Passports; Correction, 4077-4078 [E8-1205]
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Federal Register / Vol. 73, No. 16 / Thursday, January 24, 2008 / Rules and Regulations
[FR Doc. E8–1012 Filed 1–23–08; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 520
Oral Dosage Form New Animal Drugs;
Clindamycin
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval of an abbreviated new animal
drug application (ANADA) filed by
Novopharm Ltd. The ANADA provides
for the veterinary prescription use of
clindamycin hydrochloride oral
capsules in dogs for the treatment of
various infections due to susceptible
bacterial pathogens.
DATES: This rule is effective January 24,
2008.
FOR FURTHER INFORMATION CONTACT: John
K. Harshman, Center for Veterinary
Medicine (HFV–104), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–9808, email: john.harshman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
Novopharm Ltd., 30 Novopharm Ct.,
Toronto, Ontario, Canada M1B 2K9,
filed ANADA 200–383 that provides for
the veterinary prescription use of
CLINDAROBE (clindamycin
hydrochloride) Capsules in dogs for the
treatment of various infections due to
susceptible bacterial pathogens.
Novopharm Ltd.’s CLINDAROBE
Capsules is approved as a generic copy
of Pharmacia & Upjohn Co.’s
ANTIROBE Capsules, approved under
NADA 120–161. The ANADA is
approved as of December 19, 2007, and
21 CFR 520.446 is amended to reflect
the approval.
In addition, Novopharm Ltd. has not
been previously listed in the animal
drug regulations as a sponsor of an
approved application. At this time, 21
CFR 510.600(c) is being amended to add
entries for the firm.
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.
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SUMMARY:
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19:26 Jan 23, 2008
Jkt 214001
1061, Rockville, MD 20852, between 9
a.m. and 4 p.m., Monday through
Friday.
FDA has determined under 21 CFR
25.33(a)(1) that this action is of a type
that does not individually or
cumulatively have a significant effect on
the human environment. Therefore,
neither an environmental assessment
nor an environmental impact statement
is required.
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
Drug labeler
code
*
043806
*
*
*
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
21 CFR Part 520
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 520 are amended as
follows:
I
Firm name and address
*
*
*
Novopharm Ltd., 30
Novopharm Ct., Toronto,
Ontario, Canada M1B
2K9
*
*
*
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
3. The authority citation for 21 CFR
part 520 continues to read as follows:
I
Authority: 21 U.S.C. 360b.
4. In § 520.446, add paragraphs (a)(3)
and (b)(3) to read as follows:
I
§ 520.446
tablets.
21 CFR Part 510
4077
Clindamycin capsules and
(a) * * *
(3) Each capsule contains the
equivalent of 25, 75, or 150 mg
clindamycin as the hydrochloride salt.
(b) * * *
(3) No. 043806 for use of tablets
described in paragraph (a)(3) of this
section.
*
*
*
*
*
Dated: January 14, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8–1199 Filed 1–23–08; 8:45 am]
BILLING CODE 4160–01–S
PART 510—NEW ANIMAL DRUGS
1. The authority citation for 21 CFR
part 510 continues to read as follows:
I
DEPARTMENT OF STATE
22 CFR Part 51
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
RIN 1400–AC28
2. Section 510.600 is amended in the
table in paragraph (c)(1) by
alphabetically adding a new entry for
‘‘Novopharm Ltd.’’ and in the table in
paragraph (c)(2) by numerically adding
a new entry for ‘‘043806’’ to read as
follows:
[Public Notice: 6071]
I
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
*
*
*
(c) * * *
(1) * * *
*
*
Firm name and address
*
*
*
Novopharm Ltd., 30
Novopharm Ct., Toronto,
Ontario, Canada M1B
2K9
*
*
*
Drug labeler
code
*
043806
*
*
*
Passports; Correction
Department of State.
Final rule; correction.
AGENCY:
ACTION:
SUMMARY: This document contains a
correction to the revised Passport rule
published in the Federal Register on
November 19, 2007, 72 FR 64930.
DATES: Effective on February 1, 2008.
FOR FURTHER INFORMATION CONTACT:
Consuelo Pachon, Office of Legal Affairs
and Law Enforcement Liaison, Bureau
of Consular Affairs, 2100 Pennsylvania
Avenue, NW., Suite 3000, Washington,
DC., telephone number 202–663–2431.
Background
The rule reorganizes, restructures, and
updates the passport regulations in
order to make them easier for users to
access the information, to better reflect
current practice and changes in
(2) * * *
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4078
Federal Register / Vol. 73, No. 16 / Thursday, January 24, 2008 / Rules and Regulations
statutory authority, and to remove
outdated provisions.
Need for Correction
The final passport rule published on
November 19, 2007 erroneously labels
two sentences in the rule contained in
22 CFR 51.21(b) and (c) as a ‘‘Note.’’
This correction deletes the labels
‘‘Note’’ and corrects the numbering of
the two provisions.
Correction
The final passport rule published on
November 19, 2007 (72 FR 64930) is
corrected as follows:
I 1. On page 64933, 22 CFR part 51.21
is corrected by making the following
correcting amendments:
I
(iii) The most recently issued
previous passport of the same type is
submitted with the new application.
(2) The applicant must also provide
photographs as prescribed by the
Department and pay the applicable fees
prescribed in the Schedule of Fees for
Consular Services (22 CFR 22.1).
*
*
*
*
*
Dated: January 18, 2008.
Ann Barrett,
Deputy Assistant Secretary, Bureau of
Consular Affairs, Department of State.
[FR Doc. E8–1205 Filed 1–23–08; 8:45 am]
BILLING CODE 4710–06–P
DEPARTMENT OF HOMELAND
SECURITY
PART 51—PASSPORTS
Section 51.21(b) and (c) is revised to
read as follows:
Coast Guard
§ 51.21
[USCG–2007–0169]
Execution of passport application.
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*
*
*
*
*
(b) Application by mail—persons in
the United States. (1) A person in the
United States who previously has been
issued a passport valid for 10 years in
his or her own name may apply for a
new passport by filling out, signing and
mailing an application on the form
prescribed by the Department if:
(i) The most recently issued previous
passport was issued when the applicant
was 16 years of age or older;
(ii) The application is made not more
than 15 years following the issue date of
the previous passport, except as
provided in paragraph (e) of this
section; and
(iii) The most recently issued
previous passport of the same type is
submitted with the new application.
(2) The applicant must also provide
photographs as prescribed by the
Department and pay the applicable fees
prescribed in the Schedule of Fees for
Consular Services (22 CFR 22.1).
(c) Application by mail—persons
abroad. (1) A person in a foreign
country where the Department has
authorized a post to receive passport
applications by mail who previously has
been issued a passport valid for 10 years
in his or her own name may apply for
a new passport in that country by filling
out, signing and mailing an application
on the form prescribed by the
Department if:
(i) The most recently issued previous
passport was issued when the applicant
was 16 years of age or older;
(ii) The application is made not more
than 15 years following the issue date of
the previous passport, except as
provided in paragraph (e) of this
section; and
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19:26 Jan 23, 2008
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33 CFR Part 165
RIN 1625–AA00
Safety Zone: Trent River Between New
Bern and James City, NC
Coast Guard, DHS.
Temporary final rule.
AGENCY:
ACTION:
SUMMARY: The Coast Guard will
establish a safety zone on the waters of
the Trent River between New Bern and
James City, North Carolina in the
vicinity of the U.S. Route 70 Highway
Swing Bridge. This safety zone is
necessary to provide for the safety of life
on navigable waters during the
movement of bridge construction
equipment from the southern end of the
bridge construction project to the
northern end of the project.
DATES: This rule is effective from 10
a.m. on January 8, 2008 through 2 p.m.
on January 24, 2008.
ADDRESSES: Documents indicated in this
preamble as being available in the
docket are part of docket USCG–2007–
0169 and are available for inspection or
copying at Sector North Carolina 2301
East Fort Macon Road Atlantic Beach,
NC 28512 between 8 a.m. and 4 p.m.,
Monday through Friday, except Federal
holidays.
FOR FURTHER INFORMATION CONTACT:
Commander Jennifer Williams,
Prevention Department Head, United
States Coast Guard Sector North
Carolina at (252) 247–4570 or (252) 247–
457046.
SUPPLEMENTARY INFORMATION:
Regulatory Information
We did not publish a notice of
proposed rulemaking (NPRM) for this
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regulation. Under 5 U.S.C. 553(b)(B), the
Coast Guard finds that good cause exists
for not publishing an NPRM. The
publishing of an NPRM would be
impracticable and contrary to public
interest since immediate action is
needed to protect the maritime public
from the hazards associated with this
maintenance project. The necessary
information to determine whether the
construction poses a threat to persons
and vessels was not provided with
sufficient time to publish an NPRM. For
the safety concerns noted, it is in the
public interest to have this regulation in
effect during the construction.
Under 5 U.S.C. 553(d)(3), the Coast
Guard finds that good cause exists for
making this rule effective less than 30
days after publication in the Federal
Register. Delaying the effective date
would be contrary to the public interest,
since immediate action is needed to
ensure the public’s safety.
Background and Purpose
From 10 a.m. to 2 p.m. on each
Tuesday, Wednesday, and Thursday
from January 8, 2008 through January
24, 2008 Balfour Beatty Infrastructure
Inc. will relocate construction
equipment in the vicinity of the U.S.
Route 70 Highway Swing Bridge from
James City, NC to New Bern, NC. To
provide for the safety of the public, the
Coast Guard will temporarily restrict
access to this section of the Trent River
during equipment relocation.
Discussion of Rule
The Coast Guard is establishing a
temporary safety zone that will extend
from the Norfolk Southern Railroad
Bridge and Union Point, New Bern, NC
to the U.S. Route 17 Highway Bridge at
James City, NC, latitude 35°05.8′ N,
longitude 77°02.2′ W. This zone will
require mariners to avoid entry into the
area. Entry into the zone will not be
permitted except as specifically
authorized by the Captain of the Port or
his designated representative.
Regulatory Evaluation
This rule is not a ‘‘significant
regulatory action’’ under section 3(f) of
Executive Order 12866, Regulatory
Planning and Review, and does not
require an assessment of potential costs
and benefits under section 6(a)(3) of that
Order. The Office of Management and
Budget has not reviewed it under that
Order. The Coast Guard expects the
economic impact of this rule to be so
minimal that a full Regulatory
Evaluation is unnecessary.
Although this regulation will restrict
access to the regulated area, the effect of
this rule will not be significant because:
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]]>Agencies
[Federal Register Volume 73, Number 16 (Thursday, January 24, 2008)]
[Rules and Regulations]
[Pages 4077-4078]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-1205]
=======================================================================
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DEPARTMENT OF STATE
22 CFR Part 51
RIN 1400-AC28
[Public Notice: 6071]
Passports; Correction
AGENCY: Department of State.
ACTION: Final rule; correction.
-----------------------------------------------------------------------
SUMMARY: This document contains a correction to the revised Passport
rule published in the Federal Register on November 19, 2007, 72 FR
64930.
DATES: Effective on February 1, 2008.
FOR FURTHER INFORMATION CONTACT: Consuelo Pachon, Office of Legal
Affairs and Law Enforcement Liaison, Bureau of Consular Affairs, 2100
Pennsylvania Avenue, NW., Suite 3000, Washington, DC., telephone number
202-663-2431.
Background
The rule reorganizes, restructures, and updates the passport
regulations in order to make them easier for users to access the
information, to better reflect current practice and changes in
[[Page 4078]]
statutory authority, and to remove outdated provisions.
Need for Correction
The final passport rule published on November 19, 2007 erroneously
labels two sentences in the rule contained in 22 CFR 51.21(b) and (c)
as a ``Note.'' This correction deletes the labels ``Note'' and corrects
the numbering of the two provisions.
Correction
0
The final passport rule published on November 19, 2007 (72 FR 64930) is
corrected as follows:
0
1. On page 64933, 22 CFR part 51.21 is corrected by making the
following correcting amendments:
PART 51--PASSPORTS
Section 51.21(b) and (c) is revised to read as follows:
Sec. 51.21 Execution of passport application.
* * * * *
(b) Application by mail--persons in the United States. (1) A person
in the United States who previously has been issued a passport valid
for 10 years in his or her own name may apply for a new passport by
filling out, signing and mailing an application on the form prescribed
by the Department if:
(i) The most recently issued previous passport was issued when the
applicant was 16 years of age or older;
(ii) The application is made not more than 15 years following the
issue date of the previous passport, except as provided in paragraph
(e) of this section; and
(iii) The most recently issued previous passport of the same type
is submitted with the new application.
(2) The applicant must also provide photographs as prescribed by
the Department and pay the applicable fees prescribed in the Schedule
of Fees for Consular Services (22 CFR 22.1).
(c) Application by mail--persons abroad. (1) A person in a foreign
country where the Department has authorized a post to receive passport
applications by mail who previously has been issued a passport valid
for 10 years in his or her own name may apply for a new passport in
that country by filling out, signing and mailing an application on the
form prescribed by the Department if:
(i) The most recently issued previous passport was issued when the
applicant was 16 years of age or older;
(ii) The application is made not more than 15 years following the
issue date of the previous passport, except as provided in paragraph
(e) of this section; and
(iii) The most recently issued previous passport of the same type
is submitted with the new application.
(2) The applicant must also provide photographs as prescribed by
the Department and pay the applicable fees prescribed in the Schedule
of Fees for Consular Services (22 CFR 22.1).
* * * * *
Dated: January 18, 2008.
Ann Barrett,
Deputy Assistant Secretary, Bureau of Consular Affairs, Department of
State.
[FR Doc. E8-1205 Filed 1-23-08; 8:45 am]
BILLING CODE 4710-06-P
