[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action because this list of journals is outdated and because 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it will be withdrawn and FDA will follow its usual procedures for 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