9 CFR 104.4 - Products for research and evaluation. | Title 9 - Animals and Animal Products | Code of Federal Regulations

§ 104.4

Products for research and evaluation.

(a) An application for a U.S. Veterinary Biological Product Permit to import a biological product for research and evaluation shall be accompanied by a brief description of such product, methods of propagating antigens including composition of medium, species of animals or cell cultures involved, degree of inactivation or attenuation, recommendations for use, and the proposed plan of evaluation. The applicant shall also provide any information the Administrator may require in order to assess the product's impact on the environment.

(b) (1) A permit to import a biological product for research and evaluation shall not be issued unless the scientific capabilities of the investigator are determined to be adequate to safeguard domestic animals and protect public health, interest, or safety from any deleterious effects which might result from use of such product. Special restrictions or tests may be specified as part of the permit when they are deemed necessary or advisable by the Administrator.

(2) No person shall ship a product imported under this section for research and evaluation anywhere in or from the United States unless authorized by the Administrator in accordance with the provisions of § 103.3 of this subchapter.

(c) A biological product shall not be imported for Research and Evaluation which is not packaged and labeled in accordance with § 112.9 of this subchapter.

(d) When a licensed product has been exported from the United States, a permit may be issued to the producer for a small quantity of such product for in vitro Research and Evaluation tests: Provided, That, the importation of such product will not endanger the livestock or poultry of this country.

(Approved by the Office of Management and Budget under control number 0579-0013)

[38 FR 32916, Nov. 29, 1973, as amended at 48 FR 57473, Dec. 30, 1983; 52 FR 30131, Aug. 13, 1987; 56 FR 66783, Dec. 26, 1991]

Title 9 published on 2013-01-01

The following are only the Rules published in the Federal Register after the published date of Title 9.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

2013-03-29; vol. 78 # 61 - Friday, March 29, 2013

78 FR 19080 - Importation of Live Birds and Poultry, Poultry Meat, and Poultry Products From a Region in the European Union

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2013-07345
RIN	0579-AD45
Docket No.	APHIS-2009-0094

DEPARTMENT OF AGRICULTURE, Animal and Plant Health Inspection Service

Final rule.

Effective Date: April 15, 2013.

9 CFR Parts 53, 71, 82, 93, 94, 95, and 104

Summary

We are amending the regulations governing the importation of animals and animal products by recognizing 25 Member States of the European Union (EU) as the Animal and Plant Health Inspection Service (APHIS)-defined EU poultry trade region and adding it to the list of regions we consider to be free of Newcastle disease. We are taking this action based on a risk evaluation that we prepared in which we determined that the region meets our requirements for being considered free of Newcastle disease. We also determined that the region meets our requirements for being considered free of highly pathogenic avian influenza (HPAI). In addition, we are establishing requirements governing the importation of live birds and poultry and poultry meat and products from the APHIS-defined EU poultry trade region and updating avian disease terms and definitions. We are also allowing importation from the APHIS-defined EU poultry trade region of hatching eggs under official seal, including those that have transited a restricted zone established because of detection of HPAI within the boundaries of the APHIS-defined EU poultry trade region. These actions will facilitate the importation of live birds and poultry, including hatching eggs, and poultry meat and products from the APHIS-defined EU poultry trade region while maintaining safeguards to protect the United States from the introduction of communicable avian diseases.

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.

United States Code

USC : Title 21 - FOOD AND DRUGS

§ 151 - Preparation and sale of worthless or harmful products for domestic animals prohibited; preparation to be in compliance with rules at licensed establishments

§ 152 - Importation regulated and prohibited

§ 153 - Inspection of imports; denial of entry and destruction

§ 154 - Regulations for preparation and sale; licenses

§ 154a - Special licenses for special circumstances; expedited procedure; conditions; exemptions; criteria

§ 155 - Permits for importation

§ 156 - Licenses conditioned on permitting inspection; suspension of licenses

§ 157 - Inspection

§ 158 - Offenses; punishment

§ 159 - Enforcement; penalties applicable; Congressional findings

USC : Title 30 - MINERAL LANDS AND MINING

§ 957 - Promulgation of regulations

Title 9 published on 2013-01-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 9 CFR 104 after this date.

2013-03-29; vol. 78 # 61 - Friday, March 29, 2013

78 FR 19080 - Importation of Live Birds and Poultry, Poultry Meat, and Poultry Products From a Region in the European Union

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2013-07345
RIN	0579-AD45
Docket No.	APHIS-2009-0094

DEPARTMENT OF AGRICULTURE, Animal and Plant Health Inspection Service

Final rule.

Effective Date: April 15, 2013.

9 CFR Parts 53, 71, 82, 93, 94, 95, and 104

Summary

We are amending the regulations governing the importation of animals and animal products by recognizing 25 Member States of the European Union (EU) as the Animal and Plant Health Inspection Service (APHIS)-defined EU poultry trade region and adding it to the list of regions we consider to be free of Newcastle disease. We are taking this action based on a risk evaluation that we prepared in which we determined that the region meets our requirements for being considered free of Newcastle disease. We also determined that the region meets our requirements for being considered free of highly pathogenic avian influenza (HPAI). In addition, we are establishing requirements governing the importation of live birds and poultry and poultry meat and products from the APHIS-defined EU poultry trade region and updating avian disease terms and definitions. We are also allowing importation from the APHIS-defined EU poultry trade region of hatching eggs under official seal, including those that have transited a restricted zone established because of detection of HPAI within the boundaries of the APHIS-defined EU poultry trade region. These actions will facilitate the importation of live birds and poultry, including hatching eggs, and poultry meat and products from the APHIS-defined EU poultry trade region while maintaining safeguards to protect the United States from the introduction of communicable avian diseases.

9 CFR 104.4 - Products for research and evaluation.

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