[Federal Register Volume 79, Number 104 (Friday, May 30, 2014)]
[Rules and Regulations]
[Page 31021]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-12550]



 ========================================================================
 Rules and Regulations
                                                 Federal Register
 ________________________________________________________________________
 
 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.
 
 ========================================================================
 

  Federal Register / Vol. 79, No. 104 / Friday, May 30, 2014 / Rules 
and Regulations  

[[Page 31021]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Part 113

[Docket No. APHIS-2014-0033]


In Vitro Tests for Serial Release

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: We are amending the ``In vitro tests for serial release'' 
regulations by removing a footnote that refers to one method to 
calculate the relative antigen content of inactivated veterinary 
biological products and relative potency calculation software available 
from Veterinary Services' Center for Veterinary Biologics (CVB). CVB 
will no longer provide or update the software and the written method 
for using the software will no longer be used. This action will update 
the regulations.

DATES: Effective May 30, 2014.

FOR FURTHER INFORMATION CONTACT: Dr. Donna Malloy, Section Leader, 
Operational Support, 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 regulations in 9 CFR 113.8 provide criteria for acceptable in 
vitro potency tests for the serial release of live and inactivated 
veterinary biological products. As provided in the regulations, the 
potency of inactivated products is evaluated by comparing the relative 
antigen content of the product to an unexpired reference using a 
parallel line immunoassay or another acceptable procedure. The footnote 
in paragraph (c) of this section refers to one method that can be used 
to evaluate the relative antigen content using Supplementary Assay 
Method (SAM) 318 and relative potency calculation software available 
from Veterinary Services' Center for Veterinary Biologics (CVB). CVB is 
no longer providing or updating the software, and the written method 
for using the software, described in SAM 318, will no longer be used. 
Therefore, we are removing that footnote.
    This rule relates to internal agency management. Therefore, 
pursuant to 5 U.S.C. 553, notice of proposed rulemaking and opportunity 
to comment are not required, and this rule may be made effective less 
than 30 days after publication in the Federal Register. Further, since 
this rule relates to internal agency management, it is exempt from the 
provisions of Executive Orders 12866 and 12988. Finally, this action is 
not a rule as defined by the Regulatory Flexibility Act, and thus is 
exempt from the provisions of that Act.

Paperwork Reduction Act

    This rule contains no information collection or recordkeeping 
requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 
et seq.).

List of Subjects in 9 CFR Part 113

    Animal biologics, Exports, Imports, Reporting and recordkeeping 
requirements.

    Accordingly, 9 CFR part 113 is amended as follows:

PART 113--STANDARD REQUIREMENTS

0
1. 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.  113.8  [Amended]

0
2. In Sec.  113.8, paragraph (c), footnote 1 is removed.


Sec.  113.100  [Amended]

0
3. In Sec.  113.100, paragraph (f), footnote 2 is redesignated as 
footnote 1.


Sec.  113.200  [Amended]

0
4. In Sec.  113.200, paragraph (f), footnote 3 is redesignated as 
footnote 2.

    Done in Washington, DC, this 23rd day of May 2014.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2014-12550 Filed 5-29-14; 8:45 am]
BILLING CODE 3410-34-P