81 FR 57922 - Advisory Council on Blood Stem Cell Transplantation; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration

Federal Register Volume 81, Issue 164 (August 24, 2016)

Page Range		57922-57922
FR Document		2016-20198

In accordance with section 10(a)(2) of the Federal Advisory Committee Act, notice is hereby given of the following meeting of the Advisory Council on Blood Stem Cell Transplantation (ACBSCT).

Federal Register, Volume 81 Issue 164 (Wednesday, August 24, 2016)

[Federal Register Volume 81, Number 164 (Wednesday, August 24, 2016)]
[Notices]
[Page 57922]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-20198]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Advisory Council on Blood Stem Cell Transplantation; Notice of 
Meeting

SUMMARY: In accordance with section 10(a)(2) of the Federal Advisory 
Committee Act, notice is hereby given of the following meeting of the 
Advisory Council on Blood Stem Cell Transplantation (ACBSCT).

DATES: 
September 13, 2016, from 8:00 a.m. to 4:00 p.m. Eastern Time.
September 14, 2016, from 8:00 a.m. to 12:30 p.m. Eastern Time.

ADDRESSES: Crystal Gateway Marriott, 1700 Jefferson Davis Highway, 
Arlington, VA 22202.

FOR FURTHER INFORMATION CONTACT: Robert Walsh, Executive Secretary, 
Division of Transplantation, Healthcare Systems Bureau, Health 
Resources and Services Administration, 5600 Fishers Lane, Room 8W60, 
Rockville, MD 20857; telephone (301) 443-6839.

SUPPLEMENTARY INFORMATION: 
    Status: The meeting will be open to the public.
    Purpose: Pursuant to Public Law 109-129, 42 U.S.C. 274k (session 
379 of the Public Health Service Act, as amended), the ACBSCT advises 
the Secretary of the Department of Health and Human Services and 
Administrator, Health Resources and Services Administration (HRSA), on 
matters related to the activities of the C.W. Bill Young Cell 
Transplantation Program (Program) and the National Cord Blood Inventory 
Program.
    Agenda: The Council will discuss trends in the usage of various 
sources of blood stem cells used in unrelated blood stem cell 
transplants, utilization of cord blood, blood stem cell transplantation 
for treatment of sickle cell disease, and late effects in blood and 
marrow transplantation, among other topics. The Council will also 
receive a program update from the HRSA Division of Transplantation 
(DoT). Agenda items are subject to change as priorities indicate.
    After Council discussions, members of the public will have an 
opportunity to provide comment. Because of the Council's full agenda 
and timeframe in which to cover the agenda topics, public comment will 
be limited. All public comments will be included in the record of the 
ACBSCT meeting.
    The draft meeting agenda will be posted on www.ACBSCTmeeting.org. 
Those participating at this meeting should pre-register by visiting 
www.ACBSCTmeeting.org. The deadline to pre-register for this meeting is 
Friday, September 9, 2016. Registration will be confirmed on site. For 
all logistical questions and concerns, please contact Susie Gingrich, 
Leonard Resource Group, at (202) 289-8322 or send an email to 
[email protected].
    Participants can also join this meeting via teleconference by:

    1. (Audio Portion) Calling the Conference Phone Number (1-800-
832-0736) and providing the Participant Passcode (1337210); and
    2. (Visual Portion) Connecting to the ACBSCT Adobe Connect Pro 
Meeting using the following URL https://lrg.adobeconnect.com/acbsct/ 
and entering as GUEST: (Copy and paste the link into your browser if 
it does not work directly, and enter as a guest). Participants 
should plan to call and connect 15 minutes prior to the meeting for 
logistics to be set up. If you have never attended an Adobe Connect 
meeting, please test your connection using the following URL: http://www.adobe.com/go/meeting_test. In order to obtain a quick overview, 
go to the following URL: http://www.adobe.com/go/connectpro_overview. Call (202) 289-8322 or email Susie Gingrich at 
[email protected] if you are having trouble connecting to the 
meeting site.

    Public Comment: It is preferred that persons interested in 
providing an oral presentation email a written request, along with a 
copy of your presentation, to Robert Walsh, Executive Secretary, at 
[email protected]. Requests should contain the name, address, telephone 
number, email address, and any business or professional affiliation of 
the person desiring to make an oral presentation. Groups having similar 
interests are encouraged to combine their comments and present them 
through a single representative.
    The allocation of time may be adjusted to accommodate the level of 
expressed interest. Persons who do not file an advance request for a 
presentation, but desire to make an oral statement, may request it 
during the public comment period. Public participation and ability to 
comment will be limited as time permits.

Jason E. Bennett
Director, Division of the Executive Secretariat.
[FR Doc. 2016-20198 Filed 8-23-16; 8:45 am]
BILLING CODE 4165-15-P

57922 Federal Register / Vol. 81, No. 164 / Wednesday, August 24, 2016 / Notices

citizen petition requesting that ‘‘FDA Status: The meeting will be open to Public Comment: It is preferred that
impose scientifically-appropriate the public. persons interested in providing an oral
standards for demonstrating BE for Purpose: Pursuant to Public Law 109– presentation email a written request,
ANDAs and 505(b)(2) new drug 129, 42 U.S.C. 274k (session 379 of the along with a copy of your presentation,
applications’’ citing to DIFICID as the Public Health Service Act, as amended), to Robert Walsh, Executive Secretary, at
reference listed drug. FDA has reviewed the ACBSCT advises the Secretary of the RWalsh@hrsa.gov. Requests should
the issues raised in the citizen petition Department of Health and Human contain the name, address, telephone
and is responding to the citizen petition Services and Administrator, Health number, email address, and any
(Docket No. FDA–2015–P–1595, Resources and Services Administration business or professional affiliation of
available at http://www.regulations.gov). (HRSA), on matters related to the the person desiring to make an oral
This draft guidance is being issued activities of the C.W. Bill Young Cell presentation. Groups having similar
consistent with FDA’s good guidance Transplantation Program (Program) and interests are encouraged to combine
practices regulation (21 CFR 10.115). the National Cord Blood Inventory their comments and present them
The draft guidance, when finalized, will Program. through a single representative.
represent the current thinking of FDA Agenda: The Council will discuss The allocation of time may be
on the design of BE studies to support trends in the usage of various sources of adjusted to accommodate the level of
ANDAs for fidaxomicin tablets. It does blood stem cells used in unrelated blood expressed interest. Persons who do not
not establish any rights for any person stem cell transplants, utilization of cord file an advance request for a
and is not binding on FDA or the public. blood, blood stem cell transplantation presentation, but desire to make an oral
You can use an alternative approach if for treatment of sickle cell disease, and statement, may request it during the
it satisfies the requirements of the late effects in blood and marrow public comment period. Public
applicable statutes and regulations. transplantation, among other topics. The participation and ability to comment
Council will also receive a program will be limited as time permits.
II. Electronic Access
update from the HRSA Division of
Persons with access to the Internet Transplantation (DoT). Agenda items Jason E. Bennett
may obtain the draft guidance at either are subject to change as priorities Director, Division of the Executive Secretariat.
http://www.fda.gov/Drugs/Guidance indicate. [FR Doc. 2016–20198 Filed 8–23–16; 8:45 am]
ComplianceRegulatoryInformation/ After Council discussions, members BILLING CODE 4165–15–P
Guidances/default.htm or http:// of the public will have an opportunity
www.regulations.gov. to provide comment. Because of the
Dated: August 18, 2016. Council’s full agenda and timeframe in DEPARTMENT OF HEALTH AND
Jeremy Sharp, which to cover the agenda topics, public HUMAN SERVICES
Deputy Commissioner for Policy, Planning, comment will be limited. All public
Legislation, and Analysis. comments will be included in the Office of the Secretary
[FR Doc. 2016–20146 Filed 8–23–16; 8:45 am] record of the ACBSCT meeting.
The draft meeting agenda will be [Document Identifier: OMB # 0990–0424–
BILLING CODE 4164–01–P 30D]
posted on www.ACBSCTmeeting.org.
Those participating at this meeting Agency Information Collection
DEPARTMENT OF HEALTH AND should pre-register by visiting Activities; Proposed Collection; Public
HUMAN SERVICES www.ACBSCTmeeting.org. The deadline Comment Request
to pre-register for this meeting is Friday,
Health Resources and Services September 9, 2016. Registration will be AGENCY: Office of the Assistant
Administration confirmed on site. For all logistical Secretary for Health, Office of
questions and concerns, please contact Adolescent Health, HHS.
Advisory Council on Blood Stem Cell Susie Gingrich, Leonard Resource ACTION: Notice.
Transplantation; Notice of Meeting Group, at (202) 289–8322 or send an
email to sgringrich@lrginc.com. SUMMARY: In compliance with section
SUMMARY: In accordance with section
Participants can also join this meeting 3506(c)(2)(A) of the Paperwork
10(a)(2) of the Federal Advisory
via teleconference by: Reduction Act of 1995, the Office of the
Committee Act, notice is hereby given of
1. (Audio Portion) Calling the Conference Secretary (OS), Department of Health
the following meeting of the Advisory
Phone Number (1–800–832–0736) and and Human Services, announces plans
Council on Blood Stem Cell
providing the Participant Passcode to submit a Information Collection
Transplantation (ACBSCT).
(1337210); and Request (ICR), described below, to the
DATES: 2. (Visual Portion) Connecting to the Office of Management and Budget
September 13, 2016, from 8:00 a.m. to ACBSCT Adobe Connect Pro Meeting using (OMB). Prior to submitting that ICR to
4:00 p.m. Eastern Time. the following URL https://
September 14, 2016, from 8:00 a.m. to OMB, OS seeks comments from the
lrg.adobeconnect.com/acbsct/ and entering
12:30 p.m. Eastern Time. as GUEST: (Copy and paste the link into your public regarding the burden estimate,
browser if it does not work directly, and below, or any other aspect of the ICR.
ADDRESSES: Crystal Gateway Marriott,
enter as a guest). Participants should plan to DATES: Comments on the ICR must be
1700 Jefferson Davis Highway, call and connect 15 minutes prior to the
Arlington, VA 22202. received on or before September 23,
meeting for logistics to be set up. If you have 2016.
FOR FURTHER INFORMATION CONTACT: never attended an Adobe Connect meeting,
mstockstill on DSK3G9T082PROD with NOTICES

Robert Walsh, Executive Secretary, please test your connection using the ADDRESSES: Submit your comments to
Division of Transplantation, Healthcare following URL: http://www.adobe.com/go/ Information.CollectionClearance@
Systems Bureau, Health Resources and meeting_test. In order to obtain a quick hhs.gov or by calling (202) 690–6162.
Services Administration, 5600 Fishers overview, go to the following URL: http://
www.adobe.com/go/connectpro_overview. FOR FURTHER INFORMATION CONTACT:
Lane, Room 8W60, Rockville, MD Call (202) 289–8322 or email Susie Gingrich Information Collection Clearance staff,
20857; telephone (301) 443–6839. at sgringrich@lrginc.com if you are having Information.CollectionClearance@
SUPPLEMENTARY INFORMATION: trouble connecting to the meeting site. hhs.gov or (202) 690–6162.

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Document Created: 2016-08-24 03:02:34
Document Modified: 2016-08-24 03:02:34

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
Dates		September 13, 2016, from 8:00 a.m. to 4:00 p.m. Eastern Time. September 14, 2016, from 8:00 a.m. to 12:30 p.m. Eastern Time.
Contact		Robert Walsh, Executive Secretary, Division of Transplantation, Healthcare Systems Bureau, Health Resources and Services Administration, 5600 Fishers Lane, Room 8W60, Rockville, MD 20857; telephone (301) 443-6839.
FR Citation		81 FR 57922

81 FR 57922 - Advisory Council on Blood Stem Cell Transplantation; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICESHealth Resources and Services Administration

Federal Register Volume 81, Issue 164 (August 24, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration