This section of the FEDERAL REGISTER

contains regulatory documents having general

applicability and legal effect, most of which

are keyed to and codified in the Code of

Federal Regulations, which is published under

50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by

the Superintendent of Documents. Prices of

new books are listed in the first FEDERAL

REGISTER issue of each week.

Rules and Regulations Federal Register

20771 

Vol. 75, No. 76 

Wednesday, April 21, 2010 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

9 CFR Parts 102, 103, 104, 108, 112, 

113, 114, 116, and 124 

[Docket No. APHIS-2009-0069] 

Viruses, Serums, Toxins, and 

Analogous Products and Patent Term 

Restoration; Nonsubstantive 

Amendments 

AGENCY: Animal and Plant Health 

Inspection Service, USDA. 

ACTION: Direct final rule. 

SUMMARY: We are amending the VirusSerum-Toxin Act regulations 

concerning veterinary biological 

products to update the addresses 

provided for units within the Center for 

Veterinary Biologics. We are also 

making several nonsubstantive technical 

changes to the regulations to update 

information concerning the number of 

copies of Outlines of Production and 

labeling to submit, and to provide 

information concerning using the 

Internet to obtain forms and apply for 

veterinary biologics permits. 

DATES: This rule will be effective on 

June 21, 2010, unless we receive written 

adverse comments or written notice of 

intent to submit adverse comments on 

or before May 21, 2010. If we receive 

written adverse comments or written 

notice of intent to submit adverse 

comments, we will publish a document 

in the Federal Register withdrawing 

this rule before the effective date. 

ADDRESSES: You may submit comments 

by either of the following methods: 

∑ Federal eRulemaking Portal: Go to 

(http://www.regulations.gov/ 

fdmspublic/component/ 

main?main=DocketDetail&d=APHIS2009-0069) to submit or view comments 

and to view supporting and related 

materials available electronically. 

∑ Postal Mail/Commercial Delivery: 

Please send one copy of your comment 

to Docket No. APHIS-2009-0069, 

Regulatory Analysis and Development, 

PPD, APHIS, Station 3A-03.8, 4700 

River Road Unit 118, Riverdale, MD 

20737-1238. Please state that your 

comment refers to Docket No. APHIS2009-0069. 

Reading Room: You may read any 

comments that we receive on this 

docket in our reading room. The reading 

room is located in room 1141 of the 

USDA South Building, 14th Street and 

Independence Avenue SW., 

Washington, DC. Normal reading room 

hours are 8 a.m. to 4:30 p.m., Monday 

through Friday, except holidays. To be 

sure someone is there to help you, 

please call (202) 690-2817 before 

coming. 

Other Information: Additional 

information about APHIS and its 

programs is available on the Internet at 

(http://www.aphis.usda.gov). 

FOR FURTHER INFORMATION CONTACT: Dr. 

Albert P. Morgan, Chief of Operational 

Support Section, Center for Veterinary 

Biologics, Policy, Evaluation, and 

Licensing, VS, APHIS, 4700 River Road 

Unit 148, Riverdale, MD 20737-1231; 

(301) 734-8245. 

SUPPLEMENTARY INFORMATION: 

Background 

The regulations in Title 9, Code of 

Federal Regulations (9 CFR), parts 101 

through 118 (referred to below as the 

regulations), contain provisions 

implementing the Virus-Serum-Toxin 

Act, as amended (21 U.S.C. 151–159). 

The regulations in 9 CFR part 124 

contain procedural requirements for 

patent extensions for veterinary 

biologics under 35 U.S.C. 156. In 

accordance with the procedures 

explained below under ‘‘Dates,’’ this 

final rule makes several nonsubstantive 

technical changes to those regulations to 

update their provisions. Specifically: 

∑ We will amend the addresses 

throughout the regulations to reflect the 

relocation of the Center for Veterinary 

Biologics to new facilities in Ames, IA. 

∑ We will amend 9 CFR part 102, 

§ 102.3(b)(2)(i), 9 CFR part 104, 

§ 104.5(a)(4), and 9 CFR part 114, 

§§ 114.8(c) and 114.9(a)(1), (a)(5), and 

(a)(7) regarding the number of copies of 

the Outline of Production or revised 

pages of an Outline of Production, or 

special outline that are required to be 

submitted in support of an application 

for veterinary biological product license 

or permit. 

∑ We will amend 9 CFR part 103, 

§ 103.3(d), and 9 CFR part 112, 

§ 112.5(d)(1)(iii) and (d)(1)(iv) regarding 

the number of copies of finished labels 

that are required to be submitted for 

review and filing. 

∑ We will amend 9 CFR part 103, 

§ 104.3(a), and 9 CFR part 112, 

§ 112.5(a), to indicate that the Internet 

may be used to obtain forms and apply 

for certain veterinary biologics permits. 

∑ We will amend 9 CFR part 104, 

§ 104.5(a)(1), and 9 CFR part 108, 

§ 108.7, regarding the number of copies 

of all plot plans, blueprints, and legends 

required to be submitted for review and 

filing. 

Dates 

We are publishing this rule without a 

prior proposal because we view this 

action as noncontroversial and 

anticipate no adverse public comment. 

This rule will be effective, as published 

in this document, on June 21, 2010, 

unless we receive written adverse 

comments or written notice of intent to 

submit adverse comments on or before 

May 21, 2010. 

Adverse comments are comments that 

suggest the rule should not be adopted 

or that suggest the rule should be 

changed. 

If we receive written adverse 

comments or written notice of intent to 

submit adverse comments, we will 

publish a document in the Federal 

Register withdrawing this rule before 

the effective date. We will then publish 

a proposed rule for public comment. 

As discussed above, if we receive no 

written adverse comments or written 

notice of intent to submit adverse 

comments within 30 days of publication 

of this direct final rule, this direct final 

rule will become effective 60 days 

following its publication. We will 

publish a document in the Federal 

Register, before the effective date of this 

direct final rule, confirming that it is 

effective on the date indicated in this 

document. 

Executive Order 12866 and Regulatory 

Flexibility Act 

This rule is subject to Executive Order 

12866. However, for this action, the 

Office of Management and Budget has 

waived its review under Executive 

Order 12866. 


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20772 Federal Register / Vol. 75, No. 76 / Wednesday, April 21, 2010 / Rules and Regulations 

This direct final rule will affect all 

licensed manufacturers of veterinary 

biologics. Currently, there are 

approximately 125 veterinary biologics 

manufacturers, including permittees. 

According to the standards of the Small 

Business Administration, most 

veterinary biologics establishments are 

small entities. 

The provisions of this direct final rule 

that update addresses and indicate the 

availability of forms on the Internet will 

have no economic effect on any entities, 

large or small. The provisions that 

reduce from three to two the number of 

copies of certain forms, labels, plot 

plans, blueprints, and legends that 

regulated entities are required to submit 

in specific cases may result in some cost 

savings to those entities, but those 

savings will be inconsequential. 

Under these circumstances, the 

Administrator of the Animal and Plant 

Health Inspection Service has 

determined that this action will not 

have a significant economic impact on 

a substantial number of small entities. 

Executive Order 12372 

This program/activity is listed in the 

Catalog of Federal Domestic Assistance 

under No. 10.025 and is subject to 

Executive Order 12372, which requires 

intergovernmental consultation with 

State and local officials. (See 7 CFR part 

3015, subpart V.) 

Executive Order 12988 

This direct final rule has been 

reviewed under Executive Order 12988, 

Civil Justice Reform. It is not intended 

to have retroactive effect. This rule 

would not preempt any State or local 

laws, regulations, or policies where they 

are necessary to address local disease 

conditions or eradication programs. 

However, where safety, efficacy, purity, 

and potency of biological products are 

concerned, it is the Agency’s intent to 

occupy the field. This includes, but is 

not limited to, the regulation of labeling. 

Under the Act, Congress clearly 

intended that there be national 

uniformity in the regulation of these 

products. There are no administrative 

proceedings which must be exhausted 

prior to a judicial challenge to the 

regulations under this rule. 

Paperwork Reduction Act 

This rule contains no new 

information collection or recordkeeping 

requirements under the Paperwork 

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

et seq.). Further, this rule will reduce 

information collection or recordkeeping 

requirements in 9 CFR parts 102, 103, 

104, 108, 112, and 114. 

List of Subjects 

9 CFR Parts 102, 103, 114, and 116 

Animal biologics, Reporting and 

recordkeeping requirements. 

9 CFR Part 104 

Animal biologics, Imports, Reporting 

and recordkeeping requirements, 

Transportation. 

9 CFR Part 108 

Animal biologics 

9 CFR Part 112 

Animal biologics, Exports, Imports, 

Labeling, Packaging and containers, 

Reporting and recordkeeping 

requirements. 

9 CFR Part 113 

Animal biologics, Exports, Imports, 

Reporting and recordkeeping 

requirements. 

9 CFR Part 124 

Animal biologics, Patents. 

■ Accordingly, we are amending 9 CFR 

parts 102, 103, 104, 108, 112, 113, 114, 

116, and 124 as follows: 

PART 102—LICENSES FOR 

BIOLOGICAL PRODUCTS 

■ 1. The authority citation for part 102 

continues to read as follows: 

Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 

2.80, and 371.4. 

§ 102.3 [Amended] 

■ 2. In § 102.3, paragraph (b)(2)(i) is 

amended by removing the words ‘‘four 

copies’’ and adding the word ‘‘two 

copies’’ in their place. 

§ 102.5 [Amended] 

■ 3. In § 102.5, paragraph (e), the second 

sentence is amended by removing the 

words ‘‘Licensing and Policy 

Development, 510 South 17th Street, 

Suite 104, Ames, IA 50010-8197’’ and 

adding the words ‘‘Policy, Evaluation, 

and Licensing, 1920 Dayton Avenue, 

P.O. Box 844, Ames, IA 50010’’ in their 

place. 

PART 103—EXPERIMENTAL 

PRODUCTION, DISTRIBUTION, AND 

EVALUATION OF BIOLOGICAL 

PRODUCTS PRIOR TO LICENSING 

■ 4. The authority citation for part 103 

continues to read as follows: 

Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 

2.80, and 371.4. 

§ 103.3 [Amended] 

■ 5. In § 103.3, paragraph (d), the first 

sentence is amended by removing the 

words ‘‘Three copies’’ and adding the 

words ‘‘Two copies’’ in their place. 

PART 104—PERMITS FOR 

BIOLOGICAL PRODUCTS 

■ 6. The authority citation for part 104 

continues to read as follows: 

Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 

2.80, and 371.4. 

■ 7. In § 104.3, paragraph (a) is amended 

by revising the second sentence to read 

as follows: 

§ 104.3 Permit application. 

(a) * * * Application forms are 

available on the Internet at (http:// 

www.aphis.usda.gov/animal_health/ 

vet_biologics/vb_forms.shtml) and 

application for a permit to import a 

veterinary biologic for research and 

evaluation or transit shipment may be 

made on the Internet at (http:// 

www.aphis.usda.gov/animal_health/ 

permits/vet_bio_permits.shtml). 

* * * * * 

§ 104.5 [Amended] 

■ 8. Section 104.5 is amended as 

follows: 

■ a. In paragraph (a)(1), in the first 

sentence, by removing the words ‘‘Three 

copies’’ and adding the words ‘‘Two 

copies’’ in their place. 

■ b. In paragraph (a)(4), in the second 

sentence, by removing the words ‘‘Four 

copies’’ and adding the words ‘‘Two 

copies’’ in their place. 

PART 108—FACILITY REQUIREMENTS 

FOR LICENSED ESTABLISHMENTS 

■ 9. The authority citation for part 108 

continues to read as follows: 

Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 

2.80, and 371.4. 

§ 108.7 [Amended] 

■ 10. In § 108.7, the first sentence is 

amended by removing the words ‘‘Three 

copies’’ and adding the words ‘‘Two 

copies’’ in their place. 

PART 112—PACKAGING AND 

LABELING 

■ 11. The authority citation for part 112 

continues to read as follows: 

Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 

2.80, and 371.4. 

§ 112.5 [Amended] 

■ 12. Section 112.5 is amended as 

follows: 

■ a. In paragraph (a), in the first 

sentence, by removing the words 

‘‘furnished by Animal and Plant Health 

inspection Service upon request’’ and 

adding the words ‘‘available on the 


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Federal Register / Vol. 75, No. 76 / Wednesday, April 21, 2010 / Rules and Regulations 20773 

Internet at (http://www.aphis.usda.gov/ 

animal_health/vet_biologics/ 

vb_forms.shtml) ’’ in their place. 

■ b. In paragraph (d)(1)(iii), in the first 

sentence, by removing the words ‘‘three 

copies’’ and adding the words ‘‘two 

copies’’ in their place and, in the second 

sentence, by removing the words ‘‘Two 

copies’’ and adding the words ‘‘One 

copy’’ in their place. 

■ c. In paragraph (d)(1)(iv), in the first 

sentence, by removing the words ‘‘three 

copies’’ and adding the words ‘‘two 

copies’’ in their place and, in the fifth 

sentence, by removing the words ‘‘Two 

copies’’ and adding the words ‘‘One 

copy’’ in their place. 

PART 113—STANDARD 

REQUIREMENTS 

■ 13. The authority citation for part 113 

continues to read as follows: 

Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 

2.80, and 371.4. 

§ 113.113 [Amended] 

■ 14. Section 113.113 is amended as 

follows: 

■ a. In paragraph (a)(2), in the third 

sentence, by removing the words ‘‘510 

South 17th Street, Suite 104, Ames, IA 

50010-8197’’ and adding the words 

‘‘1920 Dayton Avenue, P.O. Box 844, 

Ames, IA 50010’’ in their place. 

■ b. In paragraph (a)(3), in the second 

sentence, by removing the words ‘‘510 

South 17th Street, Suite 104, Ames, IA 

50010-8197’’ and adding the words 

‘‘1920 Dayton Avenue, P.O. Box 844, 

Ames, IA 50010’’ in their place. 

■ c. In paragraph (c)(1)(iv), in the first 

sentence, by removing the words ‘‘510 

South 17th Street, Suite 104, Ames, IA 

50010-8197’’ and adding the words 

‘‘1920 Dayton Avenue, P.O. Box 844, 

Ames, IA 50010’’ in their place. 

■ d. In paragraph (c)(2)(iv)(A), in the 

second sentence, by removing the words 

‘‘Licensing and Policy Development, 510 

South 17th Street, Suite, 104, Ames, IA 

50010-8197’’ and adding the words 

‘‘Policy, Evaluation, and Licensing, 1920 

Dayton Avenue, P.O. Box 844, Ames, IA 

50010’’ in their place. 

§ 113.209 [Amended] 

■ 15. In § 113.209, paragraph (b)(1), the 

fifth sentence is amended by removing 

the words ‘‘1800 Dayton Avenue, P.O. 

Box 844, Ames, IA 50010; phone (515) 

239-8331; fax (515) 239-8673’’ and 

adding the words ‘‘1920 Dayton Avenue, 

P.O. Box 844, Ames, IA 50010; phone 

(515) 337-6100; fax (515) 337-6120’’ in 

their place and, in the seventh sentence, 

by removing the words ‘‘Licensing, and 

Policy Development, 4700 River Road, 

Riverdale, MD’’ and adding the words 

‘‘Policy, Evaluation, and Licensing, 1920 

Dayton Avenue, P.O. Box 844, Ames, IA 

50010’’ in their place. 

PART 114—PRODUCTION 

REQUIREMENTS FOR BIOLOGICAL 

PRODUCTS 

■ 16. The authority citation for part 114 

continues to read as follows: 

Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 

2.80, and 371.4. 

■ 17. In § 114.8, paragraph (c) is revised 

to read as follows: 

§ 114.8 Outline of Production required. 

* * * * * 

(c) One copy of the Outline of 

Production shall be retained by the 

Animal and Plant Health Inspection 

Service and one copy returned to the 

licensee or permittee. 

* * * * * 

§ 114.9 [Amended] 

■ 18. Section 114.9 is amended as 

follows: 

■ a. In paragraph (a)(1), in the first 

sentence, by removing the words ‘‘The 

original and not more than four’’ and 

adding the word ‘‘All’’ in their place. 

■ b. In paragraph (a)(5), in the first 

sentence, by removing the words ‘‘the 

original and one copy’’ and adding the 

words ‘‘both copies’’ in their place. 

■ c. In paragraph (a)(7), by removing the 

second sentence and adding the 

sentence ‘‘Transmittal forms are 

available on the Internet at (http:// 

www.aphis.usda.gov/animal_health/ 

vet_biologics/vb_forms.shtml) .’’ in its 

place. 

PART 116—RECORDS AND REPORTS 

■ 19. The authority citation for part 116 

continues to read as follows: 

Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 

2.80, and 371.4. 

§ 116.5 [Amended] 

■ 20. In § 116.5, paragraph (b), the 

second sentence is amended by 

removing the words ‘‘510 South 17th 

Street, Suite 104, Ames, IA 50010-8197; 

by electronic mail to 

(cvb@aphis.usda.gov); by fax to (515) 

232-7120; or by telephone to (515) 232- 

5785’’ and adding the words ‘‘1920 

Dayton Avenue, P.O. Box 844, Ames, IA 

50010; by electronic mail to 

(cvb@aphis.usda.gov); by fax to (515) 

337-6120; or by telephone to (515) 337- 

6100’’ in their place. 

PART 124—PATENT TERM 

RESTORATION 

■ 21. The authority citation for part 124 

continues to read as follows: 

Authority: 35 U.S.C. 156; 7 CFR 2.22, 2.80, 

and 371.4. 

§ 124.22 [Amended] 

■ 22. In § 124.22, paragraph (a), the 

second sentence is amended by 

removing the words ‘‘Licensing, and 

Policy Development, 510 South 17th 

Street, Suite 104, Ames, IA 50010-8197’’ 

and adding the words ‘‘Policy, 

Evaluation, and Licensing, 1920 Dayton 

Avenue, P.O. Box 844, Ames, IA 50010’’ 

in their place. 

§ 124.40 [Amended] 

■ 23. In § 124.40, paragraph (b)(3) is 

amended by removing the words 

‘‘Licensing and Policy Development, 510 

South 17th Street, Suite 104, Ames, IA 

50010-8197’’ and adding the words 

‘‘Policy, Evaluation, and Licensing, 1920 

Dayton Avenue, P.O. Box 844, Ames, IA 

50010’’ in their place. 

Done in Washington, DC, this 14th day 

of April 2010. 

Kevin Shea, 

Acting Administrator, Animal and Plant 

Health Inspection Service. 

[FR Doc. 2010–9072 Filed 4–20–10; 10:24 am] 

BILLING CODE 3410–34–S 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 71 

[Docket No. FAA–2009–0937; Airspace 

Docket No. 09–ASO–27] 

Establishment of Class E Airspace; 

Jackson, AL 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Direct final rule; confirmation of 

effective date. 

SUMMARY: This action confirms the 

effective date of a direct final rule 

published in the Federal Register 

December 7, 2009 that establishes Class 

E airspace at Jackson Muni, Jackson, AL. 

DATES: Effective Date: 0901 UTC, April 

21, 2010. 

FOR FURTHER INFORMATION CONTACT: 

Melinda Giddens, Operations Support 

Group, Eastern Service Center, Federal 

Aviation Administration, P.O. Box 

20636, Atlanta, Georgia 30320; 

telephone (404) 305–5610. 

SUPPLEMENTARY INFORMATION: 

Confirmation of Effective Date 

The FAA published this direct final 

rule with a request for comments in the 

Federal Register on December 7, 2009 

(74 FR 63973), Docket No. FAA–2009– 


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