Removal of Designated Journals

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action because this list of journals is outdated and because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it will be withdrawn and FDA will follow its usual procedures for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