37792 Federal Register / Vol. 65, No. 117 / Friday, June 16, 2000 / Notices

Patulin’’. This document is intended to

make FDA offices and industry aware of

FDA’s guidance for enforcement

concerning apple juice, apple juice

concentrates, and apple juice products

that contain patulin, a toxic substance

produced by molds that may grow on

apples, and that has been found to occur

at high levels in some apple juice

products offered for sale or import in

the United States. The agency is also

announcing the availability of a

document entitled ‘‘Patulin in Apple

Juice, Apple Juice Concentrates, and

Apple Juice Products’’ (the draft

supporting document).

DATES: Submit written comments by

August 15, 2000.

ADDRESSES: Submit written requests for

single copies of the draft CPG entitled

‘‘Apple Juice, Apple Juice Concentrates,

and Apple Juice Containing Products—

Adulteration with Patulin’’ and/or the

draft supporting document entitled

‘‘Patulin in Apple Juice, Apple Juice

Concentrates, and Apple Juice

Products’’ to Michael E. Kashtock

(address below). Send one selfaddressed adhesive label to assist that

office in processing your request. See

the SUPPLEMENTARY INFORMATION section

for electronic access to this document.

Submit written comments on the draft

CPG and the draft supporting document

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852. Comments

and requests for copies should be

identified with the docket number

found in brackets in the heading of this

document.

FOR FURTHER INFORMATION CONTACT:

Michael E. Kashtock, Center for Food

Safety and Applied Nutrition (CFSAN)

(HFS–305), Food and Drug

Administration, 200 C St. SW.,

Washington, DC 20204, 202–205–5321,

FAX 202–205–4422, e-mail:

mkashtoc@cfsan.fda.gov.

SUPPLEMENTARY INFORMATION: FDA has

developed a draft CPG on FDA’s

guidance for enforcement concerning

apple juice, apple juice concentrates,

and apple juice products that contain

patulin. This document is intended to

provide clear policy and regulatory

guidance to FDA’s field and

headquarters staff with regard to such

foods. In particular, if these products:

(1) Contain patulin at or above 50 parts

per billion (ppb) (the action level) based

on the level found or calculated to be

found in single strength apple juice,

reconstituted single strength apple juice

(if the food is an apple juice

concentrate), or the single strength

apple juice component of the product (if

the food contains apple juice as an

ingredient); and (2) the identity of

patulin is confirmed by gas

chromatography/mass spectrometry,

then the FDA field enforcement office

may consider whether to recommend

legal action against such apple juice,

apple juice concentrates, and apple

juice products in interstate commerce,

and it may consider whether to

recommend detention of the same

products when offered for import into

the United States. For the purposes of

this guidance, single strength juice is

100 percent juice that is unconcentrated

(see 21 CFR 101.30(h)). The scientific

basis for the 50 ppb action level is

presented in the draft supporting

document. The draft CPG also contains

information that may be useful to the

regulated industry and to the public.

FDA has included an import

specimen charge in this draft CPG to

assist its field personnel in

recommending refusal of admission for

imported goods when warranted. The

fact that this draft CPG contains an

import specimen charge (in addition to

the customary specimen charge

addressing regulatory action against

food in domestic commerce) does not

restrict any action FDA may take under

circumstances addressed by other CPG’s

that do not have an import specimen

charge, and it does not imply that FDA

will not take action when warranted.

The agency has adopted good

guidance practices (GGP’s) that set forth

the agency’s policies and procedures for

the development, issuance, and use of

guidance documents (62 FR 8961,

February 27, 1997). The draft CPG is

being issued as a level 1 draft guidance

consistent with GGP’s. The draft CPG

represents the agency’s current thinking

on its enforcement guidance concerning

the adulteration of apple juice, apple

juice concentrates, and apple juice

products with patulin. 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

and regulations.

Interested persons may submit to the

Dockets Management Branch (address

above) written comments regarding the

draft CPG and the draft supporting

document by August 15, 2000. 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. Received comments, the

draft CPG, and the draft supporting

document may be seen in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday. These

two documents may also be accessed at

the CFSAN home page on the Internet

at http://www.fda.cfsan.gov.

Dated: June 8, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–15122 Filed 6–15–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

Privacy Act of 1974; Report of Altered

Systems

AGENCY: Department of Health and

Human Services (HHS), Health Care

Financing Administration (HCFA).

ACTION: Notice of the modification or

alteration to 20 systems of records.

SUMMARY: In accordance with the

requirements of the Privacy Act of 1974,

we are correcting information provided

in 20 HCFA systems of records specified

in Appendix A. These systems are all

related to research or demonstration

projects under the control of the Office

of Strategic Planning. We are deleting

the published routine uses in the system

of records listed in Appendix A and

replacing them with four revised routine

uses. The routine uses are being

prioritized and renumbered accordingly.

We are taking the opportunity to update

those sections of the SORs that were

affected by the recent reorganization.

We are also updating the language in the

administrative sections to correspond

with language used in other HCFA

system of records.

The primary purpose of the

corrections to these systems is to

shorten the language, make the routine

uses easier to read, and provide clarity

to HCFA’s intention to disclose

individual-specific information related

to the purposes for which the

information is being collected.

EFFECTIVE DATES: HCFA filed a

correction to a system report with the

Chair of the House Committee on

Government Reform and Oversight, the

Chair of the Senate Committee on

Governmental Affairs, and the

Administrator, Office of Information

and Regulatory Affairs, Office of

Management and Budget (OMB) on June

12, 2000. To ensure that all parties have

adequate time in which to comment, the

corrected systems of records, including

routine uses, will become effective 40

days from the publication of the notice,

or from the date it was submitted to

OMB and the Congress, whichever is

Federal Register / Vol. 65, No. 117 / Friday, June 16, 2000 / Notices 37793

later, unless HCFA receives comments

that require alterations to this notice.

ADDRESSES: The public should address

comments to: Director, Division of Data

Liaison and Distribution (DDLD), HCFA,

Room N2–04–27, 7500 Security

Boulevard, Baltimore, Maryland 21244–

1850. Comments received will be

available for review at this location, by

appointment, during regular business

hours, Monday through Friday from 9

a.m.–3 p.m., eastern time zone.

FOR FURTHER INFORMATION CONTACT:

Sydney P. Galloway, Privacy Act

Coordinator, Systems, Technical, and

Analytic Resources Group, Office of

Strategic Planning (OSP), HCFA,

Mailstop C3–24–07, 7500 Security

Boulevard, Baltimore, Maryland 21244–

1850. The telephone number is 410–

786–6645.

SUPPLEMENTARY INFORMATION:

I. Collection and Maintenance of Data

in the System

Agency Policies, Procedures, and

Restrictions on the Routine Use

We are establishing the following

policies, procedures and restrictions on

routine use disclosures of information

that will be maintained in these

systems. In general, routine uses of

these systems (or a subset thereof) will

be approved for the minimum set of

data elements in the record needed to

accomplish the purpose of the

disclosure after HCFA:

(a) Determines that the use or

disclosure is consistent with the reason

that the data is being collected, e.g.,

conducting research related to specific

projects and demonstrations, and

monitoring the quality of care provided

to patients.

(b) Determines:

(1) That the purpose for which the

disclosure is to be made can only be

accomplished if the record is provided

in individually identifiable form;

(2) That the purpose for which the

disclosure is to be made is of sufficient

importance to warrant the potential

effect and/or risk on the privacy of the

individual that additional exposure of

the record might bring; and

(3) That there is a strong probability

that the proposed use of the data would

in fact accomplish the stated purpose(s).

(c) Requires the information recipient

to:

(1) Establish administrative, technical,

and physical safeguards to prevent

unauthorized use of disclosure of the

record; and

(2) Remove or destroy at the earliest

time all patient-identifiable information.

(d) Determines that the data are valid

and reliable.

II. Proposed Routine Use Disclosures of

Data in the System

The Privacy Act allows us to disclose

information without an individual’s

consent if the information is to be used

for a purpose that is compatible with the

purpose(s) for which the information

was collected. Any such compatible use

of data is known as a ‘‘routine use.’’ The

proposed routine uses in this system

meet the compatibility requirement of

the Privacy Act. We are correcting the

language in the following routine use

disclosures of information maintained

in these systems:

1. To an individual or organization for

research, evaluation, or epidemiological

projects related to the prevention of

disease or disability, or the restoration

or maintenance of health, and for

payment related projects.

The collected data will provide the

research, evaluation and

epidemiological projects a broader,

longitudinal, national perspective of the

data. HCFA anticipates that many

researchers will have legitimate requests

to use these data in projects that could

ultimately improve the care provided to

Medicare patients and the policy that

governs the care. HCFA understands the

concerns about the privacy and

confidentiality of the release of data for

a research use. Disclosure of data for

research and evaluation purposes may

involve aggregate data rather than

individual-specific data.

2. To agency contractors, or

consultants who have been engaged by

the agency to assist in the performance

of a service related to this system of

records and who need to have access to

the records in order to perform the

activity.

We contemplate disclosing

information under this routine use only

in situations in which HCFA may enter

into a contractual or similar agreement

with a third party to assist in

accomplishing HCFA function relating

to purposes for these systems of records.

HCFA occasionally contracts out

certain of its functions when doing so

would contribute to effective and

efficient operations. HCFA must be able

to give a contractor or consultant

whatever information is necessary for

the contractor or consultant to fulfill its

duties. In these situations, safeguards

are provided in the contract prohibiting

the contractor or consultant from using

or disclosing the information for any

purpose other than that described in the

contract and requires the contractor or

consultant to return or destroy all

information at the completion of the

contract.

3. To a member of congress or to a

congressional staff member in response

to an inquiry of the congressional office

made at the written request of the

constituent about whom the record is

maintained.

Beneficiaries sometimes request the

help of a member of congress in

resolving an issue relating to a matter

before HCFA. The member of congress

then writes HCFA, and HCFA must be

able to give sufficient information to be

responsive to the inquiry.

4. To the Department of Justice (DOJ),

court or adjudicatory body when:

(a) The agency or any component

thereof, or

(b) Any employee of the agency in his

or her official capacity, or

(c) Any employee of the agency in his

or her individual capacity where the

DOJ has agreed to represent the

employee, or

(d) The United States Government

is a party to litigation or has an interest

in such litigation, and by careful review,

HCFA determines that the records are

both relevant and necessary to the

litigation and that the use of such

records by the DOJ, court or

adjudicatory body is compatible with

the purpose for which the agency

collected the records.

Whenever HCFA is involved in

litigation, or occasionally when another

party is involved in litigation and

HCFA’s policies or operations could be

affected by the outcome of the litigation,

HCFA would be able to disclose

information to the DOJ, court or

adjudicatory body involved. A

determination would be made in each

instance that, under the circumstances

involved, the purposes served by the

use of the information in the particular

litigation is compatible with a purpose

for which HCFA collects the

information.

III. Safeguards

The systems will conform with

applicable law and policy governing the

privacy and security of federal

automated information systems. These

include but are not limited to: the

Privacy Act of 1974, Computer Security

Act of 1987, the Paperwork Reduction

Act (PRA) of 1995, the Clinger-Cohen

Act of 1996, and OMB Circular A–130,

Appendix III, ‘‘Security of Federal

Automated Information Resources.’’

HCFA has prepared a comprehensive

system security plan as required by the

Office of Management and Budget

(OMB) Circular A–130, Appendix III.

This plan conforms fully to guidance

issued by the National Institute for

Standards and Technology (NIST) in

NIST Special Publication 800–18,

37794 Federal Register / Vol. 65, No. 117 / Friday, June 16, 2000 / Notices

‘‘Guide for Developing Security Plans

for Information Technology Systems.’’

Paragraphs A–C of this section highlight

some of the specific methods that HCFA

is using to ensure the security of this

system and the information within it.

A. Authorized users: Personnel having

access to the system have been trained

in Privacy Act and systems security

requirements. Employees who maintain

records in the system are instructed not

to release any data until the intended

recipient agrees to implement

appropriate administrative, technical,

procedural, and physical safeguards

sufficient to protect the confidentiality

of the data and to prevent unauthorized

access to the data. In addition, HCFA is

monitoring the authorized users to

ensure against excessive or

unauthorized use. Records are used in a

designated work area or work station

and the system location is attended at

all times during working hours.

To assure security of the data, the

proper level of class user is assigned for

each individual user as determined at

the agency level. This prevents

unauthorized users from accessing and

modifying critical data. The system

database configuration includes five

classes of database users:

• Database Administrator class owns

the database objects, e.g., tables, triggers,

indexes, stored procedures, packages,

and has database administration

privileges to these objects;

• Quality Control Administrator class

has read and write access to key fields

in the database;

• Quality Indicator (QI) Report

Generator class has read-only access to

all fields and tables;

• Policy Research class has query

access to tables, but are not allowed to

access confidential patient

identification information; and

• Submitter class has read and write

access to database objects, but no

database administration privileges.

B. Physical Safeguards: All server

sites have implemented the following

minimum requirements to assist in

reducing the exposure of computer

equipment and thus achieve an

optimum level of protection and

security for the each system:

Access to all servers is controlled,

with access limited to only those

support personnel with a demonstrated

need for access. Servers are to be kept

in a locked room accessible only by

specified management and system

support personnel. Each server requires

a specific log-on process. All entrance

doors are identified and marked. A log

is kept of all personnel who were issued

a security card, key and/or combination

which grants access to the room housing

the server, and all visitors are escorted

while in this room. All servers are

housed in an area where appropriate

environmental security controls are

implemented, which include measures

implemented to mitigate damage to

Automated Information System (AIS)

resources caused by fire, electricity,

water and inadequate climate controls.

Protection applied to the

workstations, servers and databases

include:

• User Log-ons—Authentication is

performed by the Primary Domain

Controller/Backup Domain Controller of

the log-on domain.

• Workstation Names—Workstation

naming conventions may be defined and

implemented at the agency level.

• Hours of Operation—May be

restricted by Windows NT. When

activated all applicable processes will

automatically shut down at a specific

time and not be permitted to resume

until the predetermined time. The

appropriate hours of operation are

determined and implemented at the

agency level.

• Inactivity Log-out—Access to the

NT workstation is automatically logged

out after a specified period of inactivity.

• Warnings—Legal notices and

security warnings display on all servers

and workstations.

• Remote Access Services (RAS)—

Windows NT RAS security handles

resource access control. Access to NT

resources is controlled for remote users

in the same manner as local users, by

utilizing Windows NT file and sharing

permissions. Dial-in access can be

granted or restricted on a user-by-user

basis through the Windows NT RAS

administration tool.

There are several levels of security

found in each system. Windows NT

provides much of the overall system

security. The Windows NT security

model is designed to meet the C2-level

criteria as defined by the U.S.

Department of Defense’s Trusted

Computer System Evaluation Criteria

document (DoD 5200.28–STD,

December 1985). Netscape Enterprise

Server is the security mechanism for all

transmission connections to the system.

As a result, Netscape controls all

information access requests. Anti-virus

software is applied at both the

workstation and NT server levels.

Access to different areas on the

Windows NT server are maintained

through the use of file, directory and

share level permissions. These different

levels of access control provide security

that is managed at the user and group

level within the NT domain. The file

and directory level access controls rely

on the presence of an NT File System

(NTFS) hard drive partition. This

provides the most robust security and is

tied directly to the file system. Windows

NT security is applied at both the

workstation and NT server levels.

C. Procedural Safeguards: All

automated systems must comply with

federal laws, guidance, and policies for

information systems security as stated

previously in this section. Each

automated information system should

ensure a level of security commensurate

with the level of sensitivity of the data,

risk, and magnitude of the harm that

may result from the loss, misuse,

disclosure, or modification of the

information contained in the system.

IV. Effect of the Modified System of

Records on Individual Rights

HCFA proposes to establish each

system in accordance with the

principles and requirements of the

Privacy Act and will collect, use, and

disseminate information only as

prescribed therein. Data in each system

will be subject to the authorized releases

in accordance with the routine uses

identified in each systems of records.

HCFA will monitor the collection and

reporting of all data. All information on

beneficiaries is completed by the

contractor and submitted to HCFA

through standard systems located at the

contractor sites. HCFA will utilize a

variety of onsite and offsite edits and

audits to increase the accuracy of all

data.

HCFA will take precautionary

measures (see item III. above) to

minimize the risks of unauthorized

access to the records and the potential

harm to individual privacy or other

personal or property rights including

not collecting patient identifiable data

for non-Medicare and non-Medicaid

patients. HCFA will collect only that

information necessary to perform the

system’s functions. In addition, HCFA

will make disclosure of identifiable data

from the modified system only with

consent of the subject individual, or his/

her legal representative, or in

accordance with an applicable

exception provision of the Privacy Act.

HCFA, therefore, does not anticipate

an unfavorable effect on individual

privacy as a result of the disclosure of

information relating to individuals.

Dated: June 12, 2000.

Nancy-Ann Min DeParle,

Administrator, Health Care Financing

Administration.

The corrections to the systems of

records listed in Appendix A are as

follows:

* * * * *

Federal Register / Vol. 65, No. 117 / Friday, June 16, 2000 / Notices 37795

SECURITY CLASSIFICATION:

Level Three Privacy Act Sensitive

Data.

SYSTEM LOCATION:

HCFA Data Center, 7500 Security

Boulevard, North Building, First Floor,

Baltimore, Maryland 21244–1850.

* * * * *

ROUTINE USES OF RECORDS MAINTAINED IN THE

SYSTEM, INCLUDING CATEGORIES OF USERS AND

THE PURPOSES OF SUCH USES:

The Privacy Act allows us to disclose

information without an individual’s

consent if the information is to be used

for a purpose that is compatible with the

purpose(s) for which the information

was collected. Any such compatible use

of data is known as a ‘‘routine use.’’

Disclosure may be made:

1. To an individual or organization for

research, evaluation, or epidemiological

projects related to the prevention of

disease or disability, or the restoration

or maintenance of health, and for

payment related projects.

2. To agency contractors, or

consultants who have been engaged by

the agency to assist in the performance

of a service related to this system of

records and who need to have access to

the records in order to perform the

activity.

3. To a member of Congress or to a

Congressional staff member in response

to an inquiry of the Congressional Office

made at the written request of the

constituent about whom the record is

maintained.

4. To the Department of Justice (DOJ),

court or adjudicatory body when:

(a) The agency or any component

thereof, or

(b) Any employee of the agency in his

or her official capacity, or

(c) Any employee of the agency in his

or her individual capacity where the

DOJ has agreed to represent the

employee, or

(d) The United States Government is

a party to litigation or has an interest in

such litigation, and by careful review,

HCFA determines that the records are

both relevant and necessary to the

litigation and that the use of such

records by the DOJ, court or

adjudicatory body is compatible with

the purpose for which the agency

collected the records.

* * * * *

POLICIES AND PRACTICES FOR STORING,

RETRIEVING, ACCESSING, RETAINING, AND

DISPOSING OF RECORDS IN THE SYSTEM:

* * * * *

SAFEGUARDS:

HCFA has safeguards for authorized

users and monitors such users to ensure

against excessive or unauthorized use.

Personnel having access to the system

have been trained in the Privacy Act

and systems security requirements.

Employees who maintain records in the

system are instructed not to release any

data until the intended recipient agrees

to implement appropriate

administrative, technical, procedural,

and physical safeguards sufficient to

protect the confidentiality of the data

and to prevent unauthorized access to

the data.

In addition, HCFA has physical

safeguards in place to reduce the

exposure of computer equipment and

thus achieve an optimum level of

protection and security for the HCFA

system. For computerized records,

safeguards have been established in

accordance with Department of Health

and Human Services (HHS) 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,

HCFA Automated Information Systems

(AIS) Guide, Systems Securities

Policies, and OMB Circular No. A–130

(revised), Appendix III.

* * * * *

SYSTEM MANAGER(S) AND ADDRESS:

Director, Office of Strategic Planning,

HCFA, Room C3–20–11, 7500 Security

Boulevard, Baltimore, Maryland, 21244–

1850. The telephone number is 410–

786–6501.

NOTIFICATION PROCEDURE:

For purpose of access, the subject

individual should write to the system

manager who will require the system

name, health insurance claim number,

address, age, and sex, and for

verification purposes, the subject

individual’s name (woman’s maiden

name, if applicable) and social security

number (SSN). Furnishing the SSN is

voluntary, but it may make searching for

a record easier and prevent delay.

RECORD ACCESS PROCEDURE:

For purpose of access, use the same

procedures outlined in Notification

Procedures above. Requestors should

also reasonably specify the record

contents being sought. (These

procedures are in accordance with

Department regulation 45 CFR

5b.5(a)(2)).

CONTESTING RECORD PROCEDURES:

The subject individual should 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).

* * * * *

Appendix A

09–70–0022 Municipal Health Services

Program, HHS/HCFA/OSP

09–70–0030 National Long-Term Care

Study Follow up, HHS/HCFA/OSP

09–70–0033 Person-Level Medicaid Data

System, HHS/HCFA/OSP

09–70–0036 Evaluation of Competitive

Bidding for Durable Medical Equipment

Demonstrations, HHS/HCFA/OSP

09–70–0039 Evaluation of the Medicare

Alzheimer’s Disease Demonstration,

HHS/HCFA/OSP

09–70–0040 Health Care Financing

Administration Medicare Heart

Transplant Data File, HHS/HCFA/OSP

09–70–0042 Medicare Cancer Registry

Record System, HHS/HCFA/OSP

09–70–0045 Evaluation of the Arizona

Health Care Cost Containment and Long

Term Care Systems Demonstration, HHS/

HCFA/OSP

09–70–0046 Home Health Quality Indicator

System (HHQUIS), HHS/HCFA/OSP

09–70–0048 Monitoring of the Home Health

Agency Prospective Payment

Demonstration, HHS/HCFA/OSP

09–70–0049 Evaluation of the Home Health

Agency (HHA) Prospective Payment

Demonstration, HHS/HCFA/OSP

09–70–0050 The Medicare/Medicaid MultiState Case Mix and Quality Data Base for

Nursing Home Residents, HHS/HCFA/

OSP

09–70–0051 Quality Assurance for the

Home Health Agency (HHA) Prospective

Payment Demonstration, HHS/HCFA/

OSP

09–70–0052 Post-Hospitalization Outcomes

Studies, HHS/HCFA/OSP

09–70–0053 The Medicare Beneficiary

Health Status Registry Pilot, HHS/HCFA/

OSP

09–70–0057 Evaluation of the Medicaid

Extension of Eligibility to Certain Low

Income Families Not Otherwise qualified

to receive Medicaid Benefits

Demonstration, HHS/HCFA/OSP

09–70–0058 Evaluation of the Medicare

SELECT Program, HHS/HCFA/OSP

09–70–0059 The Medicaid Necessity,

Appropriateness, and Outcomes of Care

Study, HHS/HCFA/OSP

09–70–0063 Evaluation of the Medicaid

Demonstration for Improving Access to

Care for Substance Abusing Pregnant

Women, HHS/HCFA/OSP

09–70–0066 Evaluation of, and External

Quality Assurance for, the Community

Nursing Organization (CNO)

Demonstration, HHS/HCFA/OSP

[FR Doc. 00–15231 Filed 6–15–00; 8:45 am]

BILLING CODE 4120–03–P