New Animal Drugs; Bc6 Recombinant Deoxyribonucleic Acid Construct, 6823-6824 [E9-2881]
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6823
Rules and Regulations
Federal Register
Vol. 74, No. 27
Wednesday, February 11, 2009
This section of the FEDERAL REGISTER
contains regulatory documents having general
applicability and legal effect, most of which
are keyed to and codified in the Code of
Federal Regulations, which is published under
50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by
the Superintendent of Documents. Prices of
new books are listed in the first FEDERAL
REGISTER issue of each week.
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.
dwashington3 on PRODPC68 with RULES
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, email: 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
VerDate Nov<24>2008
14:15 Feb 10, 2009
Jkt 217001
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:
■
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Frm 00001
Fmt 4700
Sfmt 4700
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
*
*
*
GTC Biotherapeutics, Inc.,
175 Crossing Blvd., Framingham, MA 01702
*
*
*
Drug labeler
code
*
042976
*
*
*
(2) * * *
Drug labeler
code
*
042976
*
■
*
*
Firm name and address
*
*
*
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
E:\FR\FM\11FER1.SGM
11FER1
6824
Federal Register / Vol. 74, No. 27 / Wednesday, February 11, 2009 / Rules and Regulations
proposed regulations set forth in the
notice of proposed rulemaking on this
subject published in the Proposed Rules
section in this issue of the Federal
Register.
DATES: Effective Date: These regulations
are effective on February 11, 2009.
Applicability Date: These regulations
apply to acquisitions of stock occurring
on or after February 11, 2009.
FOR FURTHER INFORMATION CONTACT:
Sean W. Mullaney, (202) 622–3860 (not
a toll-free number).
SUPPLEMENTARY INFORMATION:
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.
[FR Doc. E9–2881 Filed 2–6–09; 4:15 pm]
BILLING CODE 4160–01–S
DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 1
[TD 9444]
RIN 1545–BI42
Application of Section 367 to a Section
351 Exchange Resulting From a
Transaction Described in Section
304(a)(1); Treatment of Gain
Recognized Under Section 301(c)(3) for
Purposes of Section 1248
dwashington3 on PRODPC68 with RULES
AGENCY: Internal Revenue Service (IRS),
Treasury.
ACTION: Final and temporary
regulations.
SUMMARY: This document contains final
and temporary regulations under
sections 367(a), 367(b) and 1248(a) of
the Internal Revenue Code (Code). The
final regulations under section 367
revise existing final regulations and add
cross-references. The final regulations
under section 1248 update an effective/
applicability date. The temporary
regulations under section 367(a) and (b)
revise existing final regulations
concerning transfers of stock to a foreign
corporation that are described in section
351 by reason of section 304(a)(1). The
temporary regulations under section
1248(a) provide that, for purposes of
section 1248(a), gain recognized by a
shareholder under section 301(c)(3) in
connection with the receipt of a
distribution of property from a foreign
corporation with respect to its stock
shall be treated as gain from the sale or
exchange of the stock of such foreign
corporation. The temporary regulations
affect certain persons that transfer stock
to a foreign corporation in a transaction
described in section 304(a)(1), or certain
persons that recognize gain under
section 301(c)(3) in connection with the
receipt of a distribution of property from
a foreign corporation with respect to its
stock. The text of the temporary
regulations serves as the text of the
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14:15 Feb 10, 2009
Jkt 217001
Background
Section 367(a)(1) generally provides
that if a United States person transfers
property to a foreign corporation in an
exchange described in section 332, 351,
354, 356, or 361, the foreign corporation
shall not be considered a corporation for
purposes of determining the extent to
which the United States person
recognizes gain on such transfer.
Exceptions to the general rule are
provided by section 367(a)(2) and (3),
and the Secretary has broad authority
under section 367(a)(6) to promulgate
regulations providing exceptions for
other transactions.
Section 367(b)(1) provides that in the
case of an exchange described in section
332, 351, 354, 355, 356, or 361 in
connection with which there is no
transfer of property described in section
367(a)(1), a foreign corporation shall be
considered to be a corporation except to
the extent provided in regulations
prescribed by the Secretary which are
necessary or appropriate to prevent the
avoidance of Federal income taxes.
Section 367(b)(2) provides that the
regulations prescribed pursuant to
section 367(b)(1) shall include (but shall
not be limited to) regulations dealing
with the sale or exchange of stock or
securities in a foreign corporation by a
United States person, including
regulations providing the circumstances
under which gain is recognized,
amounts are included in gross income
as a dividend, adjustments are made to
earnings and profits, or adjustments are
made to the basis of stock or securities.
Regulations under section 367(b)
generally provide that if the potential
application of section 1248 cannot be
preserved immediately following the
acquisition of the stock or assets of a
foreign corporation (foreign acquired
corporation) by another foreign
corporation in an exchange subject to
section 367(b), then certain exchanging
shareholders of the foreign acquired
corporation must include in income as
a dividend the section 1248 amount (as
defined in § 1.367(b)–2(c)) attributable
PO 00000
Frm 00002
Fmt 4700
Sfmt 4700
to the stock of the foreign acquired
corporation. See § 1.367(b)–4(b).
Section 304(a)(1) generally provides
that, for purposes of sections 302 and
303, if one or more persons are in
control of each of two corporations and
in return for property one of the
corporations (the acquiring corporation)
acquires stock in the other corporation
(the issuing corporation) from the
person (or persons) so in control, then
such property shall be treated as a
distribution in redemption of the stock
of the acquiring corporation. To the
extent section 301 applies to the
distribution, the transferor and the
acquiring corporation are treated as if
(1) the transferor transferred the stock of
the issuing corporation to the acquiring
corporation in exchange for stock of the
acquiring corporation in a transaction to
which section 351(a) applies, and (2) the
acquiring corporation then redeemed
the stock it is deemed to have issued.
Under section 304(b)(2), the
determination of the amount of the
property distribution that is a dividend
(and the source thereof) is made as if the
property is distributed by the acquiring
corporation to the extent of its earnings
and profits, and then by the issuing
corporation to the extent of its earnings
and profits.
On February 21, 2006, the IRS and
Treasury Department issued final
regulations (TD 9250) providing that
section 367(a) and (b) shall not apply to
certain transfers of stock of a foreign or
domestic corporation to a foreign
acquiring corporation to which section
351 applies (deemed section 351
exchange) by reason of section 304(a)(1)
(final 2006 regulations). Specifically,
§ 1.367(a)–3(a) provides that if, pursuant
to section 304(a)(1), a United States
person is treated as transferring stock of
a domestic or foreign corporation to a
foreign corporation in exchange for
stock of such foreign corporation in a
deemed section 351 exchange, the
deemed section 351 exchange is not a
transfer to a foreign corporation subject
to section 367(a). Similarly, § 1.367(b)–
4(a) provides that if, pursuant to section
304(a)(1), a foreign corporation is
treated as acquiring the stock of another
foreign corporation in a deemed section
351 exchange, the deemed section 351
exchange is not an acquisition subject to
section 367(b).
The preamble to the final 2006
regulations explained that the IRS and
Treasury Department determined that
the policies underlying section 367(a)
and (b) are preserved even if a deemed
section 351 exchange is not subject to
section 367(a) and (b) because generally
the income recognized by the transferor
in the transaction (dividend income,
E:\FR\FM\11FER1.SGM
11FER1
]]>Agencies
[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]
========================================================================
Rules and Regulations
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by the Superintendent of Documents.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
week.
========================================================================
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
