[Federal Register: September 6, 2006 (Volume 71, Number 172)]
[Notices]
[Page 52547-52548]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06se06-73]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total Operating
No. of Recordkepers Annual Frequency Total annual Hours per Total Hours Total Capital and Maintenance
per Recordkeeper Records Record Cost Cost
--------------------------------------------------------------------------------------------------------------------------------------------------------
700 1 700 4 2,800 $210,000 $210,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[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