Federal Register / Vol. 62, No. 51 / Monday, March 17, 1997 / Notices 12653

diligence during the regulatory review

period. To meet its burden, the petition

must contain sufficient facts to merit an

FDA investigation. (See H. Rept. 857,

part 1, 98th Cong., 2d sess., pp. 41–42,

1984.) Petitions should be in the format

specified in 21 CFR 10.30.

Comments and petitions should be

submitted to the Dockets Management

Branch (address above) in three copies

(except that individuals may submit

single copies) and identified with the

docket number found in brackets in the

heading of this document. Comments

and petitions may be seen in the

Dockets Management Branch between 9

a.m. and 4 p.m., Monday through

Friday.

Dated: March 6, 1997.

Stuart L. Nightingale,

Associate Commissioner for Health Affairs.

[FR Doc. 97–6590 Filed 3–14–97; 8:45 am]

BILLING CODE 4160–01–F

Health Resources and Services

Administration

Privacy Act of 1974; Altered System of

Records

AGENCY: Health Resources and Services

Administration, HHS.

ACTION: Notification of an altered system

of records.

SUMMARY: In accordance with the

requirements of the Privacy Act, the

Health Resources and Services

Administration (HRSA) is publishing

notice of a proposal to add a new

category of records to 09–15–0054, the

National Practitioner Data Bank for

Adverse Information on Physicians and

Other Health Care Practitioners, HHS/

HRSA/BHPr. HRSA proposes to add

specific information already available to

the public from the Health Care

Financing Administration (HCFA) on

physicians, practitioners, providers, and

other health care entities which the

Office of Inspector General (OIG), HHS

has excluded from participation in and

from recovering payment from the

Medicare and Medicaid programs.

DATES: HRSA invites interested parties

to submit comments on the proposed

internal and routine use of this

information on or before April 28, 1997.

HRSA has sent a Report of Altered

System to the Congress and to the Office

of Management and Budget (OMB) on

March 3, 1997. The alteration to the

system will be effective 40 days from

the date submitted to OMB unless

HRSA receives comments which would

result in a contrary determination.

ADDRESSEES: Please address comments

on the altered system of records to the

Health Resources and Services

Administration (HRSA) Privacy Act

Officer, Department of Health and

Human Services, 5600 Fishers Lane,

Room 14A–20, Rockville, Maryland

20857, telephone (301) 443–3780. This

is not a toll-free number.

FOR FURTHER INFORMATION CONTACT:

Director, Division of Quality Assurance,

BHPr/HRSA. Room 8A–55, Parklawn

Building, 5600 Fishers Lane, Rockville,

Maryland, telephone (301) 443–2300.

This is not a toll-free number.

SUPPLEMENTARY INFORMATION: The Office

of the Inspector General, HHS, has the

authority to exclude individuals/entities

from participating in the Medicare and/

or certain State health care plans under

sections 1128(a), 1128(b), 1892, or 1156

of the Social Security Act. The

exclusion also applies to all other

Executive Branch procurement and nonprocurement programs and activities.

Disclosure of the OIG Exclusion List to

HRSA is under authority of section

1106(a) of the Social Security Act, 42

CFR 401.105, and routine use exception

of the Privacy Act (5 U.S.C. 522a(b)(3)).

HCFA is authorized to provide certain

specific information on physicians,

practitioners, providers, and health care

entities which OIG has excluded from

participation in and from recovering

payment from the Medicare and

Medicaid programs. HCFA will retain

full responsibility for the content and

accuracy of HCFA Exclusion reports; the

Data Bank will only act as a disclosure

service. Notification of exclusion from

HCFA programs is made by HCFA.

Inquiries on the appropriateness or

content of HCFA Exclusion Reports will

be referred to HCFA for response. The

National Practitioner Data Bank (Data

Bank) will disclose such information to

authorized health care industry queriers

on request, using the Data Bank’s fully

automated and secure systems and

procedures.

Editorial changes have been made

throughout the system to enhance

clarity and specificity and to

accommodate normal updating changes.

The following notice is written in the

present, rather than the future tense, to

avoid the unnecessary expenditure of

public funds to republish the notice

after the routine use has become

effective.

Dated: March 3, 1997.

Ciro V. Sumaya,

Administrator.

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:

The SRA Corporation (the Contractor)

operates the National Practitioner Data

Bank (Data Bank) under contract with

the Bureau of Health Professions (BHPr),

Health Resources and Services

Administration (HRSA). Records are

located at the following address:

National Practitioner Data Bank, PO Box

10832, Chantilly, VA 20151. For

security reasons, the street address

cannot be disclosed.

CATEGORIES OF INDIVIDUALS COVERED BY THE

SYSTEM:

Health care practitioners including

physicians, dentists, and all other health

care practitioners (such as nurses,

optometrists, pharmacists, and

podiatrists), licensed or otherwise

authorized by a State to provide health

care services, on whose behalf a

payment has been made as a result of a

malpractice action or claim; physicians

and dentists who are the subject of

licensure disciplinary actions; and

physicians, dentists and other health

care practitioners who are on medical

staffs or who hold clinical privileges, or

who are members of professional

societies, against whom certain adverse

actions have been taken as a result of a

professional review action.

CATEGORIES OF RECORDS IN THE SYSTEM:

1. For malpractice payments.

Information on the physician, dentist or

other licensed health care practitioner

such as name; work address; home

address, if known; Social Security

number, if known, and obtained in

accordance with section 7 of the Privacy

Act of 1974; date of birth; name of each

professional school attended and year of

graduation; for each professional

license: The license number, the field of

licensure, and the name of the State or

Territory in which the license is held;

Drug Enforcement Administration

registration number(s), if known; and

name of each hospital with which the

practitioner is affiliated, if known.

Information on the person or entity

making the payment, such as the name

and address of the person or entity

making the payment; and the name,

title, and telephone number of the

responsible official submitting the

report on behalf of the entity.

Information on the payments, such as

the date of the occurrence of the acts or

omissions upon which the action or

claim was based occurred; date and

amount of payment; description of the
12654 Federal Register / Vol. 62, No. 51 / Monday, March 17, 1997 / Notices

acts or omissions and injuries or

illnesses upon which the action or claim

was based; and classification of the acts

or omission per reporting code.

2. For State Medical or Dental Board

actions. Information such as: The

physician’s or dentist’s name; work

address; homes address, if known;

Social Security number, if known, and

if obtained in accordance with section 7

of the Privacy Act of 1974; date of birth;

name of each professional school

attended and year of graduation; for

each professional license: The license

number, the field of licensure, and the

name of the State or Territory in which

the license is held; Drug Enforcement

Administration registration number, if

known; description of the acts or

omission or other reasons for the action

taken; description of the Board action;

the date the action was taken and its

effective date; and classification of the

action per reporting code.

3. For certain professional review

actions. Information such as the

physician’s, dentist’s or other health

care practitioner’s name; work address;

home address, if known; date of birth;

name of each professional school

attended and year of graduation; for

each professional license: The license

number, the field of licensure, and the

names of the State or Territory in which

the license is held; Drug Enforcement

Administration registration number, if

known; Social Security number, if

known, and if obtained in accordance

with section 7 of the Privacy Act of

1974; description of the acts or

omissions or other reasons for clinical

privilege or professional society

membership loss or, if known, for

surrender; and action taken, date the

action was taken, and effective date the

action was taken, and effective date of

the action.

4. Inquiry file. Copies of all inquiries

received by the Data Bank.

5. For OIG Medicare/Medicaid

Exclusions. Under authority of section

1106(a) of the Social Security Act, 42

CFR 401.105, and routine use exception

of the Privacy Act (5 U.S.C. 522a(b)(3)),

HCFA will provide certain specific

information on physicians,

practitioners, providers, and other

health care entities which the OIG has

excluded from participation in and from

recovering payment from the Medicare

and Medicaid programs. HCFA will

provide information such as the

physician’s, dentist’s or other health

care practitioner’s name; Social Security

number (used for Data Bank matching

purposes only; not disclosed to

authorized queriers); HCFA’s unique

practitioner identifier number; date of

birth; basis for exclusion; facts about the

exclusion; status of exclusion; and other

information as necessary to ensure

proper identification.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:

Under the Health Care Quality

Improvement Act of 1986 (the Act), as

amended, section 424(b), 42 U.S.C.

11134(b), authorizes the maintenance of

records of medical malpractice

payments, disciplinary actions taken by

Boards of Medical Examiners, and

professional review actions taken by

health care entities.

PURPOSE(S):

The purposes of the system are to (1)

Receive from insurance companies and

others making payments as a result of

malpractice actions or claims, State

Medical and Dental Boards, and health

care entities, information pertaining to

the professional performance or conduct

of physicians, dentists and other

licensed health care practitioners; and

(2) disseminate such data to health care

entities, to State professional licensing

boards, and to others as authorized by

the Act.

ROUTINE USES OF RECORDS MAINTAINED IN THE

SYSTEM, INCLUDING CATEGORIES OF USERS AND

THE PURPOSES OF SUCH USES:

Data may be disclosed to:

1. A hospital requesting data

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 also

prescribes that a hospital must query the

Bank 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.

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

professional conduct of a physician,

dentist, or other health care practitioner.

4. A State professional licensing board

conducting a review of an individual.

The purpose of these disclosures is to

aid the board in meeting its

responsibility to protect the health of

the population in its jurisdiction, by

identifying individuals whose

professional performance or

professional conduct may be

unsatisfactory.

5. 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 Bank 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 Bank on a health care

practitioner, under the conditions set

out in this routine use.

6. 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

Bank; (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 Bank. The Health Care Quality
Federal Register / Vol. 62, No. 51 / Monday, March 17, 1997 / Notices 12655

Improvement Act of 1986 includes

provisions regarding the participation of

such agencies, and of the Federal Drug

Enforcement Administration, in the

Bank.

7. 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.

POLICIES AND PRACTICES FOR STORING,

RETRIEVING, ACCESSING, RETAINING, AND

DISPOSING OF RECORDS IN THE SYSTEM:

STORAGE:

Records are maintained in electronic

folders, on magnetic tape, and/or disks.

RETRIEVABILITY:

Retrieval will be by use of personal

identifiers, including a unique identifier

assigned by the Data Bank.

SAFEGUARDS:

1. Authorized Users: Access to records

is limited to designated employees of

the Contractor and to designated HRSA

staff. The Data Bank Project Director and

Manager of Operations are among the

Contractor’s employees who are

authorized users. The Contracting

Officer’s Technical Representative

(COTR) and AIS Security Officer are

among the HRSA staff who are

authorized users. Both HRSA and the

contractor maintain lists of authorized

users.

2. Physical Safeguards: Magnetic

tapes, disks, computer equipment, and

hard copy files are stored in areas where

fire and environmental safety codes are

strictly enforced. All automated and

nonautomated documents are protected

on a 24-hour basis. Perimeter security

includes intrusion alarms, random

guard patrols, monitors, key/passcard/

combination controls, receptionist

controlled area, and reception alarm

button.

3. Procedural and Technical

Safeguards: A password is required to

access the system, and additional

identification numbers and passwords,

to limit access to data to only 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

area. All authorized users will sign a

nondisclosure statement. To protect the

confidentiality of information contained

in the system, when a person leaves or

no longer has authorized duties, the

Security Officer deletes his or her

identification number and password,

retrieves all-electronic access cards, and

changes all combinations to which the

departing employee had access. The

system automatically logs all access to

data resources.

Access to records is limited to those

authorized personnel trained in

accordance with the Privacy Act and

ADP security procedures. The

Contractor is required to assure the

confidentiality safeguards of these

records and to comply with all

provisions of the Privacy Act. All

individuals who have access to these

records must have the appropriate ADP

security clearances. Privacy Act and

ADP system security requirements are

included in the contract with the SRA

Corporation. In addition, the Data Bank

Project Officer and the System Manager

oversee compliance with these

requirements. HRSA staff who are

authorized users will make site visits to

the Contractor’s facilities to assure

compliance with security and Privacy

Act requirements.

The safeguards described above were

established in accordance with DHHS

Chapter 45–13 and supplementary

Chapter PHS hf: 45–13 of the General

Administration Manual, and the DHHS

Information Resources Management

Manual, Part 6. ‘‘ADP Systems

Security.’’

RETENTION AND DISPOSAL:

1. Project Director’s Subject File—

significant documents associated with

the creation and maintenance of the

Data Bank, such as essential policy

documents, regulations, and handbooks.

Authorized disposition is permanent.

Cut off superseded materials annually.

Transfer to the WNRC in 5-year blocks

when 5 years old. Transfer to the

National Archives 5 years thereafter.

Annual accumulation is less than one

cubic foot. Amount on hand is less than

one cubic foot.

2. Source Documents—reporting and

query forms.

Authorized disposition is temporary.

Destroy hardcopy forms after conversion

to microfilm when no longer needed for

administrative purposes. Dispose of

microfilm and diskettes in contractor

office space when no longer needed to

support the reconstruction of, or serve

as a backup to, the Master File,

whichever is later.

3. Master file and associated

documentation.

Authorized disposition is not

authorized. Maintain until NARA and

HRSA agree on a disposition. Data may

be cut off annually. As the data and

documentation remain unscheduled,

maintenance and storage procedures

shall conform with the provisions laid

out in 36 CFR 1234.28.

4. General administrative records

associated with the establishment and

maintenance of the Data Bank, both at

the contractor and at HRSA.

Authorized disposition is temporary.

Destroy when no longer needed for

administrative purposes.

SYSTEM MANAGER(S) AND ADDRESS:

Director, Division of Quality

Assurance, Bureau of Health

Professions, Health Resources and

Services Administration, Room 8A–55,

Parklawn Building, 5600 Fishers Lane,

Rockville, Maryland 20857.

NOTIFICATION PROCEDURES:

An individual is informed when a

record concerning himself or herself is

entered into the Data Bank, with the

exception of HCFA exclusion reports.

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 Drug

Enforcement Administration registration

number(s). Practitioners must sign and

have notarized their requests.

Submitting a request under false

pretenses is a criminal offense subject

to, at a minimum, a $5,000 fine under

provisions of the Privacy Act, and to a

$10,000 fine under provisions of the

Health Care Quality Improvement Act of

1986.

Requests in person: Due to security

considerations, the Data Bank cannot

accept requests in person.

Request by telephone: Practitioners

may provide all of the identifying

information stated above to the Data
12656 Federal Register / Vol. 62, No. 51 / Monday, March 17, 1997 / Notices

Bank Helpline 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:

Same as notification procedures.

Requesters will receive an accounting of

disclosure that has been made of their

records, if any.

PROCEDURES FOR CONTESTING RECORDS:

The Data Bank routinely mails a copy

of any report filed (other than those

filed by HCFA) in it to the subject

individual. Any record subject may

contest the accuracy of information in

the Data Bank (except information filed

by HCFA) concerning himself or herself

and file a dispute. To dispute the

accuracy of the information, the

individual must notify the Data Bank

by: (1) Identifying the record involved;

(2) specifying the information being

contested; (3) stating the corrective

action sought and reason for requesting

the correcting; and (4) submitting

supporting justification and/or

documentation to show how the record

is inaccurate. At the same time, the

individual must notify the reporting

entity, in writing.

Additional detail on the process of

dispute resolution can be found at 45

CFR part 60 under § 60.14 of the Data

Bank regulations.

RECORD SOURCE CATEGORIES:

Entities that have submitted records

on individuals contained in the system;

insurance companies and others who

have made payment as a result of a

malpractice action or claim; State

Medical Boards; State Boards of

Dentistry; State Licensing Boards;

hospitals and other health care entities

as defined in the Act; the Drug

Enforcement Administration; and

Federal entities which employ health

practitioners or which have authority to

sanction such practitioners covered by a

Federal program.

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS

OF THE ACT:

None.

[FR Doc. 97–6591 Filed 3–14–97; 8:45 am]

BILLING CODE 4160–15–P

National Institutes of Health

National Heart, Lung and Blood

Institute, Submission of OMB Review;

Comment Request, Evaluation of the

NHLBI Short-Term Training for

Minority Students Program

SUMMARY: Under the provisions of

Section 3506(c)(2)(A) of the Paperwork

Reduction Act of 1995, the National

Heart, Lung, and Blood Institute

(NHLBI), the National Institutes of

Health (NIH) has submitted to the Office

of Management and Budget (OMB) a

request to review and approve the

information collection listed below.

This proposed information collection

was previously published in the Federal

Register, Vol. 61, No. 207, p. 55159, on

Thursday, October 24, 1996, and

allowed 60 days for public comment.

The purpose of this notice is to allow an

additional 30 days for public comment.

The National Institutes of Health may

not conduct or sponsor, and the

respondent is not required to respond

to, an information collection that has

been extended, revised, or implemented

on or after October 1, 1995, unless it

displays a currently valid OMB control

number.

PROPOSED COLLECTION: Title: Evaluation

of the NHLBI Short-Term Training for

Minority Students Program. Type of

Information Collection Request: New.

Need and use of Information Collection:

When the short-term training program

was implemented, applicants were

provided broad guidance that enabled

them to structure their program in the

manner they deemed most likely to

accomplish the program objectives. The

proposed evaluation will assess the

effectiveness of the short-term training

program in meeting its objectives. The

results of the evaluation will be used to

modify the program and the program

announcement to ensure that all

elements identified as contributing to

the success of a program are part of all

future short-term training programs

supported by the Institute. Frequency of

Response: One-time only. Affected

Public: Individuals or households; not

for profit institutions; business or other

for profit. Type of Respondents:

Undergraduate and graduate students,

research faculty, and mentors. The

annual reporting burden is as follows:

Estimated Number of Respondents:

2,725; Estimated Number of Responses

Per Respondent: 1; Average Burden

Hours Per Response: Training grant

director—1.00 hour, research faculty—

0.334 hours, accepted students—0.5

hours, nonaccepted students—0.334

hours; and applicant and trainee data

collection form—1.50; and Estimated

Total Annual Burden House Requested:

1,210. The annualized cost to

respondents is estimated at: $18,248.

There are no Capital Costs to report.

There are no Operating or Maintenance

Costs to report.

Request for Comments

Written comments and/or suggestions

from the public and affected agencies

are invited on one or more of the

following points: (1) Whether the

proposed collection of information is

necessary for the proper performance of

the function of the agency, including

whether the information will have

practical utility; (2) the accuracy of the

agency’s estimated of the burden of the

proposed collection of information,

including the validity of the

methodology and assumptions used; (3)

ways to enhance the quality, utility, and

clarity of the information to be

collected; and (4) ways to minimize the

burden of the collection of information

on those who are to respond, including

the use of appropriate automated,

electronic, mechanical, or other

technological collection techniques or

other forms of information technology.

Direct Comments to OMB

Written comments and/or suggestions

regarding the item(s) contained in this

notice, especially regarding the

estimated public burden and associated

response time, should be directed to the

Office of Management and Budget,

Office of Regulatory Affairs, New

Executive Office Building, Room 10235,

Washington, DC 20503, Attention: Desk

Officer for NIH. To request more

information on the proposed project or

to obtain a copy of the data collection

plans and instruments, contact: Ms.

Suzanne Anthony, Project Clearance

Liaison, Management Policy and

Administrative Service Branch, NHLBI,

NIH, 31 Center Drive, Room 5A10, MSC

2490, Bethesda, Maryland 20892, or call

non-toll-free number (301) 496–9737 or

E-mail your request, including your

address to:<Anthonys@nih.gov>.

COMMENTS DUE DATE: Comments

regarding this information collection are

best assured of having their full effect if

received on or before April 16, 1997.

Dated: March 7, 1997.

Sheila Merritt,

Executive Officer, NHLBI.

[FR Doc. 97–6635 Filed 3–14–97; 8:45 am]

BILLING CODE 4140–01–M