[Federal Register Volume 75, Number 189 (Thursday, September 30, 2010)]
[Notices]
[Pages 60468-60470]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-24576]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Privacy Act of 1974; Report of an Altered System of Records

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

ACTION: Notice of an altered system of records.

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

SUMMARY: In accordance with the requirements of the Privacy Act of 
1974, the Health Resources and Services Administration (HRSA) is 
proposing to alter the system of records for the National Vaccine 
Injury Compensation Program, 09-15-0056. In accordance with the 
National Childhood Vaccine Injury Act of 1986, as amended (42 U.S.C. 
300aa-10, et seq.) (the Vaccine Act), the National Vaccine Injury 
Compensation Program receives records from individuals or 
representatives of individuals alleged to be injured by vaccines.
    The purposes of these alterations are to update the system name, 
authority, and location; make a minor change to the purposes, add new 
routine uses (numbers 10, 11, 12, 13, and 14); update the safeguards; 
update retention and disposal; and update the system manager contact 
information.

DATES: HRSA filed an altered system report with the Chair of the House 
Committee on Government Reform and Oversight, the Chair of the Senate 
Committee on Homeland Security and Governmental Affairs, and the 
Administrator, Office of Information and Regulatory Affairs, Office of 
Management and Budget (OMB) on 6/9/2010. To ensure all parties have 
adequate time in which to comment, the altered systems, including the 
routine uses, will become effective 30 days from the publication of the 
notice or 40 days from the date it was submitted to OMB and Congress, 
whichever is later, unless HRSA receives comments that require 
alterations to this notice.

ADDRESSES: Please address comments to the Director, Division of Vaccine 
Injury Compensation, HRSA/HSB, 5600 Fishers Lane, Room 11C-26, 
Rockville, Maryland 20857. Comments received will be available for 
review and inspection, by appointment, at this same address from 9 a.m. 
to 3 p.m., Eastern Standard Time, Monday through Friday.

FOR FURTHER INFORMATION CONTACT: Dr. Geoffrey Evans, Director, Division 
of Vaccine Injury Compensation, HRSA/HSB, 5600 Fishers Lane, Room 11C-
26, Rockville, Maryland 20857; Telephone 301-443-6593. This is not a 
toll-free number.

SUPPLEMENTARY INFORMATION: The Health Resources and Services 
Administration proposes to alter this system of records by updating the 
name of the system from the National Vaccine Injury Compensation 
Program, HHS/HRSA/BHPr to the National Vaccine Injury Compensation 
Program; updating the location from the Bureau of Health Professions 
(BHPr) to the Healthcare Systems Bureau (HSB); add an additional 
authority (the Vaccine Act, 42 U.S.C. 300aa-10, et seq., which 
established the National Vaccine Injury Compensation Program; make a 
minor change to the second purpose (extending the purpose beyond the 
amount of compensation to the manner of compensation), add new routine 
uses 10, 11, 12, 13, and 14 (described below), modifying the safeguards 
by replacing the words ``can be locked and secured'' to ``are kept in a 
locked and secured room'' under physical safeguards; and updating the 
system manager contact information to ``Associate Administrator, 
Healthcare Systems Bureau, Health Resources and Services 
Administration, 5600 Fishers Lane, Room 12-105, Rockville, Maryland 
20857. The new routine uses are as follows: Routine use 10 (disclosures 
to ensure that a Government Reversionary Trust established in 
connection with a Program award is being properly administered); 
routine use 11 (disclosures regarding specific medical services 
provided to an unemancipated minor to the minor's parent or legal 
guardian); routine use 12 (disclosures concerning compensation awarded 
on behalf of an unemancipated minor or an incompetent adult in the 
Program to the guardian or conservator of the estate of the minor or 
incompetent adult, as determined by a court of competent jurisdiction); 
routine use 13 (disclosures in the event a violation or potential 
violation of law is indicated); and routine use 14 (disclosures of 
information for the purpose of assisting the Department of Health and 
Human Services in efforts to respond to breaches of security or 
confidentiality maintained in the system); updating the retention and 
disposal by noting that the closed case files are transferred to the 
Washington National Records Center periodically and that written 
approval by the Program is needed before records are disposed of by 
shredding twenty-five years after the termination of all administrative 
and judicial proceedings, determined by a final adjudication; and 
updating the system manager contact information from BHPR to the 
Associate Administrator, Healthcare Systems Bureau, Health Resources 
and Administration, 5600 Fishers Lane, Room 12-105, Rockville, MD 
20857. All other aspects of the system remain the same. Accordingly, 
the notice is being published below in its entirety, as amended.

    Dated: September 13, 2010.
Mary K. Wakefield,
Administrator.
SYSTEM NUMBER:
    09-15-0056

SYSTEM NAME:
    National Vaccine Injury Compensation Program.

SECURITY CLASSIFICATION:
    None.

SYSTEM LOCATION:
    Healthcare Systems Bureau (HSB), Health Resources and Services 
Administration (HRSA), 5600 Fishers Lane, Room 11C-26, Rockville, 
Maryland 20857.

[[Page 60469]]

CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
    Persons filing claims (petitioners) under the National Vaccine 
Injury Compensation Program (NVICP).

CATEGORIES OF RECORDS IN THE SYSTEM:
    Petition for compensation, including petitioner's name and name of 
person vaccinated if different from petitioner, and all relevant 
medical records, (including autopsy reports and slides, radiological 
films, and home videos, if any), appropriate assessments, evaluations, 
prognoses, and such other records and documents as are reasonably 
necessary for the determination of eligibility for and the amount of 
compensation to be paid to, or on behalf of, the person who suffered 
such injury or who died from the administration of the vaccine.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
    The authority for maintaining this system of records is the 
National Childhood Vaccine Injury Act of 1986, as amended (42 U.S.C. 
300aa-10, et seq.) (the Vaccine Act). The Vaccine Act established the 
National Vaccine Injury Compensation Program and authorized the 
Department to track, review, and defend the Secretary, HHS in vaccine 
injury and death related cases brought before the United States Court 
of Federal Claims.

PURPOSE(S) FOR RECORDS IN THIS SYSTEM:
    1. To determine eligibility of petitioners to receive compensation 
under the National Vaccine Injury Compensation Program.
    2. To compensate successful petitioners in the amount and in the 
manner determined by the court.
    3. To evaluate vaccine safety through research programs.

ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES 
OF USERS AND THE PURPOSES OF SUCH USES:
    1. Disclosures may be made to a Congressional office from the 
record of an individual, in response to an inquiry from the 
Congressional office made at the written request of the individual.
    2. 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 (DOJ) has agreed to represent 
such employee, for example in defending against a claim 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, the Department may disclose such records as it deems 
desirable or necessary to the DOJ to enable that Department to present 
an effective defense, provided that such disclosure is compatible with 
the purpose for which the records were collected.
    3. HRSA will contract with expert medical consultants for the 
purpose of obtaining advice on petitioner's eligibility for 
compensation. To the extent necessary, relevant records may be 
disclosed to such consultants. The consultants shall be required to 
maintain Privacy Act safeguards with respect to such records and return 
all records to HRSA.
    4. HRSA will release the petitioner's complete medical file and may 
release consultants' report to the DOJ and the Special Master of the 
U.S. Court of Federal Claims for adjudication of the compensation 
claim.
    5. HRSA will disclose for publication in the Federal Register the 
name of the petitioner, the name of the person vaccinated, if not the 
petitioner, the city and State where the vaccine was administered and 
the U.S. Court of Federal Claims' Docket Number as required by the 
National Childhood Vaccine Injury Act.
    6. Records may be disclosed to organizations deemed qualified by 
the Secretary for the purpose of evaluating the administration, 
process, or outcomes of the National Vaccine Injury Compensation 
Program (as required by Congress). The purpose of the disclosure is to 
document the extent to which the National Vaccine Compensation Program 
is satisfying the goals and objectives of its authorizing legislation, 
i.e., maintaining a system for compensating those who have been injured 
by a vaccine that is fair and expeditious. Organizations to which 
information is disclosed for this use shall be required to maintain 
Privacy Act safeguards with respect to such records.
    7. To the extent necessary, a record may be disclosed to annuity 
brokers and to employees of life insurance companies for the purposes 
of obtaining financial advice and for the purchase of contracts to 
provide benefits to recipients of benefits under the Program. 
Organizations to which information is disclosed for this use will be 
required to maintain Privacy Act safeguards with respect to such 
records.
    8. To the extent necessary, a record may be disclosed to 
contractors for the purpose of providing medical review, analysis and 
determination as to whether petitions meet the medical requirements for 
compensation. Contractors will be required to maintain Privacy Act 
safeguards with respect to such records.
    9. A record may be disclosed for a research purpose when the 
Department: (A) Has determined that the 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) Is consistent with the purpose for which the Program was formed, 
which includes, but is not limited to, evaluating the safety of 
vaccines covered under the Program, (2) Cannot be reasonably 
accomplished with information in statistical form, and must be provided 
in an identifiable form to accomplish the research purpose, and (3) 
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 of 
the record except: (a) In emergency circumstances affecting the health 
or safety of any individual, (b) 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 (c) When required by law; 
and (D) Has secured a written statement attesting to the recipient's 
understanding of and willingness to abide by these provisions.
    10. To the extent necessary, a record may be disclosed for the 
purpose of ensuring that a Government Reversionary Trust established in 
connection with a Program award is being properly administered. Such 
disclosures may be made to institutions serving as trustees and medical 
administrators with respect to such trusts, to individuals serving as 
guardians of the estate of individuals compensated by the Program, and 
to attorneys representing such parties (or representing the 
Government).

[[Page 60470]]

Organizations or individuals to which information is disclosed for this 
use will be required to maintain Privacy Act safeguards with respect to 
such records. Records may also be disclosed for the same purpose to 
courts of competent jurisdiction in which trust administration issues 
arising out of Program claims are raised.
    11. Records regarding specific medical services provided to an 
unemancipated minor or an incompetent adult may be disclosed to the 
unemancipated minor's parent or legal guardian who previously consented 
to those specific medical services or a person who is now legally 
authorized to make medical decisions on behalf of the minor or the 
incompetent adult.
    12. Records concerning compensation awarded on behalf of an 
unemancipated minor (or an incompetent adult) in the Program may be 
disclosed to the guardian or conservator of the estate of the minor or 
incompetent adult, as determined by a court of competent jurisdiction.
    13. In the event that a record maintained in this system indicates 
a violation or potential violation of law, whether civil, criminal, or 
regulatory in nature, and whether arising by general statute or 
particular program statute, regulation, rule, or order issued pursuant 
thereto, the relevant records in the system of records may be referred 
to the appropriate agency, whether Federal, State, or local, charged 
with the responsibility of investigating or prosecuting such violation, 
or charged with enforcing or implementing the statute, rule, 
regulation, or order issued pursuant thereto, provided that such 
disclosure is compatible with the purpose for which records were 
collected.
    14. 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 maintained in this 
system of records, and the information disclosed is relevant and 
necessary for that assistance.

POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING, 
AND DISPOSING OF RECORDS IN THE SYSTEM
    <bullet> Storage: File folders and disks.
    <bullet> Retrievability: Retrieval is by: (1) Docket number 
assigned by the U.S. Court of Federal Claims, and (2) the petitioner 
and/or name of person vaccinated.
    <bullet> Safeguards:
    1. Authorized users: Access is limited to the System Manager and 
authorized HRSA/HSB personnel responsible for administering the 
program. HRSA/HSB will maintain a current list of authorized users.
    2. Physical safeguards: All files are stored in an electronic 
carriage filing system which are kept in a locked and secured room 
during non-work hours; disk packs and computer equipment are retained 
in areas where fire and safety codes are strictly enforced. All 
automated and non-automated documents are protected on a 24-hour basis 
in security areas. Security guards perform random checks of the 
physical security of the record storage area.
    3. Procedural safeguards: HRSA/HSB has established stringent 
safeguards in line with the sensitivity of the records. These include: 
Transmitting records to consultants by Federal Express, United Parcel 
Service, or other courier service to ensure that a signature is 
required upon receipt of the records; escorting visitors into areas 
where records are maintained; utilizing passwords for computer access; 
and securing areas where records are stored. A password is required to 
access the terminal and the data set name controls the release of data 
only to 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.

RETENTION AND DISPOSAL:
    HRSA is working with NARA to obtain the appropriate retention 
value.

NOTIFICATION PROCEDURE:
    Requests must be made to the System Manager at the above address.

REQUEST IN PERSON:
    A subject individual who appears in person seeking access or 
disclosure of records relating to him/her shall provide his/her name, 
current address, and at least one piece of tangible identification such 
as a driver's license, passport, voter registration card, or union 
card. Identification papers with current photographs are preferred but 
not required. Additional identification may be requested when there is 
a request for access to records which contain an apparent discrepancy 
between information contained in the records and that provided by the 
individual requesting access to the record. No verification of identity 
shall be required where the record is one which is required to be 
disclosed under the Freedom of Information Act.

REQUESTS BY MAIL:
    To determine if a record exist about you, write to the System 
Manager. The request must contain the name and address of the 
individual, assigned court docket number (if known), and a 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 $5000 fine.

REQUESTS BY TELEPHONE:
    Since positive identification of the caller cannot be established, 
telephone requests are not honored.

RECORDS ACCESS PROCEDURES:
    Same as notification procedures. Individuals may also request an 
accounting of disclosures that have been made of their records, if any.

CONTESTING RECORDS PROCEDURES:
    Contact the appropriate official at the address specified under 
Notification Procedures above and reasonably identify the record, 
specify the information being contested, and state the corrective 
action sought and the reason(s) for requesting the correction, along 
with supporting justification to show how the record is inaccurate, 
incomplete, untimely, or irrelevant.

RECORD SOURCE CATEGORIES:
    Petitioner, petitioner's legal representative, health care 
providers, and other interested persons.

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE PRIVACY ACT:
    None.
[FR Doc. 2010-24576 Filed 9-29-10; 8:45 am]
BILLING CODE 4160-15-P