74734 Federal Register / Vol. 75, No. 230 / Wednesday, December 1, 2010 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Guidance on Institutional Review 

Board Approval of Research With 

Conditions 

AGENCY: Department of Health and 

Human Services, Office of the Secretary, 

Office of the Assistant Secretary for 

Health, Office for Human Research 

Protections. 

ACTION: Notice. 

SUMMARY: The Office for Human 

Research Protections (OHRP), Office of 

the Assistant Secretary for Health, is 

announcing the availability of a 

guidance document entitled ‘‘Guidance 

on IRB Approval of Research with 

Conditions.’’ The guidance document 

provides OHRP’s first formal guidance 

on this topic. The document, which is 

available on OHRP’s Web site at 

http://www.hhs.gov/ohrp/policy/ 

conditionalapproval2010.html or http:// 

www.hhs.gov/ohrp/policy/ 

conditionalapproval2010.pdf, is 

intended primarily for institutional 

review boards (IRB), investigators, 

Department of Health and Human 

Services (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 

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draft guidance that was made available 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 57486). OHRP received 

comments on the draft guidance 

document from 12 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 Approval of 

Research with Conditions,’’ to the 

Division of Policy and Assurances, 

Office for Human Research Protections, 

1101 Wootton Parkway, Suite 200, 

Rockville, MD 20852. Send one selfaddressed 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 Conditional IRB Approval 

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 Approval of Research 

with Conditions.’’ The guidance 

document provides OHRP’s first formal 

guidance on this topic. 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 nine topics: 

(1) What actions can an IRB take 

when reviewing research? 

(2) What does IRB approval with 

conditions mean? 

(3) What circumstances preclude the 

IRB from approving research? 

(4) What circumstances permit the 

IRB to approve research with 

conditions? 

(5) How should the IRB handle 

changes to research that are proposed 

after the IRB has approved the research 

with conditions? 

(6) How do conditions on IRB 

approval at the time of initial review 

affect the initiation of research? 

(7) May an IRB approve some 

components of a proposed research 

study and defer taking action on other 

components at the time of initial 

review? 

(8) How do conditions on IRB 

approval at the time of continuing 

review, or at the time of review of 

proposed changes in previously 

approved research, affect ongoing 

research? 

(9) What must the IRB records include 

regarding the documentation of 

conditions of IRB approval of research? 

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 57486). OHRP received 

comments on the draft guidance 

document from 12 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. 

II. Electronic Access 

The guidance document is available 

on OHRP’s Web site at http:// 

www.hhs.gov/ohrp/policy/ 

conditionalapproval2010.html or http:// 

www.hhs.gov/ohrp/policy/ 

conditionalapproval2010.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. 2010–30201 Filed 11–30–10; 8:45 am] 

BILLING CODE 4150–36–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Guidance on Institutional Review 

Board Continuing Review of Research 

AGENCY: Department of Health and 

Human Services, Office for Human 

Research Protections, Office of the 

Assistant Secretary for Health, Office of 

the Secretary, Department of Health and 

Human Services. 

ACTION: Notice. 

SUMMARY: The Office for Human 

Research Protections (OHRP), Office of 

the Assistant Secretary for Health, 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, which 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, is intended 

primarily for institutional review boards 

(IRB), investigators, Department of 

Health and Human Services (HHS) 

funding agencies, and others that may 

be responsible for the review, conduct, 

or oversight of human subject research 


jlentini on DSKJ8SOYB1PROD with NOTICES
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