Agency Information Collection Activities: Proposed Collection: Public Comment Request, 52536-52537 [2013-20544]
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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withdrawn.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withdrawn.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:
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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
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52537
Federal Register / Vol. 78, No. 164 / Friday, August 23, 2013 / Notices
1. Training Programs
• Leadership Education in
Neurodevelopmental Disabilities
(LEND) training programs with fortythree grantees;
• Developmental Behavioral
Pediatrics (DBP) training programs with
ten grantees; and
• A National Combating Autism
Interdisciplinary Training Resource
Center grantee.
2. Research Networks Program
• Two Autism Intervention Research
Networks that focus on intervention
research, guideline development, and
information dissemination; and
• 20 R40 Maternal and Child Health
(MCH) Autism Intervention Research
Program grantees that support research
on evidence-based practices for
interventions to improve the health and
well-being of children and adolescents
with ASD and other DD.
3. State Implementation Program Grants
for Improving Services for Children and
Youth With Autism Spectrum Disorder
(ASD) and Other Developmental
Disabilities (DD)
• 18 grantees will implement state
autism plans and develop models for
improving the system of care for
children and youth with ASD and other
DD;
• 4 grantees will design state plans
for improving the system for children
and youth with ASD and other DDs; and
• A State Public Health Coordinating
Resource Center grantee.
The data gathered through this
evaluation will be used to:
1. Evaluate the grantees’ performance
in achieving the objectives of the CAAI
during the three year grant period;
2. Assess the short- and intermediateterm impacts of the grant programs on
children and families affected by ASD
and other DD; and
3. Measure the CAAI outputs and
outcomes for the report to Congress.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information, to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below. The
Principal Investigator or Project Director
from each grant program will be
interviewed. The questionnaires for the
Research Programs and the State
Implementation grant programs will be
completed by each Principal
Investigator/Project Director.
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Grant program/form name
LEND Interview Protocol ......................................................
DBP Interview Protocol ........................................................
State Implementation Program Interview Protocol ..............
State Implementation Program Questionnaire ....................
Research Program Interview Protocol (Networks only) ......
Research Program Questionnaire .......................................
Resource Centers Interview Protocol ..................................
43
10
22
22
2
20
2
Total ..............................................................................
Total
responses
121
HRSA specifically requests comments
on (1) The necessity and utility of the
proposed information collection for the
proper performance of the agency’s
functions, (2) the accuracy of the
estimated burden, (3) ways to enhance
the quality, utility, and clarity of the
information to be collected, and (4) the
use of automated collection techniques
or other forms of information
technology to minimize the information
collection burden.
tkelley on DSK3SPTVN1PROD with NOTICES
Number of
responses per
respondent
Dated: August 16, 2013.
Bahar Niakan,
Director, Division of Policy and Information
Coordination.
[FR Doc. 2013–20544 Filed 8–22–13; 8:45 am]
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121
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Council on Graduate Medical
Education; Notice of Meeting
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), notice is hereby given
of the following meeting:
Name: Council on Graduate Medical
Education (COGME).
Date and Time: September 9, 2013
(8:30 a.m.–5:00 p.m.), September 10,
2013 (8:30 a.m.–5:00 p.m.).
Place: Combined In-Person and
Webinar Format, Health Resources and
Services Administration, U.S.
Department of Health and Human
Services, 5600 Fishers Lane, Rockville,
Maryland 20852, Rooms 18–63.
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
43
10
22
22
2
20
2
Average
burden per
response
(in hours)
1
1
1
.75
1
.75
1
Total burden
hours
43
10
22
16.5
2
15
2
110.50
Status: The meeting will be open to
the public.
Purpose: The COGME provides advice
and recommendations to the Secretary
of the Department of Health and Human
Services and to Congress on a range of
issues including the supply and
distribution of physicians in the United
States, current and future physician
shortages or excesses, issues relating to
foreign medical school graduates, the
nature and financing of medical
education training, and the
development of performance measures
and longitudinal evaluation of medical
education programs.
Agenda: The meeting will begin with
opening comments from the Health
Resources and Services Administration
(HRSA) senior officials and updates on
HRSA-specific programs related to the
physician workforce. The Council is
expected to hear from subject matter
experts on new health care delivery
E:\FR\FM\23AUN1.SGM
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]]>Agencies
[Federal Register Volume 78, Number 164 (Friday, August 23, 2013)]
[Notices]
[Pages 52536-52537]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-20544]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Public Comment Request
AGENCY: Health Resources and Services Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: 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.
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.
[[Page 52537]]
1. Training Programs
Leadership Education in Neurodevelopmental Disabilities
(LEND) training programs with forty-three grantees;
Developmental Behavioral Pediatrics (DBP) training
programs with ten grantees; and
A National Combating Autism Interdisciplinary Training
Resource Center grantee.
2. Research Networks Program
Two Autism Intervention Research Networks that focus on
intervention research, guideline development, and information
dissemination; and
20 R40 Maternal and Child Health (MCH) Autism Intervention
Research Program grantees that support research on evidence-based
practices for interventions to improve the health and well-being of
children and adolescents with ASD and other DD.
3. State Implementation Program Grants for Improving Services for
Children and Youth With Autism Spectrum Disorder (ASD) and Other
Developmental Disabilities (DD)
18 grantees will implement state autism plans and develop
models for improving the system of care for children and youth with ASD
and other DD;
4 grantees will design state plans for improving the
system for children and youth with ASD and other DDs; and
A State Public Health Coordinating Resource Center
grantee.
The data gathered through this evaluation will be used to:
1. Evaluate the grantees' performance in achieving the objectives
of the CAAI during the three year grant period;
2. Assess the short- and intermediate-term impacts of the grant
programs on children and families affected by ASD and other DD; and
3. Measure the CAAI outputs and outcomes for the report to
Congress.
Burden Statement: Burden in this context means the time expended by
persons to generate, maintain, retain, disclose or provide the
information requested. This includes the time needed to review
instructions; to develop, acquire, install and utilize technology and
systems for the purpose of collecting, validating and verifying
information, processing and maintaining information, and disclosing and
providing information; to train personnel and to be able to respond to
a collection of information, to search data sources; to complete and
review the collection of information; and to transmit or otherwise
disclose the information. The total annual burden hours estimated for
this ICR are summarized in the table below. The Principal Investigator
or Project Director from each grant program will be interviewed. The
questionnaires for the Research Programs and the State Implementation
grant programs will be completed by each Principal Investigator/Project
Director.
Total Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total burden per Total burden
Grant program/form name respondents responses per responses response (in hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
LEND Interview Protocol........... 43 1 43 1 43
DBP Interview Protocol............ 10 1 10 1 10
State Implementation Program 22 1 22 1 22
Interview Protocol...............
State Implementation Program 22 1 22 .75 16.5
Questionnaire....................
Research Program Interview 2 1 2 1 2
Protocol (Networks only).........
Research Program Questionnaire.... 20 1 20 .75 15
Resource Centers Interview 2 1 2 1 2
Protocol.........................
-----------------------------------------------------------------------------
Total......................... 121 121 110.50
----------------------------------------------------------------------------------------------------------------
HRSA specifically requests comments on (1) The necessity and
utility of the proposed information collection for the proper
performance of the agency's functions, (2) the accuracy of the
estimated burden, (3) ways to enhance the quality, utility, and clarity
of the information to be collected, and (4) the use of automated
collection techniques or other forms of information technology to
minimize the information collection burden.
Dated: August 16, 2013.
Bahar Niakan,
Director, Division of Policy and Information Coordination.
[FR Doc. 2013-20544 Filed 8-22-13; 8:45 am]
BILLING CODE 4165-15-P
