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###### Department of Health and Human Services

###### Centers for Disease Control and Prevention

# AGENCY:

Division of Respiratory Disease Studies (DRDS), National Institute for Occupational Safety and Health (NIOSH), 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, 09-20-0154, “Medical and Laboratory Studies, HHS/CDC/NIOSH.” HHS is proposing to add the following Breach Response Routine Use Language to comply with the Office of Management and Budget (OMB)                                   ( print page 4472)                                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 National Institute for Occupational Safety and Health (NIOSH).

# 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 NIOSH receives comments that would result in a contrary determination.

# ADDRESSES:

You may submit comments, identified by the Privacy Act System of Record Number 09-20-0154:
      -  Federal eRulemaking Portal: http://regulations.gov . Follow the instructions for submitting comments.                        
      -  E-mail:                              Include PA SOR number 09-20-0154 in the subject line of the message.                        
      -  Phone:                              770/488-8660 (not a toll-free 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 (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:

NIOSH proposes to alter System of Records, No. 09-20-0154, “Medical and Laboratory Studies, HHS/CDC/NIOSH.” The purpose of this system is to perform medical and epidemiological research, statistical analysis, and to identify early indicators of occupationally related diseases (biochemical indices); data is given to other NIOSH units for biochemical and epidemiological studies.

This System of Record 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: December 11, 2009.

James D. Seligman,

Chief Information Officer, Centers for Disease Control and Prevention.

              Editorial Note            

#### 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 Institute for Occupational Safety and Health (NIOSH)

## Medical and Laboratory Studies

### 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. 09-20-0154 “Medical and Laboratory Studies, HHS/CDC/NIOSH.” 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

The purpose of this system is to perform medical and epidemiological research, statistical analysis, and to identify early indicators of occupationally related diseases (biochemical indices); data is given to other NIOSH units for biochemical and epidemiological studies.

## II. Authority for Maintenance of the System

Federal Mine Safety and Health Act of 1977, Section 501, “Research” (30 U.S.C. 951); and the Occupational Safety and Health Act, Section 20, “Research and Related Activities” and Section 22(d), “Authority of Director, National Institute for Occupational Safety and Health” (29 U.S.C. 669, 671 (d)).

## III. Proposed Routine Use Disclosures of Data in the System

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 and support the agency's mission:

Data may be sent to State Vital Statistics Divisions to obtain death certificates and to missing person location agencies to find those individuals who cannot otherwise be located.

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.

In the event of litigation where the defendant is: (a) The Department, any component of the Department, or any employee of the Department in his or her official capacity; (b) the United States where the Department determines that the claim, if successful, is likely to directly affect the operations of the Department or any of its components; or (c) any Department employee in his or her individual capacity where the Department of Justice has agreed to represent such employee, for example, in defending a claim against the Public Health Service based upon an individual's mental or physical condition and alleged to have arisen because of activities of the Public Health Service in connection with such individual, disclosure may be made to the Department of Justice to enable that Department to present an effective defense, provided that such disclosure is compatible with the purpose for which the records were collected.

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.

Certain communicable diseases may be reported to State and/or local health departments where the State has a legally constituted reporting program for communicable diseases and which provides for the confidentiality of the information.

                        In the event of litigation initiated at the request of NIOSH, the Institute may disclose such records as it deems                               ( print page 4473)                            desirable or necessary to the Department of Justice and to the Department of Labor, Office of the Solicitor, where appropriate, to enable the Departments to effectively represent the Institute, provided such disclosure is compatible with the purpose for which the records were collected. The only types of litigative proceedings that NIOSH is authorized to request are: (1) enforcement of a subpoena issued to an employer to provide relevant information; or (2) contempt citation against an employer for failure to comply with a warrant obtained by the Institute.                    

Disclosure may be made to NIOSH collaborating researchers (NIOSH contractors, grantees, cooperative agreement holders, or other Federal or State scientists) in order to accomplish the research purpose for which the records are collected. The collaborating researchers must agree in writing to comply with the confidentiality provisions of the Privacy Act and NIOSH must have determined that the researchers' data security procedures will protect confidentiality.

Records may be disclosed by CDC in connection with public health activities to the Social Security Administration for sources of locating information to accomplish the research or program purposes for which the records were collected.

Records may be disclosed 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 routine uses proposed for this System are compatible with the stated purpose of the System and support the agency's mission:

An individual may learn if a record exists about himself or herself 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.

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.

Individuals should contact the official at the address specified under System Manager above, reasonably identify the record and specify the information being contested, the corrective action sought, and the reasons for requesting the correction, along with supporting information to show how the record is inaccurate, incomplete, untimely, or irrelevant.

## V. Safeguards

The records in this System are stored in computer tapes/disks and printouts, CD ROMs, microfilm, microfiche, and hard copy files, and the records in this System are retrieved by Name and case number are the indices used to retrieve records from this system.

The records in this System have the following safeguards in place to maintain and protect the information as it relates to Authorized users, physical and procedural safeguards:

*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.                    

*Physical Safeguards*                        —Access to the facility is monitored, and controlled after hours, by security guard service. Hard copy records are kept in locked cabinets in locked rooms. Access to the LAN computer room is controlled by a punch lock system. The local fire department is one mile from the facility, which is of structural steel and cement block construction, with pre-cast cement panels on the envelope. No combustible materials are used in the building construction, including all interior walls. Heat sensors are installed, and portable fire extinguishers are located throughout the computer room. The active system files are backed up on a weekly basis. The entire system is backed up, with copies of the files stored in a secure, fireproof safe in a separate location within the facility.                    

*Procedural Safeguards*                        —The NIOSH Local Area Network (LAN) computer system, located within the Morgantown facility, uses a security package to control unauthorized access to the system. Attempts to gain access by unauthorized individuals are automatically recorded and reviewed on a daily basis. Protection for computerized records both on the mainframe and the NIOSH Local Area Network (LAN) includes programmed verification of valid user identification code and password prior to logging on to the system, 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 off-site storage is available for backup tapes. 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:*                         The safeguards outlined above are in accordance with the 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 NIOSH 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 the following way: Master records for completed studies are maintained in agency until transferred to the National Archives. Source documents for                               ( print page 4474)                            computer data are disposed of when no longer needed in the study, as determined by the system manager, and as provided in the signed consent form, as appropriate. Disposal methods include erasing computer tapes, burning or shredding paper materials or transferring records to the Federal Records Center when no longer needed for evaluation and analysis. Electronic records, if any, are maintained according to the provisions of the records control schedule for NIOSH electronic records, which is consistent with the records maintenance requirements for other forms of records. Copies of notifications to workers/private physicians of needed medical attention and/or medical treatment are destroyed when no longer needed for administrative purposes, but may be retained for as long as seventy (70) years. Paper records are 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:*                         “Medical and Laboratory Studies, HHS/CDC/NIOSH.”                    

*OMB Control Number:*                         09-20-0154.                    

*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. 2010-33023 Filed 1-24-11; 8:45 am]

BILLING CODE 4163-18-P