40072 Federal Register / Vol. 63, No. 143 / Monday, July 27, 1998 / Proposed Rules

The proposed rule would authorize FDA

to disclose confidential commercial

information to international

organizations, subject to the same

safeguards against public disclosure of

that information that apply in the case

of disclosures to foreign government

agencies and to disclose predecisional

information to foreign governments

under relaxed procedures. These

disclosures would likely facilitate

marketing review and approval of

various FDA-regulated products in

foreign countries, and disclosures

would almost always occur only with

the consent of the business that

generated the confidential commercial

information. This beneficial effect of the

rule would outweigh any possible

adverse impact. Thus, the agency

certifies that this proposed rule will not

have a significant impact on a

substantial number of small entities.

Therefore, under the Regulatory

Flexibility Act, no further analysis is

required. FDA requests comment on this

conclusion.

V. 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.

Interested persons may, on or before

October 13, 1998, submit to the Dockets

Management Branch (address above)

written comments regarding this

proposal. 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.

List of Subjects in 21 CFR Part 20

Confidential business information,

Courts, Freedom of information,

Government employees.

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 part 20 be amended as follows:

PART 20—PUBLIC INFORMATION

1. The authority citation for 21 CFR

part 20 is revised to read as follows:

Authority: 5 U.S.C. 552; 18 U.S.C. 1905; 19

U.S.C. 2531–2582; 21 U.S.C. 321–393, 1401–

1403; 42 U.S.C. 241, 242, 242a, 242l, 242n,

243, 262, 263, 263b–263n, 264, 265, 300u–

300u–5, 300aa–1.

2. Section 20.88 is amended by

revising paragraph (e)(1)(i) to read as

follows:

§ 20.88 Communications with State and

local government officials.

* * * * *

(e)(1) * * *

(i) The State government agency has

the authority to protect such nonpublic

documents from public disclosure and

will not disclose any such documents

provided without the written

confirmation by the Food and Drug

Administration that the documents no

longer have nonpublic status; and

* * * * *

3. Section 20.89 is amended by

revising paragraph (d)(1)(i), by removing

paragraph (d)(3), and by adding

paragraph (e) to read as follows:

§ 20.89 Communications with foreign

government officials.

* * * * *

(d)(1) * * *

(i) The foreign government agency has

the authority to protect such nonpublic

documents from public disclosure and

will not disclose any such documents

provided without the written

confirmation by the Food and Drug

Administration that the documents no

longer have nonpublic status; and

* * * * *

(e) For purposes of this section, the

term ‘‘official of a foreign government

agency’’ includes, but is not limited to,

employees (whether temporary or

permanent) of and agents contracted by

the foreign government or by an

international organization having

responsibility to facilitate global or

regional harmonization of standards and

requirements in the Food and Drug

Administration’s areas of responsibility.

For such officials, the statement and

commitment required by paragraph

(d)(1)(i) of this section shall be provided

by both the organization and the

individual.

Dated: July 20, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–19898 Filed 7–24–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 120

[Docket Nos. 97N–0511, 93N–0325, and

97N–0296]

RIN 0910–AA43

Hazard Analysis and Critical Control

Point (HACCP); Procedures for the

Safe and Sanitary Processing and

Importing of Juice; Extension of

Comment Period; Correction

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule; preliminary

regulatory impact analysis; extension of

comment period; correction.

SUMMARY: The Food and Drug

Administration (FDA) is correcting a

document that appeared in the Federal

Register of July 8, 1998 (63 FR 37057).

The document extended the comment

period on a proposed rule published in

the Federal Register of April 24, 1998,

to ensure the safe and sanitary

processing of fruit and vegetable juices

and juice products and on the related

preliminary regulatory impact analysis

and initial regulatory flexibility analysis

published in the Federal Register of

May 1, 1998. The document was

published with an incorrect agency

contact. This document corrects that

error.

FOR FURTHER INFORMATION CONTACT:

Shellee A. Davis, Center for Food Safety

and Applied Nutrition (HFS–306), Food

and Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–205–4681.

SUPPLEMENTARY INFORMATION: In FR Doc.

98–18286, appearing on page 37057 in

the Federal Register of Wednesday, July

8, 1998, the following correction is

made:

1. On page 37057, in the second

column, the agency contact is corrected

to read ‘‘FOR FURTHER

INFORMATION CONTACT: Shellee A.

Davis, Center for Food Safety and

Applied Nutrition (HFS–306), Food and

Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–205–4681.’’

Dated: July 17, 1998.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 98–19954 Filed 7–24–98; 8:45 am]

BILLING CODE 4160–01–F