# 63 FR 26690: Removal of Regulations Regarding Certification of Drugs Composed Wholly or Partly of Insulin; Companion Document to Direct Final Rule

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/FR_PRORULE_98-12452-2

## Section

- **Citation:** 63 FR 26690
- **Heading:** Removal of Regulations Regarding Certification of Drugs Composed Wholly or Partly of Insulin; Companion Document to Direct Final Rule
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** August 14, 2026
- **Source:** Compiled text
- **Location:** Federal Register / Vol. 63 / 63 FR 26690

## Text

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.

-----------------------------------------------------------------------

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 FDAMA repealed the statutory provision in the Federal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

## Nearby sections

- [63 FR 447 Rule and Regulations Under the Textile Fiber Products Identification Act](https://www.frixlaw.com/law-library/statutes/FR_PRORULE_98-101.md)
- [63 FR 456 Approval and Promulgation of Implementation Plan; Indiana](https://www.frixlaw.com/law-library/statutes/FR_PRORULE_98-241.md)
- [63 FR 770 Competitive Bidding Proceeding](https://www.frixlaw.com/law-library/statutes/FR_PRORULE_98-297.md)
- [63 FR 1072 Airworthiness Directives; Turbopropeller-Powered McDonnell Douglas Model DC-3 and DC-3C Series Airplanes](https://www.frixlaw.com/law-library/statutes/FR_PRORULE_98-476.md)
- [63 FR 1086 Abatement of Interest](https://www.frixlaw.com/law-library/statutes/FR_PRORULE_98-19.md)
- [63 FR 1396 Arkansas Regulatory Program](https://www.frixlaw.com/law-library/statutes/FR_PRORULE_98-530.md)
- [63 FR 1396 Notice of Meeting](https://www.frixlaw.com/law-library/statutes/FR_PRORULE_98-588.md)
- [63 FR 1804 Approval and Promulgation of Air Quality Implementation Plans; DelawareNew Source Review](https://www.frixlaw.com/law-library/statutes/FR_PRORULE_98-673.md)
- [63 FR 2188 Maintenance of Minimum Financial Requirements by Futures Commission Merchants and Introducing Brokers](https://www.frixlaw.com/law-library/statutes/FR_PRORULE_98-665.md)
- [63 FR 2192 Utah Abandoned Mine Land Reclamation Plan](https://www.frixlaw.com/law-library/statutes/FR_PRORULE_98-859.md)
- [63 FR 2353 General Regulations and Standards for Certain Agricultural Commodities](https://www.frixlaw.com/law-library/statutes/FR_PRORULE_98-920.md)
- [63 FR 2640 Municipal Securities Dealers](https://www.frixlaw.com/law-library/statutes/FR_PRORULE_98-815.md)
- [63 FR 2913 Proposed Revision of Class E Airspace; Alice, TX](https://www.frixlaw.com/law-library/statutes/FR_PRORULE_98-1225.md)
- [63 FR 2916 Kansas Regulatory Program and Abandoned Mine Land Reclamation Plan](https://www.frixlaw.com/law-library/statutes/FR_PRORULE_98-1216.md)

---

Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/FR_PRORULE_98-12452-2. Check the current official text before relying on it. Not legal advice.