53606 Federal Register / Vol. 79, No. 175 / Wednesday, September 10, 2014 / Rules and Regulations 

1125; email to James.Brow@

ams.usda.gov. 

SUPPLEMENTARY INFORMATION: 

This action affirms the interim rule 

concerning Executive Orders 12866, 

12988, and 13563; the Regulatory 

Flexibility Act (5 U.S.C. 601–612; the 

Paperwork Reduction Act (44 U.S.C. 

Chapter 35); and the E-Gov Act (44 

U.S.C. 101). Further, for this action, the 

Office of Management and Budget has 

determined that this action is not 

significant under Executive Order 12866 

and therefore has not been reviewed by 

OMB. 

Background Information 

The Soybean Promotion, Research, 

and Consumer Information Act (Act) (7 

U.S.C. 6301–6311) provides for the 

establishment of a coordinated program 

of promotion and research designed to 

strengthen the soybean industry’s 

position in the marketplace, and to 

maintain and expand domestic and 

foreign markets and uses for soybeans 

and soybean products. The program is 

financed by an assessment of 0.5 of 1 

percent of the net market price of 

soybeans sold by producers. The final 

rule establishing a Soybean Promotion, 

Research, and Consumer Information 

program was published in the July 9, 

1991, issue of the Federal Register (56 

FR 31043), and assessments began on 

September 1, 1991. 

The Act specifies that the Secretary 

shall, five years after the conduct of the 

initial referendum and every five years 

thereafter, provide soybean producers 

an opportunity to request a referendum 

on the Soybean Promotion, Research, 

and Consumer Information Order 

(Order). Additionally, the Act specifies 

that these subsequent polls require that 

at least 10 percent (not in excess of onefifth in any one State) of all producers 

must request a referendum in order to 

trigger the conduct of a referendum. If 

a referendum is requested, it will be 

held within one year of that 

determination. 

The next Request for Referendum will 

be conducted May 2019, at FSA county 

offices. 

Changes to the Regulations 

In the interim rule, AMS amended 

§ 1220.616 to remove the specific 

number of soybean producers from the 

regulatory language. Data provided by 

FSA has been used to amend the 

number of soybean producers prior to 

any Request for Referendum. The data 

have been sorted in such a manner as 

to include all producers who were 

engaged in the production of soybeans 

in at least one of the two years prior to 

the Request for Referendum, excluding 

counting a producer more than once if 

that producer engaged in production 

during both years. Using the last two 

crop-year acreage reports for which 

complete data is available ensures that 

all eligible producers are counted, as 

some producers use soybeans in rotation 

with other crops and do not plant 

soybeans every year. This methodology 

is consistent with that used in previous 

requests for referendum and will 

continue to be used by USDA to update 

the number of eligible soybean 

producers. 

For the 2014 Request for Referendum 

previously conducted and subsequent 

requests for referendum, the data 

provided by FSA allows the Secretary to 

update this number. 

In addition to the changes relating to 

the number of eligible soybean 

producers, AMS amended §§ 1220.619, 

1220.622 and 1220.628 with more 

flexible language. 

Comments 

On March 4, 2014, USDA published 

in the Federal Register (79 FR 12037) an 

interim rule with a request for 

comments to be received by April 3, 

2014. USDA received no comments. 

List of Subjects in 7 CFR Part 1220 

Administrative practice and 

procedure, Advertising, Agricultural 

research, Marketing agreements, 

Reporting and recordkeeping 

requirements, Soybeans and soybean 

products. 

For the reasons set forth in the 

preamble, 7 CFR Part 1220 is amended 

as follows: 

PART 1220—SOYBEAN PROMOTION, 

RESEARCH, AND CONSUMER 

INFORMATION 

■ Accordingly, the interim rule that 

amended 7 CFR Part 1220, which was 

published on March 4, 2014 at 79 FR 

12037, is adopted as a final rule without 

change. 

Dated: September 4, 2014. 

Rex A. Barnes, 

Associate Administrator. 

[FR Doc. 2014–21512 Filed 9–9–14; 8:45 am] 

BILLING CODE 3410–02–P 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

9 CFR Part 77 

[Docket No. APHIS–2014–0058] 

Bovine Tuberculosis Status of 

Michigan; Advance Counties From 

Modified Accredited Advanced to 

Accredited-Free 

AGENCY: Animal and Plant Health 

Inspection Service, USDA. 

ACTION: Interim rule and request for 

comments. 

SUMMARY: We are amending the bovine 

tuberculosis regulations to advance the 

status of Antrim, Charlevoix, 

Cheboygan, Crawford, Emmet, Otsego, 

and Presque Isle Counties in Michigan 

from modified accredited advanced to 

accredited-free. We have determined 

that these counties meet the criteria for 

accredited-free status. This action 

relieves certain restrictions on the 

interstate movement of cattle and bison 

from these areas of Michigan. 

DATES: This interim rule is effective on 

September 10, 2014. We will consider 

all comments that we receive on or 

before November 10, 2014. 

ADDRESSES: You may submit comments 

by either of the following methods: 

• Federal eRulemaking Portal: Go to 

http://www.regulations.gov/

#!docketDetail;D=APHIS-2014-0058. 

• Postal Mail/Commercial Delivery: 

Send your comment to Docket No. 

APHIS–2014–0058, Regulatory Analysis 

and Development, PPD, APHIS, Station 

3A–03.8, 4700 River Road Unit 118, 

Riverdale, MD 20737–1238. 

Supporting documents and any 

comments we receive on this docket 

may be viewed at http://

www.regulations.gov/

#!docketDetail;D=APHIS-2014-0058 or 

in our reading room, which 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) 799–7039 

before coming. 

FOR FURTHER INFORMATION CONTACT: Dr. 

C. William Hench, Senior Staff 

Veterinarian, Surveillance, 

Preparedness and Response Services, 

Cattle Health Center, VS, APHIS, 2150 

Centre Avenue, Building B, MSC 3–E– 

20, Fort Collins, CO 80526–8117; (970) 

494–7378. 

SUPPLEMENTARY INFORMATION: 

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Federal Register / Vol. 79, No. 175 / Wednesday, September 10, 2014 / Rules and Regulations 53607 

Background 

Bovine tuberculosis is a contagious 

and infectious granulomatous disease 

caused by the bacterium Mycobacterium 

bovis. Although commonly defined as a 

chronic debilitating disease, bovine 

tuberculosis can occasionally assume an 

acute, rapidly progressive course. While 

any body tissue can be affected, lesions 

are most frequently observed in the 

lymph nodes, lungs, intestines, liver, 

spleen, pleura, and peritoneum. 

Although cattle are considered to be the 

true hosts of M. bovis, the disease has 

been reported in several other species of 

livestock, most notably bison and 

captive cervids. There have also been 

instances of infection in other domestic 

and nondomestic animals, as well as in 

humans. Through the National 

Cooperative State/Federal Bovine 

Tuberculosis Eradication Program, the 

Animal and Plant Health Inspection 

Service (APHIS) of the United States 

Department of Agriculture (USDA) 

works cooperatively with the Nation’s 

livestock industry and State animal 

health agencies to eradicate bovine 

tuberculosis from domestic livestock in 

the United States and prevent its 

recurrence. 

Federal regulations implementing this 

program are contained in 9 CFR part 77, 

‘‘Tuberculosis’’ (referred to below as the 

regulations) and in the ‘‘Uniform 

Methods and Rules—Bovine 

Tuberculosis Eradication’’ (UMR) which 

is incorporated by reference within the 

regulations. 

The status of a State or zone is based 

on its prevalence of tuberculosis in 

cattle and bison, the effectiveness of the 

State’s tuberculosis eradication 

program, and the degree of the State’s 

compliance with standards for cattle 

and bison contained in the UMR. The 

regulations provide that a State may 

request partitioning into specific 

geographic regions or zones with 

different status designations (commonly 

referred to as split-State status) if bovine 

tuberculosis is detected in a portion of 

a State and the State demonstrates that 

it meets certain criteria with regard to 

zone classification. 

We have received from the State of 

Michigan a request to reclassify the 

modified accredited advanced zone in 

the State’s Lower Peninsula as 

accredited free. Based on the findings of 

a review of the tuberculosis eradication 

program in Michigan, APHIS has 

determined that the zone meets the 

criteria for advancement of status 

contained in the regulations. 

State animal health officials in 

Michigan have demonstrated that the 

State enforces and complies with the 

provisions of the UMR. The State of 

Michigan has demonstrated that the 

modified accredited advanced zone has 

zero percent prevalence of cattle and 

bison herds affected with tuberculosis 

and has had no findings of tuberculosis 

in any cattle or bison in the zone since 

the last affected herd in the zone was 

depopulated in April 2011. Therefore, 

Michigan has demonstrated that the 

zone within the State’s Lower Peninsula 

previously classified as modified 

accredited advanced meets the criteria 

for accredited-free status as set forth in 

the definition of accredited-free State or 

zone in § 77.5 of the regulations. 

Based on our evaluation of Michigan’s 

request, we are classifying the zone 

consisting of Antrim, Charlevoix, 

Cheboygan, Crawford, Emmet, Otsego, 

and Presque Isle Counties as accredited 

free. 

Immediate Action 

Immediate action is warranted to 

relieve restrictions on the interstate 

movement of cattle and bison from 

Antrim, Charlevoix, Cheboygan, 

Crawford, Emmet, Otsego, and Presque 

Isle Counties in Michigan. Under these 

circumstances, the Administrator has 

determined that prior notice and 

opportunity for public comment are 

contrary to the public interest and there 

is good cause under 5 U.S.C. 553 for 

making this action effective less than 30 

days after publication in the Federal 

Register. 

We will consider comments we 

receive during the comment period for 

this interim rule (see DATES above). 

After the comment period closes, we 

will publish another document in the 

Federal Register. The document will 

include a discussion of any comments 

we receive and any amendments we are 

making to the rule. 

Executive Order 12866 and Regulatory 

Flexibility Act 

This interim 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. 

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. The full analysis 

may be viewed on the Regulations.gov 

Web site (see ADDRESSES above for 

instructions for accessing 

Regulations.gov) or obtained from the 

person listed under FOR FURTHER

INFORMATION CONTACT. 

Michigan has submitted a request for 

split-State bovine tuberculosis status 

that will advance seven counties on the 

Lower Peninsula of Michigan (Antrim, 

Charlevoix, Cheboygan, Crawford, 

Emmet, Otsego, and Presque Isle) from 

modified accredited advanced to 

accredited-free status. This status 

advancement will eliminate premovement testing requirements for 

producers in the seven counties, saving 

them time and money. Based on 

national statistics and Small Business 

Administration size standards, most if 

not all of the cattle and dairy operations 

affected are likely to be small entities. 

The number of herds in the 7 counties 

that require surveillance testing will be 

reduced from about 390 to fewer than 

120. Tuberculosis testing, including 

veterinary fees, costs about $10 to $15 

per head. Based on an estimated 33 

head per herd, total annual cost savings 

are expected to range between $90,000 

and $135,000 yearly in the 7 counties. 

The average value of cattle and calves 

in Michigan is about $1,100 per head. 

Thus, the savings by forgoing 

tuberculosis testing represent about 1.3 

percent of the average value of the 

animals. This action will not 

significantly change program operations 

and will have no significant effects on 

other Federal agencies, State 

government, or local governments. 

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 rule has been reviewed under 

Executive Order 12988, Civil Justice 

Reform. This rule has no retroactive 

effect and does not require 

administrative proceedings before 

parties may file suit in court challenging 

this rule. 

Paperwork Reduction Act 

This interim 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 in 9 CFR Part 77 

Animal diseases, Bison, Cattle, 

Reporting and recordkeeping 

requirements, Transportation, 

Tuberculosis. 

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53608 Federal Register / Vol. 79, No. 175 / Wednesday, September 10, 2014 / Rules and Regulations 

Accordingly, we are amending 9 CFR 

part 77 as follows: 

PART 77—TUBERCULOSIS 

■ 1. The authority citation for part 77 

continues to read as follows: 

Authority: 7 U.S.C. 8301–8317; 7 CFR 2.22, 

2.80, and 371.4. 

§ 77.7 [Amended] 

■ 2. In § 77.7, paragraph (b)(1) is 

amended by removing the words ‘‘zones 

that comprise’’ and adding the words 

‘‘zone that comprises’’ in their place and 

by removing the words ‘‘§ 77.9(b)(1) 

and’’. 

■ 3. In § 77.9, paragraph (b) is revised to 

read as follows: 

§ 77.9 Modified accredited advanced 

States or zones. 

* * * * * 

(b) The following are modified 

accredited advanced zones: None. 

* * * * * 

Done in Washington, DC, this 4th day of 

September 2014. 

Kevin Shea, 

Administrator, Animal and Plant Health 

Inspection Service. 

[FR Doc. 2014–21583 Filed 9–9–14; 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–1166] 

Medical Devices; Immunology and 

Microbiology Devices; Classification of 

Dengue Virus Nucleic Acid 

Amplification Test Reagents 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final order. 

SUMMARY: The Food and Drug 

Administration (FDA) is classifying 

dengue virus nucleic acid amplification 

test reagents into class II (special 

controls). 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 October 

10, 2014. The classification was 

applicable May 24, 2012. 

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 

rulemaking process. These devices 

remain in class III and require 

premarket approval, unless and until 

the device is classified or reclassified 

into class I or II, or FDA issues an order 

finding the device to be substantially 

equivalent, in accordance with section 

513(i) of the FD&C Act, to a predicate 

device that does not require premarket 

approval. The Agency determines 

whether new devices are substantially 

equivalent to predicate devices by 

means of premarket notification 

procedures in section 510(k) of the 

FD&C Act (21 U.S.C. 360(k)) and part 

807 (21 CFR part 807) of the regulations. 

Section 513(f)(2) of the FD&C Act, as 

amended by section 607 of the Food and 

Drug Administration Safety and 

Innovation Act (Pub. L. 112–144, July 9, 

2012, 126 Statute 1054), provides two 

procedures by which a person may 

request FDA to classify a device under 

the criteria set forth in section 513(a)(1). 

Under the first procedure, the person 

submits a premarket notification under 

section 510(k) of the FD&C Act for a 

device that has not previously been 

classified and, within 30 days of 

receiving an order classifying the device 

into class III under section 513(f)(1) of 

the FD&C Act, the person requests a 

classification under section 513(f)(2). 

Under the second procedure, rather than 

first submitting a premarket notification 

under section 510(k) and then a request 

for classification under the first 

procedure, the person determines that 

there is no legally marketed device upon 

which to base a determination of 

substantial equivalence and requests a 

classification under section 513(f)(2) of 

the FD&C Act. If the person submits a 

request to classify the device under this 

second procedure, FDA may decline to 

undertake the classification request if 

FDA identifies a legally marketed device 

that could provide a reasonable basis for 

review of substantial equivalence with 

the device or if FDA determines that the 

device submitted is not of ‘‘lowmoderate risk’’ or that general controls 

would be inadequate to control the risks 

and special controls to mitigate the risks 

cannot be developed. 

In response to a request to classify a 

device under either procedure provided 

by section 513(f)(2) of the FD&C Act, 

FDA will classify the device by written 

order within 120 days. This 

classification will be the initial 

classification of the device. Within 30 

days after the issuance of an order 

classifying the device, FDA must 

publish a notice in the Federal Register 

announcing this classification. 

In accordance with section 513(f)(1) of 

the FD&C Act, FDA issued an order on 

February 24, 2012, classifying the CDC 

DENV–1–4 Real-Time RT–PCR Assay 

into class III, because it was not 

substantially equivalent to a device that 

was introduced or delivered for 

introduction into interstate commerce 

for commercial distribution before May 

28, 1976, or a device which was 

subsequently reclassified into class I or 

class II. On March 12, 2012, the Centers 

for Disease Control and Prevention 

submitted a request for de novo 

classification of the CDC DENV–1–4 

Real-Time RT–PCR Assay under section 

513(f)(2) of the FD&C Act. The 

manufacturer recommended that the 

device be classified into class II. 

In accordance with section 513(f)(2) of 

the FD&C Act, FDA reviewed the 

request for de novo classification in 

order to classify the device under the 

criteria for classification set forth in 

section 513(a)(1) of the FD&C Act. FDA 

classifies devices into class II if general 

controls by themselves are insufficient 

to provide reasonable assurance of 

safety and effectiveness, but there is 

sufficient information to establish 

special controls to provide reasonable 

assurance of the safety and effectiveness 

of the device for its intended use. After 

review of the information submitted in 

the request, FDA determined that the 

device can be classified into class II 

with the establishment of special 

controls. FDA believes these special 

controls will provide reasonable 

assurance of the safety and effectiveness 

of the device. 

The device is assigned the generic 

name dengue virus nucleic acid 

amplification test reagents, and it is 

identified as devices that consist of 

primers, probes, enzymes, and controls 

for the amplification and detection of 

dengue virus serotypes 1, 2, 3, or 4 from 

viral ribonucleic acid (RNA) in human 

serum and plasma from individuals who 

have signs and symptoms consistent 

with dengue (mild or severe). The 

identification of dengue virus serotypes 

1, 2, 3, or 4 in human serum and plasma 

(sodium citrate) collected from human 

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