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concerning the ‘‘Draft Guidance on 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
25754 Federal Register / Vol. 73, No. 89 / Wednesday, May 7, 2008 / Notices 

address, telephone number and when 

applicable, the business or professional 

affiliation of the interested person. 

An agenda and any additional 

information for the meeting will be 

posted on the agency’s Web site: 

http://www.nih.gov/about/director/acd/ 

index.htm. 

Background information may be 

obtained by contacting NIH OBA by email oba@od.nih.gov 

Dated: April 29, 2008. 

Amy P. Patterson, 

Director, Office of Biotechnology Activities. 

[FR Doc. E8–10011 Filed 5–6–08; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; Notice of 

Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of the following 

meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Cancer 

Institute Initial Review Group; Subcommittee 

F—Manpower & Training; NCI–F Manpower 

and Training Grants. 

Date: May 19, 2008. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hilton Old Town Alexandria, 1767 

King Street, Alexandria, VA 22314. 

Contact Person: Lynn M. Amende, PhD, 

Scientific Review Administrator, Resources 

and Training Review Branch, Division of 

Extramural Activities, National Cancer 

Institute, 6116 Executive Blvd., Room 8105, 

Bethesda, MD 20892, 301–451–4759, 

amendel@mail.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.392, Cancer Construction; 

93.393, Cancer Cause and Prevention 

Research; 93.394, Cancer Detection and 

Diagnosis Research; 93.395, Cancer 

Treatment Research; 93.396, Cancer Biology 

Research; 93.397, Cancer Centers Support; 

93.398, Cancer Research Manpower; 93.399, 

Cancer Control, National Institutes of Health, 

HHS) 

Dated: April 30, 2008. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E8–10013 Filed 5–6–08; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; Notice of 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of the meeting of the 

National Cancer Advisory Board. 

The meeting will be open to the 

public as indicated below, 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 below 

in advance of the meeting. 

A portion of the meeting will be 

closed to the public in accordance with 

the provisions set forth in sections 

552b(c)(4), and 552b(c)(6), Title 5 

U.S.C., as amended. The grant 

applications and the discussions could 

disclose confidential trade secrets or 

commercial property such as patentable 

material, and personal information 

concerning individuals associated with 

the grant applications, the disclosure of 

which would constitute a clearly 

unwarranted invasion of personal 

privacy. 

Name of Committee: National Cancer 

Advisory Board. 

Open: June 17, 2008, 8:30 a.m. to 3:20 p.m. 

Agenda: Program reports and 

presentations; Business of the Board. 

Place: National Cancer Institute, 9000 

Rockville Pike, Building 31, C Wing, 6th 

Floor, Conference Room 10, Bethesda, MD 

20892. 

Contact Person: Dr. Paulette S. Gray, 

Executive Secretary, National Cancer 

Institute, National Institutes of Health, 6116 

Executive Boulevard, 8th Floor, Room 8001, 

Bethesda, MD 20892–8327, (301) 496–5147. 

Name of Committee: National Cancer 

Advisory Board. 

Closed: June 17, 2008, 3:20 p.m. to 5 p.m. 

Agenda: Review of grant applications. 

Contact Person: Dr. Paulette S. Gray, 

Executive Secretary, National Cancer 

Institute, National Institutes of Health, 6116 

Executive Boulevard, 8th Floor, Room 8001, 

Bethesda, MD 20892–8327, (301) 496–5147. 

Name of Committee: National Cancer 

Advisory Board. 

Open: June 18, 2008, 8:30 a.m. to 12 p.m. 

Agenda: Program reports and 

presentations; Business of the Board. 

Contact Person: Dr. Paulette S. Gray, 

Executive Secretary, National Cancer 

Institute, National Institutes of Health, 6116 

Executive Boulevard, 8th Floor, Room 8001, 

Bethesda, MD 20892–8327, (301) 496–5147. 

Any interested person may file written 

comments with the committee by forwarding 

the statement to the Contact Person listed on 

this notice. The statement should include the 

name, address, telephone number and when 

applicable, the business or professional 

affiliation of the interested person. 

In the interest of security, NIH has 

instituted stringent procedures for entrance 

onto the NIH campus. All visitor vehicles, 

including taxicabs, hotel, and airport shuttles 

will be inspected before being allowed on 

campus. Visitors will be asked to show one 

form of identification (for example, a 

government-issued photo ID, driver’s license, 

or passport) and to state the purpose of their 

visit. 

Information is also available on the 

Institute’s/Center’s home page http:// 

deainfo.nci.nih.gov/advisory/ncab.htm, 

where an agenda and any additional 

information for the meeting will be posted 

when available. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.392, Cancer Construction; 

93.393, Cancer Cause and Prevention 

Research; 93.394, Cancer Detection and 

Diagnosis Research; 93.395, Cancer 

Treatment Research; 93.396, Cancer Biology 

Research; 93.397, Cancer Centers Support; 

93.398, Cancer Research Manpower; 93.399, 

Cancer Control, National Institutes of Health, 

HHS) 

Dated: April 30, 2008. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E8–10014 Filed 5–6–08; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Toxicology Program (NTP); 

Office of Liaison, Policy and Review; 

Meeting of the Scientific Advisory 

Committee on Alternative 

Toxicological Methods (SACATM) 

AGENCY: National Institute of 

Environmental Health Sciences 

(NIEHS), National Institutes of Health 

(NIH). 

ACTION: *COM057*Meeting 

announcement and request for 

comment. 

SUMMARY: Pursuant to section 10(a) of 

the Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of a meeting of 

SACATM on June 18–19, 2008, at the 


sroberts on PROD1PC70 with NOTICES