60468 Federal Register / Vol. 75, No. 189 / Thursday, September 30, 2010 / Notices 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, Cancer 

Metastasis. 

Date: October 4, 2010. 

Time: 12:30 p.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hyatt Regency Hotel on Capitol Hill, 

400 New Jersey Avenue, NW., Washington, 

DC 20001. 

Contact Person: Syed M Quadri, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 6210, 

MSC 7804, Bethesda, MD 20892. 301–435– 

1211. quadris@csr.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: September 24, 2010. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–24550 Filed 9–29–10; 8:45 am] 

BILLING CODE 4140–01–P 

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 twentyfive 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. 

mstockstill on DSKH9S0YB1PROD with NOTICES6

Federal Register / Vol. 75, No. 189 / Thursday, September 30, 2010 / Notices 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). 

mstockstill on DSKH9S0YB1PROD with NOTICES6

60470 Federal Register / Vol. 75, No. 189 / Thursday, September 30, 2010 / Notices 

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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Request for Nominations for AHRQ 

Study Section Members—Notice of 

Correction 

On page 55334, Volume 75, Number 

175, Federal Register notice publication 

dated September 10, 2010, under 

‘‘ADDRESSES’’ section, the correct e-mail 

address is: 

Kishena.Wadhwani@AHRQ.hhs.gov. 

Dated: September 17, 2010. 

Carolyn M. Clancy, 

Director, AHRQ. 

[FR Doc. 2010–24425 Filed 9–29–10; 8:45 am] 

BILLING CODE 4160–90–M 

mstockstill on DSKH9S0YB1PROD with NOTICES6