FY 2003 Mainstem/Systemwide proposal 200000700

Section 1. General administrative information
Section 2. Past accomplishments
Section 3. Relationships to other projects
Section 4. Budgets for planning/design phase
Section 5. Budgets for construction/implementation phase
Section 6. Budgets for operations/maintenance phase
Section 7. Budgets for monitoring/evaluation phase
Section 8. Budget summary

Reviews and Recommendations

Additional documents

Title	Type
200000700 Narrative	Narrative
200000700 Powerpoint Presentation	Powerpoint Presentation

Section 1. Administrative

Proposal title	Infrastructure to Complete FDA Registration of Erythromycin
Proposal ID	200000700
Organization	University of Idaho, College of Natural Resources (UI)
Proposal contact person or principal investigator
Name	Christine M. Moffitt
Mailing address	Department of Fish and Widlife Resources Moscow, ID 83844-1136
Phone / email	2088857047 / cmoffitt@uidaho.edu
Manager authorizing this project	Christine M. Moffitt
Review cycle	Mainstem/Systemwide
Province / Subbasin	Mainstem/Systemwide /
Short description	Continue to provide agencies and tribes access to erythromoycin feed additive while working to complete FDA approval of erythromycin feed additive, a therapeutant needed for sustained hatchery production and maintenance of captive broodstocks of salmon.
Target species	Chinook, sockeye, and coho stocks especially but available to all species.

Project location

Latitude	Longitude	Description
		Systemwide
46.7277	-117.0073	University of Idaho, College of Natural Resources

Reasonable and Prudent Alternatives (RPAs)

Sponsor-reported:

RPA
169
175,176,177, 178
179
184

Relevant RPAs based on NMFS/BPA review:

Reviewing agency	Action #	BiOp Agency	Description
NMFS	Action 184	NMFS	The Action Agencies and NMFS shall work within regional prioritization and congressional appropriation processes to establish and provide the appropriate level of FCRPS funding for a hatchery research, monitoring, and evaluation program consisting of studies to determine whether hatchery reforms reduce the risk of extinction for Columbia River basin salmonids and whether conservation hatcheries contribute to recovery.
NMFS/BPA	Action 184	NMFS	The Action Agencies and NMFS shall work within regional prioritization and congressional appropriation processes to establish and provide the appropriate level of FCRPS funding for a hatchery research, monitoring, and evaluation program consisting of studies to determine whether hatchery reforms reduce the risk of extinction for Columbia River basin salmonids and whether conservation hatcheries contribute to recovery.

Section 2. Past accomplishments

Year	Accomplishment
2000-2002	Maintained INAD to allow continued use of erythromycin feed additive for captive broods and conservation fish hatcheries.
2001	Submitted a two book summary and synthesis to FDA-CVM summarizing rates of replication of bacteria in natural environments especially in cool water temperatures to assist in analysis of risks of resistant microorganisms following antibiotic therapy.
2001	Received notification from FDA of need to reauthorize INAD since last renewal was in 1996.
2002	Submitted a book summary and synthesis to request reauthorization of INAD with all associated documentations and requested face-to-face meeting with FDA.
2002	Received review of 2001 submission on rates of replication, provided questions regarding data needed on resistant microorganisms in fish treated and not treated with erythromycin, and information on the fate of erythromycin at culture facilities.
2002	Began planning and staffing for studies to respond to FDA questions on the fate of erythromycin and resistant microorganisms.
2001-2002	Published 4 peer-reviewed manuscripts from research accomplishments.

Section 3. Relationships to other projects

Project ID	Title	Description
199204000	Redfish Lake Captive Broodstock	Provide therapeutant and expertise, potential monitoring site
199700100	Captive Rearing for Salmon River Chinook Salmon	Provide therapeutant and expertise, potential monitoring site
200001900	Tucannon River Spring Chinook Broodstock	Provide therapeutant and expertise
0	Captive broodstocks and supplementation programs in region as needed	Provide therapeutant and expertise
198805305	Oregon Hatchery Master Plan and Facilities	Provide therapeutant and expertise

Section 4. Budget for Planning and Design phase

Task-based budget

Objective	Task	Duration in FYs	Estimated 2003 cost
Objective 1. Provide infrastructure to continue INAD	all tasks	Ongoing through 2006	$5,500
Objective 2. Conduct experiments to understand resistant microflora in treated fish	all tasks	FY2003-2004	$10,000
Objective 3. Conduct experiments to address fate of erythromycin in sediments	all tasks	FY 2003-2005	$15,000
Objective 4. Provide submittals to FDA and publish results of studies	all tasks	Ongoing through 2005	$5,000

Outyear objectives-based budget

Objective	Starting FY	Ending FY	Estimated cost
Objective 1 Provide infrastructure to continue INAD	2003	2006	$20,000
Objective 2 Conduct experiments to understand resistant microflora in treated fish	2003	2004	$10,000
Objective 3 Conduct experiments to address fate of erythromycin in sediments	2003	2005	$20,000
Objective 4 Provide submittals to FDA and publish results of studies	2003	2006	$20,000

Outyear budgets for Planning and Design phase

FY 2004	FY 2005	FY 2006
$50,000	$20,000	$10,000

Section 5. Budget for Construction and Implementation phase

Task-based budget

Objective	Task	Duration in FYs	Estimated 2003 cost
Objective 1. Provide infrastructure to continue INAD	all tasks	2003-2006	$17,000
Objective 2 Conduct experiments to understand resistant microflora in treated fish	all tasks	2003-2004	$40,000
Objective 3 Conduct experiments to address fate of erythromycin in sediments	all tasks	2003-2005	$41,000
Objective 4 Provide submittals to FDA and publish results of studies	all tasks	2003-2006	$32,919

Outyear objectives-based budget

Objective	Starting FY	Ending FY	Estimated cost
Objective 1. Provide infrastructure to continue INAD	2003	2006	$55,000
Objective 2 Conduct experiments to understand resistant microflora in treated fish	2003	2004	$69,000
Objective 3 Conduct experiments to address fate of erythromycin in sediments	2003	2005	$86,000
Objective 4 Provide submittals to FDA and publish results of studies	2003	2006	$78,000

Outyear budgets for Construction and Implementation phase

FY 2004	FY 2005	FY 2006
$124,000	$99,000	$45,000

Section 6. Budget for Operations and Maintenance phase

Task-based budget

Objective	Task	Duration in FYs	Estimated 2003 cost	Subcontractor

Outyear objectives-based budget

Objective	Starting FY	Ending FY	Estimated cost

Outyear budgets for Operations and Maintenance phase

Section 7. Budget for Monitoring and Evaluation phase

Task-based budget

Objective	Task	Duration in FYs	Estimated 2003 cost	Subcontractor

Outyear objectives-based budget

Objective	Starting FY	Ending FY	Estimated cost

Outyear budgets for Monitoring and Evaluation phase

Section 8. Estimated budget summary

Itemized budget

Item	Note	FY 2003 cost
Personnel	FTE: 1.4 FTE plus two graduate students	$80,160
Fringe	36% of Post Doc, 48% of clerical, 1% of students	$17,074
Supplies	Lab and field supplies, reports and publcation	$16,960
Travel		$8,944
Indirect	@ 31.5	$39,281
Other	Graduate Student Fees	$4,000
		$166,419

Total estimated budget

Total FY 2003 cost	$166,419
Amount anticipated from previously committed BPA funds	$0
Total FY 2003 budget request	$166,419
FY 2003 forecast from 2002	$80,000
% change from forecast	108.0%

Reason for change in estimated budget

We were anticipating a change for FY 2003 for this project. The first phase of this project defined in FY2000 and FY2001 was one of reactivation of active submittals to FDA and obtaining their response. We accomplished our objective, and have a detailed response with defined questions and cooperation established. This change in funding is necessary to accomplish these defined research objectives. The planning stages are minimized in this phase.

Reason for change in scope

The research questions are defined now, and will be accomplished through collaborations with FDA, regional hatcheries and fish health professionals, and assistance from other cooperators outside the region.

Cost sharing

Organization	Item or service provided	Amount	Cash or in-kind
Idaho Department of Fish and Game	INAD Management and Reporting and Cooperation for trials (Objectives 1,2, and 3). Provide leadership and communications through PNFHPC	$30,000	in-kind
Washington Department of Fish and Wildlife	INAD Management and Reporting and Cooperation (Objectives 1, 2, 3). Provide assistance in locating sites for research and monitoring.	$20,000	in-kind
Oregon Department of Fish and Wildlife	INAD Management and Reporting and Coooperation for Trials (Objectives 1,2,3). Provide assistance for any monitoring or research needs.	$20,000	in-kind
USFWS	Maintain INAD Management and Reporting and Cooperation for Sevice and Columbia River Indian Tribes, provide communications through PNFHPC, support (Objectives 1,2,3). Provide assistance for drug approvals through National Fish Health Coordinator	$20,000	in-kind

Reviews and recommendations

This information was not provided on the original proposals, but was generated during the review process.

REVIEW:
ISRP Preliminary Review (ISRP 2002-13)

Recommendation:
Fundable - no response required

Date:
Aug 2, 2002

Comment:

Fundable, high priority. The tasks included are required by FDA to allow continued use of erythromycin for salmon. This proposal seems to be a comprehensive response to FDA and proposes to maintain close interaction with the FDA in completion of this work. The PI has a long productive history in this issue and has the necessary facilities and credentials to proceed. In the absence of different treatments for BKD, there is no other option but to proceed and meet the FDA requirements.

REVIEW:
CBFWA Funding Recommendation

Recommendation:
Urgent

Date:
Oct 24, 2002

Comment:

REVIEW:
CBFWA FY03 Budget Review Comments

Recommendation:
Urgent

Date:
Oct 24, 2002

Comment:

The reductions I can find in my project at this time would be in the field portion of the studies under Objective 3: Conduct experiments to address the fate of erythromycin in sediment ponds with a history of erythromycin treatment. This proposed savings is based on an optimistic review letter received from the Food and Drug Administration after the BPA proposal was submitted. They indicated that the scope of the field tests of environmental aspects could be reduced, providing we identified low laboratory risks.

REVIEW:
ISRP Final Review (ISRP 2002-14)

Recommendation:
Fund

Date:
Nov 5, 2002

Comment:

Fundable, high priority. We agree with the CBFWA review and Urgent ranking. The tasks included are required by the FDA to allow continued use of erythromycin for salmon. This proposal seems to be a comprehensive response to FDA and proposes to maintain close interaction with the FDA in completion of this work. The principal investigator has a long productive history in this issue and has the necessary facilities and credentials to proceed. In the absence of different treatments for BKD, there is no other option but to proceed and meet the FDA requirements.

REVIEW:
NMFS Review

Recommendation:

Date:
Jan 21, 2003

Comment:

Statement of Potential Biological Benefit
The project will continue to provide the infrastructure for the control and prevention of bacteria kidney disease leading to decreased disease related mortality in captive broodstocks.

Comments
This project is essential for the continued use of erythromycin in hatchery and captive broodstock operations.

Already ESA Required?
No

Biop?
Yes

REVIEW:
BPA Funding Recommendation

Recommendation:
Fund

Date:
Jun 2, 2003

Comment:

BPA Phase 3

REVIEW:
NWPPC Funding Recommendation

Recommendation:
Fund (Tier 1)

Date:
Jun 11, 2003

Comment:

Category:
1. Council Staff preferred projects that fit province allocation

Comments:
FDA approval seems to be taking too long. Project request funding through 2006. Anticipate completion by 05 with, no funding beyond.

REVIEW:
Project Sponsor Request for FY04-05

Recommendation:

Date:
Sep 20, 2003

Comment:

REVIEW:
BPA Funding Decision

Recommendation:
Do Not Fund

Date:
Oct 2, 2003

Comment:

Current funding extends through May 2004. Assess opportunity to reduce planned expenditures for project close-out.