New Animal Drugs; Change of Sponsor's Name and Address, 54016-54017 [2010-22044]
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54016
Federal Register / Vol. 75, No. 171 / Friday, September 3, 2010 / Rules and Regulations
§ 764.102 except § 764.102(f), which
does not apply to applicants for the CL
Program.
(b) The applicant must agree to repay
any duplicative financial benefits or
assistance to CL.
§ 764.234
Rates and terms.
(a) Rates. The interest rate:
(1) Will be the Agency’s Direct Farm
Ownership rate, available in each
Agency office.
(2) Charged will be the lower rate in
effect either at the time of loan approval
or loan closing.
(b) Terms. The following terms apply
to CLs:
(1) The Agency schedules repayment
of a CL based on the useful life of the
security.
(2) The maximum term for loans
secured by chattels only will not exceed
7 years from the date of the note.
(3) In no event will the term of the
loan exceed 20 years from the date of
the note.
§ 764.235
Security requirements.
(a) The loan must be secured:
(1) In accordance with requirements
established in §§ 764.103 through
764.106; and
(2) In the order of priority as follows:
(i) By real estate, if available, and then
(ii) By chattels, if determined
acceptable by the Agency.
(b) [Reserved]
§§ 764.236–764.250
[Reserved]
PART 765—DIRECT LOAN
SERVICING—REGULAR
37. The authority citation for part 765
continues to read as follows:
■
Authority: 5 U.S.C. 301 and 7 U.S.C. 1989.
38. In § 765.101, add paragraph (g) to
read as follows:
■
§ 765.101 Borrower graduation
requirements.
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(g) CLs are not subject to graduation
requirements under this part.
■ 39. In § 765.152, revise paragraph
(b)(6) to read as follows:
§ 765.152
erowe on DSK5CLS3C1PROD with RULES
41. Amend § 765.351, paragraph
(a)(8), by removing the word ‘‘credit’’
and adding, in its place, the words
‘‘credit on any program except for CL’’.
■
PART 766—DIRECT LOAN
SERVICING—SPECIAL
42. The authority citation for part 766
continues to read as follows:
■
Authority: 5 U.S.C. 301 and 7 U.S.C.
1981(d) and 1989.
43. Amend § 766.107 as follows:
a. In paragraph (b) introductory text,
add the acronym and punctuation ‘‘CL,’’
immediately after the acronym ‘‘OL,’’
■ b. Revise paragraph (c)(2) to read as
set forth below, and
■ c. Add paragraphs (c)(3) and (c)(4) to
read as set forth below.
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§ 766.107
40. In addition to the amendment set
forth above, in 7 CFR part 765, remove
Consolidation and rescheduling.
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(c) * * *
(2) Except for CL and RL loans, the
repayment period cannot exceed 15
years from the date of the consolidation
and rescheduling.
(3) The repayment schedule for RL
loans may not exceed 7 years from the
date of rescheduling.
(4) The repayment schedule for CLs
may not exceed 20 years from the date
of the original note or assumption
agreement.
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■ 44. Amend § 766.108 as follows:
■ a. In paragraph (a) introductory text,
add the acronym and punctuation ‘‘CL,’’
immediately after the acronym ‘‘RHF,’’
and
■ b. Add paragraph (b)(2)(v) to read as
set forth below.
Reamortization.
[FR Doc. 2010–22070 Filed 9–2–10; 8:45 am]
BILLING CODE 3410–05–P
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Food and Drug Administration
21 CFR Part 510
[Docket No. FDA–2010–N–0002]
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect a
change of sponsor’s name from
Alpharma, Inc., to Alpharma LLC. The
sponsor’s mailing address will also be
changed.
SUMMARY:
Signed in Washington, DC, August 31,
2010.
Jonathan W. Coppess,
Administrator, Farm Service Agency.
§§ 765.205–765.207 and 765.253
[Amended]
Jkt 220001
New Animal Drugs; Change of
Sponsor’s Name and Address
[Amended]
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(b) * * *
(2) * * *
(v) CLs may not exceed 20 years from
the date of the original note or
assumption agreement.
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Types of payments.
14:12 Sep 02, 2010
§ 765.351
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(b) * * *
(6) Refunds of duplicate program
benefits or assistance to be applied on
CL or EM loans; or
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VerDate Mar<15>2010
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
§ 766.108
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■
the word ‘‘graduate’’ and add, in its
place, the words ‘‘graduate on any
program except for CL’’ in the following
places:
■ a. In § 765.205 paragraph (b)(6),
■ b. In § 765.206 paragraph (b)(5),
■ c. In § 765.207 paragraph (c), and
■ d. In § 765.253 paragraph (b).
This rule is effective September
3, 2010.
FOR FURTHER INFORMATION CONTACT:
David R. Newkirk, Center for Veterinary
Medicine (HFV–100), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8307,
email: david.newkirk@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Alpharma,
Inc., 440 Rte. 22, Bridgewater, NJ 08807
has informed FDA that it has changed
its name and address to Alpharma LLC,
400 Crossing Blvd., Bridgewater, NJ
08807. Accordingly, the agency is
amending the regulations in 21 CFR
510.600(c) to reflect this change.
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.
DATES:
List of Subjects in 21 CFR Part 510
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
■ 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 part 510 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), revise the entry for
‘‘Alpharma Inc.’’; and in the table in
paragraph (c)(2), revise the entry for
‘‘046573’’ to read as follows:
■
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Federal Register / Vol. 75, No. 171 / Friday, September 3, 2010 / Rules and Regulations
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
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(c) * * *
(1) * * *
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Firm name and address
Drug labeler
code
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Alpharma LLC, 400 Crossing Blvd., Bridgewater,
NJ 08807.
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046573
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(2) * * *
Drug labeler
code
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046573
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Firm name and address
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Alpharma LLC, 400 Crossing Blvd., Bridgewater,
NJ 08807.
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Dated: August 31, 2010.
Elizabeth Rettie,
Deputy Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. 2010–22044 Filed 9–2–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 522
[Docket No. FDA–2010–N–0002]
New Animal Drugs; Change of
Sponsor; Penicillin G Benzathine and
Penicillin G Procaine Suspension;
Penicillin G Procaine Aqueous
Suspension
AGENCY:
Food and Drug Administration,
HHS.
erowe on DSK5CLS3C1PROD with RULES
21 CFR Part 510
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
21 CFR Part 522
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 parts 510 and 522 are amended as
follows:
PART 510—NEW ANIMAL DRUGS
1. The authority citation for 21 CFR
part 510 continues to read as follows:
■
§ 510.600
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect a
change of sponsor for two new animal
drug applications (NADAs) from G. C.
Hanford Manufacturing Co. to Norbrook
Laboratories, Ltd.
DATES: This rule is effective September
3, 2010.
FOR FURTHER INFORMATION CONTACT:
David R. Newkirk, Center for Veterinary
Medicine (HFV–100), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8307,
e-mail: david.newkirk@fda.hhs.gov.
SUMMARY:
14:30 Sep 02, 2010
List of Subjects
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
Final rule; technical
amendment.
ACTION:
VerDate Mar<15>2010
G. C.
Hanford Manufacturing Co., P.O. Box
1017, Syracuse, NY 13201, has informed
FDA that it has transferred ownership
of, and all rights and interest in, NADA
65–493 for Penicillin G Procaine
Aqueous Suspension and NADA 65–500
for Penicillin G Benzathine and
Penicillin G Procaine Suspension, to
Norbrook Laboratories, Ltd., Station
Works, Newry BT35 6JP, Northern
Ireland. Accordingly, the agency is
amending the regulations in 21 CFR
522.1696a and 522.1696b to reflect the
transfer of ownership.
In addition, FDA has noticed that ‘‘G.
C. Hanford’’ and ‘‘GTC Biotherapeutics,
Inc.’’ are not spelled correctly in the
listing of sponsors of approved NADAs.
At this time, the table in 21 CFR
510.600(c)(1) is amended. This action is
being taken to improve the accuracy of
the regulations.
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.
SUPPLEMENTARY INFORMATION:
Jkt 220001
[Amended]
2. In § 510.600, in the table in
paragraph (c)(1), in the entry for ‘‘G. C.
Biotherapeutics, Inc.’’, remove ‘‘G. C.’’
and in its place add ‘‘GTC’’; and in the
entry for ‘‘GTC Hanford Manufacturing
Co.’’, remove ‘‘GTC’’ and in its place add
‘‘G. C.’’.
■
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
3. The authority citation for 21 CFR
part 522 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
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54017
4. In § 522.1696a, revise paragraphs
(b)(1), (b)(2), (d)(2)(ii)(A), and (d)(2)(iii)
to read as follows:
■
§ 522.1696a Penicillin G benzathine and
penicillin G procaine suspension.
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(b) * * *
(1) Nos. 000856, 049185, 055529, and
061623 for use as in paragraph (d)(1) of
this section.
(2) Nos. 055529, 059130, and 061623
for use as in paragraphs (d)(2)(i),
(d)(2)(ii)(A), and (d)(2)(iii) of this
section.
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(d) * * *
(2) * * *
(ii) * * *
(A) Treatment of bacterial pneumonia
(Streptococcus spp., Actinomyces
pyogenes, Staphylococcus aureus);
upper respiratory infections such as
rhinitis or pharyngitis (A. pyogenes);
blackleg (Clostridium chauvoei).
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(iii) Limitations. Limit treatment to
two doses. Not for use within 30 days
of slaughter. For Nos. 049185, 055529,
059130, and 061623: A withdrawal
period has not been established for this
product in preruminating calves. Do not
use in calves to be processed for veal.
■ 5. In § 522.1696b, revise paragraphs
(b)(1), (b)(2), (d)(2)(i)(A), and
(d)(2)(iii)(B) to read as follows:
§ 522.1696b Penicillin G procaine aqueous
suspension.
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(b) * * *
(1) Nos. 053501, 055529, and 059130
for use as in paragraph (d) of this
section.
(2) No. 061623 for use as in paragraph
(d)(2) of this section.
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(d) * * *
(2) * * *
(i) * * *
(A) For Nos. 053501, 055529, 059130,
and 061623: Continue treatment at least
48 hours after symptoms disappear.
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(iii) * * *
(B) For Nos. 055529 and 059130:
Continue treatment at least 1 day after
symptoms disappear (usually 2 or 3
days).
Dated: August 31, 2010.
Elizabeth Rettie,
Deputy Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. 2010–22042 Filed 9–2–10; 8:45 am]
BILLING CODE 4160–01–S
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]]>Agencies
[Federal Register Volume 75, Number 171 (Friday, September 3, 2010)]
[Rules and Regulations]
[Pages 54016-54017]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-22044]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 510
[Docket No. FDA-2010-N-0002]
New Animal Drugs; Change of Sponsor's Name and Address
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect a change of sponsor's name from Alpharma,
Inc., to Alpharma LLC. The sponsor's mailing address will also be
changed.
DATES: This rule is effective September 3, 2010.
FOR FURTHER INFORMATION CONTACT: David R. Newkirk, Center for
Veterinary Medicine (HFV-100), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8307, email:
david.newkirk@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Alpharma, Inc., 440 Rte. 22, Bridgewater, NJ
08807 has informed FDA that it has changed its name and address to
Alpharma LLC, 400 Crossing Blvd., Bridgewater, NJ 08807. Accordingly,
the agency is amending the regulations in 21 CFR 510.600(c) to reflect
this change.
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 in 21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
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 part 510 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), revise the entry
for ``Alpharma Inc.''; and in the table in paragraph (c)(2), revise the
entry for ``046573'' to read as follows:
[[Page 54017]]
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
------------------------------------------------------------------------
Firm name and address Drug labeler code
------------------------------------------------------------------------
* * * * *
Alpharma LLC, 400 Crossing Blvd., 046573
Bridgewater, NJ 08807.
* * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * *
046573..................... Alpharma LLC, 400 Crossing Blvd.,
Bridgewater, NJ 08807.
* * * * *
------------------------------------------------------------------------
Dated: August 31, 2010.
Elizabeth Rettie,
Deputy Director, Office of New Animal Drug Evaluation, Center for
Veterinary Medicine.
[FR Doc. 2010-22044 Filed 9-2-10; 8:45 am]
BILLING CODE 4160-01-S
