Vaccines and Related Biological Products Advisory Committee; Notice of Meeting, 13866-13867 [2015-06116]
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13866
Federal Register / Vol. 80, No. 51 / Tuesday, March 17, 2015 / Notices
The Education and Community
Involvement Branch (ECIB) designed the
program to accomplish the following
goals, which align with elements of both
the NIH and NHGRI missions:
• Expand NIH and NHGRI’s
professional network to reach out to
diverse communities, and to create new
partnership opportunities.
• Prepare the next generation of
genomics professionals for an era of
genomic medicine.
• Train and diversify the pipeline of
genome professionals in alignment with
the NIH and US Department of Health
and Human Services diversity efforts.
The ECIB has systematically collected
feedback annually after the program
from participants since inception of the
Short Course in 2003, and then used the
data to tweak the program, but it has not
conducted a long-term, cumulative and
substantive outcome evaluation. NHGRI
and the ECIB propose to conduct such
an outcome evaluation, focusing on
three main objectives:
(1) To understand the degree of
genetic and genomic curriculum
integration by faculty participants;
(2) To explore the barriers and
supports faculty experience and changes
when integrating curriculum; and
(3) To investigate the influence of the
program on the participants’ career
path.
Survey findings will provide valuable
information about the various methods
and pathways instructors use to
disseminate new knowledge (and the
associated timelines), the barriers and
supports experienced by faculty as they
integrate new knowledge into their
teaching, and insights about additional
avenues of support that NHGRI could
provide teaching faculty from the types
of institutions identified. Key indicators
will also provide evidence about the
degree to which the Short Course is
meeting its goals. Collectively, the
outcome evaluation will inform future
program design and budget allocations.
OMB approval is requested for 2
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
155.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Number of
responses
per
respondent
Average
burden per
response
(in hours)
Students .............................
Faculty ...............................
110
200
1
1
30/60
30/60
55
100
............................................
310
....................
....................
155
Form name
Type of
respondents
Short Course Survey—Students .....................................
Short Course Survey—Faculty ........................................
Totals ........................................................................
Dated: March 11, 2015.
Gloria Butler,
NHGRI Project Clearance Liaison, National
Institutes of Health.
[FR Doc. 2015–06086 Filed 3–16–15; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–0001]
Vaccines and Related Biological
Products Advisory Committee; Notice
of Meeting
AGENCY:
Food and Drug Administration,
HHS.
mstockstill on DSK4VPTVN1PROD with NOTICES
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: Vaccines and
Related Biological Products 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 May 12, 2015, from 8:30 a.m. to
5 p.m.
VerDate Sep<11>2014
18:09 Mar 16, 2015
Jkt 235001
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Building
31 Conference Center, the Great Room
(Rm. 1503), Silver Spring, MD 20993.
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/AboutAdvisory
Committees/ucm408555.htm. For those
unable to attend in person, the meeting
will also be Web cast and will be
available at the following link: https://
collaboration.fda.gov/vrbpac0515/.
Contact Person: Sujata Vijh, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
6128, Silver Spring, MD 209930–0002,
240–402–7107; or Denise Royster,
Center for Biologics Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 71, Rm. 6134, Silver Spring,
MD 209930–0002, 240–402–8158; 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/
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
Total
annual
burden
hours
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: On May 12, 2015, from 8:30
a.m. to 5 p.m., the committee will meet
in open session to discuss the
development and licensure of Ebola
vaccines.
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 5, 2015. Oral
presentations from the public will be
scheduled between 1:15 p.m. and 2:15
p.m. Those individuals interested in
making formal oral presentations should
E:\FR\FM\17MRN1.SGM
17MRN1
13867
Federal Register / Vol. 80, No. 51 / Tuesday, March 17, 2015 / Notices
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 April 27, 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
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 April 28, 2015.
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 physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Sujata Vijh
(see Contact Person) 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/Advisory
Committees/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: March 13, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–06116 Filed 3–16–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVCES
Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities: Proposed Collection;
Comment Request
In compliance with Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 concerning
opportunity for public comment on
proposed collections of information, the
Substance Abuse and Mental Health
Services Administration (SAMHSA)
will publish periodic summaries of
proposed projects. To request more
information on the proposed project or
to obtain a copy of the information
collection plans, call the SAMHSA
Reports Clearance Officer on (240) 276–
1243.
Comments are invited on: (a) Whether
the proposed collection of information
are necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) ways to enhance the
quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Proposed Project Behavioral Health
Information Technologies Survey—
NEW
The Substance Abuse and Mental
Health Services Administration
(SAMHSA) Center for Substance Abuse
Treatment (CSAT) and Center for
Behavioral Health Statistics and Quality
(CBHSQ) are proposing a survey to
assess health information technology
(HIT) adoption among SAMHSA
grantees. As part of its Strategic
Initiative to advance the use of health
information technologies to support
integrated behavioral health care,
SAMHSA has been working to develop
a survey instrument that will examine
Number of
respondents
mstockstill on DSK4VPTVN1PROD with NOTICES
Type of grantee or respondent
Screening, Brief Intervention, and Referral to Treatment
(SBIRT) .............................................................................
Targeted Capacity Expansion-Targeted Assisted Care ......
Offender Re-entry Program .................................................
Primary Behavioral Health Care Integration (PBHCI) .........
National Child Traumatic Stress Initiative (NCTSI) .............
Suicide Lifeline Crisis Center Follow-up ..............................
VerDate Sep<11>2014
18:09 Mar 16, 2015
Jkt 235001
PO 00000
Frm 00046
Number of
responses
annually per
respondent
18
17
13
89
56
12
Fmt 4703
Sfmt 4703
the status of and plans for HIT adoption
by behavioral health service providers
who are implementing SAMHSA grant
programs. The selected programs are
funded by the by the Center for Mental
Health Services (CMHS), the Center for
Substance Abuse Prevention (CSAP),
and (CSAT).
This project seeks to acquire baseline
data necessary to inform the Agency’s
strategic initiative that focuses on
fostering the adoption of HIT in
community behavioral health services.
The survey of SAMHSA grantees
regarding their access to and use of
health information technology will
provide valuable information that will
inform the behavioral HIT literature.
Approval of this data collection by the
Office of Management and Budget
(OMB) will allow SAMHSA to identify
the current status of HIT adoption and
use among a diverse group of grantees.
Data from the survey will allow
SAMHSA to enhance the HIT-related
programmatic activities among its
grantees by providing data on how HIT
facilitates the implementation of
different types of SAMHSA grants,
thereby fostering the appropriate
adoption of HIT within SAMSHAfunded programs.
The survey will collect data once,
providing a snapshot view of the current
state of HIT adoption. The proposed
participant pool is comprised of
SAMHSA grantee program leadership
who are willing to provide the
assistance needed to ensure a high rate
of response. Awardees from nine
different SAMHSA programs drawn
from CMHS, CSAT, and CSAP comprise
the pool of survey participants.
The survey mode for data collection
will be web-based with embedded skip
logic for respondents to avoid questions
that are not applicable to them. The
minimum amount of time for a
respondent to complete the survey is 20
minutes, with respondents who do not
skip items taking a maximum of 30
minutes for completion. The total
estimated respondent burden is 149.6
hours.
The following table summarizes the
estimated response burden.
Total
responses
1
1
1
1
1
1
E:\FR\FM\17MRN1.SGM
Average hours
per response
18
17
13
89
56
12
17MRN1
.4
.4
.4
.4
.4
.4
Total burden
hours
7.2
6.8
5.2
35.6
22.4
4.8
Agencies
[Federal Register Volume 80, Number 51 (Tuesday, March 17, 2015)]
[Notices]
[Pages 13866-13867]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-06116]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-0001]
Vaccines and Related Biological Products 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: Vaccines and Related Biological Products
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 May 12, 2015, from 8:30
a.m. to 5 p.m.
Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building
31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD
20993. 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 Web cast and will
be available at the following link: https://collaboration.fda.gov/vrbpac0515/.
Contact Person: Sujata Vijh, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 6128, Silver Spring, MD 209930-0002, 240-402-7107; or Denise
Royster, Center for Biologics Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6134, Silver
Spring, MD 209930-0002, 240-402-8158; 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 link, or call the advisory committee
information line to learn about possible modifications before coming to
the meeting.
Agenda: On May 12, 2015, from 8:30 a.m. to 5 p.m., the committee
will meet in open session to discuss the development and licensure of
Ebola vaccines.
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
5, 2015. Oral presentations from the public will be scheduled between
1:15 p.m. and 2:15 p.m. Those individuals interested in making formal
oral presentations should
[[Page 13867]]
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
April 27, 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 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 April 28, 2015.
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
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Sujata Vijh (see
Contact Person) 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: March 13, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-06116 Filed 3-16-15; 8:45 am]
BILLING CODE 4164-01-P