Federal Register / Vol. 63, No. 139 /Tuesday, July 21, 1998 / Notices 39101

(unapproved) full or abbreviated

applications received by the agency

prior to February 19, 1998, sponsors

have until the time of next revision of

their labels or by February 19, 2003,

whichever comes first, to comply with

the amendments and they must report

these minor changes in their next

annual report. The guidance also

advises that full or abbreviated

applications received by FDA after

February 19, 1998, should provide

labels and labeling in compliance with

the amendments.

This revised guidance document

represents the agency’s current thinking

on implementation of the elimination of

certain labeling requirements. It does

not create or confer any rights for or on

any person and does not operate to bind

FDA or the public. An alternative

approach may be used if such approach

satisfies the requirements of the

applicable statute, regulations, or both.

Interested persons may, at any time,

submit written comments on the

guidance to the Dockets Management

Branch (address above). Two copies of

any comments are to be submitted,

except that individuals may submit one

copy. Comments are to be identified

with the docket number found in

brackets in the heading of this

document. The guidance and received

comments are available for public

examination in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

Dated: July 10, 1998.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 98–19317 7–20–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[HCFA–R–193]

Agency Information Collection

Activities: Submission for OMB

Review; Comment Request

In compliance with the requirement

of section 3506(c)(2)(A) of the

Paperwork Reduction Act of 1995, the

Health Care Financing Administration

(HCFA), Department of Health and

Human Services, has submitted to the

Office of Management and Budget

(OMB) the following proposal for the

collection of information. Interested

persons are invited to send comments

regarding the burden estimate or any

other aspect of this collection of

information, including any of the

following subjects: (1) the necessity and

utility of the proposed information

collection for the proper performance of

the agency’s functions; (2) the accuracy

of the estimated burden; (3) ways to

enhance the quality, utility, and clarity

of the information to be collected; and

(4) the use of automated collection

techniques or other forms of information

technology to minimize the information

collection burden.

Type of Information Collection

Request: Extension of a currently

approved collection; Title of

Information Collection: ‘‘ An Important

Message form Medicare.’’and

Supporting Regulations 42 CFR 466.78,

489.27, .20; Form No.: HCFA–R–193,

OMB # 0938–0692; Use: Hospitals

participating in the Medicare program

have agreed to distribute ‘‘ An Important

Message from Medicare’’ to beneficiaries

during each admission. Receiving this

information will provide the beneficiary

with some ability to participate and/ or

initiate discussions concerning

discussions affecting Medicare coverage

or payment and about his or her appeal

rights in response to any hospitals

notice to the effect that Medicare will no

longer cover continued care in the

hospital. Frequency: Other, as needed;

Affected Public: Individuals or

Households, Business or other for-profit,

Not-for-profit, Federal Government,

State, Local, or Tribal Government;

Number of Respondents: 6,700; Total

Annual Responses: 11,000,000.; Total

Annual Hours: 183,000.

To obtain copies of the supporting

statement for the proposed paperwork

collections referenced above, E-mail

your request, including your address

and phone number, to

Paperwork@hcfa.gov, or call the Reports

Clearance Office on (410) 786–1326.

Written comments and

recommendations for the proposed

information collections must be mailed

within 30 days of this notice directly to

the OMB Desk Officer designated at the

following address: OMB Human

Resources and Housing Branch,

Attention: Allison Eydt, New Executive

Office Building, Room 10235,

Washington, D.C. 20503.

Dated: July 9, 1998.

John P. Burke III,

HCFA Reports Clearance Officer, HCFA,

Office of Information Services, Information

Technology Investment Management Group,

Division of HCFA Enterprise Standards.

[FR Doc. 98–19386 Filed 7–20–98; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

Privacy Act of 1974; Report of New

System

AGENCY: Department of Health and

Human Services (HHS), Health Care

Financing Administration (HCFA).

ACTION: Notice of new system of records.

SUMMARY: In accordance with the

requirements of the Privacy Act of 1974,

we are proposing to establish a new

system of records, called ‘‘End-Stage

Renal Disease (ESRD) Managed Care

Demonstration System,’’ HHS/HCFA/

OSP No. 09–70–0067. We have provided

background information about the

proposed new system in the

SUPPLEMENTARY INFORMATION section

below. Although the Privacy Act

requires only that the ‘‘routine uses’’

portion of the system be published for

comment, HCFA invites comments on

all portions of this notice.

DATES: HCFA filed a new system report

with the Chairman of the Committee on

Government Reform and Oversight of

the House of Representatives, the

Chairman of the Committee on

Governmental Affairs of the Senate, and

the Administrator, Office of Information

and Regulatory Affairs, Office of

Management and Budget (OMB), on July

9, 1998. The new system of records,

including routine uses, will become

effective 40 days from the date

submitted to OMB and the Congress,

unless HCFA receives comments which

require alteration to this notice.

ADDRESSES: The public should address

comments to the HCFA Privacy Act

Officer, Division of Freedom of

Information & Privacy, Office of

Information Services, Health Care

Financing Administration, 7500

Security Boulevard, C2–01–11,

Baltimore, Maryland 21244–1850.

Comments received will be available for

review at this location by appointment,

Monday through Friday 9 a.m.–3 p.m.,

eastern time zone.

FOR FURTHER INFORMATION CONTACT: Paul

Eggers, Office of Strategic Planning,

Health Care Financing Administration,

7500 Security Boulevard, C3–24–07,

Baltimore, Maryland 21244–1850. His

telephone number is (410) 786–6691.

SUPPLEMENTARY INFORMATION: The ESRD

Managed Care Demonstration System

data file contains information on

beneficiaries enrolled in the ESRD

Managed Care Demonstration. This

information will be used by HCFA and

its evaluation contractor to monitor and

evaluate the demonstration. The system
39102 Federal Register / Vol. 63, No. 139 /Tuesday, July 21, 1998 / Notices

will include information on utilization

of specific health care services, cost and

quality of those services, clinical

outcomes and effectiveness of care, and

patient satisfaction.

Primary data collected by the

evaluator and the managed care

organizations will be linked to HCFA

administrative data to provide

information necessary for monitoring

and evaluating the demonstration and

its interventions. The demonstration is

designed to test the feasibility and

effectiveness of the following:

• Removal of the barrier to ESRD

enrollment. At present, ESRD-eligible

beneficiaries cannot enroll in Medicare

health maintenance organizations

(HMOs) (although they may remain

enrolled if they develop ESRD

subsequent to enrollment). Under the

demonstration, the sites will have yearround open enrollment of ESRD

beneficiaries.

• ESRD-focused case management,

and the potential benefits to patient,

provider, and payer, with particular

emphasis on whether outcomes of care

are improved.

• Preventive and supportive

interventions and more comprehensive

benefit coverage for ESRD patients.

Section 2355 of the Deficit Reduction

Act of 1989, as amended, requires that

HCFA pay the demonstration sites a

capitation rate based on 100 percent of

fee-for-service costs, rather than 95

percent. In order to justify receiving the

additional 5 percent, the HMO is

obliged to offer extra, non-Medicarecovered benefits beyond those that

would have been available in the

absence of the demonstration.

• An ESRD capitation rate that

adjusts for patient age, cause of renal

failure, treatment status, and services as

an alternative to both fee-for-service and

the current capitation rate for ESRD

patients in HMOs, that is unadjusted for

demographic or treatment factors.

Individual patient-level data will be

collected and linked from a variety of

sources, including, but not limited to:

Surveys conducted by the evaluation

contractor, including those using the

Kidney Disease Quality of Life (KDQOL)

instrument; data from the End-Stage

Renal Disease (ESRD) Program

Management and Medical Information

System (PMMIS) maintained by HCFA;

no-pay claims data submitted by the

sites during the course of the

demonstration; claims data on fee-forservice comparison patients; and

clinical data in regard to dialysis

adequacy measures, such as those

collected by HCFA’s core indicators

studies.

The Privacy Act permits us to disclose

information without the written consent

of individuals for ‘‘routine uses’’—that

is, disclosures that are compatible with

the purpose for which we collected the

information. The proposed routine uses

in the new system meet the

compatibility criterion of the statute. We

anticipate the disclosures under the

routine uses will not result in any

unwarranted adverse effects on personal

privacy.

Dated: July 9, 1998.

Nancy-Ann Min DeParle,

Administrator.

09–70–0067

SYSTEM NAME:

End-Stage Renal Disease (ESRD)

Managed Care Demonstration System,

HHS/HCFA/OSP.

SECURITY CLASSIFICATION:

None.

SYSTEM LOCATION:

Health Care Financing

Administration, Office of Information

Services, 7500 Security Boulevard,

Baltimore, Maryland 21244–1850.

CATEGORIES OF INDIVIDUALS COVERED BY THE

SYSTEM:

Medicare ESRD beneficiaries enrolled

in the ESRD Managed Care

Demonstration and Medicare ESRD

beneficiaries in comparison groups.

CATEGORIES OF RECORDS IN THE SYSTEM:

Individual-level information on

demographics, utilization of specific

health care services, cost and quality of

those services, clinical outcomes and

effectiveness of care, and patient

satisfaction will be collected.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:

Authority for maintenance of the

system is section 2355 of the Deficit

Reduction Act of 1984, Pub. L. 98–369,

as amended by section 4207(b)(4) of the

Omnibus Budget Reconciliation Act

(OBRA) of 1990, Pub. L. 101–508, and

as amended by section 13567(b) of

OBRA 1993, Pub. L. 103–66.

PURPOSE(S):

To collect and maintain information

on beneficiaries enrolled in the ESRD

Managed Care Demonstration, and

ESRD beneficiaries in comparison

groups, in order to monitor and evaluate

the demonstration.

ROUTINE USES OF RECORDS MAINTAINED IN THE

SYSTEM, INCLUDING CATEGORIES OF USERS AND

THE PURPOSES OF SUCH USES:

These routine uses specify additional

circumstances under which HCFA may

release information from the ESRD

Managed Care Demonstration System

without the consent of the individual to

whom such information pertains. Each

proposed disclosure of information

under these routine uses will be

evaluated to ensure that the disclosure

is legally permissible, including, but not

limited to, ensuring that the purpose of

the disclosure is compatible with the

purpose for which the information was

collected. Also, HCFA will require each

prospective recipient of such

information to agree in writing to

certain conditions to ensure the

continuing confidentiality and physical

safeguards of the information. More

specifically, as a condition of each

disclosure under these routine uses,

HCFA will, as necessary and

appropriate:

(a) Determine that no other Federal

statute specifically prohibits disclosure

of the information;

(b) Determine that the use or

disclosure does not violate legal

limitations under which the information

was provided, collected, or obtained;

(c) Determine that the purpose for

which the disclosure is to be made:

(1) Cannot reasonably be

accomplished unless the information is

provided in individually identifiable

form,

(2) Is of sufficient importance to warrant

the effect on, or the risk to, the privacy of the

individual(s) that additional exposure of the

record(s) might bring, and

(3) There is a reasonable probability

that the purpose of the disclosure will

be accomplished.

(d) Require the recipient of the

information to:

(1) Establish reasonable

administrative, technical, and physical

safeguards to prevent unauthorized

access, use, or disclosure of the record

or any part thereof. The physical

safeguards shall provide a level of

security that is at least the equivalent of

the level of security contemplated in

OMB Circular No. A–130 (revised),

Appendix III—Security of Federal

Automated Information Systems which

sets forth guidelines for security plans

for automated information systems in

Federal agencies;

(2) Remove or destroy the information

that allows subject individual(s) to be

identified at the earliest time at which

removal or destruction can be

accomplished, consistent with the

purpose of the request;

(3) Refrain from using or disclosing

the information for any purpose other

than the stated purpose under which the

information was disclosed; and

(4) Make no further uses or disclosure

of the information, except:
Federal Register / Vol. 63, No. 139 /Tuesday, July 21, 1998 / Notices 39103

(i) To prevent or address an

emergency directly affecting the health

or safety of an individual;

(ii) For use on another project under

the same conditions, provided HCFA

has authorized the additional use(s) in

writing; or

(iii) When required by law;

(e) Secure a written statement or

agreement from the prospective

recipient of the information whereby the

prospective recipient attests to an

understanding of, and willingness to

abide by the foregoing provisions and

any additional provisions that HCFA

deems appropriate in the particular

circumstances; and

(f) Determine whether the disclosure

constitutes a computer ‘‘matching

program’’ as defined in 5 U.S.C.

552a(a)(8). If the disclosure is

determined to be a computer ‘‘matching

program,’’ the procedures for matching

agreements as contained in 5 U.S.C.

552a(o) must be followed.

Disclosure may be made:

1. To a Congressional office, from the

record of an individual, in response to

an inquiry from the Congressional office

made at the request of that individual;

2. To the Bureau of Census for use in

processing research and statistical data

directly related to the programs

administered in whole or in part by

HCFA;

3. To the Department of Justice, to a

court or other tribunal, or to another

party before such tribunal, when:

(a) HHS, or any component thereof; or

(b) Any HHS employee in his or her

official capacity; or

(c) Any HHS employee in his or her

individual capacity, where the

Department of Justice (or HHS, where it

is authorized to do so) has agreed to

represent the employee; or

(d) The United States, or any agency

thereof, where HHS determines that the

litigation is likely to affect HHS or any

of its components, is a party to litigation

or has an interest in such litigation, and

HHS determines that the use of such

records by the Department of Justice, the

tribunal, or the other party is relevant

and necessary to the litigation and

would help in the effective

representation of the governmental

party or interest, provided, however,

that in each case HHS determines that

such disclosure is compatible with the

purpose for which the records were

collected.

4. To an individual or organization for

a research, demonstration, evaluation,

or epidemiological project related to the

prevention of disease or disability, the

restoration or maintenance of health, or

for purposes of determining, evaluating

and/or assessing cost, effectiveness,

and/or the quality of health care

services provided.

5. To a contractor for the purpose of

collating, analyzing, aggregating or

otherwise refining or processing records

in this system, or for developing,

modifying, and/or manipulating

automated information systems (ADP)

software. Data would also be disclosed

to contractors incidental to consultation,

programming, operation, user

assistance, or maintenance for ADP or

telecommunications systems containing

or supporting records in the system.

6. To a peer review organization or

ESRD network for health care quality

improvement projects conducted in

accordance with its contract with

HCFA.

7. To state Medicaid agencies

pursuant to agreements with the

Department of Health and Human

Services for determining Medicaid and

Medicare eligibility of recipients of

assistance under titles IV, XVIII, and

XIX of the Social Security Act, and for

the complete administration of the

Medicaid program.

8. To an agency of a state

Government, or established by state law,

for purposes of determining, evaluating

and/or assessing cost, effectiveness,

and/or the quality of health care

services provided in the state.

9. To another Federal or state agency:

(a) To contribute to the accuracy of

HCFA’s proper payment of Medicare

health benefits, including release to the

Social Security Administration for its

assistance in the implementation of

HCFA’s Medicare and Medicaid

programs, or

(b) As necessary to enable such

agency to fulfill a requirement of a

Federal statute or regulation, or a state

statute or regulation that implements a

program funded in whole or in part with

Federal funds.

10. To a HCFA contractor, including

but not limited to, fiscal intermediaries

and carriers under title XVIII of the

Social Security Act, to administer some

aspect of a HCFA-administered grant

program, which program is or could be

affected by fraud or abuse, for the

purpose of preventing, deterring,

discovering, detecting, investigating,

examining, prosecuting, suing with

respect to, defending against, correcting,

remedying, or otherwise combating such

fraud or abuse in such programs.

11. To another Federal agency or to an

instrumentality of any governmental

jurisdiction within or under the control

of the United States, including any state

or local government agency, for the

purpose of preventing, deterring,

discovering, detecting, investigating,

examining, prosecuting, suing with

respect to, defending against, correcting,

remedying, or otherwise combating such

fraud or abuse in a health benefits

program funded in whole or in part by

Federal funds.

12. To any entity that makes payment

for, or oversees administration of, health

services, for the purpose of preventing,

deterring, discovering, detecting,

investigating, examining, prosecuting,

suing with respect to, defending against,

correcting, remedying, or otherwise

combating such fraud or abuse against

such entity or the program or services

administered by such entity, provided:

(a) Such entity enters into an

agreement with HCFA to share

knowledge and information regarding

actual or potential fraudulent or abusive

practices or activities regarding the

delivery or receipt of health care

services, or regarding securing payment

or reimbursement for health care

services, or any practice or activity that,

if directed toward a HCFA-administered

program, might reasonably be construed

as actually or potentially fraudulent or

abusive;

(b) Such entity does, on a regular

basis, or at such times as HCFA may

request, fully and freely share such

knowledge and information with HCFA,

or as directed by HCFA, with HCFA’s

contractors; and

(c) HCFA determines that it may

reasonably conclude that the knowledge

or information it has received or is

likely to receive from such entity could

lead to preventing, deterring,

discovering, detecting, investigating,

examining, prosecuting, suing with

respect to, defending against, correcting,

remedying, or otherwise combating

fraud or abuse in the Medicare,

Medicaid, or other health benefits

program administered by HCFA or

funded in whole or in part by Federal

funds.

POLICIES AND PRACTICES FOR STORING,

RETRIEVING, ACCESSING, RETAINING, AND

DISPOSING OF RECORDS IN THE SYSTEM:

STORAGE:

The records are stored on magnetic

tapes and computer disks.

RETRIEVABILITY:

The records are retrieved by health

insurance claim number.

SAFEGUARDS:

Access is limited to authorized HCFA

personnel and HCFA contractor

employees in the performance of their

duties. HHS contractors and

collaborating researchers are required to

comply with the provisions of the

Privacy Act, and are required to sign

Assurance of Confidentiality Forms (or
39104 Federal Register / Vol. 63, No. 139 /Tuesday, July 21, 1998 / Notices

Data Security Statements) that are kept

on file by the contractor. For

computerized records, safeguards

established in accordance with

Department standards and National

Institute of Standards and Technology

guidelines (e.g., security codes) will be

used, limiting access to authorized

personnel. System securities are

established in accordance with HHS,

Information Resource Management

(IRM) Circular #10, Automated

Information Systems Security Program;

and HCFA Automated Information

Systems (AIS) Guide, Systems Securities

Policies, and OMB Circular No. A–130

(revised), Appendix III.

RETENTION AND DISPOSAL:

Records are maintained with

identifiers as long as needed for

program research.

SYSTEM MANAGER(S) AND ADDRESS:

Director, Office of Strategic Planning

(OSP), Health Care Financing

Administration, 7500 Security

Boulevard, Baltimore, Maryland 21244–

1850.

NOTIFICATION PROCEDURE:

The subject individual should write

the system manager, who will require

the system name, health insurance

claim number, and, for verification

purposes, name, address, date of birth,

and sex to ascertain whether or not the

individual’s record is in the system.

RECORD ACCESS PROCEDURE:

Same as notification procedures.

Requestors should also reasonably

specify the record contents being

sought. (These access procedures are in

accordance with the Department

Regulation 45 CFR 5b.5(a)(2).)

CONTESTING RECORD PROCEDURES:

Contact the system manager named

above, and reasonably identify the

record and specify the information to be

contested. State the corrective action

sought and the reasons for the

correction with supporting justification.

(These procedures are in accordance

with Department Regulation 45 CFR

5b.7.)

RECORD SOURCE CATEGORIES:

The identifying information contained

in these records is obtained from

demonstration enrollees, and from the

group health plans operating the

demonstration and their participating

providers. These data will be linked

with HCFA administrative data, such as

claims and enrollment data.

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS

OF THE ACT:

None.

[FR Doc. 98–19376 Filed 7–20–98; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Substance Abuse and Mental Health

Services Administration (SAMHSA)

Notice of Meeting

Pursuant to Public Law 92–463,

notice is hereby given of the following

meeting of the SAMHSA Special

Emphasis Panel II in July 1998.

A summary of the meeting may be

obtained from: Ms. Dee Herman,

Committee Management Liaison,

SAMHSA, Office of Program Planning

and Coordination (OPPC), Division of

Extramural Activities, Policy, and

Review, 5600 Fishers Lane, Room 17–

89, Rockville, Maryland 20857.

Telephone: (301)443–7390.

Substantive program information may

be obtained from the individual named

as Contact for the meeting listed below.

The meeting will include the review,

discussion and evaluation of individual

contract proposals. These discussions

could reveal personal information

concerning individuals associated with

the proposals and confidential and

financial information about an

individual’s proposal. Accordingly, the

meeting is concerned with matters

exempt from mandatory disclosure in

Title 5 U.S.C. 552b(c)3),(4), and (6) and

5 U.S.C. App. 2, § 10(d).

Committee Name: SAMHSA Special

Emphasis Panel II.

Meeting Date: July 22, 1998.

Place: Parklawn Building, Room 12–94,

5600 Fishers Lane, Rockville, MD 20857.

Closed: July 22, 1998, 9:00 a.m.—

adjournment.

Contact: Joan Harrison, Room 12C–05,

Parklawn Building, Telephone: (301)594–

2811 and FAX: (301)443–3437.

This notice is being published less than 15

days prior to the meeting due to the urgent

need to meet timing limitations imposed by

the review and funding cycle.

Dated: July 15, 1998.

Jeri Lipov,

Committee Management Officer, Substance

Abuse and Mental Health Services

Administration.

[FR Doc. 98–19377 Filed 7–20–98; 8:45 am]

BILLING CODE 4162–20–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Substance Abuse and Mental Health

Services Administration (SAMHSA)

Notice of Meetings

Pursuant to Public Law 92–463,

notice is hereby given of the following

meetings of the SAMHSA Special

Emphasis Panels I and II and the Center

for Substance Abuse Treatment National

Advisory Council in August 1998.

The Special Emphasis Panel I will

meet and the meeting will include the

review, discussion and evaluation of

individual grant applications. These

discussions could reveal personal

information concerning individuals

associated with the applications.

Accordingly, the meeting is concerned

with matters exempt from mandatory

disclosure in Title 5 U.S.C. 552b(c)(6)

and 5 U.S.C. App. 2, § 10(d).

A summary of the meeting may be

obtained from: Ms. Dee Herman,

Committee Management Liaison,

SAMHSA, Office of Program Planning

and Coordination (OPPC), Division of

Extramural Activities, Policy, and

Review, 5600 Fishers Lane, Room 17–

89, Rockville, Maryland 20857.

Telephone: (301) 443–7390.

Substantive program information may

be obtained from the individual named

as Contact for the meeting listed below.

Committee Name: SAMHSA Special

Emphasis Panel I.

Meeting Date: August 3–6, 1998.

Place: Hyatt Regency at Crystal City, 2799

Jefferson Davis Highway,Arlington, VA

22202.

Closed: August 3, 1998, 9:00 a.m.—5:00

p.m.; August 6, 1998, 9:00 a.m.—

adjournment.

Contact: Peggy Thompson, Room 17–75,

Parklawn Building, Telephone: (301) 443–

5062 and FAX: (301) 443–3437.

This notice is being published less than 15

days prior to the meeting due to the urgent

need to meet timing limitations imposed by

the review and funding cycle.

The Special Emphasis Panel I will have

another meeting and the meeting will include

the review, discussion and evaluation of

individual grant applications. These

discussions could reveal personal

information concerning individuals

associated with the applications.

Accordingly, the meeting is concerned with

matters exempt from mandatory disclosure in

Title 5 U.S.C. 552b(c)(6) and 5 U.S.C. App.

2, § 10(d).

A summary of the meeting may be obtained

from: Ms. Dee Herman, Committee

Management Liaison, SAMHSA, Office of

Program Planning and Coordination (OPPC),

Division of Extramural Activities, Policy, and

Review, 5600 Fishers Lane, Room 17–89,

Rockville, Maryland 20857. Telephone: (301)

443–7390.