Blood Products Advisory Committee; Notice of Meeting, 22689-22690 [2018-10414]
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Federal Register / Vol. 83, No. 95 / Wednesday, May 16, 2018 / Notices
The Department specifically requests
comments on (a) whether the proposed
collection of information is 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)
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.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2018–10461 Filed 5–15–18; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–1773]
Blood Products Advisory Committee;
Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Blood Products Advisory
Committee. The general function of the
Blood Products Advisory Committee is
to provide advice and recommendations
to the Agency on regulatory issues
related to blood and products derived
from blood. On the first day of the
meeting, the Committee will provide
advice regarding bacterial risk control
strategies to enhance the safety and
availability of platelets for transfusion.
On the second day of the meeting, the
Committee, supplemented with
members from the Microbiology Devices
Panel of the Medical Devices Advisory
Committee, will function as a medical
device panel to provide advice and
recommendations to the Agency on
classification of devices. The meeting
will be open to the public.
DATES: The meeting will be held on July
18, 2018, from 8 a.m. to 5 p.m. and July
19, 2018, from 8 a.m. to 3 p.m.
ADDRESSES: FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503, sections B and C), Silver Spring,
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
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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/Advisory
Committees/AboutAdvisoryCommittees/
ucm408555.htm.
FOR FURTHER INFORMATION CONTACT:
Bryan Emery, Division of Scientific
Advisors and Consultants, Center for
Biologics Evaluation and Research
(CBER), Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 71,
Rm. 6268, Silver Spring, MD 20993–
0002, 240–402–8054, bryan.emery@
fda.hhs.gov; or Joanne Lipkind, Division
of Scientific Advisors and Consultants,
CBER, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 71,
Rm. 6270, Silver Spring, MD 20993–
0002, 240–402–8106, joanne.lipkind@
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 website 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. For those unable to attend in
person, the meeting will be also be
available via webcast. The webcast will
be available at the following link on
both days: https://collaboration.fda.gov/
bpac0718/.
SUPPLEMENTARY INFORMATION:
Agenda: On July 18, 2018, the Blood
Products Advisory Committee will meet
in open session to discuss and provide
advice regarding bacterial risk control
strategies for blood collection
establishments and transfusion services
to enhance the safety and availability of
platelets for transfusion. The Committee
will discuss the available strategies to
control the risk of bacterial
contamination of platelets with 5-day
and 7-day dating, including bacterial
testing using culture-based devices and
rapid bacterial detection devices and
implementation of pathogen reduction
technology.
On July 19, 2018, the Committee will
function as a medical device panel. The
Committee will meet in open session to
discuss and provide advice regarding
the device reclassification from class III
to class II of nucleic acid and serology-
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22689
based point-of-care and laboratory-based
in vitro diagnostic devices indicated for
use as aids in the diagnosis of human
immunodeficiency virus (HIV)
infection. The devices that will be
discussed by the Committee during the
meeting are post-amendment devices
that currently are classified into class III
under section 513(f)(1) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
360c(f)(1)).
FDA intends to make background
material available to the public
approximately 2 weeks and no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its website 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 website 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 July 11, 2018. Oral
presentations from the public will be
scheduled between approximately 2:15
p.m. and 3:15 p.m. on July 18, 2018, and
between 12:30 p.m. and 1:30 p.m. on
July 19, 2018. 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 July 5,
2018. 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 July 6, 2018.
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 Bryan Emery
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22690
Federal Register / Vol. 83, No. 95 / Wednesday, May 16, 2018 / Notices
or Joanne Lipkin at least 7 days in
advance of the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our website 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: May 10, 2018.
Leslie Kux,
Associate Commissioner for Policy.
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0987]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Generic Clearance
for the Collection of Qualitative Data
on Tobacco Products and
Communications
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995
(PRA).
SUMMARY:
Fax written comments on the
collection of information by June 15,
2018.
DATES:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0796. Also
include the FDA docket number found
sradovich on DSK3GMQ082PROD with NOTICES
ADDRESSES:
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17:34 May 15, 2018
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FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Generic Clearance for the Collection of
Qualitative Data on Tobacco Products
and Communications
[FR Doc. 2018–10414 Filed 5–15–18; 8:45 am]
AGENCY:
in brackets in the heading of this
document.
OMB Control Number 0910–0796—
Extension
Under section 1003(d)(2)(D) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 393(d)(2)(D)), FDA is
authorized to conduct educational and
public information programs.
In conducting studies relating to the
regulation and communications related
to tobacco products, FDA will need to
employ formative qualitative research
including focus groups, usability
testing, and/or in-depth interviews
(IDIs) to assess knowledge and
perceptions about tobacco-related topics
with specific target audiences. The
information collected will serve three
major purposes. First, formative
research will provide critical knowledge
about target audiences. FDA must
understand people’s knowledge and
perceptions about tobacco-related topics
before developing survey/research
questions as well as stimuli for
experimental studies. Second, by
collecting communications usability
information, FDA will be able to serve
and respond to the ever-changing
demands of consumers of tobacco
products. Additionally, we will be able
to determine the best way to present
messages. Third, initial testing will
allow FDA to assess consumer
understanding of survey/research
questions and study stimuli. Focus
groups and/or IDIs with a sample of the
target audience will allow FDA to refine
the survey/research questions and study
stimuli while they are still in the
developmental stage. FDA will collect,
analyze, and interpret information
gathered through this generic clearance
in order to: (1) Better understand
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characteristics of the target audience—
its perceptions, knowledge, attitudes,
beliefs, and behaviors—and use these in
the development of appropriate survey/
research questions, study stimuli, or
communications; (2) more efficiently
and effectively design survey/research
questions and study stimuli; and (3)
more efficiently and effectively design
experimental studies.
FDA is requesting approval of this
new generic clearance for collecting
information through the use of
qualitative methods (i.e., individual
interviews, small group discussions,
and focus groups) for studies involving
all tobacco products regulated by FDA.
This information will be used as a first
step to explore concepts of interest and
assist in the development of quantitative
study proposals, complementing other
important research efforts at FDA. This
information may also be used to help
identify and develop communication
messages, which may be used in
education campaigns. Focus groups play
an important role in gathering
information because they allow for an
in-depth understanding of individual
attitudes, beliefs, motivations, and
feelings. Focus group research serves
the narrowly defined need for direct and
informal public opinion on a specific
topic. In the Federal Register of
November 17, 2017 (82 FR 54351), FDA
published a 60-day notice requesting
public comment on the proposed
collection of information. FDA received
one comment by a private citizen that
was PRA-related.
(Comment) The commenter stated that
FDA should use the data we have
collected in the past instead of
collecting new information. The
comment does not go in detail or
provide any alternatives.
(Response) This collection is a
valuable tool for conducting research.
The studies FDA has conducted through
this collection of information have been
essential in helping FDA meet its
mission as a science-based regulatory
agency and implementing the Family
Smoking Prevention and Tobacco
Control Act (Pub. L. 111–31). Future
submissions submitted under this
generic clearance will continue to assist
FDA in its mission to protect and
promote public health.
FDA estimates the burden of this
collection of information as follows:
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Agencies
[Federal Register Volume 83, Number 95 (Wednesday, May 16, 2018)]
[Notices]
[Pages 22689-22690]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-10414]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-1773]
Blood 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 Blood Products Advisory
Committee. The general function of the Blood Products Advisory
Committee is to provide advice and recommendations to the Agency on
regulatory issues related to blood and products derived from blood. On
the first day of the meeting, the Committee will provide advice
regarding bacterial risk control strategies to enhance the safety and
availability of platelets for transfusion. On the second day of the
meeting, the Committee, supplemented with members from the Microbiology
Devices Panel of the Medical Devices Advisory Committee, will function
as a medical device panel to provide advice and recommendations to the
Agency on classification of devices. The meeting will be open to the
public.
DATES: The meeting will be held on July 18, 2018, from 8 a.m. to 5 p.m.
and July 19, 2018, from 8 a.m. to 3 p.m.
ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm. 1503, sections B and C), 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 FURTHER INFORMATION CONTACT: Bryan Emery, Division of Scientific
Advisors and Consultants, Center for Biologics Evaluation and Research
(CBER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 6268, Silver Spring, MD 20993-0002, 240-402-8054,
[email protected]; or Joanne Lipkind, Division of Scientific
Advisors and Consultants, CBER, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 6270, Silver Spring, MD 20993-0002, 240-
402-8106, [email protected]; 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 website 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. For those unable to attend in person, the meeting will be
also be available via webcast. The webcast will be available at the
following link on both days: https://collaboration.fda.gov/bpac0718/.
SUPPLEMENTARY INFORMATION:
Agenda: On July 18, 2018, the Blood Products Advisory Committee
will meet in open session to discuss and provide advice regarding
bacterial risk control strategies for blood collection establishments
and transfusion services to enhance the safety and availability of
platelets for transfusion. The Committee will discuss the available
strategies to control the risk of bacterial contamination of platelets
with 5-day and 7-day dating, including bacterial testing using culture-
based devices and rapid bacterial detection devices and implementation
of pathogen reduction technology.
On July 19, 2018, the Committee will function as a medical device
panel. The Committee will meet in open session to discuss and provide
advice regarding the device reclassification from class III to class II
of nucleic acid and serology-based point-of-care and laboratory-based
in vitro diagnostic devices indicated for use as aids in the diagnosis
of human immunodeficiency virus (HIV) infection. The devices that will
be discussed by the Committee during the meeting are post-amendment
devices that currently are classified into class III under section
513(f)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360c(f)(1)).
FDA intends to make background material available to the public
approximately 2 weeks and no later than 2 business days before the
meeting. If FDA is unable to post the background material on its
website 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 website 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 July
11, 2018. Oral presentations from the public will be scheduled between
approximately 2:15 p.m. and 3:15 p.m. on July 18, 2018, and between
12:30 p.m. and 1:30 p.m. on July 19, 2018. 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 July 5, 2018. 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 July 6, 2018.
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 Bryan Emery
[[Page 22690]]
or Joanne Lipkin at least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our website 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: May 10, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-10414 Filed 5-15-18; 8:45 am]
BILLING CODE 4164-01-P