Advisory Committee; Drug Safety and Risk Management Advisory Committee, Renewal, 31644-31645 [2016-11773]
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mstockstill on DSK3G9T082PROD with NOTICES
31644
Federal Register / Vol. 81, No. 97 / Thursday, May 19, 2016 / Notices
796–9001, FAX: 301–847–8533, PCNS@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pursuant
to 41 CFR 102–3.65 and approval by the
Department of Health and Human
Services pursuant to 45 CFR part 11 and
by the General Services Administration,
FDA is announcing the renewal of the
Peripheral and Central Nervous System
Drugs Advisory Committee. The
committee is a discretionary Federal
advisory committee established to
provide advice to the Commissioner.
The Peripheral and Central Nervous
System Drugs Advisory Committee
advises the Commissioner or designee
in discharging responsibilities as they
relate to helping to ensure safe and
effective drugs for human use and, as
required, any other product for which
the Food and Drug Administration has
regulatory responsibility. The
Committee reviews and evaluates data
concerning the safety and effectiveness
of marketed and investigational human
drug products for use in the treatment
of neurologic diseases.
The Committee shall consist of a core
of nine voting members including the
Chair. Members and the Chair are
selected by the Commissioner or
designee from among authorities
knowledgeable in the fields of
neurology, neuropharmacology,
neuropathology, otolaryngology,
epidemiology or statistics, and related
specialties. Members will be invited to
serve for overlapping terms of up to 4
years. Almost all non-Federal members
of this committee serve as Special
Government Employees. The core of
voting members may include one
technically qualified member, selected
by the Commissioner or designee, who
is identified with consumer interests
and is recommended by either a
consortium of consumer-oriented
organizations or other interested
persons. In addition to the voting
members, the Committee may include
one non-voting member who is
identified with industry interests.
Further information regarding the most
recent charter and other information can
be found at https://www.fda.gov/
AdvisoryCommittees/Committees
MeetingMaterials/Drugs/Peripheraland
CentralNervousSystemDrugsAdvisory
Committee/ucm107494.htm or by
contacting the Designated Federal
Officer (see FOR FURTHER INFORMATION
CONTACT). In light of the fact that no
change has been made to the committee
name or description of duties, no
amendment will be made to 21 CFR
14.100.
This document is issued under the
Federal Advisory Committee Act (5
VerDate Sep<11>2014
18:47 May 18, 2016
Jkt 238001
U.S.C. app.). For general information
related to FDA advisory committees,
please visit us at https://www.fda.gov/
AdvisoryCommittees/default.htm.
Dated: May 13, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical
Programs.
[FR Doc. 2016–11776 Filed 5–18–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0001]
Advisory Committee; Drug Safety and
Risk Management Advisory
Committee, Renewal
AGENCY:
Food and Drug Administration,
HHS.
Notice; renewal of advisory
committee.
ACTION:
The Food and Drug
Administration (FDA) is announcing the
renewal of the Drug Safety and Risk
Management Advisory Committee by
the Commissioner of Food and Drugs
(the Commissioner). The Commissioner
has determined that it is in the public
interest to renew the Drug Safety and
Risk Management Advisory Committee
for an additional 2 years beyond the
charter expiration date. The new charter
will be in effect until May 31, 2018.
DATES: Authority for the Drug Safety
and Risk Management Advisory
Committee will expire on May 31, 2016,
unless the Commissioner formally
determines that renewal is in the public
interest.
FOR FURTHER INFORMATION CONTACT:
Philip A. Bautista, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993–0002, 301–
796–9001, DSARM@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pursuant
to 41 CFR 102–3.65 and approval by the
Department of Health and Human
Services pursuant to 45 CFR part 11 and
by the General Services Administration,
FDA is announcing the renewal of the
Drug Safety and Risk Management
Advisory Committee. The committee is
a discretionary Federal advisory
committee established to provide advice
to the Commissioner. The Drug Safety
and Risk Management Advisory
Committee advises the Commissioner or
designee in discharging responsibilities
as they relate to helping to ensure safe
and effective drugs for human use and,
SUMMARY:
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Fmt 4703
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as required, any other product for which
the Food and Drug Administration has
regulatory responsibility. The
Committee reviews and evaluates
information on risk management, risk
communication, and quantitative
evaluation of spontaneous reports for
drugs for human use and for any other
product for which the Food and Drug
Administration has regulatory
responsibility. The Committee also
advises the Commissioner of Food and
Drugs regarding the scientific and
medical evaluation of all information
gathered by the Department of Health
and Human Services and the
Department of Justice with regard to
safety, efficacy, and abuse potential of
drugs or other substances, and
recommends actions to be taken by the
Department of Health and Human
Services with regard to the marketing,
investigation, and control of such drugs
or other substances.
The Committee shall consist of a core
of 11 voting members including the
Chair. Members and the Chair are
selected by the Commissioner or
designee from among authorities
knowledgeable in the fields of risk
communication, risk management, drug
safety, medical, behavioral, and
biological sciences as they apply to risk
management, and drug abuse. Members
will be invited to serve for overlapping
terms of up to 4 years. Almost all nonFederal members of this committee
serve as Special Government
Employees. The core of voting members
may include one technically qualified
member, selected by the Commissioner
or designee, who is identified with
consumer interests and is recommended
by either a consortium of consumeroriented organizations or other
interested persons. In addition to the
voting members, the Committee may
include one non-voting member who is
identified with industry interests.
Further information regarding the
most recent charter and other
information can be found at https://
www.fda.gov/AdvisoryCommittees/
CommitteesMeetingMaterials/Drugs/
DrugSafetyandRiskManagement
AdvisoryCommittee/ucm094886.htm or
by contacting the Designated Federal
Officer (see FOR FURTHER INFORMATION
CONTACT). In light of the fact that no
change has been made to the committee
name or description of duties, no
amendment will be made to 21 CFR
14.100.
This document is issued under the
Federal Advisory Committee Act (5
U.S.C. app.). For general information
related to FDA advisory committees,
please visit us at https://www.fda.gov/
AdvisoryCommittees/default.htm.
E:\FR\FM\19MYN1.SGM
19MYN1
Federal Register / Vol. 81, No. 97 / Thursday, May 19, 2016 / Notices
Dated: May 13, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical
Programs.
[FR Doc. 2016–11773 Filed 5–18–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
mstockstill on DSK3G9T082PROD with NOTICES
Advisory Commission on Childhood
Vaccines; 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: Advisory Commission on
Childhood Vaccines (ACCV).
DATE AND TIME: June 3, 2016, 9:00 a.m.
to 12:30 p.m. EDT.
PLACE: 5600 Fishers Lane, Conference
Room 08SW01, Rockville, MD 20857.
STATUS: The ACCV will meet on Friday,
June 3, 2016, from 9:00 a.m. to 12:30
p.m. at 5600 Fishers Lane, Conference
Room 08SW01, Rockville, MD 20857.
The public can join the meeting by:
1. (In Person) Persons interested in
attending the meeting in person are
encouraged to submit a written
notification to: Annie Herzog, Division
of Injury Compensation Programs,
Healthcare Systems Bureau, Health
Resources and Services Administration,
5600 Fishers Lane, Room 8N146B,
Rockville, MD 20857 or email: aherzog@
hrsa.gov. Since this meeting is held in
a Federal government building,
attendees will need to go through a
security check to enter the building and
participate in the meeting. This written
notification is encouraged so that a list
of attendees can be provided for quicker
entry through security. Persons may
attend in person without providing
written notification, but their entry into
the building may be delayed due to
security checks and the requirement to
be escorted to the meeting by a Federal
government employee. To request an
escort to the meeting after entering the
building, call Mario Lombre at 301–
443–3196. The meeting will be held at
5600 Fishers Lane, Conference Room
08SW01, Rockville, MD 20857.
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 at
least 10 days prior to the meeting.
2. (Audio Portion) Calling the
conference phone number, 800–799–
VerDate Sep<11>2014
18:47 May 18, 2016
Jkt 238001
3561, and providing the following
information:
Leaders Name: Dr. Narayan Nair
Password: 8164763
3. (Visual Portion) Connecting to the
ACCV Adobe Connect Pro Meeting
using the following URL: https://
hrsa.connectsolutions.com/accv/ (copy
and paste the link into your browser if
it does not work directly, and enter as
a guest). 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:
https://www.adobe.com/go/connectpro_
overview.
Call (301) 443–6634 or send an email
to aherzog@hrsa.gov if you are having
trouble connecting to the meeting site.
Agenda: The agenda items for the
June 2016 meeting will include, but are
not limited to, updates from: The
Division of Injury Compensation
Programs (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). A draft agenda and
additional meeting materials will be
posted on the ACCV Web site (https://
www.hrsa.gov/advisorycommittees/
childhoodvaccines/) prior to
the meeting. Agenda items are subject to
change as priorities warrant.
Public Comment: Persons interested
in providing an oral presentation should
submit a written request, along with a
copy of their presentation to: Annie
Herzog, Division of Injury
Compensation Programs, Healthcare
Systems Bureau, Health Resources and
Services Administration, 5600 Fishers
Lane, Room 8N146B, Rockville, MD
20857 or email: aherzog@hrsa.gov.
Requests should contain the name,
address, telephone number, email
address, and any business or
professional affiliation of the person
desiring to make an oral presentation.
Groups having similar interests are
requested to combine their comments
and present them through a single
representative. The allocation of time
may be adjusted to accommodate the
level of expressed interest. DICP will
notify each presenter by email, mail, or
telephone of the assigned presentation
time. Persons who do not file an
PO 00000
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Fmt 4703
Sfmt 4703
31645
advance request for a presentation, but
desire to make an oral statement, may
announce it at the time of the public
comment period. Public participation
and ability to comment will be limited
to space and time as it permits.
FOR FURTHER INFORMATION CONTACT:
Anyone requiring information regarding
the ACCV should contact Annie Herzog,
Division of Injury Compensation
Programs, Healthcare Systems Bureau,
Health Resources and Services
Administration, 5600 Fishers Lane,
Room 8N146B, Rockville, MD 20857;
telephone (301) 443–6593, or email:
aherzog@hrsa.gov.
Jason E. Bennett,
Director, Division of the Executive Secretariat.
[FR Doc. 2016–11790 Filed 5–18–16; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
[Document Identifier: HHS–OS–0945–0004]
Agency Information Collection
Activities; Submission to OMB for
Review and Approval; Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
In compliance with section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, has submitted an
Information Collection Request (ICR),
described below, to the Office of
Management and Budget (OMB) for
review and approval. The ICR is for
renewal of the approved information
collection assigned OMB control
number 0945–0004, scheduled to expire
on May 31, 2016. Comments submitted
during the first public review of this ICR
will be provided to OMB. OMB will
accept further comments from the
public on this ICR during the review
and approval period.
DATES: Comments on the ICR must be
received on or before June 20, 2016.
ADDRESSES: Submit your comments to
OIRA_submission@omb.eop.gov or via
facsimile to (202) 395–5806.
FOR FURTHER INFORMATION CONTACT:
Information Collection Clearance staff,
Information.CollectionClearance@
hhs.gov or (202) 690–6162.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the OMB
control number 0945–0004 and
SUMMARY:
E:\FR\FM\19MYN1.SGM
19MYN1
]]>Agencies
[Federal Register Volume 81, Number 97 (Thursday, May 19, 2016)]
[Notices]
[Pages 31644-31645]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-11773]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0001]
Advisory Committee; Drug Safety and Risk Management Advisory
Committee, Renewal
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; renewal of advisory committee.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
renewal of the Drug Safety and Risk Management Advisory Committee by
the Commissioner of Food and Drugs (the Commissioner). The Commissioner
has determined that it is in the public interest to renew the Drug
Safety and Risk Management Advisory Committee for an additional 2 years
beyond the charter expiration date. The new charter will be in effect
until May 31, 2018.
DATES: Authority for the Drug Safety and Risk Management Advisory
Committee will expire on May 31, 2016, unless the Commissioner formally
determines that renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT: Philip A. Bautista, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-9001, DSARM@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65 and approval by
the Department of Health and Human Services pursuant to 45 CFR part 11
and by the General Services Administration, FDA is announcing the
renewal of the Drug Safety and Risk Management Advisory Committee. The
committee is a discretionary Federal advisory committee established to
provide advice to the Commissioner. The Drug Safety and Risk Management
Advisory Committee advises the Commissioner or designee in discharging
responsibilities as they relate to helping to ensure safe and effective
drugs for human use and, as required, any other product for which the
Food and Drug Administration has regulatory responsibility. The
Committee reviews and evaluates information on risk management, risk
communication, and quantitative evaluation of spontaneous reports for
drugs for human use and for any other product for which the Food and
Drug Administration has regulatory responsibility. The Committee also
advises the Commissioner of Food and Drugs regarding the scientific and
medical evaluation of all information gathered by the Department of
Health and Human Services and the Department of Justice with regard to
safety, efficacy, and abuse potential of drugs or other substances, and
recommends actions to be taken by the Department of Health and Human
Services with regard to the marketing, investigation, and control of
such drugs or other substances.
The Committee shall consist of a core of 11 voting members
including the Chair. Members and the Chair are selected by the
Commissioner or designee from among authorities knowledgeable in the
fields of risk communication, risk management, drug safety, medical,
behavioral, and biological sciences as they apply to risk management,
and drug abuse. Members will be invited to serve for overlapping terms
of up to 4 years. Almost all non-Federal members of this committee
serve as Special Government Employees. The core of voting members may
include one technically qualified member, selected by the Commissioner
or designee, who is identified with consumer interests and is
recommended by either a consortium of consumer-oriented organizations
or other interested persons. In addition to the voting members, the
Committee may include one non-voting member who is identified with
industry interests.
Further information regarding the most recent charter and other
information can be found at https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/DrugSafetyandRiskManagementAdvisoryCommittee/ucm094886.htm or by
contacting the Designated Federal Officer (see FOR FURTHER INFORMATION
CONTACT). In light of the fact that no change has been made to the
committee name or description of duties, no amendment will be made to
21 CFR 14.100.
This document is issued under the Federal Advisory Committee Act (5
U.S.C. app.). For general information related to FDA advisory
committees, please visit us at https://www.fda.gov/AdvisoryCommittees/default.htm.
[[Page 31645]]
Dated: May 13, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-11773 Filed 5-18-16; 8:45 am]
BILLING CODE 4164-01-P
