Federal Register / Vol. 74, No. 138 / Tuesday, July 21, 2009 / Rules and Regulations 35797 

[FR Doc. E9–17107 Filed 7–20–09; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF COMMERCE 

Bureau of Industry and Security 

15 CFR Part 744 

[Docket No. 090414651–91046–01] 

RIN 0694–AE59 

Addition and Removal of Certain 

Persons on the Entity List: Addition of 

Persons Acting Contrary to the 

National Security or Foreign Policy 

Interests of the United States; Removal 

of Persons Based on ERC Annual 

Review and Removal Requests; and 

Entry Modified for Purposes of 

Clarification 

AGENCY: Bureau of Industry and 

Security, Commerce. 

ACTION: Final rule. 

SUMMARY: This rule amends the Export 

Administration Regulations (EAR) by 

adding thirteen additional persons to 

the Entity List (Supplement No. 4 to 

Part 744) on the basis of Section 744.11 

of the EAR. The persons that are added 

to the Entity List have been determined 

by the U.S. Government to be acting 

contrary to the national security or 

foreign policy interests of the United 

States. This rule also amends the Export 

Administration Regulations by 

removing three persons from the Entity 

List. BIS removes one of the three 

persons from the Entity List as a result 

of a determination made by the United 

States Government during the annual 

review of the Entity List conducted by 

the End-User Review Committee (ERC). 

The two remaining persons are removed 

from the Entity List in response to a 

request for removal. Finally, this rule 

makes a correction to the address of one 

person listed on the Entity List. The 

Entity List provides notice to the public 

that certain exports and reexports to 

parties identified on the Entity List 

require a license from the Bureau of 

Industry and Security (BIS) and that 

availability of License Exceptions in 

such transactions is limited. 

DATES: Effective Date: This rule is 

effective July 21, 2009. Although there 

is no formal comment period, public 

comments on this regulation are 

welcome on a continuing basis. 

ADDRESSES: You may submit comments, 

identified by RIN 0694–AE59, by any of 

the following methods: 

E-mail: publiccomments@bis.doc.gov. 

Include ‘‘RIN 0694-AE59’’ in the subject 

line of the message. 

Fax: (202) 482–3355. Please alert the 

Regulatory Policy Division, by calling 

(202) 482–2440, if you are faxing 

comments. 

Mail or Hand Delivery/Courier: 

Timothy Mooney, U.S. Department of 

Commerce, Bureau of Industry and 

Security, Regulatory Policy Division, 

14th St. & Pennsylvania Avenue, NW., 

Room 2705, Washington, DC 20230, 

Attn: RIN 0694–AE59. 

Send comments regarding the 

collection of information associated 

with this rule, including suggestions for 

reducing the burden, to Jasmeet K. 

Seehra, Office of Management and 

Budget (OMB), by e-mail to 

Jasmeet_K._Seehra@omb.eop.gov, or by 

fax to (202) 395–7285; and to the 

Regulatory Policy Division, Bureau of 

Industry and Security, Department of 

Commerce, 14th St., & Pennsylvania 

Avenue, NW., Room 2705, Washington, 

DC 20230. Comments on this collection 

of information should be submitted 

separately from comments on the final 

rule (i.e., RIN 0694–AE59)—all 

comments on the latter should be 

submitted by one of the three methods 

outlined above. 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Scott Sangine, End-User 

Review Committee, Office of the 

Assistant Secretary, Export 

Administration, Bureau of Industry and 

Security, Department of Commerce, 

Phone: (202) 482–3343, Fax: (202) 482– 

3911, E-mail: bscott@bis.doc.gov. 

SUPPLEMENTARY INFORMATION: 

Background 

The Entity List provides notice to the 

public that certain exports and reexports 

to parties identified on the Entity List 

require a license from the Bureau of 

Industry and Security (BIS) and that 

availability of License Exceptions in 

such transactions is limited. BIS first 

published the Entity List in February 

1997 as part of its efforts to inform the 

public of entities that have engaged in 

activities that could result in an 

increased risk of diversion of exported 

and reexported items to weapons of 

mass destruction (WMD) programs. 

Since its initial publication, grounds for 

inclusion on the Entity List have 

expanded to activities sanctioned by the 

Department of State and activities 

contrary to U.S. national security and/ 

or foreign policy interests. 

ERC Entity List Decisions 

Pursuant to Supplement No. 5 to part 

744 (Procedures for End-User Review 

Committee Entity List Decisions) of the 

EAR, the ERC, composed of 

representatives of the Departments of 

Commerce, State, Defense, Energy and, 

where appropriate, the Treasury, makes 

all decisions to make additions to, 

removals from or changes to the Entity 

List. The ERC is chaired by the 

Department of Commerce and makes all 

decisions to add an entry to the Entity 

List by majority vote and all decisions 

to remove or modify an entry by 

unanimous vote. 

The ERC made a determination to add 

thirteen persons to the Entity List on the 

basis of § 744.11 (License Requirements 

that Apply to Entities Acting Contrary to 

the National Security or Foreign Policy 

Interests of the United States) of the 

EAR. The thirteen entities added to the 

Entity List consist of three persons in 

Germany, five persons in Hong Kong 

and five persons in Ireland. 

The ERC reviewed § 744.11(b) 

(Criteria for revising the Entity List) in 

making the determination to add these 

persons to the Entity List. Under that 

paragraph, entities for which there is 

reasonable cause to believe, based on 

specific and articulable facts, that the 

entity has been involved, is involved, or 

poses a significant risk of being or 

becoming involved in activities that are 

contrary to the national security or 

foreign policy interests of the United 

States and those acting on behalf of such 

entities may be added to the Entity List 

pursuant to § 744.11. 

Paragraph (b) of § 744.11 includes an 

illustrative list of activities that could be 

contrary to the national security or 

foreign policy interests of the United 

States. This illustrative list of activities 

of concern is described under 

paragraphs (b)(1)–(b)(5). The persons 

being added to the Entity List under this 

rule have been determined by the ERC 

to be involved in activities that could be 

contrary to the national security or 

foreign policy interests of the United 

States. 

In addition, the ERC made a 

determination to remove three entities 

from the Entity List. As outlined in 

Supplement No. 5 to part 744, under the 

last paragraph of that Supplement, the 

ERC conducts a systematic review of the 

Entity List. Based upon the results of 

that annual review, the ERC made a 

determination that one person in 

Pakistan should be removed from the 

Entity List, because this person is not 

engaged in activities that would warrant 

including the person on the Entity List. 

The ERC also made a determination to 

remove two other persons, located in 

the United Arab Emirates, as a result of 

a request for removal submitted by these 

two listed entities. Based upon the 

review of the information provided in 

the removal request, in accordance with 

§ 744.16 and further review that was 


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35798 Federal Register / Vol. 74, No. 138 / Tuesday, July 21, 2009 / Rules and Regulations 

conducted by the ERC’s member 

agencies of these end-users, the ERC 

determined that these two persons 

should be removed from the Entity List. 

The ERC decision to remove Feroz Jafar 

and Telectron took into account these 

two listed persons’ cooperation with the 

U.S. Government, as well as these listed 

persons’ assurances of future 

compliance with the EAR. In 

accordance with § 744.16(c), the Deputy 

Assistant Secretary for Export 

Administration has sent written 

notification to these persons informing 

them of the ERC’s decision to remove 

them from the Entity List. 

Additions to the Entity List 

This rule implements the decision of 

the ERC to add thirteen persons to the 

Entity List on the basis of § 744.11 of the 

EAR. For all of the thirteen persons 

added to the Entity List, the ERC 

specified a license requirement for all 

items subject to the EAR and established 

a license application review policy of a 

general policy of denial. The license 

requirement applies to any transaction 

in which items are to be exported or 

reexported to such persons or in which 

such persons act as purchaser, 

intermediate consignee, ultimate 

consignee, or end-user. In addition, no 

license exceptions are available for 

shipments to those persons being added 

to the Entity List. 

Specifically, this rule adds the 

following thirteen persons to the Entity 

List: 

Germany 

(1) Christof Schneider, Margaretenweg 

#10, 42929 Wermelskirchen, Germany; 

(2) Hans Werner Schneider, Bertha 

von Suttner Weg #1, 42929 

Wermelskirchen, Germany; and 

(3) Schneider GMBH, Thomas Mann 

Str. 35–37, 42929 Wermelskirchen, 

Germany; and P.O. Box 1523, 

Wermelskirchen, 42908 DE; and 

Thomas Mann Str., 35–37, P.O. Box 

1523, Wermelskirchen, 42908 DE. 

Hong Kong 

(4) Able City Development Limited, 

Unit C, 9/F Neich Tower, 128 

Gloucester Road, Wanchai, Hong Kong; 

and Unit 401, Harbour Ctr., Tower 2, 8 

Hok Cheung Street, Hung Hom, 

Kowloon, Hong Kong; 

(5) Sik Yin Ngai, a.k.a., Spencer Ngai, 

Unit 401, Harbour Ctr., Tower 2, 8 Hok 

Cheung Street Hung Hom, Kowloon, 

Hong Kong; 

(6) Siu Ching Ngai, a.k.a., Terry Ngai, 

Unit C, 9/F Neich Tower, 128 

Gloucester Road, Wanchai, Hong Kong; 

(7) Sysdynamic Limited, Unit 716A, 

7/F Enterprise Place (Building 9), No. 5 

Science Park West Avenue, Hong Kong 

Science Park, Shatin, New Territories, 

Hong Kong; and Unit 401, Harbour Ctr., 

Tower 2, 8 Hok Cheung Street, Hung 

Hom, Kowloon, Hong Kong; and 

(8) Tam Shue Ngai, Unit C, 9/F Neich 

Tower, 128 Gloucester Road, Wanchai, 

Hong Kong. 

Ireland 

(9) Mac Aviation Group, a.k.a., Mac 

Aviation Limited, Cloonmull House, 

Drumcliffe, County Sligo, Ireland; 

(10) Mac Aviation Nigeria, Cloonmull 

House, Drumcliffe, County Sligo, 

Ireland; 

(11) Sean Byrne, Cloonmull House, 

Drumcliffe, County Sligo, Ireland; 

(12) Sean McGuinn, Cloonmull 

House, Drumcliffe, County Sligo, 

Ireland; and 

(13) Thomas McGuinn a.k.a., Tom 

McGuinn, Cloonmull House, Drumcliffe, 

County Sligo, Ireland. 

A BIS license is required for the 

export or reexport of any item subject to 

the EAR to any of the persons listed 

above, including any transaction in 

which any of the listed persons will act 

as purchaser, intermediate consignee, 

ultimate consignee, or end-user of the 

items. This listing of these persons also 

prohibits the use of License Exceptions 

(see part 740 of the EAR) for exports and 

reexports of items subject to the EAR 

involving such persons. 

Removal From the Entity List 

One person being removed from the 

Entity List with this rule is removed on 

the basis of the results of the annual 

review of the Entity List that was 

conducted by the ERC in accordance 

with the procedures outlined in 

Supplement No. 5 to part 744. The 

entity is located in Pakistan: 

Pakistan 

(1) Karachi CBW Research Institute, 

University of Karachi’s Husein Ebrahim 

Jamal Research Institute of Chemistry 

(HEJRIC). 

Two additional persons are being 

removed under this rule as a result of 

the submission of a formal request for 

removal based upon the procedures 

outlined in § 744.16 of the EAR. These 

two entities are located in the United 

Arab Emirates: 

United Arab Emirates 

(2) Feroz Jafar, Al Salam St., P.O. Box 

2946 Abu Dhabi, U.A.E.; and 

(3) Telectron, Al Salam St., P.O. Box 

2946, Abu Dhabi, U.A.E. 

The removal of these three persons 

from the Entity List eliminates the 

existing license requirements in 

Supplement No. 4 to part 744 for 

exports and reexports to these persons. 

However, the removal of these persons 

from the Entity List does not relieve 

persons of other obligations under part 

744 of the EAR or under other parts of 

the EAR. Neither the removal of a 

person from the Entity List nor the 

removal of Entity List-based license 

requirements relieves persons of their 

obligations under General Prohibition 5 

in § 736.2(b)(5) of the EAR which 

provides that, ‘‘you may not, without a 

license, knowingly export or reexport 

any item subject to the EAR to an enduser or end-use that is prohibited by 

part 744 of the EAR.’’ Nor do such 

removals relieve persons of their 

obligation to apply for export or 

reexport licenses required by other 

provisions of the EAR. 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 persons are involved in 

transactions that are subject to the EAR. 

Correction to the Entity List 

This rule revises the address provided 

for one person that was listed on the 

Entity List from the United Arab 

Emirates. Specifically, this rule to 

correct an inadvertent removal of the 

name of the city where the person is 

located, which occurred in a December 

5, 2008 (73 FR 73999) final rule that 

revised this entry. 

This rule revises the name and 

address of this one listed person, as 

follows: 

United Arab Emirates 

(1) Advanced Technology General 

Trading Company, Dubai, U.A.E. (See 

alternate address under Kuwait). 

Savings Clause 

Shipments of items removed from 

eligibility for a License Exception or 

export or reexport without a license 

(NLR) as a result of this regulatory 

action that were on dock for loading, on 

lighter, laden aboard an exporting or 

reexporting carrier, or en route aboard a 

carrier to a port of export or reexport, on 

July 21, 2009, pursuant to actual orders 

for export or reexport to a foreign 

destination, may proceed to that 

destination under the previous 

eligibility for a License Exception or 

export or reexport without a license 

(NLR) so long as they are exported or 

reexported before August 20, 2009. Any 

such items not actually exported or 

reexported before midnight on August 

20, 2009, require a license in accordance 

with this rule. 

Although the Export Administration 

Act expired on August 20, 2001, the 

President, through Executive Order 


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Federal Register / Vol. 74, No. 138 / Tuesday, July 21, 2009 / Rules and Regulations 35799 

13222 of August 17, 2001, 3 CFR, 2001 

Comp., p. 783 (2002), as extended by the 

Notice of July 23, 2008, 73 FR 43603 

(July 23, 2008), has continued the 

Export Administration Regulations in 

effect under the International 

Emergency Economic Powers Act. 

Rulemaking Requirements 

1. This rule has been determined to be 

not significant for purposes of Executive 

Order 12866. 

2. Notwithstanding any other 

provision of law, no person is required 

to respond to nor 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 regulation 

involves collections previously 

approved by the OMB under control 

numbers 0694–0088, ‘‘Multi-Purpose 

Application,’’ which carries a burden 

hour estimate of 58 minutes to prepare 

and submit form BIS–748. 

Miscellaneous and recordkeeping 

activities account for 12 minutes per 

submission. Total burden hours 

associated with the Paperwork 

Reduction Act and Office and 

Management and Budget control 

number 0694–0088 are expected to 

increase slightly as a result of this rule. 

3. This rule does not contain policies 

with Federalism implications as that 

term is defined in Executive Order 

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 or foreign 

affairs function of the United States. 

(See 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 rule. Because a notice of 

proposed rulemaking and an 

opportunity for public comment are not 

required to be given for this rule by 5 

U.S.C. 553, or by any other law, the 

analytical requirements of the 

Regulatory Flexibility Act, 5 U.S.C. 601 

et seq., are not applicable. 

List of Subjects in 15 CFR Part 744 

Exports, Reporting and recordkeeping 

requirements, Terrorism. 

■ Accordingly, part 744 of the Export 

Administration Regulations (15 CFR 

parts 730–774) 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; 22 U.S.C. 7201 et seq.; 22 

U.S.C. 7210; 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 July 23, 2008, 73 FR 43603 

(July 25, 2008); Notice of November 10, 2008, 

73 FR 67097 (November 12, 2008). 

■ 2. Supplement No. 4 to part 744 is 

amended: 

■ a. By removing under Pakistan, this 

one Pakistani entity ‘‘Karachi CBW 

Research Institute, University of 

Karachi’s Husein Ebrahim Jamal 

Research Institute of Chemistry 

(HEJRIC)’’; 

■ b. By removing under United Arab 

Emirates, these two U.A.E. entities 

‘‘Feroz Jafar, Al Salam St., P.O. Box 

2946, Abu Dhabi, U.A.E.’’; and 

‘‘Telectron, Al Salam St., P.O. Box 2946, 

Abu Dhabi, U.A.E.’’; 

■ c. By adding under Germany, in 

alphabetical order, three German 

entities; 

■ d. By adding under Hong Kong, in 

alphabetical order, five Hong Kong 

entities; 

■ e. By adding, in alphabetical order, 

the country of Ireland and five Irish 

entities; and 

■ f. By revising under United Arab 

Emirates, in alphabetical order, one 

U.A.E. entity. 

The additions and revision read as 

follows: 

SUPPLEMENT NO. 4 TO PART 744—ENTITY LIST

Country Entity License requirement License review policy Federal Register 

citation 

* * * * * * * 

GERMANY 

* * * * * * * 

Christof Schneider, Margaretenweg #10, 

42929 Wermelskirchen, Germany.

For all items subject 

to the EAR. (See 

§ 744.11 of the 

EAR).

Presumption of denial 74 FR [INSERT FR 

PAGE NUMBER], 

July 21, 2009. 

* * * * * * * 

Hans Werner Schneider, Bertha von Suttner 

Weg #1, 42929 Wermelskirchen, Germany.

For all items subject 

to the EAR. (See 

§ 744.11 of the 

EAR).

Presumption of denial 74 FR [INSERT FR 

PAGE NUMBER], 

July 21, 2009. 

* * * * * * * 

Schneider GMBH, Thomas Mann Str. 35–37, 

42929 Wermelskirchen, Germany; and 

P.O. Box 1523, Wermelskirchen, 42908 

DE; and Thomas Mann Str., 35–37, P.O. 

Box 1523, Wermelskirchen, 42908 DE.

For all items subject 

to the EAR. (See 

§ 744.11 of the 

EAR).

Presumption of denial 74 FR [INSERT FR 

PAGE NUMBER], 

July 21, 2009. 

HONG KONG .............. Able City Development Limited, Unit C, 9/F 

Neich Tower, 128 Gloucester Road, 

Wanchai, Hong Kong; and Unit 401, Harbour Ctr., Tower 2, 8 Hok Cheung Street, 

Hung Hom, Kowloon, Hong Kong.

For all items subject 

to the EAR. (See 

§ 744.11 of the 

EAR).

Presumption of denial 74 FR [INSERT FR 

PAGE NUMBER], 

July 21, 2009. 


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35800 Federal Register / Vol. 74, No. 138 / Tuesday, July 21, 2009 / Rules and Regulations 

SUPPLEMENT NO. 4 TO PART 744—ENTITY LIST—Continued 

Country Entity License requirement License review policy Federal Register 

citation 

* * * * * * * 

Sik Yin Ngai, a.k.a. Spencer Ngai, Unit 401, 

Harbour Ctr., Tower 2, 8 Hok Cheung 

Street, Hung Hom, Kowloon, Hong Kong.

For all items subject 

to the EAR. (See 

§ 744.11 of the 

EAR).

Presumption of denial 74 FR [INSERT FR 

PAGE NUMBER], 

July 21, 2009. 

Siu Ching Ngai, a.k.a. Terry Ngai, Unit C, 9/ 

F Neich Tower, 128 Gloucester Road, 

Wanchai, Hong Kong.

For all items subject 

to the EAR. (See 

§ 744.11 of the 

EAR).

Presumption of denial 74 FR [INSERT FR 

PAGE NUMBER], 

July 21, 2009. 

* * * * * * * 

Sysdynamic Limited, Unit 716A, 7/F Enterprise Place (Building 9), No. 5 Science 

Park West Avenue, Hong Kong Science 

Park, Shatin, New Territories, Hong Kong; 

and Unit 401, Harbour Ctr., Tower 2, 8 

Hok Cheung Street, Hung Hom, Kowloon, 

Hong Kong.

For all items subject 

to the EAR. (See 

§ 744.11 of the 

EAR).

Presumption of denial 74 FR [INSERT FR 

PAGE NUMBER], 

July 21, 2009. 

Tam Shue Ngai, Unit C, 9/F Neich Tower, 

128 Gloucester Road, Wanchai, Hong 

Kong.

For all items subject 

to the EAR. (See 

§ 744.11 of the 

EAR).

Presumption of denial 74 FR [INSERT FR 

PAGE NUMBER], 

July 21, 2009. 

* * * * * * * 

IRELAND ..................... Mac Aviation Group, a.k.a. Mac Aviation 

Limited, Cloonmull House, Drumcliffe, 

County Sligo, Ireland.

For all items subject 

to the EAR. (See 

§ 744.11 of the 

EAR).

Presumption of denial 74 FR [INSERT FR 

PAGE NUMBER], 

July 21, 2009. 

Mac Aviation Nigeria, Cloonmull House, 

Drumcliffe, County Sligo, Ireland.

For all items subject 

to the EAR. (See 

§ 744.11 of the 

EAR).

Presumption of denial 74 FR [INSERT FR 

PAGE NUMBER], 

July 21, 2009. 

Sean Byrne, Cloonmull House, Drumcliffe, 

County Sligo, Ireland.

For all items subject 

to the EAR. (See 

§ 744.11 of the 

EAR).

Presumption of denial 74 FR [INSERT FR 

PAGE NUMBER], 

July 21, 2009. 

Sean McGuinn, Cloonmull House, 

Drumcliffe, County Sligo, Ireland.

For all items subject 

to the EAR. (See 

§ 744.11 of the 

EAR).

Presumption of denial 74 FR [INSERT FR 

PAGE NUMBER], 

July 21, 2009. 

Thomas McGuinn a.k.a. Tom McGuinn, 

Cloonmull House, Drumcliffe, County 

Sligo, Ireland.

For all items subject 

to the EAR. (See 

§ 744.11 of the 

EAR).

Presumption of denial 74 FR [INSERT FR 

PAGE NUMBER], 

July 21, 2009. 

* * * * * * * 

UNITED ARAB EMIRATES.Advanced Technology General Trading 

Company, Dubai, U.A.E. (See alternate 

address under Kuwait).

For all items subject 

to the EAR. (See 

§ 744.11 of the 

EAR).

Presumption of denial 73 FR 54509 9/22/08 

73 FR 74001 12/5/ 

08 

74 FR [INSERT FR 

PAGE NUMBER], 

July 21, 2009. 

* * * * * * * 


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Federal Register / Vol. 74, No. 138 / Tuesday, July 21, 2009 / Rules and Regulations 35801 

Dated: July 16, 2009. 

Matthew S. Borman, 

Acting Assistant Secretary for Export 

Administration. 

[FR Doc. E9–17295 Filed 7–20–09; 8:45 am] 

BILLING CODE 3510–33–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 14 

[Docket No. FDA–2009–N–0310] 

Advisory Committee; Risk 

Communication Advisory Committee; 

Termination and Recharter 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

termination and the recharter of the Risk 

Communication Advisory Committee 

(the committee). These actions are 

needed to implement the Federal Food, 

Drug, and Cosmetic Act (the act) as 

amended by the Food and Drug 

Administration Amendments Act of 

2007, to change the committee from a 

discretionary to a statutory committee. 

This document also amends the 

agency’s regulations which list advisory 

committees to reflect that the Risk 

Communication Advisory Committee 

has been rechartered and to revise the 

function statement. 

DATES: This rule is effective July 21, 

2009. The committee is being 

rechartered and the new charter will 

remain in effect until amended or 

terminated by the Commissioner of 

Food and Drugs (the Commissioner) or 

designee. 

FOR FURTHER INFORMATION CONTACT: Lee 

Zwanziger, Office of Policy and 

Planning (HFP–1), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–2895, 

FAX: 301–827–4050, or e-mail: 

Lee.Zwanziger@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

Federal Advisory Committee Act of 

October 6, 1972 (Public Law 92–463 (5 

U.S.C. app. 2)); section 904 of the act (21 

U.S.C. 394), as amended by the Food 

and Drug Administration Revitalization 

Act (Public Law 101–635); and 21 CFR 

14.40(b), FDA is announcing the 

termination and the recharter of the 

committee by the Commissioner. The 

committee advises the Commissioner 

and designees on methods to effectively 

communicate risks associated with 

products regulated by FDA, and in 

discharging responsibilities as they 

relate to helping ensure safe and 

effective drugs for human use and any 

other product for which FDA has 

regulatory responsibility. The 

committee also reviews and evaluates 

strategies and programs designed to 

communicate with the public about the 

risks and benefits of FDA-regulated 

products so as to facilitate optimal use 

of these products. In addition, the 

committee reviews and evaluates 

research relevant to such 

communication to the public by both 

FDA and other entities. It also facilitates 

interactively sharing risk and benefit 

information with the public to enable 

people to make informed independent 

judgments about using FDA-regulated 

products. 

The committee will be composed of a 

core of 15 voting members including the 

Chair. Members and the Chair are 

selected by the Commissioner or 

designee from among authorities 

knowledgeable in fields such as social 

marketing, health literacy, and other 

relevant areas. Members will include 

experts on risk communication; experts 

on emerging postmarket drug risks; and 

individuals knowledgeable about and 

experienced in the work of patient, 

consumer, and health professional 

organizations. Members will be invited 

to serve for overlapping terms of up to 

4 years. Almost all non-Federal 

members of this committee serve as 

Special Government Employees. Some 

members will be selected to provide 

experiential insight on the 

communication needs of the various 

groups who use FDA-regulated 

products. The latter may include 

patients and patients’ family members; 

health professionals; communicators in 

health, medicine, and science; and 

persons affiliated with consumer, 

specific disease, or patient safety 

advocacy groups. The Commissioner or 

designee shall also have the authority to 

select from a group of individuals 

nominated by industry to serve 

temporarily as nonvoting members who 

are identified with industry interests. 

The number of temporary members 

selected for a particular meeting will 

depend on the meeting topic(s). 

Under 5 U.S.C. 553(b)(3)(B) and (d) 

and 21 CFR 10.40(d) and (e), the agency 

finds good cause to dispense with notice 

and public comment procedures and to 

proceed to an immediate effective date 

on this rule. Notice and public comment 

and a delayed effective date are 

unnecessary and are not in the public 

interest as this final rule merely amends 

the information in § 14.100 (21 CFR 

14.100) to reflect the rechartering of the 

committee and to revise the function 

statement. 

Therefore, the agency is amending 

§ 14.100(a)(4)(i) and (a)(4)(ii) as set forth 

in the regulatory text of this document. 

List of Subjects in 21 CFR Part 14 

Administrative practice and 

procedure, Advisory committees, Color 

additives, Drugs, Radiation protection. 

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 14 is 

amended as follows: 

PART 14—PUBLIC HEARING BEFORE 

A PUBLIC ADVISORY COMMITTEE 

■ 1. The authority citation for 21 CFR 

part 14 continues to read as follows: 

Authority: 5 U.S.C. App. 2; 15 U.S.C. 

1451–1461, 21 U.S.C. 41–50, 141–149, 321– 

394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 

U.S.C. 201, 262, 263b, 264; Pub. L. 107–109; 

Pub. L. 108–155. 

■ 2. Section 14.100 is amended by 

revising paragraphs (a)(4)(i) and (a)(4)(ii) 

to read as follows: 

§ 14.100 List of standing advisory 

committees. 

* * * * * 

(a) * * * 

(4) * * * 

(i) Date Rechartered: July 9, 2009. 

(ii) Function: The committee reviews 

and evaluates strategies and programs 

designed to communicate with the 

public about the risks and benefits of 

FDA-regulated products so as to 

facilitate optimal use of these products. 

The committee also reviews and 

evaluates research relevant to such 

communication to the public by both 

FDA and other entities. It also facilitates 

interactively sharing risk and benefit 

information with the public to enable 

people to make informed independent 

judgments about use of FDA-regulated 

products. 

* * * * * 

Dated: July 10, 2009. 

Randall W. Lutter, 

Deputy Commissioner for Policy. 

[FR Doc. E9–17218 Filed 7–20–09; 8:45 am] 

BILLING CODE 4160–01–S 


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