78146 Federal Register / Vol. 76, No. 242 / Friday, December 16, 2011 / Rules and Regulations 

reservations systems to comply with the 

new rule is a complex undertaking. 

Indeed, in response to such concerns, 

we extended the effective date of this 

rule for 90 days, from October 24, 2011, 

to its present date of January 24, 2012. 

(76 FR 45181, July 28, 2011) We can 

appreciate that any errors that might 

occur the first day the new system is 

implemented would have a greater 

impact on carriers or ticket agents 

selling air transportation if that day 

happens to be their busiest business 

day. We are concerned that, similarly, 

any such problems may have a more 

wide-ranging negative effect on 

consumers, as well. For this reason, and 

because we agree that a two-day delay 

in the start of the new rule will not 

significantly affect consumers, we find 

that grant of American’s petition is in 

the public interest. In order to avoid 

confusion over airfares advertised using 

various media, which include Web sites, 

email, print, television, and radio, this 

short two-day extension will apply to all 

fare advertisements. 

The Direct Final Rule Procedure 

On January 30, 2004, OST published 

a final rule adopting direct final 

rulemaking procedures intended to 

expedite the rulemaking process for 

noncontroversial rules. By using direct 

final rulemaking, OST can reduce the 

time necessary to develop, review, clear 

and publish a rule to which no adverse 

public comment is anticipated by 

eliminating the need to publish separate 

proposed and final rules (69 FR 4455). 

OST anticipates that this regulation 

will not result in adverse or negative 

comment and, therefore, is issuing it as 

a direct final rule. Unless a written 

adverse or negative comment, or a 

written notice of intent to submit an 

adverse or negative comment is received 

within the comment period, the 

regulation will become effective on the 

date specified above. After the close of 

the comment period, if no adverse or 

negative comment or written notice of 

intent to submit such a comment is 

received, OST will publish a document 

in the Federal Register indicating that 

no adverse or negative comments were 

received and confirming the date on 

which the final rule will become 

effective. If OST does receive, within 

the comment period, an adverse or 

negative comment, or written notice of 

intent to submit such a comment, a 

document withdrawing the direct final 

rule will be published in the Federal 

Register, and a notice of proposed 

rulemaking may be published with a 

new comment period. 

Comments Invited 

Interested parties are invited to 

participate in this rulemaking by 

submitting such written data, views, or 

arguments, as they may desire. 

Comments that provide the factual basis 

supporting the views and suggestions 

presented are particularly helpful in 

developing reasoned regulatory 

decisions on the proposal. 

Regulatory Analyses and Notices 

A. Executive Order 12866 (Regulatory 

Planning and Review) and DOT 

Regulatory Policies and Procedures 

This final rule is not a significant 

regulatory action under Executive Order 

12866 and the Department of 

Transportation’s Regulatory Policies and 

Procedures. Accordingly, this final rule 

has not been reviewed by the Office of 

Management and Budget (OMB). 

B. Regulatory Flexibility Act 

Pursuant to section 605 of the 

Regulatory Flexibility Act (RFA), 5 

U.S.C. 605(b), as amended by the Small 

Business Regulatory Enforcement and 

Fairness Act of 1996 (SBREFA), DOT 

certifies that this final rule does not 

have a significant impact on a 

substantial number of small entities. 

The final rule does not impose any 

duties or obligations on small entities. 

C. Executive Order 13132 (Federalism) 

This Final Rule does not have a 

substantial direct effect 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, and therefore does 

not have federalism implications. 

D. Executive Order 13084 

This Final Rule has been analyzed in 

accordance with the principles and 

criteria contained in Executive Order 

13084 (‘‘Consultation and Coordination 

with Indian Tribal Governments’’). 

Because the rule does not significantly 

or uniquely affect the communities of 

the Indian tribal governments or impose 

substantial direct compliance costs on 

them, the funding and consultation 

requirements of Executive Order 13084 

do not apply. 

E. Paperwork Reduction Act 

The Paperwork Reduction Act of 1995 

(PRA) (44 U.S.C. 3501 et seq.) requires 

that DOT consider the impact of 

paperwork and other information 

collection burdens imposed on the 

public and, under the provisions of PRA 

section 3507(d), obtain approval from 

the Office of Management and Budget 

(OMB) for each collection of 

information it conducts, sponsors, or 

requires through regulations. DOT has 

determined that there is no new 

information collection requirements 

associated with this final rule. 

F. Unfunded Mandates Reform Act 

The Department has determined that 

the requirements of Title II of the 

Unfunded Mandates Reform Act of 1995 

do not apply to this Final Rule. 

Issued this 13th day of December 2011, in 

Washington, DC. 

Susan Kurland, 

Assistant Secretary for Aviation and 

International Affairs. 

[FR Doc. 2011–32336 Filed 12–15–11; 8:45 am] 

BILLING CODE 4910–9X–P 

DEPARTMENT OF COMMERCE 

Bureau of Industry and Security 

15 CFR Part 744 

[Docket No. 111202715–1724–01] 

RIN 0694–AF46 

Addition of Certain Persons to the 

Entity List; and Implementation of 

Entity List Annual Review Changes 

AGENCY: Bureau of Industry and 

Security, Commerce. 

ACTION: Final rule. 

SUMMARY: This rule amends the Export 

Administration Regulations (EAR) by 

adding two persons to the Entity List. 

The persons who 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. These 

persons will be listed on the Entity List 

under the United Arab Emirates 

(U.A.E.). 

This rule also amends the Entity List 

on the basis of the annual review of the 

Entity List conducted by the End-User 

Review Committee (ERC). The ERC 

conducts the annual review to 

determine if any entries on the Entity 

List should be removed or modified. 

This rule removes two persons 

located in Singapore and two persons 

located in Taiwan on the basis of the 

annual review, and revises the entry 

concerning one person located in 

Malaysia to add an alternate address. 

The Entity List provides notice to the 

public that certain exports, reexports, 

and transfers (in-country) to entities 

identified on the Entity List require a 

license from the Bureau of Industry and 

Security (BIS) and that availability of 


jlentini on DSK4TPTVN1PROD with RULES
Federal Register / Vol. 76, No. 242 / Friday, December 16, 2011 / Rules and Regulations 78147 

license exceptions in such transactions 

is limited. 

DATES: Effective Date: This rule is 

effective December 16, 2011. 

FOR FURTHER INFORMATION CONTACT: 

Karen Nies-Vogel, Chair, End-User 

Review Committee, Office of the 

Assistant Secretary, Export 

Administration, Bureau of Industry and 

Security, Department of Commerce, 

Phone: (202) 482–5991, Fax: (202) 482– 

3911, Email: ERC@bis.doc.gov. 

SUPPLEMENTARY INFORMATION: 

Background 

The Entity List (Supplement No. 4 to 

Part 744) provides notice to the public 

that certain exports, reexports, and 

transfers (in-country) to entities 

identified on the Entity List require a 

license from the Bureau of Industry and 

Security and that the availability of 

license exceptions in such transactions 

is limited. Entities are placed on the 

Entity List on the basis of certain 

sections of part 744 (Control Policy: 

End-User and End-Use Based) of the 

EAR. 

The ERC, composed of representatives 

of the Departments of Commerce 

(Chair), State, Defense, Energy and, 

when appropriate, the Treasury, makes 

all decisions regarding additions to, 

removals from, or other modifications to 

the Entity List. The ERC 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. 

ERC Entity List decisions 

Additions to the Entity List 

This rule implements the decision of 

the ERC to add two persons to the Entity 

List on the basis of Section 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 two 

entries added to the Entity List consist 

of two persons located in the U.A.E. 

The ERC reviewed Section 744.11(b) 

(Criteria for revising the Entity List) in 

making the determination to add the 

two persons located in the U.A.E. to the 

Entity List. Under that paragraph, 

persons for which there is reasonable 

cause to believe, based on specific and 

articulable facts, that the persons have 

been involved, are involved, or pose 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 persons may be 

added to the Entity List pursuant to 

Section 744.11. Paragraphs (b)(1)–(b)(5) 

of Section 744.11 include an illustrative 

list of activities that could be contrary 

to the national security or foreign policy 

interests of the United States. 

The two persons in the U.A.E. 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. Specifically, BIS’s Office of 

Export Enforcement is investigating the 

presence of Blue Coat internet filtering 

devices in Syria and has developed 

evidence regarding the parties involved 

in the transfer of these devices to Syria. 

Waseem Jawad, using the company 

name Infotec, a.k.a., Info Tech, ordered 

multiple Blue Coat SG9000–20 Proxy 

devices in December 2010 from a Blue 

Coat authorized distributor in the U.A.E. 

That authorized distributor in turn 

placed an order for the devices with 

Blue Coat. A December 2010 email 

notification identified the end-user of 

the Blue Coat products for this order as 

the Ministry of Communication 

(National Telecom), Al Fadi Street, 

Baghdad, Iraq. In February 2011, the 

devices were shipped from the United 

States to the United Arab Emirates, and 

ownership was transferred to Waseem 

Jawad, Info Tech, RAKFTZ, U.A.E. 

Approximately three days later, the 

devices departed the U.A.E. for delivery 

to Syria. Several of these devices have 

been identified by serial number as the 

devices being used by the Syrian 

Telecommunications Establishment in 

Damascus, Syria. The investigation is 

ongoing and additional parties related to 

these transactions may be added to the 

Entity List in the future. 

For the two 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 

presumption of denial. The license 

requirement applies to any transaction 

in which items are to be exported, 

reexported, or transferred (in-country) to 

such persons or in which such persons 

act as purchaser, intermediate 

consignee, ultimate consignee, or enduser. In addition, no license exceptions 

are available for exports, reexports, or 

transfers (in-country) to those persons 

being added to the Entity List. 

This final rule adds the following two 

persons under two entries to the Entity 

List: 

United Arab Emirates 

(1) Infotec, a.k.a., Info Tech., Ras Al 

Khaimah Free Trade Zone (RAKFTZ), 

U.A.E.; and 

(2) Waseem Jawad, Ras Al Khaimah 

Free Trade Zone (RAKFTZ), U.A.E.; and 

P.O. Box: 25123, Dubai U.A.E. 

Annual Review of the Entity List 

This rule also amends the Entity List 

on the basis of the annual review of the 

Entity List conducted by the ERC, in 

accordance with the procedures 

outlined in Supplement No. 5 to part 

744 (Procedures for End-User Review 

Committee Entity List Decisions). The 

changes from the annual review of the 

Entity List that are approved by the ERC 

are implemented in stages as the ERC 

completes its review of entities listed 

under different destinations on the 

Entity List. This rule implements the 

results of the annual review for entities 

located in Malaysia, Singapore, and 

Taiwan. 

A. Removals From the Entity List 

This rule removes four entities from 

the Entity List, which consists of two 

entities from Singapore and two entities 

from Taiwan. Specifically, this rule 

implements the decision of the ERC to 

remove two entities, Strive Components 

and Synoptics Imaging Systems Pte Ltd., 

located in Singapore, and two entities, 

Christine Sun and In-Tech Company, 

a.k.a., In-Tech Telecom, located in 

Taiwan, from the Entity List on the basis 

of the annual review of the Entity List, 

as follows: 

Singapore 

(1) Strive Components, Block 10 Toa 

Payoh Industrial Park Lor 8 #01–1221, 

Singapore, 319062; and 

(2) Synoptics Imaging Systems Pte 

Ltd., 12 Lor Bakar Batu #06–09, 

Singapore, 348745. 

Taiwan 

(1) Christine Sun, 7th Floor, Number 

17, Zhonghua Rd., Sec 2, Xinzhuang 

City, Taipei, Taiwan; and 

(2) In-Tech Company, a.k.a., In-Tech 

Telecom, Number 15, Lane 347, 

Jhongjheng Road, Sinjihuang City, 

Taipei, Taiwan, and 7th Floor, Number 

17, Zhonghua Rd., Sec 2, Xinzhuang 

City, Taipei, Taiwan. 

The removal of the above-referenced 

four entities from the Entity List 

eliminates the existing license 

requirements in Supplement No. 4 to 

part 744 for exports, reexports and 

transfers (in-country) to the four 

entities. However, the removal of these 

four entities 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 an entity from the Entity List 

nor the removal of Entity List-based 

license requirements relieves persons of 

their obligations under General 

Prohibition 5 in section 736.2(b)(5) of 

the EAR which provides that, ‘‘you may 

not, without a license, knowingly export 


jlentini on DSK4TPTVN1PROD with RULES
78148 Federal Register / Vol. 76, No. 242 / Friday, December 16, 2011 / Rules and Regulations 

or reexport any item subject to the EAR 

to an end-user or end-use that is 

prohibited by part 744 of the EAR.’’ 

Additionally these removals do not 

relieve persons of their obligation to 

apply for export, reexport or in-country 

transfer 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. 

B. Modifications to the Entity List 

On the basis of a decision made by the 

ERC during the annual review, this rule 

amends one entry currently on the 

Entity List under Malaysia by adding an 

alternate address, as follows: 

Malaysia 

(1) VTE Industrial Automation SDN 

BHD, 97C, Jalan Kenari 23, Puchong 

Jaya, Puchong, Selangor, Malaysia; and 

45–02, Jalan Kenari 19A, Puchong Jaya, 

47100 Malaysia. 

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 

December 16, 2011, 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 January 3, 2012. Any 

such items not actually exported or 

reexported before midnight, on January 

3, 2012, require a license in accordance 

with the EAR. 

Although the Export Administration 

Act expired on August 20, 2001, the 

President, through Executive Order 

13222 of August 17, 2001, 3 CFR, 2001 

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

Notice of August 12, 2011, 76 FR 50661 

(August 16, 2011), has continued the 

Export Administration Regulations in 

effect under the International 

Emergency Economic Powers Act. BIS 

continues to carry out the provisions of 

the Export Administration Act, as 

appropriate and to the extent permitted 

by law, pursuant to Executive Order 

13222. 

Rulemaking Requirements 

1. Executive Orders 13563 and 12866 

direct agencies to assess all costs and 

benefits of available regulatory 

alternatives and, if regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety 

effects, distributive impacts, and 

equity). Executive Order 13563 

emphasizes the importance of 

quantifying both costs and benefits, of 

reducing costs, of harmonizing rules, 

and of promoting flexibility. 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 43.8 minutes for a 

manual or electronic submission. Total 

burden hours associated with the PRA 

and OMB control number 0694–0088 

are not expected to increase as a result 

of this rule. You may 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 

email to 

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

fax to (202) 395–7285. 

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 

comment 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)). BIS implements this 

rule to protect U.S. national security or 

foreign policy interests by preventing 

items from being exported, reexported, 

or transferred (in country) to the persons 

being added to the Entity List. If this 

rule were delayed to allow for notice 

and comment and a delay in effective 

date, then entities being added to the 

Entity List by this action would 

continue to be able to receive items 

without a license and to conduct 

activities contrary to the national 

security or foreign policy interests of the 

United States. In addition, because these 

parties may receive notice of the U.S. 

Government’s intention to place these 

entities on the Entity List once a final 

rule was published it would create an 

incentive for these persons to either 

accelerate receiving items subject to the 

EAR to conduct activities that are 

contrary to the national security or 

foreign policy interests of the United 

States and/or to take steps to set up 

additional aliases, change addresses, 

and take other steps to try to limit the 

impact of the listing on the Entity List 

once a final rule was published. 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 Subject 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 January 13, 2011, 76 FR 3009, 

January 18, 2011; Notice of August 12, 2011, 

76 FR 50661 (August 16, 2011); Notice of 

November 9, 2011, 76 FR 70391 (November 

9, 2011). 

■ 2. Supplement No. 4 to part 744 is 

amended: 

■ (a) By revising under Malaysia, in 

alphabetical order, one Malaysian 

entity; 

■ (b) By removing under Singapore, the 

two Singaporean entities: ‘‘Strive 

Components, Block 10 Toa Payoh 

Industrial Park Lor 8 #01–1221, 

Singapore, 319062’’ and ‘‘Synoptics 

Imaging Systems Pte Ltd., 12 Lor Bakar 

Batu #06–09, Singapore, 348745’’; 

■ (c) By removing under Taiwan, the 

two Taiwanese entities: ‘‘Christine Sun, 


jlentini on DSK4TPTVN1PROD with RULES
Federal Register / Vol. 76, No. 242 / Friday, December 16, 2011 / Rules and Regulations 78149 

7th Floor, Number 17, Zhonghua Rd., 

Sec 2, Xinzhuang City, Taipei, Taiwan’’ 

and ‘‘In-Tech Company, a.k.a., In-Tech 

Telecom, Number 15, Lane 347, 

Jhongjheng Road, Sinjihuang City, 

Taipei, Taiwan, and 7th Floor, Number 

17, Zhonghua Rd., Sec 2, Xinzhuang 

City, Taipei, Taiwan’’; and 

■ (d) By adding under United Arab 

Emirates, in alphabetical order, two 

U.A.E. entities: 

The additions and revisions read as 

follows: 

SUPPLEMENT NO. 4 TO PART 744—ENTITY LIST

Country Entity License requirement License review policy Federal 

Register citation 

*******

Malaysia 

*******

VTE Industrial Automation SDN BHD, 97C, 

Jalan Kenari 23, Puchong Jaya, Puchong, 

Selangor, Malaysia; and 45–02, Jalan 

Kenari 19A, Puchong Jaya, 47100 Malaysia.

For all items subject 

to the EAR. (See 

§ 744.11 of the 

EAR) 

Presumption of denial 73 FR 54503, 9/22/08. 

76 FR [INSERT FR 

PAGE NUMBER] 

12/16/11. 

*******

United Arab Emirates 

*******

Infotec, a.k.a., Info Tech, Ras Al Khaimah 

Free Trade Zone (RAKFTZ), U.A.E.

For all items subject 

to the EAR. (See 

§ 744.11 of the 

EAR) 

Presumption of denial 76 FR [INSERT FR 

PAGE NUMBER] 

12/16/11. 

*******

Waseem Jawad, Ras Al Khaimah Free 

Trade Zone (RAKFTZ), U.A.E.; and P.O. 

Box: 25123, Dubai U.A.E.

For all items subject 

to the EAR. (See 

§ 744.11 of the 

EAR) 

Presumption of denial 76 FR [INSERT FR 

PAGE NUMBER] 

12/16/11. 

*******

Dated: December 12, 2011. 

Kevin J. Wolf, 

Assistant Secretary for Export 

Administration. 

[FR Doc. 2011–32341 Filed 12–15–11; 8:45 am] 

BILLING CODE 3510–33–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 520 

[Docket No. FDA–2011–N–0003] 

Oral Dosage Form New Animal Drugs; 

Estriol 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

animal drug regulations to reflect 

approval of an original new animal drug 

application (NADA) filed by Intervet, 

Inc. The NADA provides for the 

veterinary prescription use of estriol 

tablets for the control of estrogenresponsive urinary incontinence in 

ovariohysterectomized female dogs. 

DATES: This rule is effective December 

16, 2011. 

FOR FURTHER INFORMATION CONTACT: Lisa 

M. Troutman, Center for Veterinary 

Medicine (HFV–116), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, (240) 276–8322, 

email: lisa.troutman@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Intervet, 

Inc., 556 Morris Ave., Summit, NJ 

07901, filed NADA 141–325 that 

provides for the veterinary prescription 

use of INCURIN (estriol) Tablets for the 

control of estrogen-responsive urinary 

incontinence in ovariohysterectomized 

female dogs. The NADA is approved as 

of July 24, 2011, and the regulations are 

amended in 21 CFR part 520 to reflect 

the approval. 

A summary of safety and effectiveness 

data and information submitted to 

support approval of this application 

may be seen in the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852, between 

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

Friday. 

The Agency has determined under 21 

CFR 25.33 that this action is of a type 

that does not individually or 

cumulatively have a significant effect on 

the human environment. Therefore, 

neither an environmental assessment 

nor an environmental impact statement 

is required. 

Under section 512(c)(2)(F)(i) of the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 360b(c)(2)(F)(i)), this 

approval qualifies for 5 years of 

marketing exclusivity beginning on the 

date of approval. 

This rule does not meet the definition 

of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because 

it is a rule of ‘‘particular applicability.’’ 

Therefore, it is not subject to the 

congressional review requirements in 5 

U.S.C. 801–808. 

List of Subjects in 21 CFR Part 520 

Animal drugs. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs and redelegated to 

the Center for Veterinary Medicine, 21 

CFR part 520 is amended as follows: 


jlentini on DSK4TPTVN1PROD with RULES