Federal Register / Vol. 65, No. 106 / Thursday, June 1, 2000 / Rules and Regulations 34971

None of the cost estimates in the

proposed rule were corrected for the

incidence of pregnant women having

diseases under study (but not having

been included in the studies). Hence,

the cost estimates discussed in the

proposed rule were overstated. The

agency believes that the effect of this

overstatement is relatively insignificant.

The agency is aware of industry’s

concerns about liability exposure

associated with the inclusion of women

with reproductive potential in clinical

trials and the potential for harm to

offspring. Although there are cases of

injury to offspring of mothers who

ingested experimental drugs, the

inadequacy of warnings or the lack of

informed consent has been an essential

element of such lawsuits. The agency is

not aware of any reported case in which

a sponsor of an investigational drug was

held liable for injuries to offspring when

the sponsor provided adequate warnings

and obtained fully informed consent.

Therefore, the agency assumes that this

rule adds nothing to current liability

costs under existing law.

B. Small Entities

The analysis in the proposed rule

identified protocols sponsored by small

businesses. The largest additional

pregnancy testing cost incurred by a

small business in the reviewed

protocols under the rule was $990.

Projected across all CDER and CBER

review divisions and annualized, FDA

expects no more than 9 protocol

submissions per year from small

businesses that might incur increased

costs. Few small firms are likely to be

affected in any given year, and most of

these firms would incur no significant

additional costs. Therefore, under the

Regulatory Flexibility Act, the

Commissioner of Food and Drugs

certifies that this rule will not have a

significant effect on a substantial

number of small entities.

V. Environmental Impact

The agency has determined under 21

CFR 25.30(h) that this action is of a type

that does not individually or

cumulatively have a significant effect on

the human environment. Therefore,

neither an environmental assessment

nor an environmental impact statement

is required.

VI. Paperwork Reduction Act of 1995

This final rule contains no collections

of information. Therefore, clearance by

the Office of Management and Budget

under the Paperwork Reduction Act of

1995 is not required.

VII. Federalism

FDA has analyzed this final rule in

accordance with the principles set forth

in Executive Order 13132. FDA has

determined that the rule does not

contain policies that have substantial

direct effects on the States, on the

relationship between National

Government and the States, or on the

distribution of power and

responsibilities among the various

levels of government. Accordingly, the

agency has concluded that the rule does

not contain policies that have

federalism implications as defined in

the order and, consequently, a

federalism summary impact statement is

not required.

List of Subjects in 21 CFR Part 312

Drugs, Exports, Imports,

Investigations, Labeling, Medical

research, Reporting and recordkeeping

requirements, Safety.

Therefore, under the Federal Food,

Drug, and Cosmetic Act, the Public

Health Service Act, and under authority

delegated to the Commissioner of Food

and Drugs, 21 CFR part 312 is amended

as follows:

PART 312—INVESTIGATIONAL NEW

DRUG APPLICATION

1. The authority citation for 21 CFR

part 312 continues to read as follows:

Authority: 21 U.S.C. 321, 331, 351, 352,

353, 355, 371; 42 U.S.C. 262.

2. Section 312.42 is amended by

adding new paragraph (b)(1)(v) and by

revising paragraph (b)(2)(i) to read as

follows:

§ 312.42 Clinical holds and requests for

modification.

* * * * *

(b) * * *

(1) * * *

(v) The IND is for the study of an

investigational drug intended to treat a

life-threatening disease or condition that

affects both genders, and men or women

with reproductive potential who have

the disease or condition being studied

are excluded from eligibility because of

a risk or potential risk from use of the

investigational drug of reproductive

toxicity (i.e., affecting reproductive

organs) or developmental toxicity (i.e.,

affecting potential offspring). The

phrase ‘‘women with reproductive

potential’’ does not include pregnant

women. For purposes of this paragraph,

‘‘life-threatening illnesses or diseases’’

are defined as ‘‘diseases or conditions

where the likelihood of death is high

unless the course of the disease is

interrupted.’’ The clinical hold would

not apply under this paragraph to

clinical studies conducted:

(A) Under special circumstances, such

as studies pertinent only to one gender

(e.g., studies evaluating the excretion of

a drug in semen or the effects on

menstrual function);

(B) Only in men or women, as long as

a study that does not exclude members

of the other gender with reproductive

potential is being conducted

concurrently, has been conducted, or

will take place within a reasonable time

agreed upon by the agency; or

(C) Only in subjects who do not suffer

from the disease or condition for which

the drug is being studied.

(2) * * *

(i) Any of the conditions in

paragraphs (b)(1)(i) through (b)(1)(v) of

this section apply; or

* * * * *

Dated: May 24, 2000.

Jane E. Henney,

Commissioner of Food and Drugs.

Donna E. Shalala,

Secretary of Health and Human Services.

[FR Doc. 00–13664 Filed 5–31–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF TRANSPORTATION

Coast Guard

33 CFR Part 165

[CGD01–00–133]

RIN 2115–AA97

Safety Zone: Fireworks Display, East

River, Wards Island

AGENCY: Coast Guard, DOT.

ACTION: Temporary final rule.

SUMMARY: The Coast Guard is

establishing a temporary safety zone for

a fireworks display located on the East

River, New York. This action is

necessary to provide for the safety of life

on navigable waters during the event.

This action is intended to restrict vessel

traffic in a portion of the East River.

DATES: This rule is effective from 8:30

p.m. (e.s.t.) on June 29, 2000 until 10

p.m. (e.s.t.) on June 30, 2000.

ADDRESSES: Comments and material

received from the public, as well as

documents indicated in this preamble as

being available in the docket, are part of

docket (CGD01–00–133) and are

available for inspection or copying at

Coast Guard Activities New York, 212

Coast Guard Drive, room 205, Staten

Island, New York 10305, between 8 a.m.

and 3 p.m., Monday through Friday,

except Federal holidays. The telephone

number is (718) 354–4012.

34972 Federal Register / Vol. 65, No. 106 / Thursday, June 1, 2000 / Rules and Regulations

FOR FURTHER INFORMATION CONTACT:

Lieutenant M. Day, Waterways

Oversight Branch, Coast Guard

Activities New York (718) 354–4012.

SUPPLEMENTARY INFORMATION:

Regulatory Information

We did not publish a notice of

proposed rulemaking (NPRM) for this

regulation. Under 5 U.S.C. 553(b)(8), the

Coast Guard finds that good cause exists

for not publishing an NPRM. Good

cause exists for not publishing an NPRM

due to the following reasons: due to the

date the Application for Approval of

Marine Event was received, there was

insufficient time to draft and publish an

NPRM and still publish the final rule

with more than 30 days before its

effective date. Any delay encountered in

this regulation’s effective date would be

contrary to public interest since

immediate action is needed to close the

waterway and protect the maritime

public from the hazards associated with

this fireworks display. This is a local

event with minimal impact on the

waterway, vessels may still transit

through the East River during the event,

the zone is only in affect for 11⁄2 hours

and vessels can be given permission to

transit the zone except for about 45

minutes during this time. Additionally,

vessels would not be precluded from

mooring at or getting underway from

commercial or recreational piers in the

vicinity of the zone.

Background and Purpose

The Coast Guard has received an

application to hold a fireworks program

on the waters of the East River, New

York. This regulation establishes a

safety zone in all waters of the East

River within a 150-yard radius of the

fireworks land shoot in approximate

position 40°46′55.5′′ N 073°55′33′′ W

(NAD 1983), about 200 yards northeast

of the Triborough Bridge. The safety

zone is in effect from 8:30 p.m. (e.s.t.)

until 10 p.m. (e.s.t.) on Thursday, June

29, 2000. If the event is cancelled due

to inclement weather, then this section

is effective from 8:30 p.m. (e.s.t.) until

10 p.m. (e.s.t.) on Friday, June 30, 2000.

The safety zone prevents vessels from

transiting a portion of the East River and

is needed to protect boaters from the

hazards associated with fireworks

launched from shore in the area.

Recreational and commercial vessel

traffic will be able to transit through the

eastern 430 feet of the 1060-foot wide

East River during the event. This safety

zone precludes the waterway users from

entering only the safety zone itself.

Public notifications will be made prior

to the event via the Local Notice to

Mariners.

This event is currently regulated

under 33 CFR 100.114 as an annually

occurring event on July 1st. Due to the

extensive increase of marine traffic in

the Port of New York/New Jersey due to

OPSAIL 2000 and the International

Naval Review 2000 the sponsor is

changing their event date for this year.

Regulatory Evaluation

This final rule is not a significant

regulatory action under section 3(f) of

Executive Order 12866 and does not

require an assessment of potential costs

and benefits under section 6(a)(3) of that

Order. It has not been reviewed by the

Office of Management and Budget under

that Order. It is not significant under the

regulatory policies and procedures of

the Department of Transportation (DOT)

(44 FR 11040; February 26, 1979). The

Coast Guard expects the economic

impact of this final rule to be so

minimal that a full Regulatory

Evaluation under paragraph 10e of the

regulatory policies and procedures of

DOT is unnecessary. This finding is

based on the minimal time that vessels

will be restricted from the zone, that

vessels may still transit through the East

River during the event, and advance

notifications which will be made.

The size of this safety zone was

determined using National Fire

Protection Association and New York

City Fire Department standards for 4′′

mortars fired from shore combined with

the Coast Guard’s knowledge of tide and

current conditions in the area.

Small Entities

Under the Regulatory Flexibility Act

(5 U.S.C. 601 et seq.), the Coast Guard

considered whether this final rule will

have a significant economic impact on

a substantial number of small entities.

‘‘Small entities’’ include small

businesses, not-for-profit organizations

that are independently owned and

operated and are not dominant in their

fields, and governmental jurisdictions

with populations of less than 50,000.

For reasons discussed in the

Regulatory Evaluation above, the Coast

Guard certifies under section 605(b) of

the Regulatory Flexibility Act (5 U.S.C.

601 et seq.) that this final rule will not

have a significant economic impact on

a substantial number of small entities.

Collection of Information

This final rule does not provide for a

collection of information under the

Paperwork Reduction Act of 1995 (44

U.S.C. 3501 et seq.).

Federalism

The Coast Guard has analyzed this

final rule under the principles and

criteria contained in Executive Order

13132 and has determined that this final

rule does not have implications for

federalism under that Order.

Unfunded Mandates

Title II of the Unfunded Mandates

Reform Act of 1995 (UMRA) [Pub. L.

104–4, 109 Stat. 48] requires Federal

agencies to assess the effects of certain

regulatory actions on State, local, and

tribal governments, and the private

sector. UMRA requires a written

statement of economic and regulatory

alternatives for rules that contain

Federal mandates. A Federal mandate is

a new or additional enforceable duty

imposed on any State, local, or tribal

government, or the private sector. If any

Federal mandate causes those entities to

spend, in the aggregate, $100 million or

more in any one year, the UMRA

analysis is required. This final rule does

not impose Federal mandates on any

State, local, or tribal governments, or the

private sector.

Environment

The Coast Guard considered the

environmental impact of this final rule

and concluded that under figure 2–1,

paragraph 34(g), of Commandant

Instruction M16475.1C, this final rule is

categorically excluded from further

environmental documentation. This rule

fits paragraph 34(g) as it establishes a

safety zone. A ‘‘Categorical Exclusion

Determination’’ is available in the

docket for inspection or copying where

indicated under ADDRESSES.

List of Subjects in 33 CFR Part 165

Harbors, Marine Safety, Navigation

(water), Reporting and recordkeeping

requirements, Security measures,

Waterways.

Regulation

For the reasons discussed in the

preamble, the Coast Guard amends 33

CFR part 165 as follows:

PART 165—[AMENDED]

1. The authority citation for Part 165

continues to read as follows:

Authority: 33 U.S.C. 1231; 50 U.S.C. 191;

33 CFR 1.05–1(g), 6.04–1, 6.04–6, 160.5; 49

CFR 1.46.

2. Add temporary § 165.T01–133 to

read as follows:

§ 165.T01–133 Safety Zone: Fireworks

Display, East River, Wards Island.

(a) Location. The following area is a

safety zone: All waters of the East River

within a 150-yard radius of the

fireworks land shoot in approximate

position 40°46′55.5′′ N 073°55′33′′ W

Federal Register / Vol. 65, No. 106 / Thursday, June 1, 2000 / Rules and Regulations 34973

(NAD 1983), about 200 yards northeast

of the Triborough Bridge.

(b) Effective period. This section is

effective from 8:30 p.m. (e.s.t.) until 10

p.m. (e.s.t.) on June 29, 2000. If the

event is cancelled due to inclement

weather, then this section is effective

from 8:30 p.m. (e.s.t.) until 10 p.m.

(e.s.t.) on June 30, 2000.

(c) Regulations.

(1) The general regulations contained

in 33 CFR 165.23 apply.

(2) All persons and vessels shall

comply with the instructions of the

Coast Guard Captain of the Port or the

designated on-scene-patrol personnel.

These personnel comprise

commissioned, warrant, and petty

officers of the Coast Guard.

Upon being hailed by a U.S. Coast

Guard vessel by siren, radio, flashing

light, or other means, the operator of a

vessel shall proceed as directed.

Dated: May 22, 2000.

R.E. Bennis,

Captain, U.S. Coast Guard, Captain of the

Port, New York.

[FR Doc. 00–13811 Filed 5–30–00; 12:39 pm]

BILLING CODE 4910–15–P

NATIONAL ARCHIVES AND RECORDS

ADMINISTRATION

36 CFR Part 1260

RIN 3095–AA67

Records Declassification

AGENCY: National Archives and Records

Administration (NARA).

ACTION: Final rule.

SUMMARY: This rule updates NARA

regulations related to declassification of

national security-classified information

in records transferred to NARA’s legal

custody. It incorporates changes

resulting from Executive Order 12958,

Classified National Security

Information, including:

Revising the timeline for systematic

review from 30 years to 25 years;

Redefining declassification

responsibilities to reflect the E.O. 12958

requirement for agencies to maintain

systematic review programs;

Adding requirements for agencies that

elect to review their accessioned records

at NARA;

Adding requirements for loaning

records to agencies for declassification

review; and Revising requirements for

reclassification of information to meet

the provisions of E.O. 12958;

The rule affects members of the public

who file mandatory review requests and

Federal agencies.

DATES: This rule is effective July 1,

2000.

FOR FURTHER INFORMATION CONTACT:

Nancy Allard or Shawn Morton at 301–

713–7360.

SUPPLEMENTARY INFORMATION: NARA

published a notice of proposed

rulemaking on February 17, 2000, at 65

FR 8077. The comment period ended on

April 17, 2000. NARA received

comments from 9 Federal agencies and

1 professional organization. Of the

comments from the Federal agencies, 3

concurred with the proposed rule, 5

recommended clarifications or changes

and 1 offered ‘‘no comment.’’

Following is a summary of the

comments and a discussion of the

changes that we made to the proposed

rule to address those comments.

Automatic Declassification

One commenter stated that we should

add a provision to account for the

automatic declassification provisions in

section 3.4 of Executive Order 12958.

Executive Order 13142, issued on

November 19, 1999, amended Executive

Order 12958 section 3.4 to delay the

application of automatic declassification

for records accessioned into NARA until

April 17, 2003. We have made

appropriate reference to the automatic

declassification requirements in the

regulation.

As we reviewed §§ 1260.20 and

1260.40 to incorporate the reference, we

further clarified these sections by

removing the distinctions between

records that are older and younger than

25 years to focus on the responsibilities

for declassifying the information.

Restricted Data and Formerly

Restricted Data

One Federal agency commented that

the regulation does not address

declassification responsibilities for

nuclear-related information classified as

Restricted Data and Formerly Restricted

Data. This type of information is

classified under the Atomic Energy Act

of 1954, as amended, and is exempt

from all requirements under Executive

Order 12958. We added the language

suggested by the commenter as

§ 1260.28, which specifies that only

designated individuals in the

Department of Energy may declassify

records containing Restricted Data, and

that only designated officials within the

Department of Defense or the

Department of Energy may declassify

Formerly Restricted Data.

Mandatory Review Requests for White

House Originated Information

The National Security Council

recommended deleting § 1260.62 which

explains how agencies should handle

mandatory review requests for White

House originated materials from a past

administration that are in their custody.

This section would have required

agencies to forward the request, copies

of the requested records, and a

recommendation to grant or deny the

request to the Archivist. The Archivist

would then decide whether or not to

declassify the information. The

commenter noted that Federal agencies

do not segregate White House originated

information in their custody from their

Federal records, and, therefore, follow

the process for responding to Mandatory

Review and FOIA requests for Federal

records. We have accepted the comment

after consulting with the Information

Security Oversight Office.

Referring Documents Back to Agencies

for Declassification Determinations

One Federal agency commented that

§ 1260.50 should be modified in several

ways. The commenter pointed out that

at times, the association of an agency

with a particular document can be in

itself a classified fact requiring

protection. NARA currently does not

tell requesters which agencies it has

referred documents to. We have

modified § 1260.50(d) according to the

commenter’s suggestion to clarify this

existing practice.

The agency also offered alternative

language in this section to clarify when

NARA would send a document back to

an agency for declassification. The

commenter suggested that we insert the

phrase, ‘‘Where the originating agency

has not provided systematic

declassification guidance, or where

there is a question regarding the

declassification guidance provided’’ at

the beginning of the second sentence in

§ 1260.50(b). We have accepted this

comment with modification. We cannot

specify that we will refer the

information only if we are missing

guidance from the originating agency.

When NARA declassifies information

using agency systematic guidance, we

must use the guidance of every agency

that has equities in the information. If

we do not have guidance from an

agency that has equities in the

information, even when it is not the

originating agency, we review the

information using the guidance that we

do have, and then refer the information

to the agency(ies) for which we do not

have guidance for final action.

Appeals

We received a comment that NARA

should act as the recipient for all

appeals for adverse declassification

decisions from other agencies. The