Advisory Committee; Pharmacy Compounding Advisory Committee, Renewal, 27452 [2016-10585]
Download as PDF
<![CDATA[
27452
Federal Register / Vol. 81, No. 88 / Friday, May 6, 2016 / Notices
that is required for submissions to the
SRDP and providing a streamlined and
standardized format for the presentation
of the required information. Form
Number: CMS–10328 (OMB control
number: 0938–1106); Frequency:
Annually and semi-annually; Affected
Public: Private sector (Business or other
for-profits and Not-for-profits); Number
of Respondents: 200; Total Annual
Responses: 200; Total Annual Hours:
5,000. (For policy questions regarding
this collection contact Matt Edgar at
410–786–0698.)
Dated: May 3, 2016.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2016–10705 Filed 5–5–16; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1687]
Advisory Committee; Pharmacy
Compounding 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 Pharmacy Compounding
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 Pharmacy
Compounding Advisory Committee for
an additional 2 years beyond the charter
expiration date. The new charter will be
in effect until April 25, 2018.
DATES: Authority for the Pharmacy
Compounding Advisory Committee will
expire on April 25, 2016, unless the
Commissioner formally determines that
renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT:
Cindy Hong, 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,
PCAC@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
asabaliauskas on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:20 May 05, 2016
Jkt 238001
Pharmacy Compounding Advisory
Committee. The committee is a
discretionary Federal advisory
committee established to provide advice
to the Commissioner. The Pharmacy
Compounding Advisory Committee
advises the Commissioner or designee
in discharging responsibilities as they
relate to compounded drugs for human
use and, as required, any other product
for which the Food and Drug
Administration has regulatory
responsibility.
The Committee shall provide advice
on scientific, technical, and medical
issues concerning drug compounding
under sections 503A and 503B of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 353a) and (21 U.S.C. 353b),
and, as required, any other product for
which the Food and Drug
Administration has regulatory
responsibility, and make appropriate
recommendations to the Commissioner
of Food and Drugs.
The Committee shall consist of a core
of 12 voting members including the
Chair. Members and the Chair are
selected by the Commissioner or
designee from among authorities
knowledgeable in the fields of
pharmaceutical compounding,
pharmaceutical manufacturing,
pharmacy, medicine, and related
specialties. These members will include
representatives from the National
Association of Boards of Pharmacy, the
United States Pharmacopeia,
pharmacists with current experience
and expertise in compounding,
physicians with background and
knowledge in compounding, and patient
and public health advocacy
organizations. 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
or more technically qualified members,
selected by the Commissioner or
designee, who are identified with
consumer interests and are
recommended by either a consortium of
consumer-oriented organizations or
other interested persons. In addition to
the voting members, the Committee may
include one or more non-voting
members who are 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/
PharmacyCompoundingAdvisory
Committee/ucm381305.htm or by
contacting the Designated Federal
Officer (see FOR FURTHER INFORMATION
PO 00000
Frm 00066
Fmt 4703
Sfmt 4703
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.
Dated: April 29, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical
Programs.
[FR Doc. 2016–10585 Filed 5–5–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects (section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995), the
Health Resources and Services
Administration (HRSA) announces
plans to submit an Information
Collection Request (ICR), described
below, to the Office of Management and
Budget (OMB). Prior to submitting the
ICR to OMB, HRSA seeks comments
from the public regarding the burden
estimate, below, or any other aspect of
the ICR.
DATES: Comments on this Information
Collection Request must be received no
later than July 5, 2016.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14N–39, Parklawn
Building, 5600 Fishers Lane, Rockville,
MD 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call the HRSA Information Collection
Clearance Officer at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
SUMMARY:
E:\FR\FM\06MYN1.SGM
06MYN1
]]>Agencies
[Federal Register Volume 81, Number 88 (Friday, May 6, 2016)]
[Notices]
[Page 27452]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-10585]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-1687]
Advisory Committee; Pharmacy Compounding 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 Pharmacy Compounding 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 Pharmacy
Compounding Advisory Committee for an additional 2 years beyond the
charter expiration date. The new charter will be in effect until April
25, 2018.
DATES: Authority for the Pharmacy Compounding Advisory Committee will
expire on April 25, 2016, unless the Commissioner formally determines
that renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT: Cindy Hong, 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,
PCAC@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 Pharmacy Compounding Advisory Committee. The committee
is a discretionary Federal advisory committee established to provide
advice to the Commissioner. The Pharmacy Compounding Advisory Committee
advises the Commissioner or designee in discharging responsibilities as
they relate to compounded drugs for human use and, as required, any
other product for which the Food and Drug Administration has regulatory
responsibility.
The Committee shall provide advice on scientific, technical, and
medical issues concerning drug compounding under sections 503A and 503B
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353a) and (21
U.S.C. 353b), and, as required, any other product for which the Food
and Drug Administration has regulatory responsibility, and make
appropriate recommendations to the Commissioner of Food and Drugs.
The Committee shall consist of a core of 12 voting members
including the Chair. Members and the Chair are selected by the
Commissioner or designee from among authorities knowledgeable in the
fields of pharmaceutical compounding, pharmaceutical manufacturing,
pharmacy, medicine, and related specialties. These members will include
representatives from the National Association of Boards of Pharmacy,
the United States Pharmacopeia, pharmacists with current experience and
expertise in compounding, physicians with background and knowledge in
compounding, and patient and public health advocacy organizations.
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 or more technically qualified members, selected by the Commissioner
or designee, who are identified with consumer interests and are
recommended by either a consortium of consumer-oriented organizations
or other interested persons. In addition to the voting members, the
Committee may include one or more non-voting members who are 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/PharmacyCompoundingAdvisoryCommittee/ucm381305.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.
Dated: April 29, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-10585 Filed 5-5-16; 8:45 am]
BILLING CODE 4164-01-P
