80 FR 18412 - Blood Products Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 65 (April 6, 2015)

Page Range		18412-18413
FR Document		2015-07816

Federal Register, Volume 80 Issue 65 (Monday, April 6, 2015)

[Federal Register Volume 80, Number 65 (Monday, April 6, 2015)]
[Notices]
[Pages 18412-18413]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-07816]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0001]


Blood Products Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA). At least one 
portion of the meeting will be closed to the public.
    Name of Committee: Blood Products Advisory Committee.
    General Function of the Committee: To provide advice and 
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on May 13, 2015, from 8 
a.m. to 5:30 p.m.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 
Conference Center, the Great Room (Rm.1503), Silver Spring, MD 20993-
0002. For those unable to attend in person, the meeting will also be 
available via Web cast. The Web cast will be available at the following 
link: https://collaboration.fda.gov/bpac2015/. When accessing the Web 
cast please enter as a guest. Answers to commonly asked questions 
including information regarding special accommodations due to a 
disability, visitor parking, and transportation may be accessed at: 
http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    Contact Person: 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 or 240-402-8129, 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.
    Agenda: On May 13, 2015, the Blood Products Advisory Committee will 
meet in open session to discuss strategies for implementation of 
serological and nucleic acid testing for Babesia microti in blood 
donors. In the afternoon, the committee will hear update presentations 
on the following topics: (1) FDA considerations for Hemoglobin S 
Testing in blood donors; and (2) FDA considerations for a revised blood 
donor deferral policy for men who have sex with men. Following the 
update presentations, the committee will hear presentations on the 
research programs of the Laboratory of Cellular Hematology, Division of 
Hematology Research and Review, Office of Blood Research and Review, 
Center for Biologics Evaluation and Research, FDA.
    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: On May 13, 2015, from 8:30 a.m. to approximately 5 p.m., 
the meeting is open to the public. 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 May 6, 2015. Oral presentations from the public on May 13, 
2015, will be scheduled between approximately 11:15 a.m. and 12:15 p.m. 
and 4:30 p.m. until 5 p.m. 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 April 28, 2015. 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 speakers for the scheduled open public hearing session. 
The contact person will notify interested persons regarding their 
request to speak by April 29, 2015.
    Closed Committee Deliberations: On May 13, 2015, from approximately 
5 p.m. to 5:30 p.m., the meeting will be closed to the public 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 site visit report of the intramural research programs of 
the Laboratory of Cellular Hematology 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. Seating for this meeting may be limited, so the public is 
encouraged to watch the free Web cast if you are unable to attend. The 
Web cast will be available at 8:30 a.m. on May 13, 2015, at the link 
provided.
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
physical disabilities or special needs. If you require special 
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 meeting.

[[Page 18413]]

    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: March 31, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-07816 Filed 4-3-15; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 65 / Monday, April 6, 2015 / Notices 18413

Notice of this meeting is given under 215–822–8644, FAX: 215–822–8633, SUPPLEMENTARY INFORMATION: The
the Federal Advisory Committee Act (5 email: Office@socra.org, Web site: public workshop helps fulfill the
U.S.C. app. 2). http://www.socra.org. (FDA has verified Department of Health and Human
Dated: March 31, 2015. the Web site addresses throughout this Services’ and FDA’s important mission
Leslie Kux,
document, but we are not responsible to protect the public health. The
for any subsequent changes to the Web workshop will provide those engaged in
Associate Commissioner for Policy.
sites after this document publishes in FDA-regulated (human) clinical trials
[FR Doc. 2015–07816 Filed 4–3–15; 8:45 am] the Federal Register.) with information on a number of topics
BILLING CODE 4164–01–P Registration: The registration fee will
concerning FDA requirements related to
cover actual expenses including
informed consent, clinical investigation
refreshments, lunch, materials, and
DEPARTMENT OF HEALTH AND speaker expenses. Seats are limited; requirements, institutional review board
HUMAN SERVICES please submit your registration as soon inspections, electronic record
as possible. Workshop space will be requirements, and investigator-initiated
Food and Drug Administration research.
filled in order of receipt of registration.
[Docket No. FDA–2015–N–0001] Those accepted into the workshop will Topics for discussion include the
receive confirmation. The cost of the following: (1) The Role of the FDA
Society of Clinical Research registration is as follows: SOCRA District Office Relative to the
Associates—Food and Drug member, $575; SOCRA nonmember Bioresearch Monitoring Program; (2)
Administration Clinical Trial (includes membership), $650; Federal Modernizing FDA’s Clinical Trials/
Requirements, Regulations, Government member, $450; Federal BIMO Programs; (3) What FDA Expects
Compliance and Good Clinical Practice Government nonmember, $525; FDA in a Pharmaceutical Clinical Trial; (4)
employee, free (fee waived). Medical Device Aspects of Clinical
AGENCY: Food and Drug Administration, If you need special accommodations
HHS. due to a disability, please contact Research; (5) Adverse Event Reporting—
ACTION: Notice of public conference. SOCRA (see Contact) at least 21 days in Science, Regulation, Error and Safety;
advance. (6) Working with FDA’s Center for
SUMMARY: The Food and Drug Extended periods of question and Biologics Evaluation and Research; (7)
Administration (FDA) is announcing an answer and discussion have been Ethical Issues in Subject Enrollment; (8)
educational conference cosponsored included in the program schedule. Keeping Informed and Working
with the Society of Clinical Research SOCRA designates this education Together; (9) FDA Conduct of Clinical
Associates (SOCRA). The public activity for a maximum of 13.3 Investigator Inspections; (10)
conference regarding FDA’s clinical trial Continuing Education (CE) Credits for Investigator Initiated Research; (11)
requirements is designed to aid the SOCRA CE and Continuing Nurse Meetings with the FDA—Why, When,
clinical research professional’s Education (CNE). SOCRA designates and How; (12) Part 11 Compliance—
understanding of the mission, this live activity for a maximum of 13.3 Electronic Signatures; (13) IRB
responsibilities, and authority of FDA American Medical Association Regulations and FDA Inspections; (14)
and to facilitate interaction with FDA Physicians Recognition Award Category Informed Consent Regulations; (15) The
representatives. The program will focus 1 Credit(s)TM. Physicians should claim Inspection is Over—What Happens
on the relationships among FDA and only the credit commensurate with the
clinical trial staff, investigators, and Next? Possible FDA Compliance
extent of their participation. Continuing Actions; (16) Question and Answer
institutional review boards (IRBs). Medical Education for physicians:
Individual FDA representatives will Session/Panel Discussion.
SOCRA is accredited by the
discuss the informed consent process Accreditation Council for Continuing FDA has made education of the drug
including informed consent documents, Medical Education to provide and device manufacturing community a
regulations relating to drugs, devices, continuing medical education for high priority to help ensure the quality
and biologics, as well as inspections of physicians. CNE for nurses: SOCRA is of FDA-regulated drugs and devices.
clinical investigators, IRBs, and research an approved provider of continuing The workshop helps to achieve
sponsors. nursing education by the Pennsylvania objectives set forth in section 406 of the
Date and Time: The public conference State Nurses Association (PSNA), an Food and Drug Administration
will be held on May 13 and 14, 2015, accredited approver by the American Modernization Act of 1997 (21 U.S.C.
from 8 a.m. to 5 p.m. Nurses Credentialing Center’s 393), which includes working closely
Location: The conference will be held Commission on Accreditation(ANCC). with stakeholders and maximizing the
at The Westin Cincinnati, 21 East Fifth ANCC/PSNA Provider Reference availability and clarity of information to
Street, Cincinnati, OH 45202; 513–621– Number: 205–3–A–09. stakeholders and the public. The
7700. Attendees are responsible for their Registration Instructions: To register,
workshop also is consistent with the
own accommodations. Please mention please submit a registration form with
Small Business Regulatory Enforcement
SOCRA to receive the hotel room rate of your name, affiliation, mailing address,
Fairness Act of 1996 (Pub. L. 104–121),
$169 plus applicable taxes (available telephone, fax number, and email, along
until April 15, 2015, or until the SOCRA with a check or money order payable to as outreach activities by Government
room block is filled). ‘‘SOCRA’’. Mail to: SOCRA (see Contact agencies to small businesses.
Contact: John Fraser, Cincinnati for address). To register via the Internet, Dated: April 1, 2015.
tkelley on DSK4VPTVN1PROD with NOTICES

District Office, Food and Drug go to http://www.socra.org/html/FDA_ Leslie Kux,
Administration, 6751 Steger Dr., Conference.htm. Payment by major Associate Commissioner for Policy.
Cincinnati OH 45237, 513–679–2700, credit card is accepted (Visa/ [FR Doc. 2015–07810 Filed 4–3–15; 8:45 am]
FAX: 513–679–2771 or Society of MasterCard/AMEX only). For more
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Clinical Research Associates (SOCRA), information on the meeting registration,
530 West Butler Ave., Suite 109, or for questions on the workshop,
Chalfont, PA 18914, 800–762–7292 or contact SOCRA (see Contact).

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Document Created: 2015-12-18 11:18:02
Document Modified: 2015-12-18 11:18:02

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.
FR Citation		80 FR 18412

80 FR 18412 - Blood Products Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 65 (April 6, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration