Federal Register / Vol. 63, No. 143 / Monday, July 27, 1998 / Proposed Rules 40069

order regulating the handling of milk in

the Iowa marketing area is being

considered for September 1, 1998,

through November 30, 1998.

All persons who desire to submit

written data, views or arguments about

the proposed revision should send two

copies of their views to USDA/AMS/

Dairy Programs, Order Formulation

Branch, Room 2971, South Building,

P.O. Box 96456, Washington, DC 20090–

6456 by the 30th day after publication

of this notice in the Federal Register.

The filing period is limited to 30 days

because a longer period would not

provide the time needed to complete the

required procedures and include

September in the temporary revision

period.

All written submissions made

pursuant to this notice will be made

available for public inspection in the

Dairy Programs offices during regular

business hours (7 CFR 1.27(b)).

Statement of Consideration

The provision proposed to be revised

is the percentage of a supply plant’s

receipts required to be shipped to pool

distributing plants pursuant to

§ 1079.7(b) of the Iowa Federal milk

marketing order (Order 79). As

proposed, the percentage of a supply

plant’s receipts that must be shipped to

pool distributing plants (fluid milk

plants) if the supply plant is to be

considered a pool plant would be

decreased by the maximum allowable

10 percentage points, from 35 percent to

25 percent for the period September 1,

1998, through November 30, 1998.

Section 1079.7(b)(1) of the Iowa milk

marketing order allows the Deputy

Administrator, Dairy Programs, to

reduce or increase a pool supply plant’s

minimum shipping requirement by up

to 10 percentage points to prevent

uneconomic milk shipments or to assure

an adequate supply of milk for fluid use.

Beatrice Cheese, Inc. (Beatrice), a

proprietary manufacturer of dairy

products in Fredericksburg, Iowa, is

regulated under Order 79 as a pool

supply plant. Beatrice requested that the

shipping percentage be reduced by 10

percentage points for the months of

September through November 1998. The

handler’s request states that this

decrease is warranted due to the fact

that current raw milk supplies available

for fluid use exceed the needs of the

fluid milk plants in Order 79. Beatrice

states that if the pool supply shipping

percentages remain unchanged, Beatrice

will be forced to move milk

uneconomically or unfairly depool some

milk produced by Iowa dairymen,

denying them participation in the Order

79 pool.

In view of the current supply and

demand relationship, it may be

necessary to decrease the shipping

percentage requirements for pool supply

plants to provide for the efficient and

economic marketing of milk during the

period September 1, 1998, through

November 30, 1998.

List of Subjects in 7 CFR Part 1079

Milk marketing orders.

The authority citation for 7 CFR part

1079 continues to read as follows:

Authority: 7 U.S.C. 601–674.

Dated: July 21, 1998.

Richard M. McKee,

Deputy Administrator, Dairy Programs.

[FR Doc. 98–19908 Filed 7–24–98; 8:45 am]

BILLING CODE 3410–02–P

NORTHEAST DAIRY COMPACT

COMMISSION

7 CFR Part 1301

Notice of Meeting

AGENCY: Northeast Dairy Compact

Commission.

ACTION: Notice of Meeting.

SUMMARY: The Compact Commission

will hold its monthly meeting to

consider whether to adopt as a Final

rule the Proposed Rule to amend the

current Compact Over-order Price

Regulation to exclude milk from the

pool which is either diverted or

transferred, in bulk, out of the Compact

regulated area. The Commission will

also consider whether to adopt as a

Final Rule the Proposed Rule to

establish a reserve fund for

reimbursement to school food

authorities. Matters relating to

administration and the price regulation

to include the reports and

recommendations of the Commission’s

standing Committees and action upon

the Proposed Amendments to the

Bylaws as noticed to the Commission at

the July 1, 1998 are also scheduled.

DATES: The meeting is scheduled for

Wednesday, August 5, 1998 to

commence at 10:00 a.m.

ADDRESSES: The meeting will be held at

the Holiday Inn, Capitol Room, 172

North Main Street, Concord, NH (exit 14

off I–93).

FOR FURTHER INFORMATION CONTACT:

Kenneth Becker, Executive Director,

Northeast Dairy Compact Commission,

43 State Street, PO Box 1058,

Montpelier, VT 05601. Telephone (802)

229–1941.

SUPPLEMENTARY INFORMATION: The

Compact Commission will hold its

monthly meeting to consider whether to

adopt as a Final rule the Proposed Rule

to amend the current Compact Overorder Price Regulation to exclude milk

from the pool which is either diverted

or transferred, in bulk, out of the

Compact regulated area. The proposal

will limit the payment of the compact

over-order producer price to milk

disposed of within the Compact

regulated area. The Commission will

also consider whether to adopt as a

Final Rule the Proposed Rule to

establish a reserve fund for

reimbursement to school food

authorities. The current Compact Overorder Price Regulation is codified at 7

CFR 1300 through 1308. The proposed

reserve fund is required to implement

the previously issued regulation

exempting certain milk sold by school

food authorities from the Over-order

Price Regulation. Matters relating to

administration and the price regulation

to include the reports and

recommendations of the Commission’s

standing Committees and action upon

the Proposed Amendments to the

Bylaws as noticed to the Commission at

the July 1, 1998, as required, are also

scheduled.

(Authority: (a) Article V, Section 11 of the

Northeast Interstate Dairy Compact, and 7

U.S.C. 7256.)

Kenneth Becker,

Executive Director.

[FR Doc. 98–19923 Filed 7–24–98; 8:45 am]

BILLING CODE 1650–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 20

[Docket No. 98N–0518]

Public Information; Communications

With State and Foreign Government

Officials

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule.

SUMMARY: The Food and Drug

Administration (FDA) is proposing to

amend its regulations governing

communications with State and foreign

government officials. The proposed rule

would permit FDA to disclose

confidential commercial information to

international organizations having

responsibility to facilitate global or

regional harmonization of standards and

requirements. These disclosures would,

in almost all instances, occur only with
40070 Federal Register / Vol. 63, No. 143 / Monday, July 27, 1998 / Proposed Rules

the consent of the person providing the

confidential commercial information to

FDA. The proposed rule would also

streamline the process for FDA officials

to disclose certain nonpublic,

predecisional documents (such as draft

rules and guidance documents) to State

and foreign government officials. The

proposal does not alter current

procedures for sharing documents that

contain confidential commercial

information. These changes are

intended to facilitate information

exchanges with State and foreign

governments and certain international

organizations.

DATES: Written comments by October

13, 1998.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Philip L. Chao, Office of Policy (HF–23),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–3380.

SUPPLEMENTARY INFORMATION:

I. Introduction

In the Federal Register of December

24, 1974 (39 FR 44602), FDA published

a regulation implementing the Freedom

of Information Act and other laws that

affect public access to government

records and information. The rule

exempted certain records, such as law

enforcement records, from public

disclosure, but did not include any

provisions for special disclosures to

foreign government officials of

documents that were not available to the

public generally.

In the Federal Register of November

19, 1993 (58 FR 61598), FDA published

a final rule which, among other things,

authorized the agency to disclose

confidential commercial information

concerning FDA-regulated products to

foreign government officials who

perform counterpart functions to FDA.

The rule, which is now codified at

§ 20.89 (21 CFR 20.89), permits these

disclosures to occur only under various

safeguards, such as a written statement

from the foreign government agency

establishing its authority to protect the

confidential commercial information

from public disclosure and a written

commitment not to disclose such

information without the consent of the

sponsor for the confidential commercial

information or written confirmation

from FDA that the information is no

longer confidential. Additionally, the

rule requires FDA to determine either

that the sponsor of the confidential

commercial information has authorized

the disclosure to the foreign

government, or that disclosure would be

in the interest of public health, or that

disclosure is to a foreign scientist

visiting FDA as part of a joint review or

long-term cooperative training effort and

subject to other restrictions. FDA

included these safeguards to protect

sensitive commercial information and to

lessen industry concerns that foreign

governments would further disclose

such information without the sponsor’s

permission.

Later, in the Federal Register of

December 8, 1995 (60 FR 63372), FDA

issued a final rule to permit FDA to

disclose nonpublic, predecisional and

other documents, such as draft guidance

documents and regulations, to State and

foreign government officials. (Currently,

the term ‘‘nonpublic, predecisional

document,’’ as used in §§ 20.88(e) (21

CFR 20.88) and 20.89(d), does not

include documents containing

confidential commercial information

such as FDA-prepared documents that

analyze confidential commercial

information.) Disclosures of nonpublic,

predecisional documents were subject

to certain safeguards similar to those in

the 1993 rule (58 FR 61598), such as a

written statement by the State or foreign

government agency establishing its

authority to protect the nonpublic,

predecisional documents from public

disclosure and a commitment not to

disclose such documents without FDA’s

written confirmation that the documents

no longer have nonpublic status (see

§§ 20.88(e)(1)(i) and 20.89(d)(1)(i)).

The 1995 final rule (60 FR 63372) also

stated that, for purposes of disclosing

nonpublic, predecisional documents,

the term ‘‘official of a foreign

government agency’’ includes, but is not

limited to, ‘‘an agent contracted by the

foreign government, and an employee of

an international organization having

responsibility to facilitate global

harmonization of standards and

requirements in FDA’s areas of

responsibility’’ (see 21 CFR 20.89(d)(3)).

This enabled FDA to disclose

nonpublic, predecisional documents to

international organizations such as the

World Health Organization and the

Food and Agriculture Organization of

the United Nations.

The 1995 rule also established similar

authority for disclosing both

confidential commercial information

and nonpublic, predecisional

documents to U.S. State government

officials.

FDA’s experience under § 20.89 has

been excellent. Thus far, disclosures of

confidential commercial information to

foreign governments have occurred with

the sponsor’s consent in almost every

case, and only after the foreign

government has provided the necessary

documents establishing its authority to

protect the shared confidential

commercial information from

disclosure. These documents are usually

written commitments that the foreign

government has the authority to protect

the documents from public disclosure

and will protect such documents

provided by FDA, although, on

occasion, the document may be an

exchange of letters or other agreement

between FDA and the foreign country

(see, e.g., 62 FR 60901, November 13,

1997) (exchange of letters between FDA

and the Australian Therapeutic Goods

Administration regarding information

about a drug or biologic being

considered for orphan status)).

A sponsor’s consent is not always

necessary under § 20.89. FDA may

disclose confidential commercial

information without the sponsor’s

consent where the agency determines

that disclosure would be in the interest

of public health by reason of the foreign

government’s possession of information

concerning a product’s safety, efficacy,

or quality or information concerning an

investigation.

Generally, the confidential

information which FDA has shared has

consisted of internal FDA documents

discussing data (rather than the data

themselves) as the foreign governments

usually have the data in an application

for marketing authorization.

Disclosures of nonpublic,

predecisional information, mostly

involving draft guidance documents,

have been less frequent, and all have

involved disclosures to foreign

governments.

As for disclosures to international

organizations, current FDA regulations

expressly permit the agency to disclose

nonpublic, predecisional documents,

but do not permit disclosures of

confidential commercial information,

including FDA-prepared documents that

discuss confidential commercial

information, to international

organizations.

II. Description of the Proposed Rule

FDA is now contemplating possible

arrangements with international

organizations in which FDA may want

to be able to disclose confidential

commercial information to international

organizations under the same conditions

and procedures found in § 20.89 for

disclosing confidential commercial

information to foreign governments. The

agency is not proposing to change those

conditions or procedures with respect to

sharing confidential commercial
Federal Register / Vol. 63, No. 143 / Monday, July 27, 1998 / Proposed Rules 40071

information with foreign governments.

The proposal would simply add

international organizations to the

disclosure provisions of § 20.89 dealing

with confidential commercial

information.

For example, an international

organization may wish to request certain

confidential commercial information

from FDA so that it may investigate

possible adverse events associated with

an approved drug product or as part of

a cooperative investigation. This

occurred recently when the Pan

American Health Organization (PAHO)

sought certain product and

manufacturing information from FDA

after an incident in Haiti where over 80

children died and even more were

injured by an acetaminophen syrup

contaminated with diethylene glycol.

FDA was able to share the information

with PAHO only after information had

been publicly disclosed by non-FDA

sources. As stated earlier, current FDA

regulations do not explicitly provide a

mechanism for providing confidential

commercial information to an

international organization even under

the same circumstances in which FDA

can provide confidential commercial

information to a foreign government

under § 20.89.

The proposal would amend § 20.89 to

clarify that disclosures of confidential

commercial information and nonpublic,

predecisional documents may be made

to an international organization having

responsibility to facilitate

harmonization of standards and

requirements in FDA’s areas of

responsibility. Thus, the proposed rule

would move the language regarding an

‘‘official of a foreign government

agency’’ from § 20.89(d)(3), where it

applies only to disclosures of

nonpublic, predecisional documents, to

a new § 20.89(e) so that it would apply

to all disclosures under § 20.89. The

proposal would also revise the reference

to international organizations to refer to

international organizations that

facilitate ‘‘global or regional’’

harmonization of standards and

requirements. The reference to

‘‘regional’’ harmonization efforts is

intended to reflect the fact that some

international organizations operate

primarily on a regional, rather than

global, scale. (FDA, for purposes of this

rule, interprets the term ‘‘international

organizations’’ as referring to public or

intergovernmental organizations,

whether established by treaties or other

means, instead of private or

nongovernmental organizations.)

The proposal would also clarify that

the term ‘‘official of a foreign

government’’ includes both temporary

and permanent employees and agents.

When FDA first proposed § 20.89(d)(3)

on January 27, 1995 (60 FR 5530), the

term ‘‘official of a foreign government’’

was understood as including foreign

government employees. Comments

submitted in response to the 1995

proposed rule (60 FR 5530) suggested

including ‘‘agents’’ of a foreign

government, and so FDA amended the

rule to include ‘‘agents’’ on December 8,

1995 (60 FR 63372 at 63377). However,

the express mention of agents, and not

employees of a foreign government, has

caused some confusion, and so FDA is

proposing to amend the rule to refer to

employees of and agents contracted by

a foreign government or by an

international organization. This change

would be especially appropriate for

international organizations because

many international organizations rely

on government officials who are

temporarily assigned to the

international organization and on

consultants and contractors. It would

also be analogous to the existing

requirements for FDA’s consultants,

advisory committee members, and

commissioned officials who are subject

to the same disclosure restrictions that

apply to FDA employees even though

such persons are not agency employees

themselves (see 21 CFR 20.84).

Additionally, the proposed rule

would amend §§ 20.88(e)(1)(i) and

20.89(d)(1)(i) to eliminate the need for

the written statement from a U.S. State

or a foreign government agency official

when FDA provides nonpublic,

predecisional documents. The

requirement of a written statement was

originally included to mirror the

existing parallel requirement for such a

statement before FDA disclosed any

confidential commercial information to

a foreign government. However, because

information exchanges involving

nonpublic, predecisional documents do

not contain confidential commercial

information, the written statement adds

little value because only FDA’s

deliberative interests would be directly

affected by a premature public

disclosure. Furthermore, FDA’s

experience under § 20.89 suggests that

the written statement requirement is

contrary to customary international

practice in which drafts are shared with

trusted individuals in counterpart

agencies as part of a well-understood,

well-established practice that the

document will not be disclosed or made

public. Moreover, some foreign agencies

have been reluctant to execute the

written statement due to uncertainties

as to who in their government possesses

the authority to sign such a statement.

Others have even expressed concern

that the written statement might, under

their government’s policies or laws, be

considered an international agreement

under international treaty law that

might require new national legislation

or legislative consent.

Thus, the proposed rule would delete

the written statement from § 20.89(d) for

exchanges involving nonpublic,

predecisional information. Furthermore,

the proposal would delete the written

statement from § 20.88(e) so that State

government officials have the same

access to nonpublic, predecisional

documents as foreign government

officials. The agency will require State

and foreign governments to execute a

written statement establishing their

authority to protect documents from

public disclosure only where the

documents contain confidential

commercial information.

III. 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.

IV. Analysis of Impacts

FDA has examined the impacts of this

proposed rule under Executive Order

12866 and the Regulatory Flexibility Act

(5 U.S.C. 601–612). 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 new benefits

(including potential economic,

environmental, public health and safety,

and other advantages; distributive

impacts; and equity). The agency

believes that this proposed rule is

consistent with the regulatory

philosophy and the principles identified

in the Executive Order. In addition, the

proposed rule is not a significant

regulatory action as defined in the

Executive Order.

The Regulatory Flexibility Act

requires agencies to analyze regulatory

options that would minimize any

significant impact of a rule on small

entities. The proposed rule will have no

significant economic impact on small

entities under the Regulatory Flexibility

Act because it regulates only conduct of

FDA, foreign governments, and

international organizations, and not

small entities under the Regulatory

Flexibility Act. In any case, the

proposed rule will have no significant

economic impact on any small entities.
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