Vaccines and Related Biological Products Advisory Committee; Notice of Meeting, 49224-49225 [2016-17729]
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Federal Register / Vol. 81, No. 144 / Wednesday, July 27, 2016 / Notices
B. The Division of Strategy, Policy,
and Governance responsibilities include
strategy, policy, and IT governance,
including performance measurement
and innovation. Provides governance
and oversight of centralized enterprisewide IT functions, including enterprise
architecture, creation and maintenance
of the technology roadmap.
C. The Division of Security, Privacy,
and Risk Management provides security,
privacy, and risk management,
including business continuity,
standardization and oversight of
business processes, external
compliance, and security strategy and
management. The OCIO will identify
the appropriate continuing education
for staff in the domain of records
management, IT security and privacy,
and incident response protocols.
D. The Division of Infrastructure, Data
and Web Services provides service
planning and architecture, program and
project management, portfolio
management, applications management,
development and maintenance, and IT
infrastructure and operations, including
data services, big data analytics, and
business intelligence.
III. Under KP, Office of the Deputy
Assistant Secretary for Administration,
delete KP.00 Mission in its entirety and
replace with:
KP.00 MISSION. The Deputy
Assistant Secretary for Administration
serves as principal advisor to the
Assistant Secretary for Children and
Families on all aspects of personnel
administration and management;
financial management activities; grants
policy and overseeing the issuance of
grants; acquisition advisory services; the
ethics program; staff development and
training activities; organizational
development and organizational
analysis; administrative services; and
facilities management. The Deputy
Assistant Secretary for Administration
oversees the Diversity Management and
Equal Employment Opportunity
program and all administrative special
initiative activities for ACF.
IV. Under Chapter KP, Office of the
Deputy Assistant Secretary for
Administration, delete KP.10
Organization in its entirety and replace
with:
KP.10 ORGANIZATION. The Office of
the Deputy Assistant Secretary for
Administration is headed by the Deputy
Assistant Secretary who reports to the
Assistant Secretary for Children and
Families. The Office is organized as
follows:
Immediate Office of the Deputy
Assistant Secretary for Administration
(KPA)
Office of Financial Services (KPC)
VerDate Sep<11>2014
17:01 Jul 26, 2016
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Office of Workforce Planning and
Development (KPD)
Office of Grants Management (KPG)
Grants Management Regional Units
(KPGDI–X)
Office of Diversity Management and
Equal Employment Opportunity
(KPH)
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
V. Under Chapter KP, Office of the
Deputy Assistant Secretary for
Administration, Delete KP.20 Functions,
Paragraph B, Office of Information
Systems, in its entirety.
VI. Under Chapter KN, Office of
Communications, delete KN.20,
Functions, Paragraph C, in its entirety
and replace with the following:
Division of Digital Information is
responsible for the content of ACF’s
public-facing digital presence. It also
coordinates printing services for ACF.
The division conducts preparation and
clearance of ACF communications
associated with web content,
audiovisual products, digital
publications and graphic designs, but
does not include planning, budgeting,
and oversight of the Web site
maintenance and support contract. It
provides guidance and support to
program offices related to web content,
social media, print publications, audiovisual materials, and digital information
and communication activities.
VII. Delegation of Authority. Pending
further redelegation, directives, or
orders made by the Assistant Secretary
for Children and Families or Deputy
Assistant Secretary for Administration,
all delegations and redelegations of
authority made to officials and
employees of affected organizational
components will continue in them or
their successors pending further
redelegations, provided they are
consistent with this reorganization.
VIII. Funds, Personnel, and
Equipment. Transfer of organizations
and functions affected by this
reorganization shall be accompanied in
each instance by direct and support
funds, positions, personnel, records,
equipment, supplies, and other
resources.
AGENCY:
Dated: July 21, 2016.
Mark H. Greenberg,
Acting Assistant Secretary for Children and
Families.
[FR Doc. 2016–17737 Filed 7–26–16; 8:45 am]
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Food and Drug Administration
[Docket No. FDA–2016–N–0001]
Vaccines and Related Biological
Products Advisory Committee; Notice
of Meeting
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Vaccines and Related
Biological Products Advisory
Committee. The general function of the
committee is to provide advice and
recommendations to the Agency on
FDA’s regulatory issues. The meeting
will be open to the public to attend in
person at the FDA White Oak campus in
Silver Spring, MD. Members will
participate via teleconference.
DATES: The meeting will be held on
October 13, 2016, from 1 p.m. to 4:30
p.m.
SUMMARY:
FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993–0002.
Answers to commonly asked questions
including information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm. For those unable to
attend in person, the meeting will also
be Webcast and will be available at the
following link: https://
collaboration.fda.gov/vrbpac101316/.
FOR FURTHER INFORMATION CONTACT:
Sujata Vijh or Rosanna Harvey, Center
for Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
6128, Silver Spring, MD 20993–0002, at
240–402–7107, sujata.vijh@fda.hhs.gov
and 240–402–8072, rosanna.harvey@
fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area). A notice in the
Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s Web site at https://
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the
appropriate advisory committee meeting
ADDRESSES:
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Federal Register / Vol. 81, No. 144 / Wednesday, July 27, 2016 / Notices
link, or call the advisory committee
information line to learn about possible
modifications before coming to the
meeting.
sradovich on DSK3GMQ082PROD with NOTICES
SUPPLEMENTARY INFORMATION:
Agenda: On October 13, 2016, the
committee will meet in open session to
discuss and make recommendations on
the selection of strains to be included in
an influenza virus vaccine for the 2017
southern hemisphere influenza season.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before October 3, 2016.
Oral presentations from the public will
be scheduled between approximately
2:30 p.m. and 3:30 p.m. Those
individuals interested in making formal
oral presentations should notify the
contact person and submit a brief
statement of the general nature of the
evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before September 23, 2016. Time
allotted for each presentation may be
limited. If the number of registrants
requesting to speak is greater than can
be reasonably accommodated during the
scheduled open public hearing session,
FDA may conduct a lottery to determine
the speakers for the scheduled open
public hearing session. The contact
person will notify interested persons
regarding their request to speak by
September 26, 2016.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with disabilities.
If you require accommodations due to a
disability, please contact Sujata Vijh at
least 7 days in advance of the meeting.
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FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: July 21, 2016.
Janice M. Soreth,
Acting Associate Commissioner, Special
Medical Programs.
[FR Doc. 2016–17729 Filed 7–26–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0007]
Generic Drug User Fee—Abbreviated
New Drug Application, Prior Approval
Supplement, Drug Master File, Final
Dosage Form Facility, and Active
Pharmaceutical Ingredient Facility Fee
Rates for Fiscal Year 2017
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
rates for abbreviated new drug
applications (ANDAs), prior approval
supplements to an approved ANDA
(PASs), drug master files (DMFs),
generic drug active pharmaceutical
ingredient (API) facilities, and finished
dosage form (FDF) facilities user fees
related to the Generic Drug User Fee
Program for fiscal year (FY) 2017. The
Federal Food, Drug, and Cosmetic Act
(the FD&C Act), as amended by the
Generic Drug User Fee Amendments of
2012 (GDUFA), authorizes FDA to
assess and collect user fees for certain
applications and supplements for
human generic drug products, on
applications in the backlog as of October
1, 2012 (only applicable to FY 2013), on
FDF and API facilities, and on type II
active pharmaceutical ingredient DMFs
to be made available for reference. This
document establishes the fee rates for
FY 2017.
FOR FURTHER INFORMATION CONTACT:
David Haas, Office of Financial
Management, Food and Drug
Administration, 8455 Colesville Rd.,
COLE–14202I, Silver Spring, MD
20993–0002, 240–402–9845.
SUMMARY:
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SUPPLEMENTARY INFORMATION:
I. Background
Sections 744A and 744B of the FD&C
Act (21 U.S.C. 379j–41 and 379j–42)
establish fees associated with human
generic drug products. Fees are assessed
on: (1) Certain applications in the
backlog as of October 1, 2012 (only
applicable to FY 2013); (2) certain types
of applications and supplements for
human generic drug products; (3)
certain facilities where APIs and FDFs
are produced; and (4) certain DMFs
associated with human generic drug
products (see section 744B(a)(1)–(4) of
the FD&C Act).
For FY 2017, the generic drug fee
rates are: ANDA ($70,480), PAS
($35,240), DMF ($51,140), domestic API
facility ($44,234), foreign API facility
($59,234), domestic FDF facility
($258,646), and foreign FDF facility
($273,646). These fees are effective on
October 1, 2016, and will remain in
effect through September 30, 2017.
Fees for ANDA and PAS will decrease
in FY 2017 compared to the FY 2016
fees due to an increase in the number of
submissions estimated to be submitted
in FY 2017 compared to the estimated
number of submissions to be submitted
in FY 2016. Fees for DMFs will increase
in FY 2017 compared to the FY 2016 fee
due to a decrease in the number of
submissions estimated to be submitted
in FY 2017 compared to the estimated
number of submissions to be submitted
in 2016. The fees for all types of
facilities will increase in FY 2017
compared to the FY 2016 fees in due to
a decrease in the number of facilities
that self-identified for FY 2017.
II. Fee Revenue Amount for FY 2017
The base revenue amount for FY 2017
is $299 million, as set in the statute
prior to the inflation and final year
adjustments (see section 744B(c)(2) of
the FD&C Act). GDUFA directs FDA to
use the yearly revenue amount as a
starting point to set the fee rates for each
fee type. For more information about
GDUFA, please refer to the FDA Web
site (https://www.fda.gov/gdufa). The
ANDA, PAS, DMF, API facility, and
FDF facility fee calculations for FY 2017
are described in this document.
A. Inflation Adjustment
GDUFA specifies that the $299
million is to be adjusted for inflation
increases for FY 2017 using two
separate adjustments—one for personnel
compensation and benefits (PC&B) and
one for non-PC&B costs (see section
744B(c)(1) of the FD&C Act).
The component of the inflation
adjustment for PC&B costs shall be one
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]]>Agencies
[Federal Register Volume 81, Number 144 (Wednesday, July 27, 2016)]
[Notices]
[Pages 49224-49225]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-17729]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0001]
Vaccines and Related Biological Products Advisory Committee;
Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Vaccines and Related
Biological Products Advisory Committee. The general function of the
committee is to provide advice and recommendations to the Agency on
FDA's regulatory issues. The meeting will be open to the public to
attend in person at the FDA White Oak campus in Silver Spring, MD.
Members will participate via teleconference.
DATES: The meeting will be held on October 13, 2016, from 1 p.m. to
4:30 p.m.
ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-
0002. Answers to commonly asked questions including information
regarding special accommodations due to a disability, visitor parking,
and transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm. For those
unable to attend in person, the meeting will also be Webcast and will
be available at the following link: https://collaboration.fda.gov/vrbpac101316/.
FOR FURTHER INFORMATION CONTACT: Sujata Vijh or Rosanna Harvey, Center
for Biologics Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 71, Rm. 6128, Silver Spring, MD 20993-
0002, at 240-402-7107, sujata.vijh@fda.hhs.gov and 240-402-8072,
rosanna.harvey@fda.hhs.gov, or FDA Advisory Committee Information Line,
1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in
the Federal Register about last minute modifications that impact a
previously announced advisory committee meeting cannot always be
published quickly enough to provide timely notice. Therefore, you
should always check the Agency's Web site at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting
[[Page 49225]]
link, or call the advisory committee information line to learn about
possible modifications before coming to the meeting.
SUPPLEMENTARY INFORMATION:
Agenda: On October 13, 2016, the committee will meet in open
session to discuss and make recommendations on the selection of strains
to be included in an influenza virus vaccine for the 2017 southern
hemisphere influenza season.
FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
October 3, 2016. Oral presentations from the public will be scheduled
between approximately 2:30 p.m. and 3:30 p.m. Those individuals
interested in making formal oral presentations should notify the
contact person and submit a brief statement of the general nature of
the evidence or arguments they wish to present, the names and addresses
of proposed participants, and an indication of the approximate time
requested to make their presentation on or before September 23, 2016.
Time allotted for each presentation may be limited. If the number of
registrants requesting to speak is greater than can be reasonably
accommodated during the scheduled open public hearing session, FDA may
conduct a lottery to determine the speakers for the scheduled open
public hearing session. The contact person will notify interested
persons regarding their request to speak by September 26, 2016.
Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact Sujata Vijh at least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: July 21, 2016.
Janice M. Soreth,
Acting Associate Commissioner, Special Medical Programs.
[FR Doc. 2016-17729 Filed 7-26-16; 8:45 am]
BILLING CODE 4164-01-P
