Federal Register / Vol. 71, No. 173 / Thursday, September 7, 2006 / Notices 52799 

and reconstruction efforts being 

performed for purposes of the 

compensation program, and advice on 

petitions to add classes of workers to the 

Special Exposure Cohort (SEC). 

In December 2000, the President 

delegated responsibility for funding, 

staffing, and operating the Advisory 

Board to HHS, which subsequently 

delegated this authority to the CDC. 

NIOSH implements this responsibility 

for CDC. The charter was issued on 

August 3, 2001, renewed at appropriate 

intervals, and will expire on August 3, 

2007. 

Purpose: This Advisory Board is 

charged with (a) providing advice to the 

Secretary, HHS, on the development of 

guidelines under Executive Order 

13179; (b) providing advice to the 

Secretary, HHS, on the scientific 

validity and quality of dose 

reconstruction efforts performed for this 

program; and (c) upon request by the 

Secretary, HHS, advise the Secretary on 

whether there is a class of employees at 

any Department of Energy facility who 

were exposed to radiation but for whom 

it is not feasible to estimate their 

radiation dose, and on whether there is 

reasonable likelihood that such 

radiation doses may have endangered 

the health of members of this class. 

Matters to be Discussed: The agenda 

for the Subcommittee meeting includes 

Individual Dose Reconstruction Reviews 

and Procedures Reviews; Subcommittee 

Operations and Future Plans. The 

agenda for the Advisory Board meeting 

includes Presentation of SEC Petitions 

for Oak Ridge Institute of Nuclear 

Studies (ORINS), Chapman Valve, S–50 

Thermal, and Los Alamos National 

Laboratory (LANL) (Radioactive 

Lanthanum Exposure); Updates on SEC 

Petitions for Nevada Test Site (NTS), 

Pacific Proving Ground (PPG), Ames 

Laboratory, and Rocky Flats Plant; 

Working Group Reports on the 

Savannah River Site (SRS) Profile, NTS 

Site Profile, and SEC Petitions; 

Individual Dose Reconstruction 

Reviews; Procedures Review; NIOSH 

Conflict of Interest Policy; Board 

Conflict of Interest Policy; Status and 

Future Funding of Sanford Cohen & 

Associates (SC&A) Contract; Science 

Issues Updates; Charter for New 

Subcommittee; Working Group and 

Subcommittee Assignments; NIOSH, 

Office of Compensation Analysis and 

Support (OCAS) and Department of 

Labor (DOL) Status Reports; Board 

Correspondence; Board Future Plans, 

and Board Working Time. The agenda is 

subject to change as priorities dictate. 

In the event an individual cannot 

attend, written comments may be 

submitted. Any written comments 

should be submitted to the contact 

person below well in advance of the 

meeting, and the comments will be 

provided at the meeting. 

For Further Information Contact: Dr. 

Lewis V. Wade, Executive Secretary, 

NIOSH, CDC, 4676 Columbia Parkway, 

Cincinnati, Ohio 45226, Telephone 

513.533.6825, Fax 513.533.6826. 

The Director, Management Analysis 

and Services Office, has been delegated 

the authority to sign Federal Register 

notices pertaining to announcements of 

meetings and other committee 

management activities, for both CDC 

and the Agency for Toxic Substances 

and Disease Registry. 

Dated: August 31, 2006. 

Alvin Hall, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. E6–14787 Filed 9–6–06; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2006D–0336] 

Draft Guidance for Industry and Food 

and Drug Administration Staff; 

Commercially Distributed Analyte 

Specific Reagents (ASRs): Frequently 

Asked Questions; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the draft guidance 

entitled ‘‘Commercially Distributed 

Analyte Specific Reagents (ASRs): 

Frequently Asked Questions.’’ This 

guidance document is intended to 

clarify the regulations regarding ASRs 

and the role and responsibilities of ASR 

manufacturers. 

DATES: Submit written or electronic 

comments on this draft guidance by 

December 6, 2006. 

ADDRESSES: Submit written requests for 

single copies of the guidance document 

entitled ‘‘Commercially Distributed 

Analyte Specific Reagents (ASRs): 

Frequently Asked Questions’’ 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 selfaddressed adhesive label to assist that 

office in processing your request, or fax 

your request to 301–443–8818. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. 

Submit written comments concerning 

this draft 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.fda.gov/dockets/ecomments. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Courtney C. Harper, Center for Devices 

and Radiological Health (HFZ–440), 

Food and Drug Administration, 2098 

Gaither Rd., Rockville, MD 20850, 240–

276–0490. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is providing this guidance in 

order to eliminate confusion regarding 

particular marketing practices among 

ASR manufacturers. ASRs are the 

building blocks of laboratory-developed 

tests and are defined and classified in a 

rule codified at § 864.4020 (21 CFR 

864.4020). With this draft guidance 

document, FDA seeks to advise ASR 

manufacturers that it views certain 

practices as being inconsistent with the 

marketing of an ASR, as defined in 

§ 864.4020. Some manufacturers have 

believed that when they combine a 

Class I ASR, which is exempt from 

premarket notification requirements 

under section 510(l) of the Federal 

Food, Drug, and Cosmetic Act (the act), 

(21 U.S.C. 360(l)), with other products, 

or with instructions for use in a specific 

test, the product remains exempt 

because of the presence of an ASR. 

However, as explained in this draft 

guidance, when an ASR is marketed in 

certain ways, FDA views the product as 

no longer being an ASR within the 

meaning of § 860.4020. 

II. Significance of Guidance 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized will 

represent the agency’s current thinking 

on commercially distributed ASRs. 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 draft guidance may do so by using 


rwilkins on PROD1PC63 with NOTICES
52800 Federal Register / Vol. 71, No. 173 / Thursday, September 7, 2006 / Notices 

the Internet. To receive ‘‘Commercially 

Distributed Analyte Specific Reagents 

(ASRs): Frequently Asked Questions, ‘‘

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 1590 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 

on the Division of Dockets Management 

Internet site at http://www.fda.gov/ 

ohrms/dockets. 

IV. 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 807.87 have 

been approved under OMB control 

number 0910–0120; the collections of 

information in 21 CFR 809.10 and 

809.30 (§ 809.30) have been approved 

under OMB control number 0910–0485; 

and the collections of information in 21 

CFR 814.20 have been approved under 

OMB control number 0910–0231. 

The draft guidance includes 

discussion of the restrictions on the 

sale, distribution, and use of ASRs 

(§ 809.30). Under this regulation, a 

laboratory that develops an in-house test 

using an ASR must add a disclaimer 

when reporting the test result to the 

practitioner (§ 809.30(e)). Advertising 

and promotional materials for ASRs 

must not make any statement regarding 

analytical or clinical performance 

(§ 809.30(d)(4)). In addition, the labeling 

for Class I, exempt ASRs must bear the 

statement, ‘‘Analyte Specific Reagent. 

Analytical and performance 

characteristics are not established.’’

Class II or III ASRs must bear the 

statement, ‘‘Analyte Specific Reagent. 

Except as a component of the approved/ 

cleared test (name of approved/cleared 

test), analytical and performance 

characteristics are not established’’

(§ 809.30(d)(2) and (d)(3)). The 

disclaimer and these statements do not 

constitute ‘‘collections of information’’

under the PRA. Rather, they are ‘‘public 

disclosure of information originally 

supplied by the Federal government to 

the recipient for the purpose of 

disclosure to the public’’ (5 CFR 

1320.3(c)(2)). 

V. Comments 

Interested persons may submit to the 

Division of Dockets Managment (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. Recieved 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

Dated: September 1, 2006. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 06–7500 Filed 9–5–06; 4:00 pm] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2006D–0347] 

Draft Guidance for Industry, Clinical 

Laboratories, and FDA Staff on In Vitro 

Diagnostic Multivariate Index Assays; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the draft guidance 

entitled ‘‘Draft Guidance for Industry, 

Clinical Laboratories, and FDA Staff on 

In Vitro Diagnostic Multivariate Index 

Assays.’’ This draft guidance addresses 

the definition and regulatory status of a 

class of in vitro diagnostic devices 

referred to as In Vitro Diagnostic 

Multivariate Index Assays (IVDMIAs). 

The guidance also addresses premarket 

and postmarket requirements with 

respect to IVDMIAs. An IVDMIA 

employs data, derived in part from one 

or more in vitro assays, and an 

algorithm that usually, but not 

necessarily, runs on software, to 

generate a result that diagnoses a 

disease or condition or is used in the 

cure, mitigation, treatment, or 

prevention of disease. 

DATES: Submit written or electronic 

comments on this draft guidance by 

December 6, 2006. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance 

document entitled ‘‘Draft Guidance for 

Industry, Clinical Laboratories, and FDA 

Staff on In Vitro Diagnostic Multivariate 

Index Assays’’ 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 that 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 draft 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.fda.gov/dockets/ecomments. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Courtney Harper, Center for Devices and 

Radiological Health (HFZ- 440), Food 

and Drug Administration, 2098 Gaither 

Rd., Rockville, MD 20850, 240–276–

0490, ext. 162. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The definition of a device is set forth 

at section 201(h) of the Federal Food, 

Drug and Cosmetic Act (the act) (21 

U.S.C. 321(h)). It provides in relevant 

part: ‘‘The term ‘device’ * * * means an 

instrument, apparatus, implement, 

machine, contrivance, implant, in vitro 

reagent, or other similar or related 

article, including any component, part, 

or accessory, which is * * * (2) intended 

for use in the diagnosis of disease or 

other conditions, or in the cure, 

mitigation, treatment, or prevention of 

disease, in man or other animals * * *’’

(21 U.S.C. 321(h)). An IVDMIA is a test 

system that employs data, derived in 

part from one or more in vitro assays, 

and an algorithm that usually, but not 

necessarily, runs on software, to 

generate a result that diagnoses a 

disease or condition or is used in the 

cure, mitigation, treatment, or 

prevention of disease. An IVDMIA is 


rwilkins on PROD1PC63 with NOTICES