[Federal Register Volume 71, Number 172 (Wednesday, September 6, 2006)]
[Notices]
[Pages 52547-52548]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-14671]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0185]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Guidance on Informed 
Consent for In Vitro Diagnostic Device Studies Using Leftover Human 
Specimens That Are Not 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 review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by October 
6, 2006.

ADDRESSES: 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: FDA Desk Officer, 
FAX: 202-395-6974.

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

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance:

Guidance on Informed Consent for In Vitro Diagnostic Device Studies 
Using Leftover Human Specimens that Are Not Individually Identifiable--
(OMB Control Number 0910-0582)--Extension

    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 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 Committee (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 
investigational device studies are exempt from most provisions of part 
812 (21 CFR part 812), Investigational Device Exemptions, 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, 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.
    In a level 1 guidance document issued under the good guidance 
practices (GGP) regulations (21 CFR 10.115), FDA outlines the 
circumstances in which it intends to exercise enforcement discretion as 
to the informed consent regulations for clinical investigators, 
sponsors, and IRBs.
    In the Federal Register of May 19, 2006 (71 FR 29158), FDA 
published a 60-day notice requesting comments on the information 
collection provisions. In response to this notice, no comments were 
received.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Recordkeeping Burden
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                                                                                                                                        Total Operating
              No. of Recordkepers                 Annual Frequency   Total annual      Hours per      Total Hours     Total Capital     and  Maintenance
                                                  per Recordkeeper      Records         Record                             Cost               Cost
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700                                                              1             700               4           2,800           $210,000           $210,000
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[[Page 52548]]

    The recommendations of this guidance impose a minimal burden on 
industry. FDA estimates that 700 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 
2,800 hours. (700 x 4 = 2,800). FDA estimates that the cost of 
developing standard operating procedures ( SOPs) for each recordkeeper 
is $300 (6 hours of work x $50 /hour. This results in a total 
operational and maintenance cost to industry of $210,000 ($300 x 700 
recordkeepers). The total cost of this recordkeeping (i.e., capital 
cost plus operational and maintenance cost) is estimated to be 
$420,000.

    Dated: August 28, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-14671 Filed 9-5-06; 8:45 am]
BILLING CODE 4160-01-S