[Federal Register Volume 75, Number 76 (Wednesday, April 21, 2010)]
[Rules and Regulations]
[Pages 20771-20773]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-9072]



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

[[Page 20771]]



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 Virus-Serum-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=APHIS-2009-0069) 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. APHIS-2009-0069.
    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, Sec.  102.3(b)(2)(i), 9 CFR 
part 104, Sec.  104.5(a)(4), and 9 CFR part 114, Sec. Sec.  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, Sec.  103.3(d), and 9 CFR 
part 112, Sec.  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, Sec.  104.3(a), and 9 CFR 
part 112, Sec.  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, Sec.  104.5(a)(1), and 9 CFR 
part 108, Sec.  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.

[[Page 20772]]

    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.

0
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

0
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.


Sec.  102.3  [Amended]

0
2. In Sec.  102.3, paragraph (b)(2)(i) is amended by removing the words 
``four copies'' and adding the word ``two copies'' in their place.


Sec.  102.5  [Amended]

0
3. In Sec.  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

0
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.


Sec.  103.3  [Amended]

0
5. In Sec.  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

0
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.

0
7. In Sec.  104.3, paragraph (a) is amended by revising the second 
sentence to read as follows:


Sec.  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).
* * * * *


Sec.  104.5  [Amended]

0
8. Section 104.5 is amended as follows:
0
a. In paragraph (a)(1), in the first sentence, by removing the words 
``Three copies'' and adding the words ``Two copies'' in their place.
0
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

0
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.


Sec.  108.7  [Amended]

0
10. In Sec.  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

0
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.


Sec.  112.5  [Amended]

0
12. Section 112.5 is amended as follows:
0
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

[[Page 20773]]

Internet at (http://www.aphis.usda.gov/animal_health/vet_biologics/vb_forms.shtml) '' in their place.
0
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.
0
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

0
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.


Sec.  113.113  [Amended]

0
14. Section 113.113 is amended as follows:
0
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.
0
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.
0
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.
0
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.


Sec.  113.209  [Amended]

0
15. In Sec.  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

0
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.

0
17. In Sec.  114.8, paragraph (c) is revised to read as follows:


Sec.  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.
* * * * *


Sec.  114.9  [Amended]

0
18. Section 114.9 is amended as follows:
0
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.
0
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.
0
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

0
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.


Sec.  116.5  [Amended]

0
20. In Sec.  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 ([email protected]); 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 
([email protected]); by fax to (515) 337-6120; or by telephone to 
(515) 337-6100'' in their place.

PART 124--PATENT TERM RESTORATION

0
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.


Sec.  124.22  [Amended]

0
22. In Sec.  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.


Sec.  124.40  [Amended]

0
23. In Sec.  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 14\th\ 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