[Federal Register Volume 64, Number 2 (Tuesday, January 5, 1999)]
[Proposed Rules]
[Pages 448-457]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-141]
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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; 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its regulations to remove references to the repealed statutory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proposing to remove references to the repealed antibiotic monograph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 L. 105-115) repealed section 507 of the act (21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
