New Animal Drugs; Change of Sponsor's Name, 69010-69011 [E6-20250]
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69010
Federal Register / Vol. 71, No. 229 / Wednesday, November 29, 2006 / Rules and Regulations
reason, the FAA certifies that this
amendment will not have a significant
economic impact on a substantial
number of small entities under the
criteria of the Regulatory Flexibility Act.
contained in FAA form documents is
unnecessary. The provisions of this
amendment state the affected CFR
sections, with the types and effective
dates of the SIAPs and/or Weather
Takeoff Minimums. This amendment
also identifies the airport, its location,
the procedure identification and the
amendment number.
cprice-sewell on PROD1PC66 with RULES
The Rule
This amendment to 14 CFR part 97 is
effective upon publication of each
separate SIAP and/or Weather Takeoff
Minimums as contained in the
transmittal. Some SIAP and/or Weather
Takeoff Minimums amendments may
have been previously issued by the FAA
in a Flight Data Center (FDC) Notice to
Airmen (NOTAM) as an emergency
action of immediate flight safety relating
directly to published aeronautical
charts. The circumstances which
created the need for some SIAP, and/or
Weather Takeoff Minimums
amendments may require making them
effective in less than 30 days. For the
remaining SIAPs and/or Weather
Takeoff Minimums, an effective date at
least 30 days after publication is
provided.
Further, the SIAPs and/or Weather
Takeoff Minimums contained in this
amendment are based on the criteria
contained in the U.S. Standard for
Terminal Instrument Procedures
(TERPS). In developing these SIAPs
and/or Weather Takeoff Minimums, the
TERPS criteria were applied to the
conditions existing or anticipated at the
affected airports. Because of the close
and immediate relationship between
these SIAPs and/or Weather Takeoff
Minimums and safety in air commerce,
I find that notice and public procedure
before adopting these SIAPs and/or
Weather Takeoff Minimums are
impracticable and contrary to the public
interest and, where applicable, that
good cause exists for making some
SIAPs and/or Weather Takeoff
Minimums effective in less than 30
days.
Conclusion
The FAA has determined that this
regulation only involves an established
body of technical regulations for which
frequent and routine amendments are
necessary to keep them operationally
current. It, therefore—(1) is not a
‘‘significant regulatory action’’ under
Executive Order 12866; (2) is not a
‘‘significant rule’’ under DOT
Regulatory Policies and Procedures (44
FR 11034; February 26, 1979); and (3)
does not warrant preparation of a
regulatory evaluation as the anticipated
impact is so minimal. For the same
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13:36 Nov 28, 2006
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List of Subjects in 14 CFR Part 97
Air Traffic Control, Airports,
Incorporation by reference, and
Navigation (Air).
Issued in Washington, DC on November 17,
2006.
James J. Ballough,
Director, Flight Standards Service.
Adoption of the Amendment
Accordingly, pursuant to the authority
delegated to me, under Title 14, Code of
Federal Regulations, Part 97 (14 CFR
part 97) is amended by establishing,
amending, suspending, or revoking
Standard Instrument Approach
Procedures and Weather Takeoff
Minimums effective at 0901 UTC on the
dates specified, as follows:
I
PART 97—STANDARD INSTRUMENT
APPROACH PROCEDURES
1. The authority citation for part 97
continues to read as follows:
I
Authority: 49 U.S.C. 106(g), 40103, 40106,
40113, 40114, 40120, 44502, 44514, 44701,
44719, 44721–44722.
2. Part 97 is amended to read as
follows:
I
Effective 21 December 2006
Huntsville, AL, Madison County Executive,
RNAV (GPS) RWY 36, Orig
Leesburg, FL, Leesburg Regional, RNAV
(GPS) RWY 3, Orig
Leesburg, FL, Leesburg Regional, RNAV
(GPS) RWY 13, Orig
Leesburg, FL, Leesburg Regional, RNAV
(GPS) RWY 31, Orig
Leesburg, FL, Leesburg Regional, GPS RWY
13, Amdt 1, CANCELLED
Leesburg, FL, Leesburg Regional, GPS RWY
31, Amdt 1, CANCELLED
Leesburg, FL, Leesburg Regional, Takeoff
Minimums and Textual DP, Amdt 2
Boston, MA, General Edward Lawrence
Logan Intl, RNAV (GPS) RWY 32, Orig-A
Willmar, MN, Willmar Muni, RNAV (GPS)
RWY 13, Orig
Willmar, MN, Willmar Muni, RNAV (GPS)
RWY 31, Orig
New Orleans, LA, Lakefront, RNAV (GPS)
RWY 18R, Orig
New Orleans, LA, Lakefront, GPS RWY 18R,
Orig-A CANCELLED
Harrisburg, PA, Capital City, RNAV (GPS)
RWY 26, Orig-A
Evanston, WY, Evanston-Uinta County Burns
Field, RNAV (GPS) RWY 23, Amdt 3
Effective 18 January 2007
New Orleans, LA, Lakefront, ILS RWY 18R,
Amdt 12B, CANCELLED
Monroe, NC, Monroe Regional, ILS OR LOC/
NDB RWY 5, Amdt 1
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Monroe, NC, Monroe Regional, RNAV (GPS)
RWY 5, Amdt 1
Monroe, NC, Monroe Regional, RNAV (GPS)
RWY 23, Orig
Monroe, NC, Monroe, VOR OR GPS–A, Amdt
11C, CANCELLED
Monroe, NC, Monroe, VOR/DME OR GPS–B,
Amdt 6C, CANCELLED
Monroe, NC, Monroe Regional, Takeoff
Minimums and Textual DP, Orig
Muskogee, OK, Davis Field, VOR RWY 31,
Amdt 4, CANCELLED
Gettysburg, SD, Gettysburg Muni, RNAV
(GPS) RWY 13, Orig
Gettysburg, SD, Gettysburg Muni, RNAV
(GPS) RWY 31, Orig
Gettysburg, SD, Gettysburg Muni, GPS RWY
31, Orig-A, CANCELLED
Gettysburg, SD, Gettysburg Muni, Takeoff
Minimums and Textual DPs, Amdt 1
Seattle, WA, Boeing Field/King County Intl,
Takeoff Minimums and Textual DP,
Amdt 6
The FAA published an Amendment in
Docket No. 30513, Amdt No. 3184 to Part 97
of the Federal Aviation Regulations (Vol 71,
FR No. 220, Page 66447; dated November 15,
2006) under section 97.27, effective 18
January 2007, published in TL 06–25 are
hereby RESCINDED as follows:
Dayton, OH, Green County-Lewis A Jackson
Regional, RNAV (GPS) RWY 7, Orig
Dayton, OH, Greene County-Lewis A Jackson
Regional, RNAV (GPS) RWY 25, Orig
Dayton, OH, Greene County-Lewis A Jackson
Regional, NDB RWY 25, Amdt 1
Dayton, OH, Greene County-Lewis A Jackson
Regional, GPS RWY 7, Orig-A,
CANCELLED
Dayton, OH, Greene County-Lewis A Jackson
Regional, Takeoff Minimums and Textual
DP, Amdt 1
[FR Doc. E6–20154 Filed 11–28–06; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 510
New Animal Drugs; Change of
Sponsor’s Name
AGENCY:
Food and Drug Administration,
HHS.
Final rule; technical
amendment.
ACTION:
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect a
change of sponsor’s name from Bertek
Pharmaceuticals, Inc., to Mylan Bertek
Pharmaceuticals, Inc.
DATES: This rule is effective November
29, 2006.
FOR FURTHER INFORMATION CONTACT:
David R. Newkirk, Center for Veterinary
Medicine (HFV–100), Food and Drug
E:\FR\FM\29NOR1.SGM
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Federal Register / Vol. 71, No. 229 / Wednesday, November 29, 2006 / Rules and Regulations
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–6967, email: david.newkirk@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Bertek
Pharmaceuticals, Inc., 12720 Dairy
Ashford, Sugar Land, TX 77478, has
informed FDA that it has changed its
name to Mylan Bertek Pharmaceuticals,
Inc. Accordingly, the agency is
amending the regulations in 21 CFR
510.600 to reflect the 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.
I 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
2. In § 510.600 in the table in
paragraph (c)(1) remove the entry for
‘‘Bertek Pharmaceuticals, Inc.’’ and
alphabetically add a new entry for
‘‘Mylan Bertek Pharmaceuticals, Inc.’’;
and in the table in paragraph (c)(2)
revise the entry for ‘‘062794’’ to read as
follows:
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
*
Firm name and address
Drug labeler
code
*
*
*
*
*
*
(2) * * *
Drug labeler
code
*
062794
*
Firm name and address
*
*
*
*
Mylan Bertek Pharmaceuticals, Inc., 12720
Dairy Ashford, Sugar
Land, TX 77478
*
*
*
*
Dated: November 16, 2006.
Bernadette Dunham,
Deputy Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. E6–20250 Filed 11–28–06; 8:45 am]
BILLING CODE 4160–01–S
ENVIRONMENTAL PROTECTION
AGENCY
RIN 2060–AM30
I
*
062794
[EPA–HQ–OAR–2002–0021; FRL–8249–3]
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
*
*
(c) * * *
(1) * * *
Mylan Bertek Pharmaceuticals, Inc., 12720
Dairy Ashford, Sugar
Land, TX 77478.
*
*
*
Drug labeler
code
40 CFR Part 63
1. The authority citation for 21 CFR
part 510 continues to read as follows:
I
*
Firm name and address
*
National Emission Standards for
Hazardous Air Pollutants: Site
Remediation
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This action amends the
national emission standards for
hazardous air pollutants (NESHAP) for
site remediation activities. This final
rule revises specific provisions in the
rule to resolve issues and questions
subsequent to promulgation; correct
technical omissions; and correct
typographical, cross-reference, and
grammatical errors.
DATES: This final rule is effective on
November 29, 2006.
SUMMARY:
69011
EPA has established a
docket for this action under Docket ID
No. EPA–HQ–OAR–2002–0021. All
documents in the docket are listed on
the https://www.regulations.gov Web
site. Although listed in the index, some
information is not publicly available,
e.g., confidential business information
or other information whose disclosure is
restricted by statute. Certain other
material, such as copyrighted material,
is not placed on the Internet and will be
publicly available only in hard copy
form. Publicly available docket
materials are available either
electronically through https://
www.regulations.gov or in hard copy at
the Air & Radiation Docket, Docket ID
No. EPA–HQ–OAR–2002–0021, EPA/
DC, EPA West, Room B102, 1301
Constitution Ave., NW., Washington,
DC. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday
through Friday, excluding legal
holidays. The telephone number for the
Public Reading Room is (202) 566–1744,
and the telephone number for the Air
Docket is (202) 566–1742.
ADDRESSES:
Note: The EPA Docket Center suffered
damage due to flooding during the last week
of June 2006. The Docket Center is
continuing to operate. However, during the
cleanup, there will be temporary changes to
Docket Center telephone numbers, addresses,
and hours of operation for people who wish
to visit the Public Ready Room to view
documents. Consult EPA’s Federal Register
notice at 71 FR 38147 (July 5, 2006) or the
EPA Web site https://www.epa.gov/epahome/
dockets.htm for current information on
docket status, locations, and telephone
numbers.
Mr.
Greg Nizich, Chemicals and Coatings
Group, Sector Policies and Programs
Division (E143–01), U.S. EPA, Research
Triangle Park, NC 27711, telephone
number: (919) 541–3078, facsimile
number: (919) 541–0246, electronic mail
(e-mail) address: nizich.greg@epa.gov.
FOR FURTHER INFORMATION CONTACT:
Regulated
Entities. The regulated categories and
entities affected by the NESHAP
include:
SUPPLEMENTARY INFORMATION:
NAICS 1
Examples of regulated entities
Industry ............................................
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Category
325211 325192 325188 32411
49311 49319 48611 42269
42271.
Federal Government .......................
........................................................
Site remediation activities at businesses at which materials containing
organic HAP currently are or have been in the past stored, processed, treated, or otherwise managed at the facility. These facilities
include: organic liquid storage terminals, petroleum refineries,
chemical manufacturing facilities, and other manufacturing facilities
with co-located site remediation activities.
Federal agency facilities that conduct site remediation activities to
clean up materials contaminated with organic HAP.
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13:36 Nov 28, 2006
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]]>Agencies
[Federal Register Volume 71, Number 229 (Wednesday, November 29, 2006)]
[Rules and Regulations]
[Pages 69010-69011]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-20250]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 510
New Animal Drugs; Change of Sponsor's Name
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 Bertek
Pharmaceuticals, Inc., to Mylan Bertek Pharmaceuticals, Inc.
DATES: This rule is effective November 29, 2006.
FOR FURTHER INFORMATION CONTACT: David R. Newkirk, Center for
Veterinary Medicine (HFV-100), Food and Drug
[[Page 69011]]
Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-6967,
e-mail: david.newkirk@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Bertek Pharmaceuticals, Inc., 12720 Dairy
Ashford, Sugar Land, TX 77478, has informed FDA that it has changed its
name to Mylan Bertek Pharmaceuticals, Inc. Accordingly, the agency is
amending the regulations in 21 CFR 510.600 to reflect the 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) remove the entry
for ``Bertek Pharmaceuticals, Inc.'' and alphabetically add a new entry
for ``Mylan Bertek Pharmaceuticals, Inc.''; and in the table in
paragraph (c)(2) revise the entry for ``062794'' 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
------------------------------------------------------------------------
* * * * *
Mylan Bertek Pharmaceuticals, Inc., 12720 062794
Dairy Ashford, Sugar Land, TX 77478.
* * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * *
062794 Mylan Bertek Pharmaceuticals, Inc., 12720
Dairy Ashford, Sugar Land, TX 77478
* * * * *
------------------------------------------------------------------------
Dated: November 16, 2006.
Bernadette Dunham,
Deputy Director, Office of New Animal Drug Evaluation, Center for
Veterinary Medicine.
[FR Doc. E6-20250 Filed 11-28-06; 8:45 am]
BILLING CODE 4160-01-S
