Meeting of the Advisory Committee on Blood and Tissue Safety and Availability, 56802-56803 [2014-22527]

Download as PDF 56802 Federal Register / Vol. 79, No. 184 / Tuesday, September 23, 2014 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES mstockstill on DSK4VPTVN1PROD with NOTICES Civil Society Listening Session on the U.S. Domestic Response to Female Genital Mutilation/Cutting (FGM/C) Name: Civil Society Listening Session on the U.S. Domestic Response to FGM/C. Date and Time: October 2, 2014, 2:30 p.m.–4:30 p.m. Place: Hubert H. Humphrey Building, 200 Independence Avenue SW., Room 705A, Washington, DC 20201. Attendance: Open, but RSVP required to OGA.RSVP@hhs.gov. If you are a foreign national, please note this in the subject line of your RSVP, and our office will contact you for additional biographical details to process your access to the meeting site. RSVP’s must be received no later than Monday, September 22, 2014. Purpose: The U.S. Department of Health and Human Services (HHS) will host a civil society listening session on the U.S. domestic response to FGM/C. The consultation is an opportunity for the U.S. government, including representatives from the White House and other U.S. federal agencies, to hear from members of civil society who are working to address FGM/C domestically (in the United States). More specifically, the session will seek to: • Identify gaps in knowledge • Identify gaps in services for survivors and girls at risk • Identify lessons learned based on previous efforts • Share success stories and best practices at the community level • Suggest effective outreach strategies • Make connections and identify opportunities for increased collaboration and next steps Agenda: The session will be structured around four agenda items: (1) What is working, (2) lessons learned, (3) gaps in knowledge, support and services, and (4) opportunities for further collaboration between the U.S. government and civil society. Participants will be invited to speak for no more than three minutes on each topic. At the end of each agenda item, representatives from relevant federal agencies will have the opportunity to briefly respond and ask follow-up questions. Participants: All individuals working on FGM/C in the United States are invited to attend, including members of: • Public health and advocacy groups; • Minority health organizations; • Refugee and immigrant groups; • Women’s research, service and advocacy groups; VerDate Sep<11>2014 17:55 Sep 22, 2014 Jkt 232001 • Human rights groups; • Faith-based groups; and • Academic and scientific organizations. Written comments are welcome and encouraged, even for those who are planning to attend in person. These comments should also be sent to OGA.RSVP@hhs.gov. Dated: September 9, 2014. Jimmy Kolker, Assistant Secretary, Office of Global Affairs. [FR Doc. 2014–22574 Filed 9–19–14; 11:15 am] BILLING CODE 4150–38–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Meeting of the Advisory Committee on Blood and Tissue Safety and Availability Office of the Secretary, Office of the Assistant Secretary for Health, Department of Health and Human Services. ACTION: Notice. AGENCY: As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA) will hold a meeting. The meeting will be open to the public. DATES: The meeting will take place Thursday, November 13, 2014, from 8:00 a.m. to 3:10 p.m., and Friday, November 14, 2014, from 8:00 a.m. to 3:45 p.m. ADDRESSES: Veteran Health Administration National Conference Center, 2011 Crystal Drive, Suite 150, Arlington, VA 22202. FOR FURTHER INFORMATION CONTACT: Mr. James Berger, Designated Federal Officer, ACBTSA, and Senior Advisor for Blood and Tissue Safety Policy, Office of HIV/AIDS and Infectious Disease Policy, Office of the Assistant Secretary for Health, Department of Health and Human Services, 1101 Wootton Parkway, Suite 250, Rockville, MD 20852. Phone: (240) 453–8803; Fax (240) 453–8456; Email ACBTSA@ hhs.gov. SUPPLEMENTARY INFORMATION: The ACBTSA shall provide advice to the Secretary through the Assistant Secretary for Health. The Committee advises on a range of policy issues to include: (1) Identification of public health issues through surveillance of blood and tissue safety issues with national biovigilance data tools; (2) identification of public health issues SUMMARY: PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 that affect availability of blood, blood products, and tissues; (3) broad public health, ethical, and legal issues related to the safety of blood, blood products, and tissues; (4) the impact of various economic factors (e.g., product cost and supply) on safety and availability of blood, blood products, and tissues; (5) risk communications related to blood transfusion and tissue transplantation; and (6) identification of infectious disease transmission issues for blood, organs, blood stem cells and tissues. The Advisory Committee has met regularly since its establishment in 1997. At the November 2014 meeting the ACBTSA will hear updates on recent activities of the Department and its agencies in support of previous Committee recommendations. Past recommendations made by the ACBTSA may be viewed at www.hhs.gov/ bloodsafety. The focus of the meeting will be to address the implications of hemoglobin S testing in blood donors. In particular, the Committee will focus on the ethics of hemoglobin S testing as well as the perspective of affected members of the blood collecting and using community. The Committee will also continue its discussion of the current blood donor policy for men who have sex with men. A portion of the meeting will also be devoted to an emerging infectious disease, babesia, which could potentially impact the blood supply. The public will have opportunities to present their views to the Committee during public comment sessions scheduled for November 13, 2014, and November 14, 2014. Comments regarding the men who have sex with men blood donation policy should be presented on November 13, 2014. Comments regarding hemoglobin S testing and emerging infectious disease testing should be presented on November 14, 2014. Comments will be limited to five minutes per speaker and must be pertinent to the discussion. Preregistration is required for participation in the public comment sessions. Any member of the public who would like to participate in these sessions is encouraged to contact the Designated Federal Officer at his/her earliest convenience to register for time (limited to 5 minutes) and registration must be prior to close of business on November 10, 2014. If it is not possible to provide 30 copies of the material to be distributed, then individuals are requested to provide a minimum of one (1) copy of the document(s) to be distributed prior to the close of business on November 10, 2014. It is also requested that any member of the public E:\FR\FM\23SEN1.SGM 23SEN1 Federal Register / Vol. 79, No. 184 / Tuesday, September 23, 2014 / Notices who wishes to provide comments to the Committee utilizing electronic data projection submit the necessary material to the Designated Federal Officer prior to the close of business on November 10, 2014. Dated: September 17, 2014. James J. Berger, Designated Federal Officer and Senior Advisor for Blood and Tissue Safety Policy. [FR Doc. 2014–22527 Filed 9–22–14; 8:45 am] BILLING CODE 4150–41–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Clinical Laboratory Improvement Advisory Committee (CLIAC) mstockstill on DSK4VPTVN1PROD with NOTICES In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), the Centers for Disease Control and Prevention (CDC) announces the following meeting of the aforementioned committee: Times and Dates: 8:30 a.m.–5:00 p.m., November 5, 2014; 8:30 a.m.–12:00 p.m., November 6, 2014. Place: CDC, Century Center, 2500 Century Parkway NE., Room 1200/1201, Atlanta, Georgia 30345. Status: Open to the public, limited only by the space available. The meeting room accommodates approximately 100 people. This meeting will also be Webcast, please see information below. Purpose: This Committee is charged with providing scientific and technical advice and guidance to the Secretary of Health and Human Services (HHS); the Assistant Secretary for Health; the Director, Centers for Disease Control and Prevention; the Commissioner, Food and Drug Administration (FDA); and the Administrator, Centers for Medicare and Medicaid Services (CMS). The advice and guidance pertain to general issues related to improvement in clinical laboratory quality and laboratory medicine practice and specific questions related to possible revision of the Clinical Laboratory Improvement Amendment (CLIA) standards. Examples include providing guidance on studies designed to improve safety, effectiveness, efficiency, timeliness, equity, and patientcenteredness of laboratory services; revisions to the standards under which clinical laboratories are regulated; the impact of proposed revisions to the standards on medical and laboratory practice; and the modification of the standards and provision of non-regulatory guidelines to accommodate technological advances, such as new test methods and the electronic transmission of laboratory information. Matters for Discussion: The agenda will include agency updates from CDC, CMS, and FDA. Presentations and discussions will include the FDA Draft Guidance on VerDate Sep<11>2014 17:55 Sep 22, 2014 Jkt 232001 Laboratory Developed Tests; CLIA-waived testing, including the process and criteria for waiver approval; a report from the workgroup charged with providing input to CLIAC regarding the acceptability and application of virtual cross-matching in lieu of serologic cross-matching for transplantation; and issues related to laboratory biosafety in the United States. Agenda items are subject to change as priorities dictate. Webcast: The meeting will also be Webcast. Persons interested in viewing the Webcast can access information at: https:// wwwn.cdc.gov/cliac/default.aspx Online Registration Required: All people attending the CLIAC meeting in-person are required to register for the meeting online at least 5 business days in advance for U.S. citizens and at least 10 business days in advance for international registrants. Register at https://wwwn.cdc.gov/cliac/default.aspx by scrolling down and clicking the link under ‘‘Meeting Registration’’ and completing all forms according to the instructions given. Please complete all the required fields before submitting your registration and submit no later than October 29, 2014 for U.S. registrants and October 22, 2014 for international registrants. Providing Oral or Written Comments: It is the policy of CLIAC to accept written public comments and provide a brief period for oral public comments whenever possible. Oral Comments: In general, each individual or group requesting to make oral comments will be limited to a total time of five minutes (unless otherwise indicated). Speakers must also submit their comments in writing for inclusion in the meeting’s Summary Report. To assure adequate time is scheduled for public comments, speakers should notify the contact person below at least one week prior to the meeting date. Written Comments: For individuals or groups unable to attend the meeting, CLIAC accepts written comments until the date of the meeting (unless otherwise stated). However, it is requested that comments be submitted at least one week prior to the meeting date so that the comments may be made available to the Committee for their consideration and public distribution. Written comments, one hard copy with original signature, should be provided to the contact person below, and will be included in the meeting’s Summary Report. Availability of Meeting Materials: To support the green initiatives of the federal government, the CLIAC meeting materials will be made available to the Committee and the public in electronic format (PDF) on the internet instead of by printed copy. Check the CLIAC Web site on the day of the meeting for materials. Note: If using a mobile device to access the materials, please verify that the device’s browser is able to download the files from the CDC’s Web site before the meeting. https://wwwn.cdc.gov/cliac/cliac_meeting_ all_documents.aspx. Alternatively, the files can be downloaded to a computer and then emailed to the portable device. An internet connection, power source and limited hard copies may be available at the meeting location, but cannot be guaranteed. Contact Person for Additional Information: Nancy Anderson, Chief, Laboratory Practice PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 56803 Standards Branch, Division of Laboratory Science and Standards, Laboratory Science, Policy and Practice Program Office, Office of Surveillance, Epidemiology and Laboratory Services, CDC, 1600 Clifton Road NE., Mailstop F–11, Atlanta, Georgia 30329–4018; telephone (404) 498–2741; fax (404) 498– 2210; or via email at NAnderson@cdc.gov. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register Notices pertaining to announcements of meetings and other committee management activities, for the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. Claudette Grant, Acting Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. [FR Doc. 2014–22532 Filed 9–22–14; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review The Centers for Disease Control and Prevention (CDC) Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review, Epi-Centers for the Prevention of Healthcare-Associated Infections, Antimicrobial Resistance and Adverse Events, Funding Opportunity Announcement (FOA) CK11– 0010401SUPP14, held an initial review of applications on June 3, 2014. Due to administrative oversight, a notice was not published in the Federal Register. A notice should have published prior to May 16, 2014 according to the 15 day notice requirement of the Federal Advisory Committee Act (FACA) https://intranet.cdc.gov/maso/cmppa/ pdfs/faca.pdf and the GSA Final Rule https://www.gsa.gov/graphics/ogp/ FACAFinalRule_R2E-cNZ_0Z5RDZi34K-pR.pdf. The intent of 15 day prior notice is to advise the public of scheduled meetings open to the public. The meeting of June 3, 2014 was a closed meeting, having met the standard for exemptions to open meeting requirements due to the personal and/or proprietary information included in grant applications. Public participation was not impacted as a result of the notice not getting published. Contact Person for More Information: Catherine Ramadei, Acting Chief, Federal Advisory Committee Management Branch, Management E:\FR\FM\23SEN1.SGM 23SEN1

Agencies

DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 79, Number 184 (Tuesday, September 23, 2014)]
[Notices]
[Pages 56802-56803]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-22527]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES


Meeting of the Advisory Committee on Blood and Tissue Safety and 
Availability

AGENCY: Office of the Secretary, Office of the Assistant Secretary for 
Health, Department of Health and Human Services.

ACTION: Notice.

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

SUMMARY: As stipulated by the Federal Advisory Committee Act, the U.S. 
Department of Health and Human Services is hereby giving notice that 
the Advisory Committee on Blood and Tissue Safety and Availability 
(ACBTSA) will hold a meeting. The meeting will be open to the public.

DATES: The meeting will take place Thursday, November 13, 2014, from 
8:00 a.m. to 3:10 p.m., and Friday, November 14, 2014, from 8:00 a.m. 
to 3:45 p.m.

ADDRESSES: Veteran Health Administration National Conference Center, 
2011 Crystal Drive, Suite 150, Arlington, VA 22202.

FOR FURTHER INFORMATION CONTACT: Mr. James Berger, Designated Federal 
Officer, ACBTSA, and Senior Advisor for Blood and Tissue Safety Policy, 
Office of HIV/AIDS and Infectious Disease Policy, Office of the 
Assistant Secretary for Health, Department of Health and Human 
Services, 1101 Wootton Parkway, Suite 250, Rockville, MD 20852. Phone: 
(240) 453-8803; Fax (240) 453-8456; Email ACBTSA@hhs.gov.

SUPPLEMENTARY INFORMATION: The ACBTSA shall provide advice to the 
Secretary through the Assistant Secretary for Health. The Committee 
advises on a range of policy issues to include: (1) Identification of 
public health issues through surveillance of blood and tissue safety 
issues with national biovigilance data tools; (2) identification of 
public health issues that affect availability of blood, blood products, 
and tissues; (3) broad public health, ethical, and legal issues related 
to the safety of blood, blood products, and tissues; (4) the impact of 
various economic factors (e.g., product cost and supply) on safety and 
availability of blood, blood products, and tissues; (5) risk 
communications related to blood transfusion and tissue transplantation; 
and (6) identification of infectious disease transmission issues for 
blood, organs, blood stem cells and tissues. The Advisory Committee has 
met regularly since its establishment in 1997.
    At the November 2014 meeting the ACBTSA will hear updates on recent 
activities of the Department and its agencies in support of previous 
Committee recommendations. Past recommendations made by the ACBTSA may 
be viewed at www.hhs.gov/bloodsafety.
    The focus of the meeting will be to address the implications of 
hemoglobin S testing in blood donors. In particular, the Committee will 
focus on the ethics of hemoglobin S testing as well as the perspective 
of affected members of the blood collecting and using community. The 
Committee will also continue its discussion of the current blood donor 
policy for men who have sex with men. A portion of the meeting will 
also be devoted to an emerging infectious disease, babesia, which could 
potentially impact the blood supply.
    The public will have opportunities to present their views to the 
Committee during public comment sessions scheduled for November 13, 
2014, and November 14, 2014. Comments regarding the men who have sex 
with men blood donation policy should be presented on November 13, 
2014. Comments regarding hemoglobin S testing and emerging infectious 
disease testing should be presented on November 14, 2014. Comments will 
be limited to five minutes per speaker and must be pertinent to the 
discussion. Pre-registration is required for participation in the 
public comment sessions. Any member of the public who would like to 
participate in these sessions is encouraged to contact the Designated 
Federal Officer at his/her earliest convenience to register for time 
(limited to 5 minutes) and registration must be prior to close of 
business on November 10, 2014. If it is not possible to provide 30 
copies of the material to be distributed, then individuals are 
requested to provide a minimum of one (1) copy of the document(s) to be 
distributed prior to the close of business on November 10, 2014. It is 
also requested that any member of the public

[[Page 56803]]

who wishes to provide comments to the Committee utilizing electronic 
data projection submit the necessary material to the Designated Federal 
Officer prior to the close of business on November 10, 2014.

    Dated: September 17, 2014.
James J. Berger,
Designated Federal Officer and Senior Advisor for Blood and Tissue 
Safety Policy.
[FR Doc. 2014-22527 Filed 9-22-14; 8:45 am]
BILLING CODE 4150-41-P

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