4438 Federal Register / Vol. 76, No. 16 / Tuesday, January 25, 2011 / Notices 

necessary to the litigation and would 

help in the effective representation of 

the governmental party, provided, 

however, that in each case, HHS 

determines that such disclosure is 

compatible with the purpose for which 

the records were collected. 

4. Disclosure may be made to a 

congressional office from the record of 

an individual in response to a verified 

inquiry from the congressional office 

made at the written request of that 

individual. 

5. To qualified experts not within the 

definition of Department employees as 

prescribed in Department regulations for 

opinions as a part of the application 

review process. 

6. To a Federal agency, in response to 

its request, in connection with the 

letting of a contract, or the issuance of 

a license, grant, cooperative agreement, 

or other benefit by the requesting 

agency, to the extent that the record is 

relevant and necessary to the requesting 

agency’s decision on the matter. 

7. To individuals and organizations 

deemed qualified by PHS to carry out 

specific research related to the review 

and award processes of PHS. 

8. To the grantee institution relative to 

performance or administration under 

the terms and conditions of the award. 

9. Records subject to the Privacy Act 

are disclosed to private firms for data 

entry, computer systems analysis and 

computer programming services. The 

contractors promptly return data entry 

records after the contracted work is 

completed. The contractors are required 

to maintain Privacy Act safeguards. 

10. To appropriate federal agencies 

and Department contractors that have a 

need to know the information for the 

purpose of assisting the Department’s 

efforts to respond to a suspected or 

confirmed breach of the security or 

confidentiality of information disclosed 

is relevant and necessary for that 

assistance. 

IV. Effects of the Proposed System of 

Records on Individual Rights 

The first routine use permits an 

individual may learn if a record exists 

about himself or herself is by contacting 

the system manager at the address 

above. Requesters in person must 

provide driver’s license or other positive 

identification. Individuals who do not 

appear in person must either: (1) Submit 

a notarized request to verify their 

identity; or (2) certify that they are the 

individuals they claim to be and that 

they understand that the knowing and 

willful request for or acquisition of a 

record pertaining to an individual under 

false pretenses is a criminal offense 

under the Privacy Act subject to a 

$5,000 fine. 

V. Safeguards 

The records in this System are stored 

in File folders. The records in this 

System will be maintained in Locked 

cabinets in locked rooms, electronic 

anti-intrusion devices in operation at 

the Federal Records Center, 24-hour 

guard service in buildings, personnel 

screening of visitors. The records can 

only be accessed by authorized users, 

access is granted to only a limited 

number of physicians, scientists, 

statisticians, and designated support 

staff of the Centers for Disease Control 

and Prevention (CDC), as authorized by 

the system manager to accomplish the 

stated purposes for which the data in 

this system have been collected. These 

practices are in compliance with, 

Chapter 45–13, ‘‘Safeguarding Records 

Contained in Systems of Records,’’ of the 

HHS General Administration Manual. 

FRC safeguards are in compliance with 

GSA Federal Property Management 

Regulations, Subchapter B—Archives 

and Records. Procedural safeguards are 

in place and users of individually 

identified data protect information from 

public scrutiny, and only specifically 

authorized personnel may be admitted 

to the record storage area. CDC 

employees who maintain records are 

instructed to check with the system 

manager prior to making disclosures of 

data. 

VI. OMB Control Numbers, Expiration 

Dates, and Titles of Information 

Collection 

A. Full Title: Administrative Files for 

Research/Demonstration and Training 

Grants, and Cooperative Agreements 

Applications, HHS/CDC/PGO. 

OMB Control Number: 09–20–0055. 

Expiration Date: TBD. 

VII. Supporting Documentation 

A. Preamble and Proposed Notice of 

System for publication in the Federal 

Register. 

B. Agency Rules: None. 

C. Exemption Requested: None. 

D. Computer Matching Report: The 

new system does not require a matching 

report in accordance with the computer 

matching provisions of the Privacy Act. 

[FR Doc. 2010–33006 Filed 1–24–11; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Privacy Act of 1974; Report of Modified 

or Altered System of Records 

AGENCY: Divisions of Tuberculosis 

Elimination, National Center for HIV, 

STD and TB Prevention (NCHSTP), 

Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (DHHS). 

ACTION: Notification of Proposed Altered 

System of Records. 

SUMMARY: The Department of Health and 

Human Services proposes to alter 

System of Records, 09–20–0089, 

‘‘Studies of Treatment of Tuberculosis 

and other Mycobacterioses HHS/CDC/ 

NCHSTP.’’ HHS is proposing to add the 

following Breach Response Routine Use 

Language to comply with the Office of 

Management and Budget (OMB) 

Memoranda (M) 07–16, Safeguarding 

Against and responding to the Breach of 

Personally Identifiable Information: 

To appropriate Federal agencies and 

Department contractors that have a need 

to know the information for the purpose 

of assisting the Department’s efforts to 

respond to a suspected or confirmed 

breach of the security or confidentiality 

of information disclosed is relevant and 

necessary for that assistance. 

These records will be maintained by 

the Division of Tuberculosis 

Elimination, National Center for HIV, 

STD and TB Prevention (NCHSTP). 

DATES: Comments must be received on 

or before February 24, 2011. The 

proposed altered System of Records will 

be effective 40 days from the date 

submitted to the OMB, unless NCHSTP 

receives comments that would result in 

a contrary determination. 

ADDRESSES: You may submit comments, 

identified by the Privacy Act System of 

Records Number 09–20–0089: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• E-mail: Include PA SOR number 

09–20–0089 in the subject line of the 

message. 

• Phone: 770/488–8660 (not a tollfree number). 

• Fax: 770/488–8659. 

• Mail: HHS/CDC Senior Official for 

Privacy (SOP), Office of the Chief 

Information Security Officer (OCISO), 

4770 Buford Highway—M/S: F–35, 

Chamblee, GA 30341. 

• Hand Delivery/Courier: HHS/CDC 

Senior Official for Privacy (SOP), Office 

of the Chief Information Security Officer 

mstockstill on DSKH9S0YB1PROD with NOTICES2

Federal Register / Vol. 76, No. 16 / Tuesday, January 25, 2011 / Notices 4439 

(OCISO), 4770 Buford Highway—M/S: 

F–35, Chamblee, GA 30341. 

• Comments received will be 

available for inspection and copying at 

this same address from 9 a.m. to 3 p.m., 

Monday through Friday, Federal 

holidays excepted. 

SUPPLEMENTARY INFORMATION: NCHSTP 

proposes to alter System of Records, No. 

09–20–0089, ‘‘Studies of Treatment of 

Tuberculosis and other 

Mycobacterioses. HHS/CDC/NCHSTP.’’ 

This System of Records will be used to: 

Determine the effectiveness and safety 

of a variety of treatments and preventive 

measures for tuberculosis and other 

mycobacterial diseases, determine the 

best measures against drug resistant 

tuberculosis, and monitor incidence of 

complications among individuals who 

have received preventive therapy, 

including isoniazid. Adults and 

children with tuberculosis or other 

mycobacterial diseases having been or 

currently being treated or observed by a 

limited number of participating local or 

county health departments, clinics, and 

hospitals (from 1959 until the present 

time), including those individuals in 

selected areas receiving preventive 

therapy with isoniazid therapy and/or 

other changes or BCG vaccinations, and 

patients for whom routine tuberculosis 

treatment is ineffective. Also included 

are contacts to tuberculosis patients, 

adults with inactive tuberculosis, and 

controls. 

This System of Records Notice is 

being altered to add the Breach 

Response Routine Use Language to 

comply with the Office of Management 

and Budget (OMB) memorandum dated 

May 22, 2007. 

The following notice is written in the 

present tense, rather than the future 

tense, in order to avoid the unnecessary 

expenditure of public funds to republish 

the notice after the System has become 

effective. 

Dated: November 23, 2010. 

Thomas P. Madden, 

Chief Information Security Officer, Centers 

for Disease Control and Prevention. 

Editorial Note: This document was 

received at the Office of the Federal Register 

on December 27, 2010. 

Department of Health and Human 

Services (HHS) 

Centers for Disease Control and 

Prevention (CDC) 

National Center for HIV, STD and TB 

Prevention (NCHSTP) 

Studies of Treatment of Tuberculosis 

and Other Mycobacterioses—Report of 

Modified or Altered System of Records 

Narrative Statement 

I. Background and Purpose of the 

System 

A. Background 

The Department of Health and Human 

Services proposes to alter System of 

Records, No. 09–20–0089, ‘‘Studies of 

Treatment of Tuberculosis and other 

Mycobacterioses, HHS/CDC/NCHSTP.’’ 

HHS is proposing to add the following 

Breach Response Routine Use Language 

to comply with the Office of 

Management and Budget (OMB) 

Memoranda (M) 07–16, Safeguarding 

Against and responding to the Breach of 

Personally Identifiable Information: 

To appropriate Federal agencies and 

Department contractors that have a need 

to know the information for the purpose 

of assisting the Department’s efforts to 

respond to a suspected or confirmed 

breach of the security or confidentiality 

of information disclosed is relevant and 

necessary for that assistance. 

B. Purpose 

To determine the effectiveness and 

safety of a variety of treatments and 

preventive measures for tuberculosis 

and other mycobacterial diseases, to 

determine the best measures against 

drug resistant tuberculosis, and to 

monitor incidence of complications 

among individuals who have received 

preventive therapy, including isoniazid. 

II. Authority for Maintenance of the 

System 

The statutory authority for this system 

is given under the Public Health Service 

Act, Section 301, ‘‘Research and 

Investigation’’ (42 U.S.C. 241). 

III. Proposed Routine Use Disclosures 

of Data in the System 

A. The Privacy Act allows us to 

disclose information without an 

individual’s consent if the information 

is to be used for a purpose that is 

compatible with the purpose(s) for 

which the information was collected. 

Any such compatible use of data is 

known as a ‘‘routine use.’’ The routine 

uses proposed for this System are 

compatible with the stated purpose of 

the System: 

Records may be disclosed to health 

departments and other public health or 

cooperating medical authorities in 

connection with program activities and 

related collaborative efforts to deal more 

effectively with diseases and conditions 

of public health significance. 

A record may be disclosed for a 

research purpose, when the Department: 

(A) Has determined that the use or 

disclosure does not violate legal or 

policy limitations under which the 

record was provided, collected, or 

obtained; 

(B) Has determined that the research 

purpose (1) cannot be reasonably 

accomplished unless the record is 

provided in individually identifiable 

form, and (2) warrants the risk to the 

privacy of the individual that additional 

exposure of the record might bring; 

(C) Has required the recipient to: (1) 

Establish reasonable administrative, 

technical, and physical safeguards to 

prevent unauthorized use or disclosure 

of the record, (2) remove or destroy the 

information that identifies the 

individual at the earliest time at which 

removal or destruction can be 

accomplished consistent with the 

purpose of the research project, unless 

the recipient has presented adequate 

justification of a research or health 

nature for retaining such information, 

and (3) make no further use or 

disclosure of the record except (a) in 

emergency circumstances affecting the 

health or safety of any individual, (b) for 

use in another research project, under 

these same conditions, and with written 

authorization of the Department, (c) for 

disclosure to a properly identified 

person for the purpose of an audit 

related to the research project, if 

information that would enable research 

subjects to be identified is removed or 

destroyed at the earliest opportunity 

consistent with the purpose of the audit, 

or (d) when required by law; 

(D) Has secured a written statement 

attesting to the recipient’s 

understanding of, and willingness to 

abide by these provisions. 

The Department is under contract 

with private firms for the purpose of 

collating, analyzing, aggregating or 

otherwise refining records in this 

system. Relevant records are maintained 

by the contractors. The contractors are 

required to maintain Privacy Act 

safeguards with respect to such records. 

Disclosure may be made to a 

congressional office from the record of 

an individual in response to a verified 

inquiry from the congressional office 

made at the written request of that 

individual. 

Records may be disclosed to 

appropriate Federal agencies and 

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4440 Federal Register / Vol. 76, No. 16 / Tuesday, January 25, 2011 / Notices 

Department contractors that have a need 

to know the information for the purpose 

of assisting the Department’s efforts to 

respond to a suspected or confirmed 

breach of the security or confidentiality 

of information disclosed is relevant and 

necessary for that assistance. 

IV. Effects of the Proposed System of 

Records on Individual Rights 

The first routine use permits an 

individual may learn if a record exists 

about himself or herself is by contacting 

the system manager at the address 

above. Requesters in person must 

provide driver’s license or other positive 

identification. Individuals who do not 

appear in person must either: (1) Submit 

a notarized request to verify their 

identity; or (2) certify that they are the 

individuals they claim to be and that 

they understand that the knowing and 

willful request for or acquisition of a 

record pertaining to an individual under 

false pretenses is a criminal offense 

under the Privacy Act subject to a 

$5,000 fine. 

An individual who requests 

notification of or access to medical 

records shall, at the time the request is 

made, designate in writing a responsible 

representative who is willing to review 

the record and inform the subject 

individual of its contents at the 

representative’s discretion. 

A parent or guardian who requests 

notification of, or access to, a child’s 

medical record shall designate a family 

physician or other health professional 

(other than a family member) to whom 

the record, if any, will be sent. The 

parent or guardian must verify 

relationship to the child by means of a 

birth certificate or court order, as well 

as verify that he or she is who he or she 

claims to be. 

The following information must be 

provided when requesting notification: 

(1) Full name; (2) the approximate date 

and place of the study, if known; and (3) 

nature of the questionnaire or study in 

which the requester participated. 

Same as notification procedures. 

Requesters should also reasonably 

specify the record contents being 

sought. An accounting of disclosures 

that have been made of the record, if 

any, may be requested 

V. Safeguards 

The records in this System are stored 

in File folders, computer tapes/disks, 

and CD–ROMs. 

The records have the following 

safeguards in place: 

Authorized Users: A database security 

package is implemented on CDC’s 

mainframe computer to control 

unauthorized access to the system. 

Attempts to gain access by unauthorized 

individuals are automatically recorded 

and reviewed on a regular basis. Access 

is granted to only a limited number of 

physicians, scientists, statisticians, and 

designated support staff of the Centers 

for Disease Control and Prevention 

(CDC), or its contractors, as authorized 

by the system manager to accomplish 

the stated purposes for which the data 

in this system have been collected. 

Physical Safeguards: Access to the 

CDC Clifton Road facility where the 

mainframe computer is located is 

controlled by a cardkey system. Access 

to the computer room is controlled by 

a cardkey and security code (numeric 

keypad) system. Access to the data entry 

area is also controlled by a cardkey 

system. The hard copy records are kept 

in locked cabinets in locked rooms. The 

local fire department is located nearby. 

The computer room is protected by an 

automatic sprinkler system, automatic 

sensors (e.g., water, heat, smoke, etc.) 

are installed, and portable fire 

extinguishers are located throughout the 

computer room. The system is backed 

up on a nightly basis with copies of the 

files stored off site in a secure fireproof 

safe. Security guard service in buildings 

provides personnel screening of visitors. 

Procedural Safeguards: Protection for 

computerized records both on the 

mainframe and the National Center 

Local Area Network (LAN) include 

programmed verification of valid user 

identification code and password prior 

to logging on to the system, changed 

mandatory password changes, limited 

log-ins, virus protection, and user 

rights/file attribute restrictions. 

Password protection imposes user name 

and password log-in requirements to 

prevent unauthorized access. Each user 

name is assigned limited access rights to 

files and directories at varying levels to 

control file sharing. There are routine 

daily backup procedures and secure offsite storage is available for backup files. 

To avoid inadvertent data disclosure, 

‘‘degaussing’’ is performed to ensure that 

all data are removed from Privacy Act 

computer tapes and/or other magnetic 

media. Additional safeguards may be 

built into the program by the system 

analyst as warranted by the sensitivity 

of the data. 

CDC and contractor employees who 

maintain records are instructed to check 

with the system manager prior to 

making disclosures of data. When 

individually identified data are being 

used in a room, admittance at either 

CDC or contractor sites is restricted to 

specifically authorized personnel. 

Privacy Act provisions are included in 

contracts, and the CDC Project Director, 

contract officers and project officers 

oversee compliance with these 

requirements. Upon completion of the 

contract, all data will be either returned 

to CDC or destroyed, as specified by the 

contract. 

Implementation Guidelines: These 

practices are in compliance with the 

safeguards outlined above are in 

accordance with the HHS Information 

Security Program Policy and FIPS Pub 

200, ‘‘Minimum Security Requirements 

for Federal Information and Information 

Systems.’’ Data maintained on CDC’s 

Mainframe and the National Center LAN 

are in compliance with OMB Circular 

A–130, Appendix III. Security is 

provided for information collection, 

processing, transmission, storage, and 

dissemination in general support 

systems and major applications. 

The records in this System are 

retained and disposed of in accordance 

with the CDC Records Control Schedule. 

Records are maintained in agency for 

five years. Disposal methods include 

erasing computer tapes and burning or 

shredding paper materials or 

transferring records to the Federal 

Records Center when no longer needed 

for evaluation and analysis. Records 

destroyed by paper recycling process 

when 20 years old, unless needed for 

further study. 

VI. OMB Control Numbers, Expiration 

Dates, and Titles of Information 

Collection 

A. Full Title: ‘‘Studies of Treatment of 

Tuberculosis and other 

Mycobacterioses, HHS/CDC/NCHSTP.’’ 

B. OMB Control Number: 09–20–0089. 

C. Expiration Date: TBD. 

VII. Supporting Documentation 

A. Preamble and Proposed Notice of 

System for publication in the Federal 

Register. 

B. Agency Rules: None. 

C. Exemption Requested: None. 

D. Computer Matching Report: The 

new system does not require a matching 

report in accordance with the computer 

matching provisions of the Privacy Act. 

[FR Doc. 2010–33007 Filed 1–24–11; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Privacy Act of 1974; Report of Modified 

or Altered System of Records 

AGENCY: Division of Tuberculosis 

Elimination, National Center for HIV, 

STD and TB Prevention (NCHSTP), 

Centers for Disease Control and 

mstockstill on DSKH9S0YB1PROD with NOTICES2