46192 Federal Register / Vol. 62, No. 169 / Tuesday, September 2, 1997 / Rules and Regulations

(2) If any cracking is detected, prior to

further flight, accomplish the requirements of

either paragraph (b)(2)(i) or (b)(2)(ii) of this

AD.

(i) Replace the cracked fuse pin with a new

straight fuse pin, P/N 311N5067–1, and prior

to the accumulation of 2,500 total flight

cycles on the newly installed straight fuse

pin, perform an eddy current inspection to

detect fatigue cracking in the new straight

fuse pin, in accordance with the procedures

described in the alert service bulletin. Repeat

this inspection thereafter at intervals not to

exceed 750 flight cycles on the newly

installed straight fuse pin. Or

(ii) Replace the cracked fuse pin with a

new 15–5PH fuse pin, P/N 311N5217–1, and

prior to the accumulation of 14,000 total

flight cycles on the newly installed 15–5PH

fuse pin, perform an eddy current inspection

to detect fatigue cracking in the fuse pin, in

accordance with the procedures described in

the alert service bulletin. Repeat the

inspection thereafter at intervals not to

exceed 3,500 flight cycles on the newly

installed 15–5PH fuse pin.

(c) For airplanes equipped with bulkhead

fuse pins, P/N 311N5211–1: Within 3,000

flight cycles on the bulkhead fuse pins after

April 10, 1996 (the effective date of AD 96–

05–08, amendment 39–9534), replace the

bulkhead fuse pin with a new 15–5PH fuse

pin, P/N 311N5217–1, in accordance with

Boeing Service Bulletin 757–54A0020,

Revision 5, dated March 17, 1994, or Boeing

Alert Service Bulletin 757–54A0020,

Revision 6, dated July 18, 1997, and

accomplish the requirements of paragraph (d)

of this AD.

(d) For airplanes equipped with 15–5PH

fuse pins: Prior to the accumulation of 14,000

total flight cycles on the 15–5PH fuse pins,

perform an eddy current inspection to detect

fatigue cracking in those fuse pins, in

accordance with the procedures described in

Boeing Alert Service Bulletin 757–54A0020,

Revision 6, dated July 18, 1997.

(1) If no cracking is detected, repeat the

inspection thereafter at intervals not to

exceed 3,500 flight cycles on the 15–5PH fuse

pin.

(2) If any cracking is detected, prior to

further flight, replace the cracked 15–5PH

fuse pin with a new 15–5PH fuse pin, P/N

311N5217–1, and prior to the accumulation

of 14,000 total flight cycles on the newly

installed 15–5PH fuse pin, perform an eddy

current inspection to detect fatigue cracking

in the newly installed 15–5PH fuse pin; in

accordance with the procedures described in

the alert service bulletin. Repeat the

inspection thereafter at intervals not to

exceed 3,500 flight cycles on the newly

installed 15–5PH fuse pin.

(e) Fuse pins must be of the same type on

the same strut. For example, a steel fuse pin

having P/N 311N5067–1 may not be installed

on the same strut that has a 15–5PH fuse pin

having P/N 311N5217–1 installed on that

strut. However, fuse pins on one strut may

differ from those on another strut, provided

the fuse pins are not of mixed types on the

same strut.

(f) An alternative method of compliance or

adjustment of the compliance time that

provides an acceptable level of safety may be

used if approved by the Manager, Seattle

Aircraft Certification Office (ACO), FAA,

Transport Airplane Directorate. Operators

shall submit their requests through an

appropriate FAA Principal Maintenance

Inspector, who may add comments and then

send it to the Manager, Seattle ACO.

Note 3: Information concerning the

existence of approved alternative methods of

compliance with this AD, if any, may be

obtained from the Seattle ACO.

(g) Special flight permits may be issued in

accordance with sections 21.197 and 21.199

of the Federal Aviation Regulations (14 CFR

21.197 and 21.199) to operate the airplane to

a location where the requirements of this AD

can be accomplished.

(h) The inspections and replacements shall

be done in accordance with Boeing Service

Bulletin 757–54A0020, Revision 5, dated

March 17, 1994, or Boeing Alert Service

Bulletin 757–54A0020, Revision 6, dated July

18, 1997.

(1) The incorporation by reference of

Boeing Alert Service Bulletin 757–54A0020,

Revision 6, dated July 18, 1997, was

approved by the Director of the Federal

Register in accordance with 5 U.S.C. 552(a)

and 1 CFR part 51.

(2) The incorporation by reference of

Boeing Service Bulletin 757–54A0020,

Revision 5, dated March 17, 1994, was

approved previously by the Director of the

Federal Register in accordance with 5 U.S.C.

552(a) and 1 CFR part 51 as of April 10, 1996

(61 FR 9601, March 11, 1996).

(3) Copies may be obtained from Boeing

Commercial Airplane Group, P.O. Box 3707,

Seattle, Washington 98124–2207. Copies may

be inspected at the FAA, Transport Airplane

Directorate, 1601 Lind Avenue, SW., Renton,

Washington; or at the Office of the Federal

Register, 800 North Capitol Street, NW., suite

700, Washington, DC.

(i) This amendment becomes effective on

September 17, 1997.

Issued in Renton, Washington, on August

21, 1997.

Darrell M. Pederson,

Acting Manager, Transport Airplane

Directorate, Aircraft Certification Service.

[FR Doc. 97–23175 Filed 8–29–97; 8:45 am]

BILLING CODE 4910–13–U

CONSUMER PRODUCT SAFETY

COMMISSION

16 CFR Part 1015

Procedures for Disclosure or

Production of Information Under the

Freedom of Information Act;

Amendments

AGENCY: Consumer Product Safety

Commission.

ACTION: Final rule.

SUMMARY: The Electronic Freedom of

Information Act Amendments of 1996,

which amend the Freedom of

Information Act, are designed to make

government documents more accessible

to the public in electronic form. The

amendments are also intended to

expedite and streamline the process by

which agencies disclose information

generally. In this notice, the

Commission amends its Freedom of

Information Act regulations to comply

with the requirements of the new

statute.

DATES: The amendments become

effective on October 2, 1997.

FOR FURTHER INFORMATION CONTACT:

Jayme Rizzolo Epstein, Office of the

General Counsel, Consumer Product

Safety Commission, Washington, DC

20207, telephone (301) 504–0980; or

Todd Stevenson, Freedom of

Information Officer, Office of the

Secretary, Consumer Product Safety

Commission, Washington, DC 20207,

telephone (301) 504–0800.

SUPPLEMENTARY INFORMATION:

Background Information

On October 2, 1996, the President

signed into law the Electronic Freedom

of Information Act Amendments of 1996

(‘‘EFOIA’’), Public Law 231, 110 Stat.

3048 (1996). EFOIA includes provisions

authorizing or requiring agencies to

promulgate regulations implementing

certain of its requirements, including

the tracking of Freedom of Information

Act (‘‘FOIA’’) requests, the aggregation

of FOIA requests, and the expedited

processing of FOIA requests. In

addition, EFOIA changes the time limit

for responding to a FOIA request from

ten to twenty days, the requirements for

reporting on FOIA activities to

Congress, and the cases in which an

agency may extend the time for

responding to a FOIA request. EFOIA

also includes provisions regarding the

availability of documents in electronic

form, the treatment of electronic

records, and the establishment of

‘‘electronic reading rooms.’’

On May 6, 1997 the Consumer

Product Safety Commission

(‘‘Commission’’) proposed amendments

to its regulations implementing the

Freedom of Information Act, 16 CFR

Part 1015. See 62 FR 24614, May 6,

1997. The proposed amendments were

intended to revise the Commission’s

FOIA regulations to comply with

EFOIA. The Commission received three

comments in response to the proposed

amendments. The comments are

discussed below. The Commission now

issues the amendments in final form.

They are identical to the proposed

amendments, except for a few changed

words in §§ 1015.2 and 1015.5(f) that

clarify the meaning of those provisions.
Federal Register / Vol. 62, No. 169 / Tuesday, September 2, 1997 / Rules and Regulations 46193

New Provisions

A. Electronic Records

Section 3 of EFOIA amends 5 U.S.C.

552(f) to define ‘‘record’’ for purposes of

FOIA as including ‘‘any information

that would be an agency record subject

to the requirements of [5 U.S.C. section

552] when maintained by an agency in

any format, including an electronic

format.’’ Section 552(f) thus clarifies

that the term ‘‘agency record’’ includes

information stored on or by computers

as well as traditional paper documents.

The regulations amend 16 CFR 1015.1(a)

by adding language to reflect this

definition of ‘‘record’’ and to clarify that

the Commission produces all releasable

records responsive to a FOIA request,

whether in traditional paper or

electronic form.

B. Electronic Reading Room

FOIA section 552(a)(2) requires

agencies to make available for

inspection and copying the following:

(1) Final opinions and orders made in

adjudicated cases; (2) statements of

policy and interpretations not published

in the Federal Register; and (3)

administrative staff manuals and

instructions to staff that affect the

public. 5 U.S.C. 552(a)(2). As stated in

the Commission’s FOIA regulations, the

Commission maintains these materials

in its Public Information Center. 16 CFR

1015.2(a). EFOIA adds a fourth category

to the materials that agencies must place

in their reading rooms:

copies of all records * * * which have been

released to any person under [FOIA] and

which, because of the nature of their subject

matter, the agency determines have become

or are likely to become the subject of

subsequent requests for substantially the

same records.

EFOIA sec. 4; 5 U.S.C. 552(a)(2)(D).

EFOIA further requires agencies to

make available by ‘‘computer

telecommunications’’ all reading room

materials that are created on or after

November 1, 1996. The statute envisions

that each agency will ultimately have

both a traditional reading room and a

new ‘‘electronic reading room’’ on the

World-Wide Web.

Section 1015.2(c) states that the

Commission will post the requisite

materials on its Website. Where

appropriate and feasible, and as

resources permit, the Commission may

also place additional reading room

materials on the Website.

C. Multitrack Processing of Requests

EFOIA authorizes agencies to

promulgate regulations providing for

multitrack processing of requests for

records based on the amount of work

and/or time involved in processing

requests. EFOIA sec. 7(a); 5 U.S.C.

552(a)(6)(D)(i). This would expedite the

production of records where little work

or time is required. The statute states

that an agency’s regulations may

include a provision granting a FOIA

requester whose request does not

qualify for the fastest multitrack

processing an opportunity to limit the

scope of the request in order to qualify

for faster processing. 5 U.S.C.

552(6)(D)(ii).

The Commission believes that

multitrack processing is the most

efficient and fair way to process FOIA

requests. If requests were processed on

a strict first in, first out basis, easily

filled requests—for example for a press

release or Commission brochure—

would be processed only after earlierreceived, complex requests for dozens of

documents located in offices throughout

the Commission. The Commission

currently intends to process FOIA

requests on five tracks, as follows:

Track 1: Responsive documents are

available in the Office of the Secretary in

releasable form. Examples include press

releases, Commission brochures, and cleared

Commission briefing packages.

Track 2: Responsive documents are filed in

one easily identifiable location, but must be

located and copied, and require internal

clearance. Examples include meeting logs,

technical reports and contractor reports.

Track 3: Responsive documents are located

in various Commission offices and require

internal clearance.

Track 4: Responsive documents require

both internal clearance and review by

identified manufacturers pursuant to sections

6 (a) and/or (b) of the Consumer Product

Safety Act, 15 U.S.C. 2055 (a) and (b).

Examples include requests for information

regarding Commission investigations of

specific products and/or companies.

Track 5: Responsive documents are

voluminous or are located in various

Commission offices, and require section 6(a)

and/or (b) review.

In general, when a request is received,

the Freedom of Information Office will

review it and categorize it for tracking

purposes. Requests within each ‘‘track’’

will then be processed according to the

date of receipt within each category.

This should help further expedite

responses to FOIA requests that are

easier to fill. Of course, many requests

are unique and will not easily fit one of

the above descriptions. Others may

appear to qualify for a fast track but

prove complex once the search for the

responsive documents is underway. As

the Office of the Secretary implements

and gains experience with the

multitrack system, adjustments will

almost certainly be required.

Pursuant to section 1015.3(e), the

Office of the Secretary may contact

requesters whose requests do not appear

to qualify for the fastest tracks and

provide such requesters the opportunity

to limit their requests so they qualify for

a faster track. Such notification will be

at the discretion of the Office of the

Secretary and will depend largely on

whether that Office believes that a

narrowing of the request could put the

request on a faster track. The regulation

further provides that requesters who

believe that their requests qualify for the

fastest tracks and who wish to be

notified if the Office of the Secretary

disagrees may so indicate in the request.

If practicable, the Office of the Secretary

may also work with such requesters to

limit their requests to qualify for a faster

track.

D. Time Limit for Responding to

Requests

1. General: EFOIA lengthened the

time within which agencies must

respond to FOIA requests from ten to

twenty working days. EFOIA sec. 8(b);

5 U.S.C. 552(a)(6)(A)(i). The regulations

amend the Commission’s current

regulations to conform to the new time

limit. See 16 CFR 1015.4, 1015.5(a),

1015.6(c).

2. Extension of time in unusual

circumstances: Under FOIA section

552(a)(6)(B), agencies are permitted to

extend the time limit for responding to

a request or deciding an appeal of a

denial of a request in ‘‘unusual

circumstances,’’ as defined in that

section, for no more than ten working

days, upon written notice to the

requester. 5 U.S.C. 552(a)(6)(B). EFOIA

amends this provision to permit

agencies to extend the response time by

notifying the requesters and providing

them with an opportunity to: (1) Limit

the scope of the request so that it may

be timely answered; or (2) arrange with

the agency an alternative time frame for

processing the request. EFOIA sec. 7(b);

5 U.S.C. 552(a)(6)(B)(ii). EFOIA also

provides that a requester’s refusal to

modify a request or arrange an

alternative response time shall be

considered a factor in the judicial

review of an agency’s failure to comply

with the applicable time limits. EFOIA

does not alter the definition of ‘‘unusual

circumstances.’’

The regulations add a new paragraph

(d) to 16 CFR 1015.5 to implement the

amended provision.

3. Aggregation of related requests:

EFOIA authorizes agencies to

promulgate regulations providing for the

aggregation of related requests by the

same requester or a group of requesters

acting in concert when the requests

would, if treated as a single request,

present ‘‘unusual circumstances’’ as
46194 Federal Register / Vol. 62, No. 169 / Tuesday, September 2, 1997 / Rules and Regulations

defined in 5 U.S.C. 552(a)(6)(B). EFOIA

sec. 7(b); 5 U.S.C. 552(a)(6)(B)(iv).

Section 1015.5(e) implements this

provision. As EFOIA specifies, the

regulation provides that requests will be

aggregated only when the Commission

‘‘reasonably believes that such requests

actually constitute a single request’’ and

the requests ‘‘involve clearly related

matters.’’ Id.; 16 CFR 1015.5(e).

4. Requests for expedited processing:

EFOIA requires each agency to

promulgate regulations providing for the

expedited processing of FOIA requests

in cases of ‘‘compelling need’’ and in

other cases determined by the agency.

EFOIA sec. 8(a); 5 U.S.C. 552(a)(6)(E)(i).

The statute specifies two categories of

‘‘compelling need’’:

(1) That a failure to obtain requested

records on an expedited basis under this

paragraph could reasonably be expected to

pose an imminent threat to the life or

physical safety of an individual; or

(2) With respect to a request made by a

person primarily engaged in disseminating

information, urgency to inform the public

concerning actual or alleged Federal

Government activity.

5 U.S.C. 552(a)(6)(E)(v). Additionally,

the statute sets forth requirements for

the handling of requests for expedited

processing and for the judicial review of

agency denials of such requests. 5

U.S.C. 552(a)(6)(E) (ii)–(iv).

Section 1015.5(f) implements the

expedited processing requirements of

EFOIA. The Commission emphasizes

that it intends to strictly adhere to

Congress’ express intent that the

specified criteria for compelling need

‘‘be narrowly applied.’’ Expedited

processing will be granted only in those

cases meeting the specific statutory

requirements. H.R. Rep. 795, 104th

Cong., 2d Sess. 26 (1996)(hereafter

‘‘House Report’’). We expect that such

cases will be rare. As the legislative

history states, ‘‘the expedited process

procedure is intended to be limited to

circumstances in which a delay in

obtaining information can reasonably be

foreseen to cause a significant adverse

consequence to a recognized interest.’’

Id.

A requester seeking expedited

processing under the ‘‘imminent threat’’

category of the ‘‘compelling need’’

definition must show that: (1) The

failure to obtain the information

expeditiously threatens the life or safety

of an individual; and (2) the threat is

‘‘imminent.’’ That an individual or his

or her attorney needs information for an

approaching litigation deadline is not a

‘‘compelling need’’ under this

provision.

A requester seeking expedited

processing under the second, ‘‘urgency

to inform,’’ category must show that: (1)

he or she is ‘‘primarily engaged in

disseminating information;’’ (2) there is

an ‘‘urgency to inform the public’’ about

the information requested; and (3) the

information relates to an ‘‘actual or

alleged Federal government activity.’’

To meet the first ‘‘urgency to inform’’

criterion, the requester must show that

his or her principal occupation is

disseminating information to the public.

As the legislative history makes clear,

‘‘[a] requestor who only incidentally

engages in information dissemination,

besides other activities, would not

satisfy this requirement.’’ Id.

To meet the second ‘‘urgency to

inform’’ criterion, the requester must

show more than a general interest in the

‘‘public’s right to know.’’ See id. Rather,

as explained in the legislative history, a

requester must show that a delay in the

release of the requested information

would ‘‘compromise a significant

recognized interest,’’ and that the

requested information ‘‘pertain[s] to a

matter of current exigency to the

American public.’’ Id. (emphasis

added). A reporter seeking expedited

access to information would have to

show, for example, that processing the

requested information under the regular

time limits would harm the public’s

ability to assess the subject

governmental activity. (See also the

discussion of the comments, below, for

a further explanation of this criterion.)

The final ‘‘urgency to inform’’

criterion makes clear that the

information must relate to the activities

of the Commission and its staff. A

request for expedited processing could

thus be considered for information

relating, for example, to a Commission

decision. The Office of the Secretary

generally would not, however, grant a

request for expedited processing of

information the Commission has

collected regarding incidents involving

specific consumer products.

EFOIA also authorizes agencies to

expand the categories of requests

qualifying for expedited processing

beyond the two specified in the statute.

EFOIA sec. 8(a); 5 U.S.C. 552

(a)(6)(E)(i)(II). The Commission has

determined that no further categories

are currently necessary or appropriate.

As the legislative history explains,

‘‘Given the finite resources generally

available for fulfilling FOIA requests,

unduly generous use of the expedited

processing procedure would unfairly

disadvantage other requestors who do

not qualify for its treatment.’’ House

Report at 26.

Section 1015.5(f)(5) states that the

Secretary will process requests granted

expedited processing ‘‘as soon as

practicable.’’ See EFOIA sec. 8(a); 5

U.S.C. 552(a)(6)(E)(iii). Pursuant to this

requirement, the Office of the Secretary

will give priority to such requests.

5. Time limits and section 6(b) of the

Consumer Product Safety Act: Pursuant

to section 6(b) of the Consumer Product

Safety Act (15 U.S.C. 2055(b)), prior to

the release of information that identifies

a manufacturer or private labeler, the

Commission must ‘‘take reasonable

steps to assure * * * that [the

information] is accurate, and that [its]

disclosure is fair in the circumstances

and reasonably related to effectuating

the purposes of the [Consumer Product

Safety Act].’’ Section 6(b) requires that

the Commission notify identified

manufacturers and private labelers that

it intends to disclose information at

least 30 days prior to the disclosure. 15

U.S.C. 2055(b)(1). The manufacturer or

private labeler may then submit

comments regarding the disclosure of

the information to the Commission. Id.

If the Commission, after reviewing the

comments, decides to release the

information over the accuracy

objections of the manufacturer or

private labeler, it must so notify the firm

at least 10 days prior to the release. 15

U.S.C. 2055(b)(2).

The Supreme Court, in Consumer

Product Safety Commission v. GTE

Sylvania, Inc., 447 U.S. 102 (1980),

ruled that the Commission must follow

the requirements of section 6(b) prior to

the release of information in response to

a FOIA request. As a result, it is

frequently impossible for the

Commission to comply with FOIA time

limits when information responsive to a

request identifies a manufacturer or

private labeler. When the Office of the

Secretary receives a request for

information that requires section 6(b)

review, it routinely notifies the

requester that the response will be

delayed. Section 1015.5(g) is intended

to assure that requesters are aware of the

requirements of section 6(b) and of the

Commission’s section 6(b) regulations at

16 CFR Part 1101.

E. Estimates of the Volume of Materials

Denied

EFOIA requires that agency responses

denying information include an

estimate of the volume of any

responsive documents the agency is

withholding. EFOIA sec. 8(c); 5 U.S.C.

552(a)(6)(F). Additionally, EFOIA

requires that when an agency withholds

only a portion of a record, the response

shall indicate the amount of information

deleted on the released record, where

possible at the place of the deletion.

EFOIA sec. 9; 5 U.S.C. 552(b)(9). Section

1015.6 includes a new subparagraph
Federal Register / Vol. 62, No. 169 / Tuesday, September 2, 1997 / Rules and Regulations 46195

(b)(3) to implement these new

requirements.

F. Fees

Sections 1015.9 (e)(5) and (g)(1)

amend the current regulation on fees the

agency charges for the production of

documents to reflect current

Commission practices. Current section

1015.9(e)(5) sets forth the amount

charged for computerized records that

the Commission retrieves from an offsite

central processing system. Currently,

the majority of computer printouts are

made at the Commission’s offices, and

the specified calculation is inapplicable.

Section 1015.9(e)(5) amends the

regulation to specify a charge of ten

cents per page for computer printouts

generated at the Commission.

Section 1015.9(g)(1) currently states

that interest will be charged on fees

owed ‘‘on the 31st day following the day

on which the billing was sent.’’

(Emphasis added.) Section 1015.9(g)(1)

amends the regulation to provide that

interest will instead be calculated based

on the day the requester receives the

bill, as is the current Commission

practice.

G. Annual Report to Congress

The current Commission regulations

describe the information the

Commission submits to Congress

annually regarding the Commission’s

processing of FOIA requests. 16 CFR

1015.10. EFOIA amended the FOIA

provisions regarding reporting in several

ways, including the timing of reports

and the information to be reported.

EFOIA sec. 10; 5 U.S.C. 552(e). The

regulations amend section 1015.10 to

conform to the EFOIA reporting

requirements.

Comments

The Commission received three

comments in response to the proposed

rule, two from trade associations of

appliance manufacturers—the

Association of Home Appliance

Manufacturers (AHAM) and the Gas

Appliance Manufacturers Association

(GAMA)—and one from a journalists’

trade association—The Reporters

Committee for Freedom of the Press

(‘‘Reporters Committee’’). The appliance

manufacturers commented about the

effect of the EFOIA amendments on the

Commission’s regulations interpreting

section 6(b) of the CPSA. The Reporters

Committee objected to certain of the

provisions for expedited processing in

section 1015.5(f). The Reporters

Committee also objected to the absence

of a discussion in the regulations of

access to electronic records.

A. EFOIA and the Commission’s Section

6(b) Regulations

Section 1015.2(c) states: ‘‘The

[Commission] will maintain an

‘electronic reading room’ on the WorldWide Web for those records which are

required by 5 U.S.C. 552(a)(2) to be

available by ‘computer

telecommunications.’ ’’ The preamble to

the proposed rule explained that,

pursuant to 5 U.S.C. 552(a)(2)(D), those

records would include records that the

Commission releases under FOIA and

become, or are likely to become, the

subject of subsequent FOIA requests. 62

FR at 24615. Neither the regulation nor

the preamble further explained what

records the Commission would make

available on the Web.

AHAM and GAMA urged that the new

regulations include a provision

specifically addressing the effect of the

EFOIA electronic reading room

requirement on documents that are

subject to review under section 6(b) of

the CPSA. 15 U.S.C. 2055(b). As stated

above, section 6(b) provides

manufacturers the opportunity to

comment on the disclosure of

documents that identify them. AHAM

and GAMA noted that pursuant to 16

CFR 1101.31(d), the Commission

provides manufacturers the opportunity

to request renotification each time the

Commission receives a FOIA request for

the documents. AHAM and GAMA

asked that the regulations state that

those documents for which

manufacturers request renotification

will not be placed in the electronic

reading room.

The Commission does not currently

intend to place in either the traditional

or electronic reading rooms records that

are described in 5 U.S.C. 552(a)(2)(D), if

the identified manufacturer has

requested renotification. We do intend

to make available in the reading rooms

a list of those files that would be in the

reading rooms pursuant to 5 U.S.C.

552(a)(2)(D), but for the manufacturer’s

request for renotification.

We do not, however, agree that the

regulation should be changed in the

final rule to make this policy explicit.

Section 1015.2(c) simply states that the

Commission will comply with the

electronic reading room provision of

EFOIA. It does not—and we believe

need not—interpret the application of

EFOIA to specific Commission records.

B. Expedited Processing

As explained above, EFOIA requires

agencies to promulgate regulations

providing for the expedited processing

of requests when the requester

demonstrates a ‘‘compelling need’’ for

the information. 5 U.S.C. 552(a)(6)(E).

‘‘Compelling need’’ is defined to

include two categories of requests: (1)

Where information is necessary to

prevent an ‘‘imminent threat;’’ and (2)

where the requester shows an ‘‘urgency

to inform the public’’ about the

information. 5 U.S.C. 552(a)(6)(E)(v).

Section 1015.5(f) sets forth the criteria

and process for expedited processing. It

repeats, without interpretation, the

requirements of 5 U.S.C. 552(a)(6)(E).

The preamble to the proposed rule

elaborated upon the definition of

‘‘compelling need’’ with respect to the

‘‘urgency to inform’’ prong. 62 FR at

24,616. The Reporters Committee

objected to certain of these statements

and to the certification requirement of

16 CFR 1015.5(f)(2). As explained

below, we decline to modify the

regulation in response to these

comments.

1. Expedited Processing and

‘‘Compelling Need’’

The Reporters Committee argues that

the statement in the preamble to the

proposed rule that expedited processing

will be granted only in ‘‘truly

extraordinary circumstances’’ is too

restrictive. 62 FR at 24616. We do not

believe that this statement

mischaracterized Congress’ intent that

expedited review be ‘‘narrowly

applied.’’ H.R. Rep. 795, 104th Cong., 2d

Sess. 26 (1996). However, we have

modified the preamble and do not now

employ the phrase to which objection

was made. The Commission will grant

expedited review to all requests that

meet the strict statutory requirements

for ‘‘compelling need.’’

2. The ‘‘Urgency to Inform’’ Criteria

The Reporters Committee objects to

the preamble descriptions of the

showing necessary to support each of

the three criterion necessary to meet the

‘‘urgency to inform’’ prong of the

‘‘compelling need’’ definition:

a. ‘‘Primarily engaged in

disseminating information’’. The

preamble noted that the first ‘‘urgency

to inform’’ criterion—that the requester

is ‘‘primarily engaged in disseminating

information’’—requires a showing that

the requester’s principal occupation is

disseminating information to the public.

62 FR at 24616. The Reporters

Committee argues that this provision

requires only that the requester be

primarily engaged in disseminating the

information responsive to the particular

request, not that the requester be so

engaged generally.

We do not believe that this is a

reasonable interpretation of the statute,

as elaborated by the legislative history
46196 Federal Register / Vol. 62, No. 169 / Tuesday, September 2, 1997 / Rules and Regulations

quoted in the preamble. Although the

Commission does not intend, as the

Reporters Committee states, to ‘‘spend

time deciding what percentage of a

requester’s occupational workload is

devoted to the dissemination of

information,’’ we do intend to limit

expedited review to requests from

media representatives and others whose

‘‘main activity’’ is to disseminate

information. See H.R. Rep. 795, 104th

Cong., 2d Sess. 26 (1996) (‘‘The standard

of ‘primarily engaged’ requires that

information dissemination be the main

activity of the requester, although it

need not be their sole occupation.’’).

b. ‘‘Urgency to inform the public’’.

The Reporters Committee objects that

the preamble interpreted the term

‘‘urgency to inform’’ too narrowly, to

include only information ‘‘currently of

significant interest to the public.’’ See

62 FR at 24616. It argues that there may

be an ‘‘urgency to inform’’ the public

about information not yet publicly

known. We agree that there could be

information not yet publicly known that

is, in the words of the House Report, of

‘‘current exigency to the American

public,’’ in that failure to disseminate

the information would ‘‘compromise a

significant recognized interest.’’ See

H.R. Rep. at 26. Accordingly, we have

modified the discussion of the ‘‘urgency

to inform’’ criterion in the preamble to

this final rule. (See section D.4 of the

discussion of the New Provisions,

above.) We emphasize, however, that a

generalized interest in the public’s right

to know would be an insufficient

showing of ‘‘compelling need.’’

c. ‘‘Actual or alleged Federal

Government activity’’. The preamble to

the proposed rule explained that only

information that relates to the activities

of the Commission and its staff would

meet the third of the ‘‘urgency to

inform’’ criteria. 62 FR at 24616. The

preamble noted that the Office of the

Secretary generally would not grant a

request for expedited processing of

information the Commission has

collected regarding incidents involving

specific consumer products. Id. The

Reporters Committee objects, arguing

that because it is the mission of the

Commission to collect such information,

it cannot be excluded from expedited

review.

The preamble stated that such

information generally would not qualify

for expedited processing, a position to

which we adhere. The Commission’s

files include thousands of consumer

complaints and investigation reports

regarding incidents involving consumer

products that the Commission staff has

not analyzed or otherwise pursued.

Although the collection of such

information is a Commission activity,

we do not believe that the collection

alone makes the reports subject to

expedited processing as information

‘‘concerning actual or alleged Federal

Government activity.’’ This is not to

suggest that the Office of the Secretary

would never grant expedited processing

of a request for this information.

3. The Certification Requirement

Finally, the Reporters Committee

argues that the requirement of section

1015.5(f)(2) that requesters submit a

certified statement demonstrating

‘‘compelling need’’ is ‘‘absurd,’’

‘‘completely unexpected,’’ and designed

solely to ‘‘serve the bureaucratic

interests of the agency.’’ However, this

requirement is in the statute. Section

8(a) of EFOIA (codified at 5 U.S.C.

552(a)(6)(E)(vi)) states:

A demonstration of compelling need by a

person making a request for expedited

processing shall be made by a statement

certified by such person to be true and

correct to the best of such person’s

knowledge and belief.

C. Access to Records in Electronic

Format

The Reporters Committee objects to

the absence in the proposed regulations

of discussion of compliance with the

EFOIA provisions regarding access to

records in electronic format. Although

the Commission intends to comply with

the provisions of EFOIA, the proposed

regulations amend the Commission’s

current FOIA regulations only where the

statute specifically required or

authorized new regulations (for

example, the regulations regarding

expedited processing and the

aggregation of requests) or where the

current regulations conflict with EFOIA

(for example, the time limit for

responding to requests). The

Commission does not believe it is either

necessary or advisable to further amend

the FOIA regulations at this time.

Effective Date

The amendments become effective

October 2, 1997.

Impact on Small Business

In accordance with the Regulatory

Flexibility Act, 5 U.S.C. 605(b), the

Commission certifies that these

amendments will not have a significant

economic impact upon a substantial

number of small entities.

Environmental Considerations

These amendments do not fall within

any of the categories of Commission

activities described in 16 CFR 1021.5(b)

that have the potential for producing

environmental effects and which,

therefore, require environmental

assessments, and, in some cases,

environmental impact statements. The

Commission does not believe that the

amendments contain any unusual

aspects that may produce effects on the

human environment, nor can the

Commission foresee any circumstances

in which the amendments may produce

such effects. For this reason, neither an

environmental assessment nor an

environmental impact statement is

required.

Preemption

In accordance with Executive Order

12988 (February 5, 1996), the

Commission states that these

amendments have no preemptive effect.

Federalism Assessment

These amendments have been

evaluated for federalism implications in

accordance with Executive Order 12612,

and they raise no substantial federalism

concerns.

List of Subjects in 16 CFR Part 1015

Administrative practice and

procedure, Consumer protection,

Disclosure of information, Freedom of

information.

In accordance with the provisions of

5 U.S.C. 553 and under the authority of

the Consumer Product Safety Act, 15

U.S.C. 2051 et seq., the Commission

amends Part 1015 of Title 16, Chapter II,

of the Code of Federal Regulations as

follows:

PART 1015—PROCEDURES FOR

DISCLOSURE OR PRODUCTION OF

INFORMATION UNDER THE FREEDOM

OF INFORMATION ACT

1. The authority citation for part 1015

is revised to read as follows:

Authority: 15 U.S.C. 2051–2084; 15 U.S.C.

1261–1278; 15 U.S.C. 1471–1476; 15 U.S.C.

1211–1214; 15 U.S.C. 1191–1204; 5 U.S.C.

552.

2. Section 1015.1 is amended by

revising the second and third sentences

of paragraph (a) as follows:

§ 1015.1 Purpose and scope.

(a) * * * Official records of the

Consumer Product Safety Commission

consist of all documentary material

maintained by the Commission in any

format, including an electronic format.

These records include those maintained

in connection with the Commission’s

responsibilities and functions under the

Consumer Product Safety Act, as well as

those responsibilities and functions

transferred to the Commission under the

Federal Hazardous Substances Act,
Federal Register / Vol. 62, No. 169 / Tuesday, September 2, 1997 / Rules and Regulations 46197

Poison Prevention Packaging Act of

1970, Refrigerator Safety Act, and

Flammable Fabrics Act, and those

maintained under any other authorized

activity * * *

* * * * *

3. Section 1015.2 is amended by

revising paragraph (a) and adding

paragraph (c) as follows:

§ 1015.2 Public reference facilities.

(a) The Consumer Product Safety

Commission will maintain in a public

reference room or area the materials

relating to the Consumer Product Safety

Commission that are required by 5

U.S.C. 552(a)(2) and 552(a)(5) to be

made available for public inspection

and copying. The principal location will

be in the Office of the Secretary of the

Commission. The address of this office

is: Office of the Secretary, Consumer

Product Safety Commission, Room 502,

4330 East West Highway, Bethesda, MD

20814.

* * * * *

(c) The Consumer Product Safety

Commission will maintain an

‘‘electronic reading room’’ on the

World-Wide Web for those records that

are required by 5 U.S.C. 552(a)(2) to be

available by ‘‘computer

telecommunications.’’

4. Section 1015.3 is amended by

adding a new paragraph (e) as follows:

§ 1015.3 Requests for records and copies.

* * * * *

(e) The Consumer Product Safety

Commission uses a multitrack system to

process requests under the Freedom of

Information Act that is based on the

amount of work and/or time involved in

processing requests. Requests for

records are processed in the order they

are received within each track. Upon

receipt of a request for records, the

Secretary or delegate of the Secretary

will determine which track is

appropriate for the request. The

Secretary or delegate of the Secretary

may contact requesters whose requests

do not appear to qualify for the fastest

tracks and provide such requesters the

opportunity to limit their requests so as

to qualify for a faster track. Requesters

who believe that their requests qualify

for the fastest tracks and who wish to be

notified if the Secretary or delegate of

the Secretary disagrees may so indicate

in the request and, where appropriate

and feasible, will also be given an

opportunity to limit their requests.

5. Section 1015.4 is amended by

revising the last sentence to read as

follows:

§ 1015.4 Responses to requests for

records; responsibility.

* * * If no response is made by the

Commission within twenty working

days, or any extension thereof, the

requester and the Commission may take

the action specified in § 1015.7(e).

6. Section 1015.5 is amended by

revising the heading and the first

sentence of paragraph (a), changing the

phrase ‘‘Chairman of the Commission’’

to ‘‘General Counsel of the

Commission’’ in paragraph (b), and

adding new paragraphs (d), (e), (f), and

(g) as follows:

§ 1015.5 Time limitation on responses to

requests for records and requests for

expedited processing.

(a) The Secretary or delegate of the

Secretary shall respond to all written

requests for records within twenty (20)

working days (excepting Saturdays,

Sundays, and legal public

holidays). * * *

* * * * *

(d) If the Secretary at the initial stage

or the General Counsel at the appellate

stage determines that an extension of

time greater than ten (10) working days

is necessary to respond to a request

satisfying the ‘‘unusual circumstances’’

specified in paragraph (b) of this

section, the Secretary or the General

Counsel shall so notify the requester

and give the requester the opportunity

to:

(1) Limit the scope of the request so

that it may be processed within the time

limit prescribed in paragraph (b); or

(2) Arrange with the Secretary or the

General Counsel an alternative time

frame for processing the request or a

modified request.

(e) The Secretary or delegate of the

Secretary may aggregate and process as

a single request requests by the same

requester, or a group of requesters acting

in concert, if the Secretary or delegate

reasonably believes that the requests

actually constitute a single request

which would otherwise satisfy the

unusual circumstances specified in

paragraph (b) of this section, and the

requests involve clearly related matters.

(f) The Secretary or delegate of the

Secretary will provide expedited

processing of requests in cases where

the requester demonstrates a compelling

need for such processing.

(1) The term ‘‘compelling need’’

means:

(i) That a failure to obtain requested

records on an expedited basis could

reasonably be expected to pose an

imminent threat to the life or physical

safety of an individual; or

(ii) With respect to a request made by

a person primarily engaged in

disseminating information, that there is

an urgency to inform the public

concerning actual or alleged Federal

Government activity.

(2) Requesters for expedited

processing must include in their

requests a statement setting forth the

basis for the claim that a ‘‘compelling

need’’ exists for the requested

information, certified by the requester to

be true and correct to the best of his or

her knowledge and belief.

(3) The Secretary or delegate of the

Secretary will determine whether to

grant a request for expedited processing

and will notify the requester of such

determination within ten (10) days of

receipt of the request.

(4) Denials of requests for expedited

processing may be appealed to the

Office of the General Counsel as set

forth in § 1015.7 of this part. The

General Counsel will expeditiously

determine any such appeal.

(5) The Secretary or delegate of the

Secretary will process as soon as

practicable the documents responsive to

a request for which expedited

processing is granted.

(g) The Secretary may be unable to

comply with the time limits set forth in

this § 1015.5 when disclosure of

documents responsive to a request

under this part is subject to the

requirements of section 6(b) of the

Consumer Product Safety Act, 15 U.S.C.

2055(b), and the regulations

implementing that section, 16 CFR part

1101. The Secretary or delegate of the

Secretary will notify requesters whose

requests will be delayed for this reason.

7. Section 1015.6 is amended by

redesignating paragraph (b)(3) as (b)(4),

adding a new paragraph (b)(3), and

revising the first sentence of paragraph

(c) as follows:

§ 1015.6 Responses: Form and content.

* * * * *

(b) * * *

(3) An estimation of the volume of

requested material withheld. When only

a portion or portions of a document are

withheld, the amount of information

deleted shall be indicated on the

released portion(s) of the record. When

technically feasible, the indication of

the amount of material withheld will

appear at the place in the document

where any deletion is made. Neither an

estimation of the volume of requested

material nor an indication of the amount

of information deleted shall be included

in a response if doing so would harm an

interest protected by the exemption in 5

U.S.C. 552(b) pursuant to which the

material is withheld.

* * * * *
46198 Federal Register / Vol. 62, No. 169 / Tuesday, September 2, 1997 / Rules and Regulations

(c) If no response is made within

twenty (20) working days or any

extension thereof, the requester can

consider his or her administrative

remedies exhausted and seek judicial

relief in a United States District Court as

specified in 5 U.S.C. 552(a)(4)(B). * * *

8. Section 1015.9 is amended by

revising paragraphs (e)(5) and (g)(1) to

read as follows:

§ 1015.9 Fees for production of records.

* * * * *

(e) * * *

(5) Computerized records: $0.10 per

page of computer printouts or, for

central processing, $0.32 per second of

central processing unit (CPU) time; for

printer, $10.00 per 1,000 lines; and for

computer magnetic tapes or discs, direct

costs.

* * * * *

(g) * * *

(1) Interest will be charged on

amounts billed, starting on the 31st day

following the day on which the

requester received the bill. Interest will

be at the rate prescribed in 31 U.S.C.

3717.

* * * * *

9. Section 1015.10 is amended by

revising the introductory text and

paragraphs (b) through (g) as follows:

§ 1015.10 Commission report of actions to

Congress.

On or before February 1 of each year,

the Commission shall submit a report of

its activities with regard to freedom of

information requests during the

preceding fiscal year to the Attorney

General of the United States. This report

shall include:

* * * * *

(b)(1) The number of appeals made by

persons under such provisions, the

result of such appeals, and the reason

for the action upon each appeal that

results in a denial of information; and

(2) A complete list of all statutes that

the Commission relies upon to withhold

information under such provisions, a

description of whether a court has

upheld the decision of the Commission

to withhold information under each

such statute, and a concise description

of the scope of any information

withheld.

(c) The number of requests for records

pending before the Commission as of

September 30 of the preceding year, and

the median number of days that such

requests had been pending before the

Commission as of that date.

(d) The number of requests for records

received by the Commission and the

number of requests which the

Commission processed.

(e) The median number of days taken

by the Commission to process different

types of requests.

(f) The total amount of fees collected

by the Commission for processing

requests.

(g) The number of full-time staff of the

Commission devoted to processing

requests for records under such

provisions, and the total amount

expended by the Commission for

processing such requests.

Dated: August 26, 1997.

Sadye E. Dunn,

Secretary, Consumer Product Safety

Commission.

[FR Doc. 97–23242 Filed 8–29–97; 8:45 am]

BILLING CODE 6355–01–U

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 50, 56, 312, 314, 601, 812,

and 814

[Docket No. 97N–0342]

Implementation of Emergency

Research Informed Consent Waiver

Rule; Public Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notification of a public meeting.

SUMMARY: The Food and Drug

Administration (FDA) is announcing a

public meeting on the implementation

of a final rule that defined conditions

for an exception to the normal

requirements for obtaining informed

consent from persons participating as

subjects in research. FDA is holding the

public meeting because some parties

interested in research conducted under

the final rule have expressed to FDA a

need for additional information on

acceptable implementation procedures.

The purpose of this public meeting is to

provide an open discussion of the issues

involved in implementing the

requirements of the rule.

DATES: The public meeting will be held

on September 29 and 30, 1997. On

September 29, 1997, the meeting will be

from 9:30 a.m. to approximately 5:30

p.m. On September 30, 1997, the

meeting will be from 8 a.m. to

approximately 11:45 a.m. Registration is

recommended by September 19, 1997.

Opportunity for public participation

will be provided during both days of the

meeting. Written comments will be

accepted until October 31, 1997.

ADDRESSES: The public meeting will be

held at the Bethesda Holiday Inn, 8120

Wisconsin Ave., Bethesda, MD. Written

information and comments related to

the meeting should be sent to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857. Two copies of any

comments are to be submitted, except

that individuals may submit one copy.

FOR FURTHER INFORMATION CONTACT: Glen

D. Drew, Office of Health Affairs (HFY–

20), Food and Drug Administration,

5600 Fishers Lane, rm. 15–22, Rockville,

MD 20857, 301–443–1382, FAX 301–

443–0232.

SUPPLEMENTARY INFORMATION: The

purpose of this public meeting is to

provide an open discussion of the issues

involved in implementing the

requirements of the final rule.

Participants will be encouraged to

discuss their perspectives on

implementation of the final rule.

Members of the public are encouraged

to attend and provide comments during

periods of open discussion and to

provide written comments to the docket.

Written comments by interested parties

are encouraged, whether or not they are

able to attend the public meeting.

The requirement for obtaining the

informed consent of persons

participating in clinical research as

research subjects has long been

recognized, and has been included in

FDA’s regulations since the early 1960’s.

The current regulations on informed

consent part 50 (21 CFR part 50) and

institutional review boards (IRB’s) (21

CFR part 56) were finalized in 1981.

Those regulations require that clinical

researchers obtain informed consent

from all subjects, with narrowly limited

exceptions.

As the field of emergency medicine

evolved, treatments were developed for

conditions such as head trauma, stroke,

and heart attack that were previously

considered hopeless. The need for the

development of treatment methods

where only unsatisfactory methods

existed and to determine the

effectiveness of new treatments was

recognized in the medical community.

The importance of obtaining informed

consent as an integral part of the

protection of human subjects was also

recognized. The Subcommittee on

Regulation, Business Opportunities, and

Technology of the House Committee on

Small Business, held a hearing on May

23, 1994, that addressed problems

encountered in securing informed

consent of subjects in clinical trails of

investigational drugs and medical

devices. A coalition of acute

resuscitation and critical care

researchers held an October 1994