26694 Federal Register / Vol. 63, No. 92 /Wednesday, May 13, 1998 /Rules and Regulations

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

AGENCY: Food and Drug Administration,

HHS.

ACTION: Direct final rule.

SUMMARY: The Food and Drug

Administration (FDA) is repealing its

regulations governing certification of

drugs containing insulin and making

conforming amendments to other

sections of its 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 FDAMA repealed the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. FDA

is using direct final rulemaking for this

action because the agency expects that

there will be no significant adverse

comment on the rule. Most of the

amendments in this rule are a direct

result of the repeal of the statutory

certification provision. The remainder

of the amendments repeal or update outof-date, noncontroversial regulations

dealing with insulin. Elsewhere in this

issue of the Federal Register, FDA is

publishing a companion proposed rule

under FDA’s usual procedure for noticeand-comment rulemaking to provide a

procedural framework to finalize the

rule in the event the agency receives

significant adverse comments and

withdraws this direct final rule.

DATES: This regulation is effective

September 25, 1998. Submit written

comments on or before July 27, 1998. If

no timely significant adverse comments

are received, the agency will publish a

document in the Federal Register before

August 26, 1998, confirming the

effective date of the direct final rule. If

timely significant adverse comments are

received, the agency will publish a

document of significant adverse

comment in the Federal Register

withdrawing this direct final rule before

August 25, 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

On November 21, 1997, the President

signed FDAMA (Pub. L. 105–115).

Section 125(a) of FDAMA repealed

section 506 of the act (21 U.S.C. 356).

Section 506 was the section of the act

under which the agency certified drugs

composed wholly or partly of insulin.

Section 125(a) of FDAMA also removed

references to section 506 from section

301(i)(1) and (j) of the act (21 U.S.C.

331(i)(1) and (j)). Section 301(i) of the

act prohibits fraudulent use of certain

labeling required under various

provisions of the act; while section

301(j) prohibits any person from using,

or the unauthorized disclosure of, trade

secret information obtained under

authority of various provisions of the

act.

Section 125(a) of FDAMA also

repealed section 502(k) of the act (21

U.S.C. 352(k)), which provided that any

drug that is, or is represented to be,

composed wholly or partly of insulin is

misbranded unless it has been certified

or released under authority of section

506 of the act.

FDAMA also removed references to

section 506 of the act in section

510(j)(1)(A) and (j)(1)(D) of the act (21

U.S.C. 360(j)(1)(A) and (j)(1)(D)), which

is part of the drug listing provisions of

the act, and section 125(a) of FDAMA

amended a law governing procurement

of drugs by certain Federal agencies (38

U.S.C. 8126(h)(2)) by removing a

reference to drugs certified under

authority of section 506 of the act.

FDAMA added drugs composed

wholly or partly of insulin to the

prohibition in section 801(d) of the act

(21 U.S.C. 381(d)) against the

reimportation of prescription drugs

except by the original manufacturer.

This amendment to section 801(d) of the

act does not require implementing

regulations. FDA will, however, place

language reflecting this provision of

FDAMA in relevant sections of a

separate rule implementing the

Prescription Drug Marketing Act of 1987

(Pub. L. 100–293). That rulemaking was

initiated with the proposed rule

published in the Federal Register of

March 14, 1994 (59 FR 11842).

Finally, section 125(c) of FDAMA

amended section 802 of the act (21

U.S.C. 382) to exempt insulin drugs

from the export requirements of section

802 if the drugs meet the requirements

of section 801(e)(1) of the act.

II. Direct Final Rulemaking

FDA has determined that the subjects

of this rulemaking are suitable for a

direct final rule. The actions taken

should be noncontroversial, and the

agency does not anticipate receiving any

significant adverse comments.

The repeal of section 506 of the act

eliminated the statutory provision on

which the agency relied to certify drugs

composed wholly or partly of insulin.

FDA will, therefore, remove all

provisions of title 21 of the Code of

Federal Regulations (CFR) relating to the

certification of insulin products. FDA

will also make various ministerial

changes to title 21, such as removing

references to section 506 of the act in

authority sections and regulations

whose subjects are not certification of

insulin.

FDA has also determined that it is

appropriate to use direct final

rulemaking to update the definition of

insulin in § 200.15 (21 CFR 200.15). The

statutory references in the definition are

being changed to reflect changes in the

law and the scope of the definition is

being clarified to reflect the existence of

new forms of insulin that have been

introduced since the definition was

originally issued.

If FDA does not receive significant

adverse comment on or before July 27,

1998, the agency will publish a

document in the Federal Register before

August 25, 1998, confirming the

effective date of the direct final rule. 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. If timely

significant adverse comments are

received, the agency will publish a

document of significant adverse

comment in the Federal Register

withdrawing this direct final rule before

August 26, 1998.

The companion proposed rule, which

is identical to the direct final rule,

provides a procedural framework within

which the rule may be finalized in the

event the direct final rule is withdrawn

because of significant adverse comment.

The comment period for the direct final

rule runs concurrently with that of the
Federal Register / Vol. 63, No. 92 /Wednesday, May 13, 1998 /Rules and Regulations 26695

companion proposed rule. Any

comments received under the

companion proposed rule will be

treated as comments regarding the direct

final rule. Likewise, significant adverse

comments submitted to the direct final

rule will be considered comments to the

companion proposed rule, and the

agency will consider such comments in

developing a final rule. FDA will not

provide additional opportunity for

comment on the companion proposed

rule.

If a significant adverse comment

applies to part of this rule and that part

may 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. A full

description of FDA’s policy on direct

final rule procedures may be found in

a guidance document published in the

Federal Register of November 21, 1997

(62 FR 62466).

III. Description of the Rule

The rule eliminates references to

section 506 of the act in all authority

citations in 21 CFR, chapter I.

The rule amends the delegation of

authority provisions in 21 CFR part 5 to

eliminate provisions dealing with the

authority to sign citizen petitions

regarding the certification of insulin, the

authority to certify batches of insulin,

and the authority to issue regulations

under section 506 of the act pertaining

to drugs containing insulin.

The rule eliminates a reference to

section 506(c) of the act in 21 CFR

10.50, which deals with issuance of

regulations and orders after an

opportunity for a formal evidentiary

public hearing. Former section 506(c) of

the act dealt with the issuance of insulin

regulations prescribing tests or methods

of assay for batch certification that

differed from those specified in an

official compendium.

The rule removes a reference to 21

CFR 429.50, which relates to suspension

of certification services for certain

persons, in 21 CFR 16.1, which defines

the scope of 21 CFR part 16.

The regulations in 21 CFR 25.31 (see

62 FR 40570 at 40595, July 29, 1997) are

amended to eliminate testing and

certification of batches of insulin under

section 506 of the act from a list of

actions that are categorically excluded

from the requirement to prepare an

environmental assessment or an

environmental impact statement.

The rule removes a reference to

section 506 of the act in 21 CFR 50.1,

which defines the scope of 21 CFR part

50.

This rule amends the statutory

references in the definition of insulin

found in § 200.15 to reflect the repeal of

sections 502(k) and 506 of the act; the

addition of insulin drug products to the

reimportation provision of section

801(d) of the act by FDAMA; the use of

the term ‘‘insulin’’ in the export labeling

provisions of section 801(f) of the act,

which was added by the Technical

Amendments to the FDA Export Reform

and Enhancement Act of August 6, 1996

(Pub. L. 104–180); and FDAMA’s

addition of section 802(i) to the act,

which exempts insulin drugs from the

export requirements of section 802 of

the act. The new definition also clarifies

the scope of the term ‘‘insulin’’ to reflect

the existence of synthetic and

biotechnologically derived human

insulin. The definition is designed to

encompass chemical analogs of insulin,

the first of which, insulin lispro (an Eli

Lilly & Co. product), was recently

approved.

The labeling requirements found in

part 201 (21 CFR part 201) are being

amended by this rule. Section 201.50(b)

is amended to remove a sentence that

refers to labeling requirements

contained in part 429 (21 CFR part 429),

which is also being eliminated by this

rule. A reference to section 506 of the

act is being removed from

§ 201.100(c)(2).

Several references to section 506 of

the act are being removed from 21 CFR

parts 207 and 314.

FDA is repealing all of part 429 and

those portions of part 369 (21 CFR part

369) that deal with insulin drug

products.

Part 429 contains the primary

provisions the agency has relied on to

carry out the batch certification of drugs

composed wholly or partly of insulin.

Subpart A of part 429 defines key terms

used in the insulin certification

regulations; subpart B of part 429

contains packaging and labeling

requirements for products subject to

batch certification; subparts C and D of

part 429 contain applicable standards

and tests and methods of assay for

determining whether batches of insulin

may be certified; subpart E of part 429

contains the requirements for

submitting a request for certification;

subpart F of part 429 contains the

administrative procedures and fees

applicable to insulin certification; and

subpart G of part 429 imposes

additional recordkeeping requirements

applicable to batch certified insulin

products. With the repeal of section 506

of the act, and the elimination of the

insulin batch certification program, the

agency is eliminating these subparts.

The agency notes that several of the

provisions in part 429, such as those

covering packaging and labeling and

tests and methods of assay, could be

retained under provisions of the act

other than section 506 of the act.

However, the agency has determined, as

explained in this section of this

document, that it would not be

appropriate or necessary to do so at this

time.

The current regulations in § 429.10

require insulin drug products to be

packaged in sterile immediate

containers with closures through which

the insulin may be withdrawn with a

conventional hypodermic syringe and

needle. Section 429.10 also provides for

distinctive containers for certain insulin

drug products, none of which is

currently marketed. Although all insulin

drug products are currently marketed in

immediate containers that meet the

requirements contained in § 429.10,

there is no assurance that a new, safe,

and effective container/closure system

would conform to the regulation. To

avoid having to amend the regulation

each time a new, acceptable container/

closure system is developed, the agency

is removing § 429.10 and, instead, will

rely on the new drug approval process

to approve appropriate container/

closure systems for drug products

containing insulin. Applicants for drug

products containing insulin submit

descriptions of the container/closure

system with the new drug application

(NDA); FDA reviews the container/

closure system for use with the drug

product and, if appropriate, approves its

use with the drug product as part of the

NDA approval. This system is used to

approve container/closure systems for

most new drug products on the market

today, and it provides the flexibility

necessary to provide for approval of

new, safe, and effective container/

closure systems.

The current regulations in §§ 369.21,

429.11, and by cross reference § 369.5,

set out detailed requirements for the

labeling of insulin drug products. The

current regulations require, among other

information and warnings, information

on potency of the drug product,

expiration date of the lot, storage

instructions, instructions on injecting

insulin, and descriptions of how the

type of insulin-containing drug product

differs from other types of insulin drug

products.

FDA is removing §§ 369.5 and 429.11

and those portions of § 369.21 that

apply to insulin drug products, and will

rely on the new drug approval process,

in conjunction with the general drug

labeling requirements found in part 201,

to establish appropriate labeling

requirements for each drug product

containing insulin. Applicants submit

copies of proposed labeling with the
26696 Federal Register / Vol. 63, No. 92 /Wednesday, May 13, 1998 /Rules and Regulations

marketing applications for all new drug

products, including those containing

insulin; FDA then reviews the

application and, if appropriate,

approves it, after the applicant has made

necessary changes. This system is used

to establish labeling for most new drug

products and provides the flexibility

necessary to provide adequate labeling

for new types of insulin drug products.

Because all currently marketed insulin

drug products are the subject of effective

NDA’s under section 505(b) of the act,

the labeling of these products is not

expected to change as a result of the

removal of these rules.

The current regulations in § 429.12

contain a distinguishing color scheme,

which is outdated. The current system

includes distinguishing colors for 40

units per milliliter strengths of insulin

drug products, which are no longer

being marketed. It also provides an

identifying color scheme for insulin

zinc globin, which is also not marketed.

Under § 429.12, most of the currently

marketed insulin drug products are

identified by the color combination of

black and white, which provides limited

usefulness. No provisions are made for

either of the two types of mixtures of

human insulin and insulin suspension

isophane currently being marketed or

insulin lispro, a human insulin

analogue. Accordingly, FDA is removing

§ 429.12.

Major insulin manufacturers, working

with the International Diabetes

Federation (IDF), have developed a new

color coding system in which each type

of insulin would be identified with a

distinctive color. FDA has been

favorably impressed with the IDF

system. However, the agency believes

that it is administratively more efficient

to remove part 429 in its entirety at this

time, and implement the IDF system in

a separate rulemaking proceeding or

incorporate it into a guidance issued

under FDA’s ‘‘Good Guidance

Practices’’ published in the Federal

Register of February 27, 1997 (62 FR

8961).

FDA is also removing § 429.25, which

establishes standards of quality and

purity for protamine, and § 429.26,

which establishes standards of quality

and purity for globin hydrochloride. (No

insulin products using globin

hydrochloride are currently being

marketed.) FDA does not, at this time,

intend to issue regulations directly

establishing other product standards

relating to drugs composed wholly or

partly of insulin. Insulin manufacturers

and FDA laboratories use the

requirements set out in the approved

NDA for analyzing an insulin drug

product and, where appropriate, the

standards set out in the United States

Pharmacopeia (USP).

FDA is also removing § 429.30, which

sets out testing and assay methods.

Section 429.30 provides, generally, that

insulin injection, insulin suspension

protamine zinc, insulin zinc globin,

insulin suspension isophane, insulin

zinc suspension, insulin zinc

suspension prompt, and insulin zinc

suspension extended be tested and

assayed according to methods set out in

the USP. Section 429.30 also provides

tests for isophane ratio, chloride in

globin hydrochloride, sulfate in

protamine, nitrogen, and zinc. At least

one of these products (insulin zinc

globin) is no longer marketed. The tests

and methods of assay for the remaining

products are either outdated or if still in

use, have been incorporated into the

applicable NDA.

FDA intends to avoid the potential for

this type of outdated, codified

specification by not proposing at this

time regulations specifying testing or

assay methods. Instead, insulin will be

required to conform to all applicable

USP monographs and the approved

NDA for each product. This will mean

that insulin drug products will be

regulated just as other new drugs are

regulated by FDA.

IV. Environmental Impact

The agency has determined under 21

CFR 25.24(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.

V. Analysis of Impacts

FDA has examined the impacts of the

direct final 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 final rule is consistent with the

regulatory philosophy and principles

identified in the Executive Order. In

addition, the direct final 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

manufacturers currently 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 direct final 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 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.

VI. Paperwork Reduction Act of 1995

This direct final rule contains no

collections of information. Therefore,

clearance by the Office of Management

and Budget under the Paperwork

Reduction Act of 1995 is not required.

VII. 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. 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.
Federal Register / Vol. 63, No. 92 /Wednesday, May 13, 1998 /Rules and Regulations 26697

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

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-thecounter 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, 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 are 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.

§ 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).

§ 5.73 [Removed]

4. Section 5.73 Certification of insulin

is removed.

§ 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.

§ 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.

§ 16.1 [Amended]

9. Section 16.1 Scope is amended in

paragraph (b)(2) by removing the entry

for ‘‘§ 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.

§ 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.

§ 50.1 [Amended]

13. Section 50.1 Scope is amended in

the last sentence of paragraph (a) by

removing the number ‘‘506,’’.
26698 Federal Register / Vol. 63, No. 92 /Wednesday, May 13, 1998 /Rules and Regulations

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:

§ 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

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.

§ 201.50 [Amended]

20. Section 201.50 Statement of

identity is amended in paragraph (b) by

removing the second sentence.

§ 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.

§ 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,’’.

§ 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,’’.

§ 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.

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.

§ 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’’.

§ 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.

§ 369.5 [Removed]

35. Section 369.5 Warning required on

insulin intended for over-the-counter

sale is removed.

§ 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

Part 429 [Removed]

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.
Federal Register / Vol. 63, No. 92 /Wednesday, May 13, 1998 /Rules and Regulations 26699

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.

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