Federal Register / Vol. 74, No. 179 / Thursday, September 17, 2009 / Rules and Regulations 47725 

PART 240—GENERAL RULES AND 

REGULATIONS, SECURITIES 

EXCHANGE ACT OF 1934 

■ 4. The authority citation for Part 240 

continues to read, in part, as follows: 

Authority: 15 U.S.C. 77c, 77d, 77g, 77j, 

77s, 77z–2, 77z–3, 77eee, 77ggg, 77nnn, 

77sss, 77ttt, 78c, 78d, 78e, 78f, 78g, 78i, 78j, 

78j–1, 78k, 78k–1, 78l, 78m, 78n, 78o, 78p, 

78q, 78s, 78u–5, 78w, 78x, 78ll, 78mm, 80a– 

20, 80a–23, 80a–29, 80a–37, 80b–3, 80b–4, 

80b–11, and 7201 et seq.; and 18 U.S.C. 1350, 

unless otherwise noted. 

* * * * * 

§§ 240.12a–10T and 240.12h–1 [Amended] 

■ 5. In § 240.12a–10T(b), remove the 

words ‘‘September 25, 2009’’ and add, 

in their place, the words ‘‘November 30, 

2010’’. 

■ 6. In § 240.12h–1(h)T, in the last 

sentence, remove the words ‘‘September 

25, 2009’’ and add, in their place, the 

words ‘‘November 30, 2010’’. 

PART 260—GENERAL RULES AND 

REGULATIONS, TRUST INDENTURE 

ACT OF 1939 

■ 7. The authority citation for Part 260 

continues to read as follows: 

Authority: 15 U.S.C. 77eee, 77ggg, 77nnn, 

77sss, 78ll(d), 80b–3, 80b–4, and 80b–11. 

§ 260.4d–11T [Amended] 

■ 8. Section 260.4d–11T is amended by 

removing the words ‘‘September 25, 

2009’’ and adding, in their place, the 

words ‘‘November 30, 2010’’ in the last 

sentence. 

September 14, 2009. 

By the Commission. 

Elizabeth M. Murphy, 

Secretary. 

[FR Doc. E9–22389 Filed 9–16–09; 8:45 am] 

BILLING CODE 8010–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 510 and 522 

[Docket No. FDA–2009–N–0665] 

New Animal Drugs; Fomepizole 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

animal drug regulations to reflect the 

original approval of an abbreviated new 

animal drug application (ANADA) filed 

by Synerx Pharma, LLC. The ANADA 

provides for the veterinary prescription 

use of fomepizole injectable solution as 

an antidote for ethylene glycol 

(antifreeze) poisoning in dogs. 

DATES: This rule is effective September 

17, 2009. 

FOR FURTHER INFORMATION CONTACT: John 

K. Harshman, Center for Veterinary 

Medicine (HFV–104), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–8197, email: john.harshman@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Synerx 

Pharma, LLC, 100 N. State St., 

Newtown, PA 18940–2048, filed 

ANADA 200–472 that provides for 

veterinary prescription use of 

Fomepizole for Injection as an antidote 

for ethylene glycol (antifreeze) 

poisoning in dogs. Synerx Pharma, 

LLC’s Fomepizole for Injection is 

approved as a generic copy of Paladin 

Laboratories’ ANTIZOL–VET 

(fomepizole), approved under NADA 

141–075. The ANADA is approved as of 

2009, and the regulations are amended 

in 21 CFR 522.1004 to reflect the 

approval. 

In addition, Synerx Pharma, LLC, is 

not currently listed in the animal drug 

regulations as a sponsor of an approved 

application. Accordingly, 21 CFR 

510.600(c) is being amended to add 

entries for this sponsor. 

In accordance with the freedom of 

information provisions of 21 CFR part 

20 and 21 CFR 514.11(e)(2)(ii), 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. 

FDA 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. 

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 

21 CFR Part 510 

Administrative practice and 

procedure, Animal drugs, Labeling, 

Reporting and recordkeeping 

requirements. 

21 CFR Part 522 

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 parts 510 and 522 are 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. In § 510.600, in the table in 

paragraph (c)(1), alphabetically add an 

entry for ‘‘Synerx Pharma, LLC’’; and in 

the table in paragraph (c)(2), 

numerically add an entry for ‘‘068882’’ 

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 

* * * * * 

Synerx Pharma, LLC, 100 

N. State St., Newtown, 

PA 18940–2048 

068882 

* * * * * 

(2) * * * 

Drug labeler 

code Firm name and address 

* * * * * 

068882 Synerx Pharma, LLC, 100 

N. State St., Newtown, 

PA 18940–2048 

* * * * * 

PART 522—IMPLANTATION OR 

INJECTABLE DOSAGE FORM NEW 

ANIMAL DRUGS 

■ 3. The authority citation for 21 CFR 

part 522 continues to read as follows: 

Authority: 21 U.S.C. 360b. 

■ 4. In § 522.1004, revise paragraph (b) 

to read as follows: 

§ 522.1004 Fomepizole. 

* * * * * 


cprice-sewell on DSK2BSOYB1PROD with RULES
47726 Federal Register / Vol. 74, No. 179 / Thursday, September 17, 2009 / Rules and Regulations 

1A final rule reorganizing and updating the 

regulations relating to passports, and which 

incorporated the interim final rule redefining 

expedited passport processing, was published at 72 

FR 64930 (Nov. 19, 2007). As a result of the 

reorganization implemented by that rule, the 

regulation affected by this final rule is now at 22 

CFR 51.56(b). 

(b) Sponsors. See Nos. 068727 and 

068882 in § 510.600(c) of this chapter. 

* * * * * 

Dated: September 14, 2009. 

Bernadette Dunham, 

Director, Center for Veterinary Medicine. 

[FR Doc. E9–22384 Filed 9–16–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF STATE 

22 CFR Parts 22 and 51 

[Public Notice 6650] 

RIN 1400–AC39 

Passport Procedures—Amendment to 

Expedited Passport Processing 

Regulation 

AGENCY: Bureau of Consular Affairs, 

State Department. 

ACTION: Final Rule. 

SUMMARY: This rule revises the 

expedited passport process and changes 

the definition of expedited passport 

processing from three business days, 

beginning when the application arrives 

at a passport agency or when the request 

for expedited processing is approved, to 

the number of business days published 

on the Department’s Web site at 

http://www.travel.state.gov. This change 

ensures that the Department can 

continue to offer this service consistent 

with its regulations while maintaining 

sufficient flexibility to adapt to 

fluctuations in passport demand. It also 

ensures that the public can easily 

determine the current standards for 

expedited passport processing. 

DATES: September 17, 2009. 

FOR FURTHER INFORMATION CONTACT: 

Requests for additional information 

should be directed to Susan M. Bozinko, 

Bureau of Consular Affairs, Passport 

Services, Division of Legal Affairs, U.S. 

Department of State, Washington, DC 

20037 or e-mailed at 

BozinkoSM@state.gov. 

SUPPLEMENTARY INFORMATION: The 

Department published an interim final 

rule, Public Notice 5888, Vol. 72 

Federal Register No. 158, amending 

Parts 22 and 51 of Title 22 of the Code 

of Federal Regulations, along with a 

request for comments. The interim final 

rule was implemented to change the 

definition of expedited passport 

processing. The Department’s reasons 

for implementing the change were 

discussed in detail in the interim final 

rule. This final rule is unchanged from 

the interim final rule. Further, this final 

rule makes a conforming amendment to 

the Schedule of Fees for Consular 

Services to reflect a change to the 

regulation affected by this rule.1

Analysis of Comments 

Eight comments were submitted in 

response to the request for comments. 

Two were unsolicited business offers 

and one was a test e-mail to ascertain 

the accessibility of the e-mailbox being 

used. Five were substantive comments, 

including comments submitted by the 

American Immigration Lawyers 

Association (AILA). 

Notice to the Public 

Three individuals expressed concern 

that the publication of the expedited 

passport processing standard on the 

Department’s Web site would not 

provide sufficient notice of the standard 

to the public. 

The Department indicates on its Web 

site the date on which any change to the 

number of business days constituting 

expedited passport processing becomes 

effective. Moreover, the number of 

business days that constitutes expedited 

passport processing is a matter of policy 

determined by the Department. Under 5 

U.S.C. 553(b), statements of general 

agency policy are not subject to the 

requirement of notice and comment 

rulemaking. Thus, any modifications of 

the policy regarding what constitutes 

expedited passport processing, 

including changes to the number of 

business days that constitute expedited 

processing, are not subject to notice and 

comment rulemaking. 

While one commenter felt that the 

link to processing times was too 

difficult to locate, it should be noted 

that the link appears at the top of the 

home page for passport information and 

as such, is readily accessible to anyone 

seeking information on U.S. passports. 

In fact, the http://www.travel.state.gov 

Web site was designed with ease of use 

for the public as a primary goal. The 

Department believes the current Web 

site design is sufficient to meet the 

public’s needs. 

Nature of Service 

Two commenters stated that Web site 

publication of the expedited processing 

standard raised the possibility that 

applicants paying the expedite fee 

would not receive the same service and 

that they would not be able to quickly 

obtain a passport in case of emergency. 

Applicants who request expedited 

service and pay the expedited 

processing fee can expect to receive 

expedited processing within the context 

of circumstances affecting passport 

application processing times. Changes 

to the expedited processing time 

published on the Web site are intended 

to reflect those circumstances. In 

addition, citizens in emergency 

situations have always been and 

continue to be a priority to the 

Department. Applicants with urgent 

travel needs may apply for expedited 

processing either by mail or in person 

at a passport agency. 

Refunds 

One commenter suggested that the 

Department should provide a waiver of 

the expedited processing fee or a refund 

for failure to process expedited passport 

applications within the time published 

on the Department’s Web site. The 

Department’s regulations at 22 CFR 

51.53 already provide for a refund of the 

expedited processing fee in cases where 

the Department does not provide 

expedited processing as defined in 22 

CFR 51.56. Applicants seeking such a 

refund of the expedite fee must submit 

a written refund request to the 

Department. Such requests may be 

submitted to the Department by mail at 

the address provided on the 

Department’s Web site, http:// 

www.travel.state.gov, or by e-mail at the 

address provided on http:// 

www.travel.state.gov. A link to the 

Department’s e-mail portal for expedite 

fee refund requests is included on the 

Web site. 

Procedural Issues 

One commenter said the interim final 

rule was procedurally deficient because 

it sought to incorporate by reference 

information from the Department’s Web 

site in the regulation. The commenter 

objected to the Department’s alleged 

failure to follow the procedure for 

incorporation by reference. However, 

the rules applying to incorporation by 

reference—contained in 1 CFR Part 51, 

which implements 5 U.S.C. 552 (see the 

paragraph following 5 U.S.C. 

552(a)(1)(E))—normally apply when a 

rule imposes a burden or regulatory 

standard on the public. This rule does 

not regulate the public; rather, it sets the 

standard for agency conduct. For this 

reason, the procedures relating to 

incorporation by reference do not apply 

to this rule. 


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