Federal Register / Vol. 63, No. 15 / Friday, January 23, 1998 / Rules and Regulations 3463

5 5 U.S.C. 601–612.

6 5 U.S.C. 553(b).

7 15 U.S.C. 77f, 77g, 77h, 77j and 77s(a).

8 15 U.S.C. 78c, 78l, 78m, 78n, 78o, 78w and 78ll.

9 15 U.S.C. 79t.

10 15 U.S.C. 77sss.

11 15 U.S.C. 80a–8, 80a–29, 80a–30 and 80a–37.

the filing of initial registration

statements and pre-effective

amendments on Form N–14 by closedend investment companies: N–14 8C

and N–14 8C/A. In addition, the

following investment company

submission types will no longer be

subject to fees and the fee-related tags

have been removed: N–1, N–1/A, N–1A,

N–1A/A, N–3, N–3/A, N–4, N–4/A, N–

14, N–14/A, N–14AE, N–14AE/A, S–6,

S–6/A, and 487. Finally, submission

types 24F–2NT and 24F–3NT (and their

amendments) must be filed within 90

days of the registrant’s fiscal year end.

This is a change from the 60-day

requirement in effect prior to October

11, 1997.

The following investment company

submission types will no longer be

accepted by the EDGAR system: 24F–1,

24F–2EL, 24F–2EL/A, 24F–2TM, 24F–

2TM/A, N–1A EL, N–1A EL/A, N–3 EL,

N–3 EL/A, N–4 EL, N–4 EL/A, S–6EL24,

S–6EL24/A, 485A24E, 485A24F,

485B24E, 485B24F, 485BXTE,

485BXTF, N14EL24, N14EL24/A,

N14AE24, and N14AE24/A.

Rule 301 of Regulation S–T also is

being amended to provide for the

incorporation by reference of the Filer

Manual into the Code of Federal

Regulations, which incorporation by

reference was approved by the Director

of the Federal Register in accordance

with 5 U.S.C. 552(a) and 1 CFR Part 51.

The revised Filer Manual and the

amendment to Rule 301 will be effective

on January 26, 1998.

Paper copies of the updated Filer

Manual may be obtained at the

following address: Public Reference

Room, U.S. Securities and Exchange

Commission, Mail Stop 1–2, 450 Fifth

Street, N.W., Washington, D.C. 20549.

Electronic format copies will be

available on the EDGAR electronic

bulletin board and posted to the SEC’s

Web Site. The SEC’s Web Site address

for the Manual is http://www.sec.gov/

asec/ofis/filerman.htm. Copies also may

be obtained from Disclosure

Incorporated, the paper and microfiche

contractor for the Commission, at (800)

638–8241.

Since the Filer Manual relates solely

to agency procedure or practice,

publication for notice and comment is

not required under the Administrative

Procedure Act.5 It follows that the

requirements of the Regulatory

Flexibility Act 6 do not apply.

The effective date for the updated

Filer Manual and the rule amendments

is January 26, 1998. In accordance with

the Administrative Procedure Act 5

U.S.C. 553(d)(3), the Commission finds

that there is good cause to establish an

effective date less than 30 days after

publication of these rules. The EDGAR

system is scheduled to be upgraded to

Release 5.40 on January 24, 1998. The

Commission believes that it is necessary

to coordinate the effectiveness of the

updated Filer Manual with the

scheduled system upgrade in order to

avoid confusion to EDGAR filers.

Statutory Basis

The amendment to Regulation S–T is

being adopted under Sections 6, 7, 8, 10,

and 19(a) of the Securities Act of 1933,7

Sections 3, 12, 13, 14, 15, 23, and 35A

of the Securities Exchange Act of 1934,8

Section 20 of the Public Utility Holding

Company Act of 1935,9 Section 319 of

the Trust Indenture Act of 1939,10 and

Sections 8, 30, 31, and 38 of the

Investment Company Act.11

List of Subjects in 17 CFR Part 232

Incorporation by reference,

Investment companies, Registration

requirements, Reporting and

recordkeeping requirements, Securities.

Text of the Amendment

In accordance with the foregoing,

Title 17, Chapter II of the Code of

Federal Regulations is amended as

follows:

PART 232—REGULATION S–T—

GENERAL RULES AND REGULATIONS

FOR ELECTRONIC FILINGS

1. The authority citation for Part 232

continues to read as follows:

Authority: 15 U.S.C. 77f, 77g, 77h, 77j,

77s(a), 77sss(a), 78c(b), 78l, 78m, 78n, 78o(d),

78w(a), 78ll(d), 79t(a), 80a–8, 80a–29, 80a–30

and 80a–37.

2. Section 232.301 is revised to read

as follows:

§ 232.301 EDGAR Filer Manual.

Electronic filings shall be prepared in

the manner prescribed by the EDGAR

Filer Manual, promulgated by the

Commission, which sets out the

technical formatting requirements for

electronic submissions. The January

1998 edition of the EDGAR Filer

Manual: Guide for Electronic Filing with

the U.S. Securities and Exchange

Commission (Release 5.40) is

incorporated into the Code of Federal

Regulations by reference, which action

was approved by the Director of the

Federal Register in accordance with 5

U.S.C. 552(a) and 1 CFR part 51.

Compliance with the requirements

found therein is essential to the timely

receipt and acceptance of documents

filed with or otherwise submitted to the

Commission in electronic format. Paper

copies of the EDGAR Filer Manual may

be obtained at the following address:

Public Reference Room, U.S. Securities

and Exchange Commission, Mail Stop

1–2, 450 5th Street, N.W., Washington,

D.C. 20549. They also may be obtained

from Disclosure Incorporated by calling

(800) 638–8241. Electronic format

copies are available through the EDGAR

electronic bulletin board and posted to

the SEC’s Web Site. The SEC’s Web Site

address for the Manual is http://

www.sec.gov/asec/ofis/filerman.htm.

Information on becoming an EDGAR Email/electronic bulletin board

subscriber is available by contacting

CompuServe Inc. at (800) 576–4247.

By the Commission.

Dated: January 20, 1998.

Margaret H. McFarland,

Deputy Secretary.

[FR Doc. 98–1646 Filed 1–22–98; 8:45 am]

BILLING CODE 8010–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 175 and 178

[Docket No. 95F–0210]

Indirect Food Additives: Adhesives

and Components of Coatings;

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 2,2′-(2,5-thiophenediyl)-

bis(5-tert-butylbenzoxazole) as an

optical brightener in pressure-sensitive

adhesives and in all polymers used in

contact with food. This action is in

response to a petition filed by CibaGeigy Corp.

DATES: The regulation is effective

January 23, 1998. Submit written

objections and requests for a hearing by

February 23, 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.
3464 Federal Register / Vol. 63, No. 15 / Friday, January 23, 1998 / Rules and Regulations

FOR FURTHER INFORMATION CONTACT: John

R. Bryce, Center for Food Safety and

Applied Nutrition (HFS–215), Food and

Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–418–3023.

SUPPLEMENTARY INFORMATION: In a notice

published in the Federal Register of

August 18, 1995 (60 FR 43157), FDA

announced that a food additive petition

(FAP 5B4471) had been filed by CibaGeigy Corp., Seven Skyline Dr.,

Hawthorne, NY 10532–2188. The

petition proposed to amend the food

additive regulations in § 178.3297

Colorants for polymers (21 CFR

178.3297) to provide for the safe use of

2,2′-(2,5-thiophenediyl)-bis(5-tertbutylbenzoxazole) in all polymers

intended for use in food packaging and

in adhesives complying with § 175.125

Pressure-sensitive adhesives (21 CFR

175.125).

In order to clarify the use of this

additive as an optical brightener, the

petition also proposed to list the use of

the additive in adhesives complying

with § 175.105 (21 CFR 175.105) in

§ 178.3297. Because the additive is

currently listed in § 175.105 without

limitation, use of the additive as an

optical brightener in adhesives

complying with § 175.105 is a currently

permitted use that requires no further

safety evaluation. Accordingly, this final

rule lists the use of the additive in

adhesives complying with § 175.105 in

§ 178.3297 Colorants for polymers.

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 as an optical brightener in

pressure-sensitive adhesives in

§ 175.125, and in all polymers intended

for use in food packaging in § 178.3297,

is safe; that the additive will have the

intended technical effect; and that

therefore, the regulations in §§ 175.125

and 178.3297 should be amended as set

forth below.

In accordance with § 171.1(h) (21 CFR

171.1(h)), the petition and the

documents that FDA considered and

relied upon in reaching its decision to

approve the petition are available for

inspection at the Center for Food Safety

and Applied Nutrition by appointment

with the information contact person

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

the agency will delete from the

documents any materials that are not

available for public disclosure before

making the documents available for

inspection.

The agency has carefully considered

the potential environmental effects of

this action. FDA has concluded that the

action will not have a significant impact

on the human environment, and that an

environmental impact statement is not

required. The agency’s finding of no

significant impact and the evidence

supporting that finding, contained in an

environmental assessment, may be seen

in the Dockets Management Branch

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

p.m., Monday through Friday.

Any person who will be adversely

affected by this regulation may at any

time on or before February 23, 1998, file

with the Dockets Management Branch

(address above) written objections

thereto. Each objection shall be

separately numbered, and each

numbered objection shall specify with

particularity the provisions of the

regulation to which objection is made

and the grounds for the objection. Each

numbered objection on which a hearing

is requested shall specifically so state.

Failure to request a hearing for any

particular objection shall constitute a

waiver of the right to a hearing on that

objection. Each numbered objection for

which a hearing is requested shall

include a detailed description and

analysis of the specific factual

information intended to be presented in

support of the objection in the event

that a hearing is held. Failure to include

such a description and analysis for any

particular objection shall constitute a

waiver of the right to a hearing on the

objection. Three copies of all documents

shall be submitted and shall be

identified with the docket number

found in brackets in the heading of this

document. Any objections received in

response to the regulation may be seen

in the Dockets Management Branch

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

through Friday.

List of Subjects

21 CFR Part 175

Adhesives, Food additives, Food

packaging.

21 CFR Part 178

Food additives, Food packaging.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs and redelegated to

the Director, Center for Food Safety and

Applied Nutrition, 21 CFR parts 175

and 178 are amended to read as follows:

PART 175—INDIRECT FOOD

ADDITIVES: ADHESIVES AND

COMPONENTS OF COATINGS

1. The authority citation for 21 CFR

part 175 continues to read as follows:

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

2. Section 175.125 is amended by

adding paragraph (a)(7) and by revising

paragraph (b)(1) to read as follows:

§ 175.125 Pressure-sensitive adhesives.

* * * * *

(a) * * *

(7) 2,2′-(2,5-Thiophenediyl)-bis(5-tertbutylbenzoxazole) (CAS Reg. No. 7128–

64–5) as an optical brightener at a level

not to exceed 0.05 percent by weight of

the finished pressure-sensitive adhesive.

* * * * *

(b) * * *

(1) Substances listed in paragraphs

(a)(1), (a)(2), (a)(3), (a)(5), (a)(6), and

(a)(7) of this section, and those

substances prescribed by paragraph

(a)(4) of this section that are not

identified in paragraph (b)(2) of this

section.

* * * * *

PART 178—INDIRECT FOOD

ADDITIVES: ADJUVANTS,

PRODUCTION AIDS, AND SANITIZERS

3. The authority citation for 21 CFR

part 178 continues to read as follows:

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

4. Section 178.3297 is amended in the

table in paragraph (e) by revising the

entry for ‘‘2,2′-(2,5-Thiophenediyl)-

bis(5-tert-butylbenzoxazole)’’ under the

headings ‘‘Substances’’ and

‘‘Limitations’’ to read as follows:

§ 178.3297 Colorants for polymers.

* * * * *

(e) * * *
Federal Register / Vol. 63, No. 15 / Friday, January 23, 1998 / Rules and Regulations 3465

Substances Limitations

* * * * * * *

2,2′-(2,5-Thiophenediyl)-bis(5-tert-butylbenzoxazole) (CAS Reg. No.

7128–64–5).

For use as an optical brightener:

1. In all polymers at levels not to exceed 0.015 percent by weight of

the polymer. The finished articles are to contact food only under conditions of use A through H described in Table 2 of § 176.170(c) of

this chapter.

2. In all polymers at levels not to exceed 0.05 percent by weight of the

polymer. The finished articles shall contact foods only of the types

identified in Table 1 of § 176.170(c) of this chapter, under Categories

I, II, IV–B, VI–A, VI–B, VI–C, VII–B, and VIII under conditions of use

A through H described in Table 2 of § 176.170(c) of this chapter.

3. In adhesives complying with § 175.105 of this chapter and in pressure-sensitive adhesives complying with § 175.125 of this chapter.

* * * * * * *

Dated: January 5, 1998.

Fred R. Shank,

Director, Center for Food Safety and Applied

Nutrition.

[FR Doc. 98–1539 Filed 1–22–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 820

[Docket No. 90N–0172]

RIN 0910–AA09

Quality System Design Control; Open

Public Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Announcement of public

meeting.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

following meeting: Quality System

Design Control open public meeting.

The topic to be discussed is the

midcourse review of the new design

control requirements. This action is

being taken in accordance with the

current good manufacturing (CGMP)

final rule that appeared in the Federal

Register of October 7, 1996.

DATES: The meeting will be held on,

February 2, 1998, from 8:30 a.m. to 4:30

p.m. Written requests for oral

presentations by January 28, 1998.

ADDRESSES: The meeting will be held at

the National Institutes of Health (NIH),

Natcher Auditorium, 45 Center Dr.,

Bldg. 45, Bethesda, MD. Contact for any

changes: (1) Via Internet at http://

www.fda.gov/cdrh/gmp, or (2)

telephone toll-free at 1–800–638–2041.

FOR FURTHER INFORMATION CONTACT:

For information regarding

registration: Mary Ann Fitzgerald,

or

For information regarding the meeting

or requests for oral presentations:

Kimberly A. Trautman, Center for

Devices and Radiological Health

(HFZ–341), Food and Drug

Administration, 2094 Gaither Rd.,

Rockville, MD 20850, 301–594–

4648, FAX 301–594–4672.

SUPPLEMENTARY INFORMATION: In the

Federal Register of October 7, 1996 (61

FR 52602), FDA stated that it would

hold an open public meeting in early

1998 to discuss, and to further explore

any concerns industry might be having

in implementing the new design control

requirements. Specifically, the results of

the first several months of design

control inspections will be reviewed

and any adjustments to the designated

inspectional strategy of guidances will

be addressed. Also, FDA will evaluate

the information gathered at this point

and determine if design control

requirements, as written in the final

rule, are appropriate to obtain the goals

expressed in the preamble. Particular

attention will be paid to clarity of

information obtained, the

appropriateness of the information

collected with respect to the design

control requirements, the manner in

which the investigators are writing their

observations, and any requirements that

seem to be giving manufacturers a

problem or where there might be

misunderstandings as to what the

regulation requires. It is important to

note that only the requirements and

issues surrounding design controls

codified will be addressed.

Fax written requests for oral

presentations, (including name, title,

firm name, address, telephone, and fax

number), and an outline of your

presentation to the contact person listed

above by January 28, 1998. No

telephone requests will be accepted.

You will be notified by facsimile

whether or not the speaker’s list is full.

If you cannot be reached by facsimile,

please note that in your request.

If you need special accommodations

due to a disability, please contact

Georgette Smith, NIH Conference

Center, 301–496–9966, at least 7 days in

advance.

Dated: January 20, 1998.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 98–1822 Filed 1-21-98; 3:22 pm]

BILLING CODE 4160–01–F

DEPARTMENT OF DEFENSE

Office of the Secretary

32 CFR Part 104

[DoD Instruction 1205.12]

RIN 0790–AG52

Civilian Employment and

Reemployment Rights of Applicants

for, and Service Members and Former

Service Members of the Uniformed

Services

AGENCY: Department of Defense.

ACTION: Final rule.

SUMMARY: This part identifies DoD

guidelines for implementing policy,

assigns responsibilities, and prescribes

procedures for informing Service

members of their reemployment

protections. It updates, codifies, and

strengthens the civilian employment

rights and benefits of Service members

and individuals who apply for

uniformed service, and specifies the