Federal Register / Vol. 65, No. 216 / Tuesday, November 7, 2000 / Proposed Rules 66663

1Commission rules referred to herein can be

found at 17 CFR Ch. I (2000).

2Rule 4.7(b)(3) provides the requirements for

annual report filings for pools for which exemption

from the specific requirements of Rules 4.22(c) and

(d) has been claimed pursuant to Rule 4.7(b)(3)(i).

3For filing year 1998 there were more than 200

such extensions and for filing year 1999 there were

over 300 such extensions.

revocation will become final through

the issuance of a written decision to the

laboratory in the event that the

laboratory does not appeal the proposed

denial or revocation within the thirtyday period.

(2) If accreditation is revoked, the

laboratory may be given the option of

voluntarily terminating the

accreditation.

(3) A laboratory whose accreditation

has been revoked must cease use of the

NVLAP logo on any of its reports,

correspondence, or advertising related

to the area(s) affected by the revocation.

If the revocation is total, NVLAP will

instruct the laboratory to return its

Certificate and Scope of Accreditation

and to remove the NVLAP logo from all

test or calibration reports,

correspondence, or advertising. If the

revocation affects only some, but not all

of the items listed on a laboratory’s

Scope of Accreditation, NVLAP will

issue a revised Scope that excludes the

revoked area(s) in order that the

laboratory might continue operations in

accredited areas.

(d) A laboratory whose accreditation

has been voluntarily terminated, denied

or revoked, may reapply and be

accredited if the laboratory:

(1) Completes the assessment and

evaluation process; and

(2) Meets the NVLAP conditions and

criteria for accreditation.

§ 285.14 Criteria for accreditation.

The requirements for laboratories to

be recognized by the National Voluntary

Laboratory Accreditation Program as

competent to carry out tests and/or

calibrations are contained in clauses 4

and 5 of ISO/IEC 17025, General

requirements for the competence of

testing and calibration laboratories,

including revisions from time to time.

§ 285.15 Obtaining documents.

(1) Application forms, NVLAP

handbooks, and other NVLAP

documents and information may be

obtained by contacting the NVLAP,

National Institute of Standards and

Technology, 100 Bureau Drive, Mail

Stop 2140, Gaithersburg, Maryland

20899–2140; phone: 301–975–4016; fax:

301–926–2884; e-mail: nvlap@nist.gov.

(b) Copies of all ISO/IEC documents

are available from the American

National Standards Institute, 11 West

42nd Street, 13th Floor, New York, New

York, 10036; phone: 212–642–4900; fax:

212–398–0023; web site:

<www.ansi.org>. You may inspect

copies of all applicable ISO/IEC

documents at the National Voluntary

Laboratory Accreditation Program,

National Institute of Standards and

Technology, 820 West Diamond

Avenue, Room 297, Gaithersburg, MD.

[FR Doc. 00–28577 Filed 11–6–00; 8:45 am]

BILLING CODE 3510–13–M

COMMODITY FUTURES TRADING

COMMISSION

17 CFR Part 4

Extension of Time To File Annual

Reports for Commodity Pools

AGENCY: Commodity Futures Trading

Commission.

ACTION: Proposed rule amendments.

SUMMARY: Commodity Futures Trading

Commission (‘‘Commission’’) Rules

4.22(c) and (d) 1 require that commodity

pool operators (‘‘CPOs’’) distribute

annual reports containing specified

information, certified by an

independent public accountant, to each

pool participant within 90 calendar

days after the end of the pool’s fiscal

year.2 The proposed revisions to Rule

4.22 would permit CPOs to file a claim

for an extension of time to file the pool’s

annual report where the pool is invested

in other collective investment vehicles,

and the CPO’s independent accountant

cannot obtain the information necessary

to comply with the rule in a timely

manner.

DATES: Comments must be received by

December 7, 2000.

ADDRESSES: Interested persons should

submit their views and comments to

Jean A. Webb, Secretary of the

Commission, Commodity Futures

Trading Commission, 1155 21st Street,

N.W., Washington, DC 20581. In

addition, comments may be sent by

facsimile transmission to facsimile

number (202) 418–5521, or by electronic

mail to secretary@cftc.gov. Reference

should be made to ‘‘Extension of Time

to File Annual Reports for Commodity

Pools.’’

FOR FURTHER INFORMATION CONTACT:

Kevin P. Walek, Assistant Director,

Division of Trading and Markets,

Commodity Futures Trading

Commission, 1155 21st Street, NW.,

Washington, DC 20581. Telephone:

(202) 418–5463; electronic mail:

‘‘kwalek@cftc.gov’’.

SUPPLEMENTARY INFORMATION:

I. Background

Commission Rule 4.22(c) requires a

CPO to distribute to pool participants,

and file with the Commission, an

Annual Report containing specified

financial information for each pool that

it operates. The annual report

requirement is intended to ensure that

the CPO is dealing fairly with its

participants and to provide a

mechanism to facilitate the

Commission’s inspection of the

registrant’s operations. Rule 4.22(d)

requires that an independent public

accountant certify the financial

statements contained in the Annual

Report. The CPO must file this certified

Annual Report within 90 days of the

close of the pool’s fiscal year. Rule

4.22(f) currently allows CPOs to apply

for extensions of the 90-day time

requirement where the CPO cannot

distribute the report in the required time

period without ‘‘substantial undue

hardship.’’ The Commission has had the

benefit of the assistance of National

Futures Association (‘‘NFA’’) in

processing these requests.

In recent years, the number of

extensions has risen dramatically. 3 The

majority of such requests are made by

CPOs of commodity pools that invest in

other collective investment vehicles.

(These commodity pools are commonly

referred to as ‘‘funds of funds.’’) The

CPOs of these funds of funds have

explained that they cannot obtain the

information necessary for their

independent public accountants to

finish auditing the pools’ financial

statements by the time specified in Rule

4.22(c). In order to complete the audit

of the financial statements of the pool,

the independent public accountant

needs information establishing the value

of the pool’s material investments.

These investments may be in a number

of collective investment vehicles, such

as other commodity pools, securities

funds, or hedge funds, both domestic

and offshore. The information that the

independent accountant requires is

frequently unavailable until the

collective investment vehicles complete

their own certified financial statements.

Thus, in many cases, the CPO cannot

obtain the information its independent

accountant requires about the collective

investment vehicle in time for the pool’s

Annual Report to be prepared, audited,

and distributed by the due date.

Due to the increasing number of

requests for extensions of time to file

annual reports for funds of funds, the

Commission proposes to amend its

66664 Federal Register / Vol. 65, No. 216 / Tuesday, November 7, 2000 / Proposed Rules

4The criteria for qualified eligible persons are

contained in Rule 4.7(a), as amended effective

August 4, 2000 (65 FR 67848 (August 4, 2000)).

5 47 FR 18618–18621 (April 30, 1982).

6 47 FR 18619–18620.

regulations to make these extensions

available on a standardized basis. In

order to treat similarly situated pools

fairly and equitably, the Commission

proposes that the rules contained herein

apply whether or not a CPO was

previously granted an extension of time

to file the annual reports of funds of

funds. As detailed in the next section,

CPOs would file the initial notice,

containing specified representations, in

advance of the annual report’s due date

for the first year the extension is

claimed. In subsequent years, the

representations could be made in a

statement filed at the same time as the

pool’s Annual Report.

II. Description of the Proposed

Extension

The proposed extension provisions

would be added to existing Rule 4.22(f),

which will be reorganized and

renumbered, as discussed further below.

The salient features of the extension

provisions are proposed to be included

in Rule 4.22(f)(2) as follows.

Subparagraph (i) requires that the

pool’s first notice claiming the

extension be filed within 90 days after

the end of the pool’s fiscal year (the

normal deadline for filing the annual

report). Subparagraph (ii) requires that

the CPO identify itself and the pool for

which the request is being made.

Subparagraph (iii) requires that the CPO

indicate the date by which it intends to

file and distribute the annual report,

which date must be no more than 150

calendar days after the end of the pool’s

fiscal year (that is, a maximum

extension of 60 days). Thus, the CPO

must analyze the circumstances related

to the operation of its pool and specify

the period for which relief is needed.

Commission staff have reviewed past

requests and found that, in general, the

requested extension period ranged from

30 to 60 days. Thus, the Commission

believes that up to a 60 day extension

should be sufficient in most situations.

Subparagraph (iv) requires that the CPO

provide, as part of the notice, specified

representations demonstrating the need

for the extension. The CPO will not be

required to obtain a written statement

from the independent accountant

selected to audit the pool confirming

that information in the CPO’s notice.

The CPO will be required to name the

independent accountant who has

informed the CPO of the necessity of

that information. Subparagraph (v)

provides that, in subsequent years, the

requisite representations may be made

in a statement filed at the same time as

the annual report. Finally, subparagraph

(vi) requires that the CPO responsible

for the pool’s operation sign the notice

or statement.

III. Technical Changes to Rule 4.22(f)

The new fund of funds extension

provisions are proposed to be added as

Rule 4.22(f)(2). Existing Rule 4.22(f)

would be retained. Current subsections

4.22(f)(1), 4.22(f)(2) and 4.22(f)(3) are

proposed to be renumbered as

subsections 4.22(f)(1)(i) through (iii),

respectively.

IV. Additional Consideration Regarding

Rule 4.7 Entities

Pursuant to Commission Rule 4.7,

CPOs of pools whose participants are

limited to qualified eligible persons 4

may claim exemption from certain Part

4 requirements. Among the provisions

from which the CPO may claim relief is

the requirement that the exempt pool’s

financial statements distributed to pool

participants be certified by an

independent public accountant. In the

experience of Commission staff, most

CPOs operating pools for which relief

under Rule 4.7 has been claimed

nonetheless obtain certified financial

statements to include in their annual

report. The Commission does not wish

to discourage this practice. Therefore,

CPOs may claim the relief provided in

proposed Rule 4.22(f)(2) without regard

to whether they have claimed relief

pursuant to Rule 4.7. This point is

clarified in proposed Rule 4.22(f)(2).

V. Related Matters

A. Regulatory Flexibility Act

The Regulatory Flexibility Act

(‘‘RFA’’), 5 U.S.C. 601–611 (1994),

requires that agencies, in proposing

rules, consider the impact of those rules

on small businesses. The Commission

has previously established certain

definitions of ‘‘small entities’’ to be used

by the Commission in evaluating the

impact of its rules on such entities in

accordance with the RFA.5 The

Commission previously has determined

that registered CPOs are not small

entities for the purpose of the RFA.6

Therefore, the Chairman, on behalf of

the Commission, hereby certifies,

pursuant to 5 U.S.C. 605(b), that the rule

amendments proposed herein, if

adopted, will not have a significant

economic impact on a substantial

number of small entities.

B. Paperwork Reduction Act

Proposed Rule 4.22(f)(2) affects

information collection requirements. As

required by the Paperwork Reduction

Act of 1995 (44 U.S.C. 3507(d)), the

Commission has submitted a copy of

this section to the Office of Management

and Budget for its review. Collection of

Information Rules Relating to the

Operations and Activities of Commodity

Pool Operators and Commodity Trading

Advisors and to Monthly Reporting by

Futures Commission Merchants, OMB

Control Number 3038–0005.

The expected effect of the proposed

rule will be to increase the burden

previously approved by OMB for this

collection of information by 175 hours.

Specifically, the burden associated with

proposed Rule 4.22(f)(2) is expected to

be increased by 175 hours:

Estimated number of respondents

(after proposed extension): 350.

Annual responses by each

respondent: 1.

Estimated average hours per response:

0.5.

Annual reporting burden: 175.

Organizations and individuals

desiring to submit comments on the

information collection requirements

should direct them to the Office of

Information and Regulatory Affairs,

OMB, Room 10235 New Executive

Office Building, Washington, DC 20503;

Attention: Desk Officer for the

Commodity Futures Trading

Commission. The Commission

considers comments by the public on

this proposed collection of information

in—

• Evaluating whether the proposed

collection of information is necessary

for the proper performance of the

functions of the Commission, including

whether the information will have a

practical use;

• Evaluating the accuracy of the

Commission’s estimate of the burden of

the proposed collection of information,

including the validity of the

methodology and assumptions used;

• Enhancing the quality, usefulness,

and clarity of the information to be

collected; and

•Minimizing the burden of collection

of information on those who are to

respond, including through the use of

appropriate automated electronic,

mechanical, or other technological

collection techniques or other forms of

information technology, e.g., permitting

electronic submission of responses.

OMB is required to make a decision

concerning the collection of information

contained in these proposed regulations

between 30 and 60 days after

publication of this document in the

Federal Register / Vol. 65, No. 216 / Tuesday, November 7, 2000 / Proposed Rules 66665

Federal Register. Therefore, a comment

to OMB is best assured of having its full

effect if OMB receives it within 30 days

of publication. This does not affect the

deadline for the public to comment to

the Commission on the proposed

regulations. Copies of the information

collection submission to OMB are

available from the CFTC Clearance

Officer, 1155 21st Street N.W.,

Washington, DC 20581, (202) 418–5160.

List of Subjects in 17 CFR Part 4

Brokers, Commodity futures.

In consideration of the foregoing and

pursuant to the authority contained in

the Commodity Exchange Act and in

particular sections 2(a)(1), 4l, 4m, 4n,

4o, and 8a, 7 U.S.C. 2, 6l, 6m, 6n, 6o,

and 12(a), the Commission hereby

proposes to amend Chapter I of Title 17

of the Code of Federal Regulations as

follows:

PART 4—COMMODITY POOL

OPERATORS AND COMMODITY

TRADING ADVISORS

1. The authority citation for part 4

continues to read as follows:

Authority: 7 U.S.C. 1a, 2, 4, 6b, 6c, 6l, 6m,

6n, 6o, 12a, and 23.

2. Section 4.22 is amended by:

a. redesignating paragraphs (f)(1)

introductory text, (f)(1)(i), (f)(1)(ii),

(f)(1)(iii), and (f)(1)(iv) as (f)(1)(i)

introductory text, (f)(1)(i)(A), (f)(1)(i)(B),

(f)(1)(i)(C), and (f)(1)(i)(D);

b. redesignating paragraphs (f)(2)

introductory text, (f)(2)(i), and (f)(2)(ii)

as (f)(1)(ii) introductory text, (f)(1)(ii)(A),

and (f)(1)(ii)(B);

c. redesignating paragraphs (f)(3)

introductory text, (f)(3)(i), and (f)(3)(ii)

as (f)(1)(iii) introductory text,

(f)(1)(iii)(A), and (f)(1)(iii)(B); and

d. adding a new paragraph (f)(2) to

read as follows:

§ 4.22 Reporting to pool participants.

* * * * *

(f) * * *

(2) In the event a commodity pool

operator finds that it cannot obtain

information necessary to prepare

certified financial statements for a pool

that it operates within the time specified

in either paragraph (c) of this section or

§4.7(b)(3)(i), as a result of the pool

investing in another collective

investment vehicle, it may claim an

extension of time under the following

conditions:

(i) The commodity pool operator

must, within 90 calendar days of the

end of the pool’s fiscal year, file a notice

with National Futures Association and

the Commission, except as provided in

paragraph (f)(2)(v) of this section.

(ii) The notice must contain the name,

main business address, main telephone

number and the National Futures

Association registration identification

number of the commodity pool operator,

and name and the identification number

of the commodity pool.

(iii) The notice must state the date by

which the Annual Report will be

distributed and filed (the ‘‘Extended

Date’’), which must be no more than 150

calendar days after the end of the pool’s

fiscal year. The Annual Report must be

distributed and filed by the Extended

Date.

(iv) The notice must include

representations by the commodity pool

operator that:

(A) The pool for which the Annual

Report is being prepared has

investments in one or more collective

investment vehicles (the

‘‘Investments’’);

(B) The commodity pool operator has

been informed by the certified public

accountant selected to audit the

commodity pool’s financial statements

that specified information establishing

the value of the Investments is

necessary in order for the accountant to

render an opinion on the commodity

pool’s financial statements. The notice

must include the name of the

accountant; and

(C) The information specified by the

accountant cannot be obtained in

sufficient time for the Annual Report to

be prepared, audited, and distributed

before the Extended Date.

(v) For each fiscal year following the

filing of the notice described in

paragraph (f)(2)(i) of this section, the

commodity pool operator may claim the

extension of time by filing a statement

containing the representations specified

in paragraph (f)(2)(iv) of this section, at

the same time as the pool’s annual

report.

(vi) Any notice or statement filed

pursuant to paragraph (f)(2) of this

section must be signed by the

commodity pool operator in accordance

with paragraph (h) of this section.

* * * * *

Issued in Washington, D.C. on October 31,

2000 by the Commission.

Jean A. Webb,

Secretary of the Commission.

[FR Doc. 00–28367 Filed 11–6–00; 8:45 am]

BILLING CODE 6351–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 314

[Docket No. 00N–1545]

Applications for FDA Approval to

Market a New Drug; Proposed Revision

of Postmarketing Reporting

Requirements

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule.

SUMMARY: The Food and Drug

Administration (FDA) is proposing to

amend its regulations describing

postmarketing reporting requirements to

implement certain provisions of the

Food and Drug Administration

Modernization Act of 1997 (the

Modernization Act). The proposed

changes apply to drug products that are

life supporting, life sustaining, or

intended for use in the prevention of a

serious disease or condition and that

were not originally derived from human

tissue and replaced by a recombinant

product. The proposed rule would

implement provisions of the

Modernization Act by requiring an

applicant who is the sole manufacturer

of one of these products to notify FDA

at least 6 months before discontinuing

manufacture of the drug product.

DATES: Submit written comments by

February 5, 2001.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852. Comments

should be identified with the docket

number found in brackets in the

heading of this document. See the

SUPPLEMENTARY INFORMATION section for

electronic access to the guidance for

industry referred to in this proposed

rule. Submit written requests for single

copies of the guidance referred to in this

proposal to the Drug Information Branch

(HFD–210), Center for Drug Evaluation

and Research (CDER), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857; or the Office of

Communication, Training, and

Manufacturers Assistance (HFM–40),

Center for Biologics Evaluation and

Research (CBER), Food and Drug

Administration, 1401 Rockville Pike,

Rockville, MD 20852–1448, FAX 1–888–

CBERFAX or 301–827–3844. Send two

self-addressed adhesive labels to assist

the office in processing your request.

Requests should be identified with the