[Federal Register Volume 74, Number 27 (Wednesday, February 11, 2009)]
[Rules and Regulations]
[Pages 6823-6824]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-2881]



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Rules and Regulations
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Federal Register / Vol. 74, No. 27 / Wednesday, February 11, 2009 / 
Rules and Regulations

[[Page 6823]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 528

[Docket No. FDA-2009-N-0665]


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: larisa.rudenko@fda.hhs.gov.

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.

0
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

0
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.

0
2. In Sec.  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:


Sec.  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       042976
 Blvd., Framingham, MA 01702
 
                                * * * * *
------------------------------------------------------------------------

    (2) * * *

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


0
3. Add part 528 to read as follows:

PART 528--NEW ANIMAL DRUGS IN GENETICALLY ENGINEERED ANIMALS

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


Sec.  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

[[Page 6824]]

gland of goats derived from lineage progenitor 155-92.
    (b) Sponsor. See No. 042976 in Sec.  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.
[FR Doc. E9-2881 Filed 2-6-09; 4:15 pm]
BILLING CODE 4160-01-S