Advisory Council on Blood Stem Cell Transplantation; Notice of Meeting, 3913 [2011-1266]

Download as PDF WReier-Aviles on DSKGBLS3C1PROD with NOTICES Federal Register / Vol. 76, No. 14 / Friday, January 21, 2011 / Notices should always check the Agency’s Web site and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting. Agenda: The committee will discuss innovative approaches to the development of drugs for orphan and rare diseases to support decisions such as dose and trial design selection. FDA will seek input and comment on how to optimally utilize mechanistic biomarkers and apply clinical pharmacology tools, such as pharmacogenetics and modeling and simulation, to facilitate efficient and informative drug development and regulatory review. FDA will present and seek input from the committee on how lessons learned from other applications of clinical pharmacology tools in pediatrics and oncology can be applied to orphan and rare disease drugs. The committee will be asked to comment on the current status and future direction for clinical pharmacology studies (e.g., dose-response, drug-drug interactions, pharmacokinetics in patients with renal or hepatic impairment) as they pertain to drug development for orphan and rare diseases. 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 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 February 15, 2011. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 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 February 7, 2011. 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 February 8, 2011. 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 physical disabilities or special needs. If you require special accommodations due to a disability, please contact Yvette Waples, at least 7 days in advance of the meeting. VerDate Mar<15>2010 13:45 Jan 20, 2011 Jkt 223001 FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at http://www.fda.gov/ AdvisoryCommittees/AboutAdvisory Committees/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: January 18, 2011. Jill Hartzler Warner, Acting Associate Commissioner for Special Medical Programs. [FR Doc. 2011–1223 Filed 1–20–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Advisory Council on Blood Stem Cell Transplantation; Notice of Meeting In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), notice is hereby given of the following meeting: Name: Advisory Council on Blood Stem Cell Transplantation. Date and Time: February 4, 2011, from 3 p.m. to 5 p.m. EST. ACTION: Notice of Advisory Council on Blood Stem Cell Transplantation (ACBSCT) Meeting to be Held by Conference Call. The ACBSCT will be conducting a conference call to discuss: (1) Final language of recommendations from November 15, 2010, Council meeting; and (2) Interim Report to Congress. DATES: The conference call will be held on February 4, 2011, at 3 p.m. to 5 p.m. EST. Participants must dial: (800) 988– 9536 and enter the corresponding pass code 2741198. Patricia A. Stroup, MBA, MPA, is the call leader. Participants should call no later than 2:50 p.m. EST in order for the logistics to be set up. Participants are asked to register for the conference by contacting Passy Tongele at (301) 443–0437 or e-mail ptongele@hrsa.gov. The registration deadline is February 2, 2011. The Department will try to accommodate those wishing to participate in the call. Any member of the public can submit written materials that will be distributed to Council members prior to the conference call. Parties wishing to submit written comments should ensure that the comments are received no later than February 2, 2011, for consideration. Comments should be submitted to Passy Tongele, Healthcare SUMMARY: PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 3913 Systems Bureau, HRSA, Parklawn Building, Room 12C–06, 5600 Fishers Lane, Rockville, Maryland 20857; telephone (301) 443–0437; fax (301) 594–6095; or e-mail to ptongele@hrsa.gov. Members of the public can present oral comments during the conference call during the public comment period. If a member of the public wishes to speak, the Department should be notified at the time the participant registers. Others members of the public will be allocated time if time permits. FOR FURTHER INFORMATION CONTACT: Patricia A. Stroup, MBA, MPA, Executive Secretary, ACBSCT, Healthcare Systems Bureau, HRSA, Parklawn Building, Room 12C–06, 5600 Fishers Lane, Rockville, Maryland 20857; telephone (301) 443–1127; fax (301) 594–6095; or e-mail to pstroup@hrsa.gov. The purpose of this call is to hear discussion from the ACBSCT members on the final language of the eight recommendations approved at the November 15, 2010, Council meeting and to discuss the Interim Report to Congress. Public Law 111–264 states that ‘‘* * * the Secretary of Health and Human Services * * * in consultation with the Advisory Council * * * shall submit to Congress an interim report not later than 180 days after the date of enactment of this Act describing (A) the methods to distribute Federal funds to cord blood banks used at the time of submission of the report; (B) how cord blood banks contract with collection sites for the collection of cord blood units; and (C) recommendations for improving the methods to distribute Federal funds described in subparagraph (A) in order to encourage the efficient collection of high-quality and diverse cord blood units.’’ SUPPLEMENTARY INFORMATION: Dated: January 14, 2011. Robert Hendricks, Director, Division of Policy and Information Coordination. [FR Doc. 2011–1266 Filed 1–20–11; 8:45 am] BILLING CODE 4165–15–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Drug Abuse; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the Board of Scientific Counselors, NIDA. The E:\FR\FM\21JAN1.SGM 21JAN1

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[Federal Register Volume 76, Number 14 (Friday, January 21, 2011)]
[Notices]
[Page 3913]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-1266]


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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

    In accordance with section 10(a)(2) of the Federal Advisory 
Committee Act (Pub. L. 92-463), notice is hereby given of the following 
meeting:
    Name: Advisory Council on Blood Stem Cell Transplantation.
    Date and Time: February 4, 2011, from 3 p.m. to 5 p.m. EST.

ACTION: Notice of Advisory Council on Blood Stem Cell Transplantation 
(ACBSCT) Meeting to be Held by Conference Call.

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

SUMMARY: The ACBSCT will be conducting a conference call to discuss:
    (1) Final language of recommendations from November 15, 2010, 
Council meeting; and
    (2) Interim Report to Congress.

DATES: The conference call will be held on February 4, 2011, at 3 p.m. 
to 5 p.m. EST. Participants must dial: (800) 988-9536 and enter the 
corresponding pass code 2741198. Patricia A. Stroup, MBA, MPA, is the 
call leader. Participants should call no later than 2:50 p.m. EST in 
order for the logistics to be set up. Participants are asked to 
register for the conference by contacting Passy Tongele at (301) 443-
0437 or e-mail ptongele@hrsa.gov. The registration deadline is February 
2, 2011. The Department will try to accommodate those wishing to 
participate in the call.
    Any member of the public can submit written materials that will be 
distributed to Council members prior to the conference call. Parties 
wishing to submit written comments should ensure that the comments are 
received no later than February 2, 2011, for consideration. Comments 
should be submitted to Passy Tongele, Healthcare Systems Bureau, HRSA, 
Parklawn Building, Room 12C-06, 5600 Fishers Lane, Rockville, Maryland 
20857; telephone (301) 443-0437; fax (301) 594-6095; or e-mail to 
ptongele@hrsa.gov.
    Members of the public can present oral comments during the 
conference call during the public comment period. If a member of the 
public wishes to speak, the Department should be notified at the time 
the participant registers. Others members of the public will be 
allocated time if time permits.

FOR FURTHER INFORMATION CONTACT: Patricia A. Stroup, MBA, MPA, 
Executive Secretary, ACBSCT, Healthcare Systems Bureau, HRSA, Parklawn 
Building, Room 12C-06, 5600 Fishers Lane, Rockville, Maryland 20857; 
telephone (301) 443-1127; fax (301) 594-6095; or e-mail to 
pstroup@hrsa.gov.

SUPPLEMENTARY INFORMATION: The purpose of this call is to hear 
discussion from the ACBSCT members on the final language of the eight 
recommendations approved at the November 15, 2010, Council meeting and 
to discuss the Interim Report to Congress. Public Law 111-264 states 
that ``* * * the Secretary of Health and Human Services * * * in 
consultation with the Advisory Council * * * shall submit to Congress 
an interim report not later than 180 days after the date of enactment 
of this Act describing (A) the methods to distribute Federal funds to 
cord blood banks used at the time of submission of the report; (B) how 
cord blood banks contract with collection sites for the collection of 
cord blood units; and (C) recommendations for improving the methods to 
distribute Federal funds described in subparagraph (A) in order to 
encourage the efficient collection of high-quality and diverse cord 
blood units.''

    Dated: January 14, 2011.
Robert Hendricks,
Director, Division of Policy and Information Coordination.
[FR Doc. 2011-1266 Filed 1-20-11; 8:45 am]
BILLING CODE 4165-15-P