55968 Federal Register / Vol. 79, No. 181 / Thursday, September 18, 2014 / Rules and Regulations 

1To view the proposed rule and supporting 

documentation, go to http://www.regulations.gov/

#!docketDetail;D=APHIS-2013-0034. 

sentence of paragraph D.6. introductory 

text and the third sentences of 

paragraph D.6.d. to read as follows: 

§ 1980.452 FmHA or its successor agency 

under Public Law 103–354 evaluation of 

application. 

* * * * * 

D. * * * 

6. * * * Notice of approval to lender 

will be accomplished by providing or 

sending the lender the signed copy of 

Form FmHA or its successor agency 

under Public Law 103–354 1940–3 and 

Form FmHA or its successor agency 

under Public Law 103–354 449–14 six 

working days from the date funds are 

reserved, unless an exception is granted 

by the National Office. * * * 

* * * * * 

(d) * * * The obligation date will be 

the date of the request for reservation of 

authority which is being processed in 

the Finance Office. * * * 

* * * * * 

Dated: August 7, 2014. 

Doug O’Brien, 

Under Secretary, Rural Development. 

Dated: September 3, 2014. 

Michael Scuse, 

Under Secretary, Farm and Foreign 

Agricultural Services. 

[FR Doc. 2014–21704 Filed 9–17–14; 8:45 am] 

BILLING CODE 3410–XT–P 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

9 CFR Parts 101 and 113 

[Docket No. APHIS–2013–0034] 

RIN 0579–AD86 

Viruses, Serums, Toxins, and 

Analogous Products; Standard 

Requirements; Addition of 

Terminology To Define Veterinary 

Biologics Test Results 

AGENCY: Animal and Plant Health 

Inspection Service, USDA. 

ACTION: Final rule. 

SUMMARY: We are amending the 

veterinary biological product 

regulations by defining the terms used 

for reporting the results of tests 

performed on veterinary biological 

products. Licensees and permittees of 

veterinary biological products must 

conduct these tests and report the 

results to the Animal and Plant Health 

Inspection Service so that the Agency 

can determine if the products are 

eligible for release. Defining these terms 

will clarify the circumstances under 

which the results of a prescribed test 

can be reported as satisfactory, 

unsatisfactory, inconclusive, or a No 

Test. We are also removing several 

obsolete testing standard requirements 

from the regulations. These changes will 

update our regulations and improve 

communication between regulators and 

product licensees and permittees with 

respect to reporting test results. 

DATES: Effective Date: October 20, 2014. 

FOR FURTHER INFORMATION CONTACT: Dr. 

Donna Malloy, Operational Support 

Section, Center for Veterinary Biologics 

Policy, Evaluation, and Licensing, VS, 

APHIS, 4700 River Road, Unit 148, 

Riverdale, MD 20737–1231; (301) 851– 

3426. 

SUPPLEMENTARY INFORMATION: 

Background 

The Animal and Plant Health 

Inspection Service (APHIS) administers 

and enforces the Virus-Serum-Toxin Act 

(21 U.S.C. 151 et seq.). Under the VirusSerum-Toxin Act, a veterinary 

biological product must be shown to be 

pure, safe, potent, and efficacious before 

a veterinary biological product license 

may be issued. The regulations in 9 CFR 

part 113, ‘‘Standard Requirements’’ 

(referred to below as the regulations), 

prohibit the release of biological 

products prior to the completion of tests 

identified in the regulations and in the 

Outline of Production, a document 

submitted by the licensee that explains 

how a serial of product is formulated, 

tested, packaged, dated, and 

recommended for use. 

On May 30, 2014, we published in the 

Federal Register (79 FR 31054–31056, 

Docket No. APHIS–2013–0034) a 

proposal 1 to amend the regulations by 

defining the terms used for reporting the 

results of tests performed on veterinary 

biological products. We proposed to add 

definitions of the terms used to 

designate test results, ‘‘satisfactory,’’ 

‘‘unsatisfactory,’’ and ‘‘inconclusive,’’ to 

§ 101.5(l) and to revise the definition of 

‘‘No Test’’ currently in that section in 

order to align the regulations in 9 CFR 

part 113 with current industry standards 

and practices. We also proposed to 

remove §§ 113.201, 113.202, 113.203, 

113.211, 113.213, and 113.214 from the 

regulations. These standards, which 

involve testing on live animals, are no 

longer used by the industry because 

newer testing methods are available. 

We solicited comments concerning 

our proposal for 60 days ending July 29, 

2014. We did not receive any comments. 

Therefore, for the reasons given in the 

proposed rule, we are adopting the 

proposed rule as a final rule, without 

change. 

Executive Order 12866 and Regulatory 

Flexibility Act 

This final rule has been determined to 

be not significant for the purposes of 

Executive Order 12866 and, therefore, 

has not been reviewed by the Office of 

Management and Budget. 

In accordance with the Regulatory 

Flexibility Act, we have analyzed the 

potential economic effects of this action 

on small entities. The analysis is 

summarized below. Copies of the full 

analysis are available on the 

Regulations.gov Web site (see footnote 1 

in this document for a link to 

Regulations.gov) or by contacting the 

person listed under FOR FURTHER

INFORMATION CONTACT. 

APHIS is amending the regulations in 

order to better define the terminology 

used when reporting the results of tests 

performed on veterinary biological 

products, thereby bringing the 

regulations up to date with current 

industry standards. 

The changes will clarify when the 

results of a prescribed test can be 

reported as satisfactory, unsatisfactory, 

inconclusive, or can be designated as a 

No Test. The definitional changes will 

improve communication between 

APHIS and the regulated industry, and 

enable APHIS to more efficiently 

process the release of a tested product 

using current industry standards for 

reporting of test results. 

There are about 330 firms in the 

United States that manufacture 

biological products. It is not known how 

many of these firms are engaged in 

manufacturing biologic products 

specifically for veterinary purposes. The 

Small Business Administration (SBA) 

standard for a small business in this 

industry is a firm with not more than 

500 employees; the average firm in this 

industry has 93 employees. While most 

firms that would be affected by this rule 

are small, the changes will not impose 

a financial burden on them, but rather 

help make the product approval process 

timelier. 

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 


asabaliauskas on DSK5VPTVN1PROD with RULES
Federal Register / Vol. 79, No. 181 / Thursday, September 18, 2014 / Rules and Regulations 55969 

intergovernmental consultation with 

State and local officials. (See 7 CFR part 

3015, subpart V.) 

Executive Order 12988 

This final rule has been reviewed 

under Executive Order 12988, Civil 

Justice Reform. It is not intended to 

have retroactive effect. This rule will 

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 final rule contains no new 

information collection or recordkeeping 

requirements under the Paperwork 

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

et seq.). 

List of Subjects 

9 CFR Part 101 

Animal biologics. 

9 CFR Part 113 

Animal biologics, Exports, Imports, 

Reporting and recordkeeping 

requirements. 

Accordingly, we are amending 9 CFR 

parts 101 and 113 as follows: 

PART 101—DEFINITIONS 

■ 1. The authority citation for part 101 

continues to read as follows: 

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

2.80, and 371.4. 

■ 2. In § 101.5, paragraph (l) is revised 

to read as follows: 

§ 101.5 Testing terminology. 

* * * * * 

(l) Test results. Terms used to 

designate testing results are as follows: 

(1) No Test. Designation used when a 

deficiency in the test system has 

rendered a test unsuitable for drawing a 

valid conclusion. 

(2) Satisfactory. Designation is a final 

conclusion given to a valid test with 

results that meet the release criteria 

stated in the filed Outline of Production 

or Standard Requirement. 

(3) Unsatisfactory. Designation is a 

final conclusion given to a valid test 

with results that do not meet the release 

criteria stated in the filed Outline of 

Production or Standard Requirement. 

(4) Inconclusive. Designation used for 

an initial test when a sequential test 

design established in the filed Outline 

of Production or Standard Requirement 

allows further testing if a valid initial 

test is not satisfactory. 

* * * * * 

PART 113—STANDARD 

REQUIREMENTS 

■ 3. 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. 

■ 4. In § 113.5, paragraph (d) is revised 

to read as follows: 

§ 113.5 General testing. 

* * * * * 

(d) When the initial or any subsequent 

test is declared a No Test, the reasons 

shall be reported in the test records, the 

results shall not be considered as final, 

and the test may be repeated. When a 

test is declared satisfactory, the test 

designation is considered to be a final 

conclusion. When a test is declared 

unsatisfactory, the test designation is 

considered to be a final conclusion. 

When the initial or any subsequent test 

is declared inconclusive, the reasons 

shall be reported in the test records, the 

result shall not be considered as final, 

and the test may be repeated as 

established in the filed Outline of 

Production or Standard Requirement. If 

a test is designated inconclusive or No 

Test and the biological product is not 

further tested, the test designation of 

unsatisfactory is the final conclusion. 

* * * * * 

§§ 113.33, 113.36, 113.38, 113.39, 113.40, 

113.41, 113.44, 113.45, 113.47, 113.67, 

113.70, 113.71, 113.108, 113.109, 113.111, 

113.112, 113.116, 113.117, 113.118, 113.204, 

113.205, 113.207, 113.208, 113.215, 113.216, 

113.301, 113.302, 113.303, 113.304, 113.305, 

113.306, 113.310, 113.311, 113.313, 113.314, 

113.315, 113.316, 113.317, 113.318, 113.326, 

113.327, 113.328, 113.329, 113.330, 113.331, 

113.332, 113.406, 113.450, 113.454, and 

113.455 [Amended] 

■ 5. Sections 113.33, 113.36, 113.38, 

113.39, 113.40, 113.41, 113.44, 113.45, 

113.47, 113.67, 113.70, 113.71, 113.108, 

113.109, 113.111, 113.112, 113.116, 

113.117, 113.118, 113.204, 113.205, 

113.207, 113.208, 113.210, 113.215, 

113.216, 113.301, 113.302, 113.303, 

113.304, 113.305, 113.306, 113.310, 

113.311, 113.313, 113.314, 113.315, 

113.316, 113.317, 113.318, 113.326, 

113.327, 113.328, 113.329, 113.330, 

113.331, 113.332, 113.406, 113.450, 

113.454, and 113.455 are amended by 

removing the word ‘‘inconclusive’’ each 

time it occurs and by adding the words 

‘‘a No Test’’ in its place. 

§§ 113.109, 113.111, and 113.112 

[Amended] 

■ 6. Sections 113.109, 113.111, and 

113.112 are amended by removing the 

word ‘‘invalid’’ each time it occurs and 

adding the words ‘‘a No Test’’ in its 

place. 

§§ 113.201, 113.202, 113.203, and 113.211 

[Removed and Reserved] 

■ 7. Sections 113.201, 113.202, 113.203, 

and 113.211 are removed and reserved. 

§ 113.212 [Amended] 

■ 8. In § 113.212, paragraphs (b) and 

(d)(1) are amended by removing the 

word ‘‘inconclusive’’ each time it occurs 

and replacing it with the words ‘‘a No 

Test’’. 

§§ 113.213 and 113.214 [Removed and 

Reserved] 

■ 9. Sections 113.213 and 113.214 are 

removed and reserved. 

■ 10. Section 113.325 is amended as 

follows: 

■ a. By revising paragraph (b); and 

■ b. In paragraphs (c)(4), (d)(1), and 

(d)(2)(ii), by removing the word 

‘‘inconclusive’’ each time it occurs and 

replacing it with the words ‘‘a No Test’’. 

The revision reads as follows: 

§ 113.325 Avian Encephalomyelitis 

Vaccine. 

* * * * * 

(b) Each lot of Master Seed Virus shall 

be tested for pathogens by the chicken 

embryo inoculation test prescribed in 

§ 113.37, except that, if the test is a No 

Test because of a vaccine virus override, 

the test may be repeated and if the 

repeat test is inconclusive for the same 

reason, the chicken inoculation test 

prescribed in § 113.36 may be 

conducted and the virus judged 

accordingly. 

* * * * * 

Done in Washington, DC, this 12th day of 

September 2014. 

Kevin Shea, 

Administrator, Animal and Plant Health 

Inspection Service. 

[FR Doc. 2014–22294 Filed 9–17–14; 8:45 am] 

BILLING CODE 3410–34–P 


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