Pathogen Reduction Technologies for Blood Safety; Public Workshop, 46959-46960 [2018-20090]

Download as PDF Federal Register / Vol. 83, No. 180 / Monday, September 17, 2018 / Notices We base our estimate of the average burden per response on review activities familiar to the Agency. Noting that 2 hours per response is a significant amount of time, we are particularly interested in feedback regarding this estimate, including comments regarding how an alternative estimate might be derived. Dated: September 11, 2018. Leslie Kux, Associate Commissioner for Policy. Dated: September 11, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–20091 Filed 9–14–18; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–N–3236] [FR Doc. 2018–20092 Filed 9–14–18; 8:45 am] Advisory Committee; Oncologic Drugs Advisory Committee; Renewal BILLING CODE 4164–01–P AGENCY: Food and Drug Administration, HHS. DEPARTMENT OF HEALTH AND HUMAN SERVICES Notice; renewal of advisory committee. ACTION: Food and Drug Administration The Food and Drug Administration (FDA) is announcing the renewal of the Oncologic Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Oncologic Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until September 1, 2020. DATES: Authority for the Oncologic Drugs Advisory Committee will expire on September 1, 2020, unless the Commissioner formally determines that renewal is in the public interest. FOR FURTHER INFORMATION CONTACT: Lauren Tesh, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993–0002, 301–796–9001, email: ODAC@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102–3.65 and approval by the Department of Health and Human Services pursuant to 45 CFR part 11 and by the General Services Administration, FDA is announcing the renewal of the Oncologic Drugs Advisory Committee. The committee is a discretionary Federal advisory committee established to provide advice to the Commissioner. The Oncologic Drugs Advisory Committee advises the Commissioner or designee in discharging responsibilities as they relate to helping to ensure safe and effective drugs for human use and, as required, any other product for which FDA has regulatory responsibility. The committee reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of cancer and makes appropriate recommendations to the Commissioner. SUMMARY: [Docket No. FDA–2018–N–3431] Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction. The Food and Drug Administration is correcting a notice entitled ‘‘Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments’’ that appeared in the Federal Register of September 11, 2018. The document announced a forthcoming public advisory committee meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and establishment of a public docket for comments. The document was published with the incorrect docket number. This document corrects that error. SUMMARY: Lisa Granger, Office of Policy and Planning, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3330, Silver Spring, MD 20993–0002, 301–796–9115. FOR FURTHER INFORMATION CONTACT: In the Federal Register of Tuesday, September 11, 2018 (83 FR 45941), in FR Doc. 2018–19667, on page 45941, the following correction is made: On page 45941, in the first column, in the header of the document, and also in the third column under Instructions, ‘‘Docket No. FDA–2018–N–3276’’ is corrected to read ‘‘Docket No. FDA– 2018–N–3431’’. daltland on DSKBBV9HB2PROD with NOTICES SUPPLEMENTARY INFORMATION: VerDate Sep<11>2014 17:47 Sep 14, 2018 Jkt 244001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 46959 The committee shall consist of a core of 13 voting members including the Chair. Members and the Chair are selected by the Commissioner or designee from among authorities knowledgeable in the fields of general oncology, pediatric oncology, hematologic oncology, immunology oncology, biostatistics, and other related professions. Members will be invited to serve for overlapping terms of up to 4 years. Almost all non-Federal members of this committee serve as Special Government Employees. The core of voting members may include one technically qualified member, selected by the Commissioner or designee, who is identified with consumer interests and is recommended by either a consortium of consumer-oriented organizations or other interested persons. In addition to the voting members, the committee may include one non-voting member who is identified with industry interests. Further information regarding the most recent charter and other information can be found at https:// www.fda.gov/AdvisoryCommittees/ CommitteesMeetingMaterials/Drugs/ OncologicDrugsAdvisoryCommittee/ ucm107395.htm or by contacting the Designated Federal Officer (see FOR FURTHER INFORMATION CONTACT). In light of the fact that no change has been made to the committee name or description of duties, no amendment will be made to 21 CFR 14.100. This document is issued under the Federal Advisory Committee Act (5 U.S.C. app.). For general information related to FDA advisory committees, please check https://www.fda.gov/ AdvisoryCommittees/default.htm. Dated: September 11, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–20108 Filed 9–14–18; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–N–0001] Pathogen Reduction Technologies for Blood Safety; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The Food and Drug Administration (FDA) is announcing the following public workshop entitled ‘‘Pathogen Reduction Technologies for SUMMARY: E:\FR\FM\17SEN1.SGM 17SEN1 46960 Federal Register / Vol. 83, No. 180 / Monday, September 17, 2018 / Notices Blood Safety.’’ The purpose of the public workshop is to foster the development and implementation of pathogen reduction technologies for blood components intended for transfusion. The workshop will include presentations and panel discussions by experts from academic institutions, industry, and government agencies. The public workshop will be held on November 29, 2018, from 8 a.m. to 5 p.m., and on November 30, 2018, from 9 a.m. to 1 p.m. See the SUPPLEMENTARY INFORMATION section for registration date and information. DATES: The public workshop will be held at the 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. Entrance for the public workshop participants (non-FDA employees) is through Building 1, where routine security check procedures will be performed. For parking and security information, please refer to https:// www.fda.gov/AboutFDA/Workingat FDA/BuildingsandFacilities/WhiteOak CampusInformation/ucm241740.htm. ADDRESSES: Loni Warren Henderson or Sherri Revell, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 240– 402–8010, email: CBERPublicEvents@ fda.hhs.gov (subject line: Pathogen Reduction Technology and Blood Safety). FOR FURTHER INFORMATION CONTACT: SUPPLEMENTARY INFORMATION: daltland on DSKBBV9HB2PROD with NOTICES I. Background Pathogen reduction technology has the potential to improve blood safety by reducing or eliminating infectious organisms, including bacteria, viruses, and parasites, from blood components intended for transfusion. FDA granted approvals for use of a pathogen reduction technology platform in manufacturing plasma and apheresis platelets for transfusion. Ideally, pathogen reduction technology should also be available for whole blood and red blood cells. Implementation of safe and effective pathogen reduction technology may also permit alternative donor screening or donation testing strategies in the future. The purpose of the public workshop is to foster the development and implementation of pathogen reduction technologies for all blood components intended for transfusion. VerDate Sep<11>2014 17:47 Sep 14, 2018 Jkt 244001 II. Topics for Discussion at the Public Workshop The first day of the workshop will include presentations and panel discussions on the following topics: (1) Transfusion-transmitted infectious agents and their impact on blood safety; (2) status of pathogen reduction technology for blood components intended for transfusion, including challenges to implementation in the United States; and (3) the development of pathogen reduction technology for whole blood and red blood cells. The second day of the workshop will include presentations and panel discussions on the following topics: (1) Emerging pathogen reduction technologies and alternative approaches to controlling risk; (2) potential funding opportunities for research; and (3) a summary of all workshop sessions, panel discussions, and future directions. III. Participating in the Public Workshop Registration: To register for the public workshop, please visit the following website: https://www.eventbrite.com/e/ pathogen-reduction-technologies-forblood-safety-public-workshop-tickets4464956605. Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone. Registration is free and based on space availability, with priority given to early registrants. Persons interested in attending this public workshop must register by November 8, 2018, midnight Eastern Time. Early registration is recommended because seating is limited; therefore, FDA may limit the number of participants from each organization. If time and space permit, onsite registration on the day of the public workshop will be provided, beginning at 7 a.m. If you need special accommodations, due to a disability, please contact Loni Warren Henderson or Sherri Revell no later than November 19, 2018 (see FOR FURTHER INFORMATION CONTACT). Request for sign language interpretation or Computer Aided Realtime Translation (CART)/captioning should be made 2 weeks in advance of the event, no later than November 15, 2018. A request for either interpreting or captioning should be sent directly to the FDA Interpreting Services Staff email account: interpreting.services@oc.fda.gov. Streaming Webcast of the Public Workshop: This public workshop will also be webcast. Individuals who wish to view the webcast should register for the workshop at https:// www.eventbrite.com/e/pathogen- PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 reduction-technologies-for-blood-safetypublic-workshop-tickets-4464956605. A link to the live webcast will be provided upon registration. If you have never attended a Connect Pro event before, test your connection at https://collaboration.fda.gov/common/ help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program, visit https://www.adobe.com/ go/connectpro_overview. FDA has verified the website addresses in this document as of the date this document publishes in the Federal Register, but websites are subject to change over time. Transcripts: Please be advised that as soon as a transcript of the public workshop is available, it will be accessible at https://www.regulations. gov. It may be viewed at the Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. A link to the transcript will also be available on the internet at https:// www.fda.gov/BiologicsBloodVaccines/ NewsEvents/WorkshopsMeetings Conferences/default.htm. Dated: September 11, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–20090 Filed 9–14–18; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Advisory Council on Alzheimer’s Research, Care, and Services; Meeting Assistant Secretary for Planning and Evaluation, HHS. ACTION: Notice of meeting. AGENCY: This notice announces the public meeting of the Advisory Council on Alzheimer’s Research, Care, and Services (Advisory Council). The Advisory Council on Alzheimer’s Research, Care, and Services provides advice on how to prevent or reduce the burden of Alzheimer’s disease and related dementias on people with the disease and their caregivers. During the October meeting, the Long-Term Services and Supports Subcommittee will be taking charge of the theme. The topics covered will include: (1) The experience of people with dementia who have special needs due to issues like diversity, geography, and concurrent disorders; (2) How clinical care can be better integrated with community-based supports and services; and (3) Evidence-based behavioral approaches that mitigate the impact of behavioral symptoms of dementia. The meeting will also include SUMMARY: E:\FR\FM\17SEN1.SGM 17SEN1

Agencies

[Federal Register Volume 83, Number 180 (Monday, September 17, 2018)]
[Notices]
[Pages 46959-46960]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-20090]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0001]


Pathogen Reduction Technologies for Blood Safety; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
following public workshop entitled ``Pathogen Reduction Technologies 
for

[[Page 46960]]

Blood Safety.'' The purpose of the public workshop is to foster the 
development and implementation of pathogen reduction technologies for 
blood components intended for transfusion. The workshop will include 
presentations and panel discussions by experts from academic 
institutions, industry, and government agencies.

DATES: The public workshop will be held on November 29, 2018, from 8 
a.m. to 5 p.m., and on November 30, 2018, from 9 a.m. to 1 p.m. See the 
SUPPLEMENTARY INFORMATION section for registration date and 
information.

ADDRESSES: The public workshop will be held at the 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. Entrance 
for the public workshop participants (non-FDA employees) is through 
Building 1, where routine security check procedures will be performed. 
For parking and security information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.

FOR FURTHER INFORMATION CONTACT: Loni Warren Henderson or Sherri 
Revell, Center for Biologics Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 240-
402-8010, email: [email protected] (subject line: Pathogen 
Reduction Technology and Blood Safety).

SUPPLEMENTARY INFORMATION:

I. Background

    Pathogen reduction technology has the potential to improve blood 
safety by reducing or eliminating infectious organisms, including 
bacteria, viruses, and parasites, from blood components intended for 
transfusion. FDA granted approvals for use of a pathogen reduction 
technology platform in manufacturing plasma and apheresis platelets for 
transfusion. Ideally, pathogen reduction technology should also be 
available for whole blood and red blood cells. Implementation of safe 
and effective pathogen reduction technology may also permit alternative 
donor screening or donation testing strategies in the future. The 
purpose of the public workshop is to foster the development and 
implementation of pathogen reduction technologies for all blood 
components intended for transfusion.

II. Topics for Discussion at the Public Workshop

    The first day of the workshop will include presentations and panel 
discussions on the following topics: (1) Transfusion-transmitted 
infectious agents and their impact on blood safety; (2) status of 
pathogen reduction technology for blood components intended for 
transfusion, including challenges to implementation in the United 
States; and (3) the development of pathogen reduction technology for 
whole blood and red blood cells.
    The second day of the workshop will include presentations and panel 
discussions on the following topics: (1) Emerging pathogen reduction 
technologies and alternative approaches to controlling risk; (2) 
potential funding opportunities for research; and (3) a summary of all 
workshop sessions, panel discussions, and future directions.

III. Participating in the Public Workshop

    Registration: To register for the public workshop, please visit the 
following website: https://www.eventbrite.com/e/pathogen-reduction-technologies-for-blood-safety-public-workshop-tickets-4464956605. 
Please provide complete contact information for each attendee, 
including name, title, affiliation, address, email, and telephone.
    Registration is free and based on space availability, with priority 
given to early registrants. Persons interested in attending this public 
workshop must register by November 8, 2018, midnight Eastern Time. 
Early registration is recommended because seating is limited; 
therefore, FDA may limit the number of participants from each 
organization. If time and space permit, onsite registration on the day 
of the public workshop will be provided, beginning at 7 a.m.
    If you need special accommodations, due to a disability, please 
contact Loni Warren Henderson or Sherri Revell no later than November 
19, 2018 (see FOR FURTHER INFORMATION CONTACT). Request for sign 
language interpretation or Computer Aided Realtime Translation (CART)/
captioning should be made 2 weeks in advance of the event, no later 
than November 15, 2018. A request for either interpreting or captioning 
should be sent directly to the FDA Interpreting Services Staff email 
account: [email protected].
    Streaming Webcast of the Public Workshop: This public workshop will 
also be webcast. Individuals who wish to view the webcast should 
register for the workshop at https://www.eventbrite.com/e/pathogen-reduction-technologies-for-blood-safety-public-workshop-tickets-4464956605. A link to the live webcast will be provided upon 
registration.
    If you have never attended a Connect Pro event before, test your 
connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program, 
visit https://www.adobe.com/go/connectpro_overview. FDA has verified 
the website addresses in this document as of the date this document 
publishes in the Federal Register, but websites are subject to change 
over time.
    Transcripts: Please be advised that as soon as a transcript of the 
public workshop is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. A link to the transcript will also be available on 
the internet at https://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/default.htm.

    Dated: September 11, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-20090 Filed 9-14-18; 8:45 am]
 BILLING CODE 4164-01-P

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