[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repealed the statutory provision in the Federal Food, Drug, and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 L. 105-115) repealed section 507 of the act (21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