Notice: 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 Individually Identifiable

Federal Register: January 19, 2010 (Volume 75, Number 11)      
                  Page 2868-2869

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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 
February 18, 2010.

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: 202-395-7285, or e-mailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0582. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT:  Daniel Gittleson, Office of 
Information Management (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-796-5156, 
Daniel.Gittleson@fda.hhs.gov.

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 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 
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 
(21 CFR parts 50 and 56) apply to all clinical investigations that are 
regulated by FDA (see 21 CFR 50.1; 21 CFR 56.101, 21 U.S.C. 
360j(g)(3)(A), and 21 U.S.C. 360j(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 one guidance document issued under the Good Guidances 
Practices regulation, 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.
    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

[[Page 2869]]

recordkeeping burden of 2,800 hours (700 x 4 = 2,800). FDA estimates 
that the cost of developing standard operating procedures for each 
recordkeeper is $300 (6 hours of work at $50/hour (h)). This results in 
a total cost to industry of $210,000 ($300 x 700 recordkeepers). FDA 
estimates that operating costs for collecting this information is $300 
per recordkeeper (6 hours of work at $50/h). This results in a total 
operational and maintenance cost to industry of $210,000 ($300 x 700 
recordkeepers). The total cost of this recordkeeping, capital plus 
operational and maintenance cost is estimated to be $420,000.
    In the Federal Register of October 20, 2009 (74 FR 53749), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                                   Table 1.--Estimated Annual Recordkeeping Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              No. of         Annual Frequency       Total Annual
                  Section of the Act                      Recordkeepers      per Recordkeeping        Records       Hours per  Record     Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
520(g)                                                                700                     1                700                  4              2,800
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Due to a clerical error, the capital
  costs and operating and maintenance costs that appeared in a notice issued in the Federal Register of October 20, 2009 (74 FR 53749 at 53750) were
  incorrect. The costs were actually salary costs; Table 1 of this document contains the correct cost burden.


    Dated: January 12, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-791 Filed 1-15-10; 8:45 am]
BILLING CODE 4160-01-S