Removal of Regulations Regarding Certification of Drugs Composed Wholly or Partly of Insulin; Companion Document to Direct Final Rule

Part III

Department of Health and Human Services

_______________________________________________________________________

Food and Drug Administration

_______________________________________________________________________

21 CFR Parts 3, et al.

Removal of Regulations Regarding Certification of Drugs Composed Wholly

or Partly of Insulin; Proposed Rule and Rule

Proposed Rules

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 3, 5, 10, 16, 25, 50, 56, 58, 71, 200, 201, 207, 210,

211, 310, 312, 314, 369, 429, 800, and 812

[Docket No. 98N-0210]

Removal of Regulations Regarding Certification of Drugs Composed

Wholly or Partly of Insulin; Companion Document to Direct Final Rule

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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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 drugs containing insulin

and make conforming amendments to other sections of the agency's

regulations. 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 FDAMA repealed the statutory provision in the Federal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

drugs containing insulin. 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, 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

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, 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

Section 125(a) of FDAMA (Pub. L. 105-115) repealed section 506 of

the act (21 U.S.C. 356) and made other conforming amendments to the act

and another provision of Federal law. Section 506 was the statutory

provision in the act under which the agency certified drugs containing

insulin. FDA is proposing to remove all regulations relating to the

certification of insulin products, remove citations to section 506 of

the act in various authority sections in title 21 of the Code of

Federal Regulations (CFR), and eliminate citations to section 506 in

regulations that do not deal primarily with the certification of

insulin. FDA is also proposing to eliminate out-of-date provisions

dealing with labeling and testing of insulin and to update the

definition of insulin found in 21 CFR 200.15.

II. Additional Information

This proposed rule is a companion to the direct final rule

published elsewhere in 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.

Most of the amendments in this rule are a direct result of the

repeal of the statutory certification provision

hy 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 this companion 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. 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 agencies to analyze

regulatory options to minimize any significant impact on small

entities

ule 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 agencies to analyze

regulatory options to minimize any significant impact on small

entities. The only two current manufacturers marketing insulin drug

products in the United States are not small entities. Furthermore, by

eliminating the certification process, this direct final rule would

lower market entry barriers for small entities. The agency certifies

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 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 insulin

certification program will lower the

costs of marketing insulin drug products by eliminating both the direct

cost of applying for certification and the cost of holding batches of

insulin while awaiting certification. 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.

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

llion or more on any governmental entity or

the private sector, no budgetary impact statement is required.

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 September 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 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 3

Administrative practice and procedure, Biologics, Drugs, Medical

devices.

21 CFR Part 5

Authority delegations (Government agencies), Imports, Organization

and functions (Government agencies).

21 CFR Part 10

Administrative practice and procedure, News media.

21 CFR Part 16

Administrative practice and procedure.

21 CFR Part 25

Environmental impact statements, Foreign relations, Reporting and

recordkeeping requirements.

21 CFR Part 50

Human research subjects, Prisoners, Reporting and recordkeeping

requirements, Safety.

21 CFR Part 56

Human research subjects, Reporting and recordkeeping requirements,

Safety.

21 CFR Part 58

Laboratories, Reporting and recordkeeping requirements.

21 CFR Part 71

Administrative practice and procedure, Color additives,

Confidential business information, Cosmetics, Drugs, Reporting and

recordkeeping requirements.

21 CFR Part 200

Drugs, Prescription drugs.

21 CFR Part 201

21 CFR Part 56

Human research subjects, Reporting and recordkeeping requirements,

Safety.

21 CFR Part 58

Laboratories, Reporting and recordkeeping requirements.

21 CFR Part 71

Administrative practice and procedure, Color additives,

Confidential business information, Cosmetics, Drugs, Reporting and

recordkeeping requirements.

21 CFR Part 200

Drugs, Prescription drugs.

21 CFR Part 201

Drugs, Labeling, Reporting and recordkeeping requirements.

21 CFR 207

Drugs, Reporting and recordkeeping requirements.

21 CFR 210

Drugs, Packaging and containers.

21 CFR Part 211

Drugs, Labeling, Laboratories, Packaging and containers,

Prescription drugs, Reporting and recordkeeping requirements,

Warehouses.

21 CFR Part 310

Administrative practice and procedure, Drugs, Labeling, Medical

devices, Reporting and recordkeeping requirements.

21 CFR Part 312

Drugs, Exports, Imports, Investigations, Labeling, Medical

research, Reporting and recordkeeping requirements, Safety.

21 CFR Part 314

Administrative practice and procedure, Confidential business

information, Drugs, Reporting and recordkeeping requirements.

21 CFR Part 369

Labeling, Medical devices, Over-the-counter drugs.

21 CFR Part 429

Administrative practice and procedure, Drugs, Labeling, Packaging

and containers, Reporting and recordkeeping requirements.

21 CFR Part 800

Administrative practice and procedure, Medical devices, Ophthalmic

goods and services, Packaging and containers, Reporting and

recordkeeping requirements.

21 CFR Part 812

Health records, 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 Food and Drugs, it is

proposed that 21 CFR parts 3, 5, 10, 16, 25, 50, 56, 58, 71, 200, 201,

207, 210, 211, 310, 312, 314, 369, 429, 800, and 812 be amended as

follows:

PART 3--PRODUCT JURISDICTION

1. The authority citation for 21 CFR part 3 is revised to read as

follows:

ements.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under

authority delegated to the Commissioner of Food and Drugs, it is

proposed that 21 CFR parts 3, 5, 10, 16, 25, 50, 56, 58, 71, 200, 201,

207, 210, 211, 310, 312, 314, 369, 429, 800, and 812 be amended as

follows:

PART 3--PRODUCT JURISDICTION

1. The authority citation for 21 CFR part 3 is revised to read as

follows:

Authority: 21 U.S.C. 321, 351, 352, 353, 355, 357, 360, 360c-

360f, 360h-360j, 360gg-360ss, 371(a), 379e, 381, 394; 42 U.S.C. 216,

262.

PART 5--DELEGATIONS OF AUTHORITY AND ORGANIZATION

2. The authority citation for 21 CFR part 5 continues to read as

follows:

Authority: 5 U.S.C. 504, 552, App. 2; 7 U.S.C. 138a, 2271; 15

U.S.C. 638, 1261-1282, 3701-3711a; 15 U.S.C. 1451-1461; 21 U.S.C.

41-50, 61-63, 141-149, 321-394, 467f, 679(b), 801-886, 1031-1309; 35

U.S.C. 156; 42 U.S.C. 241, 242, 242a, 242l, 242n, 243, 262, 263,

264, 265, 300u-300u-5, 300aa-1; 1395y, 3246b, 4332, 4831(a), 10007-

10008; E.O. 11921, 41 FR 24294, 3 CFR, 1977 Comp., p. 124-131; E.O.

12591, 52 FR 13414, 3 CFR, 1988 Comp., p. 220-223.

Sec. 5.31 [Amended]

3. Section 5.31 Petitions under part 10 is amended by removing and

reserving paragraphs (f)(2)(iii) and (f)(2)(iv).

Sec. 5.73 [Removed]

4. Section 5.73 Certification of insulin is removed.

Sec. 5.74 [Removed]

5. Section 5.74 Issuance, amendment, or repeal of regulations

pertaining to drugs containing insulin is removed.

PART 10--ADMINISTRATIVE PRACTICES AND PROCEDURES

6. The authority citation for 21 CFR part 10 continues to read as

follows:

Authority: 21 U.S.C. 41-50, 141-149, 321-394, 467f, 679, 821,

1034; 42 U.S.C. 201, 262, 263b, 264; 15 U.S.C. 1451-1461; 5 U.S.C.

551-558, 701-721; 28 U.S.C. 2112.

Sec. 10.50 [Amended]

7. Section 10.50 Promulgation of regulations and orders after an

opportunity for a formal evidentiary public hearing is amended by

removing and reserving paragraph (c)(10).

PART 16--REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION

149, 321-394, 467f, 679, 821,

1034; 42 U.S.C. 201, 262, 263b, 264; 15 U.S.C. 1451-1461; 5 U.S.C.

551-558, 701-721; 28 U.S.C. 2112.

Sec. 10.50 [Amended]

7. Section 10.50 Promulgation of regulations and orders after an

opportunity for a formal evidentiary public hearing is amended by

removing and reserving paragraph (c)(10).

PART 16--REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION

8. The authority citation for 21 CFR part 16 continues to read as

follows:

Authority: 21 U.S.C. 41-50, 141-149, 321-394, 467f, 679, 821,

1034; 42 U.S.C. 201, 262, 264; 15 U.S.C. 1451-1461; 28 U.S.C. 2112.

Sec. 16.1 [Amended]

9. Section 16.1 Scope is amended in paragraph (b)(2) by removing

the entry for ``Sec. 429.50.''

PART 25--ENVIRONMENTAL IMPACT CONSIDERATIONS

10. The authority citation for 21 CFR part 25 continues to read as

follows:

Authority: 21 U.S.C. 321-393; 42 U.S.C. 262, 263b-264; 42 U.S.C.

4321, 4332; 40 CFR parts 1500-1508; E.O. 11514, 35 FR 4247, 3 CFR,

1971 Comp., p. 531-533 as amended by E.O. 11991, 42 FR 26967, 3 CFR,

1978 Comp., p. 123-124 and E.O. 12114, 44 FR 1957, 3 CFR, 1980

Comp., p. 356-360.

Sec. 25.31 [Amended]

11. Section 25.31 Human drugs and biologics is amended in paragraph

(f) by removing the words ``or insulin.''

PART 50--PROTECTION OF HUMAN SUBJECTS

12. The authority citation for 21 CFR part 50 is revised to read as

follows:

Authority: 21 U.S.C. 321, 346, 346a, 348, 352, 353, 355, 357,

360, 360c-360f, 360h-360j, 371, 379e, 381; 42 U.S.C. 216, 241, 262,

263b-263n.

Sec. 50.1 [Amended]

13. Section 50.1 Scope is amended in the last sentence of paragraph

h

(f) by removing the words ``or insulin.''

PART 50--PROTECTION OF HUMAN SUBJECTS

12. The authority citation for 21 CFR part 50 is revised to read as

follows:

Authority: 21 U.S.C. 321, 346, 346a, 348, 352, 353, 355, 357,

360, 360c-360f, 360h-360j, 371, 379e, 381; 42 U.S.C. 216, 241, 262,

263b-263n.

Sec. 50.1 [Amended]

13. Section 50.1 Scope is amended in the last sentence of paragraph

(a) by removing the number ``506,''.

PART 56--INSTITUTIONAL REVIEW BOARDS

14. The authority citation for 21 CFR part 56 is revised to read as

follows:

Authority: 21 U.S.C. 321, 346, 346a, 348, 351, 352, 353, 355,

357, 360, 360c-360f, 360h-360j, 371, 379e, 381; 42 U.S.C. 216, 241,

262, 263b-263n.

PART 58--GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY

STUDIES

15. The authority citation for 21 CFR part 58 is revised to read as

follows:

Authority: 21 U.S.C. 342, 346, 346a, 348, 351, 352, 353, 355,

357, 360, 360b-360f, 360h-360j, 371, 379e, 381; 42 U.S.C. 216, 262,

263b-263n.

PART 71--COLOR ADDITIVE PETITIONS

16. The authority citation for 21 CFR part 71 is revised to read as

follows:

Authority: 21 U.S.C. 321, 342, 348, 351, 355, 357, 360, 360b-

360f, 360h-360j, 361, 371, 379e, 381; 42 U.S.C. 216, 262.

PART 200--GENERAL

17. The authority citation for 21 CFR part 200 is revised to read

as follows:

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 357, 358,

360e, 371, 374, 375.

18. Section 200.15 is revised to read as follows:

Sec. 200.15 Definition of term ``insulin.''

For purposes of sections 801 and 802 of the act and this title, the

term insulin means the active principle of the pancreas that affects

the metabolism of carbohydrates in the animal body and which is of

value in the treatment of diabetes mellitus. The term includes

synthetic and biotechnologically derived products that are the same as,

or similar to, naturally occurring insulins in structure, use, and

intended effect and are of value in the treatment of diabetes mellitus.

PART 201--LABELING

ciple of the pancreas that affects

the metabolism of carbohydrates in the animal body and which is of

value in the treatment of diabetes mellitus. The term includes

synthetic and biotechnologically derived products that are the same as,

or similar to, naturally occurring insulins in structure, use, and

intended effect and are of value in the treatment of diabetes mellitus.

PART 201--LABELING

19. The authority citation for 21 CFR part 201 is revised to read

as follows:

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 357, 358,

360, 360b, 360gg-360ss, 371, 374, 379e; 42 U.S.C. 216, 241, 262,

264.

Sec. 201.50 [Amended]

20. Section 201.50 Statement of identity is amended in paragraph

(b) by removing the second sentence.

Sec. 201.100 [Amended]

21. Section 201.100 Prescription drugs for human use is amended in

paragraph (c)(2) by removing the number ``, 506,''.

PART 207--REGISTRATION OF PRODUCERS OF DRUGS AND LISTING OF DRUGS

IN COMMERCIAL DISTRIBUTION

22. The authority citation for 21 CFR part 207 is revised to read

as follows:

Authority: 21 U.S.C. 331, 351, 352, 355, 357, 360, 360b, 371,

374; 42 U.S.C. 262.

Sec. 207.25 [Amended]

23. Section 207.25 Information required in registration and drug

listing is amended in paragraphs (b)(2), (b)(5), and (b)(6) by removing

the number ``506,'' and in paragraph (b)(4) by removing the number ``,

506,''.

Sec. 207.31 [Amended]

24. Section 207.31 Additional drug listing information is amended

in paragraph (a)(1) by removing the number ``, 506,'', and in

paragraphs (a)(2), (a)(3), and (c) by removing the number ``506,''.

Sec. 207.37 [Amended]

25. Section 207.37 Inspection of registrations and drug listings is

amended in paragraph (a)(2)(i) by removing the number ``506,''.

PART 210--CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING,

PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL

26. The authority citation for 21 CFR part 210 is revised to read

as follows:

Authority: 21 U.S.C. 321, 351, 352, 355, 357, 360b, 371, 374.

ded]

25. Section 207.37 Inspection of registrations and drug listings is

amended in paragraph (a)(2)(i) by removing the number ``506,''.

PART 210--CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING,

PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL

26. The authority citation for 21 CFR part 210 is revised to read

as follows:

Authority: 21 U.S.C. 321, 351, 352, 355, 357, 360b, 371, 374.

PART 211--CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED

PHARMACEUTICALS

27. The authority citation for 21 CFR part 211 is revised to read

as follows:

Authority: 21 U.S.C. 321, 351, 352, 355, 357, 360b, 371, 374.

PART 310--NEW DRUGS

28. The authority citation for 21 CFR part 310 is revised to read

as follows:

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 357, 360b-

360f, 360j, 361(a), 371, 374, 375, 379e; 42 U.S.C. 216, 241, 242(a),

262, 263b-263n.

PART 312--INVESTIGATIONAL NEW DRUG APPLICATION

29. The authority citation for 21 CFR part 312 is revised to read

as follows:

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 357, 371; 42

U.S.C. 262.

30. The authority citation for 21 CFR part 312, subpart E is

revised to read as follows:

Authority: 21 U.S.C. 351, 352, 353, 355, 357, 371; 42 U.S.C.

262.

PART 314--APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG OR AN

ANTIBIOTIC DRUG

31. The authority citation for 21 CFR part 314 is revised to read

as follows:

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 357, 371,

374, 379e.

Sec. 314.170 [Amended]

32. Section 314.170 Adulteration and misbranding of an approved

drug is amended in the first sentence by removing the phrase ``under

sections 505, 506, and 507'' and adding in its place the phrase ``under

sections 505(j) and 507''.

Sec. 314.430 [Amended]

33. Section 314.430 Availability for public disclosure of data and

331, 351, 352, 353, 355, 357, 371,

374, 379e.

Sec. 314.170 [Amended]

32. Section 314.170 Adulteration and misbranding of an approved

drug is amended in the first sentence by removing the phrase ``under

sections 505, 506, and 507'' and adding in its place the phrase ``under

sections 505(j) and 507''.

Sec. 314.430 [Amended]

33. Section 314.430 Availability for public disclosure of data and

information in an application or abbreviated application is amended in

paragraph (f)(6) by removing the phrase ``under sections 505(j), 506,

and 507'' and adding in its place the phrase ``under sections 505(j)

and 507''.

PART 369--INTERPRETATIVE STATEMENTS RE WARNINGS ON DRUGS AND

DEVICES FOR OVER-THE-COUNTER SALE

34. The authority citation for 21 CFR part 369 is revised to read

as follows:

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 357, 371.

Sec. 369.5 [Removed]

35. Section 369.5 Warning required on insulin intended for over-

the-counter sale is removed

Sec. 369.21 [Amended]

36. Section 369.21 Drugs; warning and caution statements required

by regulations is amended by removing the entry for ``INSULIN''.

PART 429--DRUGS COMPOSED WHOLLY OR PARTLY OF INSULIN

37. Under authority of section 701(a) of the Federal Food, Drug,

and Cosmetic Act (21 U.S.C. 371(a)) and section 125(a) of the Food and

Drug Modernization Act (Pub. L. 105-115), amend Title 21 of the Code of

Federal Regulations by removing part 429.

PART 800--GENERAL

38. The authority citation for 21 CFR part 800 is revised to read

as follows:

Authority: 21 U.S.C. 321, 334, 351, 352, 355, 357, 360e, 360i,

360k, 361, 362, 371.

PART 812--INVESTIGATIONAL DEVICE EXEMPTIONS

39. The authority citation for 21 CFR part 812 is revised to read

as follows:

Authority: 21 U.S.C. 331, 351, 352, 353, 355, 357, 360, 360c-

360f, 360h-360j, 371, 372, 374, 379e, 381, 382, 383; 42 U.S.C. 216,

241, 262, 263b-263n.

0 is revised to read

as follows:

Authority: 21 U.S.C. 321, 334, 351, 352, 355, 357, 360e, 360i,

360k, 361, 362, 371.

PART 812--INVESTIGATIONAL DEVICE EXEMPTIONS

39. The authority citation for 21 CFR part 812 is revised to read

as follows:

Authority: 21 U.S.C. 331, 351, 352, 353, 355, 357, 360, 360c-

360f, 360h-360j, 371, 372, 374, 379e, 381, 382, 383; 42 U.S.C. 216,

241, 262, 263b-263n.

Dated: April 17, 1998.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 98-12452 Filed 5-12-98; 8:45 am]

BILLING CODE 4160-01-F