[Federal Register Volume 63, Number 91 (Tuesday, May 12, 1998)]
[Proposed Rules]
[Pages 26127-26129]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-12542]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 430, 431, 432, 433, 436, 440, 441, 442, 443, 444, 446, 
448, 449, 450, 452, 453, 455, and 460

[Docket No. 98N-0211]


Removal of Regulations Regarding Certification of Antibiotic 
Drugs; 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 publishing this 
companion proposed rule to the direct final rule, published elsewhere 
in this issue of the Federal Register, which is intended to repeal 
FDA's regulations governing certification of antibiotic drugs. The 
agency is taking this action in accordance with provisions of the Food 
and Drug Administration Modernization Act of 1997 (FDAMA). FDAMA 
repealed the statutory provision in the Federal Food, Drug, and 
Cosmetic Act (the act) under which the agency certified antibiotic 
drugs. FDAMA also made conforming amendments to the act.

DATES: Comments must be received on or before July 27, 1998.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Wayne H. Mitchell or Christine F. 
Rogers, Center for Drug Evaluation and Research (HFD-7), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2041.

SUPPLEMENTARY INFORMATION:

I. Background

    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 L. 105-115) repealed section 507 of the act (21 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)

[[Page 26128]]

and made conforming amendments to the act and other provisions of 
Federal law. Section 507 of the act was the section under which the 
agency certified antibiotic drugs. FDA is proposing to remove all 
provisions of Title 21 of the Code of Federal Regulations that were 
issued primarily to carry out the agency's program for the 
certification of antibiotic drugs under former section 507 of the act.

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. The 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 comment and is withdrawn. The comment 
period for the 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 rule are a direct result of the 
repeal of the statutory certification provision. If no significant 
adverse comment is received in response to the direct final rule, no 
further action will be taken related to the companion proposed rule. 
Instead, FDA will publish a confirmation notice 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 notice. 
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 in the final rules section of this issue of the Federal 
Register. All persons who may wish to comment should review the 
rationale for these amendments set out in the preamble discussion of 
the direct final rule. If FDA receives significant adverse comments, 
the agency will withdraw the companion final rule and will treat those 
comments as comments to 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 impacts 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. As discussed below, 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, for the reasons discussed 
below, 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. The elimination of the 
regulations governing the certification of antibiotic drugs will not 
result in any increased expenditures by State, local, and tribal 
governments or the private sector. Because this rule will not result in 
an expenditure of $100 million or more on any governmental entity or 
the private sector, no budgetary impact statement is required.
    This rule is intended to eliminate regulatory procedures and 
standards that the agency, as a result of the repeal of section 507 of 
the act, is no longer required to maintain. The elimination of parts 
430 et seq. is expected to streamline the regulation of antibiotic 
drugs by making these products subject to the same regulatory standards 
as all other drugs for human use. Many of the provisions that are being 
eliminated by this rulemaking have not had a material impact on the 
marketing of antibiotic drugs since 1982, when all antibiotic drugs 
were conditionally exempted from the batch certification requirement 
(47 FR 39155, September 7, 1982). Other provisions, such as the 
standards of identity, strength, quality, and purity, have in some 
instances not been kept up-to-date, are duplicative of U.S.P. 
standards, or have been incorporated into approved marketing 
applications for specific antibiotic drug products. For these reasons, 
the agency believes that this 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 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.

VI. Request for Comments

    Interested persons may, on or before July 27, 1998, submit to the 
Dockets Management Branch (address above) written comments regarding 
this proposal. 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

[[Page 26129]]

to be submitted, except that individuals may submit one copy. Comments 
are to be identified with the docket number found in brackets in the 
heading of this document. Received comments may be seen in the office 
above between 9 a.m. and 4 p.m., Monday through Friday.

List of Subjects

21 CFR Part 430

    Administrative practice and procedure, Antibiotics.

21 CFR Part 431

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

21 CFR Part 432

    Antibiotics, Labeling, Packaging and containers.

21 CFR Part 433

    Antibiotics, Labeling, Reporting and recordkeeping requirements.

21 CFR Parts 436, 440, 441, 442, 443, 444, 446, 448, 449, 450, 452, 
453, 455, and 460

    Antibiotics.
    Therefore, under the Federal Food, Drug, and Cosmetic Act, the Food 
and Drug Administration Modernization Act, and under authority 
delegated to the Commissioner of Food and Drugs, it is proposed that 21 
CFR chapter I be amended as follows:

PART 430--ANTIBIOTIC DRUGS; GENERAL

    1. Part 430 is removed.

PART 431--CERTIFICATION OF ANTIBIOTIC DRUGS

    2. Part 431 is removed.

PART 432--PACKAGING AND LABELING OF ANTIBIOTIC DRUGS

    3. Part 432 is removed.

PART 433--EXEMPTIONS FROM ANTIBIOTIC CERTIFICATION AND LABELING 
REQUIREMENTS

    4. Part 433 is removed.

PART 436--TESTS AND METHODS OF ASSAY OF ANTIBIOTIC AND ANTIBIOTIC-
CONTAINING DRUGS

    5. Part 436 is removed.

PART 440--PENICILLIN ANTIBIOTIC DRUGS

    6. Part 440 is removed.

PART 441--PENEM ANTIBIOTIC DRUGS

    7. Part 441 is removed.

PART 442--CEPHA ANTIBIOTIC DRUGS

    8. Part 442 is removed.

PART 443--CARBACEPHEM ANTIBIOTIC DRUGS

    9. Part 443 is removed.

PART 444--OLIGOSACCHARIDE ANTIBIOTIC DRUGS

    10. Part 444 is removed.

PART 446--TETRACYCLINE ANTIBIOTIC DRUGS

    11. Part 446 is removed.

PART 448--PEPTIDE ANTIBIOTIC DRUGS

    12. Part 448 is removed.

PART 449--ANTIFUNGAL ANTIBIOTIC DRUGS

    13. Part 449 is removed.

PART 450--ANTITUMOR ANTIBIOTIC DRUGS

    14. Part 450 is removed.

PART 452--MACROLIDE ANTIBIOTIC DRUGS

    15. Part 452 is removed.

PART 453--LINCOMYCIN ANTIBIOTIC DRUGS

    16. Part 453 is removed.

PART 455--CERTAIN OTHER ANTIBIOTIC DRUGS

    17. Part 455 is removed.

PART 460--ANTIBIOTIC DRUGS INTENDED FOR USE IN LABORATORY DIAGNOSIS 
OF DISEASE

    18. Part 460 is removed.

    Dated: May 1, 1998.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 98-12542 Filed 5-11-98; 8:45 am]
BILLING CODE 4160-01-F