Management Health
Resume:
Federal Register / Vol. **, No. *** / Tuesday, July 17, 2012 / Notices
cannot begin until the fee is submitted.
OMB, Attn: FDA Desk Officer, FAX: Form FDA 3728, Animal Generic Drug
202-***-****, or emailed to User Fee Act Cover Sheet 21 U.S.C. Form FDA 3728 is the Animal Generic
***************@***.***.***. All 379j 21 (OMB Control Number 0910 Drug User Fee Act (AGDUFA) Cover
comments should be identified with the 0632) Extension Sheet, which is designed to provide the
OMB control number 0910 0632. Also minimum necessary information to
Section 741 of the Federal Food, Drug,
include the FDA docket number found determine whether a fee is required for
and Cosmetic Act (FD&C Act) (21 U.S.C.
in brackets in the heading of this review of an application, to determine
379j 21) establishes three different
document. the amount of the fee required, and to
kinds of user fees: (1) Fees for certain
FOR FURTHER INFORMATION CONTACT: account for and track user fees.
types of abbreviated applications for
Denver Presley II, Office of Information generic new animal drugs, (2) annual In the Federal Register of October 5,
Management, Food and Drug fees for certain generic new animal drug 2011 (76 FR 61709), FDA published a
Administration, 1350 Piccard Dr., PI50 products, and (3) annual fees for certain 60-day notice requesting public
400B, Rockville, MD 20850, 301 796 sponsors of abbreviated applications for comment on the proposed collection of
3793. generic new animal drugs and/or information. No comments were
investigational submissions for generic
SUPPLEMENTARY INFORMATION: In received.
new animal drugs (21 U.S.C. 379j
compliance with 44 U.S.C. 3507, FDA
FDA estimates the burden of this
21(a)). Because the submission of user
has submitted the following proposed
collection of information as follows:
fees concurrent with applications is
collection of information to OMB for
required, the review of an application
review and clearance.
TABLE 1 ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
Number of Total annual Average burden
FDA Form Number responses per Total hours
respondents responses per response
respondent
3728 20 2 40 .08 (5 min.) 3.2
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
please contact Richard Forshee (see
hypothetical influenza vaccine, and to
Respondents to this collection of
seek from a range of experts, feedback
information are generic animal drug Contact Person) at least 7 days in
on the current version of the model used
applicants. Based on FDA s database advance.
by the Center for Biologics Evaluation
system, there are an estimated 20
The
SUPPLEMENTARY INFORMATION:
and Research (CBER) and suggestions
sponsors of new animal drugs
workshop will provide an opportunity
for further development.
potentially subject to AGDUFA.
for discussions on the application of
The public workshop will include
Dated: July 12, 2012.
open source influenza infectious disease
presentations and panel discussions
Leslie Kux, computer simulation models to generate
with experts from academia, regulated
Assistant Commissioner for Policy. quantitative estimates of the benefits
industry, government, and other
[FR Doc. 2012 17369 Filed 7 16 12; 8:45 am] and risks of influenza vaccination.
stakeholders.
Date and Time: The public workshop
BILLING CODE 4160 01 P
The public workshop presentations
will be held on August 23, 2012, from and panel discussions will: (1) Discuss
9 a.m. to 4 p.m. recent developments in open-source,
DEPARTMENT OF HEALTH AND Location: The public workshop will agent-based, publicly available
HUMAN SERVICES be held at the Bethesda North Marriott computer simulation tools to model
Hotel & Conference Center; 5701
influenza and other infectious diseases;
Food and Drug Administration Marinelli Rd., Bethesda, MD 20852;
(2) discuss and seek technical feedback
on the CBER quantitative model of
[Docket No. FDA 2012 N 0001]
Contact Person: Richard Forshee,
influenza vaccine benefit/risk; and (3)
Center for Biologics Evaluation and
Use of Influenza Disease Models To discuss possible applications of
Research (HFM 210), Food and Drug
Quantitatively Evaluate the Benefits quantitative benefit/risk assessment
Administration, 1401 Rockville Pike,
and Risks of Vaccines: A Technical methods to vaccine assessment of
suite 200N, Rockville, MD 20852 1448,
Workshop; Public Workshop quantitative benefit/risk assessment
301-***-****, email:
methods to vaccine assessment.
Food and Drug Administration, *******.*******@***.***.***.
AGENCY:
Registration: Mail, fax, or email your Transcripts: Please be advised that as
HHS.
registration information (including soon as possible after a transcript of the
Notice of public workshop.
ACTION:
name, title, firm name, address, public workshop is available, it will be
telephone, and fax numbers, and email accessible at: http://www.fda.gov/
The Food and Drug Administration
address) to Richard Forshee (see Contact BiologicsBloodVaccines/NewsEvents/
(FDA) is announcing a public workshop
Person) by August 16, 2012. There is no WorkshopsMeetingsConferences/
entitled: Use of Influenza Disease
tkelley on DSK3SPTVN1PROD with NOTICES
registration fee for the public workshop. TranscriptsMinutes/default.htm.
Models to Quantitatively Evaluate the
Early registration is recommended Transcripts of the public workshop may
Benefits and Risks of Vaccines: A
because seating is limited. Registration also be requested in writing from the
Technical Workshop. The purpose of
on the day of the public workshop will Division of Freedom of Information
this public workshop is to provide
be provided on a space-available basis (ELEM 1029), Food and Drug
stakeholders a forum to discuss the
beginning at 8 a.m. If you need special Administration, 12420 Parklawn Dr.,
design of a model to quantitatively
accommodations due to a disability, Rockville, MD 20857.
estimate the benefits and risks of a
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41986 Federal Register / Vol. 77, No. 137 / Tuesday, July 17, 2012 / Notices
Dated: July 11, 2012. boards and medical executive
needs of American Indian/Alaska Native
committees as needed.
(AI/AN) communities and developing,
Leslie Kux,
Second Phase: Planning Based on
managing, and administering program
Assistant Commissioner for Policy.
the community assessment, the high
functions related to PHN.
[FR Doc. 2012 17337 Filed 7 16 12; 8:45 am]
risk population is identified and the
Purpose
BILLING CODE 4160 01 P
planning of the case management
project begins. Develop case
The purpose of this IHS cooperative
management services addressing the
agreement is to improve specific health
DEPARTMENT OF HEALTH AND
priority health issues identified from the
outcomes of an identified high risk
HUMAN SERVICES
community assessment. Plan specific
group of patients through a community
guidelines for the case management
Indian Health Service case management model that utilizes the
services of the high risk group of
PHN as a case manager. Research
Division of Nursing, Public Health patients such as admission criteria,
indicates nursing case management is a
Nursing Community Based Model of caseload size, policies and procedures,
cost effective way to maximize health
PHN Case Management Services and an evaluation plan to include data
outcomes. Case management involves
tracking for outcomes generated.
the client, family, and other members of
Announcement Type: New.
Identify if there is a best practice case
the health care team. Quality of care,
Funding Announcement Number:
management model available to
continuity, and assurance of appropriate
HHS 2012 IHS PHN 0001.
replicate to target the identified high
and timely interventions are also
Catalog of Federal Domestic
risk population. Obtain additional staff
crucial. In addition to reducing the cost
Assistance Number: 93.933.
training needed for the community
of health care, case management has
Key Dates based nurse case management model
proven its worth in terms of improving
such as evidence based practice,
rehabilitation, improving quality of life,
Application Deadline Date: August
motivational interviewing, nurse
increasing client satisfaction and
14, 2012.
competencies and any other training
Review Date: August 20, 2012. compliance by promoting client self-
that would be applicable to the health
Earliest Anticipated Start Date: determination. The PHN model of
issues identified in the case
September 1, 2012. community based case management
management model. Identify or develop
utilizes roles and functions of PHN
I. Funding Opportunity Description patient education materials and
services of assessment, planning,
community education materials for the
Statutory Authority coordinating services, communication
program. Develop plans for project
and monitoring. The goals and
The Indian Health Service (IHS) is sustainability.
outcomes of the PHN case management
accepting competitive cooperative Third Phase: Implementation The
model are early detection, diagnosis,
agreement applications for the Office of case management program includes
treatment and evaluation that will
Clinical and Preventive Services admission criteria of the high risk
improve health outcomes in a cost
(OCPS), Community Based Model of population, caseload size, and
effective manner. This model utilizes all
Public Health Nursing Case appropriate health care standards.
prevention components of primary,
Management Services. This program is Establish patient caseload. Monitor
secondary and tertiary prevention in the
authorized under the Snyder Act, 25 progress and make adjustments as
home with patient and family. The
U.S.C. 13; the Transfer Act, 42 U.S.C. needed. Track patient data outcomes.
community based case management
2011; the Public Health Service Act, as Continue to plan ongoing sustainability
model addresses the PHN scope of
amended, 42 U.S.C. 241; and the Indian of the program after the award period
practice of working with individuals
Health Care Improvement Act, as ends.
and families in a population-based
amended, (IHCIA), 25 U.S.C. 1653(c). Fourth Phase: Patient Satisfaction In
practice to provide primary nursing care
This program is described in the Catalog order to evaluate program services;
services. This project will focus on a initiate a patient satisfaction program,
of Federal Domestic Assistance under
PHN community based case such as one that provides patients with
93.933.
management model. The project will be an opportunity to provide feedback on
Background conducted in a phased approach, using their experiences to assess the
the nursing process assessment,
The IHS OCPS Public Health Nursing satisfaction of the population served.
planning, implementation, and
(PHN) Program serves as the primary Analyze findings so a concentrated
evaluation.
source for national advocacy, policy effort is made to relate the customer
First Phase: Assessment Complete a
development, budget development, and satisfaction results to internal process
generic community assessment (most
allocation for clinical, preventive, and metrics, and examine trends over time
PHN programs have this readily
public health nursing programs for the in order to take action on a timely basis.
available as a part of their annual
IHS Area Offices and Service Units. The Evaluate and revise the case
program plans). Include, if available,
IHS PHN Program is a community management program if needed, review
pertinent data from other local
health nursing program that focuses on policies and procedures, education
community assessments and local
the goals of promoting health and materials and staff competencies semi-
annually. To the extent permitted by
health status data of the community in
quality of life, and preventing disease
law, report back to key stake-holders
the assessment. In addition, obtain
and disability. The PHN program
progress of the project, especially to
input from key stake-holders such as
provides quality, culturally sensitive
tkelley on DSK3SPTVN1PROD with NOTICES
inform clients about changes brought
community members, Tribal leaders,
health promotion and disease
about as a direct result of listening to
healthcare administration and
prevention nursing services through
their needs. Each site will share
community health groups to determine
primary, secondary and tertiary
program material with IHS Headquarters
the health care priorities. Obtain
prevention services to individuals,
PHN program. This information will be
approval for the establishment of the
families, and community groups. It
shared IHS-wide for replication of the
PHN case management program from
provides leadership in articulating the
project across IHS with credit given to
healthcare administration, governing
clinical, preventive, and public health
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Contact this candidate