[Federal Register Volume 64, Number 237 (Friday, December 10, 1999)]
[Rules and Regulations]
[Pages 69188-69190]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-31907]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 10, 12, and 510
[Docket No. 99N-4957]
Removal of Designated Journals
AGENCY: Food and Drug Administration, HHS.
ACTION: Direct final rule.
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SUMMARY: The Food and Drug Administration (FDA) is removing its
regulation that lists the veterinary and scientific journals available
in FDA's library. The purpose of the list is to allow individuals to
reference articles from listed journals in new animal drug applications
(NADA), documents submitted to the Dockets Management Branch, and
objections and requests for a hearing on a regulation or order instead
of submitting a copy or reprint of the article. FDA is taking this
action because this list of journals is outdated and because
individuals rarely use the regulation. Elsewhere in this issue of the
Federal Register, FDA is issuing a companion proposed rule. If
significant adverse comments are received about this direct final rule,
it will be withdrawn and FDA will follow its usual procedures for
notice-and-comment rulemaking based on the companion proposed rule.
DATES: This regulation is effective April 24, 2000. Submit written
comments on this direct final rule by February 23, 2000. If FDA
receives no significant adverse comments within the specified comment
period, the agency intends to publish in the Federal Register a
document confirming the effective date of the final rule within 30 days
after the comment period on the direct final rule ends. If timely
significant adverse comments are received, the agency will publish in
the Federal Register a document withdrawing this direct final rule
before its effective date.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Gail L. Schmerfeld, Center for
Veterinary Medicine (HFV-100), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-0205.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is amending the animal drug regulations to remove 21 CFR 510.95
Designated journals. This regulation lists veterinary and scientific
journals available in FDA's library. It permits waiving submission of
reprints and summaries of articles from listed journals. FDA is taking
this action because the regulation has rarely been used, the list of
journals is outdated, and FDA does not believe it to be a wise
expenditure of its resources to update the list and to have reviewers
retrieve copies of referenced journals from its library, given the
minimal burden on individuals to submit copies. FDA notes that the
change is more likely to expedite rather than delay review of
applications and other documents. For example, if the sponsor provides
a copy of the article in full it permits prompt and efficient review of
the application.
Prior to the bifurcation of human and animal drug regulations under
the Animal Drug Amendments of 1968, the designated journal rule was
found at 21 CFR 130.38. At that time, 21 CFR 130.4, the rule covering
new drug applications (human and animal) stated that, ``[r]eprints are
not required of reports in designated journals.'' When the NADA rule
(presently Sec. 514.1 (21 CFR 514.1)) was separated from the new human
drug applications rule, this reference to the designated journals rule
was dropped. The agency continued to consider the designated journals
provision cited above to be part of the NADA rule, however, and allowed
sponsors to omit from their NADA's copies of articles from designated
journals. The agency is not amending the NADA rule, Sec. 514.1, since
it does not refer to designated journals.
The direct final rule amends 21 CFR 10.20 Submission of documents
to the Dockets Management Branch; computation of time; availability for
public disclosure and 21 CFR 12.22 Filing objections and requests for a
hearing on a regulation or order by eliminating the designated journals
exception to the requirement that copies of cited articles be provided.
II. Rulemaking Action
In the Federal Register of November 21, 1997 (62 FR 62466), FDA
described its procedures on when and how FDA will employ direct final
rulemaking. FDA believes that this rule is appropriate for direct final
rulemaking because FDA views this rule as a noncontroversial amendment
and anticipates no significant adverse comments. Consistent with FDA's
procedures on direct final rulemaking, FDA will publish a notice of
significant adverse comment and withdraw this direct final rule within
30 days after the comment period ends if it receives any
[[Page 69189]]
significant adverse comments. If this direct final rule is withdrawn,
FDA will consider all comments received in developing a final rule
using the usual notice-and-comment rulemaking procedures, based on the
companion proposed rule published elsewhere in this issue of the
Federal Register. The companion proposed rule provides a procedural
framework within which the rule may be finalized in the event the
direct final rule is withdrawn because of any significant adverse
comment. The comment period for the direct final rule runs concurrently
with the companion proposed rule. Any comments received under the
companion proposed rule will be considered as comments regarding the
direct final rule.
FDA is providing a period of 75 days for comment on this direct
final rule, to run concurrently with the comment period for the
companion proposed rule. This comment period begins on December 10,
1999, and ends on February 23, 2000. If FDA receives any significant
adverse comment, FDA intends to publish in the Federal Register a
document to withdraw this direct final rule within 30 days after the
comment period ends. If FDA receives no significant adverse comment
during the specified comment period, FDA will publish in the Federal
Register a document within 30 days after the comment period ends to
confirm the effective date of this direct final rule.
A significant adverse comment is defined as a comment 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. In determining whether a significant adverse comment
is sufficient to terminate a direct final rulemaking, FDA will consider
whether the comment raises an issue serious enough to warrant a
substantive response in a notice-and-comment process. Comments that are
frivolous, insubstantial, or outside the scope of the rule will not be
considered significant or adverse under this procedure. A comment
suggesting a change in addition to that proposed by the rule would not
be considered a significant adverse comment, unless, as explained by
the comment, the rule would be ineffective without change.
III. Analysis of Impacts
A. 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.
B. Economic Impact
FDA has examined the impacts of the direct final rule under
Executive Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-
612), and the Unfunded Mandates Reform Act (Public Law 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). The Regulatory
Flexibility Act requires agencies to examine the economic impact of a
rule on small entities. The Unfunded Mandates Reform Act requires
agencies to prepare an assessment of anticipated costs and benefits
before enacting any rule that may result in an expenditure in any one
year by State, local, and tribal governments, in the aggregate, or by
the private sector, of $100 million (adjusted annually for inflation).
The agency has reviewed this direct final rule and has determined that
the rule is consistent with the principles set forth in the Executive
Order and in these two statutes. FDA finds that the direct final rule
will not be an economically significant rule under the Executive Order.
The direct final rule deletes the regulations regarding designated
journals that could be referenced by a sponsor in its application and
by anyone who submits a document to the Dockets Management Branch or
files an objection and request for a hearing on a regulation or order.
FDA is taking this action because the list is outdated, is not being
used, and is not an efficient use of agency resources. The customary
practice in industry is for those preparing NADA's to include a copy of
all referenced material. This is preferred because it ensures the
application is complete at submission and will not result in a delay in
the review process. FDA estimates that the additional copying cost to
those few applicants that relied on the rule would be insignificant, as
well as offset by the savings to the agency from not copying the same
material. The agency also estimates that the additional copying costs
to those few individuals that relied on the rule for documents
submitted to the Dockets Management Branch and for objections and
requests for hearings on a regulation or order would be insignificant.
In accordance with the Regulatory Flexibility Act, FDA has
considered the effect that this direct final rule will have on small
entities, including small businesses, and certifies that this direct
final rule will not have a significant economic impact on a substantial
number of small entities. FDA has also analyzed this direct final rule
in accordance with the Unfunded Mandates Reform Act and determined that
the direct final rule will not result in the expenditure in any one
year by State, local, and tribal governments, in the aggregate, or by
the private sector of $100 million. Therefore, no further analysis is
required.
IV. The Paperwork Reduction Act of 1995
This direct final rule contains no collections of information.
Therefore, clearance by the Office of Management and Budget under the
Paperwork Reduction Act of 1995 is not required.
V. Request for Comments
Interested persons may, on or before February 23, 2000, submit to
the Docket Management Branch (address above) written comments regarding
this 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. All received comments
will be considered comments regarding the proposed rule and this direct
final rule.
List of Subjects
21 CFR Part 10
Administrative practice and procedure, News media.
21 CFR Part 12
Administrative practice and procedure.
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
10, 12, and 510 are amended as follows:
PART 10--ADMINISTRATIVE PRACTICES AND PROCEDURES
1. The authority citation for 21 CFR part 10 continues to read as
follows:
[[Page 69190]]
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. 10.20 [Amended]
2. Section 10.20 Submission of documents to Dockets Management
Branch; computation of time; availability for public disclosure is
amended by adding in paragraph (c)(1)(iii) the word ``or'' after the
word ``available;'', by removing in paragraph (c)(1)(iv) the words
``agency; or'' and adding in its place the word ``agency.'', and by
removing paragraph (c)(1)(v).
PART 12--FORMAL EVIDENTIARY PUBLIC HEARING
3. The authority citation for 21 CFR part 12 continues 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. 12.22 [Amended]
4. Section 12.22 Filing objections and requests for a hearing on a
regulation or order is amended by adding in paragraph (a)(5)(i)(a) the
word ``or'' after the word ``available;'', by removing in paragraph
(a)(5)(i)(b) the words ``agency; or'' and adding in its place the word
``agency.'', and by removing paragraph (a)(5)(i)(c).
PART 510--NEW ANIMAL DRUGS
5. 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. 510.3 [Amended]
6. Section 510.3 Definitions and interpretations is amended by
removing paragraph (l).
Sec. 510.95 [Removed and Reserved]
7. Section 510.95 Designated journals is removed and reserved.
Dated: November 30, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-31907 Filed 12-9-99; 8:45 am]
BILLING CODE 4160-01-F
