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

###### Health Resources and Services Administration

# 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.                              ( print 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).                               ( print 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

    -  Storage:                          File folders and disks.                    
    -  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.                    
    - 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