Advisory Committee; Arthritis Advisory Committee, Renewal, 17665-17666 [2018-08358]
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Federal Register / Vol. 83, No. 78 / Monday, April 23, 2018 / Notices
Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2018–08383 Filed 4–20–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Board of Scientific Counselors,
National Center for Environmental
Health/Agency for Toxic Substances
and Disease Registry (BSC, NCEH/
ATSDR)
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice of meeting.
AGENCY:
In accordance with the
Federal Advisory Committee Act, the
CDC announces the following meeting
for the Board of Scientific Counselors,
National Center for Environmental
Health/Agency for Toxic Substances
and Disease Registry (BSC, NCEH/
ATSDR). This meeting is open to the
public, limited only by available
seating. The meeting room
accommodates approximately 60
people. The public is also welcome to
listen to the meeting by calling 888–
989–4501, passcode 9885805, limited by
100 lines. The deadline for notification
of attendance is May 14, 2018. The
public comment period is scheduled on
June 5, 2018 from 2:30 p.m. until 2:45
p.m., EDT and June 6, 2018 from 10:10
a.m. until 10:25 a.m., EDT. Individuals
wishing to make a comment during
Public Comment period, please email
your name, organization, and phone
number by May 7, 2018 to Amanda
Malasky at amalasky@cdc.gov.
DATES: The meeting will be held on June
5, 2018, 8:30 a.m. to 4:00 p.m., EDT and
June 6, 2018, 8:30 a.m. to 11:30 a.m.,
EDT.
ADDRESSES: CDC, 4770 Buford Highway,
CDC Building 106, Room 1B, Atlanta,
GA 30341.
FOR FURTHER INFORMATION CONTACT:
Shirley Little, Program Analyst, NCEH/
ATSDR, CDC, 4770 Buford Hwy., Mail
Stop F–45, Atlanta, GA 30341,
telephone (770) 488–0577; email snl7@
cdc.gov.
SUPPLEMENTARY INFORMATION:
Purpose: The Secretary, Department
of Health and Human Services (HHS)
and by delegation, the Director, CDC
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SUMMARY:
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and Administrator, NCEH/ATSDR, are
authorized under Section 301 (42 U.S.C.
241) and Section 311 (42 U.S.C. 243) of
the Public Health Service Act, as
amended, to: (1) Conduct, encourage,
cooperate with, and assist other
appropriate public authorities, scientific
institutions, and scientists in the
conduct of research, investigations,
experiments, demonstrations, and
studies relating to the causes, diagnosis,
treatment, control, and prevention of
physical and mental diseases and other
impairments; (2) assist states and their
political subdivisions in the prevention
of infectious diseases and other
preventable conditions and in the
promotion of health and wellbeing; and
(3) train state and local personnel in
health work. The BSC, NCEH/ATSDR
provides advice and guidance to the
Secretary, HHS; the Director, CDC and
Administrator, ATSDR; and the
Director, NCEH/ATSDR, regarding
program goals, objectives, strategies, and
priorities in fulfillment of the agency’s
mission to protect and promote people’s
health. The board provides advice and
guidance that will assist NCEH/ATSDR
in ensuring scientific quality,
timeliness, utility, and dissemination of
results. The board also provides
guidance to help NCEH/ATSDR work
more efficiently and effectively with its
various constituents and to fulfill its
mission in protecting America’s health.
Matters to be Considered: The agenda
will include discussions on Recovery
Efforts to Address Environmental Health
Impacts after the 2017 Hurricanes,
NCEH/ATSDR Program Responses to
BSC Guidance and Action Items, PFAS
multi-site study, PEASE, Biomonitoring
for PFAS in children, Use of Citizen
Science for Assessment of Health Risks,
Statistical Inferences in Environmental
Epidemiology, and NCEH/ASTDR work
with tribes/Tribal Programs. Agenda
items are subject to change as priorities
dictate.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both the
Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Elizabeth Millington,
Acting Director, Management Analysis and
Services Office, Centers for Disease Control
and Prevention.
[FR Doc. 2018–08367 Filed 4–20–18; 8:45 am]
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17665
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–1242]
Advisory Committee; Arthritis
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 Arthritis 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
Arthritis Advisory Committee for an
additional 2 years beyond the charter
expiration date. The new charter will be
in effect until April 5, 2020.
DATES: Authority for the Arthritis
Advisory Committee will expire on
April 5, 2020, unless the Commissioner
formally determines that renewal is in
the public interest.
FOR FURTHER INFORMATION CONTACT:
Yinghua Wang, 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, email: AAC@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
Arthritis Advisory Committee (the
Committee). The Committee is a
discretionary Federal advisory
committee established to provide advice
to the Commissioner.
The 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
FDA 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 arthritis,
rheumatism, and related diseases, and
makes appropriate recommendations to
the Commissioner.
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
SUMMARY:
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Federal Register / Vol. 83, No. 78 / Monday, April 23, 2018 / Notices
knowledgeable in the fields of arthritis,
rheumatology, orthopedics,
epidemiology or statistics, analgesics,
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/
CommitteesMeetingMaterials/Drugs/
ArthritisAdvisoryCommittee/
ucm094137.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 check https://www.fda.gov/
AdvisoryCommittees/default.htm.
Dated: April 16, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–08358 Filed 4–20–18; 8:45 am]
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Food and Drug Administration
[Docket No. FDA–2018–D–1334]
Opioid Dependence: Developing Depot
Buprenorphine Products for
Treatment; Draft Guidance for
Industry; Availability
Food and Drug Administration,
HHS.
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ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled ‘‘Opioid
Dependence: Developing Depot
Buprenorphine Products for
Treatment.’’ This draft guidance
addresses drug development and trial
SUMMARY:
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Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
design issues relevant to the study of
depot buprenorphine products (i.e.,
modified-release products for injection
or implantation).
DATES: Submit either electronic or
written comments on the draft guidance
by June 22, 2018 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2018–D–1334 for ‘‘Opioid Dependence:
Developing Depot Buprenorphine
Products for Treatment; Draft Guidance
for Industry; Availability.’’ Received
comments will be placed in the docket
and, except for those submitted as
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‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Silvana Borges, Center for Drug
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[Federal Register Volume 83, Number 78 (Monday, April 23, 2018)]
[Notices]
[Pages 17665-17666]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-08358]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-1242]
Advisory Committee; Arthritis 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 Arthritis 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 Arthritis Advisory Committee for
an additional 2 years beyond the charter expiration date. The new
charter will be in effect until April 5, 2020.
DATES: Authority for the Arthritis Advisory Committee will expire on
April 5, 2020, unless the Commissioner formally determines that renewal
is in the public interest.
FOR FURTHER INFORMATION CONTACT: Yinghua Wang, 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, email: [email protected].
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 Arthritis Advisory Committee (the Committee). The
Committee is a discretionary Federal advisory committee established to
provide advice to the Commissioner.
The 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 FDA
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 arthritis, rheumatism, and related diseases,
and makes appropriate recommendations to the Commissioner.
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
[[Page 17666]]
knowledgeable in the fields of arthritis, rheumatology, orthopedics,
epidemiology or statistics, analgesics, 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/CommitteesMeetingMaterials/Drugs/ArthritisAdvisoryCommittee/ucm094137.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 check https://www.fda.gov/AdvisoryCommittees/default.htm.
Dated: April 16, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-08358 Filed 4-20-18; 8:45 am]
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