40932 Federal Register / Vol. 62, No. 147 / Thursday, July 31, 1997 / Rules and Regulations

Drug labeler code Firm Name and address

* * * * * * *

099207 ...................................................................................................... Medicis Dermatologics, Inc., 4343 East Camelback Rd., suite 250,

Phoenix, AZ 85018–2700.

* * * * * * *

PART 524—OPHTHALMIC AND

TOPICAL DOSAGE FORM NEW

ANIMAL DRUGS

3. The authority citation for 21 CFR

part 524 continues to read as follows:

Authority: Sec. 512 of the Federal Food,

Drug, and Cosmetic Act (21 U.S.C. 360b).

§ 524.981a [Amended]

4. Section 524.981a Fluocinolone

acetonide cream is amended in

paragraph (b) by removing ‘‘000033’’

and adding in its place ‘‘099207’’.

§ 524.981b [Amended]

5. Section 524.981b Fluocinolone

acetonide solution is amended in

paragraph (b) by removing ‘‘000033’’

and adding in its place ‘‘099207’’.

§ 524.981c [Amended]

6. Section 524.981c Fluocinolone

acetonide, neomycin sulfate cream is

amended in paragraph (b) by removing

‘‘000033’’ and adding in its place

‘‘099207’’.

Dated: July 23, 1997.

Robert C. Livingston,

Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 97–20248 Filed 7-30-97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

Animal Drugs, Feeds, and Related

Products; Change of Sponsor;

Corrections

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule; correction.

SUMMARY: The Food and Drug

Administration (FDA) is correcting a

document that appeared in the Federal

Register of June 30, 1997 (62 FR 35075

at 35076). The document amended the

animal drug regulations to reflect the

change of sponsor for 52 approved new

animal drug applications (NADA’s) from

Fermenta Animal Health Co. to

Boehringer Ingelheim Animal Health,

Inc. The document was published with

two inadvertent errors. This document

corrects those errors.

EFFECTIVE DATE: July 31, 1997.

FOR FURTHER INFORMATION CONTACT:

Thomas J. McKay, Center for Veterinary

Medicine (HFV–102), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–827–0213.

In FR Doc. 97–16967, appearing on

page 35075, in the Federal Register of

Monday, June 30, 1997, the following

corrections are made: On page 35076, in

the first column, in amendment 11, in

the third line, ‘‘(a)(6)’’ is corrected to

read ‘‘(b)(6)’’; and on the same page, in

the second column, in amendment 19,

beginning in the fourth line, ‘‘000069,

054273, and 057561’’ is corrected to

read ‘‘000069, 054273, 057561, and

059130’’.

Dated: July 21, 1997.

Robert C. Livingston,

Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 97–20250 Filed 7-30-97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 556

Tolerances for Residues of New

Animal Drugs in Food; Apramycin

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

animal drug regulations to reflect

approval of two supplemental new

animal drug applications (NADA’s) filed

by Elanco Animal Health, A Division of

Eli Lilly & Co. The supplemental

NADA’s provide for revised tolerances

for total residues of apramycin (i.e., the

safe concentration) in edible swine

tissues.

EFFECTIVE DATE: July 31, 1997.

FOR FURTHER INFORMATION CONTACT:

George K. Haibel, Center for Veterinary

Medicine (HFV–133), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1644.

SUPPLEMENTARY INFORMATION: Elanco

Animal Health, A Division of Eli Lilly

& Co., Lilly Corporate Center,

Indianapolis, IN 46285, is sponsor of

supplemental NADA 106–964 that

provides for the use of Apralan

(apramycin sulfate) soluble powder in

swine drinking water and supplemental

NADA 126–050 that provides for the use

of Apralan (apramycin sulfate) Type A

medicated article in swine feed, both for

control of porcine colibacillosis

(weanling pig scours) caused by strains

of Escherichia coli sensitive to

apramycin. These supplemental

NADA’s provide for a change in the

tolerance for total residues of apramycin

(i.e., the safe concentration) in edible

swine tissues as provided in § 556.52

(21 CFR 556.52). Review of these

supplements involved a review of new

toxicology studies and information in

the original approvals.

In evaluating these supplements,

FDA’s Center for Veterinary Medicine

also considered that the proof of human

food safety for antimicrobial animal

drug residues includes a determination

of their antimicrobial activity for all

antimicrobial new animal drug

products. In the absence of studies to

determine the microbiological safety of

antimicrobial drug residues, the

acceptable daily intake (ADI) for

apramycin is limited to 25 micrograms

per kilogram (μg/kg) of body weight per

day (for appropriate studies see

‘‘Guidance: Microbial Testing of

Antimicrobial Drug Residues in Food,’’

January, 1996). As indicated in the

freedom of information summaries, the

safe concentration for total apramycin

residues is established at 5 parts per

million (ppm) for muscle, 15 ppm for

liver, and 30 ppm for fat and kidney.

These revised safe concentrations

warrant removal of the existing

tolerances for total residues in § 556.52,

because those tolerances are now

incorrect. Because this approval does

not result in a different tolerance than

that currently codified for marker

residue in swine kidney, and because

the sponsor did not petition FDA to

change the tolerance, the tolerance of

0.1 ppm in swine kidney remains

codified. FDA is also codifying the ADI

for apramycin of 25 μg/kg of body

weight per day. The supplement is
Federal Register / Vol. 62, No. 147 / Thursday, July 31, 1997 / Rules and Regulations 40933

approved as of June 24, 1997, and the

regulations in § 556.52 are revised to

reflect the approval. The basis of

approval is discussed in the freedom of

information summary.

In accordance with the freedom of

information provisions of 21 CFR part

20 and 514.11(e)(2)(ii), a summary of

safety and effectiveness data and

information submitted to support

approval of these applications may be

seen in the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857, between

9 a.m. and 4 p.m., Monday through

Friday.

The agency has determined under 21

CFR 25.24(d)(1)(i) 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.

List of Subjects in 21 CFR Part 556

Animal drugs, Foods.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs and redelegated to

the Center for Veterinary Medicine, 21

CFR part 556 is amended as follows:

PART 556—TOLERANCES FOR

RESIDUES OF NEW ANIMAL DRUGS

IN FOOD

1. The authority citation for 21 CFR

part 556 continues to read as follows:

Authority: Secs. 402, 512, 701 of the

Federal Food, Drug, and Cosmetic Act (21

U.S.C. 342, 360b, 371).

2. Section 556.52 is revised to read as

follows:

§ 556.52 Apramycin.

A tolerance of 0.1 part per million is

established for parent apramycin

(marker residue) in kidney (target tissue)

of swine. The acceptable daily intake

(ADI) for total residues of apramycin is

25 micrograms per kilogram of body

weight per day.

Dated: July 21, 1997.

Robert C. Livingston,

Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 97–20081 Filed 7-30-97; 8:45 am]

BILLING CODE 4160–01–F

OCCUPATIONAL SAFETY AND

HEALTH REVIEW COMMISSION

29 CFR Part 2200

Rules of Procedure for E–Z Trials

AGENCY: Occupational Safety and Health

Review Commission.

ACTION: Final Rule.

SUMMARY: This document eliminates the

sunset provision from the procedures

governing the E–Z Trial program and

continues the E–Z Trial program as part

of the Commission Rules of Procedure,

as codified in Title 29 of the Code of

Federal Regulations as Part 2200. In

addition, this document implements

revisions to the procedural rules

governing the E–Z Trial program which

are intended to assist the E–Z Trial

process in meeting its objective of

allowing parties in less complex cases to

argue their cases before the Commission

with as few legal formalities as possible.

DATES: Effective July 31, 1997.

FOR FURTHER INFORMATION CONTACT: Earl

R. Ohman, Jr., General Counsel, (202)

606–5410, Occupational Safety and

Health Review Commission, 1120 20th

Street NW, 9th Floor, Washington DC

20036–3419.

SUPPLEMENTARY INFORMATION: On June

24, 1997, the Occupational Safety and

Health Review Commission published

in the Federal Register (62 FR 34031)

proposed changes to the procedural

rules governing the E–Z Trial program.

The Commission would like to thank

those who took the time and interest to

submit comments.

The Secretary of Labor responded by

stating that it appears that many of the

concerns she initially had with the E–

Z Trial program can be avoided if the

Commission continues to exercise

sound judgment in the designation of

cases for E–Z Trial, to be receptive to

motions by either party to modify or

discontinue the procedure, and to

conduct pre-hearing conferences in such

a manner as to prevent surprises at trial.

The Secretary also expressed her wish

that the Commission remain open to

future modifications of the rule as it

gains experience with the E–Z Trial

program.

The Commission has evaluated the E–

Z Trial program during its pilot stage

and has decided to eliminate the sunset

provision of the E–Z Trial procedures

and to maintain E–Z Trial as part of the

Commission’s Rules of Procedure. The

Commission notes that E–Z Trial has

reduced the time necessary to try and

reach a decision in cases of the type

eligible for E–Z Trial from 423 days to

141 days—a two-thirds reduction. In

addition, feedback received from the

focus groups held concerning E–Z Trial

reflects that the program has realized

many of its other goals. The comments

received in response to the proposed

amendments raise issues which the

Commission hopes its modified

procedures adequately address and the

Commission remains open to future

modifications as the need may arise.

1. Eligibility for E–Z Trial

The Commission proposed amending

Rule 202 to make cases involving a

fatality or an allegation of willfulness

ineligible for E–Z Trial. The

Commission also proposed that cases

having an aggregate proposed penalty of

more than $10,000, but not more than

$20,000, may be considered for E–Z

Trial designation at the discretion of the

Chief Administrative Law Judge. The

Commission received no comments

specifically opposing these changes.

Accordingly, the Commission adopts

the proposed amendments.

2. Disclosure of Information

Currently, Rule 206 requires the

Secretary of Labor to disclose to the

employer copies of the narrative (Form

OSHA 1–A) and the worksheet (Form

OSHA 1–B), or their equivalents, within

12 working days after a case has been

designated for E–Z Trial. The

Commission proposed amending the

rule to require the Secretary to provide

the employer with reproductions of any

photographs or videotapes that the

Secretary intends to use at the hearing

within 30 calendar days of designation

for E–Z Trial.

One commentator suggested that the

Secretary should be required to disclose

all photographs or videotapes, not just

the ones the Secretary anticipates using

at the hearing. The commentator stated

that there may be photographs or

videotapes which would be helpful to

an employer’s defense, but which the

Secretary does not intend to use, and

noted that under the proposed rule, the

Secretary is not required to disclose

such evidence. While the Commission

expects that the Secretary would turn

over such material without being

required to do so, in order to make it

clear that no loophole exists in the E–

Z Trial procedures and because the E–

Z Trial process favors disclosure over

the traditional avenues of discovery, the

Commission has decided that the

Secretary should provide to the

employer as part of the disclosure

requirement any exculpatory evidence,

including photographs and videotapes.

Accordingly, the Commission has

revised Rule 206 to include the