New Animal Drugs; Change of Sponsor's Name, 23066-23067 [E8-9328]
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23066
Federal Register / Vol. 73, No. 83 / Tuesday, April 29, 2008 / Rules and Regulations
FETRA, be promulgated and
administered without regard to the
Paperwork Reduction Act.
Federal Register on June 24, 1983 (48
FR 29115).
Executive Order 12612
This rule does not have Federalism
implications that warrant the
preparation of a Federalism Assessment.
This rule will not have a substantial
direct effect on States or their political
subdivisions or on the distribution of
power and responsibilities among the
various levels of government.
E-Government Act Compliance
Executive Order 12988
List of Subjects in 7 CFR Part 1463
This final rule has been reviewed
under Executive Order 12988. This final
rule is not retroactive and it does not
preempt State or local laws, regulations,
or policies unless they present an
irreconcilable conflict with this rule.
Before any judicial action may be
brought regarding the provisions of this
rule the administrative appeal
provisions of 7 CFR parts 11 and 780
must be exhausted.
Agriculture, Agricultural
commodities, Acreage allotments,
Marketing quotas, Price support
programs, Tobacco, Tobacco Transition
Program.
Federal Assistance Program
PART 1463—2005–2014 TOBACCO
TRANSITION PROGRAM
The title and number of the Federal
assistance program as found in the
Catalog of Federal Domestic Assistance,
to which this rule applies, are:
Commodity Loans and Purchases—
10.051.
This rule contains no Federal
mandates under the regulatory
provisions of Title II of the Unfunded
Mandates Reform Act (UMRA) for State,
local, and tribal government or the
private sector. In addition, CCC was not
required to publish a notice of proposed
rulemaking for this rule. Therefore, this
rule is not subject to the requirements
of sections 202 and 205 of UMRA.
Small Business Regulatory Enforcement
Fairness Act of 1996 (SBREFA)
Section 642(c) of FETRA requires that
the Secretary use the authority in
section 808 of the Small Business
Regulatory Enforcement Fairness Act of
1996 (Pub. L. 104–121) (SBREFA),
which allows an agency to forgo
SBREFA’s usual 60-day Congressional
Review delay of the effective date of a
major regulation if the agency finds that
there is a good cause to do so.
Accordingly, this rule is effective on the
date of publication in the Federal
Register.
jlentini on PROD1PC65 with RULES
Paperwork Reduction Act
These regulations are exempt from the
requirements of the Paperwork
Reduction Act (44 U.S.C. Chapter 35), as
specified in section 642(b) of FETRA,
which provides that these regulations,
which are necessary to implement
16:32 Apr 28, 2008
Jkt 214001
Signed at Washington, DC, April 23, 2008.
Teresa C. Lasseter,
Executive Vice President, Commodity Credit
Corporation.
[FR Doc. E8–9295 Filed 4–28–08; 8:45 am]
BILLING CODE 3410–06–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 510
For the reasons provided above,
amend part 1463 of title 7 of the Code
of Federal Regulation as follows:
New Animal Drugs; Change of
Sponsor’s Name
Chapter XIV—Commodity Credit
Corporation, Department of Agriculture
HHS.
I
1. The authority citation for part 1463
continues to read as follows:
I
Authority: 7 U.S.C. 714b and 714c; and
Title VI of Pub. L. 108–357.
2. Amend § 1463.3 by revising the
definition of CCC’s point of contact to
read as follows:
I
Unfunded Mandates
VerDate Aug<31>2005
CCC is committed to complying with
the E-Government Act, to promote the
use of the Internet and other
information technologies to provide
increased opportunities for citizen
access to Government information and
services, and for other purposes.
the provisions of § 1463.6, as
determined by the Deputy
Administrator, Farm Service Agency.
*
*
*
*
*
§ 1463.3
Definitions.
*
*
*
*
*
CCC’s point of contact means, for
items physically sent to CCC, ‘‘Fibers,
Peanuts, and Tobacco Analysis Group,
Economic and Policy Analysis Staff,
Farm Service Agency, United States
Department of Agriculture (USDA),
STOP 0515, Room 3720–S, 1400
Independence Avenue, SW.,
Washington, DC 20250–0515’’ unless
otherwise specified by CCC through
actual notice.
*
*
*
*
*
3. Amend § 1463.8 by redesignating
paragraphs (b)(8) and (b)(9) as
paragraphs (b)(9) and (b)(10),
respectively, and adding a new
paragraph (b)(8) to read as follows:
I
§ 1463.8
Notification of assessments.
*
*
*
*
*
(b) * * *
(8) Beginning with the 2nd quarter of
2008, or as soon as practicable
thereafter, the applied market share for
that quarter of each other manufacturer
and importer, for the applicable class of
tobacco product of those manufacturers
and importers that have provided such
information to CCC in accordance with
PO 00000
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AGENCY:
ACTION:
Food and Drug Administration,
Final rule.
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect a
change of sponsor’s name from
Halocarbon Laboratories, Division of
Halocarbon Products Corp., to
Halocarbon Products Corp.
DATES: This rule is effective April 29,
2008.
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:
Halocarbon Laboratories, Division of
Halocarbon Products Corp., 887
Kinderkamack Rd., P.O. Box 661, River
Ridge, NJ 07661, has informed FDA that
it has changed its name to Halocarbon
Products Corp. Accordingly, the agency
is amending the regulations in 21 CFR
510.600(c) to reflect these changes. FDA
is also correcting the sponsor’s address
in the regulation.
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
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29APR1
Federal Register / Vol. 73, No. 83 / Tuesday, April 29, 2008 / Rules and Regulations
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:
I
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
‘‘Halocarbon Laboratories’’; and in the
table in paragraph (c)(2), revise the entry
for ‘‘012164’’ to read as follows:
I
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
*
*
*
(c) * * *
(1) * * *
*
*
Firm name and address
*
*
*
Halocarbon Products Corp.,
887 Kinderkamack Rd.,
River Edge, NJ 07661.
*
*
*
Drug labeler
code
*
012164
*
*
*
(2) * * *
Drug labeler
code
*
012164
*
*
*
Firm name and address
*
*
*
Halocarbon Products Corp.,
887 Kinderkamack Rd.,
River Edge, NJ 07661.
*
*
*
Dated: April 16, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8–9328 Filed 4–28–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF STATE
22 CFR Parts 40 and 41
[Public Notice: 6202]
Visas: Documentation of
Nonimmigrants Under the Immigration
and Nationality Act, as Amended
Department of State.
Final rule.
AGENCY:
jlentini on PROD1PC65 with RULES
ACTION:
SUMMARY: This final rule amends the
Department of State’s regulations related
to application for a nonimmigrant visa,
to offer a completely electronic
application procedure as an alternative
to submission of the Form DS–156.
DATES: This rule is effective on April 29,
2008.
FOR FURTHER INFORMATION CONTACT:
Charles Robertson, Legislation and
VerDate Aug<31>2005
16:32 Apr 28, 2008
Jkt 214001
Regulations Division, Visa Services,
Department of State, Washington, DC
20520–0106, (202) 663–1202, e-mail
(robertsonce3@state.gov).
SUPPLEMENTARY INFORMATION:
Why is the Department promulgating
this rule?
The Government Paperwork
Elimination Act (GPEA 1998) requires
that, when possible, Federal agencies
use electronic forms, electronic filing,
and electronic signatures to conduct
agency business with the public. For
this reason, the Department of State
developed and introduced an electronic
application process for nonimmigrant
visas to eventually replace the current
application process, which depends on
a paper form (Form DS–156, and other
forms when required, such as the Form
DS–157 and Form DS–158). The first
step was to offer an electronic visa
application form (EVAF) as a voluntary
alternative way of obtaining and
preparing the Form DS–156. While the
nonimmigrant visa applicant could
obtain and prepare the Form DS–156
electronically, he or she was required to
sign the Form DS–156 manually. On
October 1, 2006, the EVAF was made
mandatory worldwide wherever
possible. Now, while the Department
will continue to accept the EVAF
(electronic Form DS–156) where
necessary, it proposes to eventually
eliminate the Form DS–156 entirely and
replace it with the Form DS–160, an
electronic form designed to be
completed and signed electronically.
What effect does the electronic
application process have on the
nonimmigrant visa applicant?
The procedure is the same for the
nonimmigrant visa applicant except that
he or she will not be required to print
and sign a form to take to the visa
interview. All information entered into
the Form DS–160 will be available to
the consular officer at the time of the
interview, thus simplifying the process
from the point of the view of the
applicant. The applicant is required to
sign the Form DS–160 electronically.
How does the applicant sign the Form
DS–160 electronically?
The applicant will be required to click
on the box designated ‘‘Sign
Application’’ found within the
certification section of the application.
How does the consular officer identify
the applicant who has submitted an
electronic application (Form DS–160)?
Photos, passports and fingerscans
collected as part of the application
process will identify the applicant.
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23067
How does the applicant certify that the
information in the Form DS–160 is
correct?
By signing the Form DS–160
electronically (i.e., clicking on the ‘‘Sign
Application’’ box), the applicant
certifies that the information provided is
correct.
Is an electronic signature binding on a
nonimmigrant visa applicant?
Yes. The electronic signature (i.e., the
click on the ‘‘Sign Application’’ box)
indicates that the applicant is familiar
with and intends to be bound by the
statements contained in the application
and has answered all questions
truthfully, under penalty of perjury.
Can a third party prepare the Form DS–
160?
While a third party may assist the
applicant in preparing the Form DS–
160, the applicant must electronically
sign the application himself or herself.
The applicant must identify in the
application any third party who has
assisted in the preparation of the Form
DS–160.
Regulatory Findings
Administrative Procedure Act
This regulation involves a foreign
affairs function of the United States and,
therefore, in accordance with 5 U.S.C.
553(a)(1), is not subject to the rule
making procedures set forth at 5 U.S.C.
553.
Regulatory Flexibility Act/Executive
Order 13272: Small Business
Because this final rule is exempt from
notice and comment rulemaking under
5 U.S.C. 553, it is exempt from the
regulatory flexibility analysis
requirements set forth at sections 603
and 604 of the Regulatory Flexibility
Act (5 U.S.C. 603 and 604). Nonetheless,
consistent with section 605(b) of the
Regulatory Flexibility Act (5 U.S.C.
605(b)), the Department certifies that
this rule will not have a significant
economic impact on a substantial
number of small entities. This regulates
individual aliens who seek
consideration for nonimmigrant visas
and does not affect any small entities, as
defined in 5 U.S.C. 601(6).
The Unfunded Mandates Reform Act of
1995
Section 202 of the Unfunded
Mandates Reform Act of 1995 (UFMA),
Public Law 104–4, 109 Stat. 48, 2 U.S.C.
1532, generally requires agencies to
prepare a statement before proposing
any rule that may result in an annual
expenditure of $100 million or more by
E:\FR\FM\29APR1.SGM
29APR1
Agencies
[Federal Register Volume 73, Number 83 (Tuesday, April 29, 2008)]
[Rules and Regulations]
[Pages 23066-23067]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-9328]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect a change of sponsor's name from Halocarbon
Laboratories, Division of Halocarbon Products Corp., to Halocarbon
Products Corp.
DATES: This rule is effective April 29, 2008.
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.
SUPPLEMENTARY INFORMATION: Halocarbon Laboratories, Division of
Halocarbon Products Corp., 887 Kinderkamack Rd., P.O. Box 661, River
Ridge, NJ 07661, has informed FDA that it has changed its name to
Halocarbon Products Corp. Accordingly, the agency is amending the
regulations in 21 CFR 510.600(c) to reflect these changes. FDA is also
correcting the sponsor's address in the regulation.
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
[[Page 23067]]
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 ``Halocarbon Laboratories''; and in the table in paragraph (c)(2),
revise the entry for ``012164'' 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
------------------------------------------------------------------------
* * * * *
Halocarbon Products Corp., 887 Kinderkamack 012164
Rd., River Edge, NJ 07661.
* * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * *
012164 Halocarbon Products Corp., 887 Kinderkamack
Rd., River Edge, NJ 07661.
* * * * *
------------------------------------------------------------------------
Dated: April 16, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-9328 Filed 4-28-08; 8:45 am]
BILLING CODE 4160-01-S