Federal Register / Vol. 63, No. 91 /Tuesday, May 12, 1998 / Proposed Rules 26127

listing, by credit rating category and industry

segment, the current net exposure, net replacement

value, and gross replacement values; (3) a

Geographic Distribution listing, by country, the

current net exposure, the net replacement value,

and the gross replacement values; (4) a Net

Revenues Report listing, by product category and

month, the net revenue; and (5) a Consolidated

Activity Report listing, by product category, the

aggregate notional amount.

89See, e.g.: Framework for Voluntary Oversight,

supra; Principles and Practices for Wholesale

Financial Market Transactions, supra; and Global

Derivatives Study Group, Group of Thirty,

Derivatives: Practices and Principles, supra.

Commission requests comment on

whether specific reporting requirements

for participants in the OTC derivatives

markets are needed and, if so, what

reports should be made and by whom.

If the Commission were to establish

reporting requirements, it would

coordinate with other regulatory

agencies and, to the extent possible,

accept reports provided to other

regulatory agencies in satisfaction of the

Commission’s requirements. The

Commission solicits comment

concerning how these goals might best

be accomplished.

Request for comment. 70. Should the

Commission establish reporting

requirements for participants in the

OTC derivatives markets? If so, what

information should be reported? By

whom?

C. Self-Regulation

Having identified areas in which

current exemptions might be modified,

the Commission is also interested in the

views of commenters concerning

whether, and to what extent, any

needed changes concerning the

oversight of the OTC derivatives market

could be accomplished through

initiatives of industry bodies either

voluntarily or through a self-regulatory

organization empowered to establish

rules and subject to Commission

oversight. The Commission notes that

several industry organizations already

exist with an interest in maintaining

and improving the integrity of the OTC

derivatives marketplace. These

organizations include, among others, the

Derivatives Policy Group, the

International Swaps and Derivatives

Association, the Group of Thirty, and

the End-Users of Derivatives

Association. Industry groups have

already issued a number of voluntary

initiatives aimed at reducing risks and

promoting stability and integrity in the

OTC derivatives marketplace.89 The

Commission is interested in exploring

the extent to which concerns described

in this release might be addressed, and

adequate oversight of the OTC

derivatives marketplace might be

attained, through industry bodies or

through self-regulatory organizations.

Request for comment. 71. How

effective are current self-regulatory

efforts? What are their strengths and

weaknesses?

72. Are there particular areas among

those discussed above where selfregulation could obviate the need for

government regulation?

73. Please discuss the costs and

benefits of existing voluntary versus

potential mandatory self-regulatory

regimes.

74. If a self-regulatory regime were

adopted, what mechanism would best

assure effective oversight by the

Commission?

75. How best can the Commission

achieve effective coordination with

other regulators in connection with the

oversight of the OTC derivatives

market?

IV. Summary of Request for Comment

Commenters are invited to discuss the

broad range of concepts and approaches

described in this release. The

Commission specifically requests

commenters to compare the advantages

and disadvantages of the possible

changes discussed above with those of

the existing regulatory framework. In

addition to responding to the specific

questions presented, the Commission

encourages commenters to submit any

other relevant information or views.

Issued in Washington, D.C. this 6th day of

May, 1998, by the Commodity Futures

Trading Commission.

By the Commission (Chairperson BORN,

Commissioners TULL and SPEARS;

Commissioner HOLUM dissenting).

Jean A. Webb,

Secretary of the Commission.

Dissenting Remarks of Commissioner

Barbara Pedersen Holum, Concept

Release, Over-the-Counter Derivatives

In Section 4(c)(1) of the Commodity

Exchange Act, Congress authorized the

Commission to exempt certain

transactions ‘‘[i]n order to promote

responsible economic or financial

innovation and fair competition.’’

Indeed, it appears that the dramatic

growth in volume and the products

offered in the OTC derivatives market

may be attributed in part to the

Commission’s past exemptive action. In

the spirit of the Commission’s ongoing

regulatory review program, it is

appropriate to examine the continuing

applicability of the existing exemptions,

focusing on the expanding economic

significance of the OTC market.

However, in my judgement,the release

goes beyond the scope of regulatory

review by exploring regulatory areas

that may be inapplicable to an OTC

market. Accordingly, I am dissenting

from the majority’s decision to issue the

Concept Release on OTC Derivatives in

its current form.

Dated: May 6, 1998.

Barbara Pedersen Holum,

Commissioner.

[FR Doc. 98–12539 Filed 5–11–98; 8:45 am]

BILLING CODE 6351–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 430, 431, 432, 433, 436,

440, 441, 442, 443, 444, 446, 448, 449,

450, 452, 453, 455, and 460

[Docket No. 98N–0211]

Removal of Regulations Regarding

Certification of Antibiotic Drugs;

Companion Document to Direct Final

Rule

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule.

SUMMARY: The Food and Drug

Administration (FDA) is publishing this

companion proposed rule to the direct

final rule, published elsewhere in this

issue of the Federal Register, which is

intended to repeal FDA’s regulations

governing certification of antibiotic

drugs. The agency is taking this action

in accordance with provisions of the

Food and Drug Administration

Modernization Act of 1997 (FDAMA).

FDAMA repealed the statutory

provision in the Federal Food, Drug,

and Cosmetic Act (the act) under which

the agency certified antibiotic drugs.

FDAMA also made conforming

amendments to the act.

DATES: Comments must be received on

or before July 27, 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:

Wayne H. Mitchell or Christine F.

Rogers, Center for Drug Evaluation and

Research (HFD–7), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–594–2041.

SUPPLEMENTARY INFORMATION:

I. Background

As described more fully in the related

direct final rule, section 125(b) of

FDAMA (Pub. L. 105–115) repealed

section 507 of the act (21 U.S.C. 357)
26128 Federal Register / Vol. 63, No. 91 /Tuesday, May 12, 1998 / Proposed Rules

and made conforming amendments to

the act and other provisions of Federal

law. Section 507 of the act was the

section under which the agency

certified antibiotic drugs. FDA is

proposing to remove all provisions of

Title 21 of the Code of Federal

Regulations that were issued primarily

to carry out the agency’s program for the

certification of antibiotic drugs under

former section 507 of the act.

II. Additional Information

This proposed rule is a companion to

the direct final rule published in the

final rules section of this issue of the

Federal Register. The companion

proposed rule and the direct final rule

are identical. This companion proposed

rule will provide the procedural

framework to finalize the rule in the

event the direct final rule receives

significant adverse comment and is

withdrawn. The comment period for the

companion proposed rule runs

concurrently with the comment period

of the direct final rule. Any comments

received under the companion proposed

rule will be treated as comments

regarding the direct final rule.

The amendments contained in this

rule are a direct result of the repeal of

the statutory certification provision. If

no significant adverse comment is

received in response to the direct final

rule, no further action will be taken

related to the companion proposed rule.

Instead, FDA will publish a

confirmation notice within 30 days after

the comment period ends, and FDA

intends the direct final rule to become

effective 30 days after publication of the

confirmation notice. If FDA receives

significant adverse comments, the

agency will withdraw the direct final

rule. FDA will proceed to respond to all

of the comments received regarding the

rule and, if appropriate, the rule will be

finalized under this companion

proposed rule using usual notice-andcomment procedures.

For additional information, see the

corresponding direct final rule

published in the final rules section of

this issue of the Federal Register. All

persons who may wish to comment

should review the rationale for these

amendments set out in the preamble

discussion of the direct final rule. If

FDA receives significant adverse

comments, the agency will withdraw

the companion final rule and will treat

those comments as comments to this

proposed rule. The agency will address

the comments in a subsequent final rule.

FDA will not provide additional

opportunity for comment. A significant

adverse comment is one 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. A comment

recommending a rule change in addition

to this rule will not be considered a

significant adverse comment, unless the

comment states why this rule would be

ineffective without the additional

change.

III. 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.

IV. Analysis of Impacts

FDA has examined the impacts of the

proposed rule under Executive Order

12866, the Regulatory Flexibility Act (5

U.S.C. 601–612), and the Unfunded

Mandates Reform Act of 1995 (Pub. L.

104–4). Executive Order 12866 directs

agencies to assess all costs and benefits

of available regulatory alternatives and,

when regulation 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).

Executive Order 12866 classifies a rule

as significant if it meets any one of a

number of specified conditions,

including having an annual effect on the

economy of $100 million or adversely

affecting in a material way a sector of

the economy, competition, or jobs, or if

it raises novel legal or policy issues. As

discussed below, the agency believes

that this proposed rule is consistent

with the regulatory philosophy and

principles identified in the Executive

Order. In addition, the 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 that if a rule has a significant

impact on a substantial number of small

entities, the agency must analyze

regulatory options to minimize the

economic impact on small entities. The

agency certifies, for the reasons

discussed below, that the proposed rule

will not have a significant impact on a

substantial number of small entities.

Therefore, under the Regulatory

Flexibility Act, no further analysis is

required.

The Unfunded Mandates Reform Act

requires an agency to prepare a

budgetary impact statement before

issuing any rule likely to result in a

Federal mandate that may result in

expenditures by State, local, and tribal

governments or the private sector of

$100 million (adjusted annually for

inflation) in any 1 year. The elimination

of the regulations governing the

certification of antibiotic drugs will not

result in any increased expenditures by

State, local, and tribal governments or

the private sector. Because this rule will

not result in an expenditure of $100

million or more on any governmental

entity or the private sector, no budgetary

impact statement is required.

This rule is intended to eliminate

regulatory procedures and standards

that the agency, as a result of the repeal

of section 507 of the act, is no longer

required to maintain. The elimination of

parts 430 et seq. is expected to

streamline the regulation of antibiotic

drugs by making these products subject

to the same regulatory standards as all

other drugs for human use. Many of the

provisions that are being eliminated by

this rulemaking have not had a material

impact on the marketing of antibiotic

drugs since 1982, when all antibiotic

drugs were conditionally exempted

from the batch certification requirement

(47 FR 39155, September 7, 1982). Other

provisions, such as the standards of

identity, strength, quality, and purity,

have in some instances not been kept

up-to-date, are duplicative of U.S.P.

standards, or have been incorporated

into approved marketing applications

for specific antibiotic drug products. For

these reasons, the agency believes that

this rule is necessary and that it is

consistent with the principles of

Executive Order 12866; that it is not a

significant regulatory action under that

Order; that it will not have a significant

impact on a substantial number of small

entities; and that it is not likely to result

in an annual expenditure in excess of

$100 million.

V. 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

(Pub. L. 104–13) is not required.

VI. Request for Comments

Interested persons may, on or before

July 27, 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; any comments

received will be considered as

comments regarding the direct final

rule. Two copies of any comments are
Federal Register / Vol. 63, No. 91 /Tuesday, May 12, 1998 / Proposed Rules 26129

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

21 CFR Part 430

Administrative practice and

procedure, Antibiotics.

21 CFR Part 431

Administrative practice and

procedure, Antibiotics, Confidential

business information, Reporting and

recordkeeping requirements.

21 CFR Part 432

Antibiotics, Labeling, Packaging and

containers.

21 CFR Part 433

Antibiotics, Labeling, Reporting and

recordkeeping requirements.

21 CFR Parts 436, 440, 441, 442, 443,

444, 446, 448, 449, 450, 452, 453, 455,

and 460

Antibiotics.

Therefore, under the Federal Food,

Drug, and Cosmetic Act, the Food and

Drug Administration Modernization

Act, and under authority delegated to

the Commissioner of Food and Drugs, it

is proposed that 21 CFR chapter I be

amended as follows:

PART 430—ANTIBIOTIC DRUGS;

GENERAL

1. Part 430 is removed.

PART 431—CERTIFICATION OF

ANTIBIOTIC DRUGS

2. Part 431 is removed.

PART 432—PACKAGING AND

LABELING OF ANTIBIOTIC DRUGS

3. Part 432 is removed.

PART 433—EXEMPTIONS FROM

ANTIBIOTIC CERTIFICATION AND

LABELING REQUIREMENTS

4. Part 433 is removed.

PART 436—TESTS AND METHODS OF

ASSAY OF ANTIBIOTIC AND

ANTIBIOTIC-CONTAINING DRUGS

5. Part 436 is removed.

PART 440—PENICILLIN ANTIBIOTIC

DRUGS

6. Part 440 is removed.

PART 441—PENEM ANTIBIOTIC

DRUGS

7. Part 441 is removed.

PART 442—CEPHA ANTIBIOTIC

DRUGS

8. Part 442 is removed.

PART 443—CARBACEPHEM

ANTIBIOTIC DRUGS

9. Part 443 is removed.

PART 444—OLIGOSACCHARIDE

ANTIBIOTIC DRUGS

10. Part 444 is removed.

PART 446—TETRACYCLINE

ANTIBIOTIC DRUGS

11. Part 446 is removed.

PART 448—PEPTIDE ANTIBIOTIC

DRUGS

12. Part 448 is removed.

PART 449—ANTIFUNGAL ANTIBIOTIC

DRUGS

13. Part 449 is removed.

PART 450—ANTITUMOR ANTIBIOTIC

DRUGS

14. Part 450 is removed.

PART 452—MACROLIDE ANTIBIOTIC

DRUGS

15. Part 452 is removed.

PART 453—LINCOMYCIN ANTIBIOTIC

DRUGS

16. Part 453 is removed.

PART 455—CERTAIN OTHER

ANTIBIOTIC DRUGS

17. Part 455 is removed.

PART 460—ANTIBIOTIC DRUGS

INTENDED FOR USE IN LABORATORY

DIAGNOSIS OF DISEASE

18. Part 460 is removed.

Dated: May 1, 1998.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 98–12542 Filed 5–11–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 803 and 804

[Docket No. 98N–0170]

Medical Device Reporting:

Manufacturer Reporting, Importer

Reporting, User Facility Reporting, and

Distributor Reporting; 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 certain regulations governing

reporting by manufacturers, importers,

distributors, and health care (user)

facilities of adverse events related to

medical devices. This proposed rule is

a companion document to the direct

final rule, published elsewhere in this

issue of the Federal Register. The

amendments are intended to implement

provisions of 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 this 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 a significant adverse comment

and withdraws the direct final rule.

DATES: Submit written comments on or

before July 27, 1998. Submit written

comments on the information collection

requirements on or before July 13, 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:

Patricia A. Spitzig, Center for Devices

and Radiological Health (HFZ–500),

Food and Drug Administration, 1350

Piccard Dr., Rockville, MD 20850, 301–

594–2812.

SUPPLEMENTARY INFORMATION: This

proposed rule is a companion to the

direct final rule published in the final

rules section of this issue of the Federal

Register. This companion proposed rule

is substantively identical to the direct

final rule. This proposed rule will

provide a procedural framework to

finalize the rule in the event the agency

receives a significant adverse comment

and the direct final rule is withdrawn.

FDA is publishing the direct final rule