E9-2881. New Animal Drugs; Bc6 Recombinant Deoxyribonucleic Acid Construct

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule.

SUMMARY:

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the original approval of a new animal drug application (NADA) filed by GTC Biotherapeutics, Inc. The NADA provides for use of a recombinant deoxyribonucleic acid (rDNA) construct in a lineage of genetically engineered (GE) goats expressing recombinant human antithrombin in their milk. The subsequently purified antithrombin is a biological product for human therapeutic use. In a separate action, a biologics license application (BLA) has been approved by FDA for use of this antithrombin in humans.

DATES:

This rule is effective February 11, 2009.

FOR FURTHER INFORMATION CONTACT:

Larisa Rudenko, Center for Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8247, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

GTC Biotherapeutics, Inc., 175 Crossing Blvd., Framingham, MA 01702, filed NADA 141-294 that provides for use of an rDNA construct in a lineage of GE goats expressing recombinant human antithrombin in their milk. The subsequently purified antithrombin is a biological product for human therapeutic use. In a separate action, a BLA has been approved by FDA for use of this antithrombin in humans. The NADA is approved as of February 6, 2009, and the regulations are amended by adding 21 CFR part 528 to reflect the approval.

In addition, GTC Biotherapeutics, Inc., is not currently listed in the animal drug regulations as a sponsor of an approved application. Accordingly, 21 CFR 510.600(c) is being amended to add entries for this sponsor.

In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.

The agency has carefully considered the potential environmental impact of this action and has concluded that the action will not have a significant impact on the human environment and that an environmental impact statement is not required. FDA's finding of no significant impact and the evidence supporting that finding, contained in an environmental assessment, may be seen in the Division of Dockets Management (address above) between 9 a.m. and 4 p.m., Monday through Friday.

This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.

List of Subjects

21 CFR Part 510

• Administrative practice and procedure
• Animal drugs
• Labeling
• Reporting and recordkeeping requirements

21 CFR Part 528

• Animal drugs

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR chapter I is amended as follows:

PART 510—NEW ANIMAL DRUGS

1. The authority citation for 21 CFR part 510 continues to read as follows:

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

2. In § 510.600, in the table in paragraph (c)(1), alphabetically add an entry for “GTC Biotherapeutics, Inc.”; and in the table in paragraph (c)(2), numerically add an entry for “042976” to read as follows:

§ 510.600

Names, addresses, and drug labeler codes of sponsors of approved applications.

(c) * * *

(1) * * *

Firm name and address	Drug labeler code
*    *    *    *    *
GTC Biotherapeutics, Inc., 175 Crossing Blvd., Framingham, MA 01702	042976
*    *    *    *    *

(2) * * *

Drug labeler code	Firm name and address
*    *    *    *    *
042976	GTC Biotherapeutics, Inc., 175 Crossing Blvd., Framingham, MA 01702
*    *    *    *    *

3. Add part 528 to read as follows:

PART 528—NEW ANIMAL DRUGS IN GENETICALLY ENGINEERED ANIMALS

Authority: 21 U.S.C. 360b.

§ 528.1070

Bc6 recombinant deoxyribonucleic acid construct.

(a) Specifications and indications for use. Five copies of a human Bc6 recombinant deoxyribonucleic acid (rDNA) construct located at the GTC 155-92 site in a specific hemizygous diploid line of dairy breeds of domestic goats (Capra aegagrus hircus) directing the expression of the human gene for antithrombin (which is intended for the treatment of humans) in the mammary gland of goats derived from lineage progenitor 155-92.

(b) Sponsor. See No. 042976 in § 510.600 of this chapter.

(c) Limitations. Food or feed from GTC-155-92 goats is not permitted in the food or feed supply.

Dated: February 6, 2009.

Bernadette Dunham,

Director, Center for Veterinary Medicine.