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Federal Register / Vol. 86, No. 4 / Thursday, January 7, 2021 / Rules and Regulations
Controls CB applies to 1C991.c.
AT applies to entire entry.

Country chart see supp. No. 1 to part 738
CB Column 3.
AT Column 1.

List Based License Exceptions See Part 740
for a Description of All License Exceptions LVS: N/A
GBS: N/A

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List of Items Controlled Related Controls: 1 Medical products containing ricin or saxitoxin, as follows, are controlled for CW reasons under ECCN
1C351:
a Ricinus communis AgglutininII RCAII, also known as ricin D, or Ricinus Communis LectinIII RCLIII;
b Ricinus communis LectinIV RCLIV, also known as ricin E; or c Saxitoxin identified by C.A.S. 35523
898.
2 The export of a medical product that is an Investigational New Drug IND, as defined in 21 CFR 312.3, is subject to certain U.S. Food and Drug Administration FDA
requirements that are independent of the export requirements specified in this ECCN
or elsewhere in the EAR. These FDA
requirements are described in 21 CFR
312.110 and must be satisfied in addition to any requirements specified in the EAR.
3 Also see 21 CFR 314.410 for FDA
requirements concerning exports of new drugs and new drug substances.
Related Definitions: For the purpose of this entry, immunotoxins are monoclonal antibodies linked to a toxin with the intention of destroying a specific target cell while leaving adjacent cells intact. For the purpose of this entry, medical products are: 1 Pharmaceutical formulations designed for testing and human or veterinary administration in the treatment of medical conditions, 2 prepackaged for distribution as clinical or medical products, and 3 approved by the U.S.
Food and Drug Administration either to be marketed as clinical or medical products or for use as an Investigational New Drug IND see 21 CFR part 312. For the purpose of this entry, diagnostic and food testing kits are specifically developed, packaged and marketed for diagnostic or public health purposes. Biological toxins in any other configuration, including bulk shipments, or for any other end-uses are controlled by ECCN 1C351. For the purpose of this entry, vaccine is defined as a medicinal or veterinary product in a pharmaceutical formulation, approved by the U.S. Food and Drug Administration or the U.S. Department of Agriculture to be
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marketed as a medical or veterinary product or for use in clinical trials, that is intended to stimulate a protective immunological response in humans or animals in order to prevent disease in those to whom or to which it is administered.
Items:
Technical Note: For purposes of the controls described in this ECCN, toxins refers to those toxins, or their subunits, controlled under ECCN 1C351.d.
a. Vaccines containing, or designed for use against, items controlled by ECCN 1C351, 1C353 or 1C354.
b. Immunotoxins containing toxins controlled by 1C351.d;
c. Medical products that contain any of the following:
c.1. Toxins controlled by ECCN 1C351.d except for botulinum toxins controlled by ECCN 1C351.d.3, conotoxins controlled by ECCN 1C351.d.6, or items controlled for CW
reasons under ECCN 1C351.d.11 or .d.12; or c.2. Genetically modified organisms or genetic elements controlled by ECCN
1C353.a.3 except for those that contain, or code for, botulinum toxins controlled by ECCN 1C351.d.3 or conotoxins controlled by ECCN 1C351.d.6;
d. Medical products not controlled by 1C991.c that contain any of the following:
d.1. Botulinum toxins controlled by ECCN
1C351.d.3;
d.2. Conotoxins controlled by ECCN
1C351.d.6; or d.3. Genetically modified organisms or genetic elements controlled by ECCN
1C353.a.3 that contain, or code for, botulinum toxins controlled by ECCN
1C351.d.3 or conotoxins controlled by ECCN
1C351.d.6;
e. Diagnostic and food testing kits containing toxins controlled by ECCN
1C351.d except for items controlled for CW
reasons under ECCN 1C351.d.11 or .d.12.
Matthew S. Borman, Deputy Assistant Secretary for Export Administration.
FR Doc. 202027754 Filed 1621; 8:45 am BILLING CODE 351033P

COMMODITY FUTURES TRADING
COMMISSION
17 CFR Parts 39 and 140
RIN 3038AE65

ACTION:

Final rule.

The Commodity Futures Trading Commission Commission is adopting policies and procedures that the Commission will follow with respect to granting exemptions from registration as a derivatives clearing organization DCO. In addition, the Commission is amending certain related delegation provisions in its regulations.

SUMMARY:

DATES:

Effective February 8, 2021.

FOR FURTHER INFORMATION CONTACT:

Eileen A. Donovan, Deputy Director, 2024185096, edonovan@cftc.gov;
Parisa Nouri, Associate Director, 202
4186620, pnouri@cftc.gov; Eileen R.
Chotiner, Senior Compliance Analyst, 2024185467, echotiner@cftc.gov;
Brian Baum, Special Counsel, 202418
5654, bbaum@cftc.gov; August A.
Imholtz III, Special Counsel, 202418
5140, aimholtz@cftc.gov; Abigail S.
Knauff, Special Counsel, 2024185123, aknauff@cftc.gov; Division of Clearing and Risk, Commodity Futures Trading Commission, Three Lafayette Centre, 1155 21st Street NW, Washington, DC
20581; Theodore Z. Polley III, Associate Director, 3125960551, tpolley@
cftc.gov; Division of Clearing and Risk, Commodity Futures Trading Commission, 525 West Monroe Street, Chicago, Illinois 60661.
SUPPLEMENTARY INFORMATION:

Table of Contents I. Background A. Introduction B. Existing Exempt DCO Orders II. Amendments to Part 39
A. Regulation 39.1Scope B. Regulation 39.2Definitions C. Regulation 39.6Exemption From DCO
Registration D. Regulation 39.9Scope III. Amendments to Part 140
IV. Related Matters A. Regulatory Flexibility Act B. Paperwork Reduction Act C. Cost-Benefit Considerations D. Antitrust Considerations
Exemption From Derivatives Clearing Organization Registration Commodity Futures Trading Commission.

AGENCY:

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