National Advisory Committee on Rural Health and Human Services; Notice of Meeting, 60007-60008 [2016-20911]
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Federal Register / Vol. 81, No. 169 / Wednesday, August 31, 2016 / Notices
2015 when the first local transmission
was reported in Brazil. Local
transmission of ZIKV has also been
reported in areas outside of the
Americas, including the Pacific Islands
of Samoa, American Samoa, Marshall
Islands and Tonga, and Cape Verde in
Africa, and there are now at least 50
countries and territories worldwide
with active local transmission of the
virus.
The first local transmission of ZIKV in
the United States was reported from
Puerto Rico in December 2015, and soon
thereafter local transmission was also
reported in American Samoa and the
U.S. Virgin Islands. In July 2016, the
first cases of local transmission of ZIKV
occurring in the continental United
States were reported from Miami-Dade
County in Florida. The possibility of
further geographic spread of ZIKV exists
in regions where the Aedes aegypti, and
possibly the Aedes albopictus, mosquito
is present. In January 2016, ZIKV
disease was added to the list of
nationally notifiable conditions in the
United States as a subtype of Arboviral
diseases.
The most common ZIKV disease
symptoms include fever, arthralgia,
maculopapular rash, and conjunctivitis.
In addition, neurological manifestations
and congenital anomalies have been
associated with ZIKV disease outbreaks.
ZIKV infection has been associated with
´
Guillain-Barre syndrome. ZIKV
infection during pregnancy is a cause of
microcephaly and other serious fetal
brain anomalies. Other problems have
been detected in pregnancies and among
fetuses and infants infected with ZIKV
before birth, such as miscarriage,
stillbirth, absent or poorly developed
brain structures, defects of the eye,
hearing deficits, and impaired growth;
however, the full clinical spectrum of
the effects of ZIKV infection during
pregnancy is not yet known.
FDA has identified ZIKV as a
transfusion-transmitted infection under
§ 630.3(l) and RTTI under § 630.3(h)(2).
This determination is based on the
severity of the disease, risk of
transfusion-transmission by blood and
blood components, the availability of
appropriate screening measures, and
significant incidence and prevalence
affecting the potential donor population.
The guidance recommends that blood
establishments test all donations
collected in the United States and its
territories with an investigational
individual donor nucleic acid test (ID–
NAT) for ZIKV under an investigational
new drug application (IND), or when
available, a licensed test. Alternatively,
blood establishments may implement
pathogen reduction technology for
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platelets and plasma using an FDAapproved pathogen reduction device as
specified in the Instructions for Use of
the device. If an FDA-approved
pathogen reduction device becomes
available for Whole Blood or red blood
cells, blood establishments may
implement pathogen reduction
technology for such products rather
than testing the donations. Blood
establishments implementing these
measures may discontinue providing
donor educational material with respect
to ZIKV and screening donors for ZIKV
risk factors such as travel history and
deferring them as previously
recommended in the February 2016
guidance. Under 21 CFR 630.10(a), if a
donor volunteers a recent history of
ZIKV infection, a blood establishment
must not collect blood or blood
components from that donor. For such
donors, the guidance recommends a
deferral period of 120 days after a
positive viral test or the resolution of
symptoms, whichever timeframe is
longer.
FDA recommends that blood
establishments implement the
recommendations in the guidance as
follows: (1) Blood establishments that
collect Whole Blood and blood
components in U.S. States and
territories with one or more reported
locally acquired mosquito-borne cases
of ZIKV should implement the
recommendations immediately. Blood
establishments should cease blood
collection until testing or the use of
pathogen reduction technology is
implemented, consistent with the
recommendations in the guidance. As of
the date of issuance of the guidance, the
recommendations applies to blood
establishments that collect Whole Blood
and blood components in Florida and
Puerto Rico; (2) because of their
proximity to areas with locally acquired
mosquito-borne cases of ZIKV or
because of other epidemiological
linkage to ZIKV, such as the number of
travel-associated cases reported in a
State, blood establishments that collect
Whole Blood and blood components in
Alabama, Arizona, California, Georgia,
Hawaii, Louisiana, Mississippi, New
Mexico, New York, South Carolina, and
Texas should implement the
recommendations as soon as feasible,
but not later than 4 weeks after the
guidance issue date; and (3) blood
establishments that collect Whole Blood
and blood components in all other
States and territories should implement
the recommendations as soon as
feasible, but not later than 12 weeks
after the date of the issuance of this
guidance.
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60007
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
FDA is issuing this guidance for
immediate implementation in
accordance with 21 CFR 10.115(g)(2)
without initially seeking prior comment
because the Agency has determined that
prior public participation is not feasible
or appropriate. The guidance represents
the current thinking of FDA on ‘‘Revised
Recommendations for Reducing the Risk
of Zika Virus Transmission by Blood
and Blood Components.’’ It does not
establish any rights for any person and
is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
21 CFR 601.12 have been approved
under OMB control number 0910–0338;
the collections of information in 21 CFR
606.100(b) and 606.160(b)(1) have been
approved under OMB control number
0910–0795; and the collections of
information in 21 CFR 606.122 and
630.30 have been approved under OMB
control number 0910–0116.
III. Electronic Access
Persons with access to the Internet
may obtain the guidance at either https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidances/default.htm or
https://www.regulations.gov.
Dated: August 25, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–20914 Filed 8–30–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
National Advisory Committee on Rural
Health and Human Services; Notice of
Meeting
In accordance with Section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), notice is hereby given
of the following meeting:
NAME: National Advisory Committee on
Rural Health and Human Services.
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60008
Federal Register / Vol. 81, No. 169 / Wednesday, August 31, 2016 / Notices
DATES AND TIMES:
September 14, 2016, 8:30 a.m.–5:00 p.m.
MT
September 15, 2016, 8:30 a.m.–5:15 p.m.
MT
September 16, 2016, 8:30 a.m.–11:00
a.m. MT
PLACE:
Albuquerque Marriott, 2101 Louisiana
Boulevard NE., Albuquerque, New
Mexico 87110, (505) 881–6800.
STATUS: The meeting will be open to the
public.
PURPOSE: The National Advisory
Committee on Rural Health and Human
Services provides counsel and
recommendations to the Secretary with
respect to the delivery, research,
development, and administration of
health and human services in rural
areas.
AGENDA: The meeting on Wednesday,
September 14, will be called to order at
8:30 a.m. by the Chairperson of the
Committee, the Honorable Ronnie
Musgrove. The Committee will examine
the issue of social determinants of
health in rural areas. The day will
conclude with a period of public
comment at approximately 5:00 p.m.
The Committee will break into
subcommittees and depart for site visits
Thursday morning, September 15, at
approximately 8:30 a.m. Subcommittees
will visit the Presbyterian Medical
Services Cuba Health Center in Cuba,
New Mexico; the Laguna Pueblo, a
federally recognized Native American
tribe of the Pueblo people in Laguna,
New Mexico; and the Guadalupe County
Hospital in Santa Rosa, New Mexico.
The day will conclude at the
Albuquerque Marriott with the period of
public comment at approximately 5:15
p.m.
On Friday, September 16, at 8:30 a.m.,
the Committee will meet at the
Albuquerque Marriott to summarize key
findings from the site visits and develop
a work plan for the next quarter.
FOR FURTHER INFORMATION CONTACT:
Steve Hirsch, MSLS, Administrative
Coordinator, National Advisory
Committee on Rural Health and Human
Services, Health Resources and Services
Administration, 5600 Fishers Lane,
17W41D, Rockville, MD 20857,
Telephone (301) 443–0835, Fax (301)
443–2803.
Persons interested in attending any
portion of the meeting should contact
Pierre Joseph at the Federal Office of
Rural Health Policy (FORHP) via
telephone at (301) 945–0897 or by email
at PJoseph@hrsa.gov. Individuals who
plan to attend and need special
assistance, such as sign language
interpretation or other reasonable
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accommodations, should notify the
contact person listed above at least 10
days prior to the meeting. The
Committee meeting agenda will be
posted on the Committee’s Web site at
https://www.hrsa.gov/
advisorycommittees/rural/.
Jason E. Bennett,
Director, Division of the Executive Secretariat.
[FR Doc. 2016–20911 Filed 8–30–16; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Mental Health;
Notice of Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the
National Advisory Mental Health
Council.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications
and/or contract proposals and the
discussions could disclose confidential
trade secrets or commercial property
such as patentable material, and
personal information concerning
individuals associated with the grant
applications and/or contract proposals,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Advisory
Mental Health Council.
Date: September 20, 2016.
Open: 9:00 a.m. to 1:00 p.m.
Agenda: Presentation of the NIMH
Director’s Report and discussion of NIMH
program and policy issues.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852.
Closed: 2:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852.
Contact Person: Jean G. Noronha, Ph.D.,
Director, Division of Extramural Activities,
National Institute of Mental Health, NIH,
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Neuroscience Center, 6001 Executive Blvd.,
Room 6154, MSC 9609, Bethesda, MD 20892–
9609, 301–443–3367, jnoronha@mail.nih.gov.
Any member of the public interested in
presenting oral comments to the committee
may notify the Contact Person listed on this
notice at least 10 days in advance of the
meeting. Interested individuals and
representatives of organizations may submit
a letter of intent, a brief description of the
organization represented, and a short
description of the oral presentation. Only one
representative of an organization may be
allowed to present oral comments and if
accepted by the committee, presentations
may be limited to five minutes. Both printed
and electronic copies are requested for the
record. In addition, any interested person
may file written comments with the
committee by forwarding their statement to
the Contact Person listed on this notice. The
statement should include the name, address,
telephone number and when applicable, the
business or professional affiliation of the
interested person.
Information is also available on the
Institute’s/Center’s home page:
www.nimh.nih.gov/about/advisory-boardsand-groups/namhc/index.shtml., where an
agenda and any additional information for
the meeting will be posted when available.
(Catalogue of Federal Domestic Assistance
Program No. 93.242, Mental Health Research
Grants, National Institutes of Health, HHS)
Dated: August 24, 2016.
Carolyn A. Baum,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–20878 Filed 8–30–16; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Center For Complementary &
Integrative Health; Notice of Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the
National Advisory Council for
Complementary and Integrative Health.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
E:\FR\FM\31AUN1.SGM
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]]>Agencies
[Federal Register Volume 81, Number 169 (Wednesday, August 31, 2016)]
[Notices]
[Pages 60007-60008]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-20911]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
National Advisory Committee on Rural Health and Human Services;
Notice of Meeting
In accordance with Section 10(a)(2) of the Federal Advisory
Committee Act (Pub. L. 92-463), notice is hereby given of the following
meeting:
NAME: National Advisory Committee on Rural Health and Human Services.
[[Page 60008]]
DATES AND TIMES:
September 14, 2016, 8:30 a.m.-5:00 p.m. MT
September 15, 2016, 8:30 a.m.-5:15 p.m. MT
September 16, 2016, 8:30 a.m.-11:00 a.m. MT
PLACE:
Albuquerque Marriott, 2101 Louisiana Boulevard NE., Albuquerque, New
Mexico 87110, (505) 881-6800.
STATUS: The meeting will be open to the public.
PURPOSE: The National Advisory Committee on Rural Health and Human
Services provides counsel and recommendations to the Secretary with
respect to the delivery, research, development, and administration of
health and human services in rural areas.
AGENDA: The meeting on Wednesday, September 14, will be called to
order at 8:30 a.m. by the Chairperson of the Committee, the Honorable
Ronnie Musgrove. The Committee will examine the issue of social
determinants of health in rural areas. The day will conclude with a
period of public comment at approximately 5:00 p.m.
The Committee will break into subcommittees and depart for site
visits Thursday morning, September 15, at approximately 8:30 a.m.
Subcommittees will visit the Presbyterian Medical Services Cuba Health
Center in Cuba, New Mexico; the Laguna Pueblo, a federally recognized
Native American tribe of the Pueblo people in Laguna, New Mexico; and
the Guadalupe County Hospital in Santa Rosa, New Mexico. The day will
conclude at the Albuquerque Marriott with the period of public comment
at approximately 5:15 p.m.
On Friday, September 16, at 8:30 a.m., the Committee will meet at
the Albuquerque Marriott to summarize key findings from the site visits
and develop a work plan for the next quarter.
FOR FURTHER INFORMATION CONTACT: Steve Hirsch, MSLS, Administrative
Coordinator, National Advisory Committee on Rural Health and Human
Services, Health Resources and Services Administration, 5600 Fishers
Lane, 17W41D, Rockville, MD 20857, Telephone (301) 443-0835, Fax (301)
443-2803.
Persons interested in attending any portion of the meeting should
contact Pierre Joseph at the Federal Office of Rural Health Policy
(FORHP) via telephone at (301) 945-0897 or by email at
PJoseph@hrsa.gov. Individuals who plan to attend and need special
assistance, such as sign language interpretation or other reasonable
accommodations, should notify the contact person listed above at least
10 days prior to the meeting. The Committee meeting agenda will be
posted on the Committee's Web site at https://www.hrsa.gov/advisorycommittees/rural/.
Jason E. Bennett,
Director, Division of the Executive Secretariat.
[FR Doc. 2016-20911 Filed 8-30-16; 8:45 am]
BILLING CODE 4165-15-P
