Draft Guidance for Industry and Food and Drug Administration Staff; Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions; Availability, 52799-52800 [06-7500]

Download as PDF rwilkins on PROD1PC63 with NOTICES Federal Register / Vol. 71, No. 173 / Thursday, September 7, 2006 / Notices 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 VerDate Aug<31>2005 18:11 Sep 06, 2006 Jkt 208001 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 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 52799 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 https:// 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 E:\FR\FM\07SEN1.SGM 07SEN1 52800 Federal Register / Vol. 71, No. 173 / Thursday, September 7, 2006 / Notices rwilkins on PROD1PC63 with 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 https://www.fda.gov/cdrh. A search capability for all CDRH guidance documents is available at https:// www.fda.gov/cdrh/guidance.html. Guidance documents are also available on the Division of Dockets Management Internet site at https://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.’’ VerDate Aug<31>2005 18:11 Sep 06, 2006 Jkt 208001 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 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 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 https:// 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 E:\FR\FM\07SEN1.SGM 07SEN1

Agencies

[Federal Register Volume 71, Number 173 (Thursday, September 7, 2006)]
[Notices]
[Pages 52799-52800]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-7500]


-----------------------------------------------------------------------

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 self-addressed 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 https://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 Sec.  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 Sec.  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 Sec.  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

[[Page 52800]]

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 https://www.fda.gov/
cdrh. A search capability for all CDRH guidance documents is available 
at https://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 (Sec.  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 (Sec.  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 (Sec.  809.30(e)). Advertising and promotional materials 
for ASRs must not make any statement regarding analytical or clinical 
performance (Sec.  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'' (Sec.  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

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