32772 Federal Register / Vol. 63, No. 115 /Tuesday, June 16, 1998 / Proposed Rules

The cost impact figure discussed

above is based on assumptions that no

operator has yet accomplished any of

the proposed requirements of this AD

action, and that no operator would

accomplish those actions in the future if

this AD were not adopted.

Regulatory Impact

The regulations proposed herein

would not 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. Therefore,

in accordance with Executive Order

12612, it is determined that this

proposal would not have sufficient

federalism implications to warrant the

preparation of a Federalism Assessment.

For the reasons discussed above, I

certify that this proposed regulation (1)

is not a ‘‘significant regulatory action’’

under Executive Order 12866; (2) is not

a ‘‘significant rule’’ under the DOT

Regulatory Policies and Procedures (44

FR 11034, February 26, 1979); and (3) if

promulgated, will not have a significant

economic impact, positive or negative,

on a substantial number of small entities

under the criteria of the Regulatory

Flexibility Act. A copy of the draft

regulatory evaluation prepared for this

action is contained in the Rules Docket.

A copy of it may be obtained by

contacting the Rules Docket at the

location provided under the caption

ADDRESSES.

List of Subjects in 14 CFR Part 39

Air transportation, Aircraft, Aviation

safety, Safety.

The Proposed Amendment

Accordingly, pursuant to the

authority delegated to me by the

Administrator, the Federal Aviation

Administration proposes to amend part

39 of the Federal Aviation Regulations

(14 CFR part 39) as follows:

PART 39—AIRWORTHINESS

DIRECTIVES

1. The authority citation for part 39

continues to read as follows:

Authority: 49 U.S.C. 106(g), 40113, 44701.

§ 39.13 [Amended]

2. Section 39.13 is amended by

removing amendment 39–10147 (62 FR

50861, September 29, 1997), and by

adding a new airworthiness directive

(AD), to read as follows:

De Havilland, Inc.: Docket 98–NM–70–AD.

Revises AD 97–20–10, Amendment 39–

10147.

Applicability: Model DHC–8–100, –200,

and –300 series airplanes, serial numbers 3

through 472 inclusive, certificated in any

category.

Note 1: This AD applies to each airplane

identified in the preceding applicability

provision, regardless of whether it has been

modified, altered, or repaired in the area

subject to the requirements of this AD. For

airplanes that have been modified, altered, or

repaired so that the performance of the

requirements of this AD is affected, the

owner/operator must request approval for an

alternative method of compliance in

accordance with paragraph (b) of this AD.

The request should include an assessment of

the effect of the modification, alteration, or

repair on the unsafe condition addressed by

this AD; and, if the unsafe condition has not

been eliminated, the request should include

specific proposed actions to address it.

Compliance: Required as indicated, unless

accomplished previously.

To prevent simultaneous power loss to

both attitude and heading reference systems

(AHRS), which could result in reduced

controllability of the airplane, accomplish

the following:

(a) Within 400 hours time-in-service after

November 3, 1997 (the effective date of AD

97–20–10, amendment 39–10147), modify

the AHRS’s, in accordance with Bombardier

Alert Service Bulletin S.B. A8–34–117,

Revision ‘C’, dated February 14, 1997.

(b) An alternative method of compliance or

adjustment of the compliance time that

provides an acceptable level of safety may be

used if approved by the Manager, New York

Aircraft Certification Office (ACO), FAA,

Engine and Propeller Directorate. Operators

shall submit their requests through an

appropriate FAA Principal Maintenance

Inspector, who may add comments and then

send it to the Manager, New York ACO.

Note 2: Information concerning the

existence of approved alternative methods of

compliance with this AD, if any, may be

obtained from the New York ACO.

(c) Special flight permits may be issued in

accordance with sections 21.197 and 21.199

of the Federal Aviation Regulations (14 CFR

21.197 and 21.199) to operate the airplane to

a location where the requirements of this AD

can be accomplished.

Note 3: The subject of this AD is addressed

in Canadian airworthiness directive CF–97–

01R2, dated August 13, 1997.

Issued in Renton, Washington, on June 9,

1998.

Darrell M. Pederson,

Acting Manager, Transport Airplane

Directorate, Aircraft Certification Service.

[FR Doc. 98–15885 Filed 6–15–98; 8:45 am]

BILLING CODE 4910–13–U

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 10

[Docket No. 98N–0361]

Administrative Practices and

Procedures; Internal Agency Review of

Decisions; Companion Document to

Direct Final Rule

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule.

SUMMARY: The Food and Drug

Administration (FDA) is proposing to

amend the regulations governing the

review of agency decisions by inserting

a statement that sponsors, applicants, or

manufacturers of drugs (including

biologics) or devices may request review

of a scientific controversy by an

appropriate scientific advisory panel, or

an advisory committee. The agency is

taking this action to clarify the

availability of review of scientific

controversies by such advisory panels or

committees. This proposed rule is a

companion document to a direct final

rule published elsewhere in this issue of

the Federal Register. If FDA receives

any significant adverse comment, the

direct final rule will be withdrawn, and

the comments will be considered in the

development of a final rule using usual

notice and comment rulemaking based

on this proposed rule.

DATES: Comments must be received on

or before August 31, 1998.

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:

Suzanne M. O’Shea, Office of the Chief

Mediator and Ombudsman (HF–7), Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–827–

3390.

SUPPLEMENTARY INFORMATION:

I. Discussion

On November 21, 1997, President

Clinton signed into law the Food and

Drug Administration Modernization Act

of 1997 (FDAMA) (Pub. L. 105–115).

Section 404 of FDAMA amends the

Federal Food, Drug, and Cosmetic Act

(the act) (21 U.S.C. 301 et seq.) by

adding a new provision, Dispute

Resolution (section 562 of the act (21

U.S.C. 360bbb-1)). Under the dispute

resolution provision, FDA is to

determine the existence of procedures
Federal Register / Vol. 63, No. 115 /Tuesday, June 16, 1998 / Proposed Rules 32773

1FDA understands the term ‘‘scientific advisory

panel’’ to mean a public advisory committee as

discussed in 21 CFR part 14.

2An interested person, as defined in 21 CFR 10.3,

is a person who submits a petition or comment or

objection or otherwise asks to participate in an

informal or formal administrative proceeding or

court action. This definition of interested person

includes a sponsor, applicant, or manufacturer of a

drug or device.

for sponsors, applicants, and

manufacturers of drugs (including

biologics) or devices to request review

of scientific controversies. Where such

procedures do not exist, FDA is directed

to issue a regulation establishing a

procedure by which a sponsor,

applicant, or manufacturer of a drug or

device may request review of a scientific

controversy, including review by an

appropriate scientific advisory panel as

described in section 505(n) of the act1

(21 U.S.C. 355(n)), or an advisory

committee as described in section

515(g)(2)(B) of the act (21 U.S.C.

360e(g)(2)(B)).

FDA procedures currently provide

mechanisms for sponsors, applicants, or

manufacturers of drugs and devices to

request review of all scientific

controversies. Agency regulations and

policy statements contain numerous

procedures for obtaining review of

scientific controversies affecting

regulated products, including some that

provide for review by an FDA advisory

panel or committee. Moreover, any

interested person2 may obtain review of

any agency decision by raising the

matter with the supervisor of the

employee who made the decision. If the

issue is not resolved at the supervisor’s

level, the interested person may request

that the matter be reviewed at the next

higher supervisory level. This process

may continue through the agency’s

chain of command (§ 10.75 (21 CFR

10.75)).

Notwithstanding the existence of

these dispute resolution mechanisms,

FDA intends to amend § 10.75 in light

of FDAMA, to clarify that sponsors,

applicants, or manufacturers of a drug

or device subject to the act, or a product

covered by the Public Health Service

Act (42 U.S.C. 262), may request review

of scientific controversies by an

appropriate scientific advisory

committee. If this rule is adopted, FDA

would recommend that sponsors,

applicants, and manufacturers continue

to use established mechanisms for

obtaining review of scientific

controversies prior to seeking review by

an advisory committee. FDA recognizes

however, that in appropriate

circumstances, review by such an

advisory panel or committee may

provide FDA with useful advice and

recommendations about how the agency

may best resolve a controversy.

II. Rulemaking Procedures

In the final rules section of this issue

of the Federal Register, FDA is

announcing the adoption of this

amendment through direct final

rulemaking procedures. FDA described

its procedures for direct final

rulemaking in the Federal Register of

November 21, 1997 (62 FR 62466). This

action is appropriate for direct final

rulemaking because it is a

noncontroversial amendment to FDA’s

regulations that is in accord with

FDAMA. Furthermore, FDA anticipates

no significant adverse comments.

Consistent with FDA’s procedures for

direct final rulemaking, FDA will

withdraw the direct final rule if it

receives any significant adverse

comment. If the direct final rule is

withdrawn, FDA will consider all

comments received to develop a final

rule using the usual notice and

comment rulemaking procedures based

on this proposed rule.

FDA is providing a 75-day period for

comment on this companion proposed

rule, to run concurrently with the

comment period for the direct final rule.

This comment period begins on June 16,

1998, and ends on August 31, 1998. If

FDA receives any significant adverse

comment within the comment period, it

intends to publish a document in the

Federal Register to withdraw the direct

final rule by September 29, 1998. If the

direct final rule is withdrawn, FDA will

follow its usual procedures for noticeand-comment rulemaking based on this

proposed rule. If FDA does not receive

any significant adverse comment, the

agency will take no further action on

this proposed rule. In that event, FDA

will publish a document in the Federal

Register by September 29, 1998, to

confirm the October 29, 1998, effective

date of the direct final rule. For

additional information, see the direct

final rule published in the final rules

section of this issue of the Federal

Register.

III. Analysis of Impacts

A. 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.

B. Economic Impact

In accordance with Executive Order

12866, FDA has carefully analyzed the

economic effects of this rule and has

determined that it is not a major rule as

defined by the Executive Order.

FDA, in accordance with the

Regulatory Flexibility Act, has

considered the effect that this rule will

have on small entities, including small

businesses, and has determined that no

significant economic impact on a

substantial number of small entities will

derive from this action.

IV. Paperwork Reduction Act of 1995

FDA tentatively concludes that this

proposed 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.

V. Request for Comments

Interested persons may, on or before

August 31, 1998, submit to the Dockets

Management Branch (address above)

written comments regarding this

companion proposed rule, which will

also be considered as comments on the

direct final rule. 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 may be seen in the office

above between 9 a.m. and 4 p.m.,

Monday through Friday.

List of Subjects in 21 CFR Part 10

Administrative practice and

procedure, News media.

Therefore, under the Federal Food,

Drug, and Cosmetic Act, the Public

Health Service Act, and authority

delegated to the Commissioner of Food

and Drugs, it is proposed that 21 CFR

part 10 be amended as follows:

PART 10—ADMINISTRATIVE

PRACTICES AND PROCEDURES

1. The authority citation for 21 CFR

part 10 is revised to read as follows:

Authority: 5 U.S.C. 551–558, 701–706; 15

U.S.C. 1451–4161; 21 U.S.C. 141–149, 321–

397, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42

U.S.C. 201, 262, 263b, 264.

2. Section 10.75 is amended by

adding a sentence at the end of

paragraph (b) to read as follows:

§ 10.75 Internal agency review of

decisions.

* * * * *

(b) * * * A sponsor, applicant, or

manufacturer of a drug or device

regulated under the act or the Public
32774 Federal Register / Vol. 63, No. 115 /Tuesday, June 16, 1998 / Proposed Rules

Health Service Act (42 U.S.C. 262), may

request review of a scientific

controversy by an appropriate scientific

advisory panel as described in section

505(n) of the act, or an advisory

committee as described in section

515(g)(2)(B) of the act.

* * * * *

Dated: June 4, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–15814 Filed 6–15–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE TREASURY

Internal Revenue Service

26 CFR Part 31

[REG–110403–98]

RIN 1545–AW28

Federal Employment Tax Deposits—De

Minimis Rule

AGENCY: Internal Revenue Service (IRS),

Treasury.

ACTION: Notice of proposed rulemaking

by cross-reference to temporary

regulations.

SUMMARY: In the Rules and Regulations

section of this issue of the Federal

Register, the IRS is issuing temporary

regulations relating to the deposits of

Federal employment taxes. The text of

those regulations also serves as the text

of these proposed regulations.

DATES: Written comments and requests

for a public hearing must be received by

September 14, 1998.

ADDRESSES: Send submissions to:

CC:DOM:CORP:R (REG–110403–98),

room 5226, Internal Revenue Service,

POB 7604, Ben Franklin Station,

Washington, DC 20044. Submissions

may be hand delivered between the

hours of 8 a.m. and 5 p.m. to:

CC:DOM:CORP:R (REG–110403–98),

Courier’s Desk, Internal Revenue

Service, 1111 Constitution Avenue NW,

Washington, DC. Alternatively,

taxpayers may submit comments

electronically via the internet by

selecting the ‘‘Tax Regs’’ option on the

IRS Home Page, or by submitting

comments directly to the IRS internet

site at http://www.irs.ustreas.gov/prod/

taxlregs/comments.html.

FOR FURTHER INFORMATION CONTACT:

Concerning submissions, Michael

Slaughter, (202) 622–7180; concerning

the regulations, Vincent Surabian, (202)

622–4940 (not toll-free numbers).

SUPPLEMENTARY INFORMATION:

Background and Explanation of

Provisions

Temporary regulations in the Rules

and Regulations section of this issue of

the Federal Register amend the

Employment Tax and Collection of

Income Tax at Source Regulations (26

CFR part 31) relating to section 6302.

The temporary regulations change the

de minimis rule for the deposit of

Federal employment taxes. The text of

those regulations also serves as the text

of these proposed regulations. The

preamble to the temporary regulations

explains the amendments.

Special Analyses

It has been determined that this notice

of proposed rulemaking is not a

significant regulatory action as defined

in EO 12866. Therefore, a regulatory

assessment is not required. It also has

been determined that section 553(b) of

the Administrative Procedure Act (5

U.S.C. chapter 5) does not apply to these

regulations, and because these

regulations do not impose a collection

of information on small entities, the

Regulatory Flexibility Act (5 U.S.C.

chapter 6) does not apply. Pursuant to

section 7805(f) of the Internal Revenue

Code, this notice of proposed

rulemaking will be submitted to the

Chief Counsel for Advocacy of the Small

Business Administration for comment

on its impact on small business.

Comments and Requests for a Public

Hearing

Before these proposed regulations are

adopted as final regulations,

consideration will be given to any

comments that are submitted timely to

the IRS. All comments will be available

for public inspection and copying. A

public hearing may be scheduled if

requested by any person that timely

submits comments. If a public hearing is

scheduled, notice of the date, time, and

place for the hearing will be published

in the Federal Register.

Drafting Information: The principal

author of these regulations is Vincent

Surabian, Office of Assistant Chief

Counsel (Income Tax & Accounting).

However, other personnel from the IRS

and Treasury Department participated

in their development.

List of Subjects in 26 CFR Part 31

Employment taxes, Income taxes,

Penalties, Pensions, Railroad retirement,

Reporting and recordkeeping

requirements, Social security,

Unemployment compensation.

Proposed Amendments to the

Regulations

Accordingly, 26 CFR part 31 is

proposed to be amended as follows:

PART 31—EMPLOYMENT TAXES AND

COLLECTION OF INCOME TAX AT

SOURCE

Paragraph 1. The authority citation

for part 31 continues to read in part as

follows:

Authority: 26 U.S.C. 7805 * * *

Par. 2. In § 31.6302–1, paragraph (f)(4)

is revised to read as follows:

§ 31.6302–1 Federal tax deposit rules for

withheld income taxes and taxes under the

Federal Insurance Contributions Act (FICA)

attributable to payments made after

December 31, 1992.

* * * * *

(f) * * *

(4) [The text of proposed § 31.6302–

1(f)(4) is the same as the text of

§ 31.6302–1T(f)(4)].

* * * * *

Michael P. Dolan,

Deputy Commissioner of Internal Revenue.

[FR Doc. 98–15985 Filed 6–15–98; 8:45 am]

BILLING CODE 4830–01–U

DEPARTMENT OF TRANSPORTATION

Coast Guard

33 CFR Part 100

[CCD 08–98–018]

RIN 2115–AE46

Special Local Regulations; Eighth

Coast Guard District Annual Marine

Events

AGENCY: Coast Guard, DOT.

ACTION: Notice of proposed rulemaking.

SUMMARY: The Coast Guard proposes to

revise Table 1 to 33 CFR 100.801, the

list of annual marine events that occur

within the Eighth Coast Guard District.

This proposed revision will also result

the Eighth Coast Guard District’s

absorption of the territories previously

encompassed by Second the Coast

Guard District.

DATES: Comments must be received on

or before August 17, 1998.

ADDRESSES: Comments should be

mailed to Commander (dl), Eighth Coast

Guard District, 501 Magazine Street,

New Orleans, LA 70130–3396. The

comments will be available for

inspection and copying at the District

Legal Office, Room 1311, Hale Boggs

Federal Building, 501 Magazine Street,

New Orleans, LA. Office hours are