20530 Federal Register / Vol. 63, No. 80 / Monday, April 27, 1998 /Rules and Regulations

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Airspace Docket No. 98–ACE–4]

Amendment to Class D and Class E

Airspace; Joplin, MO; Correction

AGENCY: Federal Aviation

Administration, DOT.

ACTION: Direct final rule; confirmation of

effective date and correction.

SUMMARY: This notice confirms the

effective date of a direct final rule which

revises Class D and Class E airspace at

Joplin Regional Airport, MO, and

corrects the Airport Reference Point, as

published in the direct final rule.

DATES: The direct final rule published at

63 FR 8093 is effective on 0901 UTC,

June 18, 1998. This correction is

effective on June 18, 1998.

FOR FURTHER INFORMATION CONTACT:

Kathy Randolph, Air Traffic Division,

Airspace Branch, ACE–520C, Federal

Aviation Administration, 601 East 12th

Street, Kansas City, Missouri 64106;

telephone: (816) 426–3408.

SUPPLEMENTARY INFORMATION: On

February 18, 1998, the FAA published

in the Federal Register a direct final

rule; request for comments which

modified the Class D and Class E

airspace at Joplin Regional Airport, MO

(FR Document 98–3964, 63 FR 8093,

Airspace Docket No. 98–ACE–4). An

error was subsequently discovered in

the Airport Reference Point for Class D

and Class E airspace designations. After

careful review of all available

information related to the subject

presented above, the FAA has

determined that air safety and the

public interest required adoption of the

rule. The FAA has determined that this

correction will not change the meaning

of the action nor add any additional

burden on the public beyond that

already published. This action corrects

the error and confirms the effective date

of the direct final rule.

The FAA uses the direct final

rulemaking procedure for a noncontroversial rule where the FAA

believes that there will be no adverse

public comment. This direct final rule

advised the public that no adverse

comments were anticipated, and that

unless a written adverse comment, or a

written notice of intent to submit such

an adverse comment, were received

within the comment period, the

regulation would become effective on

June 18, 1998. No adverse comments

were received, and thus this notice

confirms that this direct final rule will

become effective on that date.

Correction

In rule FR Doc. 98–3964 published in

the Federal Register on February 18,

1998, 63 FR 8093, make the following

correction to the Joplin Regional

Airport, MO, Class D and Class E

airspace designation incorporated by

reference in 14 CFR 71.1:

§ 71.1 [Corrected]

ACE MO D Joplin, MO [Corrected]

On page 8095, in the first column,

under Joplin Regional Airport, MO,

change (lat. 37°09′05′′ N., long.

94°29′54′′ W.) to read (lat. 37°09′07′′ N.,

long. 94°29′54′′ W.)

ACE MO E2 Joplin, MO [Corrected]

On page 8095, in the first column,

under Joplin Regional Airport, MO,

change (lat. 37°09′05′′ N., long.

94°29′54′′ W.) to read (lat. 37°09′07′′ N.,

long. 94°29′54′′ W.)

ACE MO E5 Joplin, MO [Corrected]

On page 8095, in the first column,

under Joplin Regional Airport, MO,

change (lat. 37°09′05′′ N., long.

94°29′54′′ W.) to read (lat. 37°09′07′′ N.,

long. 94°29′54′′ W.)

Issued in Kansas City, MO on March 31,

1998.

Christopher R. Blum,

Acting Manager, Air Traffic Division, Central

Region.

[FR Doc. 98–11127 Filed 4–24–98; 8:45 am]

BILLING CODE 4910–13–M

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Airspace Docket No. 98–ACE–3]

Amendment to Class E Airspace;

Columbia, MO

AGENCY: Federal Aviation

Administration, DOT.

ACTION: Direct final rule; confirmation of

effective date.

SUMMARY: This notice confirms the

effective date of a direct final rule which

revises Class E airspace at Columbia,

MO.

DATES: The direct final rule published at

63 FR 8097 is effective on 0901 UTC,

June 18, 1998.

FOR FURTHER INFORMATION CONTACT:

Kathy Randolph, Air Traffic Division,

Airspace Branch, ACE–520C, Federal

Aviation Administration, 601 East 12th

Street, Kansas City, Missouri 64106;

telephone: (816) 426–3408.

SUPPLEMENTARY INFORMATION: The FAA

published this direct final rule with a

request for comments in the Federal

Register on February 18, 1998 (63 FR

8097). The FAA uses the direct final

rulemaking procedure for a noncontroversial rule where the FAA

believes that there will be no adverse

public comment. This direct final rule

advised the public that no adverse

comments were anticipated, and that

unless a written adverse comment, or a

written notice of intent to submit such

an adverse comment, were received

within the comment period, the

regulation would become effective on

June 18, 1998. No adverse comments

were received, and thus this notice

confirms that this direct final rule will

become effective on that date.

Issued in Kansas City, MO on March 31,

1998.

Christopher R. Blum,

Acting Manager, Air Traffic Division, Central

Region.

[FR Doc. 98–11128 Filed 4–24–98; 8:45 am]

BILLING CODE 4910–13–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 814

[Docket No. 98N–0168]

Medical Devices; 30–Day Notices and

135–Day PMA Supplement Review

AGENCY: Food and Drug Administration,

HHS.

ACTION: Direct final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending its

regulations governing the submission

and review of premarket approval

application (PMA) supplements to allow

for the submission of a 30-day notice for

modifications to manufacturing

procedures or methods of manufacture.

Amendments are being made to

implement revisions to the Federal

Food, Drug, and Cosmetic Act (the act)

as amended by the Food and Drug

Administration Modernization Act of

1997 (FDAMA). FDA is publishing these

amendments in accordance with its

direct final rule procedures. Elsewhere

in this issue of the Federal Register,

FDA is publishing a companion

proposed rule under FDA’s usual

procedures for notice and comment to

provide a procedural framework to

finalize the rule in the event the agency

receives any significant adverse
Federal Register / Vol. 63, No. 80 / Monday, April 27, 1998 /Rules and Regulations 20531

comment and withdraws the direct final

rule.

DATES: The direct final rule is effective

September 9, 1998. Submit written

comments on or before July 13, 1998.

Submit written comments on the

information collection requirements on

or before June 26, 1998. If FDA receives

no significant adverse comment within

the specified comment period, the

agency intends to publish a document

confirming the effective date of the final

rule in the Federal Register within 30

days after the comment period on this

direct final rule ends.

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:

Kathy M. Poneleit, Center for Devices

and Radiological Health (HFZ–402),

Food and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–2186.

SUPPLEMENTARY INFORMATION:

I. Background.

On November 21, 1997, the President

signed FDAMA (Pub. L. 105–115) into

law. As one of its provisions, FDAMA

added section 515(d)(6) to the act (21

U.S.C. 360e(d)(6)). This new section

provides that PMA supplements are

required for all changes that affect safety

and effectiveness unless such changes

involve modifications to manufacturing

procedures or method of manufacture.

Those types of manufacturing changes

will require a 30-day notice or, where

FDA finds such notice inadequate, a

135-day PMA supplement. Examples of

changes that potentially qualify for a 30-

day notice are those intended by the

PMA holder to reduce manufacturing

and/or labor cost, reduce manufacturing

time, reduce waste, or compensate for a

change in suppliers of raw material or

components.

Manufacturers who believe that the

change they intend to make qualifies for

this review will be required to submit a

30-day notice to FDA that describes in

detail the change the manufacturer

intends to make, summarizes the data or

information supporting the change, and

states that the change has been made in

accordance with the requirements of

part 820 (21 CFR part 820). The

manufacturer may distribute the device

30 days after FDA receives the notice,

unless FDA notifies the applicant

within that 30-day period that the notice

is not adequate. If the notice is not

adequate, FDA will inform the applicant

in writing that a 135-day supplement is

needed and will describe what further

action or information is required for

FDA to approve the change. The time

FDA uses to review the 30-day notice

will be deducted from the 135-day

supplement review period if the notice

contains the appropriate information

that is required for review of PMA

supplements.

This rule incorporates the provisions

for a 30-day notice and 135-day PMA

supplements into FDA’s regulations at

§ 814.39 (21 CFR 814.39).

The agency has developed guidance

on this issue, entitled ‘‘CDRH Guidance

for 30–Day notices and 135–Day PMA

Supplements for Manufacturing Method

or Process Changes for Use by OC, ODE,

and Industry,’’ and it has announced the

availability of the guidance in the

Federal Register of February 25, 1998

(63 FR 9570).

II. Rulemaking Action

In the Federal Register of November

21, 1997 (62 FR 62466), FDA described

when and how it will employ direct

final rulemaking. FDA believes that this

rule is appropriate for direct final

rulemaking because FDA views this rule

as making noncontroversial

amendments to an existing rule,

incorporating amendments to section

515 of the act made by FDAMA. FDA

anticipates no significant adverse

comment on this rule. Consistent with

FDA’s procedures on direct final

rulemaking, FDA is publishing

elsewhere in this issue of the Federal

Register a companion proposed rule to

amend 21 CFR part 814. This direct

final rule is substantively identical to

the companion proposed rule. The

companion proposed rule provides a

procedural framework within which the

rule may be finalized in the event the

direct final rule is withdrawn because of

a significant adverse comment. The

comment period for the direct final rule

runs concurrently with that for the

companion proposed rule. Any

comments received on the companion

proposed rule will be treated as

comments on the direct final rule.

FDA is providing a comment period

on the direct final rule of 75 days after

April 27, 1998. If the agency receives a

significant adverse comment, FDA

intends to withdraw this final rule by

publication of a notice in the Federal

Register within 30 days after the

comment period ends. A significant

comment is defined as a comment that

explains why the rule would be

inappropriate, including challenges to

the rule’s underlying premise or

approach, or would be ineffective or

unacceptable without change. In

determining whether a significant

adverse comment is sufficient to

terminate a direct final rulemaking, FDA

will consider whether the comment

raises an issue serious enough to

warrant a substantive response in a

notice-and-comment process. For

example, a comment recommending an

additional change to the rule may be

considered a significant adverse

comment if the comment demonstrates

why the rule would be ineffective

without the additional change. In

addition, if a significant adverse

comment applies to part of a rule and

that part can be severed from the

remainder of the rule, FDA may adopt

as final those parts of the rule that are

not the subject of a significant adverse

comment. Comments that are frivolous,

insubstantial, or outside the scope of the

rule will not be considered significant

or adverse under this procedure.

If FDA withdraws the direct final rule,

all comments received will be applied

to the proposed rule and will be

considered in developing a final rule

using the agency’s usual notice and

comment procedures. If FDA receives

no significant adverse comment during

the specified comment period, FDA

intends to publish a confirmation notice

within 30 days after the comment

period ends confirming that the direct

final rule will go into effect on

September 9, 1998.

III. Environmental Impact

The agency has determined under 21

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

that does not cumulatively have a

significant effect on the human

environment. Therefore, neither an

environmental assessment nor an

environmental impact statement is

required.

IV. Analysis of Impacts

FDA has examined the impacts of this

final rule under Executive Order 12866

and the Regulatory Flexibility Act (5

U.S.C. 601–612) (as amended by subtitle

D of the Small Business Regulatory

Fairness Act of 1996 (Pub. L. 104–121)),

and the Unfunded Mandates Reform Act

of 1995 (Pub. L. 104–4). Executive Order

12866 directs agencies to assess all costs

of available regulatory alternatives and,

when regulatory action is necessary, to

select regulatory approaches that

maximize net benefits (including

potential economic, environmental,

public health and safety, and other

advantages; distributive impacts; and

equity). The agency believes that this

final rule is consistent with the

regulatory philosophy and principles

identified in the Executive Order. In

addition, this direct final rule is not a

significant regulatory action as defined

by the Executive Order and so is not
20532 Federal Register / Vol. 63, No. 80 / Monday, April 27, 1998 /Rules and Regulations

subject to review under the Executive

Order.

The Regulatory Flexibility Act

requires agencies to analyze regulatory

options that would minimize any

significant impact of a rule on small

entities. The rule merely codifies

applicable statutory requirements

imposed by the FDAMA. The

Commissioner of Food and Drugs

certifies that this final rule will not have

a significant economic impact on a

substantial number of small entities.

This direct final rule also does not

trigger the requirement for a written

statement under section 202(a) of the

Unfunded Mandates Reform Act

because it does not impose a mandate

that results in an expenditure of $100

million or more by State, local, or tribal

governments in the aggregate, or by the

private sector, in any 1 year.

V. Paperwork Reduction Act of 1995

This direct final rule contains

information collection provisions that

are subject to review by the Office of

Management and Budget (OMB) under

the Paperwork Reduction Act of 1995

(44 U.S.C. 3501–3520). The title,

description, and respondent description

of the information collection provisions

are shown below along with an estimate

of the annual reporting burden.

Included in the estimate is the time for

reviewing instructions, searching

existing data sources, gathering and

maintaining the data needed, and

completing and reviewing each

collection of information.

FDA invites comments on: (1)

Whether the proposed collection of

information is necessary for the proper

performance of FDA’s functions,

including whether the information will

have practical utility; (2) the accuracy of

the agency’s estimate of the burden of

the proposed collection of information,

including the validity of the

methodology and assumptions used; (3)

ways to enhance the quality, utility, and

clarity of the information to be

collected; and, (4) ways to minimize the

burden of the collection of information

on respondents, including through the

use of automated collection techniques,

when appropriate, and other forms of

information technology.

Title: Supplements to Premarket

Approval Applications for Medical

Devices

Description: FDAMA added section

515(d)(6) to the act, modifying FDA’s

statutory authority regarding premarket

approval of medical devices. This new

section provides for an alternate form of

notice to the agency for certain types of

changes to a device for which the

manufacturer has an approved PMA.

Under this section, PMA supplements

are required for all changes that affect

safety and effectiveness unless such

changes involve modifications to

manufacturing procedures or the

method of manufacture. For those types

of manufacturing changes, the

manufacturer may submit to the agency

an alternate form of notice in the form

of a 30-day notice or, where FDA finds

such notice inadequate, a 135-day PMA

supplement. The 30-day notice must

describe the change the manufacturer

intends to make, summarize the data or

information supporting the change, and

state that the change has been made in

accordance with the requirements of

part 820.

The manufacturer may distribute the

device 30 days after FDA receives the

notice, unless FDA notifies the

applicant, within that 30-day period,

that the notice is inadequate. If the

notice is not adequate, FDA will inform

the manufacturer that a 135-day

supplement is required and will

describe what additional information or

action is necessary for FDA to approve

the change.

This rule incorporates the provisions

for a 30-day notice and 135-day

supplements into FDA’s regulations at

§ 814.39 to reflect the changes made by

FDAMA.

Description of Respondents: Businesses

or other for profit organizations.

FDA estimates the burden for this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

814.39 493 1 493 66.15 32,612

1There are no capital costs or operating and maintenance costs associated with this collection of information.

FDA believes that the amendments to

§ 814.39 permitting the submission of

30-day notices in lieu of PMA

supplements will result in

approximately a 10- percent reduction

in the total number of hours needed to

comply as compared to § 814.39. As a

result, FDA estimates that the new total

number of hours needed to comply

information collection requirements in

§ 814.39 is 32,612, for a reduction of

3,451 hours.

As provided in 5 CFR 1320.5(c)(1),

collections of information in a direct

final rule are subject to the procedures

set forth in 5 CFR 1320.10. Interested

persons and organizations may submit

comments on the information collection

requirements of this direct final rule by

June 26, 1998 to the Dockets

Management Branch (address above). At

the close of the 60-day comment period,

FDA will review the comments

received, revise the information

collection provisions as necessary, and

submit these provisions to OMB for

review. FDA will publish a notice in the

Federal Register when the information

collection provisions are submitted to

OMB, and an opportunity for public

comment to OMB will be provided at

that time. Prior to the effective date of

the direct final rule, FDA will publish

a notice in the Federal Register of

OMB’s decision to approve, modify, or

disapprove the information collection

provisions. An agency may not conduct

or sponsor, and a person is not required

to respond to, a collection of

information unless it displays a

currently valid OMB control number.

VI. Comments

Interested persons may by July 13,

1998, submit to the Dockets

Management Branch (address above)

written comments regarding this rule.

This comment period runs concurrently

with the comment period for the

companion proposed 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 the

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. All

comments received will be considered

comments regarding the proposed rule

and this direct final rule. In the event

the direct final rule is withdrawn, all

comments received regarding the
Federal Register / Vol. 63, No. 80 / Monday, April 27, 1998 /Rules and Regulations 20533

companion proposed rule and the direct

final rule will be considered comments

on the proposed rule.

List of Subjects in 21 CFR Part 814

Administrative practice and

procedure, Confidential business

information, Medical devices, Medical

research, Reporting and recordkeeping

requirements.

Therefore, under the Federal Food,

Drug, and Cosmetic Act, and under

authority delegated to the Commissioner

of the Food and Drugs, 21 CFR part 814

is amended as follows:

PART 814—PREMARKET APPROVAL

OF MEDICAL DEVICES

1. The authority citation for 21 CFR

part 814 continues to read as follows:

Authority: 21 U.S.C. 351, 352, 353, 360,

360c–360j, 371, 372, 373, 374, 375, 379, 379e,

381.

2. Section 814.39 is amended by

revising the introductory text of

paragraph (a) and paragraph (a)(4) and

by adding paragraph (f) to read as

follows:

§ 814.39 PMA supplements.

(a) After FDA’s approval of a PMA, an

applicant shall submit a PMA

supplement for review and approval by

FDA before making a change affecting

the safety or effectiveness of the device

for which the applicant has an approved

PMA, unless the change is of a type for

which FDA, under paragraph (e) of this

section, has advised that an alternate

submission is permitted or is of a type

which, under section 515(d)(6)(A) of the

act and paragraph (f) of this section,

does not require a PMA supplement

under this paragraph. While the burden

for determining whether a supplement

is required is primarily on the PMA

holder, changes for which an applicant

shall submit a PMA supplement

include, but are not limited to, the

following types of changes if they affect

the safety or effectiveness of the device:

* * * * *

(4) Changes in manufacturing

facilities, methods, or quality control

procedures that do not meet the

requirements for a submission under

paragraph (e) or (f) of this section.

* * * * *

(f) Under section 515(d) of the act,

modifications to manufacturing

procedures or methods of manufacture

that affect the safety and effectiveness of

a device subject to an approved PMA do

not require submission of a PMA

supplement under paragraph (a) of this

section and are eligible to be the subject

of a 30-day notice. A 30-day notice shall

describe in detail the change,

summarize the data or information

supporting the change, and state that the

change has been made in accordance

with the requirements of 21 CFR part

820. The manufacturer may distribute

the device 30 days after the date on

which FDA receives the 30-day notice,

unless FDA notifies the applicant

within 30 days from receipt of the

notice that the notice is not adequate. If

the notice is not adequate, FDA shall

inform the applicant in writing that a

135-day PMA supplement is needed and

shall describe what further information

or action is required for acceptance of

such change. The number of days under

review as a 30-day notice shall be

deducted from the 135-day PMA

supplement review period if the notice

meets appropriate content requirements

for a PMA supplement.

Dated: March 24, 1998.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 98–11086 Filed 4–24–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF JUSTICE

Office of the Attorney General

28 CFR Part 0

[Order No. 2147–98]

Delegation of Power of the Attorney

General Respecting Transfer of

Offenders To or From Foreign

Countries

AGENCY: Department of Justice.

ACTION: Final rule.

SUMMARY: Section 0.64–2 of Title 28,

Code of Federal Regulations, delegates

to the Assistant Attorney General in

charge of the Criminal Division all of

the powers conferred on the Attorney

General under 18 U.S.C. 4102 that have

not been delegated to the Director of the

Bureau of Prisons, including the

authority to find appropriate or

inappropriate the transfer of offenders to

or from a foreign country under a treaty

as referred to in Pub. L. 95–144. The

section also authorizes the Assistant

Attorney General in charge of the

Criminal Division to redelegate this

authority to the Deputy Assistant

Attorneys General of the Criminal

Division, the Senior Associate Director

of the Office of Enforcement Operations

in the Criminal Division, and, in the

Senior Associate Director’s absence, to

the Director of the Office of Enforcement

Operations. This final rule amends 28

CFR 0.64–2 by authorizing the Assistant

Attorney General in charge of the

Criminal Division to additionally

redelegate this authority to the Director

of the Office of Enforcement Operations

and the Associate Directors of the Office

of Enforcement Operations, and

eliminating the requirement that the

Senior Associate Director of the Office

of Enforcement Operations be absent for

this further redelegation to be effective.

This rule is intended to provide greater

flexibility within the Office of

Enforcement Operations with respect to

the management of the prisoner transfer

program, reflecting an increase in both

the number and complexity of our treaty

relationships, and the related workload

handled by the Office of Enforcement

Operations.

EFFECTIVE DATE: April 15, 1998.

FOR FURTHER INFORMATION CONTACT:

Frederick D. Hess, Director, Office of

Enforcement Operations, Criminal

Division, Department of Justice,

Washington, DC 20530; 202–514–6809.

SUPPLEMENTARY INFORMATION: The

Assistant Attorney General currently is

authorized under 28 CFR 0.65–02 to

redelegate his authority to find

appropriate or inappropriate the transfer

of offenders to or from a foreign country

under certain treaties to his Deputy

Assistant Attorneys General, the Senior

Associate Director, Office of

Enforcement Operations, and, in the

absence of the Senior Associate

Director, the Director of the Office of

Enforcement Operations. This final rule

permits redelegation of this authority to

the Director and Associate Directors of

the Office of Enforcement Operations,

regardless of whether the Senior

Associate Director is absent.

This rule is a matter of internal

Department management.

It has been drafted and reviewed in

accordance with section 1(b) of

Executive Order 12866. It has been

determined that this rule is not a

‘‘significant regulatory action’’ under

section 3(f) of Executive Order 12866

and, accordingly, this rule has not been

reviewed by the Office of Management

and Budget, and no regulatory impact

analysis has been prepared.

In accordance with the Regulatory

Flexibility Act (5 U.S.C. 601–612;

specifically at section 605(b)), the

Attorney General has reviewed this rule

and, by approving it, certifies that it will

not have a significant economic impact

on a substantial number of small

entities.

This rule will not have a substantial

direct impact upon the states, on the

relationship between the national

government and the states, or on the

distribution of power and

responsibilities among the various