Justia Regulation Tracker

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[Federal Register: April 10, 2008 (Volume 73, Number 70)]
[Notices]               
[Page 19519-19521]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10ap08-71]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration

 
Privacy Act of 1974; System of Records

AGENCY: Health Resources and Services Administration (HRSA), HHS.

ACTION: Notification of an Altered System of Records.

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SUMMARY: In accordance with the requirements of the Privacy Act, the 
Health Resources and Services Administration (HRSA) is publishing 
notice of a proposal to alter the system of records for Organ 
Procurement and Transplantation Network (OPTN)/Scientific Registry of 
Transplant Recipients (SRTR) Data System. This system of records is 
required to comply with the implementation directives of Public Law 
109-129.
    HRSA published in the Federal Register of September 8, 2003, a 
document concerning notice of a new system of records, 09-15-0055, 
Organ Procurement and Transplantation Network (OPTN)/Scientific 
Registry of Transplant Recipients (SRTR) Data System, 68 FR 52950. This 
document more fully explains the routine uses of records maintained in 
the system and amends the records' purpose and routine uses of records 
maintained in the system. Accordingly, the notice is published below in 
its entirety, as amended.

DATES: Persons wishing to comment on this revised system of records 
notice may do so until May 12, 2008. Unless there is a further notice 
in the Federal Register, this revised system of records will become 
effective on May 20, 2008.

ADDRESSES: Please address comments to: HRSA Privacy Act Officer, 
Alexandra Huttinger (Acting), 5600 Fishers Lane, Room 14A-11, 
Rockville, Maryland 20857; telephone (301) 443-1785; or e-mail 
ahuttinger@hrsa.gov. This is not

[[Page 19520]]

a toll-free number. Comments received will be available for inspection 
at this same address from 9 a.m. to 3 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT: James F. Burdick, M.D., Director, 
Division of Transplantation, HSB, HRSA, 5600 Fishers Lane, Room 12C-06, 
Rockville, Maryland 20857; telephone (301) 443-7577; fax (301) 594-
6095; or e-mail: jburdick@hrsa.gov. This is not a toll-free number.

SUPPLEMENTARY INFORMATION: The system of records, 09-15-0055, Organ 
Procurement and Transplantation Network (OPTN)/Scientific Registry of 
Transplant Recipients (SRTR) Data System. Accordingly, is published 
below in its entirety, as amended.
09-15-0055

SYSTEM NAME:
    Organ Procurement and Transplantation Network (OPTN)/Scientific 
Registry of Transplant Recipients (SRTR) Data System, HHS/HRSA/HSB/DoT 
(system of records, 09-15-0055).

SECURITY CLASSIFICATION:
    None.

SYSTEM LOCATION:
    Data collected by the OPTN are maintained by the OPTN contractor 
and shared on a monthly basis with the contractor for the SRTR and the 
DoT, within HRSA, the Federal entity that oversees the OPTN and SRTR 
contracts.
    OPTN Contractor: United Network for Organ Sharing (UNOS), P.O. Box 
2484, 700 North Fourth Street, Richmond, Virginia 23218.
    SRTR Contractor: Arbor Research Collaborative for Health (ARCH), 
315 West Huron, Suite 360, Washtenaw County, Ann Arbor, Michigan, 
48103.
    Division of Transplantation: Healthcare Systems Bureau, HRSA, 
Parklawn Building, Room 12C-06, 5600 Fishers Lane, Rockville, Maryland 
20857.

CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
    1. Living and deceased persons from whom organs have been obtained 
for transplantation.
    2. Persons who are candidates for organ transplantation.
    3. Persons who have been recipients of transplanted organs.

CATEGORIES OF RECORDS IN THE SYSTEM:
    Donor registration, transplant candidate registration, transplant 
recipient registration, histocompatibility, transplant recipient 
follow-up and living donor follow-up, forms and other non-registry 
operational information. Data items include: Name, Social Security 
number, identifiers assigned by OPTN and SRTR contractors, hospital and 
hospital provider number, State and zip code of residence, citizenship, 
race/ethnicity, gender, date and time of organ recovery and 
transplantation, name of transplant center, histocompatibility status, 
donor medical information and, if donor is deceased, cause of death, 
patient medical information before and after transplantation, 
immunosuppressive medication, cause of death (if recipient is 
deceased), health care coverage, employment and education level.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
    42 U.S.C. 274 requires that the Secretary, by contract, provide for 
the establishment and operation of an OPTN, and 42 U.S.C. 274a requires 
that the Secretary, by grant or contract, develop and maintain a 
Scientific Registry of the recipients of organ transplants. 42 CFR part 
121 authorizes collection of the information included in this system by 
the OPTN.

PURPOSE(S):
    To (1) facilitate organ placement and match donor organs with 
recipients; (2) monitor compliance of member organizations with Federal 
laws and regulations and with OPTN requirements; (3) review and report 
periodically to the public on the status of organ donation and 
transplantation in the United States; (4) provide data to researchers 
and government agencies to study the scientific and clinical status of 
organ transplantation; (5) perform transplantation-related public 
health surveillance including possible transmission of donor disease.

ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES 
OF USERS AND THE PURPOSE OF SUCH USES:
    1. Departmental contractors and/or their subcontractors who have 
been engaged by the Department to assist in accomplishment of a 
departmental function relating to the purposes for this system of 
records and who require access to the records in order to assist the 
Department.
    2. HRSA, independently and through its contractor(s), may disclose 
records regarding organ donors, organ transplant candidates, and organ 
transplant recipients to other HHS entities, transplant centers, 
histocompatibility laboratories, organ procurement organizations, the 
Transplant Transmission Sentinel Network and other public health 
agencies such as SEER registries, NCI contractors, State cancer 
registries and other State health agencies, provided that such 
disclosure is compatible with the purpose for which the records were 
collected, including: Matching donor organs with recipients, monitoring 
compliance of member organizations with Federal laws and regulations 
and OPTN requirements, reviewing and reporting periodically to the 
public on the status of organ donation and transplantation in the 
United States, and transplantation-related public health surveillance. 
These records consist of Social Security numbers, other patient 
identification information and pertinent medical information.
    3. 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 
affect directly the operation 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 in connection with such individual, disclosure may be made to 
the Department of Justice to enable the Department to present an 
effective defense.
    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. A record may be disclosed for a research purpose, when the 
Department, independently or through its contractor(s):
    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 a bona fide research/analysis purpose 
exists;
    c. Has required the data recipient to: (1) Establish strict 
limitations concerning the receipt and use of patient-identified or 
center-identified data; (2) establish reasonable administrative, 
technical, and physical safeguards to protect the confidentiality of 
the data and to prevent the unauthorized use or disclosure of the 
record; (3) remove, destroy, or return the information that identifies 
the individual or center at the earliest time at which removal or 
destruction can be accomplished consistent with the purpose of the 
research project, unless the data recipient has presented

[[Page 19521]]

adequate justification of a research or health nature for retaining 
such information; and (4) make no further use or disclosure of the 
record except as authorized by HRSA or its contractor(s) or when 
required by law;
    d. has determined that other applicable safeguards or protocols 
will be followed; and
    e. has secured a written statement attesting to the data 
recipient's understanding of, and willingness to abide by these 
provisions.

POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING, 
AND DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
    Records are maintained in file folders, magnetic tapes, and disc 
packs.

SAFEGUARDS:
    1. Authorized users: Access is limited to authorized HRSA and 
contract personnel responsible for administering the program. 
Authorized personnel include the System Manager and Project Officer, 
and the HRSA Automated Information System (AIS) Systems Security 
Officer; and the program managers/program specialists who have 
responsibilities for implementing the program. Both HRSA and its 
contractor(s) shall maintain current lists of authorized users.
    2. Physical safeguards: Magnetic tapes, disc packs, computer 
equipment, and hard-copy files are stored in areas where fire and life 
safety codes are strictly enforced. All automated and nonautomated 
documents are protected on a 24-hour basis in locked storage areas. 
Security guards perform random checks on the physical security of the 
records storage area. The OPTN and SRTR contractors are required to 
maintain off site a complete copy of the system and all necessary files 
to run the computer organ donor-recipient match and update software.
    3. Procedural safeguards: A password is required to access the 
terminal and a data set name controls the release of data to only 
authorized users. All users of personal information in connection with 
the performance of their jobs protect information from public view and 
from unauthorized personnel entering an unsupervised office. All 
authorized users must sign a nondisclosure statement. Access to records 
is limited to those staff members trained in accordance with the 
Privacy Act and Automated Data Processing (ADP) security procedures. 
The contractor(s) is required to assure that the confidentiality 
safeguards of these records will be employed and that it complies with 
all provisions of the Privacy Act. All individuals who have access to 
these records must have the appropriate ADP security clearances. 
Privacy Act and ADP system security requirements are included in the 
contracts. The HRSA Project Officer(s) and the System Manager(s) 
oversee compliance with these requirements. The HRSA authorized users 
will make visits to the contractors' facilities to assure security and 
Privacy Act compliance. The contractor(s) is/are required to adhere to 
a HRSA approved system security plan.

RETENTION AND DISPOSAL:
    Each donor, candidate, and recipient record stored within the OPTN/
SRTR Data System shall be retained for no more than 25 years beyond the 
known death of the candidate or the organ recipient.

SYSTEM MANAGER AND ADDRESS:
    Chief, Operations and Analysis Branch, Division of Transplantation, 
HSB/HRSA, Parklawn Building, Room 12C-06, 5600 Fishers Lane, Rockville, 
MD 20857.

NOTIFICATION PROCEDURE:
    Requests by mail: To determine if a record about you exists, write 
to the OPTN contractor (see System Location). The request should 
contain the name and address of the individual; the Social Security 
number if the individual chooses to provide it; the name of his/her 
transplant center, a notarized written statement that the requester is 
the person he/she claims to be and that he/she understands that the 
request or acquisition of records pertaining to another individual 
under false pretenses is a criminal offense subject to a $5,000 fine. 
These procedures are in accordance with the Department's regulations 
(45 CFR part 5b).
    Requests in person: The individual must meet all the requirements 
stated above for a request by mail, providing the information in 
written form, or provide at least one piece of tangible identification. 
The individual should recognize that in order to maintain 
confidentiality, and thus the accuracy of data released through 
repeated internal verification, securing the information by request in 
person will be time consuming. These procedures are in accordance with 
the Department's regulations (45 CFR part 5b).
    Requests by Telephone: Since positive identification of the caller 
cannot be established, telephone requests are not honored.

RECORD ACCESS PROCEDURES:
    These are the same as notification procedures. Requestors should 
also provide a reasonable description of the record being sought. 
Requestors also may request an accounting of disclosures that have been 
made of their records, if any. A parent or guardian who requests 
notification of, or access to, a minor's/incompetent person'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 minor/
incompetent person as well as his/her own identity. These procedures 
are in accordance with the Department's regulations (45 CFR part 5b).

CONTESTING RECORDS PROCEDURES:
    To contest a record in the system, contact the official at the 
address specified under notification procedure above and reasonably 
identify the record, specify the information being contested, and the 
corrective action sought, and your reasons for requesting the 
correction, along with supporting information to show how the record is 
inaccurate, incomplete, untimely, or irrelevant.

RECORD SOURCE CATEGORIES:
    Organ procurement organizations, histocompatibility laboratories, 
and organ transplant centers.

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
    None.

    Dated: April 2, 2008.
Elizabeth M. Duke,
Administrator.
[FR Doc. E8-7632 Filed 4-9-08; 8:45 am]

BILLING CODE 4165-15-P