20558 Federal Register / Vol. 63, No. 80 / Monday, April 27, 1998 / Proposed Rules

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

adding the following new airworthiness

directive:

Gulfstream Aerospace Corporation

(Formerly Grumman): Docket 97–NM–

302–AD.

Applicability: All Model G–159 (G–I)

airplanes, 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 loss of airplane controllability,

or engine overspeed and consequent loss of

engine power, caused by the power levers

being positioned below the flight idle stop

while the airplane is in flight, accomplish the

following:

(a) For turbopropeller-powered Gulfstream

Model G–159 (G–1) airplanes: Within 30 days

after the effective date of this AD, revise the

Limitations Section of the FAA-approved

Airplane Flight Manual (AFM) to include the

following statements. This action may be

accomplished by inserting a copy of this AD

into the AFM.

‘‘Positioning of the propeller flight fine

pitch lock selector to the ground interlock

position in flight is PROHIBITED. Such

positioning may lead to loss of airplane

control.’’

(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, FAA, Small

Airplane Directorate, Atlanta Aircraft

Certification Office (ACO). Operators shall

submit their requests through an appropriate

FAA Principal Operations Inspector, who

may add comments and then send it to the

Manager, Atlanta ACO.

Note 2: Information concerning the

existence of approved alternative methods of

compliance with this AD, if any, may be

obtained from the Atlanta ACO.

(c) Special flight permits may be issued in

accordance with §§ 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.

Issued in Renton, Washington, on April 21,

1998.

Darrell M. Pederson,

Acting Manager, Transport Airplane

Directorate, Aircraft Certification Service.

[FR Doc. 98–11102 Filed 4–24–98; 8:45 am]

BILLING CODE 4910–13–U

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;

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 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). This proposed rule is

a companion document to the direct

final rule published elsewhere in this

issue of the Federal Register.

DATES: Submit written comments on or

before July 13, 1998. Submit written

comments on the information collection

requirements on or before June 26, 1998.

ADDRESSES: Submit written comments

on the proposed rule 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

This proposed rule is a companion

document to the direct final rule

published elsewhere in this issue of the

Federal Register. This proposed rule is

substantively identical to its companion

direct final rule. The proposed rule will

provide the procedural framework to

finalize the rule in the event the

companion direct final rule receives any

significant adverse comment and is

withdrawn. The comment period for

this companion proposed rule runs

concurrently with that for the direct

final rule. All comments on this

proposed rule will also be considered as

comments on the companion direct final

rule. FDA is publishing the direct final

rule because the rule contains

noncontroversial changes, and FDA

anticipates that it will receive no

significant adverse comments. If no

significant comment is received in

response to the direct final rule, no

further action will be taken related to

this proposed rule. Instead, FDA will

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.

Because this rule makes

noncontroversial changes to an existing

regulation in order to implement

changes required by FDAMA, FDA

believes that publication of a direct final

rule is appropriate. Additional

information about FDA’s direct final

rulemaking procedures is set forth in a

guidance published in the Federal

Register of November 21, 1997 (62 FR

62466).

If FDA receives a significant adverse

comment regarding this rule, FDA will

publish a document withdrawing the

direct final rule within 30 days after the

comment period ends and will proceed

to respond to all of the comments

received under this companion rule

using usual notice-and-comment

procedures. The comment period for

this companion proposed rule runs

concurrently with the direct final rule’s

comment period. Any comments

received under this companion

proposed rule will also be considered

comments regarding the direct final

rule.

A significant adverse 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 a change. In determining

whether a significant adverse comment

is sufficient to terminate a direct final

rulemaking, FDA will consider whether
Federal Register / Vol. 63, No. 80 / Monday, April 27, 1998 / Proposed Rules 20559

the comment raises an issue serious

enough to warrant a substantive

response in a notice-and-comment

process. Comments that are frivolous,

insubstantial, or outside the scope of the

rule will not be considered adverse

under this procedure. For example, a

comment recommending a rule change

in addition to the rule will not be

considered a significant adverse

comment, unless the comment states

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.

This action is part of FDA’s

continuing effort to achieve the

objectives of the President’s

‘‘Reinventing Government’’ initiative,

and is intended to reduce the burden of

unnecessary regulations on medical

devices, without diminishing the

protection of public health.

On November 21, 1997, the President

signed FDAMA 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. 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.

III. Analysis of Impacts

FDA has examined the impacts of this

proposed 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 proposed rule is

consistent with the regulatory

philosophy and principles identified in

the Executive Order. In addition, this

proposed rule is not a significant

regulatory action as defined by the

Executive Order and so is not 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 proposed 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.

IV. Paperwork Reduction Act of 1995

This proposed rule contains

information collection provisions which

are subject to review by the Office of

Management and Budget (OMB) under

the Paperwork Reduction Act of 1995

(the PRA) (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

FDA’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 (Pub. L. 105–

115) 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 section 515(d)(6) of the act, 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
20560 Federal Register / Vol. 63, No. 80 / Monday, April 27, 1998 / Proposed Rules

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 would incorporate 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.

The information collection for

§ 814.39 has been approved by OMB

until September 30, 1998, under

Premarket Approval of Medical Devices,

OMB Control Number 0910–0231, for a

total of 36,063 hours. FDA believes that

the submission of 30-day notices in lieu

of PMA supplements will result in

approximately a 10 percent reduction in

total number of hours needed to comply

with § 814.39. As a result, FDA

estimates that the new total number of

hours needed to comply with the

information collection requirements in

§ 814.39 is 32,612 for a reduction of

3,451 hours.

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 proposed

amendments to § 814.39 permitting the

submission of 30-day notices in lieu of

PMA supplements would result in

approximately a 10-percent reduction in

the total number of hours needed to

comply as compared to § 814.39 prior to

these proposed amendments. As a

result, FDA estimates that the new total

number of hours that would be needed

to comply with the information

collection requirements in § 814.39 is

32,612, for a reduction of 3,451 hours.

For consistency with the direct final

rule to which this proposed rule is a

companion, FDA is following the PRA

comment procedures for direct final

rules in this proposed rule. As provided

in 5 CFR 1320.5(c)(1), collections of

information in a direct final rule is

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 proposed 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.

V. Comments

Interested persons may, by July 13,

1998, submit to the Dockets

Management Branch (address above)

written comments regarding this

proposal. This comment period runs

concurrently with the comment period

for 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 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

as comments regarding the direct final

rule and this proposed rule. In the event

the direct final rule is withdrawn, all

comments received will be considered

comments on this 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 the

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 paragraph (a) introductory text

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
Federal Register / Vol. 63, No. 80 / Monday, April 27, 1998 / Proposed Rules 20561

section and are eligible to be the subject

of a 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 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. 98–11085 Filed 4–24–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE INTERIOR

Office of Surface Mining Reclamation

and Enforcement

30 CFR Part 917

[KY–217–FOR]

Kentucky Regulatory Program;

Reopening of Public Comment Period

AGENCY: Office of Surface Mining

Reclamation and Enforcement (OSM),

Interior.

ACTION: Proposed rule; reopening of

public comment period.

SUMMARY: OSM is reopening the public

comment period on a proposed

amendment to the Kentucky regulatory

program (hereinafter the ‘‘Kentucky

program’’) under the Surface Mining

Control and Reclamation Act of 1977

(SMCRA). Kentucky submitted a letter

requesting the removal of an

amendment at 30 CFR 917.17(a) which

required that it maintain a staffing level

of 156 field inspectors and, in the same

letter, provided justification for its

request. The amendment is intended to

revise the Kentucky program to be

consistent with the corresponding

Federal regulations.

DATES: Written comments must be

received by 4:00 p.m., [E.D.T.], May 12,

1998.

ADDRESSES: Written comments and

requests to speak at the hearing should

be mailed or hand delivered to William

J. Kovacic, Director, at the address listed

below.

Copies of the Kentucky program, the

proposed amendment, a listing of any

scheduled public hearings, and all

written comments received in response

to this document will be available for

public review at the addresses listed

below during normal business hours,

Monday through Friday, excluding

holidays. Each requester may receive

one free copy of the proposed

amendment by contacting OSM’s

Lexington Field Office.

William J. Kovacic, Director, Lexington

Field Office, Office of Surface Mining

Reclamation and Enforcement, 2675

Regency Road, Lexington, Kentucky

40503, Telephone: (606) 233–2494

Department of Surface Mining

Reclamation and Enforcement, 2

Hudson Hollow Complex, Frankfort,

Kentucky 40601, Telephone: (502)

564–6940.

FOR FURTHER INFORMATION CONTACT:

William J. Kovacic, Director, Lexington

Field Office, Telephone: (606) 233–

2494.

SUPPLEMENTARY INFORMATION:

I. Background on the Kentucky

Program

On May 18, 1982, the Secretary of the

Interior conditionally approved the

Kentucky program. Background

information on the Kentucky program,

including the Secretary’s findings, the

disposition of comments, and the

conditions of approval can be found in

the May 18, 1982, Federal Register (47

FR 21404). Subsequent actions

concerning the conditions of approval

and program amendments can be found

at 30 CFR 917.11, 917.13, 917.15,

917.16, and 917.17.

II. Description of the Proposed

Amendment

By letter dated November 3, 1997

(Administrative Record No. KY–1418),

Kentucky submitted a proposed

amendment to its program requesting

the removal of an amendment at 30 CFR

917.17(a) requiring that Kentucky

maintain a staffing level of 156 field

inspectors. In the same letter, Kentucky

provided the following justification for

its request:

1. Field inspector staffing levels are

no longer based on 1984 inspection

numbers and budgetary needs.

2. A study performed during the

National Wildlife Federation Settlement

Agreement determined that a cap of 24

inspectable units per field inspector

should be established.

3. OSM has accepted the limits set by

the study in determining inspection

staff levels as indicated by the approval

of Title V administrative and

enforcement grants.

4. OSM’s annual reports indicate that

Kentucky’s Title V regulatory program

consistently meets high inspection

frequency levels.

Kentucky also maintains that using a

fixed number of field inspectors fails to

provide the latitude necessary to adapt

its inspection force to changing

conditions in the coal industry. Further,

the number of inspectors Kentucky

maintains is based on the current and

ever-changing number of inspectable

units.

The proposed amendment was

announced in the December 10, 1997,

Federal Register (62 FR 65044). The

notice did not clarify that Kentucky

submitted documents that provide

evidence that it has sufficient inspection

and enforcement staffing levels to

regulate mining in accordance with

SMCRA. Those documents are:

‘‘Historical Information on Kentucky’s

Surface Mining Primacy Program,’’

complied by Kentucky, July 1997

(Administrative Record No. KY–1418);

‘‘Review of Current Staffing and

Funding Levels,’’ prepared by the OSM

Lexington Field Office, December 1997

(Administrative Record No. KY–1420);

and ‘‘Inspection Resources Study,’’

prepared by OSM and Kentucky, August

1989 (Administrative Record No. KY–

1418).

III. Public Comment Procedures

In accordance with the provisions of

30 CFR 732.17(h), OSM is seeking

comments on whether the proposed

amendment satisfies the applicable

program approval criteria of 30 CFR

732.15. If the amendment is deemed

adequate, it will become part of the

Kentucky program.

Written Comments

Written comments should be specific,

pertain only to the issues proposed in

this rulemaking, and include

explanations in support of the

commenter’s recommendations.

Comments received after the time

indicated under DATES or at locations

other than the Lexington Field Office

will not necessarily be considered in the

final rulemaking or included in the

Administrative Record.

IV. Procedural Determinations

Executive Order 12866

This rule is exempted from review by

the Office of Management and Budget

(OMB) under Executive Order 12866

(Regulatory Planning and Review).