### 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-freegreenhouses 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


### 22283 Federal Register / Vol. 77, No. 72 / Friday, April 13, 2012 / Notices

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 regulatedby 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