[Federal Register Volume 64, Number 237 (Friday, December 10, 1999)]
[Proposed Rules]
[Pages 69209-69211]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-31908]


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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; 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 remove 
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 the new 
animal drug application (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outdated and because individuals rarely use the regulation. This 
proposed rule is a companion document to the direct final rule 
published elsewhere in this issue of the Federal Register. If FDA 
receives significant adverse comments about the direct final rule, it 
will be withdrawn, and the comments will be considered in the 
development of a final rule using usual notice-and-comment rulemaking 
based on this proposed rule.

DATES: Submit written comments on or before February 23, 2000. If FDA 
receives any significant adverse comment regarding this rule, FDA will 
publish in the Federal Register a document withdrawing the companion 
direct final rule within 30 days after the comment period ends. If FDA 
does not receive any significant adverse comment, 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. The direct final rule will be effective April 
24, 2000.

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: 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 proposes 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. Because

[[Page 69210]]

providing a copy of the reference article facilitates the review 
process with given the minimal burden, individuals routinely submit 
copies in their submissions. 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 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) because 
it does not refer to designated journals.
    The proposed rule would amend 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 Procedures

    In the final rules section of this Federal Register, FDA is 
announcing the adoption of this amendment through direct final 
rulemaking procedures. FDA described its procedures for direct final 
rulemaking in the Federal Register of November 21, 1997 (62 FR 62466). 
This action is appropriate for direct final rulemaking because it is a 
noncontroversial amendment to FDA's regulations. Furthermore, FDA 
anticipates no significant adverse comments. Consistent with FDA's 
procedures for direct final rulemaking, FDA will publish a document of 
significant adverse comment and withdraw the direct final rule within 
30 days after the comment period ends if it receives any significant 
adverse comments. If the 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 this proposed 
rule. FDA is providing a 75-day comment period on this proposed rule, 
to run concurrently with the comment period for the companion direct 
final rule. This comment period begins on December 10, 1999, and it 
ends on February 23, 2000. If FDA receives any significant adverse 
comment, the agency intends to publish in the Federal Register a 
document to withdraw the companion direct final rule within 30 days 
after the comment period ends. If FDA does not receive any significant 
adverse comment in response to the direct final rule, the agency will 
not take action on this proposed rule. Instead, FDA will publish a 
document in the Federal Register within 30 days after the comment 
period on the direct final rule ends confirming that the direct final 
rule will be effective April 24, 2000. For additional information, see 
the companion direct final rule published in the final rules section of 
this Federal Register.

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 proposed 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 proposed rule and has determined that the 
proposed rule is consistent with the principles set forth in the 
Executive Order and in these two statutes. FDA finds that the proposed 
rule will not be an economically significant rule under the Executive 
Order.
    The proposed rule would delete 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 would have 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 proposed rule will have on small 
entities, including small businesses, and certifies that the proposed 
rule will not have a significant economic impact on a substantial 
number of small entities. FDA has also analyzed this proposed rule in 
accordance with the Unfunded Mandates Reform Act and determined that 
the proposed 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

    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 is not 
required.

V. Request for Comments

    Interested persons may, on or before February 23, 2000, submit to 
the Dockets Management Branch (address above) written comments 
regarding this proposed rule. Two copies of any comments are to be 
submitted, except

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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, it is 
proposed that 21 CFR parts 10, 12, and 510 be amended as follows:

PART 10--ADMINISTRATIVE PRACTICES AND PROCEDURES

    1. 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. 10.20  [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. 99-31908 Filed 12-9-99; 8:45 am]
BILLING CODE 4160-01-F