35130 Federal Register / Vol. 63, No. 124 / Monday, June 29, 1998 /Rules and Regulations

Devon Avenue, Des Plaines, IL 60018,

telephone: (847) 294–7477.

SUPPLEMENTARY INFORMATION:

History

Federal Register Document 98–15039,

Airspace Docket No. 98–AGL–20,

published on June 5, 1998 (63 FR 30594)

rule modified Class E Airspace at

Marion, OH. One error was discovered

in the legal description for the Class E

airspace for Marion, OH. This action

corrects that error. Correction to Final

Rule.

Accordingly, pursuant to the

authority delegated to me, the legal

description for the Class E airspace

Marion, OH, as published in the Federal

Register June 5, 1998 (63 FR 30594), (FR

Doc. 98–15039), is corrected as follows:

PART 71—[CORRECTED]

§ 71.1 [Corrected]

AGL OH E5 Marion, OH [Corrected]

On page 30594, Column 3, first line

from the top of the column, in the Class

E airspace designation for Marion, OH,

incorporated by reference in § 71.1,

correct the word ‘‘Buckyrus’’ to read

‘‘Bucyrus’’.

Issued in Des Plaines, IL on June 10, 1998.

David B. Johnson,

Acting Manager, Air Traffic Division, Great

Lakes Region.

[FR Doc. 98–16637 Filed 6–16–98; 8:45 am]

BILLING CODE 4910–13–M

FEDERAL TRADE COMMISSION

16 CFR Part 5

Exemption of Insubstantial Financial

Conflicts.

AGENCY: Federal Trade Commission

(FTC).

ACTION: Final rule.

SUMMARY: The Commission is amending

a Commission Rule to make it consistent

with the Office of Government Ethics’

regulation establishing regulatory

waivers of certain financial conflicts of

interest.

EFFECTIVE DATE: This amendment is

effective on June 29, 1998.

FOR FURTHER INFORMATION CONTACT: Ira

S. Kaye, Attorney, Federal Trade

Commission, Room 594, 6th Street and

Pennsylvania Ave., NW., Washington

DC 20580. 202–326–2426.

SUPPLEMENTARY INFORMATION: When the

Standards of Ethical Conduct for

Employees of the Executive Branch

(‘‘Standards’’), 5 CFR Part 2635, became

effective on February 3, 1993, they

superseded most of the Commission’s

own standards of conduct, 16 CFR Part

5. The Commission rescinded its

superseded standards on February 8,

1993. See 58 FR 15763 (March 24,

1993). The Commission retained Rule

5.8 because it had not been superseded

by the new Standards, but renumbered

it as Rule 5.2.

Rule 5.2(a)–(c) provides the

requirements and procedures for

seeking a waiver of a financial conflict

of interest. In addition, Rule 5.2(d) notes

that a financial interest in ‘‘[s]tocks and

bonds of a diversified mutual fund or

investment company’’ is waived

automatically, pursuant to 18 U.S.C.

208(a), provided that the employee does

not own more than one percent of the

value of the fund’s reported assets.

The U.S. Office of Government Ethics

issued a final rule, 5 CFR Part 2640,

effective on January 17, 1997, describing

a number of additional circumstances

under which a financial conflict of

interest is waived automatically. For

example, an employee may participate

in a particular matter, despite holding a

financial interest that would be affected

by the matter, if the interest arises from

the ownership of publicly traded

securities and is valued at no more than

$5000. 5 CFR 2640.202(a). Thus, the

reference to an automatic waiver in

Commission Rule 5.2(d) should be

amended to reflect the existence of these

additional regulatory waivers.

This rule amendment relates solely to

agency practice, and, thus, is not subject

to the notice and comment requirements

of the Administrative Procedure Act, 5

U.S.C. 553(a)(2), or to the requirements

of the Regulatory Flexibility Act, 5

U.S.C. 601(2).

The amended rule does not involve

the ‘‘collection of information’’ as that

term is defined by the Paperwork

Reduction Act (‘‘PRA’’), 44 U.S.C. 3501–

3520.

List of Subjects in 16 CFR Part 5

Standards of conduct.

For the reasons set forth in the

preamble, the Federal Trade

Commission amends Title 16, Chapter I,

subchapter A, of the Code of Federal

Regulations as follows:

PART 5—STANDARDS OF CONDUCT

1. The authorities citation for Part 5

continues to read as follows:

Authority: 5 U.S.C. 7301; 5 U.S.C. App.

(Ethics in Government Act of 1978); 15

U.S.C. 46(g); E.O. 12674, 54 FR 15159, 3 CFR,

1989 Comp. p. 215, as modified by E.O.

12731, 55 FR 42547, 3 CFR, 1990 Comp., p.

306, 5 CFR part 2635, unless otherwise

noted.

2. Section 5.2 is amended by revising

paragraph (d) to read as follows:

§ 5.2 Exemption of insubstantial financial

conflicts.

* * * * *

(d) Pursuant to 5 CFR Part 2640,

certain financial interests are exempted

from the provisions of 18 U.S.C. 208(a)

as being too remote to too

inconsequential to affect the integrity of

an employee’s services.

By direction of the Commission.

Benjamin I. Berman,

Acting Secretary.

[FR Doc. 98–17232 Filed 6–26–98; 8:45 am]

BILLING CODE 6750–01–M

SOCIAL SECURITY ADMINISTRATION

20 CFR Part 402

RIN 0960–AE68

Electronic Freedom of Information Act

Amendments of 1996

AGENCY: Social Security Administration.

ACTION: Final rules.

SUMMARY: These rules reflect the

changes made by the Electronic

Freedom of Information Act

Amendments (EFOIA) of 1996 that give

the public access to government

information and records maintained in

an electronic format, provide for

expedited processing of certain requests,

establish ‘‘electronic reading rooms,’’

eliminate an agency backlog of work as

a justification for delay in processing

requests, require redacted material to be

estimated or indicated in an agency’s

response, and require an agency

reference guide on FOIA to be made

available.

EFFECTIVE DATE: These rules are effective

July 29, 1998.

FOR FURTHER INFORMATION CONTACT: Ron

Martorana, Social Insurance Specialist,

3–A–6 Operations Building, 6401

Security Boulevard, Baltimore, MD

21235, (410) 965–1745 for information

about these rules. For information on

eligibility on claiming benefits, call our

national toll-free number, 1–800–772–

1213.

SUPPLEMENTARY INFORMATION: These

rules revise our existing regulations to

reflect the provisions of Pub. L. 104–

231, the Electronic Freedom of

Information Act Amendments of 1996.

Pub. L. No. 104–231 amended 5 U.S.C.

552, popularly known as the Freedom of

Information Act (FOIA), to provide

public access to information in an

electronic format, provide for expedited

processing of certain requests, establish
Federal Register / Vol. 63, No. 124 / Monday, June 29, 1998 /Rules and Regulations 35131

‘‘electronic reading rooms,’’ eliminate

an agency backlog of work as a

justification for delay in processing

requests, require redacted material to be

estimated or indicated in an agency’s

response, and require an agency

reference guide on FOIA to be made

available. The rules also make technical

changes to related rules.

According to the new law, the term

‘‘record’’ encompasses information,

subject to the requirements of the FOIA,

when maintained in any format,

including an electronic format. The

category of ‘‘reading room’’ records, at 5

U.S.C. 552(a)(2), is expanded to include

records that the agency discloses in

response to a FOIA request that have

become, or are likely to become, the

subject of future requests. An index of

those records that are subject to

multiple requests must be prepared and

made available by computer

telecommunications by December 31,

1999. Furthermore, agencies must create

an ‘‘electronic reading room’’ to contain

records created after November 1, 1996

that are required to be made available

under 5 U.S.C. 552(a)(2). Additionally,

agencies must make reasonable efforts to

search for records, even when

information is maintained in an

electronic database, unless such efforts

would significantly interfere with the

operation of the agency’s automated

information system. If a requester

requests a record in a particular format,

agencies must attempt to provide the

record in that format if the record is

readily reproducible in such format.

The general period for responding to

requests has been changed from 10 days

to 20 days. Moreover, multi-track

processing may be offered as a way to

provide more timely responses.

Agencies and requesters may discuss

alternative time frames to process

requests, or modifications to the

requests, when the general 20-day time

for responding cannot be met. Expedited

processing of requests must be done

when there is a compelling need for the

records. ‘‘Compelling need’’ means that

the failure to obtain the records on an

expedited basis could reasonably be

expected to pose an imminent threat to

the life or physical safety of an

individual, or when a request is made

by a person primarily engaged in

disseminating information (e.g., the

news media), and there is an urgency to

inform the public concerning actual or

alleged Federal Government activity.

The amount of information deleted on

a record must be indicated, unless doing

so would harm an interest protected by

an exemption; and, if technically

feasible, the indication shall be at the

place in the record where the deletion

is made. If whole pages or documents

are withheld, an estimate of the volume

of material withheld must be provided

to the requester, unless doing so would

harm an interest protected by an

exemption. Furthermore, a guide for

requesting records, to include an index

and description of major record systems,

must be made available to the public.

The definition of ‘‘record’’ in § 402.30

is revised to reflect the provisions of

section 3 of Pub. L. No. 104–231 to

include information stored in an

electronic format, and the meaning of

‘‘record’’ in the Records Disposal Act,

44 U.S.C. 3301, as well as the Supreme

Court’s decision in U.S. Dept. of Justice

v. Tax Analysts, 492 U.S. 136 (1989).

Section 402.35 is revised to reflect the

provisions of section 4 of Pub. L. No.

104–231 concerning availability of

records, extent of deletions, and a

general index of records.

Section 402.40 is revised to indicate

that SSA Publications on CD–ROM are

available for purchase.

Section 402.45 is revised to add a new

category to reading room records. These

are records which ‘‘the agency

determines have become or are likely to

become the subject of subsequent

requests for substantially the same

records.’’ Also, we have provided an

electronic index for this category of

records as reflected in section 4 of the

EFOIA amendments.

Section 402.100(b) is revised to reflect

the decision in Dept. of Justice v.

Reporters Committee for Freedom of the

Press, 489 U.S. 749 (1989) concerning

whether personal information may be

released. In that case, the Court stated

that the only public interest to be

considered is whether disclosure would

shed light on how an agency performs

its statutory duties, and that the identity

of the requester or purpose for which

the information is requested is not

relevant.

Section 402.110, entitled ‘‘Exemption

seven for withholding records: Law

enforcement’’, in 20 CFR 400–499 as

revised as of April 1, 1997 is incorrectly

designated. It should be designated as

§ 402.105.

Section 402.115, which explains the

deletion of personally identifying

details in requested records, and

§ 402.120, which explains the creation

of records, has been moved for ease of

reference to § 402.145, which explains

what we are required to do when

responding to a request for information.

Section 402.130 is revised by adding

language about the electronic

availability of a guide/handbook on how

to request information from the Social

Security Administration (SSA). We also

describe how the public can request

FOIA records.

Section 402.140 is revised to include

multi-track processing, requests for

expedited processing and the changes in

time limits as provided in sections 7

and 8 of the EFOIA amendments. The

EFOIA amendments extended the

general period of 10 days for

determining whether to comply with a

request to 20 days.

The EFOIA amendments encourage

agencies which experience difficulties

in meeting FOIA’s time limits to

experiment with multi-track processing.

Before the enactment of the EFOIA

amendments, due to increased volumes

of FOIA requests and staff losses, we

experimented with various processes to

reduce backlogs, among them multitracking. The results are encouraging

and we plan to institute multi-tracking

procedures. We have established four

tracks depending on the ease of

providing an answer:

(1) Track 1—Requests that can be answered

with readily available records or information.

These are the fastest to process.

(2) Track 2—Requests where we need

records or information from other offices

throughout the Agency, but we do not expect

that the decision on disclosure will be as

time consuming as for requests in Track 3.

(3) Track 3—Requests which require a

substantive decision or input from another

office or agency and a considerable amount

of time will be needed for that, or the request

is complicated or involves a large number of

records. Usually, these cases will take the

longest to process.

(4) Track 4—Requests that will be

expedited.

The EFOIA requires agencies to

promulgate regulations providing

expedited access for requesters who

show a ‘‘compelling need’’ for a speedy

response. The EFOIA describes

compelling need as when there is ‘‘an

imminent threat to the life or physical

safety of an individual,’’ or when it is

a request from a member of the media,

and there is an ‘‘urgency to inform the

public concerning actual or alleged

Federal Government activity.’’

Section 402.145 is revised to include

new provisions on searching for,

retrieving, and furnishing records in

electronic formats, and describes how

deletions on records will be indicated.

Section 402.150 is revised to crossrefer to § 402.45 to describe the indexing

of records for the new category of

reading room records. This describes

our procedures for releasing records for

which we receive multiple requests or

expect to receive multiple requests.

Section 402.160 is revised to correct

the reference to § 402.145(b) and (c) and

to clarify these paragraphs. These
35132 Federal Register / Vol. 63, No. 124 / Monday, June 29, 1998 /Rules and Regulations

references should read § 402.155(b) and

(c).

Comments on Notice of Proposed

Rulemaking

These regulations were published in

the Federal Register (62 FR 43489) as a

notice of proposed rulemaking on

August 14, 1997. Interested parties were

given 30 days to submit comments. No

public comments were received. We are,

therefore, publishing these final rules

with no substantive changes from the

proposed rules.

Regulatory Procedures

Executive Order No. 12866

We have consulted with the Office of

Management and Budget (OMB) and

determined that these rules do not meet

the criteria for a significant regulatory

action under Executive Order 12866.

Thus, they were not subject to

mandatory OMB review.

Regulatory Flexibility Act

We certify that these rules do not have

a significant economic impact on a

substantial number of small entities

since these rules affect only individuals.

Therefore, a regulatory flexibility

analysis as provided in the Regulatory

Flexibility Act, as amended, is not

required.

Paperwork Reduction Act

These regulations impose no

additional reporting and recordkeeping

requirements subject to OMB clearance.

(Catalog of Federal Domestic Assistance

Program Nos. 96.001 Social SecurityDisability Insurance; 96.002 Social SecurityRetirement Insurance; 96.004 Social SecuritySurvivors Insurance; 96.006 Supplemental

Security Income)

List of Subjects in 20 CFR 402

Administrative practice and

procedure, Freedom of information,

Reporting and recordkeeping.

Dated: June 18, 1998.

Kenneth S. Apfel,

Commissioner of Social Security.

For the reasons set out in the

preamble, we are amending part 402 of

20 CFR chapter III as follows:

PART 402—AVAILABILITY OF

INFORMATION AND RECORDS TO

THE PUBLIC

1. The authority citation for 20 CFR

part 402 continues to read as follows:

Authority: Secs. 205, 702(a)(5), and 1106 of

the Social Security Act; (42 U.S.C. 405,

902(a)(5), and 1306); Section 413(b) of the

Federal Mine Safety and Health Act of 1977

(30 U.S.C. 923b), 5 U.S.C. 552 and 552a; 8

U.S.C. 1360; 18 U.S.C. 1905; 26 U.S.C. 6103;

31 U.S.C. 9701; E.O. 12600, 52 FR 23781, 3

CFR, 1987 Comp., p. 235.

2. Section 402.30 is amended by

revising the definition of ‘‘records’’ to

read as follows:

§ 402.30 Definitions.

* * * * *

Records means any information

maintained by an agency, regardless of

forms or characteristics, that is made or

received in connection with official

business. This includes handwritten,

typed, or printed documents (such as

memoranda, books, brochures, studies,

writings, drafts, letters, transcripts, and

minutes) and material in other forms,

such as punchcards; magnetic tapes;

cards; computer discs or other

electronic formats; paper tapes; audio or

video recordings; maps; photographs;

slides; microfilm; and motion pictures.

It does not include objects or articles

such as exhibits, models, equipment,

and duplication machines, audiovisual

processing materials, or computer

software. It does not include personal

records of an employee, or books,

magazines, pamphlets, or other

reference material in formally organized

and officially designated SSA libraries,

where such materials are available

under the rules of the particular library.

* * * * *

3. Section 402.35 is amended by

adding new paragraph (d) to read as

follows:

§ 402.35 Publication.

* * * * *

(d) Availability by

Telecommunications. To the extent

practicable, we will make available by

means of computer telecommunications

the indices and other records that are

available for inspection.

4. Section 402.40 is amended by

adding new paragraph (h) to read as

follows:

§ 402.40 Publications for sale.

* * * * *

(h) SSA Publications on CD–ROM.

5. Section 402.45 is amended by

adding new paragraph (d) to read as

follows:

§ 402.45 Availability of records.

* * * * *

(d) Electronic Reading Room. We will

prepare an index of records which have

become or are likely to become the

subject of subsequent requests. The

index, and, to the extent practicable, the

records will be made available on the

Internet or by other computer

telecommunications means.

6. Section 402.100 is amended by

revising the heading and paragraph (b)

to read as follows:

§ 402.100 Exemption six: Clearly

unwarranted invasion of personal privacy.

* * * * *

(b) Balancing test. In deciding

whether to release records to you that

contain personal or private information

about someone else, we weigh the

foreseeable harm of invading a person’s

privacy against the public interest in

disclosure. In determining whether

disclosure would be in the public

interest, we will consider whether

disclosure of the requested information

would shed light on how a Government

agency performs its statutory duties.

However, in our evaluation of requests

for records we attempt to guard against

the release of information that might

involve a violation of personal privacy

because of a requester being able to

‘‘read between the lines’’ or piece

together items that would constitute

information that normally would be

exempt from mandatory disclosure

under Exemption Six.

* * * * *

7. The first § 402.110 entitled

‘‘Exemption seven for withholding

records: Law enforcement’’ is amended

by correctly designating the section

number to read § 402.105.

§ 402.115 [Removed]

8. Section 402.115 is removed.

§ 402.120 [Removed]

9. Section 402.120 is removed.

10. Section 402.130 is revised to read

as follows:

§ 402.130 How to request a record.

You may request a record in person or

by mail or by electronic

telecommunications. To the extent

practicable, and in the future, we will

attempt to provide access for requests by

telephone, fax, Internet, and e-mail. Any

request should reasonably describe the

record you want. If you have detailed

information which would assist us in

identifying that record, please submit it

with your request. We may charge fees

for some requests (§§ 402.145–402.175

explain our fees). You should identify

the request as a Freedom of Information

Act request and mark the outside of any

envelope used to submit your request as

a ‘‘Freedom of Information Request.’’

The staff at any Social Security office

can help you prepare this request.

11. Section 402.140 is revised to read

as follows:
Federal Register / Vol. 63, No. 124 / Monday, June 29, 1998 /Rules and Regulations 35133

§ 402.140 How a request for a record is

processed.

(a) In general, we will make a

determination as to whether a requested

record will be provided within 20 days

(excepting Saturdays, Sundays, and

legal public holidays) after receipt of a

request by the appropriate official (see

§ 402.135). This 20-day period may be

extended in unusual circumstances by

written notice to you, explaining why

we need additional time, and the

extension may be for up to 10 additional

working days when one or more of the

following situations exist:

(1) The office processing the request

needs to locate and then obtain the

record from another facility;

(2) We need to locate, obtain, and

appropriately examine a large number of

records which are requested in a single

request; or

(3) The office processing the request

needs to consult with another agency

which has a substantial interest in the

subject matter of the request. This

consultation shall be conducted with all

practicable speed.

(b) If we cannot process your request

within 10 additional days, we will

notify you and provide you an

opportunity to limit the scope of the

request so that it may be processed

within the additional 10 days, or we

will provide you with an opportunity to

arrange with us an alternative time

frame for processing the request, or for

processing a modified request.

(c) Multi-tracking procedures. We will

establish four tracks for handling

requests and the track to which a

request is assigned will depend on the

nature of the request and the estimated

processing time:

(1) Track 1—Requests that can be answered

with readily available records or information.

These are the fastest to process.

(2) Track 2—Requests where we need

records or information from other offices

throughout the Agency but we do not expect

that the decision on disclosure will be as

time consuming as for requests in Track 3.

(3) Track 3—Requests which require a

decision or input from another office or

agency and a considerable amount of time

will be needed for that, or the request is

complicated or involves a large number of

records. Usually, these cases will take the

longest to process.

(4) Track 4—Requests that will be

expedited.

(d) We will provide for expedited

access for requesters who show a

‘‘compelling need’’ for a speedy

response. The EFOIA describes

compelling need as when the failure to

obtain the records on an expedited basis

could reasonably be expected to pose

‘‘an imminent threat to the life or

physical safety of an individual,’’ or

when the request is from a person

primarily engaged in disseminating

information (such as a member of the

news media), and there is an ‘‘urgency

to inform the public concerning actual

or alleged Federal Government

activity.’’ We also will expedite

processing of a request if the requester

explains in detail to our satisfaction that

a prompt response is needed because

the requester may be denied a legal

right, benefit, or remedy without the

requested information, and that it

cannot be obtained elsewhere in a

reasonable amount of time. We will

respond within 10 days to a request for

expedited processing and, if we decide

to grant expedited processing, we will

then notify you of our decision whether

or not to disclose the records requested

as soon as practicable.

12. Section 402.145 is revised to read

as follows:

§ 402.145 Responding to your request.

(a) Retrieving records. We are required

to furnish copies of records only when

they are in our possession or we can

retrieve them from storage. We will

make reasonable efforts to search for

records manually or by automated

means, including any information

stored in an electronic form or format,

except when such efforts would

significantly interfere with the operation

of our automated information system. If

we have stored the records you want in

the National Archives or another storage

center, we will retrieve and review them

for possible disclosure. However, the

Federal Government destroys many old

records, so sometimes it is impossible to

fill requests. Various laws, regulations,

and manuals give the time periods for

keeping records before they may be

destroyed. For example, there is

information about retention of records

in the Records Disposal Act of 1944, 44

U.S.C. 3301 through 3314; the Federal

Property Management Regulations, 41

CFR 101–11.4; and the General Records

Schedules of the National Archives and

Records Administration.

(b) Furnishing records. We will

furnish copies only of records that we

have or can retrieve. We are not

required to create new records or to

perform research for you. We may

decide to conserve Government

resources and at the same time supply

the records you need by consolidating

information from various records rather

than copying them all. For instance, we

could extract sections from various

similar records instead of providing

repetitious information. We generally

will furnish only one copy of a record.

We will make reasonable efforts to

provide the records in the form or

format you request if the record is

readily reproducible in that form or

format.

(c) Deletions. When we publish or

otherwise make available any record, we

may delete information that is exempt

from disclosure. For example, in an

opinion or order, statement of policy, or

other record which relates to a private

party or parties, the name or names and

other identifying details may be deleted.

When technically feasible, we will

indicate the extent of deletions on the

portion of the record that is released or

published at the place of the deletion

unless including that indication would

harm an interest protected by an

exemption. If we deny a request, in

whole or in part, we will make a

reasonable effort to estimate the volume

of any requested matter that is not

disclosed, unless such an estimate

would harm an interest protected by an

exemption.

(d) Creation of records. We are not

required to create new records merely to

satisfy a request. However, we will

search manually or by automated means

to locate information that is responsive

to the request. If extensive computer

programming is needed to respond to a

request, we may decline to commit such

resources, or if we agree to do so, we

may charge you for the reasonable cost

of doing so. We do not mean that we

will never help you get information that

does not already exist in our records.

However, diverting staff and equipment

from our other responsibilities may not

always be possible.

13. Section 402.150 is amended by

revising paragraph (a), removing

paragraph (b), and redesignating

paragraph (c) as new paragraph (b) to

read as follows:

§ 402.150 Release of records.

(a) Records previously released. If we

have released a record, or a part of a

record, to others in the past, we will

ordinarily release it to you also.

However, we will not release it to you

if a statute forbids this disclosure, and

we will not necessarily release it to you

if an exemption applies in your

situation and it did not apply, or

applied differently, in the previous

situation(s) or if the previous release

was unauthorized. See § 402.45(d)

regarding records in electronic reading

rooms.

* * * * *

14. Section 402.160 is amended by

revising paragraphs (b) and (c) to read

as follows:

§ 402.160 Fees to be charged—general

provisions.

* * * * *
35134 Federal Register / Vol. 63, No. 124 / Monday, June 29, 1998 /Rules and Regulations

(b) If we are not charging you for the

first two hours of search time, under

paragraph (c) of § 402.155, and those

two hours are spent on a computer

search, then the two free hours are the

first two hours of the time needed to

access the information in the computer.

(c) If we are not charging you for the

first 100 pages of duplication, under

paragraph (b) or (c) of § 402.155, then

those 100 pages are the first 100 pages

of photocopies of standard size pages, or

the first 100 pages of computer printout.

* * * * *

[FR Doc. 98–17104 Filed 6–26–98; 8:45 am]

BILLING CODE 4190–29–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 54

[Docket No. 93N–0445]

Financial Disclosure by Clinical

Investigators; Correction

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule; correction.

SUMMARY: The Food and Drug

Administration (FDA) is correcting a

final rule that appeared in the Federal

Register of February 2, 1998 (63 FR

5233). The document issued regulations

requiring the sponsor of any drug,

including a biological product, or device

marketing application (applicant), to

submit certain information covering the

compensation to, and financial interests

of, any clinical investigator conducting

certain clinical studies. The document

was published with an error. This

document corrects that error.

EFFECTIVE DATE: February 2, 1999.

FOR FURTHER INFORMATION CONTACT:

Mary C. Gross, Office of External

Affairs, Food and Drug Administration

(HF–60), 5600 Fishers Lane, Rockville,

MD 20857, 301–827–3440, FAX 301–

594–0113.

SUPPLEMENTARY INFORMATION: In FR Doc.

98–2407 appearing on page 5233 in the

Federal Register of February 2, 1998,

the following correction is made:

§ 54.4 [Corrected]

On page 5251, in the first column, in

§ 54.4 Certification and disclosure

requirements, paragraph (a), line 3,

‘‘519(k)’’ is corrected to read ‘‘510(k)’’.

Dated: June 19, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–17145 Filed 6–26–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 178

[Docket No. 97F–0440]

Indirect Food Additives: Adjuvants,

Production Aids, and Sanitizers

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

food additive regulations to provide for

the safe use of 1,6-hexanediamine, N, N′-

bis(2,2,6,6-tetramethyl-4-piperidinyl)-,

polymers with morpholine-2,4,6-

trichloro-1,3,5-triazine reaction

products, methylated, as a stabilizer for

olefin polymers intended for use in

contact with food. This action is in

response to a petition filed by Cytec

Industries, Inc.

DATES: The regulation is effective June

29, 1998; written objections and

requests for a hearing by July 29, 1998.

ADDRESSES: Submit written objections to

the Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Vir

D. Anand, Center for Food Safety and

Applied Nutrition (HFS–215), Food and

Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–418–3081.

SUPPLEMENTARY INFORMATION: In a notice

published in the Federal Register of

November 6, 1997 (62 FR 60095), FDA

announced that a food additive petition

(FAP 8B4562) had been filed by Cytec

Industries, Inc., c/o Keller and

Heckman, 1001 G St. NW., suite 500

West, Washington, DC 20001. The

petition proposed to amend the food

additive regulations in § 178.2010

Antioxidants and/or stabilizers for

polymers (21 CFR 178.2010) to provide

for the safe use of 1,6-hexanediamine,

N, N′-bis(2,2,6,6-tetramethyl-4-

piperidinyl)-, polymers with

morpholine-2,4,6-trichloro-1,3,5-triazine

reaction products, methylated, as a

stabilizer for olefin polymers complying

with 21 CFR 177.1520 intended for use

in contact with food.

FDA has evaluated data in the

petition and other relevant material.

Based on this information, the agency

concludes that the proposed use of the

additive is safe and the additive will

achieve its intended technical effect.

Therefore, the regulations in § 178.2010

should be amended as set forth below.

FDA’s review of this petition

indicates that the additive may contain

trace amounts of formaldehyde as an

impurity. The potential carcinogenicity

of formaldehyde was reviewed by the

Cancer Assessment Committee (the

Committee) of FDA’s Center for Food

Safety and Applied Nutrition. The

Committee noted that for many years,

formaldehyde has been known to be a

carcinogen by the inhalation route, but

the Committee concluded that these

inhalation studies are not appropriate

for assessing the potential

carcinogenicity of formaldehyde in

food. The Committee’s conclusion was

based on the fact that the route of

administration (inhalation) is not

relevant to the safety of formaldehyde

residues in food and the fact that tumors

were observed only locally at the portal

of entry (nasal turbinates). In addition,

the agency has received literature

reports of two drinking water studies on

formaldehyde: (1) A preliminary report

of a carcinogenicity study purported to

be positive by Soffritti et al. (1989),

conducted in Bologna, Italy (Ref. 1); and

(2) a negative study by Til et al. (1989),

conducted in The Netherlands (Ref. 2).

The Committee reviewed both studies

and concluded, concerning the Soffritti

study, ‘‘ * * * that data reported were

unreliable and could not be used in the

assessment of the oral carcinogenicity of

formaldehyde’’ (Ref. 3). This conclusion

is based on a lack of critical detail in the

study, questionable histopathological

conclusions, and the use of unusual

nomenclature to describe the tumors.

Based on the Committee’s evaluation,

the agency has determined that there is

no basis to conclude that formaldehyde

is a carcinogen when ingested.

In accordance with § 171.1(h) (21 CFR

171.1(h)), the petition and the

documents that FDA considered and

relied upon in reaching its decision to

approve the petition are available for

inspection at the Center for Food Safety

and Applied Nutrition by appointment

with the information contact person

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

the agency will delete from the

documents any materials that are not

available for public disclosure before

making the documents available for

inspection.

The agency has previously considered

the environmental effects of this rule as

announced in the notice of filing for