In Vitro Tests for Serial Release, 31021 [2014-12550]

Download as PDF 31021 Rules and Regulations Federal Register Vol. 79, No. 104 Friday, May 30, 2014 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. DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service 9 CFR Part 113 [Docket No. APHIS–2014–0033] In Vitro Tests for Serial Release Animal and Plant Health Inspection Service, USDA. ACTION: Final rule. AGENCY: 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: SUMMARY: ehiers on DSK2VPTVN1PROD with RULES 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 VerDate Mar<15>2010 14:58 May 29, 2014 Jkt 232001 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 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. § 113.8 [Amended] 2. In § 113.8, paragraph (c), footnote 1 is removed. ■ § 113.100 [Amended] 3. In § 113.100, paragraph (f), footnote 2 is redesignated as footnote 1. ■ § 113.200 [Amended] 4. In § 113.200, paragraph (f), footnote 3 is redesignated as footnote 2. ■ PO 00000 Frm 00001 Fmt 4700 Sfmt 4700 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 [Docket No. FDA–2014–N–0429] Medical Devices; Immunology and Microbiology Devices; Classification of Dengue Virus Serological Reagents AGENCY: Food and Drug Administration, HHS. ACTION: Final order. The Food and Drug Administration (FDA) is classifying dengue virus serological reagents into class II (special controls). The special controls that will apply to the device are identified in this order, and the codified language for the dengue serological reagents classification will include the identification of the special controls that will apply to this device. The Agency is classifying the device into class II (special controls) because special controls, in addition to general controls, will provide a reasonable assurance of safety and effectiveness of the device. DATES: This order is effective June 30, 2014. The classification was applicable April 8, 2011. FOR FURTHER INFORMATION CONTACT: Beena Puri, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5553, Silver Spring, MD 20993–0002, 301–796–6202. SUPPLEMENTARY INFORMATION: SUMMARY: I. Background In accordance with section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were not in commercial distribution before May 28, 1976 (the date of enactment of the Medical Device Amendments of 1976), generally referred to as postamendments devices, are classified automatically by statute into class III without any FDA E:\FR\FM\30MYR1.SGM 30MYR1

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[Federal Register Volume 79, Number 104 (Friday, May 30, 2014)]
[Rules and Regulations]
[Page 31021]
From the Federal Register Online via the Government Printing 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