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 


cprice-sewell on DSKGBLS3C1PROD with NOTICES
Federal Register / Vol. 74, No. 201 / Tuesday, October 20, 2009 / Notices 53751 

guidance document describes 

recommendations for device 

manufacturers submitting to FDA an 

application for determination that a 

cleared or approved device meets this 

CLIA standard (CLIA waiver 

application). 

The guidance recommends that CLIA 

waiver applications include a 

description of the features of the device 

that make it ‘‘simple’’; a report 

describing a hazard analysis that 

identifies potential sources of error, 

including a summary of the design and 

results of flex studies and conclusions 

drawn from the flex studies; a 

description of fail-safe and failure alert 

mechanisms and a description of the 

studies validating these mechanisms; a 

description of clinical tests that 

demonstrate the accuracy of the test in 

the hands of intended operators; and 

statistical analyses of clinical study 

results. Only new information 

collections not already approved are 

included in the estimate in the 

following table. Quick reference 

instructions are a short version of the 

instructions that are written in simple 

language and that can be posted. 

FDA estimates the burden of this 

collection as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of 

Respondents 

Annual Frequency 

of Response 

Total Annual 

Responses 

Hours per 

Response Total Hours Operating and Maintenance Costs 

493.15(a) and (b) 40 1 40 780 31,200 $50,200 

1There are no capital costs associated with this collection of information. 

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of 

Recordkeepers 

Annual Frequency 

per Recordkeeping 

Total Annual 

Records 

Hours per 

Record Total Hours Operating and Maintenance Costs 

493.15(a) and (b) 40 1 40 2,800 112,000 $16,000 

1There are no capital costs associated with this collection of information. 

The total number of reporting and 

recordkeeping hours is 143,200 hours. 

FDA bases the burden on an agency 

analysis of premarket submissions with 

clinical trials similar to the waived 

laboratory tests. Based on previous 

years’ experience with CLIA waiver 

applications, FDA expects 40 

manufacturers to submit one CLIA 

waiver application per year. The time 

required to prepare and submit a waiver 

application, including the time needed 

to assemble supporting data, averages 

780 hours per waiver application for a 

total of 31,200 hours for reporting. 

Based on previous years experience 

with CLIA waiver applications, FDA 

expects that each manufacturer will 

spend 2,800 hours creating and 

maintaining the record for a total of 

112,000 hours. 

The total operating and maintenance 

cost associated with the waiver 

application is estimated at $66,200. The 

cost consists of specimen collection for 

the clinical study (estimated $23,500); 

laboratory supplies, reference testing 

and study oversight (estimated $26,700); 

shipping and office supplies (estimated 

$6,000); and educational materials, 

including quick reference instructions 

(estimated $10,000). 

This guidance also refers to 

previously approved collections of 

information found in FDA regulations. 

The collections of information in 21 

CFR part 801 and § 809.10 have been 

approved under OMB control number 

0910–0485 and the collections of 

information in 21 CFR part 803 have 

been approved under OMB control 

number 0910–0437. 

Dated: October 9, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–25177 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–D–0490] 

Draft Guidance for Industry and Food 

and Drug Administration Staff: 

Investigational New Drug Applications 

for Minimally Manipulated, Unrelated 

Allogeneic Placental/Umbilical Cord 

Blood Intended for Hematopoietic 

Reconstitution for Specified 

Indications; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft document entitled 

‘‘Guidance for Industry and FDA Staff: 

Investigational New Drug Applications 

(INDs) for Minimally Manipulated, 

Unrelated Allogeneic Placental/ 

Umbilical Cord Blood Intended for 

Hematopoietic Reconstitution for 

Specified Indications,’’ dated October 

2009. In this draft guidance, we refer to 

these products for hematopoietic 

reconstitution for specified indications 

as hematopoietic progenitor cells, cord 

(HPC–C). This draft guidance provides 

advice to potential sponsors (e.g., 

generally cord blood banks, or registries, 

and individual physicians serving as 

sponsor-investigators) to assist in the 

submission of an IND for certain HPC– 

Cs, when such HPC–Cs are not licensed 

in accordance with certain FDA 

regulations, and when a suitable human 

leukocyte antigen (HLA) matched cord 

blood transplant is needed for treatment 

of a patient with a serious or lifethreatening disease or condition and 

there is no satisfactory alternative 

treatment. This draft guidance 

document is applicable only to HPC–Cs 

intended for hematopoietic 

reconstitution in patients with the 

clinical indications listed in the 

guidance entitled ‘‘Guidance for 

Industry: Minimally Manipulated, 

Unrelated Allogeneic Placental/ 

Umbilical Cord Blood Intended for 

Hematopoietic Reconstitution for 

Specified Indications’’ (HPC–C 

licensure guidance), published 

elsewhere in this issue of the Federal 

Register. FDA is also announcing that it 

no longer intends to exercise 

enforcement discretion with respect to 

the IND and biologics license 

application (BLA) requirements for 

minimally manipulated, unrelated 

allogeneic hematopoietic stem/ 

progenitor cell products and the phasein implementation period for IND and 

license application requirements will 

end as of October 20, 2011. 


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