[Federal Register: April 25, 2006 (Volume 71, Number 79)]
[Notices]
[Page 23924-23925]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25ap06-83]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006D-0150]
Guidance for Sponsors, Institutional Review Boards, Clinical
Investigators, and Food and Drug Administration Staff; Guidance on
Informed Consent for In Vitro Diagnostic Device Studies Using Leftover
Human Specimens That Are Not Individually Identifiable; 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 the guidance entitled ``Guidance on Informed Consent
for In Vitro Diagnostic Device Studies Using Leftover Human Specimens
That Are Not Individually Identifiable.'' This guidance is intended to
inform sponsors, institutional review boards, clinical investigators,
and agency staff that under circumstances described in the guidance,
that FDA does not intend to object to the use in device investigations,
without informed consent, of leftover human specimens that are not
individually identifiable. FDA intends to include in this policy
leftover specimens that are remnants of specimens collected for routine
clinical care or analysis that would otherwise have been discarded,
specimens obtained from specimen repositories, and specimens that are
leftover from specimens previously collected for other unrelated
research. This guidance document will be implemented immediately, but
it remains subject to comment in accordance with the agency's good
guidance practices (GGPs).
DATES: Submit written or electronic comments on this guidance at any
time. General comments on agency guidance documents are welcome at any
time.
[[Page 23925]]
ADDRESSES: Submit written requests for single copies of the guidance
document entitled ``Guidance on Informed Consent for In Vitro
Diagnostic Device Studies Using Leftover Human Specimens That Are Not
Individually Identifiable'' to the Division of Small Manufacturers,
International, and Consumer Assistance (HFZ-220), Center for Devices
and Radiological Health, Food and Drug Administration, 1350 Piccard
Dr., Rockville, MD 20850. Send one self-addressed adhesive label to
assist that office in processing your request, or fax your request to
301-443-8818. See the SUPPLEMENTARY INFORMATION section for information
on electronic access to the guidance.
Submit written comments concerning this guidance to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to http://www.fda.gov/dockets/ecomments. Identify comments with the
docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Sally Hojvat, Center for Devices and
Radiological Health (HFZ-440), Food and Drug Administration, 2098
Gaither Rd., Rockville, MD 20850, 240-276-0496.
SUPPLEMENTARY INFORMATION:
I. Background
Under FDA's current regulations governing the conduct of in vitro
diagnostic (IVD) studies, the definition of human subject includes
human specimens (see 21 CFR 812.3(p)). Because these regulations
require informed consent for all FDA-regulated human subject research,
except in limited circumstances specified in FDA regulations, informed
consent is required before specimens can be used in FDA-regulated
research (see 21 CFR part 50). This aspect of FDA's human subject
protection regulations has created confusion and difficulty for persons
developing IVDs. Many clinicians, research hospitals, and companies
have viewed the requirement for informed consent for IVD studies using
leftover specimens to be unnecessary to protect human subjects and to
be overly burdensome and costly.
FDA has recently focused on unnecessary obstacles to medical
product development. The agency has received comments from trade
associations and research institutions that identify the challenge of
obtaining informed consent for the use of leftover specimens as an
unnecessary obstacle and expense to investigational efforts. When
leftover specimens are available, it is often difficult, if not
impossible, to locate the donor and obtain consent.
The confusion regarding the application of informed consent
requirements to IVD studies and concerns about unnecessary obstacles to
product development have prompted FDA to issue this guidance document.
The agency believes that the policy expressed in this guidance will
facilitate product development in a manner consistent with values of
human subject protection.
FDA intends that the exercise of enforcement discretion expressed
in this guidance document begin immediately. In accordance with FDA's
GGP regulation (21 CFR 10.115), you may comment on this guidance at any
time. The agency will consider your comments and determine whether to
revise the guidance at a later date.
II. Significance of Guidance
This guidance is being issued consistent with FDA's GGP regulation.
The guidance represents the agency'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 statute
and regulations.
III. Electronic Access
To receive ``Guidance on Informed Consent for In Vitro Diagnostic
Device Studies Using Leftover Human Specimens that are Not Individually
Identifiable'' by fax, call the CDRH Facts-On-Demand system at 800-899-
0381 or 301-827-0111 from a touch-tone telephone. Press 1 to enter the
system. At the second voice prompt, press 1 to order a document. Enter
the document number 1588 followed by the pound sign (). Follow
the remaining voice prompts to complete your request.
Persons interested in obtaining a copy of the guidance may also do
so by using the Internet. CDRH maintains an entry on the Internet for
easy access to information including text, graphics, and files that may
be downloaded to a personal computer with Internet access. Updated on a
regular basis, the CDRH home page includes device safety alerts,
Federal Register reprints, information on premarket submissions
(including lists of approved applications and manufacturers'
addresses), small manufacturer's assistance, information on video
conferencing and electronic submissions, Mammography Matters, and other
device-oriented information. The CDRH Web site may be accessed at
http://www.fda.gov/cdrh A search capability for all CDRH guidance documents is available at http://www.fda.gov/cdrh/guidance.html.
Guidance documents are also available on the Division of Dockets
Management Internet site at http://www.fda.gov/ohrms/dockets.
IV. Paperwork Reduction Act of 1995
This guidance contains information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520).
The collection of information in this guidance was approved under the
emergency processing provisions of the PRA and was assigned OMB control
number 0910-0582.
V. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified 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.
Dated: April 11, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-6145 Filed 4-24-06; 8:45 am]
BILLING CODE 4160-01-S