VA Dental Insurance Program-Federalism, 15541-15542 [2014-05911]
Download as PDF
Federal Register / Vol. 79, No. 54 / Thursday, March 20, 2014 / Rules and Regulations
The NADAs listed were identified as
being affected by guidance for industry
(GFI) #213, ‘‘New Animal Drugs and
New Animal Drug Combination
Products Administered in or on
Medicated Feed or Drinking Water of
Food-Producing Animals:
Recommendations for Drug Sponsors for
Voluntarily Aligning Product Use
Conditions with GFI #209’’, December
2013.
Therefore, under authority delegated
to the Commissioner of Food and Drugs
and redelegated to the Center for
Veterinary Medicine, and in accordance
with § 514.116 Notice of withdrawal of
approval of application (21 CFR
514.116), notice is given that approval
of NADA 039–077, ANADA 200–140,
and ANADA 200–167, and all
supplements and amendments thereto,
is hereby withdrawn, effective March
31, 2014.
Elsewhere in this issue of the Federal
Register, FDA is amending the animal
drug regulations to reflect the voluntary
withdrawal of approval of these
applications.
Dated: March 12, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2014–05883 Filed 3–19–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
DATES:
ehiers on DSK2VPTVN1PROD with RULES
This rule is effective March 31,
2014.
[Docket No. FDA–2014–N–0002]
FOR FURTHER INFORMATION CONTACT:
Zoetis Inc., Withdrawal of Approval of
New Animal Drug Applications;
Chlortetracycline; Sulfathiazole;
Penicillin
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect the
withdrawal of approval of a new animal
SUMMARY:
David Alterman, Center for Veterinary
Medicine (HFV–212), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–453–6843.
Zoetis
Inc., 333 Portage St., Kalamazoo, MI
49007 has requested that FDA withdraw
approval of the following NADA and
two ANADAs because the products are
no longer manufactured or marketed:
SUPPLEMENTARY INFORMATION:
Proprietary name
CSP 250 (chlortetracycline, sulfathiazole, and penicillin) Type A medicated article.
AUREOZOL (chlortetracycline, sulfathiazole, and penicillin) Type A medicated article.
AUREOZOL 500 Granular (chlortetracycline, sulfathiazole, and penicillin) Type A medicated article.
The NADAs listed were identified as
being affected by guidance for industry
(GFI) #213, ‘‘New Animal Drugs and
New Animal Drug Combination
Products Administered in or on
Medicated Feed or Drinking Water of
Food-Producing Animals:
Recommendations for Drug Sponsors for
Voluntarily Aligning Product Use
Conditions with GFI #209’’, December
2013.
Elsewhere in this issue of the Federal
Register, FDA gave notice that approval
of NADA 039–077, ANADA 200–140,
and ANADA 200–167, and all
supplements and amendments thereto,
is withdrawn, effective March 31, 2014.
As provided in the regulatory text of
this document, the animal drug
regulations are amended to reflect these
voluntary withdrawals of approval.
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.
of Food and Drugs and redelegated to
the Center for Veterinary Medicine, 21
CFR part 558 is amended as follows:
DEPARTMENT OF VETERANS
AFFAIRS
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
RIN 2900–AO85
1. The authority citation for 21 CFR
part 558 continues to read as follows:
■
Authority: 21 U.S.C. 360b, 371.
§ 558.4
2. In § 558.4(d), in the ‘‘Category II’’
table, remove the entry for
‘‘Sulfathiazole’’ and its respective
following entries.
■
§ 558.155
■
[Removed]
3. Remove § 558.155.
Dated: March 12, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2014–05882 Filed 3–19–14; 8:45 am]
BILLING CODE 4160–01–P
14:19 Mar 19, 2014
Jkt 232001
PO 00000
Frm 00003
Fmt 4700
Sfmt 4700
38 CFR Part 17
VA Dental Insurance Program—
Federalism
Department of Veterans Affairs.
Direct final rule; confirmation of
effective date.
AGENCY:
ACTION:
[Amended]
List of Subjects in 21 CFR Part 558
Animal drugs, Animal feeds.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
VerDate Mar<15>2010
drug application (NADA) and two
abbreviated new animal drug
applications (ANADAs) for three-way,
fixed-ratio combination drug Type A
medicated articles containing
chlortetracycline, sulfathiazole, and
penicillin. This action is being taken at
the sponsor’s request because these
products are no longer manufactured or
marketed.
21 CFR Part 558
NADA/ANADA
039–077 ..............................
200–140 ..............................
200–167 ..............................
15541
The Department of Veterans
Affairs (VA) published a direct final rule
in the Federal Register on October 22,
2013, amending its regulations related
to the VA Dental Insurance Program
(VADIP), a pilot program to offer
premium-based dental insurance to
enrolled veterans and certain survivors
and dependents of veterans.
Specifically, this rule adds language to
clarify the limited preemptive effect of
certain criteria in the VADIP
regulations. VA received no comments
concerning this rule or its companion
substantially identical proposed rule
published in the Federal Register on
October 23, 2013. This document
confirms that the direct final rule
became effective on December 23, 2013.
In a companion document in this issue
SUMMARY:
E:\FR\FM\20MRR1.SGM
20MRR1
15542
Federal Register / Vol. 79, No. 54 / Thursday, March 20, 2014 / Rules and Regulations
of the Federal Register, we are
withdrawing as unnecessary the
proposed rule.
DATES: Effective Date: The effective date
of December 23, 2013, for the final rule
published October 22, 2013, 78 FR
62441, is confirmed.
FOR FURTHER INFORMATION CONTACT:
Kristin J. Cunningham, Director,
Business Policy, Chief Business Office
(10NB), Veterans Health
Administration, Department of Veterans
Affairs, 810 Vermont Ave. NW.,
Washington, DC 20420; (202) 461–1599.
(This is not a toll-free number.)
SUPPLEMENTARY INFORMATION: In a direct
final rule published in the Federal
Register on October 22, 2013, 78 FR
62441, VA amended 38 CFR 17.169 to
add language to clarify the limited
preemptive effect of certain criteria in
the VA Dental Insurance Program
(VADIP), a pilot program to offer
premium-based dental insurance to
enrolled veterans and certain survivors
and dependents of veterans. VA
published a companion substantially
identical proposed rule at 78 FR 63143
on October 23, 2013, to serve as a
proposal for the provisions in the direct
final rule in case adverse comments
were received. The direct final rule and
proposed rule each provided a 30-day
comment period that ended on
November 21 and November 22, 2013,
respectively. No comments were
received.
Under the direct final rule procedures
that were described in 78 FR 62441 and
78 FR 63143, the direct final rule
became effective on December 23, 2013,
because no comments were received
within the comment periods. In a
companion document in this issue of
the Federal Register, VA is withdrawing
the proposed rulemaking, RIN 2900–
AO86, published at 78 FR 63143, as
unnecessary.
ehiers on DSK2VPTVN1PROD with RULES
Signing Authority
The Secretary of Veterans Affairs, or
designee, approved this document and
authorized the undersigned to sign and
submit the document to the Office of the
Federal Register for publication
electronically as an official document of
the Department of Veterans Affairs. Jose
D. Riojas, Chief of Staff, Department of
Veterans Affairs, approved this
document on March 11, 2014, for
publication.
Dated: March 13, 2014.
William F. Russo,
Deputy Director, Office of Regulation Policy
and Management, Office of the General
Counsel, Department of Veterans Affairs.
[FR Doc. 2014–05911 Filed 3–19–14; 8:45 am]
BILLING CODE 8320–01–P
VerDate Mar<15>2010
14:19 Mar 19, 2014
Jkt 232001
DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
44 CFR Part 64
[Docket ID FEMA–2013–0002; Internal
Agency Docket No. FEMA–8325]
Suspension of Community Eligibility
Federal Emergency
Management Agency, DHS.
ACTION: Final rule.
AGENCY:
This rule identifies
communities where the sale of flood
insurance has been authorized under
the National Flood Insurance Program
(NFIP) that are scheduled for
suspension on the effective dates listed
within this rule because of
noncompliance with the floodplain
management requirements of the
program. If the Federal Emergency
Management Agency (FEMA) receives
documentation that the community has
adopted the required floodplain
management measures prior to the
effective suspension date given in this
rule, the suspension will not occur and
a notice of this will be provided by
publication in the Federal Register on a
subsequent date. Also, information
identifying the current participation
status of a community can be obtained
from FEMA’s Community Status Book
(CSB). The CSB is available at https://
www.fema.gov/fema/csb.shtm.
DATES: The effective date of each
community’s scheduled suspension is
the third date (‘‘Susp.’’) listed in the
third column of the following tables.
FOR FURTHER INFORMATION CONTACT: If
you want to determine whether a
particular community was suspended
on the suspension date or for further
information, contact David Stearrett,
Federal Insurance and Mitigation
Administration, Federal Emergency
Management Agency, 500 C Street SW.,
Washington, DC 20472, (202) 646–2953.
SUPPLEMENTARY INFORMATION: The NFIP
enables property owners to purchase
Federal flood insurance that is not
otherwise generally available from
private insurers. In return, communities
agree to adopt and administer local
floodplain management measures aimed
at protecting lives and new construction
from future flooding. Section 1315 of
the National Flood Insurance Act of
1968, as amended, 42 U.S.C. 4022,
prohibits the sale of NFIP flood
insurance unless an appropriate public
body adopts adequate floodplain
management measures with effective
SUMMARY:
PO 00000
Frm 00004
Fmt 4700
Sfmt 4700
enforcement measures. The
communities listed in this document no
longer meet that statutory requirement
for compliance with program
regulations, 44 CFR Part 59.
Accordingly, the communities will be
suspended on the effective date in the
third column. As of that date, flood
insurance will no longer be available in
the community. We recognize that some
of these communities may adopt and
submit the required documentation of
legally enforceable floodplain
management measures after this rule is
published but prior to the actual
suspension date. These communities
will not be suspended and will continue
to be eligible for the sale of NFIP flood
insurance. A notice withdrawing the
suspension of such communities will be
published in the Federal Register.
In addition, FEMA publishes a Flood
Insurance Rate Map (FIRM) that
identifies the Special Flood Hazard
Areas (SFHAs) in these communities.
The date of the FIRM, if one has been
published, is indicated in the fourth
column of the table. No direct Federal
financial assistance (except assistance
pursuant to the Robert T. Stafford
Disaster Relief and Emergency
Assistance Act not in connection with a
flood) may be provided for construction
or acquisition of buildings in identified
SFHAs for communities not
participating in the NFIP and identified
for more than a year on FEMA’s initial
FIRM for the community as having
flood-prone areas (section 202(a) of the
Flood Disaster Protection Act of 1973,
42 U.S.C. 4106(a), as amended). This
prohibition against certain types of
Federal assistance becomes effective for
the communities listed on the date
shown in the last column. The
Administrator finds that notice and
public comment procedures under 5
U.S.C. 553(b), are impracticable and
unnecessary because communities listed
in this final rule have been adequately
notified.
Each community receives 6-month,
90-day, and 30-day notification letters
addressed to the Chief Executive Officer
stating that the community will be
suspended unless the required
floodplain management measures are
met prior to the effective suspension
date. Since these notifications were
made, this final rule may take effect
within less than 30 days.
National Environmental Policy Act.
This rule is categorically excluded from
the requirements of 44 CFR Part 10,
Environmental Considerations. No
environmental impact assessment has
been prepared.
Regulatory Flexibility Act. The
Administrator has determined that this
E:\FR\FM\20MRR1.SGM
20MRR1
Agencies
[Federal Register Volume 79, Number 54 (Thursday, March 20, 2014)]
[Rules and Regulations]
[Pages 15541-15542]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-05911]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF VETERANS AFFAIRS
38 CFR Part 17
RIN 2900-AO85
VA Dental Insurance Program--Federalism
AGENCY: Department of Veterans Affairs.
ACTION: Direct final rule; confirmation of effective date.
-----------------------------------------------------------------------
SUMMARY: The Department of Veterans Affairs (VA) published a direct
final rule in the Federal Register on October 22, 2013, amending its
regulations related to the VA Dental Insurance Program (VADIP), a pilot
program to offer premium-based dental insurance to enrolled veterans
and certain survivors and dependents of veterans. Specifically, this
rule adds language to clarify the limited preemptive effect of certain
criteria in the VADIP regulations. VA received no comments concerning
this rule or its companion substantially identical proposed rule
published in the Federal Register on October 23, 2013. This document
confirms that the direct final rule became effective on December 23,
2013. In a companion document in this issue
[[Page 15542]]
of the Federal Register, we are withdrawing as unnecessary the proposed
rule.
DATES: Effective Date: The effective date of December 23, 2013, for the
final rule published October 22, 2013, 78 FR 62441, is confirmed.
FOR FURTHER INFORMATION CONTACT: Kristin J. Cunningham, Director,
Business Policy, Chief Business Office (10NB), Veterans Health
Administration, Department of Veterans Affairs, 810 Vermont Ave. NW.,
Washington, DC 20420; (202) 461-1599. (This is not a toll-free number.)
SUPPLEMENTARY INFORMATION: In a direct final rule published in the
Federal Register on October 22, 2013, 78 FR 62441, VA amended 38 CFR
17.169 to add language to clarify the limited preemptive effect of
certain criteria in the VA Dental Insurance Program (VADIP), a pilot
program to offer premium-based dental insurance to enrolled veterans
and certain survivors and dependents of veterans. VA published a
companion substantially identical proposed rule at 78 FR 63143 on
October 23, 2013, to serve as a proposal for the provisions in the
direct final rule in case adverse comments were received. The direct
final rule and proposed rule each provided a 30-day comment period that
ended on November 21 and November 22, 2013, respectively. No comments
were received.
Under the direct final rule procedures that were described in 78 FR
62441 and 78 FR 63143, the direct final rule became effective on
December 23, 2013, because no comments were received within the comment
periods. In a companion document in this issue of the Federal Register,
VA is withdrawing the proposed rulemaking, RIN 2900-AO86, published at
78 FR 63143, as unnecessary.
Signing Authority
The Secretary of Veterans Affairs, or designee, approved this
document and authorized the undersigned to sign and submit the document
to the Office of the Federal Register for publication electronically as
an official document of the Department of Veterans Affairs. Jose D.
Riojas, Chief of Staff, Department of Veterans Affairs, approved this
document on March 11, 2014, for publication.
Dated: March 13, 2014.
William F. Russo,
Deputy Director, Office of Regulation Policy and Management, Office of
the General Counsel, Department of Veterans Affairs.
[FR Doc. 2014-05911 Filed 3-19-14; 8:45 am]
BILLING CODE 8320-01-P