81_FR_47066 81 FR 46928 - Pre-Clinical Evaluation of Red Blood Cells for Transfusion; Public Workshop

81 FR 46928 - Pre-Clinical Evaluation of Red Blood Cells for Transfusion; Public Workshop

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 138 (July 19, 2016)

Page Range46928-46929
FR Document2016-17008

The Food and Drug Administration (FDA) is announcing a public workshop entitled ``Pre-Clinical Evaluation of Red Blood Cells for Transfusion.'' The purpose of the public workshop is to discuss new methodologies for pre-clinical evaluation of the safety and efficacy of red blood cell transfusion products. The workshop has been planned in partnership with the National Heart, Lung, and Blood Institute; National Institutes of Health (NIH); the Department of Defense; and the Office of the Assistant Secretary for Health, Department of Health and Human Services. The workshop will include presentations and panel discussions by experts from academic institutions, industry, and government Agencies.

Federal Register, Volume 81 Issue 138 (Tuesday, July 19, 2016) 
[Federal Register Volume 81, Number 138 (Tuesday, July 19, 2016)]
[Notices]
[Pages 46928-46929]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-17008]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]


Pre-Clinical Evaluation of Red Blood Cells for Transfusion; 
Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
workshop entitled ``Pre-Clinical Evaluation of Red Blood Cells for 
Transfusion.'' The purpose of the public workshop is to discuss new 
methodologies for pre-clinical evaluation of the safety and efficacy of 
red blood cell transfusion products. The workshop has been planned in 
partnership with the National Heart, Lung, and Blood Institute; 
National Institutes of Health (NIH); the Department of Defense; and the 
Office of the Assistant Secretary for Health, Department of Health and 
Human Services. 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 October 6, 2016, from 8 a.m. 
to 5 p.m. and on October 7 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 Ruth Kirschstein

[[Page 46929]]

Auditorium, Natcher Conference Center, Bldg. 45, National Institutes of 
Health Campus, 9000 Rockville Pike, Bethesda, MD 20892. The entrance 
for the public workshop participants (non-NIH employees) is through the 
NIH Gateway Center located adjacent to the Medical Center Metro, where 
routine security check procedures will be performed. Please visit the 
following Web site for NIH campus location, parking, security, and 
travel information: http://www.nih.gov/about/visitor/index.htm. Please 
visit the following Web site for information on the Natcher Conference 
Center: http://www.genome.gov/11007522.

FOR FURTHER INFORMATION CONTACT: Matthew Morrison, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, rm. 3128, Silver Spring, MD 20993, 240-402-
8126, [email protected]. For questions email: 
[email protected] (Subject line: Red Blood Cell (RBC) 
Workshop).

SUPPLEMENTARY INFORMATION: The purpose of the public workshop is to 
discuss new methodologies for pre-clinical evaluation of the safety and 
efficacy of red blood cell transfusion products including potential 
identification of biomarkers measurable during red cell storage that 
could predict the in vivo functionality of transfused red blood cells. 
The first day of the workshop will include presentations and panel 
discussions on the following topics: (1) Overview of red blood cells 
for transfusion; (2) methods for determining the suitability of red 
blood cells for transfusion; (3) new methods for detecting red blood 
cell processing and storage legions; and (4) the use of animal models 
of oxygen delivery as markers of red blood cell safety and efficacy in 
the acute bleeding and trauma resuscitation settings.
    The second day of the workshop will include presentations and panel 
discussions on the potential mechanisms of red blood cell transfusion-
associated toxicity and a summary of all workshop panel discussions, 
identified gaps, and future directions.
    Registration: Please visit the following Web site to register for 
the workshop by September 23, 2016: https://www.eventbrite.com/e/pre-clinical-evaluation-of-red-blood-cells-for-transfusion-registration-25813463765. There is no registration fee for the public workshop. 
Early registration is recommended because seating is limited. 
Registration on the day of the public workshop will be provided on a 
space available basis beginning at 7:30 a.m.
    If you need special accommodations due to a disability, please 
contact Matthew Morrison (see FOR FURTHER INFORMATION CONTACT) at least 
7 days in advance.
    Transcripts: Please be advised that as soon as possible after a 
transcript of this public workshop is available, it will be accessible 
at: http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm507890.htm.

    Dated: July 13, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-17008 Filed 7-18-16; 8:45 am]
 BILLING CODE 4164-01-P

46928 Federal Register / Vol. 81, No. 138 / Tuesday, July 19, 2016 / Notices SUMMARY: The President’s Committee disabilities: (A) expansion of authorized supportive services. The SPR for People with Intellectual Disabilities educational opportunities; (B) also collects information on the (PCPID) will host a webinar/conference promotion of homeownership; (C) demographic and functional status of call for its members to discuss the assurance of workplace integration; (D) the recipients, and is a key source for potential topics of the Committee’s 2017 improvement of transportation options; ACL performance measurement. This Report to the President. All the PCPID (E) expansion of full access to collection is an extension with no meetings, in any format, are open to the community living; and (F) increasing changes of the 2013 approved version. public. This virtual meeting will be access to assistive and universally The proposed version will be in effect conducted in a discussion format. designed technologies. for the FY 2017 reporting year and DATES: Webinar: Monday, August 22, Dated: July 6, 2016. thereafter. The proposed FY 2017 2016 from 1:30 p.m. to 3:00 p.m. (EST). Aaron Bishop, version may be found on the ACL Web ADDRESSES: Webinar Web page: https:// site link entitled Renewal SPR Commissioner, Administration on meetingserver.hhs.gov/orion/ Disabilities. Instrument for 2016 Extension With No joinmeeting.do?ED Changes available at http:// [FR Doc. 2016–16980 Filed 7–18–16; 8:45 am] =QtF0ep1Kkddkw3ioj3RkaQ== www.aoa.acl.gov/Program_Results/ BILLING CODE 4154–01–P OAA_Performance.aspx. ACL estimates FOR FURTHER INFORMATION AND the burden of this collection of REASONABLE ACCOMMODATIONS NEEDS DEPARTMENT OF HEALTH AND information as follows: 2750 hours CONTACT: Dr. MJ Karimi, PCPID Team Lead, 330 C Street SW., 1108A, HUMAN SERVICES Dated: July 12, 2016. Washington, DC 20201. Email: Kathy Greenlee, MJ.Karimie@acl.hhs.gov; telephone: Administration for Community Living Administrator and Assistant Secretary for 202–79–7374; fax: 202–205–0402. Aging. Agency Information Collection SUPPLEMENTARY INFORMATION: The [FR Doc. 2016–16978 Filed 7–18–16; 8:45 am] Activities; Proposed Extension With Committee held a conference call on No Changes of a Currently Approved BILLING CODE 4154–01–P May 2, 2016 to discuss and finalize the Collection; Submission for OMB Committee’s 2016 Report to the Review; Comment Request; State President. The purpose of this virtual DEPARTMENT OF HEALTH AND Program Report HUMAN SERVICES meeting is to provide PCPID members with an update on submission of the AGENCY: Administration for Community Living, HHS. Food and Drug Administration 2016 Report to the President and to begin exploring the topics for the ACTION: Notice. [Docket No. FDA–2016–N–0001] Committee’s 2017 report. Webinar/Conference Call: The SUMMARY: The Administration for Pre-Clinical Evaluation of Red Blood webinar is scheduled for August 22, Community Living (ACL) is announcing Cells for Transfusion; Public 2016, 1:30 p.m. to 3:00 p.m. (EST) and that the proposed collection of Workshop may end early if discussions are information listed below has been AGENCY: Food and Drug Administration, finished. submitted to the Office of Management HHS. Instructions to Participate in the and Budget (OMB) for review and Webinar/Conference Call on Monday, clearance under the Paperwork ACTION: Notice of public workshop. August 22, 2016: Reduction Act of 1995. SUMMARY: The Food and Drug 1. Enter the following WebEx Link: DATES: Submit written comments on the Administration (FDA) is announcing a https://meetingserver.hhs.gov/orion/ collection of information by August 18, public workshop entitled ‘‘Pre-Clinical joinmeeting.do?ED 2016. Evaluation of Red Blood Cells for =QtF0ep1Kkddkw3ioj3RkaQ== ADDRESSES: Submit written comments Transfusion.’’ The purpose of the public 2. Click on the ‘‘join’’ button on the on the collection of information to Elena workshop is to discuss new page Fazio at 202–795–7343 or email: methodologies for pre-clinical 3. Enter your name and email address elena.fazio@acl.hhs.gov. evaluation of the safety and efficacy of 4. Follow additional instructions as provided by WebEx. This WebEx does FOR FURTHER INFORMATION CONTACT: red blood cell transfusion products. The not require a password. Elena Fazio at 202–795–7343 or email: workshop has been planned in 5. Please dial: (888) 469–0940; Pass elena.fazio@acl.hhs.gov. partnership with the National Heart, Code: 5315454 (you should put your SUPPLEMENTARY INFORMATION: In Lung, and Blood Institute; National phone on mute during the meeting) compliance with 44 U.S.C. 3507, ACL Institutes of Health (NIH); the Background Information on the has submitted the following proposed Department of Defense; and the Office of Committee: The PCPID acts in an collection of information to OMB for the Assistant Secretary for Health, advisory capacity to the President and review and clearance. Department of Health and Human the Secretary of Health and Human The Older Americans Act (OAA) Services. The workshop will include Services on a broad range of topics requires annual program performance presentations and panel discussions by relating to programs, services and reports from States, the District of experts from academic institutions, support for individuals with intellectual Columbia, and Territories. In industry, and government Agencies. disabilities. The PCPID Executive Order compliance with this OAA provision, DATES: The public workshop will be mstockstill on DSK3G9T082PROD with NOTICES stipulates that the Committee shall: (1) ACL developed a State Program Report held on October 6, 2016, from 8 a.m. to provide such advice concerning (SPR) in 1996 as part of its National 5 p.m. and on October 7 from 9 a.m. to intellectual disabilities as the President Aging Program Information System 1 p.m. See the SUPPLEMENTARY or the Secretary of Health and Human (NAPIS). The SPR collects information INFORMATION section for registration date Services may request; and (2) provide about how State Agencies on Aging and information. advice to the President concerning the expend their OAA funds as well as ADDRESSES: The public workshop will following for people with intellectual funding from other sources for OAA be held at the Ruth Kirschstein VerDate Sep<11>2014 19:39 Jul 18, 2016 Jkt 238001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 E:\FR\FM\19JYN1.SGM 19JYN1

Federal Register / Vol. 81, No. 138 / Tuesday, July 19, 2016 / Notices 46929 Auditorium, Natcher Conference Center, space available basis beginning at 7:30 p.m. Please register for the meeting by Bldg. 45, National Institutes of Health a.m. August 8, 2016, at http:// Campus, 9000 Rockville Pike, Bethesda, If you need special accommodations pdufareauthorization.eventbrite.com. MD 20892. The entrance for the public due to a disability, please contact Submit electronic or written comments workshop participants (non-NIH Matthew Morrison (see FOR FURTHER to the public docket by August 22, 2016. employees) is through the NIH Gateway INFORMATION CONTACT) at least 7 days in ADDRESSES: The meeting and workshop Center located adjacent to the Medical advance. will be held at the FDA White Oak Center Metro, where routine security Transcripts: Please be advised that as Campus, 10903 New Hampshire Ave., check procedures will be performed. soon as possible after a transcript of this Bldg. 31 Conference Center, the Great Please visit the following Web site for public workshop is available, it will be Room (Rm. 1503, Section A), Silver NIH campus location, parking, security, accessible at: http://www.fda.gov/ Spring, MD 20993–0002. Participants and travel information: http:// BiologicsBloodVaccines/NewsEvents/ must enter through Building 1 and www.nih.gov/about/visitor/index.htm. WorkshopsMeetingsConferences/ undergo security screening. For more Please visit the following Web site for ucm507890.htm. information on parking and security information on the Natcher Conference Dated: July 13, 2016. procedures, please refer to http:// Center: http://www.genome.gov/ Leslie Kux, www.fda.gov/AboutFDA/ 11007522. WorkingatFDA/BuildingsandFacilities/ Associate Commissioner for Policy. FOR FURTHER INFORMATION CONTACT: [FR Doc. 2016–17008 Filed 7–18–16; 8:45 am] WhiteOakCampusInformation/ Matthew Morrison, Center for Biologics BILLING CODE 4164–01–P ucm241740.htm. Evaluation and Research, Food and You may submit comments as Drug Administration, 10903 New follows: Hampshire Ave., Bldg. 71, rm. 3128, DEPARTMENT OF HEALTH AND Electronic Submissions Silver Spring, MD 20993, 240–402– HUMAN SERVICES 8126, Matthew.D.Morrison@fda.hhs.gov. Submit electronic comments in the For questions email: Food and Drug Administration following way: CBERPublicEvents@fda.hhs.gov (Subject • Federal eRulemaking Portal: http:// [Docket No. FDA–2016–N–1895] line: Red Blood Cell (RBC) Workshop). www.regulations.gov. Follow the SUPPLEMENTARY INFORMATION: The Prescription Drug User Fee Act; Public instructions for submitting comments. purpose of the public workshop is to Meeting; Request for Comments Comments submitted electronically, discuss new methodologies for pre- including attachments, to http:// clinical evaluation of the safety and AGENCY: Food and Drug Administration, www.regulations.gov will be posted to efficacy of red blood cell transfusion HHS. the docket unchanged. Because your products including potential ACTION: Notice of public meeting; comment will be made public, you are identification of biomarkers measurable request for comments. solely responsible for ensuring that your during red cell storage that could comment does not include any predict the in vivo functionality of SUMMARY: The Food and Drug confidential information that you or a transfused red blood cells. The first day Administration (FDA or Agency) is third party may not wish to be posted, of the workshop will include announcing a public meeting to discuss such as medical information, your or presentations and panel discussions on proposed recommendations for the anyone else’s Social Security number, or the following topics: (1) Overview of red reauthorization of the Prescription Drug confidential business information, such blood cells for transfusion; (2) methods User Fee Act (PDUFA) for fiscal years as a manufacturing process. Please note for determining the suitability of red (FYs) 2018 through 2022. PDUFA that if you include your name, contact blood cells for transfusion; (3) new authorizes FDA to collect fees and use information, or other information that methods for detecting red blood cell them for the process for the review of identifies you in the body of your processing and storage legions; and (4) human drug applications. The current comments, that information will be the use of animal models of oxygen legislative authority for PDUFA expires posted on http://www.regulations.gov. delivery as markers of red blood cell in September 2017. At that time, new • If you want to submit a comment safety and efficacy in the acute bleeding legislation will be required for FDA to with confidential information that you and trauma resuscitation settings. continue collecting prescription drug do not wish to be made available to the The second day of the workshop will user fees in future fiscal years. public, submit the comment as a include presentations and panel Following discussions with the written/paper submission and in the discussions on the potential regulated industry and periodic manner detailed (see ‘‘Written/Paper mechanisms of red blood cell consultations with public stakeholders, Submissions’’ and ‘‘Instructions’’). transfusion-associated toxicity and a the Federal Food, Drug, and Cosmetic Act (the FD&C Act) directs FDA to Written/Paper Submissions summary of all workshop panel discussions, identified gaps, and future publish the recommendations for the Submit written/paper submissions as directions. reauthorized program in the Federal follows: Registration: Please visit the following Register, hold a meeting at which the • Mail/Hand delivery/Courier (for Web site to register for the workshop by public may present its views on such written/paper submissions): Division of September 23, 2016: https:// recommendations, and provide for a Dockets Management (HFA–305), Food www.eventbrite.com/e/pre-clinical- period of 30 days for the public to and Drug Administration, 5630 Fishers mstockstill on DSK3G9T082PROD with NOTICES evaluation-of-red-blood-cells-for- provide written comments on such Lane, Rm. 1061, Rockville, MD 20852. transfusion-registration-25813463765. recommendations. FDA will then • For written/paper comments There is no registration fee for the consider such public views and submitted to the Division of Dockets public workshop. Early registration is comments and revise such Management, FDA will post your recommended because seating is recommendations as necessary. comment, as well as any attachments, limited. Registration on the day of the DATES: The public meeting will be held except for information submitted, public workshop will be provided on a on August 15, 2016, from 9 a.m. to 2 marked and identified, as confidential, VerDate Sep<11>2014 19:39 Jul 18, 2016 Jkt 238001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 E:\FR\FM\19JYN1.SGM 19JYN1


Document Created: 2016-07-19 01:10:45
Document Modified: 2016-07-19 01:10:45
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 of public workshop.
DatesThe public workshop will be held on October 6, 2016, from 8 a.m. to 5 p.m. and on October 7 from 9 a.m. to 1 p.m. See the SUPPLEMENTARY INFORMATION section for registration date and information.
ContactMatthew Morrison, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, rm. 3128, Silver Spring, MD 20993, 240-402- 8126, [email protected] For questions email: [email protected] (Subject line: Red Blood Cell (RBC) Workshop).
FR Citation81 FR 46928 
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