22282 Federal Register / Vol. 77, No. 72 / Friday, April 13, 2012 / Notices 

vegetables into the United States from 

certain parts of the world are contained 

in ‘‘Subpart Fruits and Vegetables’’ (7 

CFR 319.56–1 through 319.56–47). The 

Animal and Plant Health Inspection 

Service (APHIS) amended the fruits and 

vegetables regulations to allow the 

importation of peppers from the 

Republic of Korea under certain 

conditions. As a condition of entry, the 

peppers would have to be grown in 

approved insect-proof, pest-free 

greenhouses and packed in pestexclusionary packinghouses. 

Need and Use of the Information: 

Each shipment of pepper from the 

Republic of Korea must be accompanied 

by a phytosanitary certificate of 

inspection with a declaration issued by 

the National Plant Quarantine Service of 

Korea officials stating the peppers were 

grown in greenhouses in accordance 

with the regulations in 7 CFR 319–56– 

42 and found free of certain plant pests. 

Failing to collect this information would 

cripple APHIS’ ability to ensure that 

peppers from Korea are not carrying 

plant pests and would cause millions of 

dollars in damage to U.S. agriculture. 

Description of Respondents: Federal 

Government (Foreign). 

Number of Respondents: 1. 

Frequency of Responses: Reporting: 

On occasion. 

Total Burden Hours: 3. 

Ruth Brown, 

Departmental Information Collection 

Clearance Officer. 

[FR Doc. 2012–8959 Filed 4–12–12; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF AGRICULTURE 

Agricultural Marketing Service 

[Doc. No. AMS–DA–10–0089; DA–11–01] 

Milk in the Northeast and Other 

Marketing Areas; Determination of 

Equivalent Price Series 

AGENCY: Agricultural Marketing Service, 

USDA. 

ACTION: Determination of equivalent 

price series. 

SUMMARY: It has been determined by the 

Deputy Administrator of Dairy Programs 

that the dairy products price series in 

the Dairy Products Sales report released 

by the Agricultural Marketing Service 

(AMS) is equivalent to the price series 

previously released by the National 

Agricultural Statistics Service (NASS) in 

the Dairy Products Prices report. The 

dairy product price series is used in the 

price discovery mechanism for raw milk 

component values, and the component 

values are then used in determining 

Federal milk market order (FMMO) 

minimum classified milk prices. AMS 

previously used the NASS prices in the 

determination of raw milk component 

values; however, the responsibility for 

the collection of dairy product sales 

data was transferred from NASS to AMS 

effective April, 1, 2012 (77 FR 8717), at 

which time NASS discontinued the 

publication of its Dairy Products Prices 

report. The data collected by AMS 

through this new system will be used 

for future component value 

computations and the subsequent 

calculation of FMMO minimum 

classified milk prices. The 

establishment of an equivalent dairy 

products price series is essential to the 

continuing operation of the FMMO 

program. 

DATES: April 18, 2012. 

FOR FURTHER INFORMATION CONTACT: Bret 

Tate, Order Formulation and 

Enforcement Division, USDA/AMS/ 

Dairy Programs, STOP 0231–Room 

2963, 1400 Independence Ave. SW., 

Washington, DC 20250–0231, (202) 720– 

7183, email address: 

Bret.Tate@ams.usda.gov. 

SUPPLEMENTARY INFORMATION: This 

action provides an equivalent series of 

dairy products prices for the calculation 

of milk component values and classified 

milk prices in all FMMOs (7 CFR parts 

1001, 1005, 1006, 1007, 1030, 1032, 

1033, 1124, 1126, and 1131). The 

Department of Agriculture (Department) 

has been using the Dairy Products Prices 

report as published weekly by NASS in 

the calculation of raw milk component 

values, as referenced in section 1000.50. 

These component values are 

subsequently used in the computation 

of the minimum classified prices used 

by the FMMO program. 

Pursuant to the provisions of the 

Agricultural Marketing Agreement Act 

of 1937, as amended (7 U.S.C. 601–674 

and 7253), and part 1000 and the 

applicable provisions of the orders 

regulating the handling of milk in the 

previously mentioned marketing areas, 

it is found and determined that: 

(1) In September 2010, the Mandatory 

Price Reporting Act of 2010 (Pub. L. 

111–239) amended section 273(d) of the 

Agricultural Marketing Act of 1946 (7 

U.S.C. 1637b) to require that the 

Secretary establish an electronic 

reporting system for reporting data 

under the dairy product mandatory 

reporting program. 

(2) As such, AMS implemented the 

electronic reporting system (77 FR 8717) 

and, as part of that rulemaking, it also 

announced the transfer of the collection 

of dairy product sales data from NASS 

to AMS, effective April 1, 2012. 

Subsequently, NASS discontinued its 

Dairy Products Prices report as of 

Friday, March 30, 2012. 

(3) AMS began releasing its own dairy 

products price series for cheddar cheese 

(40 pound blocks and 500 pound 

barrels), butter, nonfat dry milk, and dry 

whey in a report titled Dairy Products 

Sales on April 4, 2012. 

(4) Section 1000.54 provides that if for 

any reason a price required by the order 

for computing class prices is not 

available as prescribed in the order, the 

market administrator may use an 

equivalent price as determined by the 

Deputy Administrator, Dairy Programs, 

AMS. 

(5) As the NASS publication 

stipulated in the order is unavailable for 

use in the computation of class prices, 

the Deputy Administrator for Dairy 

Programs has determined that the AMS 

price series is equivalent to those data 

previously collected by NASS, in 

accordance with the authorities granted 

by section 1000.54. 

(6) Effective April 18, 2012, and 

thereafter, the data series contained in 

the AMS Dairy Products Sales report 

will be used to compute the raw milk 

component values that are used in 

determining FMMO minimum classified 

prices. 

Authority: 7 U.S.C. 601–674, and 7253 

Dated: April 9, 2012. 

Ruihong Guo, 

Associate Administrator, Agricultural 

Marketing Service. 

[FR Doc. 2012–8911 Filed 4–12–12; 8:45 am] 

BILLING CODE 3410–02–P 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

[Docket No. APHIS–2012–0022] 

Draft Guidelines on Biologics Quality 

Monitoring: Testing for the Detection 

of Mycoplasma Contamination 

AGENCY: Animal and Plant Health 

Inspection Service, USDA. 

ACTION: Notice of availability and 

request for comments. 

SUMMARY: The International Cooperation 

on Harmonization of Technical 

Requirements for the Registration of 

Veterinary Medicinal Products (VICH) 

has developed a draft guideline titled 

‘‘Testing for the Detection of 

Mycoplasma Contamination.’’ This draft 

guideline identifies stages of 

manufacture where products are to be 

tested and test procedures used to detect 


pmangrum on DSK3VPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 72 / Friday, April 13, 2012 / Notices 22283 

the presence of Mycoplasma 

contamination. Because the guidelines 

apply to final product and master seed/ 

cell testing in veterinary vaccines 

regulated by the Animal and Plant 

Health Inspection Service under the 

Virus-Serum-Toxin Act, we are 

requesting comments on the scope of 

the guideline and its provisions so that 

we may include any relevant public 

input on the draft in the Agency’s 

comments to the VICH Steering 

Committee. 

DATES: We will consider all comments 

that we receive on or before June 12, 

2012. 

ADDRESSES: You may submit comments 

by either of the following methods: 

• Federal eRulemaking Portal: Go to 

http://www.regulations.gov/ 

#!documentDetail;D=APHIS-2012-0022- 

0001. 

• Postal Mail/Commercial Delivery: 

Send your comment to Docket No. 

APHIS–2012–0022, 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-2012-0022 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. 

Donna L. Malloy, Section Leader, 

Operational Support, Center for 

Veterinary Biologics, Policy, Evaluation, 

and Licensing, VS, APHIS, 4700 River 

Road Unit 148, Riverdale Maryland 

20737–1231; (301) 851–3426. 

SUPPLEMENTARY INFORMATION: The 

International Cooperation on 

Harmonization of Technical 

Requirements for the Registration of 

Veterinary Medicinal Products (VICH) is 

a unique project conducted under the 

auspices of the World Organization for 

Animal Health that brings together the 

regulatory authorities of the European 

Union, Japan, and the United States and 

representatives from the animal health 

industry in the three regions. The 

purpose of VICH is to harmonize 

technical requirements for veterinary 

products (both drugs and biologics). 

Regulatory authorities and industry 

experts from Australia and New Zealand 

participate in an observer capacity. The 

World Federation of the Animal Health 

Industry (COMISA, the Confederation 

Mondiale de L’Industrie de la Sante 

Animale) provides the secretarial and 

administrative support for VICH 

activities. 

The United States Government is 

represented in VICH by the Food and 

Drug Administration (FDA) and the 

Animal and Plant Health Inspection 

Service (APHIS). The FDA provides 

expertise on veterinary drugs, while 

APHIS fills a corresponding role for 

veterinary biological products. As VICH 

members, APHIS and FDA participate in 

efforts to enhance harmonization and 

have expressed their commitment to 

seeking scientifically based, harmonized 

technical requirements for the 

development of veterinary drugs and 

biological products. One of the goals of 

harmonization is to identify and reduce 

the differences in technical 

requirements for veterinary drugs and 

biologics among regulatory agencies in 

different countries. 

The draft guideline ‘‘Testing for the 

Detection of Mycoplasma 

Contamination’’ (VICH Topic GL34) has 

been made available by the VICH 

Steering Committee for comments by 

interested parties. Mycoplasma 

contaminants may be introduced into 

cell culture and in ovo origin biological 

products through the master seeds, the 

master cell seed (stock), starting 

materials of animal origin, and in 

processing of biological materials during 

passage and product assembly. 

Therefore, it is necessary to demonstrate 

through testing that Mycoplasmas are 

not present, within the limits of the test, 

in the final product, working seeds and 

cells and harvests, and starting materials 

such as the master seed, master cell 

seed, and ingredients of animal origin. 

The draft guideline establishes stages of 

manufacture to be tested and test 

procedures to detect the presence of 

Mycoplasma contamination and would 

provide a unified standard to facilitate 

the mutual acceptance of test data by 

the relevant regulatory authorities. 

Because the draft guideline would apply 

to final product and master seed/cell 

testing in veterinary vaccines regulated 

by the APHIS under the Virus-SerumToxin Act (VSTA), we are requesting 

comments on its provisions so that we 

may include any relevant public input 

on the draft in the Agency’s comments 

to the VICH Steering Committee. 

In accordance with the VICH process, 

once a final draft of the document has 

been approved, the guideline will be 

recommended for adoption by the 

regulatory bodies of the European 

Union, Japan, and the United States. As 

with all VICH documents, each final 

guideline will not create or confer any 

rights for or on any person and will not 

operate to bind APHIS or the public. 

Further, the VICH guidelines 

specifically provide for the use of 

alternative approaches if those 

approaches satisfy applicable regulatory 

requirements. 

Ultimately, APHIS intends to consider 

the VICH Steering Committee’s final 

guideline for use by U.S. veterinary 

biologics licensees, permittees, and 

applicants. In addition, we may 

consider using the final guideline as the 

basis for proposed amendments to the 

regulations in 9 CFR chapter I, 

subchapter E (Viruses, Serums, Toxins, 

and Analogous Products; Organisms and 

Vectors). Because we anticipate that 

applicable provisions of the final 

version of ‘‘Testing for the Detection of 

Mycoplasma Contamination’’ may be 

introduced into APHIS’ veterinary 

biologics regulatory program in the 

future, we encourage your comments on 

the draft guideline. 

The draft guideline may be viewed on 

the Regulations.gov Web site or in our 

reading room (see ADDRESSES above for 

instructions for accessing 

Regulations.gov and information on the 

location and hours of the reading room). 

You may request copies of the draft 

guideline by calling or writing to the 

person listed under FOR FURTHER

INFORMATION CONTACT. 

Authority: 21 U.S.C. 151 et seq. 

Done in Washington, DC, this 9th day of 

April 2012. 

Kevin Shea, 

Acting Administrator, Animal and Plant 

Health Inspection Service. 

[FR Doc. 2012–8908 Filed 4–12–12; 8:45 am] 

BILLING CODE 3410–34–P 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

[Docket No. APHIS–2012–0017] 

Availability of an Environmental 

Assessment for Field Testing Feline 

Interleukin-2 Immunomodulator, Live 

Canarypox Vector 

AGENCY: Animal and Plant Health 

Inspection Service, USDA. 

ACTION: Notice. 

SUMMARY: We are advising the public 

that the Animal and Plant Health 

Inspection Service has prepared an 

environmental assessment concerning 

authorization to ship for the purpose of 

field testing, and then to field test, an 

unlicensed Feline Interleukin-2 


pmangrum on DSK3VPTVN1PROD with NOTICES