Request for Nominations on the Vaccines and Related Biological Products Advisory Committee, 26928-26929 [2015-11258]
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Federal Register / Vol. 80, No. 90 / Monday, May 11, 2015 / Notices
applicants (both treatment and control)
through baseline data collection; and (3)
individual enrolled program
participants’ activities and outcomes.
The universe of information
collection proposed for HPOG Next Gen
includes the HPOG Next Gen
Participant Accomplishment and Grant
Evaluation System (PAGES). PAGES is a
performance management system that
will collect information from all
grantees on their programs and
participants on a semi-annual basis over
the grant period of performance and
intake information on eligible
applicants (both treatment and control)
through baseline data collection. The
data system will meet the performance
data needs of the HPOG Next Gen
grantees and of the ACF Office of
Family Assistance to monitor the
performance of the grants and prepare
the report to Congress on the grants, as
well as support an impact study, a
coordinated Tribal evaluation, and other
future research and evaluation efforts
sponsored by ACF.
Respondents: Grantee- and
participant-level data to be collected by
program staff in the approximately 40
grantee organizations (higher education
institutions, workforce investment
boards, private training institutions,
nonprofit organizations, and tribal
entities). Applicants at the 40 grantee
organizations.
ANNUAL BURDEN ESTIMATES
Total number
of respondents
Instrument
PAGES Grantee—and Participant-Level Data Collection
(all grantees) ....................................................................
PAGES Participant-Level Baseline Data Collection (participants at non-Tribal grantees participating in impact
study) ................................................................................
PAGES Participant-Level Baseline Data Collection (participants at Tribal grantees) ..................................................
Karl Koerper,
OPRE Reports Clearance Officer.
tkelley on DSK3SPTVN1PROD with NOTICES
[FR Doc. 2015–11266 Filed 5–8–15; 8:45 am]
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31.75
2,540
31,500
10,500
1
.5
5,250
1,200
400
1
.25
100
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........................
........................
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7,890
[Docket No. FDA–2015–N–0001]
Request for Nominations on the
Vaccines and Related Biological
Products Advisory Committee
Food and Drug Administration,
HHS.
Notice.
The Food and Drug
Administration (FDA) is requesting that
any industry organizations interested in
participating in the selection of a
nonvoting industry representative to
serve on the Vaccines and Related
Biological Products Advisory
Committee for the Center for Biologics
Evaluation and Research (CBER) notify
FDA in writing. FDA is also requesting
nominations for a nonvoting industry
representative(s) to serve on the
Vaccines and Related Biological
Products Advisory Committee. A
nominee may either be self-nominated
or nominated by an organization to
serve as a nonvoting industry
representative. Nominations will be
accepted for current vacancies effective
with this notice.
DATES: Any industry organization
interested in participating in the
selection of an appropriate nonvoting
member to represent industry interests
must send a letter stating that interest to
the FDA by June 10, 2015, (see sections
SUMMARY:
PO 00000
Annual burden
hours
2
Food and Drug Administration
ACTION:
Average
burden hours
per response
40
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
Number of
responses per
respondent
120
Estimated Total Annual Burden Hours: ........................
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Planning, Research and Evaluation, 370
L’Enfant Promenade SW., Washington,
DC 20447, Attn: OPRE Reports
Clearance Officer. All requests should
be identified by the title of the
information collection. Email address:
OPREinfocollection@acf.hhs.gov.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after publication of this
document in the Federal Register.
Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project, Email: OIRA_
SUBMISSION@OMB.EOP.GOV, Attn:
Desk Officer for the Administration for
Children and Families.
Annual
number of
respondents
Frm 00040
Fmt 4703
Sfmt 4703
I and II of this document for further
details). Concurrently, nomination
materials for prospective candidates
should be sent to FDA by June 10, 2015.
ADDRESSES: All statements of interest
from interested industry organizations
interested in participating in the
selection process of nonvoting industry
representative nomination should be
sent to Sujata Vijh (see FOR FURTHER
INFORMATION CONTACT). All nominations
for nonvoting industry representatives
may be submitted electronically by
accessing the FDA Advisory Committee
Membership Nomination Portal: https://
www.accessdata.fda.gov/scripts/
FACTRSPortal/FACTRS/index.cfm or by
mail to Advisory Committee Oversight
and Management Staff, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5103, Silver Spring,
MD 20993–0002. Information about
becoming a member of an FDA advisory
committee can also be obtained by
visiting FDA’s Web site: https://
www.fda.gov/AdvisoryCommittees/
default.htm.
FOR FURTHER INFORMATION CONTACT:
Sujata Vijh, Division of Scientific
Advisors and Consultants, Center for
Biologics Evaluation and Research,
10903 New Hampshire Ave., Bldg. 71,
Rm. 6128, Silver Spring, MD 20993–
0002, 240–402–7107, FAX: 301–595–
1307, email: Sujata.vijh@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The
Agency intends to add a nonvoting
industry representative(s) to the
following advisory committee:
E:\FR\FM\11MYN1.SGM
11MYN1
Federal Register / Vol. 80, No. 90 / Monday, May 11, 2015 / Notices
I. CBER Vaccines and Related
Biological Products Advisory
Committee
The CBER Vaccines and Related
Biological Products Advisory
Committee (the Committee) reviews and
evaluates data concerning the safety,
effectiveness, and appropriate use of
vaccines and related biological products
which are intended for use in the
prevention, treatment, or diagnosis of
human diseases, and, as required, any
other product for which FDA has
regulatory responsibility. The
Committee also considers the quality
and relevance of FDA’s research
program which provides scientific
support for the regulation of these
products and makes appropriate
recommendations to the Commissioner
of Food and Drugs.
II. Selection Procedure
Any industry organization interested
in participating in the selection of an
appropriate nonvoting member to
represent industry interests should send
a letter stating that interest to the FDA
contact (see FOR FURTHER INFORMATION
CONTACT) within 30 days of publication
(see DATES). Within the subsequent 30
days, FDA will send a letter to each
organization that has expressed an
interest, attaching a complete list of all
such organizations; and a list of all
nominees along with their current
resumes. The letter will also state that
it is the responsibility of the interested
organizations to confer with one another
and to select a candidate, within 60
days after the receipt of the FDA letter,
to serve as the nonvoting member to
represent industry interests for the
committee. The interested organizations
are not bound by the list of nominees in
selecting a candidate. However, if no
individual is selected within 60 days,
the Commissioner will select the
nonvoting member to represent industry
interests.
tkelley on DSK3SPTVN1PROD with NOTICES
III. Application Procedure
Individuals may self-nominate and/or
an organization may nominate one or
more individuals to serve as a nonvoting
industry representative. Contact
information, a current curriculum vitae,
and the name of the committee of
interest should be sent to the FDA
Advisory Committee Membership
Nomination Portal (see ADDRESSES)
within 30 days of publication (see
DATES). FDA will forward all
nominations to the organizations
expressing interest in participating in
the selection process for the committee.
(Persons who nominate themselves as
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nonvoting industry representatives will
not participate in the selection process).
FDA seeks to include the views of
women, and men, members of all racial
and ethnic groups, and individuals with
and without disabilities on its advisory
committees and, therefore encourages
nominations of appropriately qualified
candidates from these groups.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to advisory committees.
Dated: May 5, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical
Programs.
[FR Doc. 2015–11258 Filed 5–8–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–0001]
Pulmonary-Allergy Drugs Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: PulmonaryAllergy Drugs Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on June 11, 2015, from 8 a.m. to 5
p.m.
Location: Hilton Washington DC
North/Gaithersburg, Grand Ballroom,
620 Perry Pkwy., Gaithersburg, MD
20877. 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.
Contact Person: Kristina Toliver,
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, email:
PADAC@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
PO 00000
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26929
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
link, or call the advisory committee
information line to learn about possible
modifications before coming to the
meeting.
Agenda: The committee will discuss
biologics license application (BLA)
125526, for mepolizumab for injection,
submitted by GlaxoSmithKline for the
proposed indication of add-on
maintenance treatment in patients 12
years and older with severe eosinophilic
asthma identified by blood eosinophils
greater than or equal to 150 cells/
microliter at initiation of treatment or
blood eosinophils greater than or equal
to 300 cells/microliter in the past 12
months.
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 May 28, 2015. Oral
presentations from the public will be
scheduled between approximately 1
p.m. and 2 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 May 19,
2015. 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
E:\FR\FM\11MYN1.SGM
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]]>Agencies
[Federal Register Volume 80, Number 90 (Monday, May 11, 2015)]
[Notices]
[Pages 26928-26929]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-11258]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-0001]
Request for Nominations on the Vaccines and Related Biological
Products Advisory Committee
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is requesting that any
industry organizations interested in participating in the selection of
a nonvoting industry representative to serve on the Vaccines and
Related Biological Products Advisory Committee for the Center for
Biologics Evaluation and Research (CBER) notify FDA in writing. FDA is
also requesting nominations for a nonvoting industry representative(s)
to serve on the Vaccines and Related Biological Products Advisory
Committee. A nominee may either be self-nominated or nominated by an
organization to serve as a nonvoting industry representative.
Nominations will be accepted for current vacancies effective with this
notice.
DATES: Any industry organization interested in participating in the
selection of an appropriate nonvoting member to represent industry
interests must send a letter stating that interest to the FDA by June
10, 2015, (see sections I and II of this document for further details).
Concurrently, nomination materials for prospective candidates should be
sent to FDA by June 10, 2015.
ADDRESSES: All statements of interest from interested industry
organizations interested in participating in the selection process of
nonvoting industry representative nomination should be sent to Sujata
Vijh (see FOR FURTHER INFORMATION CONTACT). All nominations for
nonvoting industry representatives may be submitted electronically by
accessing the FDA Advisory Committee Membership Nomination Portal:
https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm or
by mail to Advisory Committee Oversight and Management Staff, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103,
Silver Spring, MD 20993-0002. Information about becoming a member of an
FDA advisory committee can also be obtained by visiting FDA's Web site:
https://www.fda.gov/AdvisoryCommittees/default.htm.
FOR FURTHER INFORMATION CONTACT: Sujata Vijh, Division of Scientific
Advisors and Consultants, Center for Biologics Evaluation and Research,
10903 New Hampshire Ave., Bldg. 71, Rm. 6128, Silver Spring, MD 20993-
0002, 240-402-7107, FAX: 301-595-1307, email: Sujata.vijh@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The Agency intends to add a nonvoting
industry representative(s) to the following advisory committee:
[[Page 26929]]
I. CBER Vaccines and Related Biological Products Advisory Committee
The CBER Vaccines and Related Biological Products Advisory
Committee (the Committee) reviews and evaluates data concerning the
safety, effectiveness, and appropriate use of vaccines and related
biological products which are intended for use in the prevention,
treatment, or diagnosis of human diseases, and, as required, any other
product for which FDA has regulatory responsibility. The Committee also
considers the quality and relevance of FDA's research program which
provides scientific support for the regulation of these products and
makes appropriate recommendations to the Commissioner of Food and
Drugs.
II. Selection Procedure
Any industry organization interested in participating in the
selection of an appropriate nonvoting member to represent industry
interests should send a letter stating that interest to the FDA contact
(see FOR FURTHER INFORMATION CONTACT) within 30 days of publication
(see DATES). Within the subsequent 30 days, FDA will send a letter to
each organization that has expressed an interest, attaching a complete
list of all such organizations; and a list of all nominees along with
their current resumes. The letter will also state that it is the
responsibility of the interested organizations to confer with one
another and to select a candidate, within 60 days after the receipt of
the FDA letter, to serve as the nonvoting member to represent industry
interests for the committee. The interested organizations are not bound
by the list of nominees in selecting a candidate. However, if no
individual is selected within 60 days, the Commissioner will select the
nonvoting member to represent industry interests.
III. Application Procedure
Individuals may self-nominate and/or an organization may nominate
one or more individuals to serve as a nonvoting industry
representative. Contact information, a current curriculum vitae, and
the name of the committee of interest should be sent to the FDA
Advisory Committee Membership Nomination Portal (see ADDRESSES) within
30 days of publication (see DATES). FDA will forward all nominations to
the organizations expressing interest in participating in the selection
process for the committee. (Persons who nominate themselves as
nonvoting industry representatives will not participate in the
selection process).
FDA seeks to include the views of women, and men, members of all
racial and ethnic groups, and individuals with and without disabilities
on its advisory committees and, therefore encourages nominations of
appropriately qualified candidates from these groups.
This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.
Dated: May 5, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2015-11258 Filed 5-8-15; 8:45 am]
BILLING CODE 4164-01-P
