25752 Federal Register / Vol. 73, No. 89 / Wednesday, May 7, 2008 / Notices 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued 

Section of 

the 2007 

Amendments 

FDA Form No. No. 

of Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours 

per Response Total Hours 

Total Hours 30,796 

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

2One time burden. 

3Annual increase in burden. 

The estimates in table 1 of this 

document are based on FDA’s 

experience, data from the device 

registration and listing database, and 

our estimates of the time needed to 

complete the previously required forms. 

We estimate that the time needed to 

enter registration and listing 

information electronically using FDA 

Form 3673 will not differ significantly 

from the time needed to fill in the paper 

forms (FDA Forms 2891, 2891a, and 

2892) that previously were used for this 

purpose because the information 

required is essentially identical. 

In addition, under section 224 of 

FDAAA, device establishments owner/ 

operators for whom registering and 

listing by electronic means is not 

reasonable may request a waiver from 

the Secretary. Because a device 

establishment’s owner/operator required 

to register and list would only need to 

have access to a computer, Internet, and 

an e-mail address for registration and 

list by electronic means, the agency did 

not anticipate the receipt of a large 

number of requests for waiver. For the 

first few months of operation of the 

web-based system, i.e., October through 

December 2007, FDA received fewer 

than 10 requests for waivers from the 

requirement to submit registration and 

listing information electronically. As 

data for more than 16,000 

establishments have been received 

electronically for the same period, these 

requests amount to less than 1 percent 

of the total number of establishments 

that have responded. 

Based on information taken from our 

databases, FDA estimates that there are 

29,370 owner/operators who 

collectively register a total of 33,490 

device establishments. The number of 

respondents listed for section 224 of 

FDAAA in the burden table is 29,370, 

which corresponds to the number of 

owner/operators who annually register 

one or more establishments. In addition, 

FDA estimates that 4,988 owner/ 

operators are initial importers who must 

register their establishments but who, 

under FDA’s existing regulations, are 

not required to list their devices unless 

they initiate or develop the 

specifications for the devices or 

repackage or relabel the devices. The 

number of respondents included in the 

burden table for section 223 of FDAAA 

is 24,382, which corresponds to the 

number of owner/operators who list one 

or more devices annually (29,370 - 4,988 

= 24,382). 

To calculate the burden estimate for 

waiver requests under section 224 of 

FDAAA, we assume as stated previously 

that less than one tenth of one percent 

of the 33,490 total device establishments 

would request waivers from FDA. This 

means the total number of waiver 

requests would probably not exceed 20 

requests (33,490 x 0.0006). We also 

estimate that the one-time burden on 

these establishments would be an hour 

of time for a mid-level manager to draft, 

approve, and mail a letter. In addition, 

FDA estimates the total number of 

establishments will increase by 2,600 

new establishments each year. Of the 

2,600 new registrants each year, we 

assume that less than one percent (i.e., 

1) of these will also request waivers 

each year. The total, therefore, is 21 

waiver requests, which could increase 

by only 1 additional request each year. 

Dated: May 1, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–10194 Filed 5–6–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–D–0228] (formerly 

Docket No. 00D–1401) 

Guidance for Industry and Food and 

Drug Administration Staff; 

Administrative Procedures for CLIA 

Categorization; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the guidance entitled 

‘‘Administrative Procedures for CLIA 

Categorization.’’ The guidance describes 

FDA’s current practices concerning the 

administrative aspects of categorizing 

commercially available in vitro 

diagnostic tests under the Clinical 

Laboratory Improvement Amendments 

of 1988 (CLIA). The guidance discusses 

what manufacturers should submit to 

help expedite CLIA categorization by 

FDA. 

DATES: Submit written or electronic 

comments on this guidance at any time. 

General comments on agency guidance 

documents are welcome at any time. 

ADDRESSES: Submit written requests for 

single copies of the guidance document 

entitled ‘‘Administrative Procedures for 

CLIA Categorization’’ to the Division of 

Small Manufacturers, International, and 

Consumer Assistance (HFZ–220), Center 

for Devices and Radiological Health, 

Food and Drug Administration, 1350 

Piccard Dr., Rockville, MD 20850. Send 

one self-addressed adhesive label to 

assist the office in processing your 

request, or fax your request to 240–276–

3151. See the SUPPLEMENTARY

INFORMATION section for information on 

electronic access to the guidance. 

Submit written comments concerning 

this guidance to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.regulations.gov. Identify 

comments with the docket number 

found in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Carol Benson, Center for Devices and 

Radiological Health (HFZ–440), Food 

and Drug Administration, 2098 Gaither 

Rd., Rockville, MD 20850, 240–276–

0491, ext. 117. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On February 28, 1992, the Department 

of Health and Human Services 

published the final laboratory standards 

regulations (57 FR 7002) implementing 

CLIA (42 U.S.C. 263a). The 

implementing regulations are codified at 

42 CFR part 493. CLIA regulates 

laboratory testing and requires that 

clinical laboratories obtain a certificate 


sroberts on PROD1PC70 with NOTICES
Federal Register / Vol. 73, No. 89 / Wednesday, May 7, 2008 / Notices 25753 

before accepting materials derived from 

the human body for the purpose of 

providing information for the diagnosis, 

prevention, or treatment of any disease 

or the impairment of, or assessment of 

the health of human beings. The type of 

CLIA certificate a laboratory obtains 

depends upon the complexity of the 

tests it performs. CLIA regulations 

describe three levels of test complexity: 

Waived tests, moderate complexity 

tests, and high complexity tests. 

On January 31, 2000, the 

responsibility for categorization of 

commercially marketed in vitro 

diagnostic (IVD) tests was transferred 

from the Centers for Disease Control and 

Prevention to FDA (64 FR 73561, 

December 30, 1999). This allows IVD 

test manufacturers to submit premarket 

(510(k)) notifications or applications 

and requests for complexity 

categorization under CLIA to one 

agency. This notice announces the 

availability of a guidance document that 

describes the general administrative 

procedures FDA uses to assign a 

device’s complexity category under 

CLIA. 

The draft of this guidance was issued 

August 14, 2000, and the comment 

period closed on November 13, 2000. 

FDA did not receive any comments 

concerning the ‘‘Draft Guidance on 

Administrative Procedures for CLIA 

Categorization.’’ In preparing the final 

guidance, however, FDA needed to 

obtain an approval for a new collection 

of information from the Office of 

Management and Budget (OMB). We 

obtained this approval (see section IV. 

Paperwork Reduction Act of 1995) and 

are now issuing the final guidance. 

Updates added to the guidance include 

a revised background section and 

procedures for CLIA categorization for 

510(k) submissions submitted 

electronically. The guidance also notes 

that manufacturers who wish to request 

CLIA waiver for a device (other than 

those devices already waived under 42 

CFR 493.15), should refer to the 

guidance entitled ‘‘Guidance for 

Industry and FDA Staff: 

Recommendations for Clinical 

Laboratory Improvement Amendments 

of 1988 (CLIA) Waiver Applications for 

Manufacturers of In Vitro Diagnostic 

Devices,’’ issued in January 2008. 

II. Significance of Guidance 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the agency’s 

current thinking on administrative 

procedures for CLIA categorization. It 

does not create or confer any rights for 

or on any person and does not operate 

to bind FDA or the public. An 

alternative approach may be used if 

such approach satisfies the 

requirements of the applicable statute 

and regulations. 

III. Electronic Access 

Persons interested in obtaining a copy 

of the guidance may do so by using the 

Internet. To receive ‘‘Administrative 

Procedures for CLIA Categorization,’’

you may either send an e-mail request 

to dsmica@fda.hhs.gov to receive an 

electronic copy of the document or send 

a fax request to 240–276–3151 to receive 

a hard copy. Please use the document 

number 1143 to identify the guidance 

you are requesting. 

CDRH maintains an entry on the 

Internet for easy access to information 

including text, graphics, and files that 

may be downloaded to a personal 

computer with Internet access. Updated 

on a regular basis, the CDRH home page 

includes device safety alerts, Federal 

Register reprints, information on 

premarket submissions (including lists 

of approved applications and 

manufacturers’ addresses), small 

manufacturer’s assistance, information 

on video conferencing and electronic 

submissions, Mammography Matters, 

and other device-oriented information. 

The CDRH web site may be accessed at 

http://www.fda.gov/cdrh. A search 

capability for all CDRH guidance 

documents is available at http:// 

www.fda.gov/cdrh/guidance.html. 

Guidance documents are also available 

at http://www.regulations.gov. 

IV. Paperwork Reduction Act of 1995 

This guidance contains information 

collection provisions that are subject to 

review by OMB under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501–

3520). The collections of information in 

this guidance were approved under 

OMB control number 0910–0607. 

V. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

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. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

Please note that on January 15, 2008, 

the FDA Division of Dockets 

Management Web site transitioned to 

the Federal Dockets Management 

System (FDMS). FDMS is a 

Government-wide, electronic docket 

management system. Electronic 

comments or submissions will be 

accepted by FDA only through FDMS at 

http://www.regulations.gov. 

Dated: April 30, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–10178 Filed 5–6–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Office of the Director, National 

Institutes of Health; Office of 

Biotechnology Activities; Recombinant 

DNA Research; Notice of a Meeting of 

an NIH Blue Ribbon Panel 

There will be a meeting of the NIH 

Blue Ribbon Panel to advise on the Risk 

Assessment of the National Emerging 

Infectious Diseases Laboratories (NEIDL) 

at Boston University Medical Center. 

The meeting will be held on Friday, 

May 16, 2008, at The Commonwealth of 

Massachusetts Bureau of State Office 

Buildings, State House, Gardner 

Auditorium, 24 Beacon Street, Boston, 

Massachusetts 02133, from 

approximately 9 a.m. to 12 p.m. 

Discussions will include the charge to 

the Panel and the process and 

framework for deliberations. There will 

also be time allotted on the agenda for 

public comment. Sign up for public 

comment will begin at approximately 8 

a.m. on May 16, 2008. In the event that 

time does not allow for all those 

interested to present oral comments, 

anyone may file written comments 

using the address below. 

To file written comments or for 

further information concerning this 

meeting contact Ms. Laurie Lewallen, 

Advisory Committee Coordinator, Office 

of Biotechnology Activities, Office of 

the Director, National Institutes of 

Health, Mail Stop Code 7985, Bethesda, 

MD 20892–7985, 301–496–9838, 

lewallla@od.nih.gov 

The meeting will be open to the 

public, with attendance limited to space 

available. Individuals who plan to 

attend and need special assistance, such 

as sign language interpretation or other 

reasonable accommodations, should 

notify the Contact Person listed above in 

advance of the meeting. Any interested 

person may file written comments with 

the panel by forwarding the statement to 

the Contact Person listed on this notice. 

The statement should include the name, 


sroberts on PROD1PC70 with NOTICES