[Federal Register Volume 74, Number 201 (Tuesday, October 20, 2009)]
[Notices]
[Pages 53749-53750]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-25178]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0487]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; 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 an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on guidance on informed consent 
for in vitro diagnostic device studies using leftover human specimens 
that are not individually identifiable.

DATES: Submit written or electronic comments on the collection of 
information by December 21, 2009.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of 
Information Management (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-796-3793.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these 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--
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

[[Page 53750]]

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.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Recordkeeping Burden
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                                           No. of        Annual Frequency    Total Annual   Hours  per     Total    Total  Capital   Total Operating and
         FD&C  Act Section:            Recordkeepers     per Recordkeeping      Records       Record       Hours        Costs         Maintenance Costs
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520(g)                                            700                     1           700             4     2,800         $210,000              $420,000
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    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 
2,400 hours (700 x 4 = 2,800). FDA estimates that the cost of 
developing standard operating procedures for each record keeper 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 record 
keeper (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.

    Dated: October 13, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-25178 Filed 10-19-09; 8:45 am]
BILLING CODE 4160-01-S