Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance Characteristics of Nucleic Acid-Based In Vitro Diagnostic Devices for the Detection and Differentiation of Methicillin-Resistant Staphylococcus aureus and Staphylococcus aureus; Availability, 569-570 [2010-33292]

Download as PDF Federal Register / Vol. 76, No. 3 / Wednesday, January 5, 2011 / Notices records are processed and stored in a secure environment. All records are stored in an area that is physically safe from access by unauthorized persons at all times. Safeguards conform to the HHS Information Security Program, https:// www.hhs.gov/ocio/securityprivacy/ index.html. jlentini on DSKJ8SOYB1PROD with NOTICES RETENTION AND DISPOSAL: (1) Records provided from State child support agencies. (a) Electronic records furnished by the State child support agency containing child support case and order information (input files) are retained for 60 days and then deleted. (b) State agency records (as posted to the FCR) remain within the FCR until removed, upon notification by the State agency that the case is closed and notifies OCSE to remove it from the FCR, provided that, upon request, a sample may be retained for research purposes found by OCSE to be likely to contribute to achieving the purposes of child support programs or the TANF program, but without personal identifiers. (c) Records pertaining to closed cases are archived on the fiscal year basis and retained for two years. Family violence indicators are removed from the individual’s record, upon request by the State that initiated the indicator. (2) Locate requests and match results. (a) Locate requests submitted by State child support agencies and other authorized persons are retained for 60 days and are then deleted. (b) Audit trail records of locate requests and disclosures of match results pursuant to those requests, which include indications of which Federal agencies were contacted for locate information, whether information was located, and the type(s) of information returned to the requesting entity are archived once a year based on the fiscal year. The records are retained for two completed fiscal years and then destroyed. These records indicate the type of information located for the authorized user, not the information itself. (c) Records containing information from the NDNH or from other agencies obtained pursuant to locate requests are provided to authorized persons through the FCR. Copies of records provided are then retained within the FCR for the purpose of electronically filtering and suppressing redundant information from being provided. NDNH information is retained within the FCR for one year and information from other agencies is retained for up to three years. Thereafter such information is deleted. (3) Match results generated as a result of FCR to FCR comparisons which locate individuals who are VerDate Mar<15>2010 16:26 Jan 04, 2011 Jkt 223001 participants in child support cases or orders in more than one State are transmitted to the relevant States. Copies of FCR to FCR match results are retained for 60 days and then deleted. (4) Any record relating or potentially relating to a fraud or abuse investigation or a pending or ongoing legal action including a class action, is retained until conclusion of the investigation or legal action. (5) Copies of the FCR records transmitted annually to the IRS for the purpose of administering the earned income tax credit (routine use 12) are retained for one year and then deleted. SYSTEM MANAGER(S) AND ADDRESS: Director, Division of Federal Systems, Office of Automation and Program Operations, Office of Child Support Enforcement, Administration for Children and Families, Department of Health and Human Services, 370 L’Enfant Promenade, SW., 4th Floor East, Washington, DC 20447. NOTIFICATION PROCEDURES: Individuals seeking to determine whether this system of records contains information about themselves should address written inquiries to the System Manager. The request should include the name, telephone number and/or email address, SSN, and address of the individual, and the request must be signed by the individual to whom such information pertains. The requester’s letter must provide sufficient particulars to enable the System Manager to distinguish between records on subject individuals with the same name. Verification of identity as described in HHS’s Privacy Act regulations may be required. 45 CFR 5b.5. 569 request should (1) include the name, telephone number and/or email address, SSN, and address of the individual, and should be signed by the individual to whom such information pertains; (2) identify the system of records that the individual believes includes his or her records or otherwise provide enough information to enable the identification of the individual’s record; (3) identify the information that the individual believes is not accurate, relevant, timely, or complete; (4) indicate what corrective action is sought; and (5) include supporting justification or documentation for the requested amendment. Verification of identity as described in HHS’s Privacy Act regulations may be required. 45 CFR 5b.5. RECORD SOURCE CATEGORIES: Records maintained within the FCR are furnished by State child support agencies. Records disseminated from the FCR for the purpose of providing locate information from the NDNH and other Federal agencies are furnished by departments, agencies, or instrumentalities of the United States or any State, employers, financial institutions, and insurers or their agents. Records maintained for the purpose of filtering redundant data are also furnished by these sources. EXEMPTIONS CLAIMED FOR THE SYSTEM: The portions of this system consisting of investigatory material compiled for law enforcement purposes have been exempted pursuant to 5 U.S.C. 552a(k)(2) from the following provisions of the Privacy Act, subject to the limitations set forth in that subsection and to the limitation in 42 U.S.C. 653(b)(2): 5 U.S.C. 552a(c)(3) and (d). RECORD ACCESS PROCEDURES: [FR Doc. 2010–33295 Filed 1–4–11; 8:45 am] Individuals seeking access to a record about themselves in this system of records should address written inquiries to the System Manager. The request should include the name, telephone number and/or email address, SSN, and address of the individual, and should be signed by the individual to whom such information pertains. The requester’s letter must provide sufficient particulars to enable the System Manager to distinguish between records on subject individuals with the same name. Verification of identity as described in HHS’s Privacy Act regulations may be required. 45 CFR 5b.5. BILLING CODE 4184–42–P CONTESTING RECORD PROCEDURES: Individuals seeking to amend a record about themselves in this system of records should address the request for amendment to the System Manager. The PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–D–0634] Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance Characteristics of Nucleic Acid-Based In Vitro Diagnostic Devices for the Detection and Differentiation of Methicillin-Resistant Staphylococcus aureus and Staphylococcus aureus; Availability AGENCY: Food and Drug Administration, HHS. ACTION: E:\FR\FM\05JAN1.SGM Notice. 05JAN1 570 Federal Register / Vol. 76, No. 3 / Wednesday, January 5, 2011 / Notices The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ‘‘Establishing the Performance Characteristics of Nucleic Acid-Based In vitro Diagnostic Devices for the Detection and Differentiation of Methicillin-Resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA).’’ The draft guidance document provides industry and Agency staff with updated recommendations for studies to establish the analytical and clinical performance of nucleic acid-based in vitro diagnostic devices (IVDs) intended for the detection and differentiation of methicillin-resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA). This draft guidance is not final nor is it in effect at this time. 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 of this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by April 5, 2011. ADDRESSES: Submit written requests for single copies of the draft guidance document entitled ‘‘Establishing the Performance Characteristics of Nucleic Acid-Based In vitro Diagnostic Devices for the Detection and Differentiation of Methicillin-Resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA)’’ to the Division of Small Manufacturers, International, and Consumer Assistance, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 4613, Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 301–847– 8149. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit electronic comments on the draft guidance to https:// 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. Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Li Li, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5558, Silver Spring, MD 20993– 0002, 301–796–6200. SUPPLEMENTARY INFORMATION: jlentini on DSKJ8SOYB1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 16:26 Jan 04, 2011 Jkt 223001 I. Background FDA is issuing the draft guidance to provide industry and Agency staff with recommendations for studies to establish the analytical and clinical performance of nucleic acid-based IVDs intended for the detection and differentiation of MRSA and SA. These devices are used to aid in the prevention and control of MRSA/SA infections in healthcare settings. This document is limited to studies intended to establish the performance characteristics of devices that detect the MRSA/SA genome (nucleic acid). It does not address detection of MRSA/SA antigens or serological response from the host to the MRSA/SA antigens, nor does it address establishing performance of non-MRSA/SA components of multianalyte or multiplex devices. 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 establishing the performance characteristics of nucleic acid-based IVDs for the detection and differentiation of MRSA and SA. 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 the Internet. A search capability for all CDRH guidance documents is available at https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm. Guidance documents are also available at https://www.regulations.gov. To receive ‘‘Establishing the Performance Characteristics of Nucleic Acid-Based In vitro Diagnostic Devices for the Detection and Differentiation of Methicillin-Resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA),’’ you may either send an email request to dsmica@fda.hhs.gov to receive an electronic copy of the document or send a fax request to 301– 847–8149 to receive a hard copy. Please use the document number 1722 to identify the guidance you are requesting. IV. Paperwork Reduction Act of 1995 The draft guidance refers to previously approved collections of information found in FDA regulations and guidance documents. These PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 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 807, subpart E have been approved under OMB control number 0910–0120; the collections of information in 21 CFR part 812 have been approved under OMB control number 0910–0078; the collections of information in 21 CFR 50.23 have been approved under OMB control number 0910–0586; and the collections of information in 21 CFR 56.115 have been approved under OMB control number 0910–0130. V. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES), either electronic or written comments regarding this document. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Identify comments 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. Dated: December 30, 2010. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010–33292 Filed 1–4–11; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–D–0636] Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Antibodies to Borrelia Burgdorferi; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ‘‘Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Antibodies to Borrelia burgdorferi.’’ FDA is issuing this draft guidance to provide industry and agency staff with recommendations for studies to establish the analytical and clinical performance of in vitro SUMMARY: E:\FR\FM\05JAN1.SGM 05JAN1

Agencies

[Federal Register Volume 76, Number 3 (Wednesday, January 5, 2011)]
[Notices]
[Pages 569-570]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-33292]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0634]


Draft Guidance for Industry and Food and Drug Administration 
Staff; Establishing the Performance Characteristics of Nucleic Acid-
Based In Vitro Diagnostic Devices for the Detection and Differentiation 
of Methicillin-Resistant Staphylococcus aureus and Staphylococcus 
aureus; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

[[Page 570]]

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the draft guidance entitled ``Establishing the 
Performance Characteristics of Nucleic Acid-Based In vitro Diagnostic 
Devices for the Detection and Differentiation of Methicillin-Resistant 
Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA).'' The 
draft guidance document provides industry and Agency staff with updated 
recommendations for studies to establish the analytical and clinical 
performance of nucleic acid-based in vitro diagnostic devices (IVDs) 
intended for the detection and differentiation of methicillin-resistant 
Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA). This draft 
guidance is not final nor is it in effect at this time.

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 of this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by April 5, 2011.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Establishing the Performance 
Characteristics of Nucleic Acid-Based In vitro Diagnostic Devices for 
the Detection and Differentiation of Methicillin-Resistant 
Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA)'' to the 
Division of Small Manufacturers, International, and Consumer 
Assistance, Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 4613, Silver 
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist 
that office in processing your request, or fax your request to 301-847-
8149. See the SUPPLEMENTARY INFORMATION section for information on 
electronic access to the guidance.
    Submit electronic comments on the draft guidance to https://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. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Li Li, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5558, Silver Spring, MD 20993-0002, 301-796-6200.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is issuing the draft guidance to provide industry and Agency 
staff with recommendations for studies to establish the analytical and 
clinical performance of nucleic acid-based IVDs intended for the 
detection and differentiation of MRSA and SA. These devices are used to 
aid in the prevention and control of MRSA/SA infections in healthcare 
settings. This document is limited to studies intended to establish the 
performance characteristics of devices that detect the MRSA/SA genome 
(nucleic acid). It does not address detection of MRSA/SA antigens or 
serological response from the host to the MRSA/SA antigens, nor does it 
address establishing performance of non-MRSA/SA components of multi-
analyte or multiplex devices.

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 establishing 
the performance characteristics of nucleic acid-based IVDs for the 
detection and differentiation of MRSA and SA. 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 the Internet. A search capability for all CDRH guidance 
documents is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at https://www.regulations.gov. To receive 
``Establishing the Performance Characteristics of Nucleic Acid-Based In 
vitro Diagnostic Devices for the Detection and Differentiation of 
Methicillin-Resistant Staphylococcus aureus (MRSA) and Staphylococcus 
aureus (SA),'' you may either send an email request to 
dsmica@fda.hhs.gov to receive an electronic copy of the document or 
send a fax request to 301-847-8149 to receive a hard copy. Please use 
the document number 1722 to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    The draft guidance refers to previously approved collections of 
information found in FDA regulations and guidance documents. 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 
807, subpart E have been approved under OMB control number 0910-0120; 
the collections of information in 21 CFR part 812 have been approved 
under OMB control number 0910-0078; the collections of information in 
21 CFR 50.23 have been approved under OMB control number 0910-0586; and 
the collections of information in 21 CFR 56.115 have been approved 
under OMB control number 0910-0130.

V. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES), either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments 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.

    Dated: December 30, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-33292 Filed 1-4-11; 8:45 am]
BILLING CODE 4160-01-P
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