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] 

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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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53752 Federal Register / Vol. 74, No. 201 / Tuesday, October 20, 2009 / Notices 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

electronic or written comments on the 

draft guidance by January 19, 2010. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Office of Communication, Outreach and 

Development (HFM–40), Center for 

Biologics Evaluation and Research 

(CBER), Food and Drug Administration, 

1401 Rockville Pike, suite 200N, 

Rockville, MD 20852–1448. Send one 

self-addressed adhesive label to assist 

the office in processing your requests. 

The draft guidance may also be obtained 

by mail by calling CBER at 1–800–835– 

4709 or 301–827–1800. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the draft guidance 

document. 

Submit electronic comments on the 

draft guidance to http:// 

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Tami Belouin, Center for Biologics 

Evaluation and Research (HFM–17), 

Food and Drug Administration, 1401 

Rockville Pike, suite 200N, Rockville, 

MD 20852–1448, 301–827–6210. 

SUPPLEMENTARY INFORMATION: 

I. Background 

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. 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 21 CFR part 601, 

and when a suitable 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 as listed in the 

guidance entitled ‘‘Guidance for 

Industry: Minimally Manipulated, 

Unrelated Allogeneic Placental/ 

Umbilical Cord Blood Intended for 

Hematopoietic Reconstitution in 

Patients with 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 IND and BLA 

requirements for minimally 

manipulated unrelated allogeneic 

hematopoietic stem/progenitor cell 

products and the phase-in 

implementation period for IND and 

license application requirements for 

these products will end (see the 

SUMMARY for the ending date). We 

encourage sponsors to send in 

applications as soon as possible to allow 

sufficient time for review, comment, 

and resubmission as needed to complete 

all actions by the end of this 2-year 

period. 

In the Federal Register notice of 

January 20, 1998 (63 FR 2985), FDA 

requested submission of comments 

proposing establishment controls, 

process controls, and product standards 

designed to ensure the safety and 

effectiveness of minimally manipulated 

unrelated allogeneic hematopoietic 

stem/progenitor cell products derived 

from peripheral and cord blood for 

hematopoietic reconstitution. Also, in 

the January 20, 1998, notice, FDA 

announced its intention to phase in 

implementation of IND and license 

application requirements for minimally 

manipulated unrelated allogeneic 

hematopoietic stem/progenitor cell 

products to permit the development of 

licensing standards for those products 

where possible. 

In the Federal Register notice of 

January 17, 2007 (72 FR 1999), FDA 

announced the availability of the draft 

guidance entitled ‘‘Guidance for 

Industry: Minimally Manipulated, 

Unrelated, Allogeneic Placental/ 

Umbilical Cord Blood Intended for 

Hematopoietic Reconstitution in 

Patients with Hematological 

Malignancies,’’ dated December 2006. 

FDA received comments on the 

December 2006 draft guidance and those 

comments were considered as the 

guidance was finalized. The HPC–C 

licensure guidance finalizes the 

December 2006 draft guidance. Some of 

the comments received by FDA 

expressed the importance of access and 

availability of HPC–C products that do 

not meet the standards for licensure and 

therefore, cannot be licensed. FDA 

recognizes the importance of providing 

guidance for such products and is 

publishing this IND draft guidance for 

comment. The HPC–C licensure 

guidance document is effective on its 

date of publication. 

This draft guidance is consistent with 

FDA’s good guidance practices 

regulation (21 CFR 10.115). The draft 

guidance when finalized will represent 

FDA’s current thinking on these topics. 

It does not create or confer any rights for 

or on any person and does not operate 

to bind FDA or the public. Alternative 

approaches may be used if such 

approaches satisfy the requirements of 

the applicable statutes and regulations. 

II. Paperwork Reduction Act of 1995 

This draft guidance refers to 

previously approved collections of 

information found in FDA regulations. 

These collections of information are 

subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3520). The collections 

of information in 21 CFR part 312 have 

been approved under OMB Control No. 

0910–0014; 21 CFR part 1271 have been 

approved under OMB Control Nos. 

0910–0559, 0910–0469, and 0910–0543; 

and FDA Form 1571 has been approved 

under OMB Control No. 0910–0014. 

III. Comments 

The draft guidance is being 

distributed for comment purposes only 

and is not intended for implementation 

at this time. Interested persons may still, 

at any time, submit to the Division of 

Dockets Management (see ADDRESSES) 

electronic or written comments 

regarding the draft guidance. Submit a 

single copy of electronic comments or 

two paper copies of any mailed 

comments, except that individuals may 

submit one paper copy. Comments are 

to be identified with the docket number 

found in brackets in the heading of this 

document. A copy of the draft guidance 

and received comments are available for 

public examination in the Division of 

Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the draft guidance at either 

http://www.fda.gov/BiologicsBlood

Vaccines/GuidanceCompliance

RegulatoryInformation/Guidances/ 

default.htm. 

Dated: October 14, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–25136 Filed 10–19–09; 8:45 am] 

BILLING CODE 4160–01–S 


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