Blood Products Advisory Committee; Notice of Meeting, 12229-12230 [2017-03944]

Download as PDF Federal Register / Vol. 82, No. 39 / Wednesday, March 1, 2017 / Notices (301) 427–1111; TTY (toll free): (866) 438–7231; TTY (local): (301) 427–1130; Email: pso@ahrq.hhs.gov. SUPPLEMENTARY INFORMATION: Background The Patient Safety Act authorizes the listing of PSOs, which are entities or component organizations whose mission and primary activity are to conduct activities to improve patient safety and the quality of health care delivery. HHS issued the Patient Safety Rule to implement the Patient Safety Act. AHRQ administers the provisions of the Patient Safety Act and Patient Safety Rule relating to the listing and operation of PSOs. The Patient Safety Rule authorizes AHRQ to list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ‘‘delisted’’ if it is found to no longer meet the requirements of the Patient Safety Act and Patient Safety Rule, when a PSO chooses to voluntarily relinquish its status as a PSO for any reason, or when a PSO’s listing expires. Section 3.108(d) of the Patient Safety Rule requires AHRQ to provide public notice when it removes an organization from the list of federally approved PSOs. The Surgical Momentum PSO, PSO number P0154, a component entity of the Surgical Momentum, LLC, chose to let its listing expire by not seeking continued listing. Accordingly, the Surgical Momentum PSO was delisted effective at 12:00 Midnight ET (2400) on January 21, 2017. More information on PSOs can be obtained through AHRQ’s PSO Web site at http://www.pso.ahrq.gov. Sharon B. Arnold, Acting Director. [FR Doc. 2017–03999 Filed 2–28–17; 8:45 am] BILLING CODE 4160–90–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2017–N–0001] asabaliauskas on DSK3SPTVN1PROD with NOTICES Blood Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Blood Products Advisory Committee. The general function of the SUMMARY: VerDate Sep<11>2014 18:09 Feb 28, 2017 Jkt 241001 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 April 4, 2017, from 8:30 a.m. to 3:45 p.m. and on April 5, 2017, from 8:30 a.m. to 12 p.m. ADDRESSES: The meeting will be held at Tommy Douglas Conference Center, 10000 New Hampshire Ave., Silver Spring, MD 20903. The conference center’s telephone number is 240–645– 4000. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: http://www.tommydouglascenter.com. FOR FURTHER INFORMATION CONTACT: Bryan Emery or Joanne Lipkind, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6132, Silver Spring, MD 20993–0002, 240–402–8054, 240–402–8106, bryan.emery@fda.hhs.gov, joanne.lipkind@fda.hhs.gov; 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 Web site at http:// 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 for both days: April 4, 2017, 115th Meeting of the Blood Products Advisory Committee—Day 1 at: http:// fda.yorkcast.com/webcast/Play/ bb044b891a7b48ff82cc30b18ece526e1d; April 5, 2017, 115th Meeting of the Blood Products Advisory Committee— Day 2 at: http://fda.yorkcast.com/ webcast/Play/b4068ead1c874966860584 b421dcfd231d. SUPPLEMENTARY INFORMATION: Agenda: On April 4, 2017, in open session, the Committee will discuss Recombinant Human Coagulation Factor IX, GlycoPEGylated. In the afternoon, in open session, the Committee will hear an update presentation on a summary of responses to Docket FDA–2016–N–1502: Blood Donor Deferral Policy for PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 12229 Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products. On April 5, 2017, in open session, the committee will hear overview presentations on the research programs in the Laboratory of Emerging Pathogens in the Division of Emerging Transfusion-Transmitted Diseases, Office of Blood Research and Review, Center for Biologics Evaluation and Research, FDA. At 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). During the closed session, the Committee will discuss the research progress made by staff involved in the intramural research programs and make recommendations regarding their personnel actions and staffing decisions. 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 Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at: http://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee meeting link. Procedure: 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 March 28, 2017. Oral presentations from the public will be scheduled between approximately 10:50 a.m. to 11:20 a.m. and will be scheduled between approximately 3:15 p.m. to 3:45 p.m. on April 4, 2017. Oral presentations from the public will be scheduled between approximately 10:15 a.m. and 11:15 a.m. on April 5, 2017. 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 March 20, 2017. 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 E:\FR\FM\01MRN1.SGM 01MRN1 12230 Federal Register / Vol. 82, No. 39 / Wednesday, March 1, 2017 / Notices speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by March 21, 2017. Closed Committee Deliberations: On April 5, 2017, from 11:15 a.m. to 12:00 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)). The Committee will discuss the report of the intramural research program and make recommendations regarding personnel staffing decisions. 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 Web site at http://www.fda.gov/Advisory Committees/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: February 24, 2017. Janice M. Soreth, Associate Commissioner for Special Medical Programs. [FR Doc. 2017–03944 Filed 2–28–17; 8:45 am] BILLING CODE 4164–01–P would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Center for Scientific Review Special Emphasis Panel; Biomedical Engineering. Date: March 2–3, 2017. Time: 8:00 a.m. to 9:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting). Contact Person: Joseph D Mosca, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5158, MSC 7808, Bethesda, MD 20892, (301) 435– 2344, moscajos@csr.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Health Services Organization and Delivery. Date: March 6, 2017. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call). Contact Person: Gabriel B Fosu, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3108, MSC 7808, Bethesda, MD 20892, (301) 435– 3562, fosug@csr.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393–93.396, 93.837–93.844, 93.846–93.878, 93.892, 93.893, National Institutes of Health, HHS) Dated: February 23, 2017. Michelle Trout, Program Analyst, Office of Federal Advisory Committee Policy. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health [FR Doc. 2017–03903 Filed 2–28–17; 8:45 am] asabaliauskas on DSK3SPTVN1PROD with NOTICES Center for Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which VerDate Sep<11>2014 18:09 Feb 28, 2017 Jkt 241001 BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies Substance Abuse and Mental Health Services Administration, HHS. ACTION: Notice. AGENCY: PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). A notice listing all currently HHScertified laboratories and IITFs is published in the Federal Register during the first week of each month. If any laboratory or IITF certification is suspended or revoked, the laboratory or IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory or IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at http://www.samhsa.gov/ workplace. SUMMARY: FOR FURTHER INFORMATION CONTACT: Giselle Hersh, Division of Workplace Programs, SAMHSA/CSAP, 5600 Fishers Lane, Room 16N03A, Rockville, Maryland 20857; 240–276–2600 (voice). SUPPLEMENTARY INFORMATION: The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908); September 30, 1997 (62 FR 51118); April 13, 2004 (69 FR 19644); November 25, 2008 (73 FR 71858); December 10, 2008 (73 FR 75122); and on April 30, 2010 (75 FR 22809). The Mandatory Guidelines were initially developed in accordance with Executive Order 12564 and section 503 of Public Law 100–71. The ‘‘Mandatory Guidelines for Federal Workplace Drug Testing Programs,’’ as amended in the revisions listed above, requires strict standards that laboratories and IITFs must meet in order to conduct drug and specimen validity tests on urine specimens for federal agencies. To become certified, an applicant laboratory or IITF must undergo three rounds of performance testing plus an on-site inspection. To maintain that certification, a laboratory or IITF must participate in a quarterly performance E:\FR\FM\01MRN1.SGM 01MRN1

Agencies

[Federal Register Volume 82, Number 39 (Wednesday, March 1, 2017)]
[Notices]
[Pages 12229-12230]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-03944]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-0001]


Blood Products Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

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 April 4, 2017, from 8:30 a.m. to 
3:45 p.m. and on April 5, 2017, from 8:30 a.m. to 12 p.m.

ADDRESSES: The meeting will be held at Tommy Douglas Conference Center, 
10000 New Hampshire Ave., Silver Spring, MD 20903. The conference 
center's telephone number is 240-645-4000. Answers to commonly asked 
questions including information regarding special accommodations due to 
a disability, visitor parking, and transportation may be accessed at: 
http://www.tommydouglascenter.com.

FOR FURTHER INFORMATION CONTACT: Bryan Emery or Joanne Lipkind, Center 
for Biologics Evaluation and Research, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 71, Rm. 6132, Silver Spring, MD 20993-
0002, 240-402-8054, 240-402-8106, bryan.emery@fda.hhs.gov, 
joanne.lipkind@fda.hhs.gov; 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 Web site at http://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 for both days: April 4, 2017, 115th Meeting of the Blood 
Products Advisory Committee--Day 1 at: http://fda.yorkcast.com/webcast/Play/bb044b891a7b48ff82cc30b18ece526e1d; April 5, 2017, 115th Meeting 
of the Blood Products Advisory Committee--Day 2 at: http://fda.yorkcast.com/webcast/Play/b4068ead1c874966860584b421dcfd231d.

SUPPLEMENTARY INFORMATION:
    Agenda: On April 4, 2017, in open session, the Committee will 
discuss Recombinant Human Coagulation Factor IX, GlycoPEGylated. In the 
afternoon, in open session, the Committee will hear an update 
presentation on a summary of responses to Docket FDA-2016-N-1502: Blood 
Donor Deferral Policy for Reducing the Risk of Human Immunodeficiency 
Virus Transmission by Blood and Blood Products.
    On April 5, 2017, in open session, the committee will hear overview 
presentations on the research programs in the Laboratory of Emerging 
Pathogens in the Division of Emerging Transfusion-Transmitted Diseases, 
Office of Blood Research and Review, Center for Biologics Evaluation 
and Research, FDA. At 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). During the closed session, the Committee will discuss the 
research progress made by staff involved in the intramural research 
programs and make recommendations regarding their personnel actions and 
staffing decisions.
    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 Web site prior to the meeting, the 
background material will be made publicly available at the location of 
the advisory committee meeting, and the background material will be 
posted on FDA's Web site after the meeting. Background material is 
available at: http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting 
link.
    Procedure: 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 
March 28, 2017. Oral presentations from the public will be scheduled 
between approximately 10:50 a.m. to 11:20 a.m. and will be scheduled 
between approximately 3:15 p.m. to 3:45 p.m. on April 4, 2017. Oral 
presentations from the public will be scheduled between approximately 
10:15 a.m. and 11:15 a.m. on April 5, 2017. 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 March 20, 2017. 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

[[Page 12230]]

speakers for the scheduled open public hearing session. The contact 
person will notify interested persons regarding their request to speak 
by March 21, 2017.
    Closed Committee Deliberations: On April 5, 2017, from 11:15 a.m. 
to 12:00 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)). The Committee will discuss the report of 
the intramural research program and make recommendations regarding 
personnel staffing decisions.
    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 Web site at http://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: February 24, 2017.
Janice M. Soreth,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2017-03944 Filed 2-28-17; 8:45 am]
BILLING CODE 4164-01-P