65540 Federal Register / Vol. 69, No. 219 / Monday, November 15, 2004 / Rules and Regulations 

3. MOSO Company 

4. The Scientific Research and Design 

Institute of Power Technology (aka 

NIKIET, Research and Development 

Institute of Power Engineering (RDIPE), 

and ENTEK).

The Department of State made its 

determination with regard to, and 

imposed nonproliferation measures 

against, Europalace 2000, Grafit, and 

MOSO Company on July 30, 1998 (63 

FR 42089). BIS imposed conforming 

license requirements on these three 

entities under the EAR on July 29, 1998 

(63 FR 40363). The Department of State 

made its determination with regard to, 

and imposed nonproliferation measures 

against, the Scientific Research and 

Design Institute of Power Technology on 

January 8, 1999 (64 FR 2935), and BIS 

imposed license requirements on this 

entity under the EAR on March 26, 1999 

(64 FR 14605). 

On March 23, 2004, the Department of 

State determined that it is in the foreign 

policy and national security interests of 

the United States to remove 

nonproliferation measures imposed on 

these four Russian entities (69 FR 

17262). In conformance with this 

determination, this final rule removes 

the license requirements under section 

744.10 for exports and reexports to these 

entities, and removes these entities from 

the Entity List.

The removal of these entities from the 

Entity List eliminates the license 

requirements under section 744.10 of 

the EAR for exports and reexports to 

these entities. However, license 

requirements for exports and reexports 

set forth in part 744 still apply to these 

entities when the exporter or reexporter 

knows that the item will be used in a 

prohibited activity. BIS strongly urges 

the use of Supplement No. 3 to part 732 

of the EAR, ‘‘BIS’s ‘Know Your 

Customer’ Guidance and Red Flags’’

when exporting or reexporting. 

Although the Export Administration 

Act expired on August 20, 2001, 

Executive Order 13222 of August 17, 

2001 (66 FR 44025, August 22, 2001), 

extended by the Notice of August 6, 

2004, 69 FR 48763 (August 10, 2004), 

continues the EAR in effect under the 

International Emergency Economic 

Powers Act. 

Rulemaking Requirements 

1. This final rule has been determined 

to be not significant for purposes of E.O. 

12866. 

2. Notwithstanding any other 

provision of law, no person is required 

to respond to, nor shall any person be 

subject to a penalty for failure to comply 

with a collection of information, subject 

to the requirements of the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501 

et seq.) (PRA), unless that collection of 

information displays a currently valid 

Office of Management and Budget 

(OMB) Control Number. This rule 

involves a collection of information 

subject to the PRA. This collection has 

been approved by OMB under control 

number 0694–0088, ‘‘Multi-Purpose 

Application,’’ which carries a burden 

hour estimate of 58 minutes for a 

manual or electronic submission. Send 

comments regarding these burden 

estimates or any other aspect of these 

collections of information, including 

suggestions for reducing the burden, to 

David Rostker, Office of Management 

and Budget (OMB), by e-mail to 

David_Rostker@omb.eop.gov, or by fax 

to (202)395–7285; and to the Office of 

Administration, Bureau of Industry and 

Security, Department of Commerce, 

14th and Pennsylvania Avenue, NW., 

Room 6883, Washington, DC 20230. 

3. This rule does not contain policies 

with Federalism implications as that 

term is defined under E.O. 13132. 

4. The provisions of the 

Administrative Procedure Act (5 U.S.C. 

553) requiring notice of proposed 

rulemaking, the opportunity for public 

participation, and a delay in effective 

date, are inapplicable because this 

regulation involves a military and 

foreign affairs function of the United 

States (5 U.S.C. 553(a)(1)). Further, no 

other law requires that a notice of 

proposed rulemaking and an 

opportunity for public comment be 

given for this final rule. Because a 

notice of proposed rulemaking and an 

opportunity for public comment are not 

required to be given for this rule under 

the Administrative Procedure Act or by 

any other law, the analytical 

requirements of the Regulatory 

Flexibility Act (5 U.S.C. 601 et seq.) are 

not applicable. 

Therefore, this regulation is issued in 

final form. Although there is no formal 

comment period, public comments on 

this regulation are welcome on a 

continuing basis. Please refer to the 

ADDRESSES section cited above for 

comment submission.

List of Subjects in 15 CFR Part 744 

Exports, Foreign trade, Reporting and 

recordkeeping requirements.

■ Accordingly, part 744 of the Export 

Administration Regulations (15 CFR 

parts 730–799) is amended as follows:

PART 744—[AMENDED]

■ 1. The authority citation for 15 CFR 

part 744 continues to read as follows:

Authority: 50 U.S.C. app. 2401 et seq.; 50 

U.S.C. 1701 et seq.; 22 U.S.C. 3201 et seq.; 

42 U.S.C. 2139a; Sec. 901–911, Pub. L. 106–

387; Sec. 221, Pub. L. 107–56; E.O. 12058, 43 

FR 20947, 3 CFR, 1978 Comp., p. 179; E.O. 

12851, 58 FR 33181, 3 CFR, 1993 Comp., p. 

608; E.O. 12938, 59 FR 59099, 3 CFR, 1994 

Comp., p. 950; E.O. 12947, 60 FR 5079, 3 

CFR, 1995 Comp., p. 356; E.O. 13026, 61 FR 

58767, 3 CFR, 1996 Comp., p. 228; E.O. 

13099, 63 FR 45167, 3 CFR, 1998 Comp., p. 

208; E.O. 13222, 66 FR 44025, 3 CFR, 2001 

Comp., p. 783; E.O. 13224, 66 FR 49079, 3 

CFR, 2001 Comp., p. 786; Notice of 

November 9, 2001, 66 FR 56965, 3 CFR, 2001 

Comp., p. 917; Notice of August 6, 2004, 69 

FR 48763 (August 10, 2004).

■ 2. Supplement No. 4 to part 744 is 

amended by removing entries for the 

entities ‘‘Europalace 2000, Moscow,’’

‘‘Grafit (a.k.a. State Scientific Research 

Institute of Graphite or NIIGRAFIT), 2 

Ulitsa Elektrodnaya, 111524, Moscow,’’

‘‘MOSO Company, Moscow,’’ and ‘‘The 

Scientific Research and Design Institute 

of Power Technology (a.k.a. NIKIET, 

Research and Development Institute of 

Power Engineering (RDIPE), and ENTEK) 

(including at 101000, P.O. Box 788, 

Moscow, Russia)’’ under the country of 

‘‘Russia’’.

Dated: November 8, 2004. 

Peter Lichtenbaum, 

Assistant Secretary for Export 

Administration.

[FR Doc. 04–25308 Filed 11–12–04; 8:45 am] 

BILLING CODE 3510–33–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 180

[Docket No. 2004F–0066]

Food Additives Permitted in Food on 

an Interim Basis or in Contact With 

Food Pending Additional Study; 

Mannitol

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

food additive regulations to permit the 

manufacture of mannitol by 

fermentation of sugars such as fructose, 

glucose, or maltose by the action of the 

microorganism Lactobacillus 

intermedius (fermentum). This action is 

in response to a petition filed by 

zuChem, Inc.

DATES: This rule is effective November 

15, 2004. Submit written or electronic 

objections and requests for a hearing by 

December 15, 2004.

ADDRESSES: You may submit written 

objections and requests for a hearing, 

Federal Register / Vol. 69, No. 219 / Monday, November 15, 2004 / Rules and Regulations 65541

identified by Docket No. 2004F–0066, 

by any of the following methods:

• Federal eRulemaking Portal: http://

www.regulations.gov. Follow the 

instructions for submitting comments.

• Agency Web site: http://

www.fda.gov/dockets/ecomments. 

Follow the instructions for submitting 

comments on the agency Web site.

• E-mail: fdadockets@oc.fda.gov. 

Include Docket No. 2004F–0066 in the 

subject line of your e-mail message.

• FAX: 301–827–6870.

• Mail/Hand delivery/Courier [For 

paper, disk, or CD-ROM submissions]: 

Division of Dockets Management (HFA–

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852.

Instructions: All submissions received 

must include the agency name and 

docket number for this rulemaking. All 

objections received will be posted 

without change to http://www.fda.gov/

ohrms/dockets/default.htm, including 

any personal information provided. For 

detailed instructions on submitting 

objections, see the ‘‘Objections’’ heading 

of the SUPPLEMENTARY INFORMATION

section of this document.

Docket: For access to the docket to 

read background documents or 

comments received, go to http://

www.fda.gov/ohrms/dockets/

default.htm and insert the docket 

number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Celeste Johnston, Center for Food Safety 

and Applied Nutrition (HFS–265), Food 

and Drug Administration, 5100 Paint 

Branch Pkwy., College Park, MD 20740–

3835, 301–436–1282.

SUPPLEMENTARY INFORMATION:

I. Background

In a notice published in the Federal 

Register of February 19, 2004 (69 FR 

7759), FDA announced that a food 

additive petition (FAP 4A4754) had 

been filed by zuChem, Inc., c/o Hyman, 

Phelps and McNamara, P.C., 700 13th 

Street NW., Washington, DC 20005. The 

petition proposed to amend the food 

additive regulations in § 180.25 

Mannitol (21 CFR 180.25) to permit the 

manufacture of mannitol by 

fermentation of sugars such as fructose, 

glucose, and maltose by the action of the 

microorganism L. intermedius

(fermentum).

In 1973, the agency proposed to affirm 

mannitol as generally recognized as safe 

(GRAS) based on the findings by the 

Select Committee on GRAS Substances 

from the Life Sciences Research Office 

of the Federation of American Societies 

for Experimental Biology (38 FR 20046, 

July 26, 1973). In response to the 

proposal, the agency received 

comments, including information 

raising questions about the safety of 

mannitol. Rather than affirm the GRAS 

status of mannitol, the agency instead 

decided to establish an interim food 

additive regulation for mannitol, 

pending additional study of the 

ingredient (39 FR 34178, September 23, 

1974) and based on the conclusion that 

there would be no increased risk to the 

public health to continue existing uses 

and levels of use of mannitol while 

additional studies were carried out. The 

regulation was subsequently amended 

(61 FR 7990, March 1, 1996) to permit 

the manufacture of mannitol by 

fermentation of sugars or sugar alcohols 

by the action of the yeast 

Zygosaccharomyces rouxii.

The proposed fermentation organism, 

L. fermentum, is currently used in 

various food applications. For example, 

strains of L. fermentum are used in 

sourdough bread and pressed curd 

cheeses, and FDA has affirmed as GRAS 

a urease preparation from L. fermentum

for use in the manufacture of wine. The 

petitioner has submitted data in support 

of the microbiological safety of mannitol 

produced by this bacterium. In addition, 

the petitioner has provided detailed 

information on the process used to 

produce mannitol by this fermentation 

method, including information on the 

purification steps that are used. FDA 

concludes, having considered the 

evidence concerning the production 

organism and the purification 

procedures, that L. intermedius

(fermentum) will not be present in the 

final product and can be safely used in 

the fermentation of fructose and other 

sugars to produce mannitol provided 

that the purity of the culture is 

maintained, and that a nonpathogenic, 

nontoxicogenic strain of L. intermedius

(fermentum) is used (Ref. 1).

II. Conclusion

The current interim regulation for 

mannitol specifies manufacturing 

procedures that do not include the 

proposed fermentation process. FDA has 

reviewed data and information in the 

petition on the chemical equivalence of 

mannitol produced using L. intermedius

(fermentum) and mannitol produced by 

the currently-regulated methods. Based 

on its review, the agency concludes that 

mannitol manufactured by fermentation 

of sugars by the action of L. intermedius

(fermentum) is equivalent to mannitol 

produced by the currently-regulated 

methods as described in § 180.25. In 

addition, mannitol manufactured by the 

proposed fermentation process will 

have the same intended technical effect 

and uses as mannitol produced by the 

currently-regulated methods. 

Consequently, there will be no change 

in exposure to mannitol (Refs. 2 and 3). 

Therefore, FDA concludes that § 180.25 

should be amended as set forth in this 

document.

III. Public Disclosure

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 (see FOR FURTHER INFORMATION

CONTACT). 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.

IV. Environmental Impact

The agency has previously considered 

the environmental effects of this rule as 

announced in the notice of filing for 

FAP 4A4754. No new information or 

comments have been received that 

would affect the agency’s previous 

determination that there is no 

significant impact on the human 

environment and that an environmental 

impact statement is not required.

V. Paperwork Reduction Act of 1995

This final rule contains no collection 

of information. Therefore, clearance by 

the Office of Management and Budget 

under the Paperwork Reduction Act of 

1995 is not required.

VI. Objections

Any person who will be adversely 

affected by this regulation may file with 

the Division of Dockets Management 

(see ADDRESSES) written or electronic 

objections (see DATES). 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 

65542 Federal Register / Vol. 69, No. 219 / Monday, November 15, 2004 / Rules and Regulations 

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 

are to be submitted and are to 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 Division of Dockets Management 

(see ADDRESSES) between 9 a.m. and 4 

p.m., Monday through Friday.

VII. References

The following references have been 

placed on display in the Division of 

Dockets Management (see ADDRESSES) 

and may be seen by interested persons 

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

through Friday.

1. FDA memorandum from P. C. DeLeo, 

Division of Petition Review, to C. Johnston, 

Division of Petition Review, April 21, 2004.

2. FDA memorandum from D. E. Folmer, 

Division of Petition Review, to C. Johnston, 

Division of Petition Review, April 20, 2004.

3. FDA memorandum from D. E. Folmer, 

Division of Petition Review, to C. Johnston, 

Division of Petition Review, July 29, 2004.

List of Subjects in 21 CFR Part 180

Food additives.

■ 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 part 180 is 

amended as follows:

PART 180—FOOD ADDITIVES 

PERMITTED IN FOOD ON AN INTERIM 

BASIS OR IN CONTACT WITH FOOD 

PENDING ADDITIONAL STUDY

■ 1. The authority citation for 21 CFR 

part 180 continues to read as follows:

Authority: 21 U.S.C. 321, 342, 343, 348, 

371; 42 U.S.C. 241.

■ 2. Section 180.25 is amended by 

adding paragraph (a)(3) to read as 

follows:

§ 180.25 Mannitol.

(a) * * *

(3) A pure culture fermentation of 

sugars such as fructose, glucose, or 

maltose using the nonpathogenic, 

nontoxicogenic bacterium Lactobacillus 

intermedius (fermentum).

* * * * *

Dated: October 27, 2004.

Leslye M. Fraser,

Director, Office of Regulations and Policy, 

Center for Food Safety and Applied Nutrition.

[FR Doc. 04–25243 Filed 11–12–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF JUSTICE

28 CFR Part 0

[AG Order No. 2738–2004] 

Delegations of Authority; Federal 

Bureau of Investigation

AGENCY: Department of Justice.

ACTION: Final rule.

SUMMARY: Recent consultations between 

criminal law enforcement investigative 

agencies and the Department of Justice 

have suggested the need to simplify and 

clarify the delegations of authority to 

the Federal Bureau of Investigation to 

investigate any criminal violations of 

law in certain foreign 

counterintelligence areas. This final rule 

changes the language of the delegations 

of authority to eliminate confusion 

about the scope of the delegation.

EFFECTIVE DATE: November 15, 2004.

FOR FURTHER INFORMATION CONTACT:

Bruce C. Swartz, Deputy Assistant 

Attorney General, Criminal Division, 

United States Department of Justice, 

Washington, DC 20530 (202) 514–2333 

(this is not a toll-free number).

SUPPLEMENTARY INFORMATION: The 

Attorney General has authority to 

investigate any violation of the criminal 

laws of the United States. 28 U.S.C. 533. 

As a general proposition, the Attorney 

General has delegated general 

investigative authority to the Federal 

Bureau of Investigation. 28 CFR 0.85(a). 

Recent consultations among 

investigative agencies have indicated 

that confusion has been created by the 

use of limiting language in the formal 

delegations of authority within the 

Department. The limitation of the 

Federal Bureau of Investigation’s 

authority to the extent that investigative 

authority is assigned elsewhere was not 

intended as other than an internal 

management tool. The Department has 

determined that the limitation should be 

stated more clearly and applicable only 

when statute or other authority, such as 

an Executive Order or Attorney General 

delegation, assigns investigative 

authority exclusively to another agency 

or component. Accordingly, this final 

rule amends the language in 28 CFR part 

0. 

Administrative Procedure Act 

This rule relates to matters of agency 

management and personnel and, 

therefore, is exempt from the usual 

requirements of prior notice and 

comment and a 30-day delay in effective 

date. See 5 U.S.C. 553(a)(2) and (d). The 

rule only alters an internal delegation to 

the Federal Bureau of Investigation. 

Regulatory Flexibility Act 

The Attorney General, in accordance 

with the Regulatory Flexibility Act, 5 

U.S.C. 605(b), has reviewed this rule 

and, by approving it, certifies that it will 

not have a significant economic impact 

on a substantial number of small entities 

because it pertains to personnel and 

administrative matters affecting the 

Department. Further, a Regulatory 

Flexibility Analysis is not required for 

this final rule because the Department 

was not required to publish a general 

notice of proposed rulemaking for this 

matter. 

Executive Order 12866

This rule has been drafted and 

reviewed in accordance with Executive 

Order 12866, Regulatory Planning and 

Review, section 1(b), Principles of 

Regulation. This rule is limited to 

agency organization, management and 

personnel matters as described by 

Executive Order 12866, § 3(d)(3) and, 

therefore, is not a ‘‘regulation’’ or ‘‘rule’’

as defined by that Executive Order. 

Executive Order 12988

This regulation meets the applicable 

standards set forth in sections 3(a) and 

3(b)(2) of Executive Order 12988, Civil 

Justice Reform. 

Executive Order 13132

This rule will not have substantial 

direct effects on the States, on the 

relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government. Therefore, in 

accordance with Executive Order 13132, 

Federalism, the Department has 

determined that this rule does not have 

sufficient federalism implications to 

warrant the preparation of a federalism 

summary impact statement. 

Unfunded Mandates Reform Act of 

1995

This rule will not result in the 

expenditure by State, local, and tribal 

governments, in the aggregate, or by the 

private sector, of $100 million or more 

in any one year, and it will not 

significantly or uniquely affect small 

governments. Therefore, no actions are 

necessary under the provisions of the 

Unfunded Mandates Reform Act of 

1995, 2 U.S.C. 1501 et seq.

Small Business Regulatory Enforcement 

Fairness Act of 1996

This rule is not a major rule as 

defined by section 251 of the Small 

Business Regulatory Enforcement 

Fairness Act of 1996 (SBREFA), 5 U.S.C. 

804. This rule will not result in an