Federal Register / Vol. 75, No. 230 / Wednesday, December 1, 2010 / Notices 74735 

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notice finalizes the draft guidance that 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. 

DATES: 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: 

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; 

(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. 

II. Electronic Access 

The guidance document is available 

on OHRP’s Web site at http:// 

www.hhs.gov/ohrp/policy/ 

continuingreview2010.html or http:// 

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 


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 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 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 

http://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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0001] 

Food Labeling Workshop; Public 

Workshop 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop. 

SUMMARY: The Food and Drug 

Administration (FDA), Office of 

Regulatory Affairs, Southwest Regional 

Small Business Representative (SWR 

SBR) Program, in collaboration with 

Iowa State University, is announcing a 

public workshop entitled ‘‘Food 

Labeling Workshop.’’ This public 

workshop is intended to provide 

information about FDA food labeling 

regulations and other related subjects to 

the regulated industry, particularly 

small businesses and startups. 

Date and Time: This public workshop 

will be held on March 3 and 4, 2011, 

from 8 a.m. to 5 p.m. 

Location: The public workshop will 

be held at the Scheman Conference 

Center, Lincoln Way and University 

Avenue, Iowa State Center, Ames, IA. 

Contact: David Arvelo, Food and Drug 

Administration, Southwest Regional 

Office, 4040 North Central Expressway, 

suite 900, Dallas, TX 75204, 214–253– 

4952, FAX: 214–253–4970, or email: 

david.arvelo@fda.hhs.gov. 

For information on accommodation 

options, visit http:// 

www.fshn.hs.iastate.edu/foodlabel/ 

register.php or contact Dr. Ruth 

MacDonald, 2312 Food Sciences 

Building, Iowa State University, Ames, 

IA 50011, 515–294–5991, FAX: 515– 

294–8181, email: ruthmacd@iastate.edu. 

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 

the day of the public workshop 

beginning at 8 a.m. The cost of 

registration at the site is $350 payable 

to: ‘‘Iowa State University.’’ If you need 

special accommodations due to a 

disability, please contact Dr. Ruth 

MacDonald (see Contact) at least 14 

days in advance. 

Registration Form Instructions: To 

register, please complete the online 

registration form at http:// 

www.fshn.hs.iastate.edu/foodlabel/ 

register.php, or submit your full name, 

business or organization name, 

complete mailing address, telephone 

number, email address, optional fax 

number, and any special 

accommodations required due to 

disability, along with a check or money 

order for $250 payable to ‘‘Iowa State 

University.’’ Mail to: Dr. Ruth 

MacDonald, Food Science and Human 

Nutrition, 2312 Food Sciences Building, 

Ames, IA 50011. 

Transcripts: Transcripts of the public 

workshop will not be available due to 

the format of this workshop. Requests 

for workshop handouts may be obtained 

through David Arvelo (see Contact). 

SUPPLEMENTARY INFORMATION: This 

public workshop is being held in 

response to the large volume of food 

labeling inquiries from small food 

manufacturers and startups originating 

from the area covered by FDA’s Kansas 

City District Office. The SWR SBR 

presents these workshops to help 

achieve objectives set forth in section 

406 of the Food and Drug 

Administration Modernization Act of 

1997 (21 U.S.C. 393), which include 

working closely with stakeholders and 

maximizing the availability and clarity 

of information to stakeholders and the 

public. This is consistent with the 

purposes of the SBR Program, which are 

in part to respond to industry inquiries, 

develop educational materials, and 

sponsor workshops and conferences to 

provide firms, particularly small 

businesses, with firsthand working 

knowledge of FDA’s requirements and 

compliance policies. This workshop is 


jlentini on DSKJ8SOYB1PROD with NOTICES