Federal Register / Vol. 66, No. 14 / Monday, January 22, 2001 / Rules and Regulations 6465

DEPARTMENT OF COMMERCE

Bureau of Export Administration

15 CFR Parts 740 and 748

[Docket No. 010112014–1014–01]

RIN 0694–AC41

Implementation of Presidential

Announcement of January 10, 2001:

Revisions to License Exception CTP;

Corrections

AGENCY: Bureau of Export

Administration, Commerce.

ACTION: Final rule.

SUMMARY: On January 19, 2001 the

Bureau of Export Administration (BXA)

published a final rule revising License

Exception CTP. This rule corrects

inadvertent citation references in the

January 19 rule.

DATES: This rule is effective January 19,

2001.

FOR FURTHER INFORMATION CONTACT:

Sharron Cook in the Office of Exporter

Services, Bureau of Export

Administration, at (202) 482–2440.

SUPPLEMENTARY INFORMATION:

Rulemaking Requirements

1. This final rule has been determined

to be not significant for purposes of

Executive Order 12866.

2. Notwithstanding any other

provision of law, no person is required

to respond to nor be subject to a penalty

for failure to comply with a collection

of information subject to the

requirements of the Paperwork

Reduction Act unless that collection of

information displays a current valid

OMB Control Number. This regulation

involves collections previously

approved by the Office of Management

and Budget under control numbers

0694–0088, ‘‘Multi-Purpose

Application,’’ which carries a burden

hour estimate of 45 minutes per manual

submission and 40 minutes per

electronic submission. Miscellaneous

and recordkeeping activities account for

12 minutes per submission. Information

is also collected under OMB control

number 0694–0107, ‘‘National Defense

Authorization Act,’’ Advance

Notifications and Post-Shipment

Verification Reports, which carries a

burden hour estimate of 15 minutes per

report. This rule also involves

collections of information under OMB

control number 0694–0073, ‘‘Export

Controls of High Performance

Computers’’ and OMB control number

0694–0093, ‘‘Import Certificates and

End-User Certificates.’’

3. This rule does not contain policies

with Federalism implications as that

term is defined in Executive Order

13132.

4. The provisions of the

Administrative Procedure Act requiring

notice of proposed rule making, the

opportunity for public participation,

and a delay in effective date, are

inapplicable because this regulation

involves a military or foreign affairs

function of the United States (see 5

U.S.C. 553(a)(1)). Further, no other law

requires that a notice of proposed rule

making and an opportunity for public

comment be given for this rule. Because

a notice of proposed rule making and

opportunities for public comment are

not required to be given for this rule by

5 U.S.C. 553, or by any other law, the

analytical requirements of the

Regulatory Flexibility Act, 5 U.S.C. 601

et seq., are inapplicable.

Therefore, this regulation is issued in

final form. Although there is no formal

comment period, public comments on

this regulation are welcome on a

continuing basis. Comments should be

submitted to Office of Exporter Services,

Bureau of Export Administration,

Department of Commerce, P.O. Box 273,

Washington, DC 20044.

List of Subjects in 15 CFR Parts 740 and

748

Administrative practice and

procedure, Exports, Foreign trade,

Reporting and record keeping

requirements.

Accordingly, parts 740 and 748 of the

Export Administration Regulations (15

CFR Parts 730–799) are amended as

follows:

1. The authority citation for 15 CFR

Part 740 is revised to read as follows:

Authority: 50 U.S.C. app. 2401 et seq.; Pub.

L. No. 106–508; 50 U.S.C. 1701 et seq.; E.O.

12924, 59 FR 43437, 3 CFR, 1994 Comp., p.

917; E.O. 13026, 61 FR 58767, 3 CFR, 1996

Comp., p. 228; Notice of August 3, 2000 (65

FR 48347, August 8, 2000).

2. The authority citation for part 748

is revised to read as follows:

Authority: 50 U.S.C. app. 2401 et seq.; Pub.

L. No. 106–508; 50 U.S.C. 1701 et seq.; E.O.

12924, 59 FR 43437, 3 CFR, 1994 Comp., p.

917; E.O. 13026, 61 FR 58767, 3 CFR, 1996

Comp., p. 228; Notice of August 3, 2000 (65

FR 48347, August 8, 2000).

PART 740—CORRECTED

3. Part 740 is corrected by revising the

phrase ‘‘paragraph (d)(2)’’ to read

‘‘paragraphs (d)(5)(i)(A) or (d)(5)(i)(B)’’

in paragraph 740.7(d)(4).

PART 748—CORRECTED

4. Section 748.10 is corrected by

revising the citation reference

‘‘§ 740.7(d)(2)’’ to read

‘‘§ 740.7(d)(5)(i)(A) or

§ 740.7(d)(5)(i)(B)’’ in paragraph

(b)(3)(i).

Dated: January 17, 2001.

Eileen M. Albanese,

Director, Office of Exporter Services, Export

Administration.

[FR Doc. 01–1863 Filed 1–19–01; 8:45 am]

BILLING CODE 3510–33–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 10, 14, and 16

[Docket No. 98–1042]

Revision of Administrative Practices

and Procedures; Meetings and

Correspondence; Public Calendars

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending its

regulations relating to meetings,

correspondence, and the agency’s public

calendar. This action makes FDA’s

procedures more concise and

understandable to the public, minimizes

confusion about publicly available

information concerning agency

meetings, provides for more effective

disclosure of such information, and

allows the FDA to reallocate resources

to areas of more urgent public health

need.

DATES: This rule is effective January 22,

2001.

FOR FURTHER INFORMATION CONTACT:

Brian Mayhew, Office of Policy (HF–22),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–5211, e-mail:

bmayhew@oc.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of December

17, 1998 (63 FR 69575), FDA issued a

proposed rule to modify certain

regulations pertaining to the public

calendar and public meetings because

such regulations are no longer effective

in serving their intended purposes.

In that proposed rule, FDA tentatively

concluded that the proposed action

would make its procedures for public

calendars and public meetings more

concise and understandable to the

public, minimize confusion about

publicly available information

6466 Federal Register / Vol. 66, No. 14 / Monday, January 22, 2001 / Rules and Regulations

concerning agency meetings, provide for

more effective disclosure of such

information, and allow FDA to

reallocate resources to areas of more

urgent public health need.

Interested parties were given until

March 2, 1999, to comment on the

proposal. Three letters, each containing

one or more comments, were received in

response to the proposal. Such letters

were from a research laboratory, a blood

bank association, and a research

institute. The blood bank association

supported the proposal, while the two

other organizations suggested a number

of modifications. The comments

received and FDA’s responses are

addressed below.

II. Comments and Agency Response

A. The Prospective Public Calendar

(Comment 1) The proposed regulation

would eliminate the prospective public

calendar. Three comments addressed

the elimination. One comment

suggested that FDA evaluate whether

the use of the prospective public

calendar affects participation in FDA

sponsored events before eliminating the

prospective public calendar. Another

comment noted that the proposed rule

included no data to support the agency’s

tentative conclusion that maintenance

of the prospective public calendar is no

longer practical, workable, or beneficial

to the public.

While the agency has not formally

studied the impact of the public

calendar on the amount of participation

in a public event, FDA notes that it

generally does a great deal of outreach

through other mechanisms, including

the Federal Register, the Internet, direct

mailings, and other direct

communications. In fact, the

prospective public calendar may be one

of the least effective mechanisms for

notifying the public of upcoming public

events, given that maintenance of the

calendar has been given a lower priority

and fewer resources have been

expended to ensure that information on

the public calendar is accurate and

current. FDA has not performed a study

regarding the maintenance of the public

calendar either. However, the agency

believes that it is much more efficient to

allocate its limited resources to more

effective methods of communication to

its stakeholders.

(Comment 2) One comment requested

that FDA not abandon any important

communication mechanism such as the

prospective public calendar that is

designed to fulfill its obligation to notify

the participants about future events

until it fully examines whether some

simple improvements to the existing

system will fix problems for FDA and

the public.

Due to the extremely positive

response that the agency receives at its

public meetings, public hearings, and

other widely-attended events, the

agency believes that other mechanisms,

such as the Internet and the Federal

Register, are effectively communicating

the relevant information about FDA

events. FDA does not believe that

simple improvements to the current

prospective public calendar will

significantly improve its effectiveness.

(Comment 3) One comment asserted

that the reasons provided for removing

the prospective public calendar (i.e.,

need for frequent changes to the

calendar, difficulty in projecting entries

4 weeks in advance) do not appear

sufficient to warrant elimination of the

availability of this information from the

general public, especially in light of the

resources expended on direct mail, the

Federal Register, and FDA Internet

activities.

The agency notes that it is precisely

because of the availability of these other

mechanisms that it is deleting the

prospective public calendar

requirements from its regulations. The

agency will continue to use these very

effective and efficient mechanisms in

the future. Resources devoted to these

other mechanisms will more adequately

ensure that the public receives

information regarding FDA meetings

than if those same resources were

devoted to maintaining the prospective

public calendar.

(Comment 4) One comment stressed

the importance of the agency providing

adequate advance time for its

announcements through other

mechanisms.

The agency agrees with this comment,

and it will strive to ensure that adequate

time will be provided to the public

when it disseminates information about

public events via the Internet, the

Federal Register, or other mechanisms.

(Comment 5) One comment suggested

that with the abandonment of the

prospective public calendar, it is

extremely important that FDA maintain

the timely publication of all meeting

summaries because they are important

and useful to the public.

FDA agrees with this comment.

(Comment 6) One comment argued

that it was unrealistic to expect that the

public at large is able to access the same

information via the Internet as in the

publication it plans to discontinue.

The agency believes that Internet

access has become increasingly

widespread in recent years. However,

even in the event that a person did not

have Internet access, other mechanisms,

including Federal Register notices and

direct mail, will provide adequate

notification to the public regarding

information previously contained in the

prospective public calendar.

B. The Retrospective Public Calendar

(Comment 7) Under the proposed

regulations, only meetings between

certain senior agency officials and

persons outside the executive branch of

Government would be included on the

retrospective public calendar. If a large

number of persons is in attendance at a

meeting, the name of each person need

not be specified in the calendar entry,

and if more than one FDA

representative is in attendance, only the

most senior official would report the

meeting. One comment stated that these

proposed changes would significantly

limit the availability of potentially

important information and would

significantly restrict the range of input

reflecting the various levels within FDA.

As stated in the proposed rule (63 FR

69575), the agency finds that it has

become unduly burdensome for

assistants, deputies, and representatives

of the agency’s senior officials to report

meetings. FDA anticipates that despite

this limitation on the reporting of some

meetings, those meetings that are of

greatest interest to the public will be

reflected on the retrospective public

calendar, thereby providing an

appropriate level of public access to

information.

C. Public Meetings

(Comment 8) Under the proposed

regulations, FDA representatives may

determine when it is appropriate to

create an official transcript, recording,

or memorandum of a meeting. One

comment stated that, due to these

changes in § 10.65(b) through (f) (21

CFR 10.65(b) through (f)), the

availability of potentially important

information will be denied to the

public.

Because of limited resources, the

agency finds that the determination of

whether memoranda of a given meeting

should be prepared should be left to the

discretion of the senior agency official

attending the meeting, taking into

consideration the subject matter of the

meeting, the public interest in the issue,

and the value of using agency resources

to prepare such transcripts, recordings,

or memoranda. The agency does not

believe that this change will

significantly diminish the amount of

important information made available to

the public. This change will allow

resources to be redirected to areas of

greater public health need. This change

does not preclude a participant from

Federal Register / Vol. 66, No. 14 / Monday, January 22, 2001 / Rules and Regulations 6467

preparing a summary of the meeting for

inclusion into the administrative record,

regardless of whether the agency creates

an official record.

(Comment 9) Under the proposed

regulations, meetings may be public or

private at FDA’s discretion. One

comment requested that FDA exclude

any individual representing a company

that is the sponsor of an application

pending before the agency from the

definition of ‘‘person outside the

Federal government.’’ The reason for

this request was that the comment did

not want such an individual to have his/

her meeting denied in favor of a meeting

with a larger audience, raising issues

about confidential business information.

The agency will not schedule larger

meetings in place of necessary meetings

with a sponsor of a product with an

application pending before the agency.

Instead, this clarification in the

regulation is intended to provide the

agency with the discretion to combine

certain meeting requests of a similar

nature. The agency has no intention of

denying necessary meetings with

sponsors where confidential

information may be discussed. The

comment misinterpreted the intent of

the amendment, and the agency does

not, therefore, find it necessary to

change the definition of ‘‘person outside

the Federal Government’’

(Comment 10) One comment

suggested that FDA should publish the

criteria that it uses in making a

determination about whether a meeting

should be public or private.

The agency believes that this

comment suggests a more elaborate

process for this determination than the

agency contemplated or than the agency

believes necessary. While FDA is

increasingly striving to make its

processes open, transparent, and

predictable, the agency is continuing to

minimize an unnecessary burden on

itself or its constituents. The agency

reserves the discretion to make

determinations about whether a given

meeting is public or private on an

informal and largely ad hoc basis.

However, to the extent possible, FDA

will make every effort to honor meeting

requests and make its meetings as open

and accessible to the public as practical.

(Comment 11) One comment

suggested that the agency clarify that if

other publicly available documents,

such as hearing transcripts,

congressional letters, and hearing

testimony were not issued in a timely

fashion from other sources, FDA will

then issue a memorandum.

The agency declines to commit to

issuing of a meeting memorandum

whenever other sources do not make

other documents available. However,

FDA will make every effort to ensure

that information about meetings with

Congress covered by this rule is

available as quickly as possible.

III. Changes From the Proposed Rule

Proposed revised § 10.65(e)(1) and

(e)(2) have been modified and

redesignated as § 10.65(f) to provide

information about the filing of

memoranda or summaries in the

administrative file.

Proposed revised § 10.65(k) has been

deleted because the statutory

requirement upon which it was based

has been repealed. (Public Law 105–

362, title VI, section 601(a)(2)(A), 112

Stat. 3285 (1998).)

In this final rule, the agency is

amending § 10.100(b)(3) (21 CFR

10.100(b)(3)) to more accurately reflect

the current personnel structure of the

agency. A reorganization of the Office of

the Commissioner of Food and Drugs

(the Commissioner) has changed the

organizational structure of that office.

This reorganization reduces the number

of senior officials who would be covered

by § 10.100 (b)(3). Therefore, only the

Commissioner, Senior Associate

Commissioners, Deputy Commissioners,

Associate Commissioner for Regulatory

Affairs, Center Directors, and the Chief

Counsel will be required to report

meetings on the retrospective calendar.

IV. Environmental Impact

The agency has determined under 21

CFR 25.30(h) that this action is of a type

that would not individually or

cumulatively have a significant effect on

the human environment. Therefore,

neither an environmental assessment

nor an environmental impact statement

would be required.

V. Analysis of Impact

FDA has examined the impacts of the

final rule under Executive Order 12866

and the Regulatory Flexibility Act (5

U.S.C. 601–612) (as amended by subtitle

D of the Small Business Regulatory

Fairness Act of 1996 (Public L. 104–

121)) and the Unfunded Mandates

Reform Act of 1995 (Pub. Law 104–4).

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

net benefits (including potential

economic, environmental, public health

and safety, and other advantages;

distributive impacts; and equity).

The Regulatory Flexibility Act

requires an analysis of regulatory

options that would minimize any

significant impact of a rule on small

entities. The Unfunded Mandates

Reform Act requires that agencies

prepare an assessment of anticipated

costs and benefits before proposing any

rule that may result in an expenditure

by State, local, and tribal governments,

in the aggregate, or by the private sector,

of $100 million (adjusted annually for

inflation) in any one year. The agency

believes that this final rule is consistent

with the regulatory philosophy and

principles identified in the Executive

Order. This final rule does not impose

any mandates on State, local, or tribal

governments, nor is it a significant

regulatory action under the Unfunded

Mandates Reform Act. Furthermore, the

agency certifies that this final rule will

not have a significant economic impact

on a substantial number of small

entities. Therefore, under the Regulatory

Flexibility Act, no further regulatory

flexibility analysis is required.

VI. Paperwork Reduction Act of 1995

This regulation would impose no

reporting or recordkeeping requirements

that would necessitate Office of

Management and Budget clearance.

List of Subjects

21 CFR Part 10

Administrative practice and

procedure, News media.

21 CFR Part 14

Administrative practice and

procedure, Advisory committees, Color

additives, Drugs, Radiation protection.

21 CFR Part 16

Administrative practice and

procedure.

Therefore, under the Federal Food,

Drug, and Cosmetic Act, the Public

Health Service Act, and under authority

delegated to the Commissioner of Food

and Drugs, 21 CFR parts 10, 14, and 16

are amended to read as follows:

PART 10—ADMINISTRATIVE

PRACTICES AND PROCEDURES

1. The authority citation for 21 CFR

part 10 continues to read as follows:

Authority: 5 U.S.C. 551–558, 701–706; 15

U.S.C. 1451–1461, 21 U.S.C. 141–149, 321–

397, 467f, 679, 821 1034; 28 U.S.C. 2112; 42

U.S.C. 201, 262, 263b, 264.

§ 10.30 [Amended]

2. Section 10.30 Citizen petition is

amended in paragraph (i)(6) by

removing ‘‘§ 10.65(h)’’ and adding in its

place ‘‘§ 10.65(f)’’.

§ 10.33 [Amended]

3. Section 10.33 Administrative

reconsideration of action is amended in

paragraph (k)(6) by removing

6468 Federal Register / Vol. 66, No. 14 / Monday, January 22, 2001 / Rules and Regulations

‘‘§ 10.65(h)’’ and adding in its place

‘‘§ 10.65(f)’’.

§ 10.35 [Amended]

4. Section 10.35 Administrative stay

of action is amended in paragraph (h)(6)

by removing ‘‘§ 10.65(h)’’ and adding in

its place ‘‘§ 10.65(f)’’.

§ 10.40 [Amended]

5. Section 10.40 Promulgation of

regulations for the efficient enforcement

of the law is amended in paragraph

(g)(7) by removing ‘‘§ 10.65(h)’’ and

adding in its place ‘‘§ 10.65(f)’’.

6. Section 10.65 is revised to read as

follows:

§ 10.65 Meetings and correspondence.

(a) In addition to public hearings and

proceedings established under this part

and other sections of this chapter,

meetings may be held and

correspondence may be exchanged

between representatives of FDA and an

interested person outside FDA on a

matter within the jurisdiction of the

laws administered by the

Commissioner. Action on meetings and

correspondence does not constitute final

administrative action subject to judicial

review under § 10.45.

(b) The Commissioner may conclude

that it would be in the public interest to

hold an open public meeting to discuss

a matter (or class of matters) pending

before FDA, in which any interested

person may participate.

(1) The Commissioner shall inform

the public of the time and place of the

meeting and of the matters to be

discussed.

(2) The meeting will be informal, i.e.,

any interested person may attend and

participate in the discussion without

prior notice to the agency unless the

notice of the meeting specifies

otherwise.

(c) Every person outside the Federal

Government may request a private

meeting with a representative of FDA in

agency offices to discuss a matter. FDA

will make reasonable efforts to

accommodate such requests.

(1) The person requesting a meeting

may be accompanied by a reasonable

number of employees, consultants, or

other persons with whom there is a

commercial arrangement within the

meaning of § 20.81(a) of this chapter.

Neither FDA nor any other person may

require the attendance of a person who

is not an employee of the executive

branch of the Federal Government

without the agreement of the person

requesting the meeting. Any person may

attend by mutual consent of the person

requesting the meeting and FDA.

(2) FDA will determine which

representatives of the agency will attend

the meeting. The person requesting the

meeting may request, but not require or

preclude, the attendance of a specific

FDA employee.

(3) A person who wishes to attend a

private meeting, but who is not invited

to attend either by the person requesting

the meeting or by FDA, or who

otherwise cannot attend the meeting,

may request a separate meeting with

FDA to discuss the same matter or an

additional matter.

(d) FDA employees have a

responsibility to meet with all segments

of the public to promote the objectives

of the laws administered by the agency.

In pursuing this responsibility, the

following general policy applies where

agency employees are invited by

persons outside the Federal Government

to attend or participate in meetings

outside agency offices as representatives

of the agency.

(1) A person outside the executive

branch may invite an agency

representative to attend or participate in

a meeting outside agency offices. The

agency representative is not obligated to

attend or participate, but may do so

where it is in the public interest and

will promote the objectives of the act.

(2) The agency representative may

request that the meeting be open if that

would be in the public interest. The

agency representative may decline to

participate in a meeting held as a

private meeting if that will best serve

the public interest.

(3) An agency representative may not

knowingly participate in a meeting that

is closed on the basis of gender, race, or

religion.

(e) An official transcript, recording, or

memorandum summarizing the

substance of any meeting described in

this section will be prepared by a

representative of FDA when the agency

determines that such documentation

will be useful.

(f) FDA promptly will file in the

appropriate administrative file

memoranda of meetings prepared by

FDA representatives and all

correspondence, including any written

summary of a meeting from a

participant, that relate to a matter

pending before the agency.

(g) Representatives of FDA may

initiate a meeting or correspondence on

any matter concerning the laws

administered by the Commissioner.

Unless otherwise required by law,

meetings may be public or private at

FDA’s discretion.

(h) A meeting of an advisory

committee is subject to the requirements

of part 14 of this chapter.

7. Section 10.100 is revised to read

follows:

§ 10.100 Public calendar.

(a) Public calendar. A public calendar

will be prepared and made publicly

available by FDA each week showing, to

the extent feasible, significant events of

the previous week, including significant

meetings with persons outside the

executive branch, that involve the

representatives of FDA designated

under paragraph (c) of this section.

(1) Public calendar entries will

include:

(i) Significant meetings with members

of the judiciary, representatives of

Congress, or staffs of congressional

committees when the meeting relates to

a pending court case, administrative

hearing, or other regulatory action or

decision;

(ii) Significant meetings, conferences,

seminars, and speeches; and

(iii) Social events sponsored by the

regulated industry.

(2) The public calendar will not

include reports of meetings that would

prejudice law enforcement activities

(e.g., a meeting with an informant) or

invade privacy (e.g., a meeting with a

candidate for possible employment at

FDA), meetings with members of the

press, or meetings with onsite

contractors.

(b) Calendar entries. The calendar

will specify for each entry the date,

person(s), and subject matter involved.

If a large number of persons are in

attendance, the name of each individual

need not be specified. When more than

one FDA representative is in attendance,

the most senior agency official will

report the meeting on the public

calendar.

(c) Affected persons. The following

FDA representatives are subject to the

requirements of this section:

(1) Commissioner of Food and Drugs.

(2) Senior Associate Commissioners.

(3) Deputy Commissioners.

(4) Associate Commissioner for

Regulatory Affairs.

(5) Center Directors.

(6) Chief Counsel for the Food and

Drug Administration.

(d) Public display. The public

calendar will be placed on public

display at the following locations:

(1) Dockets Management Branch.

(2) Office of the Associate

Commissioner for Public Affairs.

(3) The FDA home page, to the extent

feasible.

PART 14—PUBLIC HEARING BEFORE

A PUBLIC ADVISORY COMMITTEE

8. The authority citation for 21 CFR

part 14 continues to read as follows:

Authority: 5 U.S.C. App. 2; 15 U.S.C.

1451–1461; 21 U.S.C. 141–149, 321–394,

Federal Register / Vol. 66, No. 14 / Monday, January 22, 2001 / Rules and Regulations 6469

467f, 679, 821, 1034; 28 U.S.C. 2112; 42

U.S.C. 201, 262, 263b, 264.

§ 14.20 [Amended]

9. Section 14.20 Notice of hearing

before an advisory committee is

amended by removing paragraph (e).

PART 16—REGULATORY HEARING

BEFORE THE FOOD AND DRUG

ADMINISTRATION

10. The authority citation for 21 CFR

part 16 continues to read as follows:

Authority: 15 U.S.C. 1451–1461; 21 U.S.C.

141–149, 321–394, 467f, 679, 821, 1034; 28

U.S.C. 2112; 42 U.S.C. 201–262, 263b, 364.

§ 16.60 [Amended]

11. Section 16.60 Hearing procedure

is amended by removing paragraph

(a)(3).

Dated: January 5, 2001.

Ann M. Witt,

Acting Associate Commissioner for Policy.

[FR Doc. 01–1566 Filed 1–19–01; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 178

[Docket No. 99F–2336]

Indirect Food Additives: Adjuvants,

Production Aids, and Sanitizers

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

food additive regulations to provide for

the safe use of manganese ammonium

pyrophosphate (C.I. Pigment Violet 16)

as a colorant for all polymers intended

for use in contact with food. This action

is in response to a petition filed by

Holliday Pigments, Ltd.

DATES: This rule is effective January 22,

2001. Submit written objections and

requests for a hearing by February 21,

2001.

ADDRESSES: Submit written objections to

the Dockets Management Branch (HFA–

305), Food and Drug Administration,

5630 Fishers Lane, rm. 1061, Rockville,

MD 20852.

FOR FURTHER INFORMATION CONTACT:

Mark A. Hepp, Center for Food Safety

and Applied Nutrition (HFS–215), Food

and Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–418–3098.

SUPPLEMENTARY INFORMATION: In a notice

published in the Federal Register of

July 21, 1999 (64 FR 39146), FDA

announced that a food additive petition

(FAP 9B4670) had been filed by

Holliday Pigments, Ltd., Morley St.,

Kingston upon Hull, HU8 8DN

ENGLAND. The petition proposed to

amend the food additive regulations in

§ 178.3297 Colorants for polymers (21

CFR 178.3297) to provide for the safe

use of manganese ammonium

pyrophosphate (C.I. Pigment Violet 16)

as a colorant for all polymers intended

for use in contact with food.

FDA has evaluated the data in the

petition and other relevant material.

Based on this information, the agency

concludes that the proposed use of the

additive is safe, that the additive will

achieve its intended technical effect,

and therefore, that the regulations in

§ 178.3297 should be amended as set

forth below.

In accordance with § 171.1(h) (21 CFR

171.1(h)), the petition and the

documents that FDA considered and

relied upon in reaching its decision to

approve the petition are available for

inspection at the Center for Food Safety

and Applied Nutrition by appointment

with the information contact person

listed above. As provided in § 171.1(h),

the agency will delete from the

documents any materials that are not

available for public disclosure before

making the documents available for

inspection.

The agency has carefully considered

the potential environmental effects of

this action. FDA has concluded that the

action will not have a significant impact

on the human environment, and that an

environmental impact statement is not

required. The agency’s finding of no

significant impact and the evidence

supporting that finding, contained in an

environmental assessment, may be seen

in the Dockets Management Branch

(address above) between 9 a.m. and 4

p.m., Monday through Friday.

This final 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.

Any person who will be adversely

affected by this regulation may at any

time file with the Dockets Management

Branch (address above) written

objections by February 21, 2001. Each

objection shall be separately numbered,

and each numbered objection shall

specify with particularity the provisions

of the regulation to which objection is

made and the grounds for the objection.

Each numbered objection on which a

hearing is requested shall specifically so

state. Failure to request a hearing for

any particular objection shall constitute

a waiver of the right to a hearing on that

objection. Each numbered objection for

which a hearing is requested shall

include a detailed description and

analysis of the specific factual

information intended to be presented in

support of the objection in the event

that a hearing is held. Failure to include

such a description and analysis for any

particular objection shall constitute a

waiver of the right to a hearing on the

objection. Three copies of all documents

are to be submitted with the docket

number found in brackets in the

heading of this document. Any

objections received in response to the

regulation may be seen in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

List of Subjects in 21 CFR Part 178

Food additives, Food packaging.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs and redelegated to

the Director, Center for Food Safety and

Applied Nutrition, 21 CFR part 178 is

amended as follows:

PART 178—INDIRECT FOOD

ADDITIVES: ADJUVANTS,

PRODUCTION AIDS, AND SANITIZERS

1. The authority citation for 21 CFR

part 178 continues to read as follows:

Authority: 21 U.S.C. 321, 342, 348, 379e.

2. Section 178.3297 is amended in the

table in paragraph (e) by alphabetically

adding an entry under the headings

‘‘Substances’’ and ‘‘Limitations’’ to read

as follows:

§ 178.3297 Colorants for polymers.

* * * * *

(e) * * *