Pre-Clinical Evaluation of Red Blood Cells for Transfusion; Public Workshop, 46928-46929 [2016-17008]

Download as PDF 46928 Federal Register / Vol. 81, No. 138 / Tuesday, July 19, 2016 / Notices The President’s Committee for People with Intellectual Disabilities (PCPID) will host a webinar/conference call for its members to discuss the potential topics of the Committee’s 2017 Report to the President. All the PCPID meetings, in any format, are open to the public. This virtual meeting will be conducted in a discussion format. DATES: Webinar: Monday, August 22, 2016 from 1:30 p.m. to 3:00 p.m. (EST). ADDRESSES: Webinar Web page: https:// meetingserver.hhs.gov/orion/ joinmeeting.do?ED =QtF0ep1Kkddkw3ioj3RkaQ== SUMMARY: mstockstill on DSK3G9T082PROD with NOTICES FOR FURTHER INFORMATION AND REASONABLE ACCOMMODATIONS NEEDS CONTACT: Dr. MJ Karimi, PCPID Team Lead, 330 C Street SW., 1108A, Washington, DC 20201. Email: MJ.Karimie@acl.hhs.gov; telephone: 202–79–7374; fax: 202–205–0402. SUPPLEMENTARY INFORMATION: The Committee held a conference call on May 2, 2016 to discuss and finalize the Committee’s 2016 Report to the President. The purpose of this virtual meeting is to provide PCPID members with an update on submission of the 2016 Report to the President and to begin exploring the topics for the Committee’s 2017 report. Webinar/Conference Call: The webinar is scheduled for August 22, 2016, 1:30 p.m. to 3:00 p.m. (EST) and may end early if discussions are finished. Instructions to Participate in the Webinar/Conference Call on Monday, August 22, 2016: 1. Enter the following WebEx Link: https://meetingserver.hhs.gov/orion/ joinmeeting.do?ED =QtF0ep1Kkddkw3ioj3RkaQ== 2. Click on the ‘‘join’’ button on the page 3. Enter your name and email address 4. Follow additional instructions as provided by WebEx. This WebEx does not require a password. 5. Please dial: (888) 469–0940; Pass Code: 5315454 (you should put your phone on mute during the meeting) Background Information on the Committee: The PCPID acts in an advisory capacity to the President and the Secretary of Health and Human Services on a broad range of topics relating to programs, services and support for individuals with intellectual disabilities. The PCPID Executive Order stipulates that the Committee shall: (1) provide such advice concerning intellectual disabilities as the President or the Secretary of Health and Human Services may request; and (2) provide advice to the President concerning the following for people with intellectual VerDate Sep<11>2014 19:39 Jul 18, 2016 Jkt 238001 disabilities: (A) expansion of educational opportunities; (B) promotion of homeownership; (C) assurance of workplace integration; (D) improvement of transportation options; (E) expansion of full access to community living; and (F) increasing access to assistive and universally designed technologies. Dated: July 6, 2016. Aaron Bishop, Commissioner, Administration on Disabilities. [FR Doc. 2016–16980 Filed 7–18–16; 8:45 am] BILLING CODE 4154–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Community Living Agency Information Collection Activities; Proposed Extension With No Changes of a Currently Approved Collection; Submission for OMB Review; Comment Request; State Program Report Administration for Community Living, HHS. ACTION: Notice. AGENCY: The Administration for Community Living (ACL) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Submit written comments on the collection of information by August 18, 2016. ADDRESSES: Submit written comments on the collection of information to Elena Fazio at 202–795–7343 or email: elena.fazio@acl.hhs.gov. FOR FURTHER INFORMATION CONTACT: Elena Fazio at 202–795–7343 or email: elena.fazio@acl.hhs.gov. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, ACL has submitted the following proposed collection of information to OMB for review and clearance. The Older Americans Act (OAA) requires annual program performance reports from States, the District of Columbia, and Territories. In compliance with this OAA provision, ACL developed a State Program Report (SPR) in 1996 as part of its National Aging Program Information System (NAPIS). The SPR collects information about how State Agencies on Aging expend their OAA funds as well as funding from other sources for OAA SUMMARY: PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 authorized supportive services. The SPR also collects information on the demographic and functional status of the recipients, and is a key source for ACL performance measurement. This collection is an extension with no changes of the 2013 approved version. The proposed version will be in effect for the FY 2017 reporting year and thereafter. The proposed FY 2017 version may be found on the ACL Web site link entitled Renewal SPR Instrument for 2016 Extension With No Changes available at http:// www.aoa.acl.gov/Program_Results/ OAA_Performance.aspx. ACL estimates the burden of this collection of information as follows: 2750 hours Dated: July 12, 2016. Kathy Greenlee, Administrator and Assistant Secretary for Aging. [FR Doc. 2016–16978 Filed 7–18–16; 8:45 am] BILLING CODE 4154–01–P 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. 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 SUMMARY: E:\FR\FM\19JYN1.SGM 19JYN1 mstockstill on DSK3G9T082PROD with NOTICES Federal Register / Vol. 81, No. 138 / Tuesday, July 19, 2016 / Notices 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, Matthew.D.Morrison@fda.hhs.gov. For questions email: CBERPublicEvents@fda.hhs.gov (Subject line: Red Blood Cell (RBC) Workshop). SUPPLEMENTARY INFORMATION: The purpose of the public workshop is to discuss new methodologies for preclinical 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-clinicalevaluation-of-red-blood-cells-fortransfusion-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 VerDate Sep<11>2014 19:39 Jul 18, 2016 Jkt 238001 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–N–1895] Prescription Drug User Fee Act; Public Meeting; Request for Comments AGENCY: Food and Drug Administration, HHS. Notice of public meeting; request for comments. ACTION: The Food and Drug Administration (FDA or Agency) is announcing a public meeting to discuss proposed recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA) for fiscal years (FYs) 2018 through 2022. PDUFA authorizes FDA to collect fees and use them for the process for the review of human drug applications. The current legislative authority for PDUFA expires in September 2017. At that time, new legislation will be required for FDA to continue collecting prescription drug user fees in future fiscal years. Following discussions with the regulated industry and periodic consultations with public stakeholders, the Federal Food, Drug, and Cosmetic Act (the FD&C Act) directs FDA to publish the recommendations for the reauthorized program in the Federal Register, hold a meeting at which the public may present its views on such recommendations, and provide for a period of 30 days for the public to provide written comments on such recommendations. FDA will then consider such public views and comments and revise such recommendations as necessary. DATES: The public meeting will be held on August 15, 2016, from 9 a.m. to 2 SUMMARY: PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 46929 p.m. Please register for the meeting by August 8, 2016, at http:// pdufareauthorization.eventbrite.com. Submit electronic or written comments to the public docket by August 22, 2016. ADDRESSES: The meeting and workshop will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503, Section A), Silver Spring, MD 20993–0002. Participants must enter through Building 1 and undergo security screening. For more information on parking and security procedures, please refer to http:// www.fda.gov/AboutFDA/ WorkingatFDA/BuildingsandFacilities/ WhiteOakCampusInformation/ ucm241740.htm. You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: http:// www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, E:\FR\FM\19JYN1.SGM 19JYN1

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[Federal Register Volume 81, Number 138 (Tuesday, July 19, 2016)]
[Notices]
[Pages 46928-46929]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.

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

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, Matthew.D.Morrison@fda.hhs.gov. For questions email: 
CBERPublicEvents@fda.hhs.gov (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