
[Federal Register Volume 77, Number 113 (Tuesday, June 12, 2012)]
[Notices]
[Pages 34958-34959]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-14295]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0835]


Draft Guidance for Institutional Review Boards, Clinical 
Investigators, and Sponsors: Considerations When Transferring Clinical 
Investigation Oversight to Another Institutional Review Board; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance entitled ``Considerations When 
Transferring Clinical Investigation Oversight to Another IRB.'' The 
draft guidance discusses regulatory responsibilities of institutional 
review boards (IRBs), clinical investigators, and sponsors when 
oversight of a previously approved clinical investigation under FDA's 
jurisdiction is transferred from one IRB to another IRB. The draft 
guidance also addresses questions that have been previously raised 
concerning procedures and processes that are required and/or 
recommended by FDA when such oversight is transferred.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either written or electronic comments on the draft 
guidance by August 13, 2012.

ADDRESSES: Submit written requests for single copies of this draft 
guidance to the Division of Drug Information, Center for Drug 
Evaluation and Research (CDER), Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002 (1-
888-463-6332 or 301-796-3400); or the Office of Communication, Outreach 
and Development (HFM-40), Center for Biologics Evaluation and Research 
(CBER), Food and Drug Administration, 1401 Rockville Pike, Suite 200N, 
Rockville, MD 20852-1448 (1-800-835-4709 or 301-827-1800); or the 
Division of Small Manufacturers, International and Consumer Assistance, 
Center for Devices and Radiological Health (CDRH), Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4622, Silver 
Spring, MD 20993 (1-800-638-2041 or 301-796-7100). Send one self-
addressed adhesive label to assist that office in processing your 
requests.
    Submit electronic comments on the draft guidance 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. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Bridget Foltz, Office of Good Clinical 
Practice, Food and Drug Administration, 10903 New Hampshire Ave., Bldg, 
32, Rm. 5174, Silver Spring, MD 20993-0002, 301-796-8340.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance entitled 
``Considerations When Transferring Clinical Investigation Oversight to 
Another IRB.'' The draft guidance discusses the regulatory 
responsibilities of IRBs, clinical investigators, and sponsors when 
oversight of a previously approved clinical investigation under FDA's 
jurisdiction is transferred from one IRB to another IRB. In particular, 
the draft guidance discusses eight steps to be considered when 
transferring oversight of a previously approved clinical investigation 
between two IRBs. These include: Identifying those studies for which 
IRB oversight is being transferred; ensuring availability and retention 
of pertinent records; establishing an effective date for the transfer; 
conducting a review of research by the receiving IRB, where 
appropriate; confirming or establishing the date for the next 
continuing review; determining whether the consent form needs to be 
revised; notifying the key parties; and updating IRB registration 
information. This list is not meant to be exhaustive as the 
circumstances involved in the transfer may vary.
    To enhance human subject protections and reduce regulatory burden, 
FDA and the Office for Human Research Protections (OHRP) have been 
actively working to harmonize the Agencies' regulatory requirements and 
guidance for human subjects research. This draft guidance document was 
developed as a part of these efforts. OHRP has simultaneously published 
in this same issue of the Federal Register a draft guidance document 
entitled ``Considerations in Transferring a Previously Approved 
Research Project to a New IRB or Research Institution'' that is similar 
to FDA's draft document.
    FDA and OHRP recognize that the two documents may appear somewhat 
different as there are minor variations in formatting and some 
necessary variations due to differences in the regulated entities under 
FDA's and OHRP's jurisdiction. The Agencies wish to stress, however, 
that our intent was to provide harmonized guidance to IRBs, sponsors, 
institutions, investigators, and other entities involved in the study 
oversight transfer process. FDA and OHRP will continue to work closely 
in the development of final guidance and appreciate comments from 
interested parties.
    The draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent FDA's current thinking on this topic. It does 
not create or confer any rights for or on any person and does not 
operate to bind FDA or the public. An alternative approach may be used 
if such approach satisfies the requirements of the applicable statutes 
and regulations.

II. The Paperwork Reduction Act of 1995

    This draft guidance includes information collections provisions 
that are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information referenced in this draft guidance that are 
related to IRB recordkeeping requirements under 21 CFR 56.115, which 
include the requirements for records related to informed consent, have 
been approved under OMB control number 0910-0130; the collection of 
information in 21 CFR part 312 have been approved under OMB control 
number 0910-0014; and the collections of information in 21 CFR part 812 
have been approved under

[[Page 34959]]

OMB control number 0910-0078. In accordance with the PRA, prior to 
publication of any final guidance document, FDA intends to solicit 
public comment and obtain OMB approval for any information collections 
recommended in this draft guidance that are new or that would represent 
material modifications to these previously approved collections of 
information found in FDA regulations.

III. Comments

    The draft guidance is being distributed for comment purposes only 
and is not intended for implementation at this time. Interested persons 
may submit to the Division of Dockets Management (see ADDRESSES) either 
electronic or written comments regarding this document. 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.

IV. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at either http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ProposedRegulationsandDraftGuidances/default.htm 
or http://www.regulations.gov.

    Dated: June 6, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-14295 Filed 6-11-12; 8:45 am]
BILLING CODE 4160-01-P


