Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Rules and Regulations 1257

Action Compliance Time Procedures

(2) Modify the windshield deicing system wires

and circuit breakers. You may remove the

POH temporary revision referenced in paragraph (d)(1) of this AD after accomplishing

this modification..

Within the next 12 months after February 24,

2001 (the effective date of this AD), unless

already accomplished..

In accordance with the modification procedures in the Accomplishment Instructions

section of Pilatus Service Bulletin No. 30–

006, dated May 22, 2000.

(3) Do not install, on any affected airplane, P/N

959.81.10.107 LH and P/N 959.81.10.108

RH windshields (PPG P/N NP172121–5 LH

and NP172121–6 RH or FAA-approved

equivalent part numbers), without incorporating the modification required in paragraph (d)(2) of this AD..

As of February 24, 2001 (the effective date of

this AD.).

Not applicable.

Note 1: Temporary Revision No. 21 to PC–

12 Pilot’s Operating Handbook, Report No.

01973–001, Section 2, Windshield Heater

Operation 101–320, Issued: May 19, 2000,

eliminates the need for Temporary Revision

No. 14 in the POH.

(e) Can I comply with this AD in any other

way? You may use an alternative method of

compliance or adjust the compliance time if:

(1) Your alternative method of compliance

provides an equivalent level of safety; and

(2) The Manager, Small Airplane

Directorate, approves your alternative.

Submit your request through an FAA

Principal Maintenance Inspector, who may

add comments and then send it to the

Manager, Small Airplane Directorate.

Note 2: This AD applies to each airplane

identified in paragraph (a) of this AD,

regardless of whether it has been modified,

altered, or repaired in the area subject to the

requirements of this AD. For airplanes that

have been modified, altered, or repaired so

that the performance of the requirements of

this AD is affected, the owner/operator must

request approval for an alternative method of

compliance in accordance with paragraph (e)

of this AD. The request should include an

assessment of the effect of the modification,

alteration, or repair on the unsafe condition

addressed by this AD; and, if you have not

eliminated the unsafe condition, specific

actions you propose to address it.

(f) Where can I get information about any

already-approved alternative methods of

compliance? Contact Roman T. Gabrys,

Aerospace Engineer, FAA, Small Airplane

Directorate, 1201 Walnut, suite 900, Kansas

City, Missouri 64106; telephone: (816) 329–

4141; facsimile: (816) 329–4090.

(g) What if I need to fly the airplane to

another location to comply with this AD? The

FAA can issue a special flight permit under

sections 21.197 and 21.199 of the Federal

Aviation Regulations (14 CFR 21.197 and

21.199) to operate your airplane to a location

where you can accomplish the requirements

of this AD.

(h) Are any service bulletins incorporated

into this AD by reference? Actions required

by this AD must be done in accordance with

Pilatus Service Bulletin No. 30–006, dated

May 22, 2000. The Director of the Federal

Register approved this incorporation by

reference under 5 U.S.C. 552(a) and 1 CFR

part 51. You can get copies from Pilatus

Aircraft Ltd., Customer Liaison Manager,

CH–6371 Stans, Switzerland; or from Pilatus

Business Aircraft Ltd., Product Support

Department, 11755 Airport Way, Broomfield,

Colorado 80021. You can look at copies at the

FAA, Central Region, Office of the Regional

Counsel, 901 Locust, Room 506, Kansas City,

Missouri, or at the Office of the Federal

Register, 800 North Capitol Street, NW, suite

700, Washington, DC.

(i) When does this amendment become

effective ? This amendment becomes effective

on February 24, 2001.

Note 3: The subject of this AD is addressed

in Swiss AD HB 2000–393, dated September

6, 2000.

Issued in Kansas City, Missouri, on

December 22, 2000.

Marvin R. Nuss,

Acting Manager, Small Airplane Directorate,

Aircraft Certification Service.

[FR Doc. 01–184 Filed 1–5–01; 8:45 am]

BILLING CODE 4910–13–U

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 14

[Docket No. 00N–1634]

Public Hearing Before a Public

Advisory Committee; Examination of

Administrative Record and Other

Advisory Committee Records

AGENCY: Food and Drug Administration,

HHS.

ACTION: Direct final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending its

administrative regulations governing the

public disclosure of written information

for consideration by an advisory

committee at an advisory committee

meeting. This action amends the

regulations to state that the written

information for consideration by an

advisory committee at a committee

meeting is available for public

disclosure, whenever practicable, before

or at the time of the meeting. FDA is

taking this action to reflect current FDA

policy in conformance with applicable

law. Elsewhere in this issue of the

Federal Register, FDA is publishing a

companion proposed rule, under FDA’s

usual procedure for notice-andcomment rulemaking, to provide a

procedural framework to finalize the

rule in the event the agency receives any

significant adverse comments and

withdraws this direct final rule.

DATES: This rule is effective May 23,

2001. Submit written comments by

March 26, 2001. If no timely significant

adverse comments are received, the

agency will publish a document in the

Federal Register before April 23, 2001,

confirming the effective date of the

direct final rule. The agency intends to

make the direct final rule effective 30

days after publication of the

confirmation notice in the Federal

Register. If timely significant adverse

comments are received, the agency will

publish a document of significant

adverse comments in the Federal

Register and withdraw this direct final

rule before April 23, 2001.

ADDRESSES: Submit written comments

on the direct final rule to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 5630 Fishers

Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Andrea C. Masciale, Center for Drug

Evaluation and Research (HFD–7), Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–594–

2041.

SUPPLEMENTARY INFORMATION:

I. Discussion

A. Background

Advisory committees provide

independent advice and

recommendations to FDA on scientific

and technical matters related to

products regulated by the agency. To

assist committee members in preparing

to discuss the issues that will be raised

at a committee meeting, the agency and,

in certain circumstances, affected

members of the regulated industry

prepare written background materials

1258 Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Rules and Regulations

for committee members. Generally,

advisory committee members are

provided these materials soon after they

are completed, often weeks before a

committee meeting.

FDA’s advisory committees are

established under the Federal Advisory

Committee Act (5 U.S.C. app. 2) (the

FACA). FDA’s procedures for the

administration of advisory committees

are set forth in part 14 (21 CFR part 14).

Section 14.75(a)(1) states that, unless it

is otherwise exempt from disclosure,

written information for consideration by

the committee at the meeting should be

available for public disclosure at the

same time it is made available to the

committee. As described below, FDA

finds this provision for simultaneous

disclosure unnecessary and detrimental

to the advisory committee process.

Therefore, FDA is amending this

provision in its administrative

regulations.

B. Rationale for the Rule

As interpreted by case law, the FACA

requires that, whenever practicable and

subject to any applicable exemption of

the Freedom of Information Act (the

FOIA) (5 U.S.C. 552), information

prepared for or provided to an advisory

committee be made publicly available

before or at the time of the advisory

committee meeting at which the

information is used and discussed (see,

e.g., Food Chemical News v. Department

of Health and Human Services, 980 F.2d

1468 (D.C. Cir. 1992)). Therefore, FDA’s

provision for disclosing information to

the public at the same time the

information is provided to the advisory

committee (§ 14.75(a)(1)) goes beyond

the requirements of the FACA. The

agency is not obligated under the FACA

to provide the materials to the public at

the same time they are provided to the

advisory committee.

Under § 14.75(b)(1), the public

disclosure provision of § 14.75(a)(1) is

subject to FDA’s regulations in part 20

(21 CFR part 20). The regulations in part

20 describe the agency’s policies and

procedures for disclosing information to

the public under the FOIA. Information

that generally may be released to the

public, including information described

in § 14.75(a)(1), may not be released if

it falls within one or more of the

exemptions described in part 20.

Written materials provided to an

advisory committee for consideration at

a committee meeting often include

information that is not made publicly

available because the information is

subject to one or more of the following

exemptions: (1) Trade secrets and

commercial or financial information

that is privileged or confidential

(§ 20.61); (2) inter- or intra-agency

memoranda or letters (§ 20.62); and (3)

personnel, medical, and similar files,

the disclosure of which constitutes a

clearly unwarranted invasion of

personal privacy (§ 20.63).

If written materials contain some

information that is disclosable and some

information that is not subject to

disclosure, the agency can make the

materials available to the public after

deleting the nondisclosable information

(§ 20.22). The process of reviewing the

advisory committee materials,

determining which information is

exempt from disclosure, and redacting

the documents to remove the

nondisclosable information requires a

significant amount of time. For example,

in the Federal Register of December 22,

1999 (64 FR 71794), FDA announced the

availability of a draft guidance

document entitled ‘‘Disclosing

Information Provided to Advisory

Committees in Connection With Open

Advisory Committee Meetings Related

to the Testing or Approval of New Drugs

and Convened by the Center for Drug

Evaluation and Research, Beginning on

January 1, 2000.’’ In the draft guidance

document, the agency described a 4-

week process of reviewing and redacting

an advisory committee package

submitted by a sponsor of a new drug

application and a 3-week process of

reviewing and redacting an advisory

committee package generated by the

Center for Drug Evaluation and

Research.

Materials that are otherwise exempt

from disclosure under §§ 20.61, 20.62,

and 20.63, however, may be disclosed to

advisory committee members who are

special government employees for use

in connection with their work on an

advisory committee (§ 20.84). Therefore,

the materials provided to advisory

committee members need not go

through the extensive and timeconsuming review and redaction

process.

Advisory committees provide

meaningful advice to FDA on technical

and scientific matters related to the

development and evaluation of FDAregulated products. The value of the

advice provided by FDA advisory

committees depends, in large part, on

the ability of advisory committee

members to evaluate diverse, complex,

and sometimes contentious scientific

issues during the course of a committee

meeting. It is crucial that the agency

provide advisory committee members

background information as soon as

practicable after the materials are

generated so the members can

adequately prepare for the meeting.

Because § 14.75(a)(1) provides for the

public availability of these materials at

the same time as the materials are

provided to an advisory committee, and

because the advisory committee

materials often need to be redacted

before being made publicly available,

complying with § 14.75(a)(1) would

require the agency to wait until the

materials are redacted before sending

the information to the advisory

committees. This, in turn, would result

in less time for the committee members

to review the materials prior to the

committee meeting. This delay would

be detrimental to the advisory

committee process. Furthermore,

simultaneous availability of briefing

materials to the advisory committee and

to the public is not required under the

FACA.

Therefore, the agency is amending

§ 14.75(a)(1) to state that the written

information for consideration by an

advisory committee at any meeting is

available for public disclosure whenever

practicable, before or at the time of the

meeting.

II. Direct Final Rulemaking

FDA has determined that the subject

of this rulemaking is suitable for a direct

final rule. This direct final rule revises

§ 14.75(a)(1) to reflect current agency

policy in conformance with applicable

law. The actions taken should be

noncontroversial, and the agency does

not anticipate receiving any significant

adverse comment on this rule.

If FDA does not receive significant

adverse comment by March 26, 2001,

the agency will publish a document in

the Federal Register before April 23,

2001, confirming the effective date of

the direct final rule. The agency intends

to make the direct final rule effective 30

days after publication of the

confirmation document in the Federal

Register. A significant adverse comment

is one that explains why the rule would

be inappropriate, including challenges

to the rule’s underlying premise or

approach, or would be ineffective or

unacceptable without a change. A

comment recommending a rule change

in addition to this rule will not be

considered a significant adverse

comment unless the comment states

why this rule would be ineffective

without the additional change. If timely

significant adverse comments are

received, the agency will publish a

notice of significant adverse comment in

the Federal Register withdrawing this

direct final rule before April 23, 2001.

Elsewhere in this issue of the Federal

Register, FDA is publishing a

companion proposed rule, identical to

the direct final rule, that provides a

procedural framework within which the

Federal Register / Vol. 66, No. 5 / Monday, January 8, 2001 / Rules and Regulations 1259

rule may be finalized in the event the

direct final rule is withdrawn because of

significant adverse comment. The

comment period for the direct final rule

runs concurrently with that of the

companion proposed rule. Any

comments received under the

companion proposed rule will be

treated as comments regarding the direct

final rule. Likewise, significant adverse

comments submitted to the direct final

rule will be considered as comments to

the companion proposed rule and the

agency will consider such comments in

developing a final rule. FDA will not

provide additional opportunity for

comment on the companion proposed

rule.

If a significant adverse comment

applies to part of this rule and that part

may be severed from the remainder of

the rule, FDA may adopt as final those

parts of the rule that are not the subject

of a significant adverse comment. A full

description of FDA’s policy on direct

final rule procedures may be found in

a guidance document published in the

Federal Register of November 21, 1997

(62 FR 62466).

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

direct final rule under Executive Order

12866, the Regulatory Flexibility Act (5

U.S.C. 601–612), and the Unfunded

Mandates Reform Act of 1995 (2 U.S.C.

1501 et seq.). 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 agency

believes that this rule is consistent with

the regulatory philosophy and

principles identified in Executive Order

12866 and in the other two statutes.

This rule is not a significant regulatory

action as defined by the Executive

order.

Under the Regulatory Flexibility Act,

if a rule has a significant impact on a

substantial number of small entities, an

agency must analyze regulatory options

that would minimize any significant

impact of the rule on small entities. The

agency has considered the effect that

this rule will have on small entities.

Because the rule amends only internal

agency procedures, the agency certifies

that the rule will not have a significant

economic impact on a substantial

number of small entities. Therefore,

under the Regulatory Flexibility Act, no

further analysis is required.

Section 202(a) of the Unfunded

Mandates Reform Act of 1995 (Public

Law 104–4) requires that agencies

prepare a written statement 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 in any

one year (adjusted annually for

inflation). FDA is not required to

prepare a statement of the costs and

benefits of this rule because the rule is

not expected to result in any 1-year

expenditure that would exceed $100

million adjusted for inflation. The

current inflation-adjusted statutory

threshold is $110 million.

V. Federalism

FDA has analyzed this final rule in

accordance with the principles set forth

in Executive Order 13132. FDA has

determined that the final rule does not

contain policies that have substantial

direct effects on the States, on the

relationship between the National

Government and the States, or on the

distribution of power and

responsibilities among the various

levels of government. Accordingly, the

agency has concluded that the final rule

does not contain policies that have

federalism implications as defined in

the order and, consequently, a

federalism summary impact statement is

not required.

VI. Paperwork Reduction Act of 1995

This direct final rule does not require

information collections and, thus, is not

subject to review by the Office of

Management and Budget under the

Paperwork Reduction Act of 1995.

VII. Request for Comments

Interested persons may submit to the

Dockets Management Branch (address

above) written comments regarding this

rule by March 26, 2001. 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 Dockets Management Branch

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

through Friday.

List of Subjects in 21 CFR Part 14

Administrative practice and

procedure, Advisory committees, Color

additives, Drugs, Radiation protection.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, 21 CFR part 14 is

amended to read as follows:

PART 14—PUBLIC HEARING BEFORE

A PUBLIC ADVISORY COMMITTEE

1. The authority citation for 21 CFR

part 14 is revised to read as follows:

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

1451–1461; 21 U.S.C. 41–50, 141–149, 321–

394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42

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

2. Section 14.75 is amended by

revising paragraph (a)(1) to read as

follows:

§ 14.75 Examination of administrative

record and other advisory committee

records.

(a) * * *

(1) The written information for

consideration by the committee at any

meeting: Whenever practicable, before

or at the time of the meeting.

* * * * *

Dated: December 29, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 01–389 Filed 1–5–01; 8:45 am]

BILLING CODE 4160–01–F

COURT SERVICES AND OFFENDER

SUPERVISION AGENCY FOR THE

DISTRICT OF COLUMBIA

28 CFR Chapter VIII

[CSOSA–0001]

RIN 3225–ZA00

Organization and Functions

AGENCY: Court Services and Offender

Supervision Agency for the District of

Columbia.

ACTION: Final rule.

SUMMARY: The Court Services and

Offender Supervision Agency for the

District of Columbia (‘‘CSOSA’’) is

issuing regulations describing its

organization and general functions. This

description includes information on the

District of Columbia Pretrial Services

Agency (‘‘PSA’’), an independent entity

within CSOSA. CSOSA provides

supervisory and treatment services to

individuals on probation, parole and

supervised release for District of

Columbia Code violations. CSOSA also