83_FR_23564 83 FR 23466 - Blood Products Advisory Committee; Notice of Meeting

83 FR 23466 - Blood Products Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 98 (May 21, 2018)

Page Range23466-23467
FR Document2018-10734

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Blood Products Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. At least one portion of the meeting will be closed to the public.

Federal Register, Volume 83 Issue 98 (Monday, May 21, 2018) 
[Federal Register Volume 83, Number 98 (Monday, May 21, 2018)]
[Notices]
[Pages 23466-23467]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-10734]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-1708]


Blood Products Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 committee is to provide advice 
and recommendations to the Agency on FDA's regulatory issues. At least 
one portion of the meeting will be closed to the public.

DATES: The meeting will be held on June 22, 2018, from 11 a.m. to 4:20 
p.m.

ADDRESSES: Great Room A, Building 31, FDA White Oak Campus, 10903 New 
Hampshire Ave., 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 FURTHER INFORMATION CONTACT: Bryan Emery or Joanne Lipkind, 
Division of Scientific Advisors and Consultants, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993-0002, Bldg. 71, Rm. 6132, at 
240-402-8054, [email protected] and Rm. 6270, at 240-402-8106, 
[email protected], respectively, 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 
also be available via webcast. The webcast will be available at the 
following link: https://collaboration.fda.gov/bpac0618/.

SUPPLEMENTARY INFORMATION: 
    Agenda: On June 22, 2018, in the morning open session, under Topic 
1, the Committee will hear presentations on the research programs in 
the Laboratory of Emerging Pathogens (LEP), Laboratory of bacterial and 
TSE Agents (LBTSE), and from the Laboratory of Molecular Virology (LMV) 
in the Division of Emerging Transfusion-Transmitted Diseases (DETTD), 
Office of Blood Research and Review (OBRR), Center for Biologics 
Evaluation and Research (CBER), FDA. After the conclusion of the open 
session, the meeting will be closed to permit discussion where 
disclosure would constitute an unwarranted invasion of personal privacy 
in accordance with 5 U.S.C. 552b(c)(6).
    In the afternoon, in open session, under Topic II, the Committee 
will hear presentations on the research program in the Hemostasis 
Branch (HB), in the Division of Plasma Protein Therapeutics (DPPT), 
Office of Tissues and Advanced Therapies (OTAT), Center for Biologics 
Evaluation and Research (CBER), FDA. After the open session, the 
meeting will be closed to the public to permit discussion where 
disclosure would constitute an unwarranted invasion of personal privacy 
in accordance with 5 U.S.C. 552.b(c)(6).
    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 website prior to the meeting, the 
background material will

[[Page 23467]]

be made publicly available at the venue of the advisory committee 
meeting, and the background material will be posted on FDA's website 
after the meeting. Background material will be available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the 
appropriate advisory committee meeting link.
    Procedure: On June 22, 2018, from 11 a.m. to 12:55 p.m. and 2:20 
p.m. to 3:45 p.m.., the meeting is open to the public. 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 June 15, 2018. Oral presentations 
from the public will be scheduled between approximately 12:25 p.m. to 
12:55 p.m. and from 3:15 p.m. to 3:45 p.m. on June 22, 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 June 
7, 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 June 8, 2018.
    Closed Committee Deliberations: On June 22, 2018 between 12:55 p.m. 
and 1:40 p.m. and between 3:45 p.m. and 4:20 p.m., the meeting will be 
closed to permit discussion where disclosure would constitute a clearly 
unwarranted invasion of personal privacy (5 U.S.C. 552b(c)(6)). During 
the closed sessions, the Committee will discuss the research progress 
made by staff involved in the intramural research programs and make 
recommendations regarding personnel actions and staffing.
    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 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 15, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-10734 Filed 5-18-18; 8:45 am]
 BILLING CODE 4164-01-P

23466 Federal Register / Vol. 83, No. 98 / Monday, May 21, 2018 / Notices advertising will consist of a print smoking cigarettes, using nicotine products are harmful to users’ health. advertisement. The study will assess replacement therapies, and quitting all Measures of intentions and doubt will participants’ perceptions of various tobacco and nicotine products. The be used to help assess the validity of the health risks from using the product, as study will also assess participants’ measures of health risk perception. well as their perceptions of health risk intentions to use the product and their FDA estimates the burden of this from using the product compared to level of doubt about whether tobacco collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of Average Number of Total annual Activity responses per burden per Total hours respondents responses respondent response Invitation: Young Adults (Ages 18–25) ................................ 29,000 1 29,000 0.02 580 Invitation: Adults (Ages 26+) ............................................... 29,000 1 29,000 0.02 580 Consent and Screener: Young Adults (Ages 18–25) .......... 11,000 1 11,000 0.10 1,100 Consent and Screener: Adults (Ages 26+) ......................... 16,500 1 16,500 0.10 1,650 Study: Young Adults (Ages 18–25) ..................................... 3,300 1 3,300 0.33 1,089 Study: Adults (Ages 26+) ..................................................... 3,300 1 3,300 0.33 1,089 Total .............................................................................. ........................ ........................ ........................ ........................ 6,088 1 There are no capital costs or operating and maintenance costs associated with this collection of information. FDA’s burden estimate is based on committee is to provide advice and modifications before coming to the prior experience with research that is recommendations to the Agency on meeting. For those unable to attend in similar to this proposed study. FDA’s regulatory issues. At least one person, the meeting will also be Approximately 58,000 people will portion of the meeting will be closed to available via webcast. The webcast will receive a study invitation, estimated to the public. be available at the following link: take 1 minute to read (approximately DATES: The meeting will be held on June https://collaboration.fda.gov/bpac0618/. 0.02 hours), for a total of 1,160 hours for 22, 2018, from 11 a.m. to 4:20 p.m. SUPPLEMENTARY INFORMATION: invitations. Approximately 27,500 ADDRESSES: Great Room A, Building 31, Agenda: On June 22, 2018, in the people will complete the informed FDA White Oak Campus, 10903 New morning open session, under Topic 1, consent and screener to determine Hampshire Ave., Silver Spring, MD the Committee will hear presentations eligibility for participation in the study, 20993. Answers to commonly asked on the research programs in the estimated to take 6 minutes (0.10 hours), questions including information Laboratory of Emerging Pathogens for a total of 2,750 hours for informed regarding special accommodations due (LEP), Laboratory of bacterial and TSE consent and screening activities. to a disability, visitor parking, and Agents (LBTSE), and from the Approximately 6,600 people will transportation may be accessed at: Laboratory of Molecular Virology (LMV) complete the full study, estimated to https://www.fda.gov/Advisory in the Division of Emerging take 20 minutes (approximately 0.33 Committees/AboutAdvisoryCommittees/ Transfusion-Transmitted Diseases hours), for a total of 2,178 hours for ucm408555.htm. (DETTD), Office of Blood Research and study completion activities. The Review (OBRR), Center for Biologics estimated total hour burden of the FOR FURTHER INFORMATION CONTACT: Evaluation and Research (CBER), FDA. collection of information is 6,088 hours. Bryan Emery or Joanne Lipkind, After the conclusion of the open Division of Scientific Advisors and session, the meeting will be closed to Dated: May 15, 2018. Consultants, Center for Biologics permit discussion where disclosure Leslie Kux, Evaluation and Research, Food and would constitute an unwarranted Associate Commissioner for Policy. Drug Administration, 10903 New invasion of personal privacy in [FR Doc. 2018–10723 Filed 5–18–18; 8:45 am] Hampshire Ave., Silver Spring, MD accordance with 5 U.S.C. 552b(c)(6). BILLING CODE 4164–01–P 20993–0002, Bldg. 71, Rm. 6132, at 240– In the afternoon, in open session, 402–8054, bryan.emery@fda.hhs.gov under Topic II, the Committee will hear and Rm. 6270, at 240–402–8106, presentations on the research program DEPARTMENT OF HEALTH AND joanne.lipkind@fda.hhs.gov, in the Hemostasis Branch (HB), in the HUMAN SERVICES respectively, or FDA Advisory Division of Plasma Protein Therapeutics Committee Information Line, 1–800– (DPPT), Office of Tissues and Advanced Food and Drug Administration 741–8138 (301–443–0572 in the Therapies (OTAT), Center for Biologics [Docket No. FDA–2018–N–1708] Washington, DC area). A notice in the Evaluation and Research (CBER), FDA. Federal Register about last minute After the open session, the meeting will Blood Products Advisory Committee; modifications that impact a previously be closed to the public to permit Notice of Meeting announced advisory committee meeting discussion where disclosure would AGENCY: Food and Drug Administration, cannot always be published quickly constitute an unwarranted invasion of enough to provide timely notice. sradovich on DSK3GMQ082PROD with NOTICES HHS. personal privacy in accordance with 5 ACTION: Notice. Therefore, you should always check the U.S.C. 552.b(c)(6). Agency’s website at https:// FDA intends to make background SUMMARY: The Food and Drug www.fda.gov/AdvisoryCommittees/ material available to the public no later Administration (FDA) announces a default.htm and scroll down to the than 2 business days before the meeting. forthcoming public advisory committee appropriate advisory committee meeting If FDA is unable to post the background meeting of the Blood Products Advisory link, or call the advisory committee material on its website prior to the Committee. The general function of the information line to learn about possible meeting, the background material will VerDate Sep<11>2014 19:04 May 18, 2018 Jkt 244001 PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 E:\FR\FM\21MYN1.SGM 21MYN1

Federal Register / Vol. 83, No. 98 / Monday, May 21, 2018 / Notices 23467 be made publicly available at the venue https://www.fda.gov/Advisory effective drugs for human use and, as of the advisory committee meeting, and Committees/AboutAdvisoryCommittees/ required, any other product for which the background material will be posted ucm111462.htm for procedures on FDA has regulatory responsibility. on FDA’s website after the meeting. public conduct during advisory The Committee reviews and evaluates Background material will be available at committee meetings. available data concerning the safety and http://www.fda.gov/Advisory Notice of this meeting is given under the Federal Advisory Committee Act (5 effectiveness of marketed and Committees/Calendar/default.htm. Scroll down to the appropriate advisory U.S.C. app.2). investigational human drug products committee meeting link. including analgesics, e.g., abuse- Dated: May 15, 2018. deterrent opioids, novel analgesics, and Procedure: On June 22, 2018, from 11 Leslie Kux, issues related to opioid abuse, and those a.m. to 12:55 p.m. and 2:20 p.m. to 3:45 Associate Commissioner for Policy. for use in anesthesiology and makes p.m.., the meeting is open to the public. Interested persons may present data, [FR Doc. 2018–10734 Filed 5–18–18; 8:45 am] appropriate recommendations to the information, or views, orally or in BILLING CODE 4164–01–P Commissioner. writing, on issues pending before the The Committee shall consist of a core committee. Written submissions may be of 11 voting members including the made to the contact person on or before DEPARTMENT OF HEALTH AND HUMAN SERVICES Chair. Members and the Chair are June 15, 2018. Oral presentations from selected by the Commissioner or the public will be scheduled between Food and Drug Administration designee from among authorities approximately 12:25 p.m. to 12:55 p.m. and from 3:15 p.m. to 3:45 p.m. on June [Docket No. FDA–2018–N–0001] knowledgeable in the fields of 22, 2018. Those individuals interested anesthesiology, analgesics (such as: in making formal oral presentations Advisory Committee; Anesthetic and abuse deterrent opioids, novel should notify the contact person and Analgesic Drug Products Advisory analgesics, and issues related to opioid submit a brief statement of the general Committee, Renewal abuse) epidemiology or statistics, and nature of the evidence or arguments related specialties. Members will be AGENCY: Food and Drug Administration, they wish to present, the names and HHS. invited to serve for overlapping terms of addresses of proposed participants, and up to 4 years. Almost all non-Federal ACTION:Notice; renewal of advisory an indication of the approximate time members of this committee serve as committee. requested to make their presentation on Special Government Employees. The or before June 7, 2018. Time allotted for SUMMARY: The Food and Drug core of voting members may include one each presentation may be limited. If the Administration (FDA) is announcing the technically qualified member, selected number of registrants requesting to renewal of the Anesthetic and Analgesic by the Commissioner or designee, who speak is greater than can be reasonably Drug Products Advisory Committee (the is identified with consumer interests accommodated during the scheduled Committee) by the Commissioner of and is recommended by either a open public hearing session, FDA may Food and Drugs (the Commissioner). consortium of consumer-oriented conduct a lottery to determine the The Commissioner has determined that organizations or other interested speakers for the scheduled open public it is in the public interest to renew the persons. In addition to the voting hearing session. The contact person will Committee for an additional 2 years members, the Committee may include notify interested persons regarding their beyond the charter expiration date. The one non-voting member who is request to speak by June 8, 2018. new charter will be in effect until May Closed Committee Deliberations: On identified with industry interests. 1, 2020. June 22, 2018 between 12:55 p.m. and Further information regarding the DATES: Authority for the Committee will 1:40 p.m. and between 3:45 p.m. and most recent charter and other expire on May 1, 2020, unless the 4:20 p.m., the meeting will be closed to information can be found at https:// Commissioner formally determines that permit discussion where disclosure renewal is in the public interest. www.fda.gov/AdvisoryCommittees/ would constitute a clearly unwarranted CommitteesMeetingMaterials/Drugs/ FOR FURTHER INFORMATION CONTACT: invasion of personal privacy (5 U.S.C. AnestheticandAnalgesicDrugProducts Moon Hee Choi, Center for Drug 552b(c)(6)). During the closed sessions, AdvisoryCommittee/default.htm or by Evaluation and Research, Food and the Committee will discuss the research contacting the Designated Federal Drug Administration, 10903 New progress made by staff involved in the Officer (see FOR FURTHER INFORMATION Hampshire Ave., Bldg. 31, Rm. 2417, intramural research programs and make CONTACT). In light of the fact that no Silver Spring, MD 20993–0002; 301– recommendations regarding personnel change has been made to the committee 796–9001, email: AADPAC@ actions and staffing. name or description of duties, no Persons attending FDA’s advisory fda.hhs.gov. amendment will be made to 21 CFR committee meetings are advised that the SUPPLEMENTARY INFORMATION: Pursuant 14.100. Agency is not responsible for providing to 41 CFR 102–3.65 and approval by the access to electrical outlets. Department of Health and Human This document is issued under the FDA welcomes the attendance of the Services pursuant to 45 CFR part 11 and Federal Advisory Committee Act (5 public at its advisory committee by the General Services Administration, U.S.C. app.). For general information meetings and will make every effort to FDA is announcing the renewal of the related to FDA advisory committees, please check https://www.fda.gov/ sradovich on DSK3GMQ082PROD with NOTICES accommodate persons with disabilities. Committee. The Committee is a If you require accommodations due to a discretionary Federal advisory AdvisoryCommittees/default.htm. disability, please contact Bryan Emery committee established to provide advice Dated: May 15, 2018. at least 7 days in advance of the to the Commissioner. Leslie Kux, meeting. The Committee advises the FDA is committed to the orderly Commissioner or designee in Associate Commissioner for Policy. conduct of its advisory committee discharging responsibilities as they [FR Doc. 2018–10731 Filed 5–18–18; 8:45 am] meetings. Please visit our website at relate to helping to ensure safe and BILLING CODE 4164–01–P VerDate Sep<11>2014 18:20 May 18, 2018 Jkt 244001 PO 00000 Frm 00054 Fmt 4703 Sfmt 9990 E:\FR\FM\21MYN1.SGM 21MYN1


Document Created: 2018-11-02 11:07:20
Document Modified: 2018-11-02 11:07:20
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesThe meeting will be held on June 22, 2018, from 11 a.m. to 4:20 p.m.
ContactBryan Emery or Joanne Lipkind, Division of Scientific Advisors and Consultants, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, Bldg. 71, Rm. 6132, at 240-402-8054, [email protected] and Rm. 6270, at 240-402-8106, [email protected], respectively, 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 also be available via webcast. The webcast will be available at the following link: https://collaboration.fda.gov/bpac0618/.
FR Citation83 FR 23466 
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