Blood Products Advisory Committee; Notice of Meeting, 22689-22690 [2018-10414]

Download as PDF 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: VerDate Sep<11>2014 17:34 May 15, 2018 Jkt 244001 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- PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 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 E:\FR\FM\16MYN1.SGM 16MYN1 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: VerDate Sep<11>2014 17:34 May 15, 2018 Jkt 244001 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 PO 00000 Frm 00080 Fmt 4703 Sfmt 4703 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: E:\FR\FM\16MYN1.SGM 16MYN1

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]


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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