Endocrinologic and Metabolic Drugs Advisory Committee; Amendment of Notice, 19978 [2016-07906]
Download as PDF
19978
Federal Register / Vol. 81, No. 66 / Wednesday, April 6, 2016 / Notices
FoodborneIllnessContaminants/Metals/
UCM352467.pdf).
4. U.S. Food and Drug Administration,
‘‘Analytical Results from Inorganic Arsenic
in Rice Cereals for Infants, Non-rice Infant
Cereal and Other Foods Commonly Eaten by
Infants and Toddlers,’’ 2016, (https://
www.fda.gov/Food/FoodScienceResearch/
RiskSafetyAssessment/ucm485278.htm).
5. U.S. Food and Drug Administration,
‘‘Arsenic in Rice and Rice Products Risk
Assessment: Report,’’ 2016, (https://
www.fda.gov/Food/FoodScienceResearch/
RiskSafetyAssessment/ucm485278.htm).
6. U.S. Food and Drug Administration,
‘‘External Peer Review Report. Arsenic in
Rice and Rice Products Risk Assessment:
Draft Report, Addendum, and Model,’’ 2015,
(https://www.fda.gov/downloads/Food/
FoodScienceResearch/RiskSafetyAssessment/
UCM486544.pdf).
7. U.S. Food and Drug Administration,
‘‘FDA’s Response to External Peer Review on
FDA’s Arsenic in Rice and Rice Products
Risk Assessment: Draft Report (July 2015),
Addendum to FDA’s Arsenic in Rice and
Rice Products Risk Assessment, and Arsenic
in Rice and Rice Products Risk Assessment
Cancer Model,’’ 2016, (https://www.fda.gov/
downloads/Food/FoodScienceResearch/
RiskSafetyAssessment/UCM487230.pdf).
BILLING CODE 4164–01–P
Food and Drug Administration
[Docket No. FDA–2016–N–0001]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Advisory Committee; Bone,
Reproductive and Urologic Drugs
Advisory Committee, Renewal
Food and Drug Administration
[Docket No. FDA–2016–N–0001]
AGENCY:
Endocrinologic and Metabolic Drugs
Advisory Committee; Amendment of
Notice
Food and Drug Administration,
HHS.
Notice.
The Food and Drug
Administration (FDA) is announcing an
amendment to the notice of a meeting of
the Endocrinologic and Metabolic Drugs
Advisory Committee. This meeting was
announced in the Federal Register of
March 17, 2016. The amendment is
being made to reflect a change in the
Date and Time portion of the document.
The Date of the meeting is changed to
May 24, 2016. There are no other
changes.
asabaliauskas on DSK3SPTVN1PROD with NOTICES
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
LaToya Bonner, 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, FAX: 301–847–8533,
VerDate Sep<11>2014
17:54 Apr 05, 2016
[FR Doc. 2016–07906 Filed 4–5–16; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2016–07840 Filed 4–5–16; 8:45 am]
ACTION:
Dated: April 1, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical
Programs.
BILLING CODE 4164–01–P
Dated: April 1, 2016.
Leslie Kux,
Associate Commissioner for Policy.
AGENCY:
EMDAC@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area). Please call the
Information Line for up-to-date
information on this meeting.
SUPPLEMENTARY INFORMATION: In the
Federal Register of March 17, 2016 (81
FR 14448), FDA announced that a
meeting of the Endocrinologic and
Metabolic Drugs Advisory Committee
would be held on May 25, 2016. On
page 14449, in the first column, the Date
and Time portion of the document is
changed to read as follows:
Date and Time: The meeting will be
held on May 24, 2016, from 8 a.m. to 5
p.m.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to the advisory committees.
Jkt 238001
Food and Drug Administration,
HHS.
Notice; renewal of advisory
committee.
ACTION:
The Food and Drug
Administration (FDA) is announcing the
renewal of the Bone, Reproductive and
Urologic Drugs 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 Bone,
Reproductive and Urologic Drugs
Advisory Committee for an additional 2
years beyond the charter expiration
date. The new charter will be in effect
until March 23, 2018.
DATES: Authority for the Bone,
Reproductive and Urologic Drugs
Advisory Committee will expire on
March 23, 2018, unless the
Commissioner formally determines that
renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT:
Kalyani Bhatt, Division of Advisory
Committee and Consultant
Management, Center for Drug
SUMMARY:
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993–0002, 301–
796–9001, email: BRUDAC@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
Bone, Reproductive and Urologic Drugs
Advisory Committee. The committee is
a discretionary Federal advisory
committee established to provide advice
to the Commissioner. The Bone,
Reproductive and Urologic 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
on the safety and effectiveness of
marketed and investigational human
drug products for use in the practice of
osteoporosis and metabolic bone
disease, obstetrics, gynecology, urology
and related specialties, and makes
appropriate recommendations to the
Commissioner of Food and Drugs.
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
osteoporosis and metabolic bone
disease, obstetrics, gynecology, urology,
pediatrics, 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/
CommitteesMeetingMaterials/Drugs/
ReproductiveHealthDrugsAdvisory
Committee/ucm107572.htm or by
contacting the Designated Federal
Officer (see FOR FURTHER INFORMATION
E:\FR\FM\06APN1.SGM
06APN1
Agencies
[Federal Register Volume 81, Number 66 (Wednesday, April 6, 2016)]
[Notices]
[Page 19978]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-07906]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0001]
Endocrinologic and Metabolic Drugs Advisory Committee; Amendment
of Notice
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
amendment to the notice of a meeting of the Endocrinologic and
Metabolic Drugs Advisory Committee. This meeting was announced in the
Federal Register of March 17, 2016. The amendment is being made to
reflect a change in the Date and Time portion of the document. The Date
of the meeting is changed to May 24, 2016. There are no other changes.
FOR FURTHER INFORMATION CONTACT: LaToya Bonner, 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, FAX: 301-847-8533, EMDAC@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1-800-741-8138 (301-443-0572 in the
Washington, DC area). Please call the Information Line for up-to-date
information on this meeting.
SUPPLEMENTARY INFORMATION: In the Federal Register of March 17, 2016
(81 FR 14448), FDA announced that a meeting of the Endocrinologic and
Metabolic Drugs Advisory Committee would be held on May 25, 2016. On
page 14449, in the first column, the Date and Time portion of the
document is changed to read as follows:
Date and Time: The meeting will be held on May 24, 2016, from 8
a.m. to 5 p.m.
This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees.
Dated: April 1, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-07906 Filed 4-5-16; 8:45 am]
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