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, 53749-53750 [E9-25178]

Download as PDF Federal Register / Vol. 74, No. 201 / Tuesday, October 20, 2009 / Notices 53749 TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN1—Continued No. of Recordkeepers Activity Annual Frequency per Recordkeeping Total Annual Records2 Total ..................................................................................... Hours per Records Total Hours 450 1 There are no capital costs or operating and maintenance costs associated with this collection of information. 2 For purposes of estimating number of records and hours per record, a ‘‘record’’ means all records kept for an individual reportable food by the responsible party or a voluntary reporter. Dated: October 13, 2009. David Horowitz, Assistant Commissioner for Policy. [FR Doc. E9–25100 Filed 10–19–09; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES [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 Food and Drug Administration, HHS. cprice-sewell on DSKGBLS3C1PROD with NOTICES ACTION: Notice. 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 https:// 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 VerDate Nov<24>2008 14:46 Oct 19, 2009 Jkt 220001 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. 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. SUPPLEMENTARY INFORMATION: Food and Drug Administration AGENCY: docket number found in brackets in the heading of this document. PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 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 FDAregulated 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 § 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 E:\FR\FM\20OCN1.SGM 20OCN1 53750 Federal Register / Vol. 74, No. 201 / Tuesday, October 20, 2009 / Notices 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 FD&C Act Section: No. of Recordkeepers 520(g) Annual Frequency per Recordkeeping 700 1 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–N–0489] Agency Information Collection Activities; Proposed Collection; Comment Request; Recommendations for Clinical Laboratory Improvement Amendments of 1988 Waiver Applications AGENCY: Food and Drug Administration, cprice-sewell on DSKGBLS3C1PROD with NOTICES HHS. ACTION: Notice. 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 VerDate Nov<24>2008 14:46 Oct 19, 2009 Jkt 220001 Total Annual Records Hours per Record 700 Total Hours 4 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 collections of information associated with the guidance issued January 30, 2008, and titled ‘‘Recommendations: Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices’’. 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 https:// 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 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 2,800 Total Capital Costs $210,000 Total Operating and Maintenance Costs $420,000 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. Recommendations for Clinical Laboratory Improvement Amendments of 1988 Waiver Applications—21 CFR Section 493 (OMB Control Number 0910–0598)—Extension Congress passed the Clinical Laboratory Improvements Amendment (CLIA) (Public Law 100–578) in 1988 to establish quality standards for all laboratory testing. The purpose was to ensure the accuracy, reliability, and timeliness of patient test results regardless of where the test took place. CLIA requires that clinical laboratories obtain a certificate from the Secretary of Health and Human Services (the Secretary), before accepting materials derived from the human body for laboratory tests (42 U.S.C. 263a(b)). Laboratories that perform only tests that are ‘‘simple’’ and that have an ‘‘insignificant risk of an erroneous result’’ may obtain a certificate of waiver (42 U.S.C. 263a(c)(2)). The Secretary has delegated to FDA the authority to determine whether particular tests (waived tests) are ‘‘simple’’ and have ‘‘an insignificant risk of an erroneous result’’ under CLIA (69 FR 22849, April 27, 2004). This E:\FR\FM\20OCN1.SGM 20OCN1

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[Federal Register Volume 74, Number 201 (Tuesday, October 20, 2009)]
[Notices]
[Pages 53749-53750]
From the Federal Register Online via the Government Printing 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.

-----------------------------------------------------------------------

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 https://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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
520(g) 700 1 700 4 2,800 $210,000 $420,000
--------------------------------------------------------------------------------------------------------------------------------------------------------

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

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