Conforming Regulations Regarding Removal of Section 507 of the Federal Food, Drug, and Cosmetic Act; Companion Document to Direct Final Rule

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; Companion Document to Direct

Final Rule

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend

its regulations to remove references to the repealed statutory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. The agency is also

proposing to remove references to the repealed antibiotic monograph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). This proposed rule is a companion document to the direct

final rule published elsewhere in this issue of the Federal Register.

[[Page 449]]

DATES: Submit written comments on or before March 22, 1999.

ADDRESSES: Submit written comments on the proposed rule 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

As described more fully in the related direct final rule, section

125(b) of FDAMA (Pub. L. 105-115) repealed section 507 of the act (21

U.S.C. 357) and made conforming amendments to the act and other

provisions of Federal law. Section 507 of the act was the statutory

provision under which the agency certified antibiotic drugs. FDA is

proposing to make conforming amendments to Title 21 of the Code of

Federal Regulations. This proposed rule removes citations to section

507 of the act. It also removes references to: Certification of

antibiotics, the antibiotic certification regulations, specific

antibiotic monographs, references to antibiotic drug applications,

abbreviated antibiotic drug applications, and supplemental antibiotic

drug applications.

II. Additional Information

This proposed rule is a companion to the direct final rule

published in the final rules section of this issue of the Federal

Register. This companion proposed rule and the direct final rule are

identical. This companion proposed rule will provide the procedural

framework to finalize the rule in the event the direct final rule

receives significant adverse comments and is withdrawn. The comment

period for this companion proposed rule runs concurrently with the

comment period of the direct final rule. Any comments received under

the companion proposed rule will be treated as comments regarding the

direct final rule.

The amendments contained in this proposed rule are a direct result

of the repeal of the statutory provision. If no significant adverse

comment is received in response to the direct final rule, no further

action will be taken related to this proposed rule. Instead, FDA will

publish a confirmation document within 30 days after the comment period

ends, and FDA intends the direct final rule to become effective 30 days

after publication of the confirmation document. If FDA receives

significant adverse comments, the agency will withdraw the direct final

rule. FDA will proceed to respond to all of the comments received

regarding the rule and, if appropriate, the rule will be finalized

under this companion proposed rule using usual notice-and-comment

procedures.

For additional information, see the corresponding direct final

rule published elsewhere in the final rules section of this issue of

the Federal Register. If FDA receives significant adverse comments, the

agency will withdraw the direct final rule within 30 days after the

comment period ends and will treat those comments as comments on this

proposed rule. The agency will address the comments in a subsequent

final rule. FDA will not provide additional opportunity for comment. 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.

III. Environmental Impact

The agency has determined under 21 CFR 25.30(h) that this action

is of a type that does not individually or cumulatively have a

significant effect on the human environment. Therefore, neither an

environmental assessment nor an environmental impact statement is

required.

IV. Analysis of Impacts

FDA has examined the impact of the proposed rule under Executive

Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the

Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Order

12866 directs agencies to assess all costs and benefits of available

regulatory alternatives and, when regulation is necessary, to select

regulatory approaches that maximize net benefits (including potential

economic, environmental, public health and safety, and other

advantages; distributive impacts; and equity). Executive Order 12866

classifies a rule as significant if it meets any one of a number of

specified conditions, including having an annual effect on the economy

of $100 million or adversely affecting in a material way a sector of

the economy, competition, or jobs, or if it raises novel legal or

policy issues. The agency believes that this proposed rule is

consistent with the regulatory philosophy and principles identified in

the Executive Order. In addition, the proposed rule is not a

significant regulatory action as defined by the Executive Order and so

is not subject to review under the Executive Order.

The Regulatory Flexibility Act requires 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 that the proposed rule will not

have a significant impact on a substantial number of small entities.

Therefore, under the Regulatory Flexibility Act, no further analysis is

required.

The Unfunded Mandates 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 proposed 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 proposed rule is intended to make conforming changes to FDA's

regulations necessitated by repeal of the section 507 of the act that

provided for the certification of antibiotic drugs. Accordingly, the

agency believes that the proposed 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

FDA tentatively concludes that this proposed rule contains no

collections of information. Therefore, clearance by the Office of

Management and Budget under the Paperwork Reduction Act of 1995 (Pub.

L. 104-13) is not required.

[[Page 450]]

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 proposal. This comment period runs concurrently with the comment

period for the direct final rule; any comments received will be

considered as comments regarding the direct final rule. Two copies of

any comments are to be submitted, except that individuals may submit

one copy. Comments are to be identified with the docket number found in

brackets in the heading of this document. Received comments may be seen

in the office above between 9 a.m. and 4 p.m., Monday through Friday.

In the event the direct final rule is withdrawn, all comments received

will be considered comments on this proposed rule.

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, 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, it is

proposed that 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 be 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.

[[Page 451]]

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''.

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

[[Page 452]]

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:

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

[[Page 453]]

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).

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,

[[Page 454]]

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) 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.

[[Page 455]]

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.

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

[[Page 456]]

``(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).

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).

[[Page 457]]

Dated: December 12, 1998.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 99-141 Filed 1-4-99; 8:45 am]

BILLING CODE 4160-01-F