Federal Register / Vol. 62, No. 62 / Tuesday, April 1, 1997 / Rules and Regulations 15391

needed for the agency to complete its

review of the issues raised by the

petition. Additionally, FDA believes

that it should seek comment on these

issues from other interested persons.

Given these factors, the agency is

persuaded that it is in the public

interest to stay the provisions for the

lower standards for sodium in the

definition of ‘‘healthy’’ in § 101.65

while the agency endeavors to resolve

the issues raised by the petition.

Therefore, the agency is staying the

provisions for further reducing the

sodium level in foods labeled as

‘‘healthy’’ until January 1, 2000, to

allow time for FDA to reevaluate the

standard, including the data contained

in the petition and any additional data

that the agency may receive, to conduct

any necessary notice-and-comment

rulemaking, and for industry to respond

to the rule or to any change in the rule

that may result from the agency’s

reevaluation.

To assist the agency in its

reevaluation, FDA intends to issue an

advance notice of proposed rulemaking

(ANPR) in the near future to ask for

comments on the petition as well as for

additional data regarding the

technological feasibility of reducing the

sodium content of individual foods to

360 mg per RACC and of meals and

main dishes to 480 mg sodium per

RACC. The agency will also be seeking

comments on other approaches to

reduce the amount of sodium in foods

labeled ‘‘healthy.’’ It is important that

consumers seeking to eat a healthpromoting diet have food choices that

enable them to further reduce the

amount of sodium in their diet.

Interested persons need not wait for the

publication of the ANPR but should feel

free to review the petition and to submit

to the agency any information or views

they have on consumer acceptance of

foods with low sodium levels and on

the lack of acceptable sodium

substitutes and the difficulties in

manufacturing lines of food products

with low sodium levels.

Accordingly, FDA is announcing a

stay of the provisions in

§ 101.65(d)(2)(ii)(C) and (d)(4)(ii)(B)

until January 1, 2000. Interested persons

may also submit comments regarding

the appropriateness of the basis of this

stay. In doing so, however, FDA

encourages manufacturers who can meet

the lower sodium levels for particular

foods and still produce an acceptable

product to do so even as the agency

reevaluates the issues discussed

previously in this document.

Interested persons may, on or before

May 1, 1997 submit to the Dockets

Management Branch (address above)

written comments regarding this

document. 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.

This document is issued under

sections 4, 5, 6 of the Fair Packaging and

Labeling Act (15 U.S.C. 1453, 1454,

1455); secs. 201, 301, 402, 403, 409, 701

of the Federal Food, Drug, and Cosmetic

Act (21 U.S.C. 321, 331, 342, 343, 348,

371).

For the reasons set forth in the

preamble, 21 CFR 101.65(d)(2)(ii)(C) and

(d)(4)(ii)(B) are stayed until January 1,

2000.

Dated: March 26, 1997.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 97–8127 Filed 3–31–97; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Parts 556 and 558

Animal Drugs, Feeds, and Related

Products; Tilmicosin Phosphate Type

A Medicated Article; 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 December 27, 1996 (61 FR

68147). The document amended the

animal drug regulations to reflect

approval of Elanco Animal Health’s new

animal drug application (NADA) 141–

064 for use of a Type A medicated

article containing tilmicosin phosphate

in manufacturing a Type B or Type C

medicated feed indicated for the control

of swine respiratory disease associated

with certain bacterial organisms. The

document was published with some

errors. This document corrects those

errors.

EFFECTIVE DATE: December 27, 1996.

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.

In FR Doc. 96–32881, appearing on p.

68147, in the Federal Register of Friday,

December 27, 1996, the following

corrections are made:

§ 556.735 [Corrected]

1. On page 68148, in the second

column, in line 2, ‘‘7.2’’ is corrected to

read ‘‘7.5’’.

§ 558.618 [Corrected]

2. On page 68148, in the second

column, in paragraph (d)(1), ‘‘181.8’’

and ‘‘363.6’’ are corrected to read ‘‘181’’

and ‘‘363’’, respectively.

Dated: February 7, 1997.

Robert C. Livingston,

Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 97–8116 Filed 3–31–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Parts 1300, 1309 and 1310

[DEA No. 132C]

RIN 1117–AA33

Consolidation, Elimination, and

Clarification of Various Regulations;

Correction

AGENCY: Drug Enforcement

Administration (DEA), Justice.

ACTION: Correction to final regulations.

SUMMARY: This document contains

corrections to the final regulations (DEA

132) which were published on Monday,

March 24, 1997 (62 FR 13938). The

regulations related to the consolidation,

elimination, and clarification of DEA’s

regulations as part of the President’s

National Performance Review,

Regulatory Reinvention Initiative.

EFFECTIVE DATE: April 1, 1997.

FOR FURTHER INFORMATION CONTACT:

G. Thomas Gitchel, Chief, Liaison and

Policy Section, Office of Diversion

Control, Drug Enforcement

Administration, Washington, D.C. 20537,

Telephone (202) 307–7297.

SUPPLEMENTARY INFORMATION: The final

regulations that are the subject of these

corrections revise Title 21, Code of

Federal Regulations (CFR), Chapter II in

accordance with the President’s

Regulatory Reinvention Initiative. As

published, the final regulations contain

errors that could cause confusion in the

regulated industry. Specifically, the

final regulations did not take into

account the amendment of certain

definitions and the amendment of 21

CFR 1310.09 that were included in an

Interim Rule published by DEA on

February 10, 1997 (62 FR 5914), which