Food Advisory Committee; Notice of Meeting, 74735-74736 [2010-30187]

Download as PDF Federal Register / Vol. 75, No. 230 / Wednesday, December 1, 2010 / Notices conducted or supported by HHS. The guidance document announced in this notice finalizes the draft guidance that was made available for public comment through a notice in the Federal Register on November 6, 2009 (74 FR 57487). OHRP received comments on the draft guidance document from 18 individuals and organizations, and those comments were considered as the guidance was finalized. Comments on OHRP guidance documents are welcome at any time. ADDRESSES: Submit written requests for a single copy of the guidance document entitled, ‘‘Guidance on IRB Continuing Review of Research,’’ to the Division of Policy and Assurances, Office for Human Research Protections, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 301–402–2071. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance document. Submit written comments to Comments on Continuing Review Guidance, Office for Human Research Protections, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852. Comments also may be sent via e-mail to ohrp@hhs.gov or via facsimile at 240– 402–2071. FOR FURTHER INFORMATION CONTACT: Irene Stith-Coleman, PhD, Office for Human Research Protections, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852, 240–453–6900; e-mail Irene.Stith-Coleman@hhs.gov. SUPPLEMENTARY INFORMATION: DATES: jlentini on DSKJ8SOYB1PROD with NOTICES I. Background OHRP is announcing the availability of a guidance document entitled ‘‘Guidance on IRB Continuing Review of Research.’’ The guidance document supersedes OHRP’s January 15, 2007 guidance entitled ‘‘Guidance on Continuing Review.’’ The document is intended primarily for IRBs, investigators, HHS funding agencies, and others that may be responsible for the review, conduct, or oversight of human subject research conducted or supported by HHS. The guidance document applies to non-exempt human subjects research conducted or supported by HHS. It provides guidance on the authority of IRBs to approve research with conditions. In particular, the guidance addresses the following 11 topics: (1) Key IRB Considerations When Evaluating Research Undergoing Continuing Review; VerDate Mar<15>2010 20:11 Nov 30, 2010 Jkt 223001 (2) Process for Conducting Continuing Review; (3) Additional Considerations for Continuing Review of Multicenter Research Projects; (4) When Expedited Review Procedures may be Used by an IRB for Continuing Review; (5) Determining the Frequency of Continuing Review; (6) Determining the Effective Date of Initial IRB Approval and the Dates for Continuing Review; (7) Lapses in IRB Approval; (8) Communicating the IRB’s Continuing Review Determination to Investigators and the Institution; (9) Suspension or Termination of IRB Approval of Research or Disapproval of Research at the Time of Continuing Review; (10) Identifying the Point When Continuing Review is no Longer Necessary; and (11) Continuing Review is Not Required for Exempt Human Subjects Research Projects. The guidance document announced in this notice finalizes the draft guidance that was made available for public comment through a notice in the Federal Register on November 6, 2009 (74 FR 57487). OHRP received comments on the draft guidance document from 18 individuals and organizations, and those comments were considered as the guidance was finalized. The majority of commenters expressed general support for the draft guidance document. The final guidance document is largely unchanged from what was proposed in the draft guidance, with only minor clarifying edits made in response to many of the comments. To enhance human subject protections and reduce regulatory burden, OHRP and the Food and Drug Administration (FDA) have been actively working to harmonize the agencies’ regulatory requirements and guidance for human subjects research. The guidance document announced in this notice was developed as a part of these efforts. When FDA finalizes its related guidance entitled ‘‘Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Continuing Review After Clinical Investigation Approval,’’ which was made available in draft for public comment through a notice in the Federal Register on January 13, 2010 (75 FR 1790), OHRP will update the guidance document announced in this notice as needed to harmonize with FDA’s final guidance document. PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 74735 II. Electronic Access The guidance document is available on OHRP’s Web site at https:// www.hhs.gov/ohrp/policy/ continuingreview2010.html or https:// www.hhs.gov/ohrp/policy/ continuingreview2010.pdf. III. Comments Interested persons may submit comments regarding this guidance document to OHRP at any time. Please see the ADDRESSES section for information on where to submit written comments. Dated: November 24, 2010. Jerry Menikoff, Director, Office for Human Research Protections. [FR Doc. 2010–30198 Filed 11–30–10; 8:45 am] BILLING CODE 4150–36–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–N–0001] Food Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Food 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 March 30 and 31, 2011, from 8:30 a.m. to 4:30 p.m. Location: The Hilton Hotel, Silver Spring, 8727 Colesville Rd., Silver Spring, MD 20910, 301–589–5200. Contact Person: Carolyn Jeletic, Center for Food Safety and Applied Nutrition (HFS–024), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301– 436–1913 or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area), code 3014510564. Please call the Information Line for up-to-date information on this meeting. A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly E:\FR\FM\01DEN1.SGM 01DEN1 jlentini on DSKJ8SOYB1PROD with NOTICES 74736 Federal Register / Vol. 75, No. 230 / Wednesday, December 1, 2010 / Notices enough to provide timely notice. Therefore, you 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 Food Advisory Committee will meet to discuss whether available relevant data demonstrate a link between children’s consumption of synthetic color additives in food and adverse effects on behavior. 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 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 23, 2011. Oral presentations from the public will be scheduled between approximately 10 a.m. and 11 a.m. on March 31, 2011. 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 15, 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 March 16, 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 Carolyn VerDate Mar<15>2010 20:11 Nov 30, 2010 Jkt 223001 Jeletic 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). Registration: You are encouraged to register by February 21, 2011. The workshop has a $250 registration fee to cover the cost of facilities, materials, lunch on day 1, and breaks. There is no registration fee for FDA employees. Seats are limited; please submit your registration as soon as possible. Workshop space will be filled in order of receipt of registration. Those accepted into the workshop will receive confirmation. Registration will close after the workshop is filled. Registration at the site is not guaranteed but may be possible on a space available basis on Dated: November 24, 2010. the day of the public workshop Jill Hartzler Warner, beginning at 8 a.m. The cost of Acting Associate Commissioner for Special registration at the site is $350 payable Medical Programs. to: ‘‘Iowa State University.’’ If you need [FR Doc. 2010–30187 Filed 11–30–10; 8:45 am] special accommodations due to a BILLING CODE 4160–01–P disability, please contact Dr. Ruth MacDonald (see Contact) at least 14 days in advance. DEPARTMENT OF HEALTH AND Registration Form Instructions: To HUMAN SERVICES register, please complete the online registration form at https:// Food and Drug Administration www.fshn.hs.iastate.edu/foodlabel/ [Docket No. FDA–2010–N–0001] register.php, or submit your full name, business or organization name, Food Labeling Workshop; Public complete mailing address, telephone Workshop number, email address, optional fax AGENCY: Food and Drug Administration, number, and any special HHS. accommodations required due to ACTION: Notice of public workshop. disability, along with a check or money order for $250 payable to ‘‘Iowa State SUMMARY: The Food and Drug University.’’ Mail to: Dr. Ruth Administration (FDA), Office of MacDonald, Food Science and Human Regulatory Affairs, Southwest Regional Nutrition, 2312 Food Sciences Building, Small Business Representative (SWR Ames, IA 50011. SBR) Program, in collaboration with Transcripts: Transcripts of the public Iowa State University, is announcing a workshop will not be available due to public workshop entitled ‘‘Food the format of this workshop. Requests Labeling Workshop.’’ This public for workshop handouts may be obtained workshop is intended to provide through David Arvelo (see Contact). information about FDA food labeling SUPPLEMENTARY INFORMATION: This regulations and other related subjects to public workshop is being held in the regulated industry, particularly response to the large volume of food small businesses and startups. Date and Time: This public workshop labeling inquiries from small food manufacturers and startups originating will be held on March 3 and 4, 2011, from the area covered by FDA’s Kansas from 8 a.m. to 5 p.m. City District Office. The SWR SBR Location: The public workshop will presents these workshops to help be held at the Scheman Conference achieve objectives set forth in section Center, Lincoln Way and University 406 of the Food and Drug Avenue, Iowa State Center, Ames, IA. Contact: David Arvelo, Food and Drug Administration Modernization Act of 1997 (21 U.S.C. 393), which include Administration, Southwest Regional working closely with stakeholders and Office, 4040 North Central Expressway, maximizing the availability and clarity suite 900, Dallas, TX 75204, 214–253– of information to stakeholders and the 4952, FAX: 214–253–4970, or email: public. This is consistent with the david.arvelo@fda.hhs.gov. For information on accommodation purposes of the SBR Program, which are options, visit https:// in part to respond to industry inquiries, www.fshn.hs.iastate.edu/foodlabel/ develop educational materials, and register.php or contact Dr. Ruth sponsor workshops and conferences to MacDonald, 2312 Food Sciences provide firms, particularly small Building, Iowa State University, Ames, businesses, with firsthand working IA 50011, 515–294–5991, FAX: 515– knowledge of FDA’s requirements and 294–8181, email: ruthmacd@iastate.edu. compliance policies. This workshop is PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 E:\FR\FM\01DEN1.SGM 01DEN1

Agencies

[Federal Register Volume 75, Number 230 (Wednesday, December 1, 2010)]
[Notices]
[Pages 74735-74736]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-30187]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0001]


Food Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

    This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA). The meeting will 
be open to the public.
    Name of Committee: Food 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 March 30 and 31, 2011, 
from 8:30 a.m. to 4:30 p.m.
    Location: The Hilton Hotel, Silver Spring, 8727 Colesville Rd., 
Silver Spring, MD 20910, 301-589-5200.
    Contact Person: Carolyn Jeletic, Center for Food Safety and Applied 
Nutrition (HFS-024), Food and Drug Administration, 5100 Paint Branch 
Pkwy., College Park, MD 20740, 301-436-1913 or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area), code 3014510564. Please call the Information Line for up-to-date 
information on this meeting. A notice in the Federal Register about 
last minute modifications that impact a previously announced advisory 
committee meeting cannot always be published quickly

[[Page 74736]]

enough to provide timely notice. Therefore, you 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 Food Advisory Committee will meet to discuss whether 
available relevant data demonstrate a link between children's 
consumption of synthetic color additives in food and adverse effects on 
behavior.
    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 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 23, 2011. Oral presentations from the public will be scheduled 
between approximately 10 a.m. and 11 a.m. on March 31, 2011. 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 15, 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 March 16, 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 Carolyn Jeletic 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: November 24, 2010.
 Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-30187 Filed 11-30-10; 8:45 am]
BILLING CODE 4160-01-P

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