Document ID: FDA-2006-D-0031-0125
Agency: fda
Document Type: Notice
Title: Draft Informed Consent Information Sheet: Guidance for Institutional
Review Boards, Clinical Investigators, and Sponsors; Reopening of the
Comment Period
Posted Date: 2014-09-26T04:00Z

[Federal Register Volume 79, Number 187 (Friday, September 26, 2014)]
[Notices]
[Page 57940]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-22951]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2006-D-0031]

Draft Informed Consent Information Sheet: Guidance for 
Institutional Review Boards, Clinical Investigators, and Sponsors; 
Reopening of the Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; reopening of the comment period.

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

SUMMARY: The Food and Drug Administration (FDA) is reopening the 
comment period for the draft guidance document entitled ``Informed 
Consent Information Sheet.'' A notice of availability requesting 
comments on the draft guidance document appeared in the Federal 
Register of July 15, 2014. The Agency is reopening the comment period 
to update comments and to receive any new information.

DATES: Submit either electronic or written comments by October 27, 
2014.

ADDRESSES: Submit electronic comments to http://www.regulations.gov. 
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Marsha Melvin, Office of Good Clinical 
Practice, Food and Drug Administration, 10903 New Hampshire Ave., 
Building 32, Silver Spring, MD 20993, marsha.melvin@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of July 15, 2014 (79 FR 41291), FDA 
published a notice of availability with a 60-day comment period to 
request comments on the draft guidance document entitled ``Informed 
Consent Information Sheet.''
    The Agency has received a request for a 30-day extension of the 
comment period for the draft guidance. The request conveyed concern 
that the current 60-day comment period does not allow sufficient time 
to develop a meaningful or thoughtful response to the draft guidance.
    FDA is reopening the comment period for 30 days. The Agency 
believes that a 30-day extension allows adequate time for interested 
persons to submit comments without significantly delaying finalizing 
the guidance on these important issues.

II. Request for Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

    Dated: September 19, 2014
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-22951 Filed 9-25-14; 8:45 am]
BILLING CODE 4164-01-P