Federal Register / Vol. 65, No. 3 / Wednesday, January 5, 2000 / Proposed Rules 427

combined residues of azoxystrobin and

its Z isomer in or on pistachios at 0.02

ppm and in or on tree nuts at 0.02 ppm.

EPA’s assessment of the dietary

exposures and risks associated with

establishing the tolerances were

published in 64 FR 13106 (March 17,

1999), the final rule that established the

initial tolerances for residues of

azoxystrobin in or on pistachios at 0.01

ppm and in or on tree nuts at 0.01 ppm.

In that rule the Agency concluded that

there was a reasonable certainty that no

harm would result from the

establishment of azoxystrobin tolerances

for several other commodities. A

reassessment of the risk associated with

increasing the azoxystrobin tolerances

for pistachios and tree nuts to 0.02 ppm

demonstrated that the calculated risk

increases were so small (generally at the

fourth decimal place) that the risk

assessment values (rounded) reported in

64 FR 13106 (March 17, 1999) were not

changed. That is, the risk increase

resulting from this proposed rule will be

negligible. Accordingly, EPA concludes

that modifying these tolerances as

described will be safe for the general

population, including infants and

children. EPA reaffirms its specific risk

findings set forth in the March 1999

azoxystrobin tolerance action.

D. International Residue Limits

There are no Codex, Canadian or

Mexican Maximum Residue Limits

(MRL) established for azoxystrobin for

pistachios or tree nuts. Thus,

harmonization is not an issue.

III. Regulatory Assessment

Requirements

This proposed rule seeks to establish

a tolerance under FFDCA section 408(e).

The Office of Management and Budget

(OMB) has exempted these types of

actions from review under Executive

Order 12866, entitled Regulatory

Planning and Review (58 FR 51735,

October 4, 1993). This action does not

contain any information collections

subject to OMB approval under the

Paperwork Reduction Act (PRA), 44

U.S.C. 3501 et seq., or impose any

enforceable duty or contain any

unfunded mandate as described under

Title II of the Unfunded Mandates

Reform Act of 1995 (UMRA) (Public

Law 104–4). Nor does it require any

prior consultation as specified by

Executive Order 13084, entitled

Consultation and Coordination with

Indian Tribal Governments (63 FR

27655, May 19,1998); special

considerations as required by Executive

Order 12898, entitled Federal Actions to

Address Environmental Justice in

Minority Populations and Low-Income

Populations (59 FR 7629, February 16,

1994); or require OMB review or any

Agency action under Executive Order

13045, entitled Protection of Children

from Environmental Health Risks and

Safety Risks (62 FR 19885, April 23,

1997). This action does not involve any

technical standards that would require

Agency consideration of voluntary

consensus standards pursuant to section

12(d) of the National Technology

Transfer and Advancement Act of 1995

(NTTAA), Public Law 104–113, section

12(d) (15 U.S.C. 272 note). Pursuant to

the Regulatory Flexibility Act (RFA) (5

U.S.C. 601 et seq.), the Agency

previously assessed whether

establishing tolerances, exemptions

from tolerances, raising tolerance levels

or expanding exemptions might

adversely impact small entities and

concluded, as a generic matter, that

there is no adverse economic impact.

The factual basis for the Agency’s

generic certification for tolerance

actions published on May 4, 1981 (46

FR 24950), and was provided to the

Chief Counsel for Advocacy of the Small

Business Administration. In addition,

the Agency has determined that this

action will not have a substantial direct

effect on States, on the relationship

between the national government and

the States, or on the distribution of

power and responsibilities among the

various levels of government, as

specified in Executive Order 13132,

entitled Federalism (64 FR 43255,

August 10, 1999). Executive Order

13132 requires EPA to develop an

accountable process to ensure

‘‘meaningful and timely input by State

and local officials in the development of

regulatory policies that have federalism

implications.’’ ‘‘Policies that have

federalism implications’’ is defined in

the Executive Order to include

regulations that have ‘‘substantial direct

effects on the States, on the relationship

between the national government and

the States, or on the distribution of

power and responsibilities among the

various levels of government.’’ This rule

directly regulates growers, food

processors, food handlers and food

retailers, not States. This action does not

alter the relationships or distribution of

power and responsibilities established

by Congress in the preemption

provisions of FFDCA section 408(n)(4).

List of Subjects in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: December 16, 1999.

James Jones,

Director, Registration Division, Office of

Pesticide Programs.

Therefore, it is proposed that 40 CFR

chapter I shall be amended as follows:

PART 180—[AMENDED]

1. The authority citation for part 180

continues to read as follows:

Authority: 21 U.S.C. 321(q), (346a) and

371.

2. In § 180.507, the table to paragraph

(a)(1), by revising the entries for

pistachios and tree nuts to read as

follows:

§ 180.507 Azoxystrobin; tolerances for

residues.

(a) General. (1) * * *

Commodity Parts per million

*****

Pistachios ............. 0.02

*****

Tree nuts .............. 0.02

*****

*****

[FR Doc. 00–75 Filed 1–4–00; 8:45 am]

BILLING CODE 6560–50–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Office of the Secretary

45 CFR Parts 160 and 164

[RIN 0991–AB08]

Standards for Privacy of Individually

Identifiable Health Information

AGENCY: Office of the Assistant

Secretary for Planning and Evaluation,

DHHS.

ACTION: Proposed rule; correction.

SUMMARY: This document corrects the

preamble and proposed regulatory text

published in the Federal Register of

November 3, 1999, regarding the

Standards for Privacy of Individually

Identifiable Health Information.

FOR FURTHER INFORMATION CONTACT:

Roxanne Gibson, (202) 260–5083.

SUPPLEMENTARY INFORMATION:

Corrections

In the proposed rule 45 CFR Parts 190

through 164, beginning on page 59918

428 Federal Register / Vol. 65, No. 3 / Wednesday, January 5, 2000 / Proposed Rules

in the issue of November 3, 1999, make

the following corrections.

On page 59919 in the first column,

C.3. currently says, ‘‘Right to restrict

uses and disclosures.’’ It should read,

‘‘Right to request restrictions on uses

and disclosures.’’

On page 59919 in the first column,

D.6. currently says, ‘‘Inclusion in the

accounting for uses and disclosures.’’

This should be changed to say,

‘‘Inclusion in the accounting for

disclosures.’’

On page 59919 in the second column,

III.3. currently says, ‘‘Accounting for

uses and disclosures.’’ This should be

changed to say, ‘‘Accounting for

disclosures.’’

On page 59919 in the second column,

IV.G.5. currently says, ‘‘Right to restrict

uses and disclosures.’’ It should read,

‘‘Right to request restrictions on uses

and disclosures.’’

On page 59942 in the second full

paragraph of the second column

currently reads, ‘‘We considered

including other disclosures permitted

under proposed § 164.510 within the

prohibition described in this provision,

but were unsure if psychotherapy notes

were ever relevant to the public policy

purposes underlying those disclosures.

For example, we would assume that

such notes are rarely disclosed for

public health purposes or to next of kin.

We solicit comment on whether there

are additional categories of disclosures

permitted under proposed § 164.510 for

which the disclosure of psychotherapy

notes by covered entities without

specific individual authorization would

be appropriate.’’ That paragraph should

read, ‘‘We considered including the

disclosures permitted under proposed

§ 164.510 within the prohibition

described in this provision, but were

unsure if psychotherapy notes were ever

relevant to the public policy purposes

underlying those disclosures. For

example, we would assume that such

notes are rarely disclosed for public

health purposes or to next of kin. We

solicit comment on whether there are

categories of disclosures permitted

under proposed § 164.510 for which the

disclosure of psychotherapy notes by

covered entities without specific

individual authorization would not be

appropriate.’’

On page 59943 in the second full

paragraph of the first column currently

reads, ‘‘We considered including other

of the uses and disclosures that would

be permitted under § 164.510 within the

prohibition described in this provision,

but were unsure if research information

unrelated to treatment would ever be

relevant to the public policy purposes

underlying those disclosures. We solicit

comment on whether there are

additional categories of uses or

disclosures that would be permitted

under proposed § 164.510 for which the

use or disclosure of such information by

covered entities without specific

individual authorization would be

appropriate.’’ That paragraph should

read, ‘‘We considered including the uses

and disclosures that would be permitted

under § 164.510 within the prohibition

described in this provision, but were

unsure if research information unrelated

to treatment would ever be relevant to

the public policy purposes underlying

those disclosures. We solicit comment

on whether there are categories of uses

or disclosures that would be permitted

under proposed § 164.510 for which use

or disclosure of such information by

covered entities without specific

individual authorization would not be

appropriate.’’

On page 59945 in the second column,

3 currently says, ‘‘Right to Restrict Uses

and Disclosures.’’ It should read, ‘‘Right

to Request Restrictions on Uses and

Disclosures.’’

On page 59945 in the second column,

under 3 currently says, ‘‘[Please label

comments about this section with the

subject: ‘‘Right to restrict’’].’’ It should

read, ‘‘[Please label comments about

this section with the subject: ‘‘Right to

request restrictions’’].’’

On page 59946 in the first column

paragraph four, the sentence, ‘‘Limiting

the right to restrict to self-pay patients

also would reduce the number of

requests that would be made under this

provision.,’’ should read, ‘‘Limiting the

right to request restrictions to self-pay

patients also would reduce the number

of requests that would be made under

this provision.’’

On page 59958 in the second line of

the first column, the phrase ‘‘(often

refereed to as ‘‘deemed status’’)’’ should

be deleted.

On page 59987 in the second column

section b. Grounds for denial of request

for amendment, the first sentence

currently reads, ‘‘We are proposing that

a covered plan or provider would be

permitted to deny a request for

amendment or correction if, after a

reasonable review, the plan or provider

determines that it did not create the

information at issue, the information

would not be available for inspection

and copying under proposed § 164.514,

the information is accurate and

complete, or if it is erroneous or

incomplete, it would not be adversely

affect the individual.’’ We are correcting

this sentence to read, ‘‘We are proposing

that a covered plan or provider would

be permitted to deny a request for

amendment or correction if, after a

reasonable review, the plan or provider

determines that it did not create the

information at issue, the information

would not be available for inspection

and copying under proposed § 164.514,

or the information is accurate and

complete.’’

On page 60004 in the first column, 3.

currently says, ‘‘Accounting for uses

and disclosures.’’ This should be

changed to say, ‘‘Accounting for

disclosures.’’

On page 60004 in the first column, the

preamble text under 3. currently says,

‘‘Covered plans and providers would

have to be able to provide an accounting

for the uses and disclosures of protected

health information for purposes other

than treatment, payment, or health care

operations.’’ This should be changed to

say, ‘‘Covered plans and providers

would have to be able to provide an

accounting for disclosures of protected

health information for purposes other

than treatment, payment, or health care

operations.’’

On page 60007 in table 1, the cost of

notice development for all entities in

the initial or first year cost (2000)

column should be 30,000,000 rather

than 20,000,000.

On page 60007 in table 1, the total

cost of the regulation in the initial or

first year cost (2000) column should be

$1,185,230,000 rather than

$1,165,230,000.

On page 60012 in the second column

the third full paragraph begins, ‘‘It is

also important to point out that none of

the States appear to offer individuals the

right to restrict disclosure of their

protected health information for

treatment.’’ It should read, ‘‘It is also

important to point out that none of the

States appear to offer individuals the

right to request restrictions on

disclosure of their protected health

information for treatment.’’

On page 60016 in the first column in

the first paragraph under the heading

Notice of Privacy Practices, the

sentences that currently read, ‘‘Data

from the 1996 Medical Expenditure

Panel Survey shows that there are

approximately 200 million ambulatory

care encounters per year, nearly 20

million persons with a hospital episode,

7 million with home-health episodes,

and over 170 million with prescription

drug use (350 million total). For the

remaining four years of the five year

period, we have estimated that, on

average, a quarter of the remaining

population will enter the system, and

thus receive a notice.’’ are changed to

read, ‘‘Data from the 1996 Medical

Expenditure Panel Survey shows that

there are approximately 200 million

ambulatory care encounters per year,

Federal Register / Vol. 65, No. 3 / Wednesday, January 5, 2000 / Proposed Rules 429

nearly 20 million persons with a

hospital episode, 7 million with homehealth episodes, and over 170 million

with prescription drug use (397 million

total). For the remaining four years of

the five year period, we have estimated

that one-quarter to three-quarters of

patients without an encounter in the

first year will enter the system.’’

On page 60016 in the second column,

the sentence starting on line five

currently reads, ‘‘The cost for this

would be $0.75 over five years.’’ This

sentence should read, ‘‘The cost for

health plans to issue notice would be

$0.75 over five years.’’

On page 60017 in table 2, the cost of

notice development for all entities in

the initial or first year cost (2000)

column should be 30,000,000 rather

than 20,000,000.

On page 60018 in table 2, the total

cost of the regulation in the initial or

first year cost (2000) column should be

$1,185,230,000 rather than

$1,165,230,000.

On page 60024 in the first column, 5

currently says, ‘‘Right to Restrict Uses

and Disclosures.’’ It should read, ‘‘Right

to Request Restrictions on Uses and

Disclosures.’’

On page 60024 in the second full

paragraph in the second column, the

sentence, ‘‘Limiting the right to restrict

to self-pay patients also would reduce

the number of requests that would be

made under this provision,’’ should

read, ‘‘Limiting the right to request

restrictions to self-pay patients also

would reduce the number of requests

that would be made under this

provision.’’

On page 60037 in the first paragraph

of the first column, the sentence that

currently reads, ‘‘These small

businesses represent 83.8% of all health

entities we have examined,’’ should

read, ‘‘These small businesses represent

84.9% of all health entities we have

examined.’’

On page 60039 in the second column,

c. currently says, ‘‘Right to restrict.’’ It

should read, ‘‘Right to request

restrictions on uses and disclosures.’’

On page 60041 in the first column

under ‘‘i. Documentation requirements

for covered entities,’’ the sentence that

currently reads, ‘‘These areas would

include use within the entity; informing

business partners; disclosures with and

without authorizations; limitations on

use and disclosure for self-pay;

inspection and copying; amendment or

correction; accounting for uses and

disclosure; notice development,

maintenance, and dissemination;

sanctions; and complaint procedures.,’’

should read, ‘‘These areas would

include use within the entity; informing

business partners; disclosures with and

without authorization; inspection and

copying; amendment or correction;

accounting for disclosure; notice

development, maintenance, and

dissemination; sanctions; and complaint

procedures.’’

On page 60045 in the table

summarizing the PRA burden hours, the

line that says, ‘‘§ 164.515 Accounting for

uses and disclosures of protected health

information,’’ should read, ‘‘§ 164.515

Accounting for disclosures of protected

health information.’’

On page 60046 column three the

heading ‘‘Section 164.515 Accounting

for Uses and Disclosures of Protected

Health Information’’ should be changed

to ‘‘Section 164.515 Accounting for

Disclosures of Protected Health

Information.’’

On page 60049 in the first column, the

title Appendix to the Preamble: Sample

Contact of Provider Notice should read

Appendix to the Preamble: Sample

Content of Provider Notice.

On page 60053 in the third column,

under 164.506(a)(1), (i) currently reads,

‘‘Except for research information

unrelated to treatment, to carry out

treatment, payment, or health care

operations;.’’ It should read, ‘‘Except for

research information unrelated to

treatment and psychotherapy notes, to

carry out treatment, payment, or health

care operations;’’

On page 60055 in the third column,

(3)(iii) currently reads, ‘‘A covered

entity may not condition treatment,

enrollment in a health plan, or payment

on a requirement that the individual

authorize use of disclosure of

psychotherapy notes relating to the

individual.’’ It should read, ‘‘A covered

entity may not condition treatment,

enrollment in a health plan, or payment

on a requirement that the individual

authorize use or disclosure of research

information unrelated to treatment or

psychotherapy notes relating to the

individual.’’

On page 60057 in the third column,

the following should be deleted because

it duplicates information in the second

column:

(5) Urgent circumstances. The

disclosure is of the protected health

information of an individual who is or

is suspected to be a victim of a crime,

abuse, or other harm, if the law

enforcement official represents that:

(i) Such information is needed to

determine whether a violation of law by

a person other than the victim has

occurred; and

(ii) Immediate law enforcement

activity that depends upon obtaining

such information may be necessary.

Dated: December 27, 1999.

Brian P. Burns,

Deputy Assistant Secretary for Information

Resources Management.

[FR Doc. 00–124 Filed 1–4–00; 8:45 am]

BILLING CODE 4150–04–M

NATIONAL AERONAUTICS AND

SPACE ADMINISTRATION

48 CFR Parts 1804 and 1852

Security Requirements for Unclassified

Information Technology Resources

AGENCY: National Aeronautics and

Space Administration.

ACTION: Proposed rule.

SUMMARY: This is a proposed rule to

amend the NASA FAR Supplement

(NFS) to include a requirement for

contractors and subcontractors working

with NASA Information Technology

Systems to take certain Information

Technology (IT) security related actions,

to document those actions, and submit

related reports to NASA.

DATES: Comments should be submitted

on or before March 6, 2000.

ADDRESSES: Interested parties should

submit written comments to Karl Beisel,

NASA Headquarters Office of

Procurement, Analysis Division (Code

HC), Washington, DC 20546. Comments

may also be submitted by email to

Karl.Beisel@hq.nasa.gov.

FOR FURTHER INFORMATION CONTACT:

KARL BEISEL, 202–358–0416, EMAIL:

KARL.BEISEL@HQ.NASA.GOV.

SUPPLEMENTARY INFORMATION:

A. Background

This revision to the NASA FAR

Supplement will require NASA

contractors and subcontractors to

comply with the security requirements

outlined in NASA Policy Directive

(NPD) 2810.1, ‘‘Security of Information

Technology,’’ and NASA Procedures

and Guidelines (NPG) 2810.1, ‘‘Security

of Information Technology,’’ and to

comply with additional safeguarding

requirements delineated in the proposed

contract clause.

Currently NASA contractors have no

definitive contractual requirement to

follow NASA directed policy in

safeguarding unclassified NASA data

held via information technology

(computer systems). This proposed rule

establishes these requirements in a

contract clause. The clause also requires

compliance with additional

safeguarding requirements. These

policies apply to all IT systems and

networks under NASA’s purview