Withdrawal of Approval of New Animal Drug Applications; Quali-Tech Products, Inc.; Bambermycins; Pyrantel; Tylosin; Virginiamycin, 52535-52536 [2013-20615]
Download as PDF
<![CDATA[
52535
Federal Register / Vol. 78, No. 164 / Friday, August 23, 2013 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of
respondents
Type of respondents
Form No. and name
Medical/Clinical Laboratory Technologist ......
Staff RN .........................................................
57.305: Hemovigilance Incident ....................
57.400: Outpatient Procedure Component—
Annual Facility Survey.
57.401: Outpatient Procedure Component—
Monthly Reporting Plan.
57.402: Outpatient Procedure Component
Event.
57.403: Outpatient Procedure Component—
Monthly Denominators and Summary.
57.500: Outpatient Dialysis Center Practices
Survey.
57.501: Dialysis Monthly Reporting Plan ......
57.502: Dialysis Event ..................................
57.503: Denominator for Outpatient Dialysis
57.504: Prevention Process Measures
Monthly Monitoring for Dialysis.
57.505: Dialysis Patient Influenza Vaccination.
57.506: Dialysis Patient Influenza Vaccination Denominator.
57.600: State Health Department Validation
Record.
Staff RN .........................................................
Staff RN .........................................................
Staff RN .........................................................
Registered Nurse (Infection Preventionist) ....
Staff
Staff
Staff
Staff
RN
RN
RN
RN
.........................................................
.........................................................
.........................................................
.........................................................
Staff RN .........................................................
Staff RN .........................................................
Epidemiologist ................................................
Kimberly S. Lane,
Deputy Director, Office of Scientific Integrity,
Office of the Associate Director for Science,
Office of the Director, Centers for Disease
Control and Prevention.
[FR Doc. 2013–20609 Filed 8–22–13; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
tkelley on DSK3SPTVN1PROD with NOTICES
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP): Initial Review
The meeting announced below
concerns Impact of Japanese
Encephalitis Vaccination in Cambodia,
Funding Opportunity Announcement
(FOA) CK14–001, initial review.
In accordance with Section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the aforementioned meeting:
Time and Date: 1:00 p.m.–3:00 p.m.,
October 17, 2013 (Closed).
Place: Teleconference.
Status: The meeting will be closed to
the public in accordance with
provisions set forth in Section 552b(c)
(4) and (6), Title 5 U.S.C., and the
Determination of the Director,
Management Analysis and Services
Office, CDC, pursuant to Public Law 92–
463.
Matters To Be Discussed: The meeting
will include the initial review,
VerDate Mar<15>2010
18:43 Aug 22, 2013
Jkt 229001
discussion, and evaluation of
applications received in response to
‘‘Impact of Japanese Encephalitis
Vaccination in Cambodia, FOA CK14–
001’’.
Contact Person for More Information:
Gregory Anderson, M.S., M.P.H.,
Scientific Review Officer, CDC, 1600
Clifton Road NE., Mailstop E60, Atlanta,
Georgia 30333, Telephone: (404) 718–
8833.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both the
Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2013–20531 Filed 8–22–13; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0002]
Withdrawal of Approval of New Animal
Drug Applications; Quali-Tech
Products, Inc.; Bambermycins;
Pyrantel; Tylosin; Virginiamycin
AGENCY:
Food and Drug Administration,
HHS.
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
Average burden
per response
(in hrs.)
500
5,000
12
1
10/60
5/60
5,000
12
15/60
5,000
25
40/60
5,000
12
40/60
6,000
1
6,000
6,000
6,000
600
12
60
12
12
5/60
13/60
6/60
30/60
250
75
10/60
250
5
10/60
152
50
15/60
ACTION:
1.75
Notice.
The Food and Drug
Administration (FDA) is withdrawing
approval of four new animal drug
applications (NADAs) held by QualiTech Products, Inc., at the sponsor’s
request because the products are no
longer manufactured or marketed.
DATES: Withdrawal of approval is
effective September 3, 2013.
FOR FURTHER INFORMATION CONTACT:
David Alterman, Center for Veterinary
Medicine (HFV–212), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855; 240–453–6843;
email: david.alterman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: QualiTech Products, Inc., has requested that
FDA withdraw approval of the
following four NADAs because the
products, used to manufacture Type C
medicated feeds, are no longer
manufactured or marketed: NADA 097–
980 for Quali-Tech TYLAN–10 (tylosin
phosphate) Premix, NADA 118–815 for
Q.T. BAN–TECH (pyrantel tartrate),
NADA 132–705 for FLAVOMYCIN
(bambermycins), and NADA 133–335
for STAFAC (virginiamycin) Swine Pak
10.
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 NADAs 097–980, 118–815, 132–705,
and 133–335, and all supplements and
SUMMARY:
E:\FR\FM\23AUN1.SGM
23AUN1
52536
Federal Register / Vol. 78, No. 164 / Friday, August 23, 2013 / Notices
amendments thereto, is hereby
withdrawn.
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: August 20, 2013.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2013–20615 Filed 8–22–13; 8:45 am]
BILLING CODE 4160–01–P
with § 514.116 Notice of withdrawal of
approval of application (21 CFR
514.116), notice is given that approval
of NADA 098–371, NADA 098–374, and
NADA 123–116, and all supplements
and amendments thereto, is hereby
withdrawn.
Elsewhere in this issue of the Federal
Register, FDA is amending the animal
drug regulations to reflect the
withdrawal of approval of these
applications.
Dated: August 19, 2013.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2013–20541 Filed 8–22–13; 8:45 am]
BILLING CODE 4160–01–P
Food and Drug Administration
[Docket No. FDA–2013–N–0835]
Withdrawal of Approval of New Animal
Drug Applications;
Diethylcarbamazine; Nicarbazin;
Penicillin; Roxarsone
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is withdrawing
approval of three new animal drug
applications (NADAs) at the sponsors’
request because the products are no
longer manufactured or marketed.
DATES: Withdrawal of approval is
effective September 3, 2013.
FOR FURTHER INFORMATION CONTACT:
David Alterman, Center for Veterinary
Medicine (HFV–212), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–453–6843,
email: david.alterman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Phibro
Animal Health Corp., 65 Challenger Rd.,
3d Floor, Ridgefield Park, NJ 07660 has
requested that FDA withdraw approval
of NADA 098–371 for use of nicarbazin,
penicillin, and roxarsone in 3-way,
combination drug Type C medicated
feeds for broiler chickens and NADA
098–374 for use of nicarbazin and
penicillin in 2-way, combination drug
Type C medicated feeds for broiler
chickens because the products are no
longer manufactured or marketed.
R. P. Scherer North America, P.O. Box
5600, Clearwater, FL 33518 has
requested that FDA withdraw approval
of NADA 123–116 for
Diethylcarbamazine Citrate Capsules
used in dogs for the prevention of
heartworm disease because the product
is no longer manufactured or marketed.
Therefore, under authority delegated
to the Commissioner of Food and Drugs
and redelegated to the Center for
Veterinary Medicine, and in accordance
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
17:28 Aug 22, 2013
Jkt 229001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects (Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995), the
Health Resources and Services
Administration (HRSA) announces
plans to submit an Information
Collection Request (ICR), described
below, to the Office of Management and
Budget (OMB). Prior to submitting the
ICR to OMB, HRSA seeks comments
from the public regarding the burden
estimate, below, or any other aspect of
the ICR.
DATES: Comments on this Information
Collection Request must be received
within 60 days of this notice.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 10–29, Parklawn
Building, 5600 Fishers Lane, Rockville,
MD 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call the HRSA Information Collection
Clearance Officer at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
SUMMARY:
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
Information Collection Request Title:
Combating Autism Act Initiative
Evaluation (OMB No. 0915–0335
[Revision]
Abstract: In response to the growing
need for research and resources devoted
to autism spectrum disorders (ASD) and
other developmental disabilities (DD),
the U.S. Congress passed the Combating
Autism Act (CAA) in 2006. The Act
included funding for the U.S.
Department of Health and Human
Services (HHS), Health Resources and
Services Administration (HRSA) to
increase awareness, reduce barriers to
screening and diagnosis, promote
evidence-based interventions, train
health care professionals to screen for,
diagnose or rule out, and provide
evidence-based interventions for ASD
and other DD. In 2011, the Combating
Autism Reauthorization Act (CARA)
was signed into law, reauthorizing
funding for the CAA’s programs for an
additional 3 years at the existing
funding levels. Through the CARA,
HRSA is tasked with increasing
awareness of ASD and other DD,
reducing barriers to screening and
diagnosis, promoting evidence-based
interventions, and training health care
professionals in the use of valid and
reliable screening and diagnostic tools.
Need and Proposed Use of the
Information: HRSA’s activities under
the CARA legislation are delegated to
the Maternal and Child Health Bureau
(MCHB), which is implementing the
Combating Autism Act Initiative (CAAI)
in response to the legislative mandate.
The purpose of this evaluation is to
design and implement an evaluation to
assess the effectiveness of MCHB’s
activities in meeting the goals and
objectives of the CAAI, and to provide
sufficient data to inform MCHB and the
Congress as to the utility of the grant
programs funded under the Initiative.
The evaluation will focus on indicators
related to: (1) Increasing awareness of
ASD and other DD among health care
providers, other MCH professionals, and
the general public; (2) reducing barriers
to screening and diagnosis; (3)
supporting research on evidence-based
interventions; (4) promoting the
development of evidence-based
guidelines and tested/validated
intervention tools; (5) training
professionals; and (6) building capacity
for systems of services in states.
Likely Respondents: Grantees funded
by HRSA under the CAAI will be the
respondents for this data collection
activity. The programs to be evaluated
are listed below.
E:\FR\FM\23AUN1.SGM
23AUN1
]]>Agencies
[Federal Register Volume 78, Number 164 (Friday, August 23, 2013)]
[Notices]
[Pages 52535-52536]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-20615]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0002]
Withdrawal of Approval of New Animal Drug Applications; Quali-
Tech Products, Inc.; Bambermycins; Pyrantel; Tylosin; Virginiamycin
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of four new animal drug applications (NADAs) held by Quali-Tech
Products, Inc., at the sponsor's request because the products are no
longer manufactured or marketed.
DATES: Withdrawal of approval is effective September 3, 2013.
FOR FURTHER INFORMATION CONTACT: David Alterman, Center for Veterinary
Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855; 240-453-6843; email: david.alterman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Quali-Tech Products, Inc., has requested
that FDA withdraw approval of the following four NADAs because the
products, used to manufacture Type C medicated feeds, are no longer
manufactured or marketed: NADA 097-980 for Quali-Tech TYLAN-10 (tylosin
phosphate) Premix, NADA 118-815 for Q.T. BAN-TECH (pyrantel tartrate),
NADA 132-705 for FLAVOMYCIN (bambermycins), and NADA 133-335 for STAFAC
(virginiamycin) Swine Pak 10.
Therefore, under authority delegated to the Commissioner of Food
and Drugs and redelegated to the Center for Veterinary Medicine, and in
accordance with Sec. 514.116 Notice of withdrawal of approval of
application (21 CFR 514.116), notice is given that approval of NADAs
097-980, 118-815, 132-705, and 133-335, and all supplements and
[[Page 52536]]
amendments thereto, is hereby withdrawn.
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: August 20, 2013.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2013-20615 Filed 8-22-13; 8:45 am]
BILLING CODE 4160-01-P
