This section of the FEDERAL REGISTER

contains notices to the public of the proposed

issuance of rules and regulations. The

purpose of these notices is to give interested

persons an opportunity to participate in the

rule making prior to the adoption of the final

rules.

Proposed Rules Federal Register

45766

Vol. 62, No. 168

Friday, August 29, 1997

DELAWARE RIVER BASIN

COMMISSION

18 CFR Part 401

Rules of Practice and Procedure;

Proposed Amendments to

Administrative Manual—Rules of

Practice and Procedure; Public

Hearing

AGENCY: Delaware River Basin

Commission.

ACTION: Notice of proposed rulemaking

and public hearing.

SUMMARY: Notice is hereby given that

the Delaware River Basin Commission

will hold a public hearing to review

comments on proposed amendments to

its Rules of Practice and Procedure

which are intended to delete obsolete

provisions, to clarify certain provisions

of the rules and better inform the

signatory parties, applicants and the

general public with regard to the

Commission’s practices and procedures.

The proposed revisions conform the

rules to existing Commission

interpretations and practices.

DATES: The public hearing will be held

on October 22, 1997 beginning at 3:00

p.m. and continuing until 5:00 p.m., as

long as there are people present wishing

to testify.

The deadline for inclusion of written

comments in the hearing record will be

announced at the hearing.

ADDRESSES: The public hearing will be

held in the Goddard Conference Room

of the Commission’s offices at 25 State

Police Drive, West Trenton, New Jersey.

Written comments should be submitted

to Susan M. Weisman, Delaware River

Basin Commission, P.O. Box 7360, West

Trenton, New Jersey 08628.

FOR FURTHER INFORMATION CONTACT:

Susan M. Weisman, Commission

Secretary, Delaware River Basin

Commission, P.O. Box 7360, West

Trenton, New Jersey 08628. Telephone

(609) 883–9500 ext. 203.

SUPPLEMENTARY INFORMATION:

Background and Rationale

The Rules of Practice and Procedure

of the Delaware River Basin

Commission have been modified and

changed periodically since they were

originally adopted December 13, 1961.

There has not been a comprehensive

review of these rules, however, for more

than twenty years.

The proposed revisions are

summarized below.

1. Deletion of Article 4, Environmental

Impact Statements, and Related

Sections

Existing Article 4 sets forth DRBC’s

requirements with regard to

environmental impact statements and

reviews. Although these provisions have

remained in DRBC’s Rules, a copy of

DRBC Resolution No. 80–11 suspending

those provisions of the Commission’s

Rules of Practice and Procedure relating

to environmental assessments has been

inserted at the end of the existing rules.

Since the adoption of this Resolution in

1980, the Commission has not

conducted environmental assessments

pursuant to DRBC’s rules. The

continued inclusion of these suspended

sections, however, has been a source of

confusion and misunderstanding to

many individuals and groups interested

in DRBC’s review requirements. For

example, when DRBC recently solicited

public comments concerning its

regulations for controlling toxic

pollutants in the Delaware River

Estuary, comments were received

suggesting that DRBC had not complied

with the environmental review

requirements under its rules.

When Resolution No. 80–11 to

suspend was adopted, the Resolution

would have permitted reinstatement of

environmental reviews if ‘‘financial

resources are developed.’’ The

experiences of the last 17 years, and the

financial constraints that have

developed recently, make it clear that

Federal or other funding is not likely to

be available for the foreseeable future.

To avoid continuing confusion, the

deletion of Article 4 is proposed.

DRBC’s review of projects, however,

will continue to require all projects to

comply with all environmental and

other policies in the Commission’s

Comprehensive Plan.

2. Review of Projects Having a NonSubstantial Impact on Basin Waters

In 1976 the Commission adopted

Resolution No. 76–20 which provided

two administrative changes designed to

reduce the project review activity of

DRBC staff.

The first was an attempt to provide

more flexibility in the determination of

what constitutes substantial projects

resulting in more projects determined to

be nonsubstantial and not subject to

Commission review. Experience with a

few projects indicated the process was

not cost effective and staff reverted back

to strictly following the exemptions list

in the Rules Section 2.3.5(a). The 1976

revisions included in Sections 2.3.4 and

2.3.5(d) which provided for this

procedure have not been applied since

1978.

The second administrative change

provided for in Sections 2.3.5(e), 2.3.9

(b) and (c) was to have state staff review

and submit a determination (called an

action report) that each project

forwarded to the Commission did not

impair or conflict with the DRBC’s

Comprehensive Plan. Even though three

states signed new administrative

agreements to implement this

procedure, state staffs did not provide

the determinations and the procedure

was never implemented.

Section 2.3.10 is proposed to be

deleted and all rules regarding hearings

are proposed to be consolidated in

revised Article 6.

Summary of Proposed Revisions

1. Introduction

In view of the changes included

within the proposed revision, the

Introduction has been rewritten to

update the description of what is

included in the Commission’s Rules of

Practice and Procedure.

2. Article 1—Comprehensive Plan

The proposed revisions to this article

clarify the meaning of Comprehensive

Plan within DRBC’s rules. The revisions

further clarify the procedure related to

application for inclusion of projects

within the Comprehensive Plan and the

review by the Commission of proposals

for changes and additions to the

Comprehensive Plan. These revisions

conform with existing Commission

interpretation of the provisions within

Article 1.
Federal Register / Vol. 62, No. 168 / Friday, August 29, 1997 / Proposed Rules 45767

3. Article 2—Water Resources Program

No proposed revisions to this article

are recommended at this time.

4. Article 3—Project Review Under

Section 3.8 of the Compact

(a) The proposed revisions to Article

3 relating to environmental reviews and

non-substantial projects are discussed

above.

(b) The proposed revision would

delete Section 2–3.5.1. The

regionalization policy was slightly

modified with the adoption of revised

Water Quality Regulations in December

1992 (Section 2.30, Basin Regulation—

Water Quality). Deleting these

requirements eliminates confusion and

allows the more recent and flexible

policy to control. The revised rule

would add (6) in Section 2.1.4 requiring

applications to include a discussion of

the alternates considered and in Section

2.3.8 (a) ‘‘Exhibits to Accompany

Application’’, it would revise (8) to

include analysis and conclusions of

regional water supply and waste water

investigations.

(c) The proposed revision would also

delete Section 2.3.5.2. This policy was

adopted in 1971, Resolution No. 71–3,

when the DRBC was involved in four or

five nuclear plants and several major

expansions or new fossil fuel plants, all

by the seven major electric utilities

serving the Basin. Planning at that time

centered around mega stations of 1000

to 3000 Megawatts and use of multi

MGD of water. Future locations of such

large single use water demands was

essential for any future water resource

planning. A consortium of the utilities

was formed known as DRBEUG

(Delaware River Basin Electric Utilities

Group) to address this DRBC

requirement. Between 1971 and 1989,

periodic siting studies were submitted

to DRBC. In 1989 DRBEUG explained

that they no longer could present a

comprehensive siting study since the

regulators were now encouraging NUGs

(Non Utility Generators) and they could

not in any way appear to represent these

non-utility electric generators.

Essentially, the major utilities have

abandoned plans for any new major

stations. New applications for several

years now have been non-utility projects

and generally no more than 200 MW.

After several meetings between

DRBEUG and staff, it was concluded

that the siting study would no longer

serve its intended purpose for DRBC.

(d) The remaining sections are

intended to clarify the Commission’s

procedures with regard to Section 3.8

applications and the review thereof.

5. Article 4—Environmental Impact

Statements

The Commission proposes deletion of

the existing provisions of Article 4 as

discussed above. Article 4 will be

reserved for future use.

6. Article 5—Review in Water Quality

Cases

The proposed revisions to Article 5

clarify that this article applies to

administrative actions and decisions by

the Executive Director. The procedures

for review, hearing and decisions of

objections to the Executive Director’s

actions and decisions will be pursuant

to Article 6. The time for requesting a

hearing is extended to thirty days to

conform with the thirty day period

provided for in Article 6. The remaining

proposed changes are to broaden the

wasteload allocations section to cover

allocations in general (including

proposed allocations of toxics) as well

as the existing allocation program of

carbonaceous oxygen demand.

7. Article 6—Conduct of Hearings

The proposed revisions in this article

reflect the practices employed by the

Commission in connection with

hearings, clarify the application of

Article 6 to contested hearings and

codify existing practices with regard to

such hearings.

8. Articles 7, 8 and 9

No changes to these articles are

proposed at this time.

Copies of the full text of the proposed

amendments to the Administrative

Manual—Rules of Practice and

Procedure may be obtained by

contacting Susan M. Weisman at the

address provided in FOR FURTHER

INFORMATION CONTACT. Persons wishing

to testify are requested to notify the

Secretary in advance.

Dated: August 18, 1997.

Delaware River Basin Compact, 75 Stat.

688.

Susan M. Weisman,

Secretary.

[FR Doc. 97–23058 Filed 8–28–97; 8:45 am]

BILLING CODE 6360–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 336, 338, 341, and 348

[Docket No. 97N–0128]

RIN 0910–AA01

Labeling of DiphenhydramineContaining Drug Products for Overthe-Counter Human Use

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice of proposed rulemaking.

SUMMARY: The Food and Drug

Administration (FDA) is proposing to

amend the tentative final monograph for

over-the-counter (OTC) external

analgesic drug products, and the final

monographs for oral OTC

diphenhydramine drug products for

antiemetic, antihistamine, antitussive,

and nighttime sleep-aid indications. The

amendment adds warning statements

concerning diphenhydramine toxicity.

The proposed warnings advise

consumers not to use topical products

containing diphenhydramine on

chicken pox, poison ivy, sunburn, large

areas of the body, blistered or oozing

skin, more often than directed, or with

any other product containing

diphenhydramine, even one taken by

mouth, and not to use oral OTC

diphenhydramine products with any

other product containing

diphenhydramine including products

used topically. This proposal is part of

the ongoing review of OTC drug

products conducted by FDA.

DATES: Submit written comments by

November 28, 1997. FDA is proposing

that any final rule that may issue based

on this proposal become effective 12

months after the date of its publication

in the Federal Register.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Nahid Mokhtari-Rejali, Center for Drug

Evaluation and Research (HFD–560),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–2222.

SUPPLEMENTARY INFORMATION:

I. Background

Diphenhydramine hydrochloride is

proposed for inclusion in the

monograph for OTC external analgesic

drug products for topical use as an

antihistamine external analgesic.