83 FR 22689 - Blood Products Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 95 (May 16, 2018)

Page Range		22689-22690
FR Document		2018-10414

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.

Federal Register, Volume 83 Issue 95 (Wednesday, May 16, 2018)

[Federal Register Volume 83, Number 95 (Wednesday, May 16, 2018)]
[Notices]
[Pages 22689-22690]
From the Federal Register Online  [www.thefederalregister.org]
[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, 
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-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

22690 Federal Register / Vol. 83, No. 95 / Wednesday, May 16, 2018 / Notices

or Joanne Lipkin at least 7 days in in brackets in the heading of this characteristics of the target audience—
advance of the meeting. document. its perceptions, knowledge, attitudes,
FDA is committed to the orderly FOR FURTHER INFORMATION CONTACT: beliefs, and behaviors—and use these in
conduct of its advisory committee Amber Sanford, Office of Operations, the development of appropriate survey/
meetings. Please visit our website at Food and Drug Administration, Three research questions, study stimuli, or
https://www.fda.gov/Advisory White Flint North, 10A–12M, 11601 communications; (2) more efficiently
Committees/AboutAdvisoryCommittees/ Landsdown St., North Bethesda, MD and effectively design survey/research
ucm111462.htm for procedures on 20852, 301–796–8867, PRAStaff@ questions and study stimuli; and (3)
public conduct during advisory fda.hhs.gov. more efficiently and effectively design
committee meetings. experimental studies.
SUPPLEMENTARY INFORMATION: In
Notice of this meeting is given under FDA is requesting approval of this
the Federal Advisory Committee Act (5 compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed new generic clearance for collecting
U.S.C. app. 2). information through the use of
collection of information to OMB for
Dated: May 10, 2018. review and clearance. qualitative methods (i.e., individual
Leslie Kux, interviews, small group discussions,
Generic Clearance for the Collection of and focus groups) for studies involving
Associate Commissioner for Policy.
Qualitative Data on Tobacco Products all tobacco products regulated by FDA.
[FR Doc. 2018–10414 Filed 5–15–18; 8:45 am]
and Communications This information will be used as a first
BILLING CODE 4164–01–P
OMB Control Number 0910–0796— step to explore concepts of interest and
Extension assist in the development of quantitative
DEPARTMENT OF HEALTH AND study proposals, complementing other
Under section 1003(d)(2)(D) of the important research efforts at FDA. This
HUMAN SERVICES Federal Food, Drug, and Cosmetic Act information may also be used to help
(21 U.S.C. 393(d)(2)(D)), FDA is identify and develop communication
Food and Drug Administration authorized to conduct educational and messages, which may be used in
public information programs. education campaigns. Focus groups play
[Docket No. FDA–2014–N–0987] In conducting studies relating to the an important role in gathering
regulation and communications related
Agency Information Collection information because they allow for an
to tobacco products, FDA will need to
Activities; Submission for Office of in-depth understanding of individual
employ formative qualitative research
Management and Budget Review; attitudes, beliefs, motivations, and
including focus groups, usability
Comment Request; Generic Clearance feelings. Focus group research serves
testing, and/or in-depth interviews
for the Collection of Qualitative Data the narrowly defined need for direct and
(IDIs) to assess knowledge and
on Tobacco Products and informal public opinion on a specific
perceptions about tobacco-related topics
Communications topic. In the Federal Register of
with specific target audiences. The
November 17, 2017 (82 FR 54351), FDA
AGENCY: Food and Drug Administration, information collected will serve three
published a 60-day notice requesting
HHS. major purposes. First, formative
research will provide critical knowledge public comment on the proposed
ACTION: Notice. collection of information. FDA received
about target audiences. FDA must
understand people’s knowledge and one comment by a private citizen that
SUMMARY: The Food and Drug
perceptions about tobacco-related topics was PRA-related.
Administration (FDA) is announcing
that a proposed collection of before developing survey/research (Comment) The commenter stated that
information has been submitted to the questions as well as stimuli for FDA should use the data we have
Office of Management and Budget experimental studies. Second, by collected in the past instead of
(OMB) for review and clearance under collecting communications usability collecting new information. The
the Paperwork Reduction Act of 1995 information, FDA will be able to serve comment does not go in detail or
(PRA). and respond to the ever-changing provide any alternatives.
demands of consumers of tobacco (Response) This collection is a
DATES: Fax written comments on the products. Additionally, we will be able valuable tool for conducting research.
collection of information by June 15, to determine the best way to present The studies FDA has conducted through
2018. messages. Third, initial testing will this collection of information have been
ADDRESSES: To ensure that comments on allow FDA to assess consumer essential in helping FDA meet its
the information collection are received, understanding of survey/research mission as a science-based regulatory
OMB recommends that written questions and study stimuli. Focus agency and implementing the Family
comments be faxed to the Office of groups and/or IDIs with a sample of the Smoking Prevention and Tobacco
Information and Regulatory Affairs, target audience will allow FDA to refine Control Act (Pub. L. 111–31). Future
OMB, Attn: FDA Desk Officer, Fax: 202– the survey/research questions and study submissions submitted under this
395–7285, or emailed to oira_ stimuli while they are still in the generic clearance will continue to assist
submission@omb.eop.gov. All developmental stage. FDA will collect, FDA in its mission to protect and
comments should be identified with the analyze, and interpret information promote public health.
OMB control number 0910–0796. Also gathered through this generic clearance FDA estimates the burden of this
sradovich on DSK3GMQ082PROD with NOTICES

include the FDA docket number found in order to: (1) Better understand collection of information as follows:

VerDate Sep<11>2014 17:34 May 15, 2018 Jkt 244001 PO 00000 Frm 00080 Fmt 4703 Sfmt 4703 E:\FR\FM\16MYN1.SGM 16MYN1

Document Created: 2018-11-02 09:13:39
Document Modified: 2018-11-02 09:13:39

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
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.
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/.
FR Citation		83 FR 22689

83 FR 22689 - Blood Products Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 95 (May 16, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration