[Federal Register Volume 71, Number 5 (Monday, January 9, 2006)]
[Notices]
[Pages 1429-1430]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-73]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0507]


Agency Emergency Processing Under Office of Management and Budget 
Review; Guidance on Informed Consent for In Vitro Diagnostic Device 
Studies Using Leftover Human Specimens That are Not Individually 
Identifiable

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for emergency processing under the 
Paperwork Reduction Act of 1995 (the PRA). FDA believes, and is 
preparing a guidance document explaining, that it is possible in 
certain circumstances for In Vitro Diagnostic (IVD) device studies to 
be conducted using leftover specimens obtained without informed consent 
while protecting the human subjects who are the source of such 
specimens. This notice solicits comments on the proposed collection of 
information associated with the guidance document entitled ``Guidance 
on Informed Consent for In Vitro Diagnostic Device Studies Using 
Leftover Human Specimens that are Not Individually Identifiable.''

DATES: Fax written comments on the collection of information by 
February 8, 2006. FDA is requesting approval of this emergency 
processing by January 17, 2006.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. To ensure that comments on the information 
collection are received, OMB recommends that written comments be faxed 
to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie 
Yokota, Desk Officer for FDA, FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Information 
Resources Management (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, rm. 16B-26, Rockville, MD 20857, 301-827-1472.

SUPPLEMENTARY INFORMATION: FDA has requested emergency processing of 
this proposed collection of information under section 3507(j) of the 
PRA (44 U.S.C. 3507(j)) and 5 CFR 1320.13. The Center for Devices and 
Radiological Health (CDRH) intends to issue a guidance document that 
addresses an immediate need of the research community. CDRH's guidance 
will identify the circumstances when the agency intends to exercise 
enforcement discretion regarding the informed consent requirements. 
These requirements normally apply to all FDA-regulated clinical 
studies, including studies using only leftover human specimens that are 
not individually identifiable. The agency intends to issue this 
guidance because the existing requirements are bringing a halt to a 
class of very valuable research that can produce new diagnostic tests, 
without appreciably adding protection for human subjects.
    With respect to the following proposed collection of information, 
FDA invites comments on the following topics: (1) Whether the proposed 
collection of information is necessary for the proper performance of 
FDA's functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Guidance on Informed Consent for In Vitro Diagnostic Device Studies 
Using Leftover Human Specimens That are Not Individually Identifiable

    FDA's investigational device regulations are intended to encourage 
the development of new, useful devices in a manner that is consistent 
with public health, safety, and with ethical standards. Investigators 
should have freedom to pursue the least burdensome means of 
accomplishing this goal. However, to ensure that the balance is 
maintained between product

[[Page 1430]]

development and the protection of public health, safety, and ethical 
standards, FDA has established human subject protection regulations 
addressing requirements for informed consent and institutional review 
board (IRB) review that apply to all FDA-regulated clinical 
investigations involving human subjects. In particular, informed 
consent requirements further both safety and ethical considerations by 
allowing potential subjects to consider both the physical and privacy 
risks they face if they agree to participate in a trial.
    Under FDA regulations, clinical investigations using human 
specimens conducted in support of premarket submissions to FDA are 
considered human subject investigations (see 21 CFR 812.3(p)). Many IVD 
device studies are exempt from most provisions of part 812 (21 CFR part 
812), Investigational Device Exemptions (IDEs), under Sec.  
812.2(c)(3), but FDA's regulations for the protection of human subjects 
(parts 50 and 56 (21 CFR parts 50 and 56)) apply to all clinical 
investigations that are regulated by FDA (see Sec. Sec.  50.1 and 
56.101, and section 520(g)(3)(A) and (g)(3)(D) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360j(g)(3)(A) and (g)(3)(D))).
    FDA regulations do not contain exceptions from the requirements of 
informed consent on the grounds that the specimens are not identifiable 
or that they are remnants of human specimens collected for routine 
clinical care or analysis that would otherwise have been discarded. Nor 
do FDA regulations allow IRBs to decide whether or not to waive 
informed consent for research involving leftover or unidentifiable 
specimens.
    FDA intends to notify the public, in a level 1 guidance document 
issued under the good guidances practices regulation (21 CFR 10.115), 
of the circumstances in which it intends to exercise enforcement 
discretion as to the informed consent regulations for clinical 
investigators, sponsors, and IRBs. In the guidance document, FDA 
recommends that sponsors of studies that meet the conditions maintain 
documentation of how these conditions were met and of the types of 
human subject protection procedures followed by the specimen provider 
to ensure that the subject cannot be identified.
    Sponsors that wish to follow the recommendations of the guidance 
will substitute use of records to demonstrate conformance to this 
enforcement discretion policy in place of the more detailed and 
patient-specific records for obtaining and documenting informed 
consent. Most fundamentally, this means collecting and maintaining 
information about the protections that are in place to prevent the 
identification of the specimens, since making sure that the specimens 
are not identifiable is key to obtaining FDA's enforcement discretion.
    FDA intends to exercise enforcement discretion when all the 
following are true:
     The investigation meets the IDE exemption criteria at 
Sec.  812.2(c)(3);
     The study uses leftover specimens, that is, remnants of 
specimens collected for routine clinical care or analysis that would 
have been discarded if not used in the study;
     The specimens provided to the investigator are accompanied 
by only minimal clinical information such as age, gender, and existing 
laboratory result;
     The specimens are not individually identifiable;
     The specimens are provided to the investigator(s) without 
identifiers and the supplier of the specimens has established policies 
and procedures to prevent the release of personal information;
     The individuals caring for the patients are different 
from, and do not share information with, those conducting the 
investigation; and
     The study has been reviewed by an IRB in accordance with 
21 CFR part 56.
    FDA estimates the burden of this collection of information as 
follows:

                               Table 1.--Estimated Annual Recordkeeping Burden\1\
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                                     Annual Frequency       Total Annual
       No. of Recordkeepers             per Record            Records       Hours per  Record     Total Hours
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600                                                   1                600                  4              2,400
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    The recommendations of this guidance impose a minimal burden on 
industry. FDA estimates that 600 studies will be affected annually. 
Each study will result in one recordkeeping per year, estimated to take 
4 hours to complete. This results in a total recordkeeping burden of 
2,400 hours (600 x 4 = 2,400).

    Dated: January 3, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-73 Filed 1-6-06; 8:45 am]
BILLING CODE 4160-01-S