[Federal Register Volume 76, Number 97 (Thursday, May 19, 2011)]
[Notices]
[Pages 28991-28994]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-12258]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Privacy Act of 1974; Report of a New System of Records

AGENCY: Health Resources and Services Administration, HHS.

ACTION: Notice of a new system of records.

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SUMMARY: In accordance with the requirements of the Privacy Act of 
1974, the Health Resources and Services Administration (HRSA) is 
proposing a new system of records. The Countermeasures Injury 
Compensation Program (CICP), authorized by the Public Readiness and 
Emergency Preparedness Act (PREP Act), provides compensation to certain 
individuals for serious physical injuries or deaths resulting from the 
administration or use of pandemic, epidemic, or security 
countermeasures identified in declarations issued by the Secretary of 
the U.S. Department of Health and Human Services (the Secretary) 
pursuant to section 319F-3(b) of the Public Health Service Act (PHS 
Act) (42 U.S.C. 247d-6d). The Secretary has issued several declarations 
specifying covered countermeasures, such as the pandemic 2009 H1N1 
influenza vaccines, antiviral medications (e.g., Tamiflu), anthrax 
vaccines, and smallpox vaccines. The PREP Act directs the Secretary to 
establish administrative procedures to compensate individuals who 
sustained serious injuries as the direct result of the administration 
or use of covered countermeasures. This system of records is required 
to comply with the implementation directives of the PREP Act, Public 
Law 109-148. The records will be used for the CICP's resource planning, 
administrative implementation (e.g., making medical and/or financial 
eligibility determinations), compensating requesters, evaluation, 
scientific research, monitoring, and document storage purposes.

DATES: HRSA invites interested parties to submit comments on the 
proposed New System of Records on or before June 20, 2011. As of the 
date of the publication of this Notice, HRSA has sent a Report of New 
System of Records to Congress and to the Office of Management and 
Budget (OMB). The New System of Records will be effective 40 days from 
the date submitted to OMB unless HRSA receives comments that would 
result in a contrary determination.

ADDRESSES: Please address comments to the Director, Countermeasures 
Injury Compensation Program, Healthcare Systems Bureau, Health 
Resources and Services Administration, 5600 Fishers Lane, Room 11C-06, 
Rockville, Maryland 20857; telephone 1-800-ASK-HRSA (275-4772). This is 
a toll-free number. Comments received will be available for inspection 
at this same address from 9 a.m. to 3 p.m., Eastern Standard Time, 
Monday through Friday.

FOR FURTHER INFORMATION CONTACT: Director, Countermeasures Injury 
Compensation Program, Healthcare Systems Bureau, Health Resources and 
Services Administration, 5600 Fishers Lane, Room 11C-06, Rockville, 
Maryland 20857; telephone toll-free 1-800-ASK-HRSA (275-4772).

SUPPLEMENTARY INFORMATION: HRSA proposes to establish a new system of 
records: ``The Countermeasures Injury Compensation Program, HHS/HRSA/
HSB.'' The PREP Act which is a part of the ``Department of Defense, 
Emergency Supplemental Appropriations to Address Hurricanes in the Gulf 
of Mexico, and Pandemic Influenza Act, 2006'' (Pub. L. 109-148), was 
enacted on December 30, 2005, and confers broad liability protections 
on covered persons, as defined in section 319F-3(i)(2) of the PHS Act, 
and authorizes the creation of a Countermeasures Injury Compensation 
Program (CICP or the Program) to compensate individuals injured by the 
administration or use of covered countermeasures, as defined in section 
319F-3(i)(1) of the PHS Act, in the event of designated present or 
future public health emergencies. The Secretary has issued regulations 
for the administrative implementation of the Program at 42 CFR part 
110.
    The PREP Act provides the Secretary the authority, which was 
delegated by the Secretary on November 8, 2006 to the Administrator of 
HRSA, to compensate eligible individuals for covered injuries from a 
covered countermeasure.
    Compensation benefits will be provided for eligible individuals who 
suffer serious physical injuries or death resulting from pandemic, 
epidemic, or security countermeasures such as vaccines identified in 
declarations issued by the Secretary under a ``PREP Act declaration'' 
issued in response to a current public health emergency, or to a 
credible risk that the disease, condition, or threat may in the future 
constitute such an emergency. The Secretary has issued several pandemic 
influenza declarations specifying

[[Page 28992]]

covered countermeasures, such as the pandemic 2009 H1N1 influenza 
vaccines, antiviral medications (e.g., Tamiflu), diagnostic kits, 
mechanical ventilators and N-95 masks. The Secretary has also issued 
declarations for countermeasures against the threats of anthrax, 
smallpox, botulism, and radiation syndrome.
    In order to be considered for CICP benefits, an injured 
countermeasure recipient must have been administered or used a covered 
countermeasure according to the terms of a declaration (or in a good 
faith belief of such). The injured countermeasure recipient must also 
have sustained a serious physical injury or died as a result of the 
covered countermeasure. The PREP Act also allows certain survivors of 
an injured countermeasure recipient to be eligible to receive death 
benefits if the death resulted from the administration or use of the 
covered countermeasure. Also, the estate of a deceased injured 
countermeasure recipient may be eligible for certain benefits, 
regardless of the cause of death
    Subject to certain provisions, the PREP Act authorizes benefits and 
other compensatory payments as payer of last resort for the following:
     Medical Expenses--Reasonable and necessary costs incurred 
for unreimbursed medical items and services may be paid to diagnose, 
treat or prevent a covered countermeasure-related injury of an eligible 
individual.
     Lost Employment Income--The individual may receive 
compensation for loss of employment income incurred as a result of the 
covered countermeasure injury. The amount of compensation is based on 
income at the time of injury. Certain limitations are placed on such 
benefits.
     Survivor Death Benefits--Death benefits may be paid to 
certain survivors of covered countermeasures recipients who have died 
as a direct result of a covered injury.
    Individuals have one (1) year from the date the vaccine or other 
covered countermeasure was administered or used to request benefits.
    This system of records is required to comply with the 
implementation directives set forth in the PREP Act. It will be used 
for Program resource planning, administrative implementation, 
compensation, evaluation, scientific research, monitoring, and document 
storage purposes. HRSA permits disclosure of the records to third 
parties pursuant to the following routine uses: The first routine use 
permits disclosure to a Congressional office to allow subject 
individuals to obtain assistance from their representatives in 
Congress, if they wish to do so. The second routine use allows 
disclosure to Federal, State or local Government entities or to private 
entities for the purpose of their providing information relevant to 
medical, legal or financial documentation required for determinations 
of eligibility or payment. The third routine use allows disclosure of 
records to contractors engaged by the Department of Health and Human 
Services (DHHS or the Department) who need access to the records in 
order to assist the Department, e.g., medical experts or consultants 
providing advice on requester eligibility for benefits and/or 
compensation. The fourth routine use allows disclosure of records to 
contractors engaged by the Department who need access to the records in 
order to assist the Department, in evaluating the effectiveness of the 
CICP. The fifth routine use allows disclosure of records to individuals 
and/or entities as necessary for the purposes of obtaining financial 
advice and providing benefits to requesters approved for payment under 
the Program. The sixth routine use allows disclosure of records to a 
Federal agency administering aspects of the Program under a Memorandum 
of Agreement or assisting in the accomplishment of a Departmental 
function related to the purposes of the Program. The seventh routine 
use allows disclosure of records to the Department of Justice or a 
court in the event of litigation. The eighth routine use allows 
disclosure to the appropriate Federal, State or local agency in the 
event of a violation of law. The ninth routine use allows disclosure of 
records to researchers for certain scientific research purposes. 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 becomes effective.

    Dated: April 15, 2011.
Mary K. Wakefield,
Administrator, Health Resources and Services Administration.
SYSTEM NUMBER:
    09-15-0071.

SYSTEM NAME:
    Countermeasures Injury Compensation Program, HHS/HRSA/HSB.

SECURITY CLASSIFICATION:
    None.

SYSTEM LOCATION:
    Healthcare Systems Bureau (HSB), Health Resources and Services 
Administration (HRSA), 5600 Fishers Lane, Room 11C-06, Rockville, 
Maryland 20857.

CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
    Individuals covered by the system are injured countermeasure 
recipients or their representatives, survivors of such recipients or 
their representatives, and representatives of the estates of deceased 
injured countermeasure recipients, filing for benefits under the 
Countermeasures Injury Compensation Program (CICP or the Program).

CATEGORIES OF RECORDS IN THE SYSTEM:
    Records consist of documents that may include, but are not limited 
to, general or congressional correspondence, requests, case number 
assignment, HHS responses to correspondence, 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, and other related 
case processing documents.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
    The authority for maintaining this system of records is 42 U.S.C. 
247d-6e. Management of the system is authorized by Public Law 109-148, 
the Public Readiness and Emergency Preparedness Act (PREP Act), enacted 
on December 30, 2005 (42 U.S.C. 247d-6e).

PURPOSE(S):
    The purpose of the system is 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. Requests for Benefits must be submitted to 
the CICP no later than (one) 1 year from the date the recipient was 
administered or used a covered countermeasure.

ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES 
OF USERS AND THE PURPOSES OF SUCH USES:
    1. Disclosure may be made to a Congressional office from the record 
of a subject individual, in response to an inquiry from the 
Congressional office made at the written request of that individual or 
his/her legal or personal representative.
    2. Disclosure may be made to Federal, State or local Government 
entities or to private entities for the purpose of their providing 
information relevant to

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medical, legal, or financial (e.g., insurance, payment) documentation 
required for determinations of eligibility or payment, provided that 
such disclosure is compatible with the purpose for which the records 
were collected.
    3. Disclosure of records may be made to contractors engaged by the 
Department who need access to the records in order to assist the 
Department, e.g., medical experts or consultants providing advice on 
requesters' eligibility for benefits. All such individuals shall be 
required to maintain Privacy Act safeguards with respect to such 
records and return all records to HRSA and not retain any copies.
    4. Disclosure of records may be made to contractors engaged by the 
Department who need access to the records in order to assist the 
Department in evaluating the effectiveness of the CICP.
    5. 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 
Program. 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.
    6. Disclosure of records may be made to a Federal agency assisting 
in the accomplishment of a Departmental function relating to the 
purposes of this system of records, provided that such disclosure is 
compatible with the purposes for which the records are collected, or to 
a Federal agency administering aspects of the Program, as authorized by 
a Memorandum of Agreement between the Secretary or her designee and the 
head of the Federal agency or designee.
    7. Disclosure of records may be made 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 
action, 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 (DOJ) has agreed to represent such employee, 
for example, in defending an action against the Department in 
connection with such individual, disclosure may be made to DOJ to 
enable DOJ to present an effective defense, provided that such 
disclosure is compatible with the purpose for which the records were 
collected.
    8. Disclosure may be made in the event that a system of records 
maintained by this agency to carry out its functions 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 the records were collected.
    9. 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) Established strict limitations acceptable to the Department 
concerning the receipt and use of any patient-identifiable data;
    (2) Established 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) Secures and approves a written statement attesting to the 
recipient's understanding of, and agreement to abide by, these 
conditions of disclosure.
    Violation of these provisions is subject to penalties set forth 
under 5 U.S.C. 552a(i)(3) and any other applicable Federal law.
    10. Disclosure of records may be made 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:
STORAGE:
    Records are maintained in file folders, on computer hard drives and 
shared drives, and/or in electronic media storage.

RETRIEVABILITY:
    Records can be retrieved by the requester's name and by the case 
number assigned based on the order in which the Letter of Intent to 
File a Request for Benefits or the Request for Benefits form is filed.

SAFEGUARDS:
    1. Assign Responsibility for Security: Responsibility is assigned 
to a CICP management official who is knowledgeable about the nature of 
the information in this system of records, the process of reviewing 
records contained in it, and in the management, personnel, operational, 
and technical controls used to protect it.
    2. Perform Risk Assessment: A risk assessment is to be conducted in 
conjunction with the development of, and prior to the approval of, the 
system design and will ensure that vulnerabilities, risks, and other 
security concerns are identified and addressed in the system design and 
throughout the life cycle of the project. This is consistent with the 
Information Security Program Policy, HHS IRM Policy 2004-002.001 (Dec. 
15, 2004), Section 3.7.3.
    3. Develop CICP Request Security Plan: Plan for the adequate 
security of the CICP Request for Benefits system, taking into account 
the security of all systems in which Requests for Benefits will 
operate. CICP request security plans shall address request rules, 
training on

[[Page 28994]]

use of the system, personnel security, contingency planning, technical 
controls, information sharing, and public access controls.
    4. Review CICP Request for Benefits System Controls: Perform an 
independent review or audit of the CICP Request for Benefits system 
security control in accordance with applicable Federal requirements 
and/or guidelines.
    5. Authorize Processing: Ensure that a management official 
authorizes, in writing, confirmation that the security plan as 
implemented adequately secures the CICP Request for Benefits system. 
The CICP Request for Benefits system must be authorized prior to 
operating and reauthorized in accordance with applicable Federal 
requirements and/or guidelines.
    6. Implementation Guidelines: DHHS Chapter 45-13 ``Safeguarding 
Records Contained in Systems of Records;'' the Information Security 
Program Policy, HHS IRM Policy 2004-002.001 (Dec. 15, 2004); and 
Appendix III to OMB Circular No. A-130 ``Security of Federal Automated 
Information Resources;'' Appendix I to OMB Circular No. A-130, 
``Federal Agency Responsibilities for Maintaining Records About 
Individuals.''

RETENTION AND DISPOSAL:
    HRSA is working with NARA to obtain the appropriate retention 
value. Records will be retained and disposed of in accordance with the 
Records Control Schedule of the Health Resources and Services 
Administration.

SYSTEM MANAGER(S) AND ADDRESS:
    Director, Countermeasures Injury Compensation Program, Healthcare 
Systems Bureau, Health Resources and Services Administration, 5600 
Fishers Lane, Room 11C-06, Rockville, Maryland 20857, or the Director's 
designee.

NOTIFICATION PROCEDURE:
    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 whom 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 (45 CFR 5b.5(b)(2)(ii)).
    Requests in person: Record access procedures are the same as 
notification procedures. 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. A parent 
or guardian who requests notification of, or access to, a minor/legally 
incompetent person's medical records must verify his/her relationship 
to the minor/legally incompetent person as well as his/her own identity 
and shall designate a family physician or other health professional 
(other than a family member) to whom the record, 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 (e-mail) requests will not be honored.

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

CONTESTING RECORDS 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.

RECORD SOURCE CATEGORIES:
    Sources of 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 medical or 
legal 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).

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:
    None.

[FR Doc. 2011-12258 Filed 5-18-11; 8:45 am]
BILLING CODE 4160-15-P