82 FR 12229 - Blood Products Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 39 (March 1, 2017)

Page Range		12229-12230
FR Document		2017-03944

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.

Federal Register, Volume 82 Issue 39 (Wednesday, March 1, 2017)

[Federal Register Volume 82, Number 39 (Wednesday, March 1, 2017)]
[Notices]
[Pages 12229-12230]
From the Federal Register Online  [www.thefederalregister.org]
[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.

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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

12230 Federal Register / Vol. 82, No. 39 / Wednesday, March 1, 2017 / Notices

speakers for the scheduled open public would constitute a clearly unwarranted SUMMARY: The Department of Health and
hearing session. The contact person will invasion of personal privacy. Human Services (HHS) notifies federal
notify interested persons regarding their Name of Committee: Center for Scientific agencies of the laboratories and
request to speak by March 21, 2017. Review Special Emphasis Panel; Biomedical Instrumented Initial Testing Facilities
Closed Committee Deliberations: On Engineering. (IITF) currently certified to meet the
April 5, 2017, from 11:15 a.m. to 12:00 Date: March 2–3, 2017. standards of the Mandatory Guidelines
p.m., the meeting will be closed to Time: 8:00 a.m. to 9:00 p.m. for Federal Workplace Drug Testing
permit discussion where disclosure Agenda: To review and evaluate grant Programs (Mandatory Guidelines).
applications.
would constitute a clearly unwarranted Place: National Institutes of Health, 6701
A notice listing all currently HHS-
invasion of personal privacy (5 U.S.C. Rockledge Drive, Bethesda, MD 20892 certified laboratories and IITFs is
552b(c)(6)). The Committee will discuss (Virtual Meeting). published in the Federal Register
the report of the intramural research Contact Person: Joseph D Mosca, Ph.D., during the first week of each month. If
program and make recommendations Scientific Review Officer, Center for any laboratory or IITF certification is
regarding personnel staffing decisions. Scientific Review, National Institutes of suspended or revoked, the laboratory or
Persons attending FDA’s advisory Health, 6701 Rockledge Drive, Room 5158, IITF will be omitted from subsequent
MSC 7808, Bethesda, MD 20892, (301) 435– lists until such time as it is restored to
committee meetings are advised that the
2344, moscajos@csr.nih.gov.
Agency is not responsible for providing full certification under the Mandatory
This notice is being published less than 15 Guidelines.
access to electrical outlets. days prior to the meeting due to the timing
FDA welcomes the attendance of the limitations imposed by the review and If any laboratory or IITF has
public at its advisory committee funding cycle. withdrawn from the HHS National
meetings and will make every effort to Name of Committee: Center for Scientific Laboratory Certification Program (NLCP)
accommodate persons with disabilities. Review Special Emphasis Panel; Member during the past month, it will be listed
If you require accommodations due to a Conflict: Health Services Organization and at the end and will be omitted from the
disability, please contact Bryan Emery Delivery. monthly listing thereafter.
at least 7 days in advance of the Date: March 6, 2017. This notice is also available on the
meeting. Time: 8:00 a.m. to 5:00 p.m. Internet at http://www.samhsa.gov/
Agenda: To review and evaluate grant
FDA is committed to the orderly applications.
workplace.
conduct of its advisory committee Place: National Institutes of Health, 6701 FOR FURTHER INFORMATION CONTACT:
meetings. Please visit our Web site at Rockledge Drive, Bethesda, MD 20892 Giselle Hersh, Division of Workplace
http://www.fda.gov/Advisory (Telephone Conference Call). Programs, SAMHSA/CSAP, 5600
Committees/AboutAdvisoryCommittees/ Contact Person: Gabriel B Fosu, Ph.D.,
Fishers Lane, Room 16N03A, Rockville,
ucm111462.htm for procedures on Scientific Review Officer, Center for
Scientific Review, National Institutes of Maryland 20857; 240–276–2600 (voice).
public conduct during advisory
committee meetings. Health, 6701 Rockledge Drive, Room 3108, SUPPLEMENTARY INFORMATION: The
MSC 7808, Bethesda, MD 20892, (301) 435– Department of Health and Human
Notice of this meeting is given under 3562, fosug@csr.nih.gov.
the Federal Advisory Committee Act (5 Services (HHS) notifies federal agencies
This notice is being published less than 15 of the laboratories and Instrumented
U.S.C. app. 2). days prior to the meeting due to the timing Initial Testing Facilities (IITF) currently
Dated: February 24, 2017. limitations imposed by the review and
funding cycle.
certified to meet the standards of the
Janice M. Soreth, Mandatory Guidelines for Federal
Associate Commissioner for Special Medical (Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
Workplace Drug Testing Programs
Programs. (Mandatory Guidelines). The Mandatory
93.333, Clinical Research, 93.306, 93.333,
[FR Doc. 2017–03944 Filed 2–28–17; 8:45 am] 93.337, 93.393–93.396, 93.837–93.844, Guidelines were first published in the
BILLING CODE 4164–01–P 93.846–93.878, 93.892, 93.893, National Federal Register on April 11, 1988 (53
Institutes of Health, HHS) FR 11970), and subsequently revised in
Dated: February 23, 2017. the Federal Register on June 9, 1994 (59
DEPARTMENT OF HEALTH AND FR 29908); September 30, 1997 (62 FR
Michelle Trout,
HUMAN SERVICES 51118); April 13, 2004 (69 FR 19644);
Program Analyst, Office of Federal Advisory
Committee Policy. November 25, 2008 (73 FR 71858);
National Institutes of Health December 10, 2008 (73 FR 75122); and
[FR Doc. 2017–03903 Filed 2–28–17; 8:45 am]
Center for Scientific Review; Notice of on April 30, 2010 (75 FR 22809).
BILLING CODE 4140–01–P
Closed Meetings The Mandatory Guidelines were
initially developed in accordance with
Pursuant to section 10(d) of the DEPARTMENT OF HEALTH AND Executive Order 12564 and section 503
Federal Advisory Committee Act, as HUMAN SERVICES of Public Law 100–71. The ‘‘Mandatory
amended (5 U.S.C. App.), notice is Guidelines for Federal Workplace Drug
hereby given of the following meetings. Substance Abuse and Mental Health Testing Programs,’’ as amended in the
The meetings will be closed to the Services Administration revisions listed above, requires strict
public in accordance with the standards that laboratories and IITFs
provisions set forth in sections Current List of HHS-Certified must meet in order to conduct drug and
asabaliauskas on DSK3SPTVN1PROD with NOTICES

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Laboratories and Instrumented Initial specimen validity tests on urine
as amended. The grant applications and Testing Facilities Which Meet Minimum specimens for federal agencies.
the discussions could disclose Standards To Engage in Urine Drug To become certified, an applicant
confidential trade secrets or commercial Testing for Federal Agencies laboratory or IITF must undergo three
property such as patentable material, AGENCY: Substance Abuse and Mental rounds of performance testing plus an
and personal information concerning Health Services Administration, HHS. on-site inspection. To maintain that
individuals associated with the grant certification, a laboratory or IITF must
ACTION: Notice.
applications, the disclosure of which participate in a quarterly performance

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Document Created: 2017-03-01 03:39:20
Document Modified: 2017-03-01 03:39:20

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
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.
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, [email protected], [email protected]; 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.
FR Citation		82 FR 12229

82 FR 12229 - Blood Products Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 39 (March 1, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration