70996 Federal Register / Vol. 70, No. 226 / Friday, November 25, 2005 / Rules and Regulations 

must demonstrate to the Designated 

School Official (DSO) at the academic 

institution where the F–1 student 

currently is enrolled that such 

employment is necessary to avoid 

severe economic hardship resulting 

from Hurricane Katrina. See 8 CFR 

214.2(f)(9)(i). The DSO should sign, 

date, and include the following notation 

in the student employment box on page 

3 of Form I–20: ‘‘Approved for more 

than 20 hours per week of on-campus 

employment until February 1, 2006, 

pursuant to Hurricane Katrina Special 

Student Relief.’’ By making this 

notation, the DSO certifies that the F–

1 student is covered by this Notice. 

2. Off-Campus Employment 

An F–1 student covered by this 

Notice, who seeks to pursue off-campus 

employment pursuant to this Notice, 

must file a complete Form I–765, 

Application for Employment 

Authorization, including required 

supporting documentation, with the 

USCIS Texas Service Center at: 

U.S. Citizenship and Immigration 

Services, Texas Service Center, P.O. Box 

853062, Mesquite, TX 75815–3062. 

The front of the envelope, on the 

bottom right-hand side, should include 

the following notation: ‘‘HURRICANE 

KATRINA SPECIAL STUDENT 

RELIEF.’’ Failure to include this 

notation may result in significant 

processing delays. 

An application package is complete if 

it contains: (1) A properly completed 

Form I–765, Application for 

Employment Authorization, with the 

required fee or, if the F–1 student 

believes he or she is eligible for a waiver 

of this fee, a written affidavit or 

unsworn declaration, which requests 

waiver of the fee under 8 CFR 103.7(c) 

and explains the reasons why the 

student is unable to pay the prescribed 

fee, and (2) Form I–20 with a 

recommendation for off-campus 

employment from the DSO at the 

academic institution where the F–1 

student is currently enrolled. See 8 CFR 

214.2(f)(9)(ii)(D). The DSO should sign, 

date, and include the following notation 

in the student employment box on page 

3 of Form I–20: ‘‘Approved for more 

than 20 hours per week of off-campus 

employment until February 1, 2006, 

pursuant to Hurricane Katrina Special 

Student Relief.’’ By making this 

notation, the DSO certifies that the F–

1 student is covered by this Notice. 

If U.S. Citizenship and Immigration 

Services (USCIS) approves the F–1 

student’s Form I–765, Application for 

Employment Authorization, USCIS will 

send the student a Form I–766, 

Employment Authorization Document, 

to evidence his or her employment 

authorization. The Form I–766 will 

contain an expiration date that will not 

extend beyond February 1, 2006. If 

USCIS denies the F–1 student’s Form I–

765, Application for Employment 

Authorization, USCIS will notify the 

student of the decision, and the 

reason(s) for the denial. 

Is there a cut-off date for the filing of 

a Form I–765, Application for 

Employment Authorization, pursuant to 

this Notice? 

No. DHS has not established a cut-off 

date for the filing of a Form I–765, 

Application for Employment 

Authorization, pursuant to this Notice. 

Any benefits granted by means of this 

Notice, however, will expire no later 

than February 1, 2006. While USCIS 

will exercise its best efforts to process 

such applications in as prompt a 

manner as possible, F–1 students 

applying for employment authorization 

pursuant to this Notice should bear in 

mind this expiration date when 

submitting their Forms I–765, 

Applications for Employment 

Authorization. 

Will F–2 dependents (spouse or minor 

children) of F–1 students covered by 

this Notice be eligible to apply for 

employment authorization? 

No. Pursuant to 8 CFR 214.2(f)(15)(i), 

an F–2 dependent (spouse or minor 

children) of an F–1 student, may not 

accept employment. 

Will F–1 students covered by this 

Notice be required to apply for 

reinstatement after February 1, 2006? 

No. F–1 students, who are granted 

employment authorization pursuant to 

this Notice, will be deemed to be 

engaged in a ‘‘full course of study’’ for 

the duration of their employment 

authorization, provided such 

undergraduate level F–1 students 

remain registered for a minimum of 6 

semester/quarter hours of instruction 

per academic term, and such graduate 

level F–1 students remain registered for 

a minimum of 3 semester/quarter hours 

of instruction per academic term. See 8 

CFR 214.2(f)(5)(v). Such F–1 students, 

therefore, would not be required to 

apply for reinstatement under 8 CFR 

214.2(f)(16) if they are otherwise 

maintaining F–1 status. 

How long will this Notice remain in 

effect? 

This Notice grants temporary relief to 

a specific group of F–1 students for the 

estimated length of the current 

academic term. As such, this Notice will 

remain in effect until February 1, 2006. 

During this period, DHS will continue 

to monitor the adverse impact of 

Hurricane Katrina in the affected areas 

to determine if modification or 

rescission of these special provisions is 

warranted. Should these special 

provisions be modified or rescinded 

prior to February 1, 2006, DHS will 

announce such changes in the Federal 

Register. 

Paperwork Reduction Act 

The information collection 

requirements contained in this rule have 

been cleared by the Office of 

Management and Budget (OMB) under 

the provisions of the Paperwork 

Reduction Act. Clearance numbers for 

these collections are contained in 8 CFR 

299.5, Display Control Numbers, and are 

noted herein. Form I–765, Application 

for Employment Authorization, OMB 

Control Number 1615–0040. 

Dated: November 17, 2005. 

Michael Chertoff, 

Secretary. 

[FR Doc. 05–23309 Filed 11–23–05; 8:45 am] 

BILLING CODE 4410–10–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 510 

New Animal Drugs; Change of 

Sponsor’s Address 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

animal drug regulations to reflect a 

change of sponsor’s address for 

Schering-Plough Animal Health Corp. 

DATES: This rule is effective November 

25, 2005. 

FOR FURTHER INFORMATION CONTACT: 

David R. Newkirk, Center for Veterinary 

Medicine (HFV–100), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 301–827–6967, email: david.newkirk@fda.gov. 

SUPPLEMENTARY INFORMATION: ScheringPlough Animal Health Corp., 1095 

Morris Ave., Union, NJ 07083, has 

informed FDA of a change of address to 

556 Morris Ave., Summit, NJ 07901. 

Accordingly, the agency is amending 

the regulations in 21 CFR 510.600(c) to 

reflect the change. 

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.’’

Federal Register / Vol. 70, No. 226 / Friday, November 25, 2005 / Rules and Regulations 70997 

Therefore, it is not subject to the 

congressional review requirements in 5 

U.S.C. 801–808. 

List of Subjects in 21 CFR Part 510 

Administrative practice and 

procedure, Animal drugs, Labeling, 

Reporting and recordkeeping 

requirements. 

■ 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 510 is amended as follows: 

PART 510—NEW ANIMAL DRUGS 

■ 1. The authority citation for 21 CFR 

part 510 continues to read as follows: 

Authority: 21 U.S.C. 321, 331, 351, 352, 

353, 360b, 371, 379e. 

■ 2. Section 510.600 is amended in the 

table in paragraph (c)(1) by revising the 

entry for ‘‘Schering-Plough Animal 

Health Corp.’’; and in the table in 

paragraph (c)(2) by revising the entry for 

‘‘000061’’ to read as follows. 

§ 510.600 Names, addresses, and drug 

labeler codes of sponsors of approved 

applications. 

* * * * * 

(c) * * * 

(1) * * * 

Firm name and address Drug labeler 

code 

* * * * * 

Schering-Plough Animal 

Health Corp., 556 Morris 

Ave., Summit, NJ 07901.

000061 

* * * * * 

(2) * * * 

Drug labeler 

code Firm name and address 

* * * * * 

000061 Schering-Plough Animal 

Health Corp., 556 Morris 

Ave., Summit, NJ 07901 

* * * * * 

Dated: November 15, 2005. 

Steven D. Vaughn, 

Director, Office of New Animal Drug 

Evaluation, Center for Veterinary Medicine. 

[FR Doc. 05–23296 Filed 11–23–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 510 

New Animal Drugs; Change of 

Sponsor’s Name 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

animal drug regulations to reflect a 

change of sponsor’s name from Phoenix 

Scientific, Inc., to IVX Animal Health, 

Inc. In order to improve the accuracy of 

the regulations, erroneous entries for 

Phoenix Pharmaceutical, Inc., are also 

being removed at this time. 

DATES: This rule is effective November 

25, 2005. 

FOR FURTHER INFORMATION CONTACT: 

David R. Newkirk, Center for Veterinary 

Medicine (HFV–100), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 301–827–6967, email: david.newkirk@fda.gov. 

SUPPLEMENTARY INFORMATION: Phoenix 

Scientific, Inc., 3915 South 48th Street 

Ter., St. Joseph, MO 64503, has 

informed FDA that it has changed its 

name to IVX Animal Health, Inc. 

Accordingly, the agency is amending 

the regulations in § 510.600 (21 CFR 

510.600) to reflect the change. 

In addition, FDA has noticed that 

Phoenix Pharmaceutical, Inc., is no 

longer a sponsor of an approved new 

animal drug application. At this time, 

§ 510.600 is amended to remove entries 

for this sponsor. This action is being 

taken to improve the accuracy of the 

regulations. 

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 510 

Administrative practice and 

procedure, Animal drugs, Labeling, 

Reporting and recordkeeping 

requirements. 

■ 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 510 is amended as follows: 

PART 510—NEW ANIMAL DRUGS 

■ 1. The authority citation for 21 CFR 

part 510 continues to read as follows: 

Authority: 21 U.S.C. 321, 331, 351, 352, 

353, 360b, 371, 379e. 

■ 2. Section 510.600 is amended in the 

table in paragraph (c)(1) by removing 

the entries for ‘‘Phoenix Pharmaceutical, 

Inc.’’ and ‘‘Phoenix Scientific, Inc.’’, and 

by alphabetically adding a new entry for 

‘‘IVX Animal Health, Inc.’’; and in the 

table in paragraph (c)(2) by removing 

the entry for ‘‘057319’’ and by revising 

the entry for ‘‘059130’’ to read as 

follows: 

§ 510.600 Names, addresses, and drug 

labeler codes of sponsors of approved 

applications. 

* * * * * 

(c) * * * 

(1) * * * 

Firm name and address Drug labeler 

code 

* * * * * 

IVX Animal Health, Inc., 

3915 South 48th Street 

Ter., St. Joseph, MO 

64503.

059130 

* * * * * 

(2) * * * 

Drug labeler 

code Firm name and address 

* * * * * 

059130 IVX Animal Health, Inc., 

3915 South 48th Street 

Ter., St. Joseph, MO 

64503 

* * * * * 

Dated: November 15, 2005. 

Steven D. Vaughn, 

Director, Office of New Animal Drug 

Evaluation, Center for Veterinary Medicine. 

[FR Doc. 05–23297 Filed 11–23–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 522 

Implantation or Injectable Dosage 

Form New Animal Drugs; Boldenone 

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 a supplemental new animal 

drug application (NADA) filed by Fort 

Dodge Animal Health. The 

supplemental NADA provides for