Federal Register / Vol. 76, No. 3 / Wednesday, January 5, 2011 / Notices 569 

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, http:// 

www.hhs.gov/ocio/securityprivacy/ 

index.html. 

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 

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. 

RECORD ACCESS PROCEDURES: 

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. 

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 

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). 

[FR Doc. 2010–33295 Filed 1–4–11; 8:45 am] 

BILLING CODE 4184–42–P 

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. 


jlentini on DSKJ8SOYB1PROD with NOTICES
570 Federal Register / Vol. 76, No. 3 / Wednesday, January 5, 2011 / Notices 

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 http:// 

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 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 http://www.fda.gov/MedicalDevices/ 

DeviceRegulationandGuidance/ 

GuidanceDocuments/default.htm. 

Guidance documents are also available 

at http://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 

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. 

SUMMARY: 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 


jlentini on DSKJ8SOYB1PROD with NOTICES