[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]
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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Draft Guidance for Institutional Review Boards, Clinical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.
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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availability of a draft guidance entitled ``Considerations When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draft guidance discusses regulatory responsibilities of institutional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 The draft
guidance also addresses questions that have been previously raised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draft guidance before it begins work on the final version of the
guidance, submit either written or electronic comments on the draft
guidance by August 13, 2012.
ADDRESSES: Submit written requests for single copies of this draft
guidance to the Division of Drug Information, Center for Drug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]
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