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
20534 Federal Register / Vol. 63, No. 80 / Monday, April 27, 1998 /Rules and Regulations

levels of government. Therefore, in

accordance with Executive Order 12612,

it is determined that this rule does not

have sufficient federalism implications

to warrant the preparation of a

Federalism Assessment.

This rule is not a major rule as

defined by section 804 of the Small

Business Regulatory Enforcement Act of

1996. This rule will not result in an

annual effect on the economy of $100

million or more; a major increase in

costs or prices; or significant adverse

effects on competition, employment,

investment, productivity, innovation, or

on the ability of United States-based

companies to compete with foreignbased companies in domestic and

export markets.

List of Subjects in 28 CFR Part 0

Authority delegations (Government

agencies), Government employees,

Organization and functions

(Government agencies), Prisoners,

Whistleblowing.

For the reasons stated in the

preamble, Title 28, Part 0, Subpart K of

the Code of Federal Regulations is

amended as follows:

PART 0—[AMENDED]

1. The authority citation for Part 0

continues to read as follows:

Authority: 5 U.S.C. 301; 28 U.S.C. 509,

510, 515–519.

2. Section 0.64–2 is amended as

follows:

a. The phrase ‘‘Public Law 95–44’’ is

removed and the phrase ‘‘Public Law

95–144’’ is inserted in its place;

b. The final sentence is revised to read

as follows:

§ 0.64–2 Delegation respecting transfer of

offenders to or from foreign countries.

* * * The Assistant Attorney General

in charge of the Criminal Division is

authorized to redelegate this authority

to his Deputy Assistant Attorneys

General, the Director of the Office of

Enforcement Operations, and the Senior

Associate Director and Associate

Directors of the Office of Enforcement

Operations.

Dated: April 15, 1998.

Janet Reno,

Attorney General.

[FR Doc. 98–10832 Filed 4–24–98; 8:45 am]

BILLING CODE 4410–01–M

FEDERAL COMMUNICATIONS

COMMISSION

47 CFR Part 69

[CC Docket 96–128; DA 98–481]

Implementation of the Pay Telephone

Reclassification and Compensation

Provisions of the Telecommunications

Act of 1996

AGENCY: Federal Communications

Commission.

ACTION: Final rule; clarification and

waivers.

SUMMARY: The Common Carrier Bureau

adopted a Memorandum Opinion and

Order, which clarifies the requirements

for the provision of payphone-specific

coding digits by local exchange carriers

(LECs) and payphone service providers

(PSPs) to interexchange carriers (IXCs).

The order also clarifies that automatic

number identification indicators (‘‘ANI

ii’’) and flexible automatic numbering

identification (‘‘FLEX ANI’’), are the

methods to provide payphone-specific

coding digits that comply with the

requirements of the Payphone Orders. In

addition, the order clarifies the tariff

requirements that LECs must file

pursuant to the Payphone Orders. The

order also grants a waiver of part 69 of

the Commission’s rules so that LECs can

establish rate elements to recover the

costs of implementing FLEX ANI to

provide payphone-specific coding digits

for per-call compensation. Additionally,

this order provides limited waivers to

LECs, PSPs, and IXCs, when

appropriate, to facilitate the

implementation of per call

compensation.

DATES: Effective March 9, 1998.

FOR FURTHER INFORMATION CONTACT: Rose

Crellin, Formal Complaints and

Information Branch, Enforcement

Division, Common Carrier Bureau (202)

418–0960.

SUPPLEMENTARY INFORMATION: This is a

summary of the Bureau’s Memorandum

Opinion and Order in CC Docket No.

96–128 [DA 98–481], adopted on March

9, 1998, and released on March 9, 1998.

The full text of the Memorandum

Opinion and Order (‘‘Order’’) is

available for inspection and copying

during normal business hours in the

FCC Reference Center, Room 239, 1919

M Street, N.W., Washington, D.C. The

complete text of this decision also may

be purchased from the Commission’s

duplicating contractor, International

Transcription Services, 1231 20th

Street, N.W., Washington, D.C. 20036.

Paperwork Reduction Act

The Federal Communications

Commission has received Office of

Management and Budget (OMB)

approval for the following public

information collections contained in the

Order pursuant to the Paperwork

Reduction Act of 1995, Public Law 104–

13. 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

control number.

OMB Control Number: 3060–0823.

Expiration Date: 09/30/98.

Title: Pay Telephone Reclassification

Memorandum Opinion and Order, CC

Docket No. 96–128.

Form No.: N/A.

Respondents: Business or other forprofit entities.

Information collection requirement

No. of respondents

(approximately)

Est. time per

response

(hours)

Total annual

burden

a. LEC Tariff To Provide FLEX ANI to IXCs ................................................................................ 400 35 14,000

b. LEC Tariff To Recover Costs ................................................................................................... 400 35 14,000

c. LECS Must Provide IXCs on Payphones that Provide Payphone specific Coding Digits ...... 400 24 9,600

d. LECs must Provide IXCs and PSPs Information on where FLEX ANI is Available Now and

When it is to be Scheduled in the Future ................................................................................ 400 16 6,400

e. Waiver; LECs to Provide Cost Analysis Upon Request .......................................................... 20 35 700

Total Annual Burden: 44,700 Hours.

Estimated Annual Reporting and

Recordkeeping cost Burden: $0.

Needs and Uses: In the MO&O, the

Bureau clarifies and provides waivers of

requirements established in the

Payphone Orders for the provision of

payphone-specific coding digits by LECs

and PSPs, to IXCs, beginning October 7,

1997. The information disclosure rules

and policies governing the payphone

industry to implement Section 276 of

the Act will ensure the payment per-call