[Federal Register Volume 64, Number 2 (Tuesday, January 5, 1999)]
[Rules and Regulations]
[Pages 396-404]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-140]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 2, 3, 5, 10, 12, 16, 20, 25, 50, 54, 56, 58, 60, 70, 
71, 200, 201, 202, 206, 207, 210, 211, 299, 300, 310, 312, 314, 
316, 320, 333, 369, 510, 514, 520, 522, 524, 529, 800, 801, 807, 
809, 812, and 860

[Docket No. 98N-0720]


Conforming Regulations Regarding Removal of Section 507 of the 
Federal Food, Drug, and Cosmetic Act

AGENCY: Food and Drug Administration, HHS.

ACTION: Direct final rule.

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SUMMARY:  The Food and Drug Administration (FDA) is amending its 
regulations to remove references to the repealed statutory provision of 
the Federal Food, Drug, and Cosmetic Act (the act) under which the 
agency certified antibiotic drugs. FDA is also removing references to 
the repealed antibiotic monograph regulations and to those regulations 
dealing with antibiotic applications. The agency is taking this action 
in accordance with provisions of the Food and Drug Administration 
Modernization Act of 1997 (FDAMA). Elsewhere in this issue of the 
Federal Register, FDA is publishing a companion proposed rule, under 
FDA's usual procedures for notice and comment, to provide a procedural 
framework to finalize the rule in the event the agency receives any 
significant adverse comment and withdraws the direct final rule.

DATES:  This rule is effective May 20, 1999. Submit written comments on 
or before March 22, 1999. If no timely significant adverse comments are 
received, the agency will publish a document in the Federal Register 
before April 20, 1999, confirming the effective date of the direct 
final rule. The agency intends to make the direct final rule effective 
30 days after publication of the confirmation document in the Federal 
Register. 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 April 20, 
1999.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:
    For human drugs, Christine F. Rogers or Wayne H. Mitchell, Center 
for Drug Evaluation and Research (HFD-7), Food and Drug Administration, 
5600 Fishers Lane, Rockville, MD 20857, 301-594-2041.
    For animal drugs, Richard L. Arkin, Center for Veterinary Medicine 
(HFV-6), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 
20855, 301-827-0141.

SUPPLEMENTARY INFORMATION:

I. Background

    On November 21, 1997, the President signed FDAMA (Pub. L. 105-115). 
Section 125(b) of FDAMA repealed section 507 of the act (21 U.S.C. 
357). Section 507 of the act was the statutory provision under which 
the agency certified antibiotic drugs. Section 125(b) of FDAMA also 
made conforming amendments to other sections of the act. With the 
repeal of section 507 of the act, antibiotic drugs previously regulated 
under section 507 will be subject to the provisions of section 505 of 
the act (21 U.S.C. 355).
    FDA has determined that it will be most efficient to make changes 
in its regulations to reflect the repeal of section 507 of the act in 
phases. In the first phase, FDA published in the Federal Register of 
May 12, 1998 (63 FR 26066), a direct final rule removing parts 430 
through 460 (21 CFR parts 430 through 460), which had provided the 
procedures and standards used to certify antibiotic drugs. This direct 
final rule is the second phase of rulemaking in which the agency is 
making various, noncontroversial conforming amendments to the balance 
of Title 21 of the Code of Federal Regulations. The rule removes 
citations to section 507 of the act. It removes references to the 
certification of antibiotics, to the antibiotic certification 
regulations, and to specific antibiotic monographs. It also removes 
references to antibiotic drug applications, abbreviated antibiotic drug 
applications, and supplemental drug antibiotic applications.
    The agency recognizes that as it implements the transition from 
regulating the premarket review and approval of antibiotic drugs under 
section 507 of the act to section 505 of the act, other issues may 
arise that could require additional rulemaking. These issues will be 
addressed in the third phase of implementation.

II. Direct Final Rulemaking

    FDA has determined that the subject of this rulemaking is suitable 
for a direct final rule. The repeal of section 507 of the act 
eliminates the statutory provision on which the agency relied to 
certify antibiotic drugs. FDA will, therefore, remove all provisions of 
Title 21 of the Code of Federal Regulations that were issued primarily 
to carry out the agency's certification of antibiotic drugs under 
former section 507 of the act. All direct references to section 507 of 
the act will be removed, as well as all references to regulations that 
were issued to carry out programs under section 507 and all references 
to forms and applications that were unique to the regulation of 
antibiotics under section 507. The actions taken should be 
noncontroversial, and the agency does not anticipate receiving any 
significant adverse comments on this rule.
    If FDA does not receive significant adverse comment on or before 
March 22, 1999, the agency will publish a document in the Federal 
Register before April 20, 1999, confirming the effective date of the 
direct final rule. The agency intends to make the direct final rule 
effective 30 days after publication of the confirmation document in the 
Federal Register. 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 April 
20, 1999.
    Elsewhere in this issue of the Federal Register, FDA is publishing 
a companion proposed rule, which is identical to the direct final rule, 
that provides a procedural framework within which the rule may be 
finalized in the event the direct final rule is withdrawn

[[Page 397]]

because of significant adverse comment. The comment period for the 
direct final rule runs concurrently with that of the 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 as 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 an amendment, 
paragraph, or section of this rule and that provision may be severed 
from the remainder of the rule, FDA may adopt as final those provisions 
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. Environmental Impact

    The agency has determined under 21 CFR 25.30(h) that this action is 
of a class of actions that do not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.

IV. Analysis of Impacts

    FDA has examined the impacts of the 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 in this section of this document, 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 that if a rule has a 
significant impact on a substantial number of small entities, the 
agency must analyze regulatory options to minimize the economic impact 
on small entities. The agency certifies, for the reasons discussed 
below, that the 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. These conforming amendments will 
not result in any increased expenditures by State, local, and tribal 
governments or the private sector. Because this rule will not result in 
an expenditure of $100 million or more on any governmental entity or 
the private sector, no budgetary impact statement is required.
    This rule is intended to make conforming changes to FDA's 
regulations necessitated by repeal of the section 507 of the act that 
had provided for the certification of antibiotic drugs. Accordingly, 
the agency believes that the rule is necessary and that it is 
consistent with the principles of Executive Order 12866; that it is not 
a significant regulatory action under that Executive Order; that it 
will not have a significant impact on a substantial number of small 
entities; and that it is not likely to result in an annual expenditure 
in excess of $100 million.

V. Paperwork Reduction Act of 1995

    This direct final rule does not require information collections 
and, thus, is not subject to review by the Office of Management and 
Budget under the Paperwork Reduction Act of 1995 (Pub. L. 104-13).

VI. Request for Comments

    Interested persons may, on or before March 22, 1999, submit to the 
Dockets Management Branch (address above) written comments regarding 
this 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 2

    Administrative practice and procedure, Cosmetics, Drugs, Foods.

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 Parts 12 and 16

    Administrative practice and procedure.

21 CFR Part 20

    Confidential business information, Courts, Freedom of information, 
Government employees.

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 54

    Biologics, Drugs, Medical devices, Reporting and recordkeeping 
requirements.

21 CFR Part 56

    Human research subjects, Reporting and recordkeeping requirements, 
Safety.

21 CFR Part 58

    Laboratories, Reporting and recordkeeping requirements.

21 CFR Part 60

    Administrative practice and procedure, Drugs, Food additives, 
Inventions and patents, Medical devices, Reporting and recordkeeping 
requirements.

21 CFR Part 70

    Color additives, Cosmetics, Drugs, Labeling, Packaging and 
containers.

21 CFR Part 71

    Administrative practice and procedure, Color additives, 
Confidential business information, Cosmetics, Drugs,

[[Page 398]]

Reporting and recordkeeping requirements.

21 CFR Parts 200 and 300

    Drugs, Prescription drugs.

21 CFR Part 201

    Drugs, Labeling, Reporting and recordkeeping requirements.

21 CFR Part 202

    Advertising, Prescription drugs.

21 CFR Parts 206 and 299

    Drugs.

21 CFR Parts 207 and 320

    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 316

    Administrative practice and procedure, Drugs, Reporting and 
recordkeeping requirements.

21 CFR Part 333

    Labeling, Over-the-counter drugs.

21 CFR Part 369

    Labeling, Medical devices, Over-the counter drugs.

21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling, 
Reporting and recordkeeping requirements.

21 CFR Part 514

    Administrative practice and procedure, Animal drugs, Confidential 
business information, Reporting and recordkeeping requirements.

21 CFR Parts 520, 522, 524, and 529

    Animal drugs.

21 CFR Part 800

    Administrative practice and procedure, Medical devices, Ophthalmic 
goods and services, Packaging and containers, Reporting and 
recordkeeping requirements.

21 CFR Part 801

    Labeling, Medical devices, Reporting and recordkeeping 
requirements.

21 CFR Part 807

    Confidential business information, Imports, Medical devices, 
Reporting and recordkeeping requirements.

21 CFR Part 809

    Labeling, Medical devices.

21 CFR Part 812

    Health records, Medical devices, Medical research, Reporting and 
recordkeeping requirements.

21 CFR Part 860

    Administrative practice and procedure, Medical devices.
    Therefore, under the Federal Food, Drug, and Cosmetic Act, and 
under authority delegated to the Commissioner of Food and Drugs, 21 CFR 
parts 2, 3, 5, 10, 12, 16, 20, 25, 50, 54, 56, 58, 60, 70, 71, 200, 
201, 202, 206, 207, 210, 211, 299, 300, 310, 312, 314, 316, 320, 333, 
369, 510, 514, 520, 522, 524, 529, 800, 801, 807, 809, 812, and 860 are 
amended as follows:

PART 2--GENERAL ADMINISTRATIVE RULINGS AND DECISIONS

    1. The authority citation for 21 CFR part 2 is revised to read as 
follows:

    Authority:  21 U.S.C. 321, 331, 335, 342, 346a, 348, 351, 352, 
355, 360b, 361, 371, 372, 374; 15 U.S.C. 402, 409.

PART 3--PRODUCT JURISDICTION

    2. The authority citation for 21 CFR part 3 is revised to read as 
follows:

    Authority:  21 U.S.C. 321, 351, 352, 353, 355, 360, 360c-360f, 
360h-360j, 360gg-360ss, 371(a), 379e, 381, 394; 42 U.S.C. 216, 262.

Sec. 3.2   [Amended]

    3. Section 3.2 Definitions is amended in paragraph (k) by removing 
``507,'' and ``antibiotic application,''.

PART 5--DELEGATIONS OF AUTHORITY AND ORGANIZATION

    4. 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]

    5. Section 5.31 Petitions under part 10 is amended by removing and 
reserving paragraphs (f)(2)(v), (f)(2)(vi), and (f)(2)(vii).


Sec. 5.70   [Amended]

    6. Section 5.70 Issuance of notice implementing the provisions of 
the Drug Amendments of 1962 is amended by removing ``sections 505 and 
507'' and adding in its place ``section 505''.


Sec. 5.75   [Removed]

    7. Section 5.75 Designation of official master and working 
standards for antibiotic drugs is removed.


Sec. 5.76   [Removed]

    8. Section 5.76 Certification of antibiotic drugs is removed.


Sec. 5.78   [Removed]

    9. Section 5.78 Issuance, amendment, or repeal of regulations 
pertaining to antibiotic drugs is removed.

PART 10--ADMINISTRATIVE PRACTICES AND PROCEDURES

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

    Authority: 5 U.S.C. 551-558, 701-706; 15 U.S.C. 1451-1461; 21 
U.S.C. 141-149, 321-397, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 
U.S.C. 201, 262, 263b, 264.

Sec. 10.50   [Amended]

    11. Section 10.50 Promulgation of regulations and orders after an 
opportunity for a formal evidentiary public hearing is amended by 
removing ``314.300,'' from paragraph (a)(2) and by removing and 
reserving paragraph (c)(11).


Sec. 10.55   [Amended]

    12. Section 10.55 Separation of functions; ex parte communications 
is amended in paragraph (c) by removing ``314.300,'' from the first 
sentence.


Sec. 10.80   [Amended]

    13. Section 10.80 Dissemination of draft Federal Register notices 
and regulations is amended in paragraph (g) by removing the phrase ``or 
a proposed or final antibiotic regulation''.

[[Page 399]]

PART 12--FORMAL EVIDENTIARY PUBLIC HEARING

    14. The authority citation for 21 CFR part 12 is revised to read as 
follows:

    Authority:  21 U.S.C. 141-149, 321-393, 467f, 679, 821, 1034; 42 
U.S.C. 201, 262, 263b-263n, 264; 15 U.S.C. 1451-1461; 5 U.S.C. 551-
558, 701-721; 28 U.S.C. 2112.

Sec. 12.20   [Amended]

    15. Section 12.20 Initiation of a hearing involving the issuance, 
amendment, or revocation of a regulation is amended by removing 
``507(f),'' from the introductory text of paragraph (a), by removing 
the phrase ``or for an antibiotic petition in Sec. 431.50'' from 
paragraph (a)(2)(i), and by removing and reserving paragraph (c).


Sec. 12.24   [Amended]

    16. Section 12.24 Ruling on objections and requests for hearing is 
amended by removing ``314.300,'' from paragraphs (b)(6) and (c).


Sec. 12.87   [Amended]

    17. Section 12.87 Purpose; oral and written testimony; burden of 
proof is amended by removing ``antibiotic,'' from the first sentence of 
paragraph (d).

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

    18. The authority citation for 21 CFR part 16 continues to read as 
follows:

    Authority:  15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-394, 
467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201-262, 263b, 364.

Sec. 16.1   [Amended]

    19. Section 16.1 Scope is amended by removing Secs. 431.52, 
433.2(d), 433.12(b)(5), 433.13(b), 433.14(b), 433.15(b), 433.16(b), and 
514.210 from the list of regulatory provisions in paragraph (b)(2).

PART 20--PUBLIC INFORMATION

    20. The authority citation for 21 CFR part 20 is revised to read as 
follows:

    Authority:  5 U.S.C. 552; 18 U.S.C. 1905; 19 U.S.C. 2531-2582; 
21 U.S.C. 321-393, 1401-1403; 42 U.S.C. 241, 242, 242a, 242l, 242n, 
243, 262, 263, 263b-263n, 264, 265, 300u-300u-5, 300aa-1.

Sec. 20.100   [Amended]

    21. Section 20.100 Applicability; cross-reference to other 
regulations is amended by removing and reserving paragraphs (c)(20) and 
(c)(21).


Sec. 20.117   [Amended]

    22. Section 20.117 New drug information is amended by removing 
``antibiotic applications,'' from paragraph (a)(3).

PART 25--ENVIRONMENTAL IMPACT CONSIDERATIONS

    23. 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. 25.5   [Amended]

    24. Section 25.5 Terminology is amended by removing the phrase ``, 
an abbreviated antibiotic application,'' from paragraph (b)(1).


Sec. 25.31   [Amended]

    25. Section 25.31 Human drugs and biologics is amended by removing 
paragraph (f) and redesignating paragraph (g) as paragraph (f), by 
removing paragraph (h), and by redesignating paragraph (i) through 
paragraph (l) as paragraph (g) through paragraph (j).

PART 50--PROTECTION OF HUMAN SUBJECTS

    26. 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, 360, 
360c-360f, 360h-360j, 371, 379e, 381; 42 U.S.C. 216, 241, 262, 263b-
263n.

Sec. 50.1   [Amended]

    27. Section 50.1 Scope is amended by removing ``, 507(d),'' from 
the first sentence of paragraph (a) and removing ``507,'' from the last 
sentence of paragraph (a).


Sec. 50.3   [Amended]

    28. Section 50.3 Definitions is amended by removing and reserving 
paragraph (b)(11) and removing ``, 507(d),'' from paragraph (c).


Sec. 50.23   [Amended]

    29. Section 50.23 Exception from general requirements is amended in 
paragraph (d)(1) by removing the phrase ``(including an antibiotic or 
biological product)'' and adding in its place the phrase ``(including a 
biological product)''.

PART 54--FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS

    30. The authority citation for 21 CFR part 54 is revised to read as 
follows:

    Authority:  21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 360c-
360j, 371, 372, 373, 374, 375, 376, 379; 42 U.S.C. 262.

Sec. 54.4   [Amended]

    31. Section 54.4 Certification and disclosure requirements is 
amended by removing ``507,'' from paragraph (a).

PART 56--INSTITUTIONAL REVIEW BOARDS

    32. 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, 
360, 360c-360f, 360h-360j, 371, 379e, 381; 42 U.S.C. 216, 241, 262, 
263b-263n.

Sec. 56.101   [Amended]

    33. Section 56.101 Scope is amended by removing ``, 507(d),'' from 
paragraph (a).


Sec. 56.102   [Amended]

    34. Section 56.102 Definitions is amended by removing paragraph 
(b)(10), by redesignating paragraph (b)(11) through paragraph (b)(21) 
as paragraph (b)(10) through paragraph (b)(20), and by removing ``, 
507(d),'' from the first sentence of paragraph (c).

PART 58--GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY 
STUDIES

    35. 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, 
360, 360b-360f, 360h-360j, 371, 379e, 381; 42 U.S.C. 216, 262, 263b-
263n.

Sec. 58.1   [Amended]

    36. Section 58.1 Scope is amended by removing ``507,'' from 
paragraph (a).


Sec. 58.3   [Amended]

    37. Section 58.3 Definitions is amended by removing and reserving 
paragraph (e)(9).

PART 60--PATENT TERM RESTORATION

    38. The authority citation for 21 CFR part 60 is revised to read as 
follows:

    Authority: 21 U.S.C. 348, 355, 360e, 360j, 371, 379e; 35 U.S.C. 
156; 42 U.S.C. 262.

Sec. 60.3   [Amended]

    39. Section 60.3 Definitions is amended by removing ``507(d),'' 
from paragraph (b)(5); by removing ``, antibiotic drug,'' from 
paragraph (b)(10); and by removing ``or 507'' from paragraphs 
(b)(11)(i) and (b)(12)(i).
    40. Section 60.22 is amended by revising paragraphs (a)(1) and (2) 
to read as follows:

[[Page 400]]

Sec. 60.22   Regulatory review period determinations.

* * * * *
    (a) * * *
    (1) The testing phase begins on the date an exemption under section 
505(i) of the Act becomes effective (or the date an exemption under 
former section 507(d) of the Act became effective) for the approved 
human drug product and ends on the date a marketing application under 
section 351 of the Public Health Service Act or section 505 of the act 
is initially submitted to FDA (or was initially submitted to FDA under 
former section 507 of the Act), and
    (2) The approval phase begins on the date a marketing application 
under section 351 of the Public Health Service Act or section 505(b) of 
the Act is initially submitted to FDA (or was initially submitted under 
former section 507 of the Act) and ends on the date the application is 
approved.
* * * * *

PART 70--COLOR ADDITIVES

    41. The authority citation for 21 CFR part 70 continues to read as 
follows:

    Authority:  21 U.S.C. 321, 341, 342, 343, 348, 351, 360b, 361, 
371, 379e.

Sec. 70.10   [Amended]

    42. Section 70.10 Color additives in standardized foods, new drugs, 
and antibiotics is amended by revising the heading to read ``Color 
additives in standardized foods and new drugs'', by revising the 
heading of paragraph (b) to read ``New drugs.'', and by removing the 
phrases ``or for certification of an antibiotic drug'' from the first 
sentence of paragraph (b)(1), ``or certification of an antibiotic 
drug'' from the first sentence of paragraph (b)(2), and ``or the 
request for certification of the antibiotic drug'' from paragraph 
(b)(3).

PART 71--COLOR ADDITIVE PETITIONS

    43. The authority citation for 21 CFR part 71 is revised to read as 
follows:

    Authority:  21 U.S.C. 321, 342, 348, 351, 355, 360, 360b-360f, 
360h-360j, 361, 371, 379e, 381; 42 U.S.C. 216, 262.

Sec. 71.2   [Amended]

    44. Section 71.2 Notice of filing of petition is amended by 
removing the phrase ``or certifiable antibiotic'' from the last 
sentence of paragraph (a).

PART 200--GENERAL

    45. 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, 358, 360e, 
371, 374, 375.

PART 201--LABELING

    46. 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, 358, 360, 
360b, 360gg-360ss, 371, 374, 379e; 42 U.S.C. 216, 241, 262, 264.

    47. Section 201.59 is amended by revising paragraph (a)(1) to read 
as follows:


Sec. 201.59   Effective date of Secs. 201.56, 201.57, 201.100(d)(3), 
and 201.100(e).

    (a) * * *
    (1) If the drug is a prescription drug that is not a biologic and 
not subject to section 505 of the act (21 U.S.C. 355), and was not 
subject to former section 507 of the act (21 U.S.C. 357, repealed 
1997), Secs. 201.56, 201.57, and 201.100(d)(3) are effective on April 
10, 1981.
* * * * *


Sec. 201.100   [Amended]

    48. Section 201.100 Prescription drugs for human use is amended by 
removing ``or 507'' from paragraph (c)(2), and by removing ``or 507'' 
and ``or 507, respectively'' from paragraph (d)(1).


Sec. 201.150   [Amended]

    49. Section 201.150 Drugs; processing, labeling, or repacking is 
amended by removing paragraphs (e) through (h).

PART 202--PRESCRIPTION DRUG ADVERTISING

    50. The authority citation for 21 CFR part 202 is revised to read 
as follows:

    Authority: 21 U.S.C. 321, 331, 352, 355, 360b, 371.

Sec. 202.1   [Amended]

    51. Section 202.1 Prescription-drug advertisements is amended by 
removing paragraph (e)(4)(ii) and redesignating paragraph (e)(4)(iii) 
as paragraph (e)(4)(ii), by removing the words ``paragraphs (e)(4)(i) 
and (ii)'' from newly redesignated paragraph (e)(4)(ii) and by adding 
in their place the words ``paragraph (e)(4)(i)'', by removing 
``(e)(4)(iii)'' and by adding in its place ``(e)(4)(ii)'' in paragraph 
(e)(6)(i), by removing ``, 507, or 512'' from paragraph (e)(6)(xvii), 
by removing the phrase ``or antibiotic'' from indefinitely stayed 
paragraph (e)(6)(ii)(a); and by removing the phrase ``or a certified or 
released antibiotic,'' from indefinitely stayed paragraph 
(e)(6)(ii)(b).

PART 206--IMPRINTING OF SOLID ORAL DOSAGE FORM DRUG PRODUCTS FOR 
HUMAN USE

    52. The authority citation for 21 CFR part 206 is revised to read 
as follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 355, 371; 42 U.S.C. 
262.

PART 207--REGISTRATION OF PRODUCERS OF DRUGS AND LISTING OF DRUGS 
IN COMMERCIAL DISTRIBUTION

    53. The authority citation for 21 CFR part 207 is revised to read 
as follows:

    Authority: 21 U.S.C. 331, 351, 352, 355, 360, 360b, 371, 374; 42 
U.S.C. 262.

Sec. 207.20   [Amended]

    54. Section 207.20 Who must register and submit a drug list is 
amended by removing the words ``an antibiotic application,'' from 
paragraph (c).


Sec. 207.21   [Amended]

    55. Section 207.21 Times for registration and drug listing is 
amended by removing the words ``antibiotic application,'' from the 
second sentence of paragraph (a).


Sec. 207.25   [Amended]

    56. Section 207.25 Information required in registration and drug 
listing is amended by removing ``507,'' and by removing the phrase 
``new animal drug application number, or antibiotic application 
number'' from paragraph (b)(2) and by adding in its place the phrase 
``or new animal drug application number'', by removing ``or 507'' from 
paragraph (b)(4), and by removing ``507,'' from paragraph (b)(5) and 
paragraph (b)(6).


Sec. 207.31   [Amended]

    57. Section 207.31 Additional drug listing information is amended 
by removing the phrase ``or 507'' from paragraph (a)(1) and by removing 
``507,'' from paragraphs (a)(2) and (a)(3), and paragraph (c).


Sec. 207.35   [Amended]

    58. Section 207.35 Notification of registrant; drug establishment 
registration number and drug listing number is amended by removing the 
phrase ``, or supplemental antibiotic application'' from paragraph 
(b)(3)(v).


Sec. 207.37   [Amended]

    59. Section 207.37 Inspection of registrations and drug listings is 
amended by removing ``507,'' from paragraph (a)(2)(i).

[[Page 401]]

PART 210--CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, 
PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL

    60. The authority citation for 21 CFR part 210 is revised to read 
as follows:

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

PART 211--CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED 
PHARMACEUTICALS

    61. The authority citation for 21 CFR part 211 is revised to read 
as follows:

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

PART 299--DRUGS; OFFICIAL NAMES AND ESTABLISHED NAMES

    62. The authority citation for 21 CFR part 299 continues to read as 
follows:

    Authority: 21 U.S.C. 331, 351, 352, 355, 358, 360b, 371.

Sec. 299.4   [Amended]

    63. Section 299.4 Established names for drugs is amended by 
removing the phrase ``or a new antibiotic drug'' from the fifth 
sentence of paragraph (d).

PART 300--GENERAL

    64. The authority citation for 21 CFR part 300 is revised to read 
as follows:

    Authority: 21 U.S.C. 331, 351, 352, 355, 360b, 361, 371.

Sec. 300.50   [Amended]

    65. Section 300.50 Fixed-combination prescription drugs for humans 
is amended by removing the words ``or antibiotic monograph'' from 
paragraph (b).

PART 310--NEW DRUGS

    66. 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, 360b-360f, 
360j, 361(a), 371, 374, 375, 379e; 42 U.S.C. 216, 241, 242(a), 262, 
263b-263n.

    67. Section 310.502 is amended by revising the introductory text of 
paragraph (a) and removing and reserving paragraph (b) to read as 
follows:


Sec. 310.502   Certain drugs accorded new drug status through 
rulemaking procedures.

    (a) The drugs listed in this paragraph have been determined by 
rulemaking procedures to be new drugs within the meaning of section 
201(p) of the act. An approved new drug application under section 505 
of the act and part 314 of this chapter is required for marketing the 
following drugs:
* * * * *

PART 312--INVESTIGATIONAL NEW DRUG APPLICATION

    68. 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, 371; 42 
U.S.C. 262.

Sec. 312.2   [Amended]

    69. Section 312.2 Applicability is amended by removing ``or 507'' 
from paragraph (a) and by removing ``or antibiotic drug'' from 
paragraph (d).


Sec. 312.3   [Amended]

    70. Section 312.3 Definitions and interpretations is amended by 
removing ``, antibiotic drug,'' from the paragraph defining 
``Investigational new drug'' and by removing the phrase ``, a request 
to provide for certification of an antibiotic submitted under section 
507 of the Act,'' from the paragraph defining ``Marketing 
application''.

Subpart E--Drugs Intended to Treat Life-Threatening and Severely-
Debilitating Illnesses

    71. 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, 371; 42 U.S.C. 262.

Sec. 312.81   [Amended]

    72. Section 312.81 Scope is amended by removing ``, antibiotic,'' 
from the introductory text.
    73. Section 312.110 is amended by revising paragraph (b)(4) and by 
removing paragraph (b)(5) to read as follows:


Sec. 312.110   Import and export requirements.

* * * * *
    (b) * * *
    (4) This paragraph does not apply to the export of new drugs 
(including biological products, antibiotic drugs, and insulin) approved 
or authorized for export under section 802 of the act (21 U.S.C. 382) 
or section 351(h)(1)(A) of the Public Health Service Act (42 U.S.C. 
262(h)(1)(A)).


Sec. 312.120   [Amended]

    74. Section 312.120 Foreign clinical studies not conducted under an 
IND is amended by removing ``or antibiotic drug'' from the last 
sentence of paragraph (a).


Sec. 312.130   [Amended]

    75. Section 312.130 Availability for public disclosure of data and 
information in an IND is amended by removing ``or antibiotic drug'' 
from paragraph (b).

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

    76. 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, 371, 374, 
379e.

    77. The heading for part 314 is revised to read as set forth above.
    78. Section 314.1 is amended by revising paragraph (a) to read as 
follows:


Sec. 314.1   Scope of this part.

    (a) This part sets forth procedures and requirements for the 
submission to, and the review by, the Food and Drug Administration of 
applications and abbreviated applications to market a new drug under 
section 505 of the Federal Food, Drug, and Cosmetic Act, as well as 
amendments, supplements, and postmarketing reports to them.
* * * * *


Sec. 314.50   [Amended]

    79. Section 314.50 Content and format of an application is amended 
by removing ``or 507'' from the introductory text of paragraph (d).


Sec. 314.81   [Amended]

    80. Section 314.81 Other postmarketing reports is amended in 
paragraph (a) by removing the words ``sections 505(k) and 507(g)'' and 
by adding in their place the words ``section 505(k)''.


Sec. 314.92   [Amended]

    81. Section 314.92 Drug products for which abbreviated applications 
may be submitted is amended by removing and reserving paragraph (a)(2).


Sec. 314.94   [Amended]

    82. Section 314.94 Content and format of an abbreviated application 
is amended by removing and reserving paragraph (c) and paragraph 
(d)(3).


Sec. 314.96   [Amended]

    83. Section 314.96 Amendments to an unapproved abbreviated 
application is amended by removing paragraph (c).


Sec. 314.98   [Amended]

    84. Section 314.98 Postmarketing reports is amended in paragraph 
(a) by removing the phrase ``approved abbreviated antibiotic 
application under Sec. 314.94 or'' and in paragraph (c) by removing the 
words ``sections 505(k)

[[Page 402]]

and 507(g)'' and by adding in their place the words ``section 505(k)''.


Sec. 314.100   [Amended]

    85. Section 314.100 Timeframes for reviewing applications and 
abbreviated applications is amended in paragraph (a) by removing the 
phrase ``or of an application or abbreviated application for an 
antibiotic drug under section 507 of the act,''.


Sec. 314.101   [Amended]

    86. Section 314.101 Filing an application and an abbreviated 
antibiotic application and receiving an abbreviated new drug 
application is amended by revising the heading to read ``Filing an 
application and receiving an abbreviated new drug application'', by 
removing the phrase ``or abbreviated antibiotic application'' each time 
it appears in this section, and by removing the phrase ``or abbreviated 
antibiotic'' in the first sentence of paragraph (a)(2).


Sec. 314.105   [Amended]

    87. Section 314.105 Approval of an application and an abbreviated 
application is amended by removing the phrases ``or an abbreviated 
antibiotic application'' and ``or abbreviated antibiotic application'' 
from the first sentence of paragraph (a), by removing the fourth and 
sixth sentences of paragraph (a), and by removing the phrase ``or 
abbreviated antibiotic application'' from the first sentence of 
paragraph (b) both times it appears.


Sec. 314.110   [Amended]

    88. Section 314.110 Approvable letter to the applicant is amended 
by removing the phrases ``or abbreviated antibiotic application'', ``or 
an abbreviated antibiotic application'', and ``or the abbreviated 
antibiotic application'' each time they appear in this section; by 
removing and reserving paragraph (a)(4); by removing ``, or (a)(4)'' 
from the first sentence of paragraph (a)(5); and by removing the words 
``under Sec. 314.99'' from paragraph (a)(2) and paragraph (a)(5).


Sec. 314.120   [Amended]

    89. Section 314.120 Not approvable letter to the applicant is 
amended by removing the phrase ``or abbreviated antibiotic 
application'' from the first sentence of the introductory text of 
paragraph (a) and from the third sentence of paragraph (a)(3), by 
adding the word ``or'' to the end of paragraph (a)(3), by removing and 
reserving paragraph (a)(4), and by removing the phrase ``(a)(3), or 
(a)(4)'' and adding in its place ``or (a)(3)'' in the first sentence of 
paragraph (a)(5).


Sec. 314.125   [Amended]

    90. Section 314.125 Refusal to approve an application or 
abbreviated antibiotic application is amended by revising the heading 
to read ``Refusal to approve an application''; by removing the phrase 
``or abbreviated antibiotic application'' each time it appears in this 
section; by removing the phrase ``, or for an antibiotic publish a 
proposed regulation based on an acceptable petition under 
Sec. 314.300,'' from the introductory text of paragraph (a); by 
removing the phrase ``or files a petition for an antibiotic proposing 
the issuance, amendment, or repeal of a regulation'' from paragraph 
(a)(2); and by removing ``or 507'' from paragraph (b)(2).


Sec. 314.126   [Amended]

    91. Section 314.126 Adequate and well-controlled studies is amended 
in paragraph (a) by removing the word ``sections'' and adding in its 
place the word ``section'' and removing the words ``and 507'' from the 
third sentence and by removing the words ``and antibiotics'' from the 
fourth sentence.


Sec. 314.150   [Amended]

    92. Section 314.150 Withdrawal of approval of an application or 
abbreviated application is amended by removing the phrase ``or, for an 
antibiotic, rescind a certification or release, or amend or repeal a 
regulation providing for certification under section 507 of the act and 
under the procedure in Sec. 314.300,'' from the introductory text of 
paragraphs (a) and (b).
    93. Section 314.170 is amended by revising the first sentence and 
by removing the phrase ``and approved antibiotic drugs'' from the 
second sentence to read as follows:


Sec. 314.170   Adulteration and misbranding of an approved drug.

     All drugs, including those the Food and Drug Administration 
approves under section 505 of the act and this part, are subject to the 
adulteration and misbranding provisions in sections 501, 502, and 503 
of the act. * * *


Subpart F--[Removed and Reserved]

    94. Subpart F, consisting of Sec. 314.300, is removed and reserved.
    95. Section 314.410 is amended by revising the heading, by removing 
the phrase ``or an antibiotic'' from paragraph (a)(1), by removing the 
phrase ``or, in the case of an antibiotic not exempt from certification 
under part 433, it is also certified or released'' from paragraph 
(a)(1)(i), by removing the phrases ``or an antibiotic'' and ``, and, in 
the case of an antibiotic, it is certified or released,'' from 
paragraph (b)(1), and by revising paragraph (b)(3) to read as follows:


Sec. 314.410  Imports and exports of new drugs.

* * * * *
    (b) * * *
    (3) Insulin or an antibiotic drug may be exported without regard to 
the requirements in section 802 of the act if the insulin or antibiotic 
drug meets the requirements of section 801(e)(1) of the act.


Sec. 314.430   [Amended]

    96. Section 314.430 Availability for public disclosure of data and 
information in an application or abbreviated application is amended by 
removing paragraph (e)(8) and in paragraph (f)(6) by removing 
``sections 505(j) and 507'' and adding in its place ``section 505''.


Sec. 314.500   [Amended]

    97. Section 314.500 Scope is amended by removing the phrase ``and 
antibiotic''.


Sec. 314.530   [Amended]

    98. Section 314.530 Withdrawal procedures is amended by removing 
the phrase ``and antibiotics'' from paragraph (a).

PART 316--ORPHAN DRUGS

    99. The authority citation for 21 CFR part 316 continues to read as 
follows:

    Authority:  21 U.S.C. 360aa, 306bb, 360cc, 360dd, 371.

Sec. 316.3   [Amended]

    100. Section 316.3 Definitions is amended by removing the phrase 
``, a request for certification of an antibiotic under section 507 of 
the act,'' from paragraph (b)(9).

PART 320--BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS

    101. The authority citation for 21 CFR part 320 is revised to read 
as follows:

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

Sec. 320.38   [Amended]

    102. Section 320.38 Retention of bioavailability samples is amended 
by removing ``or 507'' from paragraph (a).


Sec. 320.63   [Amended]

    103. Section 320.63 Retention of bioequivalence samples is amended 
by removing ``or 507'' from the first sentence.

[[Page 403]]

PART 333--TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER 
HUMAN USE

    104. The authority citation for 21 CFR part 333 continues to read 
as follows:

    Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.


Sec. 333.103   [Amended]

    105. Section 333.103 Definitions is amended by removing paragraph 
(a) and by removing the designation for paragraph (b).


Sec. 333.110   [Amended]

    106. Section 333.110 First aid antibiotic active ingredients is 
amended in paragraph (a) by removing the phrase ``: Provided, That it 
meets the tests and methods of assay in Sec. 448.510a(b)''; in 
paragraph (b) by removing the phrase ``: Provided, That it meets the 
tests and methods of assay in Sec. 448.513f(b)''; in paragraph (c) by 
removing the phrase ``: Provided, That it meets the tests and methods 
of assay in Sec. 446.510(b)''; in paragraph (d) by removing the phrase 
``: Provided, That it meets the tests and methods of assay in 
Sec. 444.542a(b)''; in paragraph (e) by removing the phrase ``: 
Provided, That it meets the tests and methods of assay in 
Sec. 444.542b(b)''; and in paragraph (f) by removing the phrase ``: 
Provided, That it meets the tests and methods of assay in 
Sec. 446.581d(b)''.


Sec. 333.120  [Amended]

    107. Section 333.120 Permitted combinations of active ingredients 
is amended in paragraph (a)(1) by removing the phrase ``: Provided, 
That it meets the tests and methods of assay in Sec. 448.510d(b)''; in 
paragraph (a)(2) by removing the phrase ``; Provided, That it meets the 
tests and methods of assay in Sec. 448.510e(b)''; in paragraph (a)(3) 
by removing the phrase ``: Provided, That it meets the tests and 
methods of assay in Sec. 448.510f(b)''; in paragraph (a)(4) by removing 
the phrase ``: Provided, That it meets the tests and methods of assay 
in Sec. 448.513b(b)''; in paragraph (a)(5) by removing the phrase ``; 
Provided, That it meets the tests and methods of assay in 
Sec. 448.513c(b)''; in paragraph (a)(6) by removing the phrase ``: 
Provided, That it meets the tests and methods assay in 
Sec. 448.513a(b)''; in paragraph (a)(7) by removing the phrase ``: 
Provided, That is meets the tests and methods of assay in 
Sec. 448.513e(b) of this chapter''; in paragraph (a)(8) by removing the 
phrase ``: Provided, That it meets the tests and methods of assay in 
Sec. 448.513d(b)''; in paragraph (a)(9) by removing the phrase ``: 
Provided, That it meets the tests and methods of assay in 
Sec. 444.542e(b)''; in paragraph (a)(10) by removing the phrase ``: 
Provided, That it meets the tests, methods of assay, and potency in 
Sec. 444.5421(b)''; in paragraph (a)(11) by removing the phrase ``: 
Provided, That it meets the tests and methods assay in 
Sec. 446.567b(b)''; in paragraph (a)(12) by removing the phrase ``: 
Provided, That it meets the tests and methods assay in 
Sec. 446.567c(b)''; in paragraph (b)(1) by removing the phrase ``: 
Provided, That it meets the tests and methods of assay in 
Sec. 448.510a(b)''; in paragraph (b)(2) by removing the phrase 
``Provided, That it meets the tests and methods of assay in 
Sec. 448.510e(b)''; in paragraph (b)(3) by removing the phrase ``: 
Provided, That it meets the tests and methods of assay in 
Sec. 448.510f(b) of this chapter''; in paragraph (b)(4) by removing the 
phrase ``; Provided, That it meets the tests and methods of assay in 
Sec. 448.513c(b) of this chapter''; in paragraph (b)(5) by removing the 
phrase ``: Provided, That it meets the tests and methods of assay in 
Sec. 448.513a(b) of this chapter''; and in paragraph (b)(6) by removing 
the phrase ``: Provided, That it meets the tests and methods of assay 
in Sec. 444.5421(b) of this chapter''.

PART 369--INTERPRETATIVE STATEMENTS RE WARNINGS ON DRUGS AND 
DEVICES FOR OVER-THE-COUNTER SALE

    108. 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, 371.

PART 510--NEW ANIMAL DRUGS

    109. The authority citation for 21 CFR part 510 continues to read 
as follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

Sec. 510.45  [Removed]

    110. Section 510.45 Packaging requirements for drugs for animal use 
is removed.


Sec. 510.110   [Amended]

    111. Section 510.110 Antibiotics used in food-producing animals is 
amended by removing the phrase ``to amend or revoke antibiotic 
regulations under the provisions of section 507 of the act, or'' in 
paragraph (e), by removing the phrase ``(except certifiable 
antibiotics)'' in the first sentence of paragraph (f), and by removing 
the last sentence of paragraph (f).

PART 514--NEW ANIMAL DRUG APPLICATIONS

    112. The authority citation for 21 CFR part 514 continues to read 
as follows:

    Authority: 21 U.S.C. 351, 352, 360b, 371, 379e, 381.

Sec. 514.10  [Removed]

    113. Section 514.10 Confidentiality of data and information in an 
investigational new animal drug notice and a new animal drug 
application file for an antibiotic drug is removed.

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

    114. The authority citation for 21 CFR part 520 continues to read 
as follows:

    Authority:  21 U.S.C. 360b.

Sec. 520.1204   [Amended]

    115. Section 520.1204 Kanamycin sulfate, aminopentamide hydrogen 
sulfate, pectin, bismuth subcarbonate, activated attapulgite suspension 
is amended in paragraph (a) by removing the phrase ``(the kanamycin 
used conforms to the standards of identity, strength, quality, and 
purity prescribed by Sec. 444.30 of this chapter)''.
    116. Section 520.1263a is amended by revising paragraph (a) to read 
as follows:


Sec. 520.1263a   Lincomycin hydrochloride monohydrate tablets and 
sirup.

     (a) Specifications. The sirup contains lincomycin hydrochloride 
equivalent to either 25 milligrams or 50 milligrams of lincomycin.
* * * * *


Sec. 520.1263b   [Amended]

    117. Section 520.1263b Lincomycin hydrochloride monohydrate and 
spectinomycin sulfate tetrahydrate soluble powder is amended by 
removing the first complete sentence in paragraph (a).

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

    118. The authority citation for 21 CFR part 522 continues to read 
as follows:

    Authority: 21 U.S.C. 360b.

    119. Section 522.1204 is amended by revising paragraph (a) to read 
as follows:


Sec. 522.1204  Kanamycin sulfate injection.

    (a) Specifications. Each milliliter of kanamycin sulfate injection 
veterinary contains either 50 or 200 milligrams of kanamycin.
* * * * *


Sec. 522.1484   [Amended]

    120. Section 522.1484 Neomycin sulfate sterile solution is amended 
by removing the second sentence of paragraph (a) but retaining footnote 
1 at the end of paragraph (a).

[[Page 404]]

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

    121. The authority citation for 21 CFR part 524 continues to read 
as follows:

    Authority: 21 U.S.C. 360b.

Sec. 524.1200a   [Amended]

    122. Section 524.1200a Kanamycin ophthalmic ointment is amended by 
removing paragraph (a)(1) and by removing the designation for paragraph 
(a)(2).
    123. Section 524.1200b is amended by revising paragraph (a) to read 
as follows:


Sec. 524.1200b   Kanamycin ophthalmic aqueous solution.

     (a) Specifications. The drug, which is in an aqueous solution 
including suitable and harmless preservatives and buffer substances, 
contains 10 milligrams of kanamycin activity (as the sulfate) per 
milliliter of solution.
* * * * *


Sec. 524.1204   [Amended]

    124. Section 524.1204 Kanamycin sulfate, calcium amphomycin, and 
hydrocortisone acetate is amended by removing paragraph (a)(1), by 
redesignating paragraphs (a)(2)(i) through (a)(2)(iii) as paragraphs 
(a)(1)(i) through (a)(1)(iii), and by redesignating paragraph (a)(3) as 
paragraph (a)(2).

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

    125. The authority citation for 21 CFR part 529 continues to read 
as follows:

    Authority: 21 U.S.C. 360b.

Sec. 529.360   [Amended]

    126. Section 529.360 Cephalothin discs is amended by removing the 
phrase ``, comply with the requirements of Sec. 460.1 of this chapter'' 
from paragraph (a) and adding in its place ``have a uniform potency of 
30 micrograms cephalothin per disc''.

PART 800--GENERAL

    127. The authority citation for 21 CFR part 800 is revised to read 
as follows:

    Authority: 21 U.S.C. 321, 334, 351, 352, 355, 360e, 360i, 360k, 
361, 362, 371.

PART 801--LABELING

    128. The authority citation for 21 CFR part 801 is revised to read 
as follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 360i, 360j, 371, 374.

PART 807--ESTABLISHMENT AND REGISTRATION AND DEVICE LISTING FOR 
MANUFACTURERS AND DISTRIBUTORS OF DEVICES

    129. The authority citation for 21 CFR part 807 continues to read 
as follows:

    Authority: 21 U.S.C. 331, 351, 352, 360, 360c, 360e, 360i, 360j, 
371, 374.

Sec. 807.25   [Amended]

    130. Section 807.25 Information required or requested for 
establishment registration and device listing is amended by removing 
``, 507,'' in paragraph (f)(3).

PART 809--IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE

    131. The authority citation for 21 CFR part 809 is revised to read 
as follows:

    Authority: 21 U.S.C. 331, 351, 352, 355, 360b, 360c, 360d, 360h, 
360i, 360j, 371, 372, 374, 381.

Sec. 809.5  [Removed]

    132. Section 809.5 Exemption from batch certification requirements 
for in vitro antibiotic susceptibility devices subject to section 507 
of the act is removed.


Sec. 809.6  [Removed]

    133. Section 809.6 Conditions on the effectiveness of exemptions of 
antibiotic susceptibility devices from batch certification requirements 
is removed.

PART 812--INVESTIGATIONAL DEVICE EXEMPTIONS

    134. The authority citation for 21 CFR part 812 is revised to read 
as follows:

    Authority: 21 U.S.C. 331, 351, 352, 353, 355, 360, 360c-360f, 
360h-360j, 371, 372, 374, 379e, 381, 382, 383; 42 U.S.C. 216, 241, 
262, 263b-263n.

PART 860--MEDICAL DEVICE CLASSIFICATION PROCEDURES

    135. The authority citation for 21 CFR part 860 continues to read 
as follows:

    Authority: 21 U.S.C. 360c, 360d, 360e, 360i, 360j, 371, 374.

Sec. 860.84   [Amended]

    136. Section 860.84 Classification procedures for ``old devices'' 
is amended by removing the fourth sentence in paragraph (a).

    Dated: December 16, 1998.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 99-140 Filed 1-4-99; 8:45 am]
BILLING CODE 4160-01-F