Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting, 73472-73473 [2012-29706]

Download as PDF 73472 Federal Register / Vol. 77, No. 237 / Monday, December 10, 2012 / Notices 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 Caleb Briggs 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 https://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: December 4, 2012. Jill Hartzler Warner, Acting Associate Commissioner for Special Medical Programs. [FR Doc. 2012–29650 Filed 12–7–12; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–N–0001] Cellular, Tissue and Gene Therapies Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. mstockstill on DSK4VPTVN1PROD with ACTION: Notice. This notice announces a forthcoming teleconference 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: Cellular, Tissue and Gene Therapies Advisory Committee. General Function of the Committee: To provide advice and recommendations to the Agency on FDA’s regulatory issues. DATES: Date and Time: The teleconference meeting will be held on January 15, 2013 from 2 p.m. to 5:30 p.m., Eastern Time. Location: National Institutes of Health (NIH), Building 29B, Conference Room C, 9000 Rockville Pike, Bethesda, MD 20892. The public is welcome to attend the meeting at the specified location where a speakerphone will be provided. Public participation in the meeting is VerDate Mar<15>2010 18:30 Dec 07, 2012 Jkt 229001 limited to the use of the speakerphone in the conference room. Important information about transportation and directions to the NIH campus, parking and security procedures is available on the internet at https://www.nih.gov/ about/visitor/index.htm. (FDA has verified the Web site address, but FDA is not responsible for any subsequent changes to the Web site after this document publishes in the Federal Register.) Visitors must show two forms of identification, one of which must be a government-issued photo identification such as a Federal employee badge, driver’s license, passport, green card, etc. Detailed information about security procedures is located at https://www.nih.gov/about/ visitorsecurity.htm. Due to the limited available parking, visitors are encouraged to use public transportation. Contact Person: Gail Dapolito, Center for Biologics Evaluation and Research (HFM–71), Food and Drug Administration, 1401 Rockville Pike, Rockville MD 20852, 301–827–1289, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area), to find out further information regarding FDA advisory committees. 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 https:// 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 January 15, 2013, the committee will meet in open session to hear updates of research programs in the Laboratory of Immunology, Division of Therapeutic Proteins, Office of Biotechnology Products, Center for Drug 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 https://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee meeting link. PO 00000 Frm 00072 Fmt 4703 Sfmt 4703 Procedure: On January 15, 2013, from 2 p.m. to 4:30 p.m. (Eastern Time) 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 January 8, 2013. Oral presentations from the public will be scheduled between approximately 3:30 p.m. and 4:30 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 December 31, 2012. 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 January 2, 2013. Closed Committee Deliberations: On January 15, from 4:30 p.m. to 5:30 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 reports of intramural research programs 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 physical disabilities or special needs. If you require special accommodations due to a disability, please contact Gail Dapolito 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 https://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). E:\FR\FM\10DEN1.SGM 10DEN1 73473 Federal Register / Vol. 77, No. 237 / Monday, December 10, 2012 / Notices Dated: December 5, 2012. Jill Hartzler Warner, Acting Associate Commissioner for Special Medical Programs. further comments from the public during the review and approval period. To request a copy of the clearance requests submitted to OMB for review, email paperwork@hrsa.gov or call the HRSA Reports Clearance Office at (301) 443–1984. [FR Doc. 2012–29706 Filed 12–7–12; 8:45 am] BILLING CODE 4160–01–P Information Collection Request Title: The Health Education Assistance Loan (HEAL) Program: Forms (OMB No. 0915–0043)—Extension DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request ACTION: Notice. In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Health Resources and Services Administration (HRSA) will submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB). Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept SUMMARY: Abstract: The Health Education Assistance Loan (HEAL) program continues to administer and to monitor outstanding loans which were provided to eligible students to pay for educational costs in a number of health professions. HEAL forms collect information that is required for responsible program management. The HEAL Repayment Schedule, Fixed and Variable, provides the borrower with the cost of a HEAL loan, the number and amount of payments, and the Truth-inLending disclosures. The Lender’s Report on HEAL Student Loans Outstanding (Call Report), provides information on the status of loans outstanding by the number of borrowers and total number of loans whose loan Number of respondents Instrument Responses per respondent payments are in various stages of the loan cycle, such as student education and repayment, and the corresponding dollar amounts. These forms are needed to provide borrowers with information on the cost of their loan(s) and to determine which lenders may have excessive delinquencies and defaulted loans. Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose, or provide the information requested. This includes the time needed to review instructions; to develop, acquire, install, and utilize technology and systems for the purpose of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information; to search data sources; to complete and review the collection of information; and to transmit or otherwise disclose the information. The total annual burden hours estimated for this ICR are summarized in the table below. The annual estimate of burden is as follows: Total responses Hours per response Total burden hours Disclosure: Repayment Schedule HRSA 502–1,2 ............ Reporting: Call Report HRSA 512 ..................................... 7 15 50 4 350 60 .50 .75 175 45 Total Reporting and Disclosure .................................. 22 .......................... 410 ........................ 220 Submit your comments to the desk officer for HRSA either by email to OIRA_submission@omb.eop.gov or by fax to 202–395–5806. Please direct all correspondence to the ‘‘attention of the desk officer for HRSA.’’ Deadline: Comments on this ICR should be received within 30 days of this notice. ADDRESSES: Dated: December 3, 2012. Bahar Niakan, Director, Division of Policy and Information Coordination. [FR Doc. 2012–29728 Filed 12–7–12; 8:45 am] mstockstill on DSK4VPTVN1PROD with BILLING CODE 4165–15–P VerDate Mar<15>2010 18:30 Dec 07, 2012 Jkt 229001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration National Advisory Council on the National Health Service Corps; 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: National Advisory Council on the National Health Service Corps (NHSC). Dates And Time: January 10, 2013— 9:30 a.m.—4:45 p.m., January 11, 2013— 8:00 a.m.—12:00 p.m. Place: Health Resources and Services Administration, Parklawn Building, 5600 Fishers Lane, Room 16–49, Rockville, MD 20857. Status: The meeting will be open to the public. Agenda: The Council is convening in Rockville, Maryland to hear the Health Resources and Services Administration PO 00000 Frm 00073 Fmt 4703 Sfmt 9990 and NHSC program updates and discuss NHSC’s retention strategy and interagency workforce efforts. A portion of the meeting will be open for public comment and questions on the second day. The public can join the meeting via audio conference call on the dates and times specified above using the following information: Dial-in number: 1–888–455–9651; Passcode: 7699967. FOR FURTHER INFORMATION CONTACT: Njeri Jones, Bureau of Clinician Recruitment and Service, Health Resources and Services Administration, Parklawn Building, Room 13–64, 5600 Fishers Lane, Rockville, MD 20857; email: NJones@hrsa.gov; Telephone: (301) 443–2541. Dated: December 3, 2012. Bahar Niakan, Director, Division of Policy and Information Coordination. [FR Doc. 2012–29727 Filed 12–7–12; 8:45 am] BILLING CODE 4165–15–P E:\FR\FM\10DEN1.SGM 10DEN1

Agencies

[Federal Register Volume 77, Number 237 (Monday, December 10, 2012)]
[Notices]
[Pages 73472-73473]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-29706]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0001]


Cellular, Tissue and Gene Therapies Advisory Committee; Notice of 
Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

    This notice announces a forthcoming teleconference 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: Cellular, Tissue and Gene Therapies Advisory 
Committee.
    General Function of the Committee: To provide advice and 
recommendations to the Agency on FDA's regulatory issues.

DATES: Date and Time: The teleconference meeting will be held on 
January 15, 2013 from 2 p.m. to 5:30 p.m., Eastern Time.
    Location: National Institutes of Health (NIH), Building 29B, 
Conference Room C, 9000 Rockville Pike, Bethesda, MD 20892. The public 
is welcome to attend the meeting at the specified location where a 
speakerphone will be provided. Public participation in the meeting is 
limited to the use of the speakerphone in the conference room. 
Important information about transportation and directions to the NIH 
campus, parking and security procedures is available on the internet at 
https://www.nih.gov/about/visitor/index.htm. (FDA has verified the Web 
site address, but FDA is not responsible for any subsequent changes to 
the Web site after this document publishes in the Federal Register.) 
Visitors must show two forms of identification, one of which must be a 
government-issued photo identification such as a Federal employee 
badge, driver's license, passport, green card, etc. Detailed 
information about security procedures is located at https://www.nih.gov/about/visitorsecurity.htm. Due to the limited available parking, 
visitors are encouraged to use public transportation.
    Contact Person: Gail Dapolito, Center for Biologics Evaluation and 
Research (HFM-71), Food and Drug Administration, 1401 Rockville Pike, 
Rockville MD 20852, 301-827-1289, or FDA Advisory Committee Information 
Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), to find 
out further information regarding FDA advisory committees. 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 https://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 January 15, 2013, the committee will meet in open 
session to hear updates of research programs in the Laboratory of 
Immunology, Division of Therapeutic Proteins, Office of Biotechnology 
Products, Center for Drug 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 https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting 
link.
    Procedure: On January 15, 2013, from 2 p.m. to 4:30 p.m. (Eastern 
Time) 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 January 8, 2013. Oral presentations from the public 
will be scheduled between approximately 3:30 p.m. and 4:30 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 
December 31, 2012. 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 January 2, 2013.
    Closed Committee Deliberations: On January 15, from 4:30 p.m. to 
5:30 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 reports of 
intramural research programs 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 
physical disabilities or special needs. If you require special 
accommodations due to a disability, please contact Gail Dapolito 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 https://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).


[[Page 73473]]


    Dated: December 5, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2012-29706 Filed 12-7-12; 8:45 am]
BILLING CODE 4160-01-P

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.