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Rules and Regulations Federal Register

31021 

Vol. 79, No. 104 

Friday, May 30, 2014 

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 

■ 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. 

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. 

SUMMARY: 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: 

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 


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