Removal of Designated Journals; Companion Document to Direct Final Rule

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outdated and because individuals rarely use the regulation.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will be withdrawn, and the comments will be considered in the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

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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