center for Biologics,
Administration. The Web site address Programs (DICP), Health Resources and Evaluation and Research (Food and
for the FACA database is http:// Services Administration in one of three Drug Administration). A draft agenda
www.facadatabase.gov/. ways: (1) Send a request to the following and additional meeting materials will be
address: Annie Herzog, Program posted on the ACCV Web site (http://
Jason E. Bennett,
Analyst, DICP, Health Resources and www.hrsa.gov/advisorycommittees/
Director, Division of the Executive Secretariat.
Services Administration, 5600 Fishers childhoodvaccines/index.html) prior to
[FR Doc. 2016–25857 Filed 10–25–16; 8:45 am] the meeting. Agenda items are subject to
Lane, 08N146B, Rockville, Maryland
BILLING CODE 4165–15–P
20857; (2) call (301) 443–6593; or (3) change as priorities dictate.
Members of the public will have the
send an email to aherzog@hrsa.gov.
At this time the meeting is scheduled opportunity to provide comments. Oral
DEPARTMENT OF HEALTH AND comments will be honored in the order
HUMAN SERVICES to be held over 2 days via conference
call and Adobe Connect webinar; they are requested and may be limited
Health Resources and Service however, meeting times and locations as time allows. Requests to make oral
Administration could change. For the latest information comments or provide written comments
regarding meeting start time and to the ACCV should be sent to Annie
Advisory Commission on Childhood location, please check the ACCV Web Herzog using the address and phone
Vaccines site: http://www.hrsa.gov/ number above by November 29, 2016.
advisorycommittees/childhoodvaccines/ Individuals who need special
AGENCY: Health Resources and Service assistance, such as sign language
Administration, HHS. index.html.
interpretation or other reasonable
ACTION: Notice of meeting. SUPPLEMENTARY INFORMATION: The ACCV accommodations, should notify Annie
was established by section 2119 of the Herzog, using the address and phone
SUMMARY: In accordance with section Public Health Service Act (the Act) (42 number above at least 10 days prior to
10(a)(2) of the Federal Advisory U.S.C. 300aa–19), as enacted by Public the meeting.
Committee Act (Public Law 92–463), Law (Pub. L.) 99–660, and as
notice is hereby given that a meeting is subsequently amended, and advises the Jason E. Bennett,
scheduled for the Advisory Commission Secretary of Health and Human Services Director, Division of the Executive Secretariat.
on Childhood Vaccines (ACCV). This (the Secretary) on issues related to [FR Doc. 2016–25875 Filed 10–25–16; 8:45 am]
meeting will be open to the public. implementation of the National Vaccine BILLING CODE 4165–15–P
Information about the ACCV and the Injury Compensation Program (VICP).
agenda for this meeting can be obtained Other activities of ACCV include:
by accessing the following Web site: Recommending changes to the Vaccine DEPARTMENT OF HEALTH AND
http://www.hrsa.gov/ Injury Table at its own initiative or as HUMAN SERVICES
advisorycommittees/childhoodvaccines/ the result of the filing of a petition;
index.html. advising the Secretary in implementing Renewal of Charters for Certain
section 2127 of the Act regarding the Federal Advisory Committees
DATES: The meeting will be held on
December 1 and 2, 2016, at 10:00 a.m. need for childhood vaccination AGENCY: Office of the Assistant
EST. products that result in fewer or no Secretary for Health, Office of the
ADDRESSES: This meeting will be held significant adverse reactions; surveying Secretary, Department of Health and
via Adobe Connect Webinar. The public federal, state, and local programs and Human Services.
activities related to gathering
asabaliauskas on DSK3SPTVN1PROD with NOTICES

can join the meeting by: ACTION: Notice.
1. (Audio Portion) Calling the information on injuries associated with
conference phone number 800–779– the administration of childhood SUMMARY: As stipulated by the Federal
3561 and providing the following vaccines, including the adverse reaction Advisory Committee Act, as amended (5
information: reporting requirements of section U.S.C. App), the U.S. Department of
Leader Name: Dr. Narayan Nair. 2125(b) of the Act; advising the Health and Human Services is hereby
Password: 8164763. Secretary on the methods of obtaining, announcing that the charters have been
2. (Visual Portion) Connecting to the compiling, publishing, and using renewed for the following federal
ACCV Adobe Connect Pro Meeting credible data related to the frequency advisory committees for which Office of

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74458 Federal Register / Vol. 81, No. 207 / Wednesday, October 26, 2016 / Notices

appointed for the Committee leadership. technical needs for non-animal test receipt of the requested information is
The Committee structure has been methods that could be used to evaluate December 12, 2016.
expanded to include ex-officio the potential of chemicals to induce Responses to this request are
representation from the Department of inflammation and immune-related voluntary. No proprietary, classified,
Veterans Affairs (VA). The VA has the conditions. confidential, or sensitive information
largest conglomerate of hospitals in the should be included in responses. This
DATES: Receipt of information: Deadline
United States. The agency has request for information is for planning
is December 12, 2016.
responsibility for the largest patient purposes only and is not a solicitation
population that uses the largest quantity ADDRESSES: Data and information
for applications or an obligation on the
of blood and tissue products in the should be submitted electronically at
part of the U.S. Government to provide
United States. Therefore, it was http://ntp.niehs.nih.gov/go/input.
support for any ideas identified in
determined that involvement of the VA FOR FURTHER INFORMATION CONTACT: Dr. response to the request. Please note that
would be beneficial to the ACBTSA for Dori Germolec, Toxicology Branch, the U.S. Government will not pay for
ensuring that the Committee properly Division of NTP, NIEHS; email: the preparation of any information
addresses current issues and concerns germolec@niehs.nih.gov; telephone: submitted or for its use of that
regarding blood and tissue safety and (919) 541–3230. information.
availability. SUPPLEMENTARY INFORMATION: Background Information on NTP: NTP
On October 5, 2016, the new charter Background: NTP has an interest in is an interagency program established in
for the ACBTSA was approved by the developing more efficient and scalable 1978 (43 FR 53060) to strengthen the
Secretary of Health and Human test platforms to provide the scientific Department’s activities in toxicology
Services, and it was filed with the basis for predictive models of chemical research and testing and to develop and
appropriate Congressional committees effects on human disease. Short-term validate new and better testing methods.
and the Library of Congress on October toxicity tests may be conducted to Other activities of the program focus on
9, 2016. ACBTSA is authorized to determine the potential for a single or strengthening the science base in
operate until October 9, 2018. A copy of short-term dose of a substance to cause toxicology and providing information
the charter can be obtained on the inflammation-related responses or about potentially toxic chemicals to
ACBTSA Web site at http:// impact local and systemic immune health-regulatory and research agencies,
www.hhs.gov/ash/bloodsafety. function when inhaled (inhalation
Copies of the charters for the scientific and medical communities,
toxicity testing), swallowed (oral and the public. NTP is located
designated committees also can be
toxicity testing), or absorbed through the administratively at the NIEHS.
obtained by accessing the FACA
skin (dermal toxicity testing). A number Information about NIEHS and NTP is
database that is maintained by the
of observations support a role for available at http://www.niehs.nih.gov
Committee Management Secretariat
environmental influences on and http://ntp.niehs.nih.gov,
under the General Services
inflammatory and immune-related respectively.
Administration. The Web site address
diseases such as diabetes. One specific Dated: October 20, 2016.
for the FACA database is http://
use of information received in response
facadatabase.gov/. John R. Bucher,
to this request is to assist NTP in
Dated: October 20, 2016. identifying in vitro or alternative animal Associate Director, National Toxicology
Karen B. DeSalvo, Program.
model screens that might be used to
[FR Doc. 2016–25924 Filed 10–25–16; 8:45 am]
Acting Assistant Secretary for Health. assess the potential for chemicals to
cause outcomes related to Type 1 BILLING CODE 4140–01–P
[FR Doc. 2016–25916 Filed 10–25–16; 8:45 am]
BILLING CODE 4150–28–P diabetes. In addition, information
received from this request will provide
fundamental knowledge on the use of DEPARTMENT OF HEALTH AND
DEPARTMENT OF HEALTH AND these in vitro platforms for identifying HUMAN SERVICES
HUMAN SERVICES environmental triggers of excessive National Institutes of Health
inflammation and exaggerated immune
National Institutes of Health responses that could lead to tissue National Institute of Allergy and
injury. Infectious Diseases; Notice of Closed
Short-Term Alternative Animal Models
Request for Information: NTP requests Meetings
or In Vitro Tests Used To Identify
available data and information on
Substances With the Potential To Pursuant to section 10(d) of the
approaches and/or technologies
Cause Excessive Inflammation or Federal Advisory Committee Act, as
currently used to identify substances
Exaggerated Immune Responses; amended (5 U.S.C. App.), notice is
with the potential to cause excessive
Request for Information hereby given of the following meetings.
inflammation or exaggerated immune
SUMMARY: The National Toxicology responses leading to tissue injury. The meetings will be closed to the
Program (NTP) at the National Institute Respondents should provide public in accordance with the
of Environmental Health Sciences information on any activities relevant to provisions set forth in sections
(NIEHS) requests available data and the development or validation of 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
information on approaches and/or alternatives to in vivo tests currently as amended. The grant applications and
asabaliauskas on DSK3SPTVN1PROD with NOTICES

technologies currently used to identify used in the assessment of immune the discussions could disclose
substances with the potential to cause toxicity and autoimmunity. confidential trade secrets or commercial
excessive inflammation or exaggerated Respondents to this request for property such as patentable material,
immune responses leading to tissue information should include their name, and personal information concerning
injury when swallowed, inhaled, or affiliation (if applicable), mailing individuals associated with the grant
absorbed through the skin. Submitted address, telephone, email, and applications, the disclosure of which
information will be used to assess the sponsoring organization (if any) with would constitute a clearly unwarranted
state of the science and determine their communications. The deadline for invasion of personal privacy.

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Document Created: 2016-10-26 02:17:59
Document Modified: 2016-10-26 02:17:59

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.
Contact		Olga B. Nelson, Committee Management Officer, Office of the Assistant Secretary for Health; U.S. Department of Health and Human Services; 200 Independence Avenue SW., Room 714B; Washington, DC 20201; (202) 690-5205.
FR Citation		81 FR 74456