New Animal Drugs; Change of Sponsor's Name; Liquid Crystalline Trypsin, Peru Balsam, Castor Oil, 36595 [E7-13010]
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36595
Federal Register / Vol. 72, No. 128 / Thursday, July 5, 2007 / Rules and Regulations
requests for records under the Freedom
of Information Act, and requests for
correction or amendment under the
Privacy Act. 5 U.S.C.(d)(3).
Because notice and opportunity for
comment are not required pursuant to 5
U.S.C. 553 or any other law, the
analytical requirements of the
Regulatory Flexibility Act (5 U.S.C. 601
et seq.) are inapplicable. Therefore, a
regulatory flexibility analysis is not
required and has not been prepared.
List of Subjects in 15 CFR Part 4
Freedom of information, Privacy.
For the reasons above, amend 15 CFR
Part 4 as follows:
I
PART 4—DISCLOSURE OF
GOVERNMENT INFORMATION
1. The authority citation for Part 4
continues to read as follows:
I
Authority: 5 U.S.C. 301; 5 U.S.C. 552; 5
U.S.C. 552a; 5 U.S.C. 553; 31 U.S.C. 3717; 44
U.S.C. 3101; Reorganization Plan No. 5 of
1950.
Appendix B to Part 4—[Amended]
2. In Appendix B to part 4, under the
heading ECONOMICS AND
STATISTICS ADMINISTRATION,
delete ‘‘Bureau of the Census: Manager,
Freedom of Information Act’’ and
replace with ‘‘Bureau of the Census:
Freedom of Information Act Officer’’.
I
Dated: June 28, 2007.
Brenda Dolan,
Departmental Freedom of Information and
Privacy Act Officer.
[FR Doc. E7–13001 Filed 7–3–07; 8:45 am]
FOR FURTHER INFORMATION CONTACT:
David R. Newkirk, Center for Veterinary
Medicine (HFV–100), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–6967, email: david.newkirk@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Mylan
Bertek Pharmaceuticals, Inc., 12720
Dairy Ashford, Sugar Land, TX 77478,
has informed FDA that it has changed
its name to UDL Laboratories, Inc., and
is using a new drug labeler code.
Accordingly, the agency is amending
the regulations in 21 CFR 510.600(c) to
reflect these changes. A conforming
change is being made in 21 CFR
524.2620 for this sponsor’s sole product.
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.
Firm name and address
UDL Laboratories, Inc.,
12720 Dairy Ashford,
Sugar Land, TX 77478.
*
*
*
Drug labeler
code
051079
*
*
(2) * * *
Drug labeler
code
*
051079
*
*
*
Firm name and address
*
*
*
UDL Laboratories, Inc.,
12720 Dairy Ashford,
Sugar Land, TX 77478
*
*
*
PART 524—OPHTHALMIC AND
TOPICAL DOSAGE FORM NEW
ANIMAL DRUGS
3. The authority citation for 21 CFR
part 524 continues to read as follows:
I
List of Subjects
Authority: 21 U.S.C. 360b.
21 CFR Part 510
§ 524.2620
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
I
[Amended]
4. In paragraph (a)(2) of § 524.2620,
remove ‘‘062794’’ and add in its place
‘‘051079’’.
21 CFR Part 524
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 524 are amended as
follows:
I
Dated: June 21, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary
Medicine.
[FR Doc. E7–13010 Filed 7–3–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF THE INTERIOR
PART 510—NEW ANIMAL DRUGS
1. The authority citation for 21 CFR
part 510 continues to read as follows:
Food and Drug Administration
New Animal Drugs; Change of
Sponsor’s Name; Liquid Crystalline
Trypsin, Peru Balsam, Castor Oil
Food and Drug Administration,
HHS.
Final rule; technical
amendment.
jlentini on PROD1PC65 with RULES
ACTION:
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect a
change of sponsor’s name from Mylan
Bertek Pharmaceuticals, Inc., to UDL
Laboratories, Inc.
DATES: This rule is effective July 5,
2007.
VerDate Aug<31>2005
15:50 Jul 03, 2007
Jkt 211001
[VA–123–FOR]
2. In § 510.600, in the table in
paragraph (c)(1), remove the entry for
‘‘Mylan Bertek Pharmaceuticals, Inc.’’
and alphabetically add a new entry for
‘‘UDL Laboratories, Inc.’’; and in the
table in paragraph (c)(2) remove the
entry for ‘‘062749’’ and numerically add
a new entry for ‘‘051079’’ to read as
follows:
I
21 CFR Parts 510 and 524
AGENCY:
30 CFR Part 946
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of Surface Mining Reclamation
and Enforcement
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BILLING CODE 3510–07–P
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
*
PO 00000
*
*
(c) * * *
(1) * * *
*
*
Firm name and address
Drug labeler
code
*
*
*
Frm 00007
*
Fmt 4700
Sfmt 4700
*
Virginia Regulatory Program
Office of Surface Mining
Reclamation and Enforcement (OSM),
Interior.
ACTION: Final rule; approval of
amendment.
AGENCY:
SUMMARY: We are approving an
amendment to the Virginia regulatory
program under the Surface Mining
Control and Reclamation Act of 1977
(SMCRA or the Act). Virginia is revising
its remining regulations to make three of
those provisions permanent by deleting
a termination date of September 30,
2004, from the regulations. The
amendment is intended to render the
State regulations consistent with recent
amendments to SMCRA.
EFFECTIVE DATE: July 5, 2007.
E:\FR\FM\05JYR1.SGM
05JYR1
]]>Agencies
[Federal Register Volume 72, Number 128 (Thursday, July 5, 2007)]
[Rules and Regulations]
[Page 36595]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-13010]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 524
New Animal Drugs; Change of Sponsor's Name; Liquid Crystalline
Trypsin, Peru Balsam, Castor Oil
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect a change of sponsor's name from Mylan
Bertek Pharmaceuticals, Inc., to UDL Laboratories, Inc.
DATES: This rule is effective July 5, 2007.
FOR FURTHER INFORMATION CONTACT: David R. Newkirk, Center for
Veterinary Medicine (HFV-100), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-6967, e-mail:
david.newkirk@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Mylan Bertek Pharmaceuticals, Inc., 12720
Dairy Ashford, Sugar Land, TX 77478, has informed FDA that it has
changed its name to UDL Laboratories, Inc., and is using a new drug
labeler code. Accordingly, the agency is amending the regulations in 21
CFR 510.600(c) to reflect these changes. A conforming change is being
made in 21 CFR 524.2620 for this sponsor's sole product.
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 524
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 parts 510 and
524 are 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), remove the entry
for ``Mylan Bertek Pharmaceuticals, Inc.'' and alphabetically add a new
entry for ``UDL Laboratories, Inc.''; and in the table in paragraph
(c)(2) remove the entry for ``062749'' and numerically add a new entry
for ``051079'' 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
------------------------------------------------------------------------
* * * * *
UDL Laboratories, Inc., 12720 Dairy Ashford, 051079
Sugar Land, TX 77478.
* * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * *
051079 UDL Laboratories, Inc., 12720 Dairy
Ashford, Sugar Land, TX 77478
* * * * *
------------------------------------------------------------------------
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
0
3. The authority citation for 21 CFR part 524 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 524.2620 [Amended]
0
4. In paragraph (a)(2) of Sec. 524.2620, remove ``062794'' and add in
its place ``051079''.
Dated: June 21, 2007.
Bernadette Dunham,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. E7-13010 Filed 7-3-07; 8:45 am]
BILLING CODE 4160-01-S
