[Federal Register Volume 84, Number 119 (Thursday, June 20, 2019)]
[Notices]
[Pages 28829-28833]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-13091]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Privacy Act of 1974; System of Records

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

ACTION: Notice of a modified system of records and rescindment of a 
system of records notice.

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SUMMARY: In accordance with the requirements of the Privacy Act of 
1974, as amended, the HHS is modifying a system of records maintained 
by HRSA, Healthcare Systems Bureau (HRSA/HSB), System No. 09-15-0056, 
``National Vaccine Injury Compensation Program'' (VICP), and renaming 
it ``Injury Compensation Programs, HHS/HRSA/HSB.'' The primary purpose 
of the modification is to include records covered by a related system 
of records also maintained by HRSA/HSB, System No. 09-15-0071, 
``Countermeasures Injury Compensation Program, HHS/HRSA/HSB'' (CICP), 
in order to consolidate the two systems of records and rescind System 
No. 09-15-0071.

DATES: In accordance with 5 U.S.C. 552a(e)(4) and (11), this notice is 
applicable June 20, 2019, subject to a 30-day period in which to 
comment on the new and revised routine uses, described below. Please 
submit any comments by July 22, 2019.

ADDRESSES: Please address written comments to the Director, Division of 
Injury Compensation Programs, HSB, HRSA, 5600 Fishers Lane, Rm. 8N146B, 
Rockville, MD 2085 or [email protected]. Comments received 
will be available for inspection at this same address from 9:00 a.m. to 
3:00 p.m. (Eastern Standard Time), Monday through Friday.

FOR FURTHER INFORMATION CONTACT: General questions about the system of 
records may be submitted to Dr. Narayan Nair, Director, Division of 
Injury Compensation Programs, HSB, HRSA, HHS, 5600 Fishers Lane, Rm. 
8N146B, Rockville, MD 20857. General questions about the system of 
records may also be submitted to Dr. Narayan Nair via telephone at 1-
800-338-2382 or email at [email protected].

[[Page 28830]]


SUPPLEMENTARY INFORMATION: System No. 09-15-0056 currently covers 
records about individuals who file claims with the Vaccine Injury 
Compensation Program (VICP) seeking compensation for alleged vaccine-
related injuries. In addition to other changes, the system is being 
modified to include the records covered by a related system of records 
that is being rescinded, System No. 09-15-0071, which is about 
individuals requesting benefits from the Countermeasures Injury 
Compensation Program (CICP) for injuries alleged to have been caused by 
administration or use of covered countermeasures, such as the 2009 H1N1 
vaccine.

I. Explanation of Modifications to System No. 09-15-0056

    The modifications to the System of Records Notice (SORN) for System 
No. 09-15-0056 are as follows:
     The SORN has been reformatted to comply with OMB Circular 
A-108.
     The name of the system of records has been changed from 
``National Vaccine Injury Compensation Program'' to ``Injury 
Compensation Programs, HHS/HRSA/HSB,'' to reflect its expanded scope.
     The System Location and System Manager contact information 
has been updated with a new room number.
     CICP-related descriptions have been added to the 
Authority, Purpose, Categories of Individuals, Categories of Records, 
Records Source Categories, Routine Uses, and Policies and Practices for 
Retrieval of Records sections.
     Two unnecessary routine uses, numbered as 11 and 12 in the 
current SORN, have been removed. They permitted records about an 
individual record subject who is a minor or incompetent adult to be 
disclosed to the individual's parent or guardian. Such disclosures are 
considered to be disclosures to the individual record subject under 5 
U.S.C. 552a(h) and therefore do not require a routine use.
     Routine uses 2 and 13 have been added:
    [cir] New routine use 2 applies to both VICP and CICP records (it 
previously applied to only CICP records, and was numbered as 2 in the 
CICP SORN).
    [cir] New routine use 13 applies to CICP records only. It was 
numbered as 5 in the CICP SORN.
     The following routine uses have been revised or 
renumbered:
    [cir] Routine use 1 (authorizing disclosures to contractors, 
medical experts and consultants, another federal agency, or others 
engaged to assist the agency) combines routine uses which were numbered 
as 3 and 8 in the VICP SORN and as 3 and 4 and in the CICP SORN.
    [cir] Routine use 3 (numbered as 9 in the VICP SORN) authorizes 
disclosures for research purposes and the wording has been changed to 
the wording in routine use 9 in the CICP SORN.
    [cir] Routine use 4 (authorizing disclosures to the U.S. Department 
of Justice (DOJ) or a court or other tribunal in proceedings) combines 
routine uses which were numbered as 2 and 4 in the VICP SORN and as 7 
in the CICP SORN. The word ``litigation'' has been changed to 
``proceedings.''
    [cir] Routine use 5 (authorizing disclosures to congressional 
offices) was numbered 1 in the VICP SORN and as 1 in the CICP SORN.
    [cir] Routine use 6 (authorizing disclosures in the event of a 
violation or potential violation of law) was numbered 13 in the VICP 
SORN and 8 in the CICP SORN.
    [cir] Routine uses 7 (numbered as 14 in the VICP SORN, and as 10 in 
the CICP SORN) and 8 (not previously numbered) are breach response-
related routine uses which were previously revised or added as required 
by OMB Memorandum M-17-12 (see 83 FR 6591 published Feb. 14, 2018).
    [cir] Routine use 9 (numbered as 10 in the VICP SORN) previously 
applied to only VICP records. The words ``program award'' has been 
changed to ``program award or benefit,'' in order to make this one 
routine use apply to both VICP and CICP records (to avoid providing 
separate, nearly identical routine uses). The words ``local, state and 
the Federal'' have been added before ``government.''
    [cir] Routine use 10 was numbered 5 in the VICP SORN.
    [cir] Routine use 11 was numbered 6 in the VICP SORN.
    [cir] Routine use 12 was numbered 7 in the VICP SORN.
     The Storage section has been revised to change ``disks'' 
to ``portable electronic media.''
     The Retrieval section has been revised to remove docket 
number and case number, which are not direct personal identifiers.
     The Retention section has been revised to remove language 
referring to the ``Records Control Schedule of HRSA'' and to add the 
term ``disposition schedule.''

II. Reason for Rescinding Related System No. 09-15-0071

    The CICP records previously maintained in system of records 09-15-
0071 are now covered in modified system of records 09-15-0056. 
Accordingly, HHS is rescinding System No. 09-15-0071 as duplicative of 
System No. 09-15-0056.

    Dated: June 14, 2019.
George Sigounas,
Administrator.

SYSTEM NAME AND NUMBER:
    Injury Compensation Programs, HHS/HRSA/HSB, 09-15-0056.

SECURITY CLASSIFICATION:
    Unclassified.

SYSTEM LOCATION:
    The address of the agency component responsible for the system is 
Division of Injury Compensation Programs (DICP), Healthcare Systems 
Bureau (HSB), Health Resources and Services Administration (HRSA), 5600 
Fishers Ln., Rm. 8N146B, Rockville, MD 20857.

SYSTEM MANAGER(S):
    Director, Division of Injury Compensation Programs, Healthcare 
Systems Bureau, Health Resources and Services Administration, 5600 
Fishers Ln., Rm. 8N146B, Rockville, MD 20857, or the Director's 
designee.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
    National Vaccine Injury Compensation Program (VICP): National 
Childhood Vaccine Injury Act of 1986, as amended (Vaccine Act), 42 
U.S.C. 300aa-10, et seq.
    Countermeasures Injury Compensation Program (CICP): Public 
Readiness and Emergency Preparedness Act of 2005 (PREP Act), 42 U.S.C. 
247d-6e.

PURPOSE(S) OF THE SYSTEM:
    VICP records are used to determine eligibility of petitioners to 
receive compensation, and to compensate successful petitioners in the 
amount and in the manner determined by the U.S. Court of Federal Claims 
(Court). CICP records are used to determine eligibility for benefits 
and to provide benefits to certain individuals who have sustained a 
covered injury as a result of the administration or use of a covered 
countermeasure, and to provide benefits to the survivors and/or estates 
of deceased injured countermeasure recipients. Note that any 
overpayment or other debt-related information arising from VICP or CICP 
may be used and disclosed for debt management and collection purposes 
as described in the SORN published for HHS' Debt Management and 
Collection System, System No. 09-40-0012, last published in full at 63 
FR 68596 (Dec.11, 1998), updated at 80 FR 67767 (Nov. 3, 2015) and 83 
FR 6591 (Feb. 14, 2018).

[[Page 28831]]

CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
    The records in this system of records are about:
     Individuals who file claims with the VICP (VICP 
Petitioners); and
     Individuals who request benefits from the CICP (CICP 
requesters or their representatives).

CATEGORIES OF RECORDS IN THE SYSTEM:
    The records consist of medical records, including medical expense 
records, employment records, and other documents used to support injury 
compensation claims and to make program recommendations and decisions. 
Records may contain the following information about each category of 
individual:
     VICP petitioners: Claim or 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), 
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, payment information, general or 
congressional correspondence, HHS responses to correspondence, and 
other related case processing documents.
     CICP requesters: Request for benefits, including 
requester's name and name of injured countermeasure recipient if 
different from requester, case number assignment, medical and legal 
documentation, employment documentation, documentation concerning 
services or benefits available from the United States or any third 
party (including any state or local governmental entity, private 
insurance carrier, or employer), payment information, general or 
congressional correspondence, HHS responses to correspondence, and 
other related case processing documents.

RECORD SOURCE CATEGORIES:
    Records about a VICP petitioner are obtained from the petitioner, 
petitioner's legal representative, health care providers, and other 
interested persons. Records about a CICP requester are obtained from 
the requester, requester's representative, health care providers, and 
other interested persons. Sources of VICP records include, but are not 
limited to the petitioner, petitioner's legal representative, health 
care providers and other interested parties. Sources of CICP records 
include, but are not limited to, countermeasure recipients and/or their 
legal or personal representatives under the Countermeasures Injury 
Compensation Program, and any other sources of information or 
documentation submitted by any other person or entity for inclusion in 
a request for the purpose of determining eligibility for, or amount of 
benefits and/or compensation under, the Program (e.g., federal, state, 
or local government or private health care entities participating in 
the administration of covered countermeasures under a Secretarial 
declaration).

ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING RECORD 
SOURCE CATEGORIES AND CATEGORIES OF USERS AND PURPOSES OF SUCH USES:
    Information about an individual VICP petitioner or CICP requester 
may be disclosed from this system of records to parties outside the 
agency without the individual's prior, written consent pursuant to 
these routine uses:
    1. Records may be disclosed to an agency contractor, another 
federal agency, agency consultants, or others who have been engaged by 
HHS to assist with accomplishment of an HHS function relating to the 
purposes of this system of records and who need to have access to the 
records in order to assist HHS. For example:
    a. HRSA will contract with expert medical consultants to obtain 
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 
concerning such records and return all records to HRSA.
    b. To the extent necessary, a record may be disclosed to agency 
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 concerning such records.
    c. Disclosure of records may be made to contractors engaged by the 
Department who need access to the records to assist the Department in 
evaluating the effectiveness of the CICP.
    2. Disclosure may be made to federal, state or local government 
entities or to private entities for the purpose of requesting, and 
enabling them to locate and provide information relevant to medical, 
legal, or financial (e.g., insurance, payment) documentation required 
for determinations of eligibility or payment.
    3. A record may be disclosed to researchers for a scientific 
research purpose, only when the Department has determined:
    (A) That the use or disclosure does not violate legal or policy 
limitations under which the record was provided, collected, or 
obtained;
    (B) That the research purpose is consistent with the purpose for 
which the program was formed;
    (C) That the proposed research is scientifically sound in its 
methods and analyses and is likely to answer the proposed research 
question;
    (D) That the information sought is not available from any other 
source;
    (E) That the record made available for scientific research is 
redacted of all personal identifiers regarding injured individuals, 
health care practitioners, and employers that are not essential for the 
accomplishment of the approved research purpose, and;
    (F) That the recipient of records for scientific research purposes:
    (1) Establishes strict limitations acceptable to the Department 
concerning the receipt and use of any patient-identifiable data;
    (2) Establishes reasonable administrative, technical, and physical 
safeguards and/or protocols acceptable to the Department to protect the 
confidentiality of the data and to prevent the unauthorized use or 
disclosure of the record;
    (3) Removes or destroys the information that identifies an 
individual at the earliest time that removal or destruction can be 
accomplished consistent with the purpose of the research project;
    (4) Makes no further use or disclosure of the record, except when 
required by law; and
    (5) Provides a written statement (approved by the agency) attesting 
to the recipient's understanding of, and agreement to abide by, these 
conditions of disclosure and that violation of these provisions is 
subject to penalties set forth under 5 U.S.C. 552a(i)(3) and any other 
applicable federal law.
    4. Records may be disclosed to DOJ or to a court or other tribunal 
when: (a) HHS or any of its components; or (b) any employee of HHS 
acting in the employee's official capacity; or (c) any employee of HHS 
acting in the employee's individual capacity where the DOJ or HHS has 
agreed to represent the employee; or (d) the United States Government, 
is a party to a proceeding or has an interest in such proceeding and 
the disclosure of such records is deemed by the agency to be relevant 
and necessary to the proceeding. For example:

[[Page 28832]]

    a. HRSA will release the petitioner's complete medical file and may 
release a consultant(s)' report to the DOJ and the court for 
adjudication of a VICP compensation claim.
    5. Disclosures may be made to a congressional office from the 
record of an individual, in response to a written inquiry from the 
congressional office made at the written request of the individual or 
his/her legal or personal representative.
    6. Where a record, either alone or in combination with other 
information, 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 or by regulation, 
rule, or order issued pursuant thereto, the relevant records may be 
referred to the appropriate agency, whether federal, state, local, 
tribal, territorial, or foreign, 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.
    7. Records may be disclosed to appropriate agencies, entities, and 
persons when (1) HHS suspects or has confirmed that there has been a 
breach of the system of records, (2) HHS has determined that as a 
result of the suspected or confirmed breach there is a risk of harm to 
individuals, HHS (including its information systems, programs, and 
operations), the federal government, or national security, and (3) the 
disclosure made to such agencies, entities, and persons is reasonably 
necessary to assist in connection with HHS's efforts to respond to the 
suspected or confirmed breach or to prevent, minimize, or remedy such 
harm.
    8. Records may be disclosed to another federal agency or federal 
entity, when HHS determines that information from this system of 
records is reasonably necessary to assist the recipient agency or 
entity in: (1) Responding to a suspected or confirmed breach or (2) 
preventing, minimizing, or remedying the risk of harm to individuals, 
the recipient agency or entity (including its information systems, 
programs, and operations), the federal government, or national 
security, resulting from a suspected or confirmed breach.
    9. To the extent necessary, a record may be disclosed for the 
purpose of ensuring that a government reversionary trust or government-
owned annuity established in connection with a program award or benefit 
is being properly administered. Such disclosures may be made to 
institutions serving as trustees and medical administrators concerning 
such trusts, to insurance companies administering such government-owned 
annuities, to individuals serving as guardians of the estate of 
individuals compensated by the program, and to attorneys representing 
such parties (or representing local, state, tribal, territorial, 
foreign and the federal government). Organizations or individuals to 
which information is disclosed for this use will be required to 
maintain Privacy Act safeguards concerning such records. Records may 
also be disclosed for the same purpose to courts of competent 
jurisdiction in which trust administration or government-owned annuity 
issues arising out of program claims are raised.
    10. Consistent with its obligation under the Vaccine Act, HRSA will 
disclose for publication in the Federal Register the following 
information from VICP records: The name of the petitioner; the name of 
the person vaccinated, if not the petitioner; the city and State where 
the vaccine was administered (if unknown, then the city and state of 
the person or attorney filing the claim); and the court's docket 
number.
    11. VICP records may be disclosed to organizations deemed qualified 
by the Secretary of Health and Human Services (Secretary) for the 
purpose of evaluating the administration, process, or outcomes of the 
VICP (as required by Congress). The purpose of the disclosure is to 
document the extent to which the VICP 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 
concerning such records.
    12. To the extent necessary, VICP records may be disclosed to 
annuity brokers, reversionary trust banks/trustees, and to employees of 
life insurance companies to obtain financial advice and for the 
purchase of contracts to provide compensation to eligible petitioners 
under the Program. Organizations to which information is disclosed for 
this use will be required to maintain Privacy Act safeguards concerning 
such records and return all records to HRSA without retaining any 
copies.
    13. Disclosure of records may be made to individuals and/or 
entities as necessary for the purposes of obtaining financial advice 
and providing benefits to requesters approved for payment under the 
CICP. All individuals and/or entities permitted disclosure for this use 
shall be required to maintain Privacy Act safeguards with respect to 
such records and return all records to HRSA without retaining any 
copies.
    The disclosures authorized by publication of the above routine uses 
pursuant to 5 U.S.C. 552a(b)(3) are in addition to other disclosures 
authorized directly in the Privacy Act at 5 U.S.C. 552a(b)(4)-(11).

POLICIES AND PRACTICES FOR STORAGE OF RECORDS:
    Records are stored in the Injury Compensation System (ICS), 
portable electronic media storage, and paper file folders.

POLICIES AND PRACTICES FOR RETRIEVAL OF RECORDS:
     VICP: Records are retrieved by the name of the petitioner 
and/or the name of the individual vaccinated.
     CICP: Records are retrieved by the name of the requester 
and/or the individual who was administered or used a countermeasure.

POLICIES AND PRACTICES FOR RETENTION AND DISPOSAL OF RECORDS:
    Records are disposed of 25 years after the case file is closed, in 
accordance with records disposition schedule N1-512-96-1.

ADMINISTRATIVE, TECHNICAL, AND PHYSICAL SAFEGUARDS:
    1. Authorized users: Access is limited to the System Manager, 
authorized HRSA/HSB personnel responsible for administering these 
programs, and authorized HHS Office of the General Counsel personnel 
responsible for advising these programs. HRSA/HSB maintains a current 
list of authorized users.
    2. Physical safeguards: All hard copy files are stored in filing 
cabinets which are kept in locked and secured rooms during non-work 
hours; portable electronic storage and computer equipment are retained 
in areas where fire and safety codes are strictly enforced. All 
electronic and hard copy 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 another courier service to ensure that a signature is 
required upon receipt of the records; escorting visitors into areas 
where records are maintained; utilizing two-

[[Page 28833]]

factor authentication for computer access; and securing areas where 
records are stored. Job-specific assigned roles control 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 unauthorized personnel entering an unsupervised office.
    4. Risk assessment: Risk assessments and continuous monitoring 
activities ensure that vulnerabilities, risks, and other security 
concerns are identified and addressed in the system design and 
throughout the life cycle of the project.

RECORD ACCESS PROCEDURES:
    Record access procedures are the same as Requests in Person 
procedures below.

CONTESTING RECORD PROCEDURES:
    To contest a record in the system, contact the System Manager at 
the address specified above and reasonably identify the record, 
stipulate the information being contested, state the corrective action 
sought and the reason(s) for requesting the correction, along with 
supporting documentation to show how the record is inaccurate, 
incomplete, untimely, or irrelevant.

NOTIFICATION PROCEDURES:
    Requests must be made to the System Manager.
    Requests by mail: Requests for information and/or access to records 
received by mail must contain information providing the identity of the 
writer, and a reasonable description of the record desired, and who it 
concerns. Written requests must contain the name and address of the 
requester, his/her date of birth and his/her signature for comparison 
purposes. Requests must be notarized to verify the identity of the 
requester, or the requester must certify that (s)he is the individual 
who (s)he claims to be and that (s)he understands that to knowingly and 
willfully request or acquire a record pertaining to another individual 
under false pretenses is a criminal offense under the Privacy Act 
subject to a $5,000 fine. The requester should provide a reasonable 
description of the contents of the record being sought. Records will be 
mailed only to the requester's address that is on file unless a 
different address is demonstrated by official documentation.
    Requests in person: An individual who makes a request in person 
shall provide to the System Manager at least one piece of tangible 
identification such as a driver's license, passport, alien or voter 
registration card, or union card to verify his/her identity. If an 
individual does not have identification papers to verify identity, 
(s)he must certify in writing that (s)he is the individual (s)he claims 
to be and that (s)he understands that the knowing and willful request 
for, or acquisition of, a record pertaining to an individual under 
false pretenses is a criminal offense subject to a $5,000 fine.
    Requests on behalf of a minor/legally incompetent person: A parent 
or guardian who makes a request on behalf of a minor/legally 
incompetent person must verify his/her relationship to the minor/
legally incompetent person as well as his/her own identity. If 
requesting a minor or legally incompetent person's medical records, the 
parent or guardian of a minor/legally incompetent person must designate 
a family physician or other health professional (other than a family 
member) to whom the records, if any, will be sent.
    Requests by telephone/facsimile/electronic mail: Since positive 
identification of the requester cannot be established, telephone, 
facsimile, or electronic mail (email) requests will not be honored.

EXEMPTIONS PROMULGATED FOR THE SYSTEM:
    None.

HISTORY:
    75 FR 60468 (Sept. 30, 2010), 83 FR 6591 (Feb. 14, 2018).

Notice of Rescindment

    For the reason explained in the SUPPLEMENTARY INFORMATION section 
at II., the following system of records is rescinded:

SYSTEM NAME AND NUMBER:
    Countermeasures Injury Compensation Program, HHS/HRSA/HSB, 09-15-
0071.

HISTORY:
    76 FR 28991 (May 19, 2011), 83 FR 6591 (Feb. 14, 2018).

[FR Doc. 2019-13091 Filed 6-19-19; 8:45 am]
 BILLING CODE 4165-15-P