[Federal Register Volume 71, Number 79 (Tuesday, April 25, 2006)]
[Notices]
[Pages 23924-23925]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-6145]


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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