[Federal Register Volume 63, Number 92 (Wednesday, May 13, 1998)]
[Rules and Regulations]
[Pages 26694-26699]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-12452]
Federal Register / Vol. 63, No. 92 / Wednesday, May 13, 1998 / Rules
and Regulations
[[Page 26694]]
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.
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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repealed the statutory provision in the Federal Food, Drug, and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amendments repeal or update out-of-date, noncontroversial regulations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 notice-and-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 Sec. 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
[[Page 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 Sec. 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 Sec. 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 Sec. 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 Sec. 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 Sec. 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 Secs. 369.21, 429.11, and by cross
reference Sec. 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 Secs. 369.5 and 429.11 and those portions of
Sec. 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
[[Page 26696]]
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 Sec. 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 Sec. 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 Sec. 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 Sec. 429.25, which establishes standards of
quality and purity for protamine, and Sec. 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 Sec. 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.
[[Page 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-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, 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.
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
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
(a) by removing the number ``506,''.
[[Page 26698]]
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
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.
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
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
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.
[[Page 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
