Federal Register / Vol. 74, No. 201 / Tuesday, October 20, 2009 / Notices 53749 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN1—Continued 

Activity 

No. of 

Recordkeepers 

Annual Frequency 

per Recordkeeping 

Total Annual 

Records2

Hours per 

Records Total Hours 

Total ..................................................................................... 450 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

2For 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 

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 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 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 


cprice-sewell on DSKGBLS3C1PROD with NOTICES
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 

Annual Frequency 

per Recordkeeping 

Total Annual 

Records 

Hours 

per Record 

Total 

Hours 

Total 

Capital Costs 

Total Operating and 

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 

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, 

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 

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 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. 

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 


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