44892 Federal Register / Vol. 62, No. 164 / Monday, August 25, 1997 / Rules and Regulations

Rockville, MD 20857, between 9 a.m.

and 4 p.m., Monday through Friday. To

expedite the processing, written notices

of participation may also be FAXED to

301–827–3079. Two copies of any

comments are to be submitted, except

individuals may submit one copy.

Comments should be identified with the

docket number found in brackets in the

heading of this notice.

Those persons interested in attending

this meeting should submit their

registration information, including

name, title, firm name, address,

telephone and fax number, to Toni

Toomer (address below).

FOR FURTHER INFORMATION CONTACT: Toni

Toomer, Center for Biologics Evaluation

and Research (HFM–49), Division of

Manufacturers Assistance and Training,

Food and Drug Administration, 1401

Rockville Pike, suite 200N, Rockville,

MD 20852–1448, 301–827–1310, FAX

301–827–3079.

SUPPLEMENTARY INFORMATION: In the

Federal Register of July 24, 1997, FDA

published a final rule entitled, ‘‘Changes

to an Approved Application’’ (62 FR

39890) and two notices of availability

announcing corresponding guidance

documents entitled, ‘‘Guidance for

Industry: Changes to an Approved

Application: Biological Products’’ (62

FR 39904) and ‘‘Guidance for Industry:

Changes to an Approved Application for

Specified Biotechnology and Specified

Synthetic Biological Products’’ (62 FR

39904).

FDA is announcing an open public

meeting to discuss regulatory issues

related to the final rule. The first part of

the meeting will include an agency

presentation of the regulatory provisions

of the final rule and a discussion of the

corresponding guidance documents,

followed by a question and answer

session.

In the second part of the meeting, the

agency will solicit public comment on

the use of a comparability protocol,

which is an option available to

applicants under the final rule. A

comparability protocol describes the

specific tests and validation studies and

acceptable limits to be achieved to

demonstrate the lack of adverse effect

for specified types of changes on the

safety or effectiveness of a product.

Every effort will be made to

accommodate each person who wants to

participate in the public meeting.

However, because presentations will be

limited to the second part of the

meeting, the agency may not be able to

accommodate all requests for formal

presentations. Nevertheless, each person

may participate in the open discussion

at the end of the meeting. Accordingly,

each person who wants to participate in

the meeting is encouraged to submit a

written request for participation, by

close of business on September 3, 1997,

and to include the following

information: (1) File a written request

for participation containing the name,

address, telephone and fax number,

affiliation, if any, of the participant, and

topic of the presentation, and (2) submit

a copy or a brief summary of their

presentation, or any written comments

for possible discussion at the meeting.

The requested information, including

the written notice for participation, may

be submitted to the Dockets

Management Branch (address above).

Registration at the site will be done on

a space-available basis on the day of the

open public meeting beginning at 8:30

a.m.

Prior to the meeting, CBER will

determine the schedule for the

presenters. A schedule of the presenters

will be filed with the Dockets

Management Branch (address above)

and mailed or faxed to each participant

before the meeting. Interested persons

attending the meeting who did not

request an opportunity to make a

presentation or those who did request

an opportunity to make a presentation

but due to the time limitations were not

granted the request will be given the

opportunity to make an oral

presentation at the conclusion of the

meeting, as time permits. There is no

registration fee for this public meeting,

but advance registration is suggested.

Interested persons are encouraged to

register early because space may be

limited.

FDA will consider information

presented and discussed at the meeting

and written comments submitted to the

Dockets Management Branch (address

above) in the development of future

guidance documents.

Dated: August 19, 1997.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 97–22555 Filed 8-22-97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

New Animal Drugs for Use in Animal

Feeds; Bacitracin Methylene

Disalicylate and Chlortetracycline;

Correction

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule; correction.

SUMMARY: The Food and Drug

Administration (FDA) is correcting a

final rule that appeared in the Federal

Register of March 19, 1997 (62 FR

12951) that amended the animal drug

regulations to reflect approval of a

supplemental new animal drug

application (NADA) filed by Alpharma

Inc. The document stated incorrectly

that bacitracin methylene disalicylate

and chlortetracycline Type B feeds were

included in the approval. This

document corrects that error.

EFFECTIVE DATE: March 19, 1997.

FOR FURTHER INFORMATION CONTACT:

David L. Gordon, Center for Veterinary

Medicine (HFV–6), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1739.

In FR Doc. 97–6876, appearing on

page 12951, in the Federal Register of

Wednesday, March 19, 1997, the

following correction is made:

1. On page 12951, in the third column

under the ‘‘SUMMARY’’caption, in line 9,

‘‘Types B and C’’ is corrected to read

‘‘Type C’’.

Dated: August 12, 1997.

Michael J. Blackwell,

Deputy Commissioner for Veterinary

Medicine.

[FR Doc. 97–22553 Filed 8-22-97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 573

[Docket No. 86F–0060]

Food Additives Permitted in Feed and

Drinking Water of Animals; Selenium

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is adopting

without change the provisions of an

interim rule regarding the approved use

of selenium as a food additive in animal

feeds. The interim rule implemented

certain provisions of the Agriculture,

Rural Development, FDA, and Related

Agencies Appropriations Act of 1994,

and the Federal Crop Insurance Reform

and Department of Agriculture

Reorganization Act of 1994.

EFFECTIVE DATE: September 9, 1997.

FOR FURTHER INFORMATION CONTACT:

Sharon A. Benz, Center for Veterinary

Medicine (HFV–228), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1724.
Federal Register / Vol. 62, No. 164 / Monday, August 25, 1997 / Rules and Regulations 44893

SUPPLEMENTARY INFORMATION:

I. Background

A. 1987 Amendments

In the Federal Register of April 6,

1987 (52 FR 10887), and corrected on

June 4, 1987 (52 FR 21001), FDA issued

a final rule amending the selenium food

additive regulation (§ 573.920 (21 CFR

573.920)) to increase the maximum

amount of selenium supplementation

permitted in animal feeds. The action

was based on a food additive petition

(FAP 2201) filed by the American Feed

Industry Association, Inc. (AFIA), 1701

North Fort Myer Dr., Arlington, VA

22209. In issuing the 1987 amendments

FDA determined, based on an

environmental impact analysis report

submitted by AFIA, that the amended

uses would not have a significant

impact on the human environment.

B. 1993 Stay of 1987 Amendments

In the Federal Register of September

13, 1993 (58 FR 47962), FDA published

a final rule that provided for a stay of

the 1987 amendments to the selenium

food additive regulations (hereinafter

referred to as the 1993 final rule). This

action resulted from allegations of

inadequacies in FDA’s finding of no

significant impact and in the petitioners

environmental assessment that

supported the 1987 amendments. As a

result of the stay of the 1987

amendments, the maximum permitted

use levels of selenium in animal feeds

returned to those levels permitted before

FDA issued the 1987 amendments. FDA

also stayed a 1989 amendment (54 FR

14214, April 10, 1989), to the regulation

that provided for the use of a bolus for

selenium supplementation at the

increased levels, because the

environmental assessment for the use of

the bolus relied on the 1987

environmental analysis.

C. Legislative Actions

The 103d Congress passed two laws

(Pub. L. 103–330 and Pub. L. 103–354)

that provided for suspension of FDA’s

1993 stay until certain conditions were

met. As a result, selenium is allowed to

be administered in animal feed as

sodium selenite or sodium selenate in

the complete feed for chickens, swine,

turkeys, sheep, cattle, and ducks as

provided for by the 1987 amendments to

§ 573.920, until further notice. The

published regulation provides for the

currently acceptable levels of selenium

supplementation of feed; that is, levels

not to exceed 0.3 part per million (ppm)

in complete feeds of chickens, swine,

turkeys, sheep, cattle, and ducks; in feed

supplements for sheep not to exceed 0.7

milligram (mg) per head per day and in

beef cattle not to exceed 3 mg per head

per day; and in free-choice salt-mineral

mixes for sheep up to 90 ppm but not

to exceed 0.7 mg per head per day and

for beef cattle up to 120 ppm in a

mixture for free-choice feeding not to

exceed an intake of 3 mg per head per

day. In addition, the orally

administered, osmotically controlled,

and constant release bolus for beef and

dairy cattle provided for on April 10,

1989 (54 FR 14214), was also available

until further notice.

D. 1995 Interim Rule

In the Federal Register of October 17,

1995 (60 FR 53702), FDA published an

interim rule that implemented the

relevant provisions of the Agriculture,

Rural Development, FDA, and Related

Agencies Appropriations Act of 1994,

and the Federal Crop Insurance Reform

and Department of Agriculture

Reorganization Act of 1994. Under the

provisions of the Administrative

Procedure Act in 5 U.S.C. 553(b)(B) and

FDA’s administrative practices and

procedures regulation in § 10.40(e) (21

CFR 10.40(e)), the Commissioner of

Food and Drugs (the Commissioner)

found for good cause that prior notice

and comment on this interim rule was

not necessary. The interim rule did not

involve any exercise of discretion by the

Commissioner. It merely repeated the

terms of Pub. L. 103–354. As provided

in FDA’s administrative practices and

procedures regulation at § 10.40(e), FDA

provided an opportunity for public

comment on whether the interim rule

should be modified or revoked.

II. Summary of Comments

FDA received three comments in

response to the interim rule. Two of the

three comments were in full agreement

with the interim rule. The third

comment commented on the legislation

rather than the interim rule. The

comment indicated that no one opposed

the stated purpose of the legislation, ‘‘to

permit higher levels of selenium

addition to feeds to assure proper

animal and poultry nutrition.’’ This

comment however objected to what it

characterized as the statute’s

elimination of the quality assurance

provision of the 1993 final rule that

every batch of selenium premix be

analyzed. Specifically, the comment

stated that in cases where animals or

poultry were killed by consuming feed

over-fortified with selenium,

overfortification of the premix was the

cause. Therefore, the comment believed

that adherence to good manufacturing

practice alone does not result in

appropriate control of selenium levels

in animal feeds from an animal safety

perspective and that the statute should

have retained a premix batch analysis

requirement. Because this comment

addressed the statute rather than FDA’s

implementation of the statute in the

interim rule, no changes have been

made to this final rule.

III. Analysis of Impacts

FDA has examined the impact of the

final rule under Executive Order 12866,

under the Regulatory Flexibility Act (5

U.S.C. 601–612), and under the

Unfunded Mandates Reform Act (Pub.

L. 104–4). Executive Order 12866

directs agencies to assess all costs and

benefits of available regulatory

approaches that maximize net benefits

(including potential economic,

environmental, public health and safety,

and other advantages, distributive

impacts and equity). The agency has

reviewed this final rule and has

determined that the rule is consistent

with the principles set forth in the

Executive Order and these two statutes.

Furthermore, the final rule is not a

significant regulatory action as defined

by the Executive Order.

With this rule, FDA is adopting

without change the provisions of an

interim rule published in the Federal

Register of October 17, 1995, regarding

the approved use of selenium as a food

additive in animal feeds. The interim

rule implemented certain provisions of

the Agriculture, Rural Development,

FDA, and Related Agencies

Appropriations Act of 1994, and the

Federal Crop Insurance Reform and

Department of Agriculture

Reorganization Act of 1994. This

legislation suspended the 1993 stay of a

1987 food additive approval, which

amended the selenium food additive

regulations to increase the maximum

amount of selenium supplementation

permitted in animal feeds, until certain

conditions are met.

By now reaffirming the interim final

rule, which merely implemented the

legislation discussed in section I.D of

this document, FDA has not imposed

any new requirements on industry. The

cost of the rule, therefore, is zero. The

quality assurance provision stayed by

the 1993 final rule, which required

every batch of selenium premix to be

analyzed, was not reinstated by the

legislation or the interim final rule. The

continued elimination of this

requirement may result in a small cost

savings to feed mills and others who

were previously required to analyze

every batch of premix and who will now

have the option of doing so.

Under the Regulatory Flexibility Act,

unless an agency certifies that a rule
44894 Federal Register / Vol. 62, No. 164 / Monday, August 25, 1997 / Rules and Regulations

will not have a significant impact on a

substantial number of small entities, the

agency must analyze regulatory options

that would minimize any significant

impact of a rule on small entities. The

agency can identify at least one

company which manufactures quality

assurance products which are used in

the selenium batch testing process. FDA

has not prohibited the use of these batch

testing products. They will still be

available to feed mills if the feed mills

wish to test every batch of selenium

premix. As this final rule does not

impose any new costs on this or other

firms, under the Regulatory Flexibility

Act (5 U.S.C. 605(b)), the agency

certifies that this final rule will not have

a significant economic impact on a

substantial number of small entities.

The Unfunded Mandates Reform Act

requires (in section 202) that agencies

prepare an assessment of anticipated

costs and benefits before proposing any

expenditure by State, local, and tribal

Governments, in the aggregate, or by the

private sector of $100 million. Because

the rule does not require any

expenditures by industry members or

State or local governments, FDA is not

required to perform a cost/benefit

analysis under the Unfunded Mandates

Reform Act.

IV. Final Action

The Commissioner has determined

that the interim rule published on

October 17, 1995, should be finalized

without modification.

List of Subjects in 21 CFR Part 573

Animal feeds, Food additives.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, 21 CFR part 573 is

amended as follows:

PART 573—FOOD ADDITIVES

PERMITTED IN FEED AND DRINKING

WATER OF ANIMALS

1. The authority citation for 21 CFR

part 573 continues to read as follows:

Authority: Secs. 201, 402, 409 of the

Federal Food, Drug, and Cosmetic Act (21

U.S.C. 321, 342, 348).

2. Accordingly, the interim rule

amending 21 CFR 573.920 that was

published in the Federal Register of

October 17, 1995 (60 FR 53702), is

adopted as a final rule without change.

Dated: August 8, 1997.

William K. Hubbard,

Acting Deputy Commissioner for Policy.

[FR Doc. 97–22476 Filed 8-22-97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE INTERIOR

Office of Surface Mining Reclamation

and Enforcement

30 CFR Part 904

[SPATS No. AR–027–FOR]

Arkansas Regulatory Program

AGENCY: Office of Surface Mining

Reclamation and Enforcement (OSM),

Interior.

ACTION: Final rule; correction.

SUMMARY: OSM is correcting a final rule

that appeared in the Federal Register of

April 29, 1997 (62 FR 23129). This

document amended the Arkansas

regulatory program (hereinafter referred

to as the ‘‘Arkansas program’’) under the

Surface Mining Control and

Reclamation Act of 1977 (SMCRA).

When citing the part of the regulation

that Arkansas proposed to remove, OSM

inadvertently omitted the letter of the

paragraph that was proposed for

removal. Likewise, OSM inadvertently

omitted the letter of the paragraph from

the Federal regulation that was a

counterpart to this State regulation that

was proposed for removal.

EFFECTIVE DATE: The amendment to 30

CFR part 904 (62 FR 23129) is effective

April 29, 1997.

FOR FURTHER INFORMATION CONTACT:

Michael C. Wolfrom, Director, Tulsa

Field Office, Office of Surface Mining

Reclamation and Enforcement, 5100

East Skelly Drive, Suite 470, Tulsa,

Oklahoma 74135–6548, Telephone:

(918) 581–6430.

SUPPLEMENTARY INFORMATION: In FR Doc.

97–10990, appearing on page 23129 in

the Federal Register of Tuesday, April

29, 1997, the following correction is

made:

On page 23133, the second column,

lines two and three, ‘‘ASCMRC 816.89’’

and ‘‘30 CFR 816.89’’ should read

‘‘ASCMRC 816.89(d)’’ and ‘‘30 CFR

816.89(d)’’, respectively.

Dated: August 7, 1997.

Charles E. Sandberg,

Acting Regional Director, Mid-Continent

Regional Coordinating Center.

[FR Doc. 97–22414 Filed 8–22–97; 8:45 am]

BILLING CODE 4310–05–M

DEPARTMENT OF THE INTERIOR

Office of Surface Mining Reclamation

and Enforcement

30 CFR Part 914

[SPATS No. IN–138–FOR; State Program

Amendment No. 95–3 II]

Indiana Regulatory Program

AGENCY: Office of Surface Mining

Reclamation and Enforcement (OSM),

Interior.

ACTION: Final rule; approval of

amendment.

SUMMARY: OSM is approving a proposed

amendment to the Indiana regulatory

program (hereinafter referred to as the

‘‘Indiana program’’) under the Surface

Mining Control and Reclamation Act of

1977 (SMCRA). Indiana proposed

revisions to its rules pertaining to the

small operator assistance program

(SOAP). Topics covered in the proposed

amendment are definitions for program

administrator and qualified laboratory,

eligibility for assistance, filing for

assistance, application approval and

notice, program services and data

requirements, qualified laboratories,

assistance funding, and applicant

liability. The amendment is intended to

revise the Indiana program to be

consistent with the corresponding

Federal regulations and to incorporate

changes desired by the State.

EFFECTIVE DATE: August 25, 1997.

FOR FURTHER INFORMATION CONTACT:

Andrew R. Gilmore, Director,

Indianapolis Field Office, Office of

Surface Mining Reclamation and

Enforcement, Minton-Capehart Federal

Building, 575 North Pennsylvania

Street, Room 301, Indianapolis, Indiana

46204–1521, Telephone (317) 226–6700.

SUPPLEMENTARY INFORMATION:

I. Background on the Indiana Program

II. Submission of the Proposed Amendment

III. Director’s Findings

IV. Summary and Disposition of Comments

V. Director’s Decision

VI. Procedural Determinations

I. Background on the Indiana Program

On July 29, 1982, the Secretary of the

Interior conditionally approved the

Indiana program. Background

information on the Indiana program,

including the Secretary’s findings, the

disposition of comments, and the

conditions of approval can be found in

the July 26, 1982, Federal Register (47

FR 32107). Subsequent actions

concerning the conditions of approval

and program amendments can be found

at 30 CFR 914.10, 914.15, and 914.16.