Federal Register / Vol. 77, No. 62 / Friday, March 30, 2012 / Notices 19295 

issues, including the status of farmworker 

health at the local and national levels. 

Agenda items are subject to change as 

priorities indicate. 

For Further Information Contact: Gladys 

Cate, Office of Special Population Health, 

Bureau of Primary Health Care, Health 

Resources and Services Administration, 5600 

Fishers Lane, Room 15–62, Rockville, 

Maryland 20857; telephone (301) 594–0367. 

Dated: March 22, 2012. 

Reva Harris, 

Acting Director, Division of Policy and 

Information Coordination. 

[FR Doc. 2012–7613 Filed 3–29–12; 8:45 am] 

BILLING CODE 4165–15–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 (SOR). 

SUMMARY: In accordance with the 

requirements of the Privacy Act of 1974 

(5 U.S.C. 552a), as amended, the Health 

Resources and Services Administration 

(HRSA) is publishing a notice to alter 

the system of records for the National 

Practitioner Data Bank for Adverse 

Information on Physicians and Other 

Health Care Practitioners, HHS/HRSA/ 

BHPR. The System of Records Notice 

(SORN) 09–15–0054 was last published 

on October 1, 2010 (75 FR 60763). The 

Health Care Quality Improvement Act of 

1986, as amended, title IV of Public Law 

99–660 (42 U.S.C. 11101 et seq.) 

authorized the Secretary to establish a 

National Practitioner Data Bank (NPDB) 

to collect and release certain 

information relating to the professional 

competence and conduct of physicians, 

dentists, and other health care 

practitioners. By law, the information is 

releasable only to the specific entities 

described in the SORN. The law 

requires the maintenance of records 

such as medical malpractice payments, 

adverse licensure and clinical privilege 

actions, disciplinary actions taken by 

Boards of Medical Examiners, and 

professional review actions taken by 

entities against physicians, dentists, and 

other healthcare practitioners. Section 

1921 of the Social Security Act, as 

amended, expands reporting to the 

NPDB to authorize maintenance of 

records of adverse licensure actions and 

negative actions or findings taken by a 

State licensing authority, peer review 

organization, or private accreditation 

entity against all health care 

practitioners or healthcare entities. 

The primary purpose of this alteration 

is to publish the Privacy Act exemptions 

that became necessary after 

implementation of Section 1921, which 

entitles law enforcement agencies to 

access NPDB information and which 

therefore requires a similar exemption 

from certain provisions of the Privacy 

Act that the Healthcare Integrity and 

Protection Data Bank (HIPDB) has for 

investigative materials. Because some of 

the records may be queried by law 

enforcement agencies for investigative 

purposes (i.e., as opposed to 

employment or other purposes), the 

system will be exempt from certain 

Privacy Act requirements to the extent 

necessary to avoid revealing law 

enforcement investigative interest and 

compromising law enforcement 

investigations. Another purpose of this 

alteration is to add a new routine use 

pertaining to system security, which is 

being added to other SORNs published 

by HHS. 

DATES: As required by the Privacy Act 

(5 U.S.C. 552a(r)), HRSA filed an altered 

system of records report with the Chair 

of the House Committee on Oversight 

and Government Reform, 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 

1/25/12. To ensure all parties have 

adequate time in which to comment, the 

altered system will become effective 30 

days from the publication of this 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 

Associate Administrator, Bureau of 

Health Professions, Health Resources 

and Services Administration, 5600 

Fishers Lane, Room 8–103, Rockville, 

Maryland 20857. Comments received 

will be available for inspection at this 

same address from 9 a.m. to 3 p.m. 

(Eastern Standard Time Zone), Monday 

through Friday. 

FOR FURTHER INFORMATION CONTACT: 

Director, Division of Practitioner Data 

Banks, Bureau of Health Professions, 

5600 Fishers Lane, Room 8–103, 

Rockville, Maryland 20857; Telephone: 

(301) 443–2300. This is not a toll-free 

number. 

SUPPLEMENTARY INFORMATION: The 

National Practitioner Data Bank (NPDB) 

is primarily an alert or flagging system 

intended to facilitate a comprehensive 

review of health care practitioners’ 

professional credentials for the purpose 

of protecting the public from unfit 

practitioners. On January 28, 2010, the 

Health Resources and Services 

Administration published a final rule in 

the Federal Register (75 FR 4656) 

designed to implement section 1921 of 

the Social Security Act (herein referred 

to as section 1921). Section 1921 

expands the scope of the NPDB. Section 

1921 requires each state to adopt a 

system of reporting to the Secretary 

certain adverse licensure actions taken 

against health care practitioners and 

health care entities by any authority of 

the state responsible for the licensing of 

such practitioners or entities. It also 

requires each state to report any 

negative action or finding that a state 

licensing authority, a peer review 

organization, or a private accreditation 

entity has finalized against a health care 

practitioner or entity. Practically 

speaking, Section 1921 resulted in, 

among other consequences, the 

inclusion of the vast majority of 

information contained in the Healthcare 

Integrity and Protection Data Bank 

(HIPDB), a companion data bank, in the 

NPDB. 

The HIPDB was created by the Health 

Insurance Portability and 

Accountability Act (HIPAA) of 1996, 

Public Law (Pub. L. 104–191), which 

required the Secretary of HHS, acting 

through the Office of Inspector General 

(OIG) and the United States Attorney 

General, to establish a new health care 

fraud and abuse control program to 

combat health care fraud and abuse. 

Although their purposes are different, 

together the HIPDB and NPDB serve to 

facilitate review of health care 

practitioners’ and entities’ backgrounds. 

The HIPDB is exempt from certain 

provisions of the Privacy Act (see 45 

CFR 5b.11(b)(2)(ii)(F)). In order to 

maintain the exemption for the HIPDB 

investigative materials, which are now 

also available through the NPDB, and 

other expanded information which law 

enforcement agencies can access, it was 

necessary to extend similar Privacy Act 

exemptions for the HIPDB to the NPDB. 

The new routine use that is being added 

for this system pertains to system 

security. It is not specific to the NPDB 

system; it is being added to new, 

existing, and updated SORNs published 

by HHS for other systems that are 

affected by the same security 

requirement. 

mstockstill on DSK4VPTVN1PROD with NOTICES

19296 Federal Register / Vol. 77, No. 62 / Friday, March 30, 2012 / Notices 

Dated: March 21, 2012. 

Mary K. Wakefield, 

Administrator. 

SYSTEM NUMBER: 

09–15–0054. 

SYSTEM NAME: 

National Practitioner Data Bank for 

Adverse Information on Physicians and 

Other Health Care Practitioners, HHS/ 

HRSA/BHPR. 

SECURITY CLASSIFICATION: 

None. 

SYSTEM LOCATION: 

A contractor, SRA International, Inc., 

operates and maintains an Internetbased system through a technical 

service contract for the Division of 

Practitioner Data Banks, Bureau of 

Health Professions, Health Resources 

and Services Administration. SRA’s 

physical address is 4350 Fair Lakes 

Courts, Fairfax, Virginia 22033–4233. 

This system is located at the AT&T Data 

Center, a secure facility; the street 

address will not be disclosed for 

security reasons. 

CATEGORIES OF INDIVIDUALS COVERED BY THE

SYSTEM: 

The system collects and maintains 

records pertaining to the professional 

competence and conduct of individual 

health care practitioners (doctors, 

dentists, nurses, allied health care 

professionals, social workers, etc.) and 

health care entities (hospitals, 

laboratories, pharmacies, etc.). 

CATEGORIES OF RECORDS IN THE SYSTEM: 

The system collects and maintains 

reports and query history records. 

Reports include: (1) Medical 

malpractice payment reports for all 

health care practitioners, i.e., 

physicians, dentists, nurses, 

optometrists, pharmacists, and 

podiatrists, etc.; (2) adverse clinical 

privilege action reports for physicians, 

dentists, and other healthcare 

practitioners who may have medical 

staff privileges either restricted or 

surrendered; (3) adverse licensure 

action reports for physicians, dentists 

and other healthcare practitioners and 

healthcare entities such as a suspension 

or revocation; (4) adverse professional 

society membership action reports for 

physicians, dentists, and other health 

care practitioners; (5) reports of the 

results of formal proceedings by a State 

licensing authority, peer review 

organization, or private accreditation 

organization concluded against a health 

care practitioner or entity; (6) reports of 

Medicare/Medicaid exclusions of all 

healthcare practitioners; and (7) reports 

of adverse actions taken against the U.S. 

Drug Enforcement Administration 

(DEA) registration of all healthcare 

practitioners. 

Reports may contain the following 

personally-identifiable data elements: 

1. Name; 

2. Work address; 

3. Home address; 

4. Social Security number; 

5. Date of birth; 

6. Name of each professional school 

attended and year of graduation; 

7. Professional license(s) number; 

8. Field of licensure; 

9. Name of the State or Territory in 

which the license is held; 

10. DEA registration numbers; 

11. CMS unique practitioner 

identification number (for exclusions 

only); 

12. Names of each hospital with 

which the practitioner is affiliated; 

13. Name and address of the entity 

making the payment; 

14. Name, title, and telephone number 

of the official responsible for submitting 

the report on behalf of the entity; 

15. Payment information including 

the date and amount of payment and 

whether it is for a judgment or 

settlement; 

16. Date action occurred; 

17. Acts or omissions upon which the 

action or claim was based; 

18. Description of the action/ 

omissions and injuries or illnesses upon 

which the action or claim was based; 

19. Description of the Board action, 

the date of action and its effective date; 

and 

20. Classification of the action/ 

omission per reporting code. 

Query histories indicate the dates that 

an individual health care practitioner’s 

report(s) were accessed/queried in the 

system and by whom. Each 

practitioner’s report(s) and query history 

are available to him or her, if the 

practitioner elects to submit a selfquery. However, the query history will 

not include query activity by law 

enforcement agencies, if any, due to the 

system’s exemption. 

AUTHORITY FOR MAINTENANCE OF THE SYSTEM: 

The Health Care Quality Improvement 

Act of 1986, as amended, title IV of 

Public Law 99–660 [42 U.S.C. 11101 et 

seq.], and Section 1921 of the Social 

Security Act, as amended. 

PURPOSE(S): 

The purpose of the system is to: 

(1) Receive information such as adverse 

licensure actions on all healthcare 

practitioners or entities, clinical 

privileges and professional society 

membership actions on physicians and 

dentists based on professional 

competence and conduct, medical 

malpractice payment history on all 

health care practitioners, as well as the 

results of formal proceedings by a State 

authority, peer review organization or 

private accreditation organization 

concluded against any health care 

practitioner or entity; (2) store such 

reports so that future queriers may have 

access to pertinent information 

regarding the review of a health care 

practitioner and/or a healthcare entity 

in their process of making important 

decisions related to the delivery of 

health care services; and (3) disseminate 

such data to entities that qualify to 

receive the reports under the governing 

statutes as authorized by the Health 

Care Quality Improvement Act of 1986 

and Section 1921 of the Social Security 

Act to protect the public from unfit 

practitioners and prevent unfit 

practitioners from providing patient 

care. 

ROUTINE USES OF RECORDS MAINTAINED IN THE

SYSTEM, INCLUDING CATEGORIES OF USERS AND

THE PURPOSES OF SUCH USES: 

Information from this system shall be 

disclosed to: 

1. Hospitals requesting information, 

such as, adverse licensure actions, 

medical malpractice payments or 

exclusions from Medicare and Medicaid 

programs taken against all licensed 

healthcare practitioners such as 

physicians, dentists, nurses, podiatrists, 

chiropractors, and psychologists. The 

information is accessible to both public 

and private sector hospitals who can 

request information concerning a 

physician, dentist or other health care 

practitioner who is on its medical staff 

(courtesy or otherwise) or who has 

clinical privileges at the hospital, for the 

purpose of: (a) Screening the 

professional qualifications of 

individuals who apply for staff 

positions or clinical privileges at the 

hospital; and (b) meeting the 

requirements of the Health Care Quality 

Improvement Act of 1986, which 

prescribes that a hospital must query the 

NPDB once every 2 years regarding all 

individuals on its medical staff or who 

hold clinical privileges. 

2. Other health care entities, as 

defined in 45 CFR 60.3, to which a 

physician, dentist or other health care 

practitioner has applied for clinical 

privileges or appointment to the 

medical staff or who has entered or may 

be entering an employment or affiliation 

relationship. The purpose of these 

disclosures is to identify individuals 

whose professional conduct may be 

unsatisfactory. 

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Federal Register / Vol. 77, No. 62 / Friday, March 30, 2012 / Notices 19297 

3. A health care entity with respect to 

professional review activity. The 

purpose of these disclosures is to aid 

health care entities in the conduct of 

professional review activities, such as 

those involving determinations of 

whether a physician, dentist, or other 

health care practitioner may be granted 

membership in a professional society; 

the conditions of such membership, or 

of changes to such membership; and 

ongoing professional review activities 

conducted by a health care entity which 

provides health care services, of the 

professional performance or conduct of 

a physician, dentist, or other health care 

practitioner. 

4. A State healthcare practitioner and/ 

or entity licensing or certification 

authority can request information 

expanded by Section 1921 of the Social 

Security Act in conducting a review of 

all healthcare practitioners or health 

entities. A State healthcare practitioner 

and entity licensing or certification 

authority may also request information 

when making licensure determinations 

about healthcare practitioners and 

entities. The purpose of these 

disclosures is to aid the board or 

certification authority in meeting its 

responsibility to protect the health of 

the population in its jurisdiction, by 

identifying individuals whose 

professional performance or conduct 

may be unsatisfactory. 

5. Federal and State health care 

programs (and their contractors) can 

request information reported under 

Section 1921 of the Social Security Act. 

The purpose of these disclosures is to 

aid Federal and State health programs to 

ensure the integrity and professional 

competence of affiliated health care 

practitioners and uncovering 

information needed to make appropriate 

decisions in the delivery of healthcare. 

6. State Medicaid Fraud Control Units 

(MFCUs) can request information 

reported under Section 1921 of the 

Social Security Act to assist with 

investigating fraud and prosecution of 

healthcare practitioners and providers 

in the administration of the Medicaid 

programs. 

7. U.S. Comptroller General can 

request information reported under 

Section 1921 of the Social Security Act 

to assist in determining the fitness of 

individuals to provide healthcare 

services, and protect the health and 

safety of individuals receiving health 

care through programs who employ 

these individuals. 

8. U.S. Attorney General and other 

law enforcement agencies can request 

information reported under Section 

1921 of the Social Security Act to assist 

with healthcare investigations involving 

healthcare practitioners and healthcare 

entities. The purpose of the disclosure 

would assist in determining the fitness 

of individuals to provide healthcare 

services, and protect the health and 

safety of individuals receiving health 

care through programs who employ 

these individuals. 

9. Utilization and quality control Peer 

Review Organizations and those entities 

which are under contract with the CMS 

can request information reported under 

Section 1921 of the Social Security Act 

to protect and improve the quality of 

care for Medicare beneficiaries when 

performing quality of care reviews and 

other related activities. 

10. A physician, dentist, or other 

health care practitioner can request 

information concerning himself or 

herself. 

11. An entity that has been reported 

on may query the system to receive 

information concerning itself. 

12. A person or entity can request 

statistical information, in a form which 

does not permit the identification of any 

individual or entity pursuant to the 

procedures established by the 

Department. An example of this 

disclosure involves researchers who 

may use statistical information to 

identify the total number of nurses with 

adverse licensure actions in a specific 

State. 

13. An attorney, or individual 

representing himself or herself, who has 

filed a medical malpractice action or 

claim in a State or Federal court or other 

adjudicative body against a hospital, 

and who requests information regarding 

a specific physician, dentist, or other 

health care practitioner who is also 

named in the action or claim provided 

that: (a) This information will be 

disclosed only upon the submission of 

evidence that the hospital failed to 

request information from the NPDB as 

required by law; and (b) the information 

will be used solely with respect to 

litigation resulting from the action or 

claim against the hospital. The purpose 

of these disclosures is to permit an 

attorney (or a person representing 

himself or herself in a medical 

malpractice action) to have information 

from the NPDB on a health care 

practitioner, under the conditions set 

out in this routine use. 

14. Any Federal entity, employing or 

otherwise engaging under arrangement 

(e.g., such as a contract) the services of 

a physician, dentist, or other health care 

practitioner, or having the authority to 

sanction such practitioners covered by a 

Federal program, which: (a) Enters into 

a memorandum of understanding with 

HHS regarding its participation in the 

NPDB; (b) engages in a professional 

review activity in determining an 

adverse action against a practitioner; 

and (c) maintains a Privacy Act system 

of records regarding the health care 

practitioners it employs, or whose 

services it engages under arrangement. 

The purpose of such disclosures is to 

enable hospitals and other facilities and 

health care providers under the 

jurisdiction of Federal agencies such as 

the Public Health Service, HHS; the 

Department of Defense; the Department 

of Veterans’ Affairs; the U.S. Coast 

Guard; and the Bureau of Prisons, 

Department of Justice, to participate in 

the NPDB. The Health Care Quality 

Improvement Act of 1986 includes 

provisions regarding the participation of 

such agencies and of the DEA. 

15. 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 

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 has agreed to 

represent such employee, for example in 

defending a claim against the Public 

Health Service 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, disclosures may be made to 

the Department of Justice to enable the 

Department to present an effective 

defense, provided that such disclosure 

is compatible with the purpose for 

which the records were collected. 

16. The contractor, SRA International 

Inc., accesses the system to operate and 

maintain it. These functions include but 

are not limited to providing continuous 

user availability, develop system 

enhancements, upgrade of hardware and 

software, security information 

assurance, and system backups. 

17. 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. 

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19298 Federal Register / Vol. 77, No. 62 / Friday, March 30, 2012 / Notices 

POLICIES AND PRACTICES FOR STORING, 

RETRIEVING, ACCESSING, RETAINING, AND

DISPOSING OF RECORDS IN THE SYSTEM: 

STORAGE: 

Records are maintained on database 

servers with disk storage, optical 

jukebox storage, backup tapes and 

printed reports. 

RETRIEVABILITY: 

Records are retrieved by name, date of 

birth, social security number, 

educational information, and license 

number. The matching algorithm uses 

these data elements to match reports to 

the subject. 

SAFEGUARDS FOR ACCESSING RECORDS: 

1. Authorized Users include internal 

users such as the government and 

contractor personnel staff who support 

the NPDB and are required to obtain 

favorable adjudication for a Level 5 

Position of Public Trust. New 

employees of the NPDB and the 

contractor must attend security training, 

sign a Non-Disclosure Agreement, and 

sign the Rules of Behavior which is 

renewed annually. Authorized users are 

given role-based access to the system on 

a limited need-to-know basis. All 

physical and logical access to the 

system is removed upon termination of 

employment. External users, who are 

responsible for meeting Title IV 

reporting and/or querying requirements 

to the NPDB, are responsible for 

determining their eligibility to access 

the NPDB through a self-certification 

process which requires completing an 

Entity Registration form. All external 

users must acknowledge the Rules of 

Behavior. All external users must reregister every two years to access the 

NPDB. Both HRSA and the contractor 

maintain lists of authorized users. 

2. Physical Safeguards involve 

physical controls that are in place 24 

hours a day/7 days a week such as 

identification badge access, cipher 

locks, locked hardware cages, man trap 

with biometric hand scanner, security 

guard monitoring, and closed circuit 

TV. All sites are protected with fire and 

environmental safety controls. 

3. Technical Safeguards include 

firewalls, network intrusion detection, 

host-based intrusion detection and file 

integrity monitoring, user identification, 

and passwords restrictions. All Webbased traffic is encrypted using 128 bit 

SSL and all network traffic is encrypted 

internally. 

4. Administrative Safeguards involve 

certification and accreditation that is 

required every three years, which 

authorizes operation of the system based 

on acceptable risk. Security assessments 

are conducted continuously throughout 

the year to verify compliance with all 

required controls. 

RETENTION AND DISPOSAL OF RECORDS: 

HRSA is working with NARA to 

obtain the appropriate retention value. 

SYSTEM MANAGER(S) AND ADDRESS: 

Director, Division of Practitioner Data 

Banks, Bureau of Health Professions, 

Health Resources and Services 

Administration, Room 8–103, Parklawn 

Building, 5600 Fishers Lane, Rockville, 

Maryland 20857. 

NOTIFICATION PROCEDURE: 

Subject to the exemption from the 

Privacy Act notification procedure 

requirement, information is available 

upon request, to the persons or entities, 

or to the authorized agents in such form 

or manner as the Secretary prescribes. 

Currently, the subject of a report is 

notified via U.S. mail when a report 

concerning the individual is submitted 

to the NPDB via Subject Notification 

Document (SND). This procedure is 

unchanged by the exemption. 

REQUESTS BY MAIL: 

Practitioners may submit a ‘‘Request 

for Information Disclosure’’ to the 

address under system location for any 

report on themselves. The request must 

contain the following: Name, address, 

date of birth, gender, Social Security 

Number (optional), professional schools 

and years of graduation, and the 

professional license(s). For license, 

include: The license number, the field 

of licensure, the name of the State or 

Territory in which the license is held, 

and DEA registration number(s). The 

practitioner must submit a signed and 

notarized self-query request. 

PENALTIES FOR VIOLATION: 

Submitting a request under false 

pretenses is a criminal offense and 

subject to a civil monetary penalty of up 

to $11,000 for each violation. 

REQUESTS IN PERSON: 

Due to security considerations, the 

NPDB cannot accept requests in person. 

REQUESTS BY TELEPHONE: 

Practitioners may provide all of the 

identifying information stated above to 

the NPDB Customer Service Center 

operator. Before the data request is 

fulfilled, the operator will return a 

paper copy of this information for 

verification, signature and notarization. 

RECORD ACCESS PROCEDURES: 

Although this system will be exempt 

from the Privacy Act access 

requirement, the exemption will be 

limited and discretionary. An 

individual health care practitioner may 

continue to seek access to his or her 

records in the NPDB by submitting a 

self-query request form on-line at: 

www.npdb-hipdb.hrsa.gov. The requests 

are submitted over the web using the 

Integrated Query and Reporting Service 

(IQRS), Query and Reporting Extensible 

Markup Language Service (QRXS), 

Interface Control Document (ICD) 

Transfer Program (ITP) or the Proactive 

Disclosure Service (PDS). Self-query, as 

described previously, may be initiated 

via the electronic system and is 

completed using the conventional mail 

system. Requesters, including selfqueries, will receive an accounting of 

disclosure that has been made of their 

records, if any. The exemption will 

prevent law enforcement query activity 

from being disclosed to the health care 

practitioner in response to a self-query. 

Notwithstanding the access 

exemption, a practitioner may request 

access to his or her full query history 

(i.e., including law enforcement query 

activity, if any), by submitting a written 

request to the System Manager 

identified above and following the same 

procedures indicated under 

‘‘Notification Procedure.’’ The request 

will be processed pursuant to the 

agency’s discretionary access authority 

under 45 CFR 5b.11(d). 

CONTESTING RECORD PROCEDURES: 

Because of the system’s exemption, 

the procedures for disputing a NPDB 

report will not apply to any query 

history information that is exempt from 

access. The NPDB routinely mails a 

copy of any report filed in it to the 

subject individual. A subject individual 

may contest the accuracy of information 

in the NPDB concerning himself or 

herself and file a dispute. To dispute the 

accuracy of the information, the 

individual must contact the NPDB and 

the reporting entity to: (1) Request for 

the reporting entity to file correction to 

the report; and (2) request the 

information be entered into a 

‘‘disputed’’ status and submit a 

statement regarding the basis for the 

inaccuracy of the information in the 

report. If the reporting entity declines to 

change the disputed report or takes no 

actions, the subject may request that the 

Secretary of HHS review the disputed 

report. In order to seek a Secretarial 

Review, the subject must: (1) Provide 

written documentation containing clear 

and brief factual information regarding 

the information of the report; (2) submit 

supporting documentation or 

justification substantiating that the 

reporting entity’s information is 

inaccurate; and (3) submit proof that the 

subject individual has attempted to 

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Federal Register / Vol. 77, No. 62 / Friday, March 30, 2012 / Notices 19299 

resolve the disagreement with reporting 

entity but was unsuccessful. The 

Department can only determine whether 

the report was legally required to be 

filed and whether the report accurately 

depicts the action taken and the 

reporter’s basis for action. Additional 

detail on the process of dispute 

resolution and Secretarial Review 

process can be found at 45 CFR 60.14 

of the NPDB regulations. 

RECORD SOURCE CATEGORIES: 

The records contained in the system 

are submitted by the following entities: 

(1) Insurance companies and others who 

have made payment as a result of a 

malpractice action or claim, (2) State 

Boards of Medical and Dental 

Examiners; (3) State Licensing Boards; 

(4) hospitals and other health care 

entities; (5) DEA; and (6) Federal 

entities which employ health 

practitioners or who have authority to 

sanction such practitioners covered by a 

Federal program. Section 1921 of the 

Social Security Act expands reporting of 

actions submitted by State health care 

practitioner licensing and certification 

authorities (including medical and 

dental boards), State entity licensing 

and certification authorities, peer 

review organizations and private 

accreditation organizations. 

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS

OF THE ACT: 

The Secretary has exempted this 

system from certain provisions of the 

Act. In accordance with 5 U.S.C. 

552(k)(2) and 45 CFR 5b.11(b)(ii)(L), this 

system is exempt from subsections 5 

U.S.C. 552a(c)(3), (d)(1)–(4), (e)(4)(G) 

and (H), and (f). 

[FR Doc. 2012–7612 Filed 3–29–12; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Government-Owned Inventions; 

Availability for Licensing 

AGENCY: National Institutes of Health, 

Public Health Service, HHS. 

ACTION: Notice. 

SUMMARY: The inventions listed below 

are owned by an agency of the U.S. 

Government and are available for 

licensing in the U.S. in accordance with 

35 U.S.C. 207 to achieve expeditious 

commercialization of results of 

federally-funded research and 

development. Foreign patent 

applications are filed on selected 

inventions to extend market coverage 

for companies and may also be available 

for licensing. 

ADDRESSES: Licensing information and 

copies of the U.S. patent applications 

listed below may be obtained by writing 

to the indicated licensing contact at the 

Office of Technology Transfer, National 

Institutes of Health, 6011 Executive 

Boulevard, Suite 325, Rockville, 

Maryland 20852–3804; telephone: 301– 

496–7057; fax: 301–402–0220. A signed 

Confidential Disclosure Agreement will 

be required to receive copies of the 

patent applications. 

MUC–1 Tumor Antigen Agonist 

Epitopes for Enhancing T-cell 

Responses to Human Tumors 

Description of Technology: The MUC– 

1 tumor associated antigen has been 

shown to be overexpressed and/or 

underglycosylated in a wide range of 

human cancers. The C-terminus region 

of MUC–1 (MUC–1C) has been shown to 

be an oncogene and has been associated 

with a more aggressive phenotype in 

several different cancers. 

Scientists at NIH have identified 7 

new agonist epitopes of the MUC–1 

tumor associated antigen. Compared to 

their native epitope counterparts, 

peptides reflecting these agonist 

epitopes have been shown to enhance 

the generation of human tumor cells, 

which in turn have a greater ability to 

kill human tumor cells endogenously 

expressing the native MUC–1 epitope. 

The agonist epitopes span both the 

VNTR region of MUC–1 and the Cterminus region. The epitopes 

encompass 2 major MHC alleles 

reflecting the majority of the population. 

Along with the method of use, the 

technology encompasses the use of 

these agonist epitopes in peptide- and 

protein-based vaccines, with dendritic 

cells or other antigen presenting cells, or 

encoding sequences in DNA, viral, 

bacterial, yeast, or other types of 

vectors, or to stimulate T-cells in vitro 

for adoptive immunotherapy protocols. 

Potential Commercial Applications: 

• As a therapeutic vaccine to enhance 

patient’s immune responses to a range 

of human cancers 

• As a preventive vaccine for patients 

with preneoplastic conditions or a high 

risk of developing cancer 

• As a preventive vaccine for cancers 

• For in vitro stimulation of 

lymphocytes for adoptive transfer 

protocols for cancer 

Competitive Advantages: 

• The agonist epitopes have been 

shown to be much more potent than 

their natural counterparts in activating 

human T-cells to MUC–1. 

• Compared to T-cells activated with 

the corresponding native epitopes, the 

T-cells activated by the agonist epitopes 

lyse tumor cells to a greater extent. 

• The technology can be used in a 

wide range of cancer vaccine platforms 

and in adoptive immunotherapy 

protocols. 

• The technology can be combined 

with existing vaccine platforms 

including those currently showing 

patient benefit, as well as with other 

therapeutic modalities. 

Development Stage: 

• Pre-clinical 

• In vitro data available 

Inventors: Jeffrey Schlom and KwongYok Tsang (NCI). 

Intellectual Property: HHS Reference 

No. E–001–2012/0—U.S. Patent 

Application No. 61/582,723 filed 03 Jan 

2012. 

Related Technologies: 

• HHS Reference No. E–154–1998/0 

—PCT Application No. PCT/US98/ 

03693 

• HHS Reference No. E–321–2003/0 

—PCT Application No. PCT/US2004/ 

41921 

Licensing Contact: Sabarni Chatterjee, 

Ph.D., MBA; 301–435–5587; 

chatterjeesa@mail.nih.gov. 

Collaborative Research Opportunity: 

The Laboratory of Tumor Immunology 

and Biology, National Cancer Institute, 

is seeking statements of capability or 

interest from parties interested in 

collaborative research to further 

develop, evaluate or commercialize the 

use of MUC–1 tumor antigen agonist 

epitopes for the treatment or prevention 

of cancer. For collaboration 

opportunities, please contact John 

Hewes, Ph.D. at hewesj@mail.nih.gov. 

Novel Diagnostic, Prognostic and 

Therapeutic Biomarker for 

Hepatocellular Carcinoma 

Description of Technology: Scientists 

at the National Cancer Institute have 

discovered that Stearol-CoA desaturase1 (SCD–1) is associated with 

hepatocellular carcinoma (HCC). 

Utilizing a microarray to analyze HCC 

patient samples, the investigators found 

SCD–1 is elevated in liver tumor tissues 

and it is a marker for a highly aggressive 

form of HCC, hepatic stem cell-like HCC 

subtype (HpSC HCC), which retains 

stem-cell features capable of cellular 

plasticity and cell motility. The 

investigators found SCD–1 is 

significantly elevated in HpSC tumors 

in comparison to less aggressive HCC 

tumors and it is associated with poor 

patient survival. In vitro studies 

demonstrate SCD–1 inhibition and/or 

addition of saturated palmitic acid 

reduces HpSC HCC characteristics. In 

addition to diagnostic, prognostic, and 

treatment applications, this technology 

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