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1. NOTICE: Cervids Dual Path Platform Test for Bovine TB Raised to 500 for Reindeer
USDA Animal and Plant Health Inspection Service Bulletin
April 19, 2016
On April 25, 2016, Animal and Plant Health Inspection Service (APHIS), Veterinary Services will raise the optical density (OD) cut-off value for a positive test. The Dual Path Platform serological test for bovine tuberculosis in reindeer will be raised from the current level of 200 to 500 for a positive test result. The current OD cut-off values for all other species will remain unchanged (i.e., fallow deer at 200; elk, red deer, and whit-tailed deer at 500). There are no other changes for sample collection, submission, or testing procedures. This change in cut-off value for reindeer is in response to a 2015 United States Animal Health Association resolution that asked APHIS to reevaluate the cut-off values to reduce the number of false positive test results.
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2. Welcoming the U.S. Chief Veterinary Officer, Dr. Jack Shere
USDA Blog
Posted by Lillian McIntyre, APHIS Intern
April 19, 2016
The new face of USDA/APHIS Veterinary Medicine, Dr. Jack Shere, is also a familiar one.
Dr. Jack Shere, a long-time employee of USDA's Animal and Plant Health Inspection Service (APHIS), was recently named USDA's Chief Veterinary Officer leading APHIS's Veterinary Services program.
Dr. Shere joined APHIS in 1990 and has held a variety of field and leadership positions - serving as the area commander during the exotic Newcastle disease outbreak in 2003 and spending many weeks in Iowa during the 2015 Highly Pathogenic Avian Influenza outbreak where he represented USDA and Secretary Vilsack. Dr. Shere also spent several years in private veterinary practice prior to joining APHIS.
Asked about his goals for Veterinary Services under his leadership, Dr. Shere explained that the program has faced with budget changes over the past several years, which has reduced our field force and the ability to respond as quickly as we would like. He's committed to moving the program forward and addressing those needs. "The challenge is to re-strengthen and build us back to what we used to be."
Dr. Shere will bring his enthusiasm for learning to his new role. While he already has many degrees - B.S. in Biology and Chemistry, M.S. in Education with a minor in counseling, doctorate in Veterinary Medicine, and Ph.Ds in both Poultry Science and Microbiology - Dr. Shere wants to continue to be a lifetime learner. "There's always new knowledge out there, and you can always acquire more. It's just fascinating to know how much you won't ever know!"
But what brought him to the veterinary field was his love of caring for animals. As a child, he would often take wounded animals home to take care of, and Dr. Shere said his mother "never knew what she would find in [his] top dresser drawer." A few years later, he made the conscious decision to become a veterinarian when dealing with his family's German Shepard puppy, which had become increasingly ill. On a Friday evening, the puppy had a violent seizure. The family vet said he was closing his office for the day, and recommended that the animal be euthanized on Monday morning if it was still alive. Dr. Shere's father was left in a terrible position, and decided to put the animal out of its misery that night. While heartbreaking, it prompted Dr. Shere to resolve that after becoming a veterinarian himself, he would always go and help an animal if he was called - "So when I was in practice, if anyone called me, I would go, no matter what the time." And he's kept that vow in the years since graduating vet school.
Dr. Shere brings a wealth of knowledge, experience and passion to the table, which will only benefit this country's livestock and poultry populations.
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3. Brucellosis team considering several 'tools' [WY]
By: Joy Ufford
Sublette Examiner
April 18, 2016
SUBLETTE COUNTY - Wyoming's Brucellosis Coordination Team (BCT) discussed a number of possible ways to reduce the disease's transmission between elk and cattle at its April 13 meeting in Pinedale.
Research projects, affected herd updates, budget crunches and new data were shared by Wyoming, Montana and Idaho agencies, closing with a call for the BCT to move forward.
Wyoming State Veterinarian Jim Logan reported on an affected Sublette County cattle herd that first found six "reactor" cull cows during routine blood tests before their sale. On a following herd test, five more seropositive cows were discovered and removed from the herd; the producer then had one "clean" whole-herd blood test.
Of those 11, only one did not test culture positive for brucellosis, the lab reported.
Three clean blood tests are required before an affected herd can be released from quarantine.
On the Sublette herd's next test in March, two more cows tested seropositive for brucellosis and were removed to the state vet lab for testing, Logan said. Both cows were pregnant last fall; both lost their calves over the winter.
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4. State Veterinarian Says Biosecurity a Priority with Three Cases of EHM Confirmed at Fonner Park in Grand
Island [NE]
Nebraska Dept. of Agriculture News Release
April 19, 2016
LINCOLN - Three cases of the Equine Herpes Myeloencephalopathy (EHM) have been confirmed at Fonner Park in Grand Island resulting in State Veterinarian Dr. Dennis Hughes calling for horse owners to use best biosecurity practices. Samples were collected and sent to the National Veterinary Services Laboratory in Ames, Iowa, where the disease was confirmed. One of the affected horses was euthanized on site while the other two have been isolated on the premises.
The Nebraska Department of Agriculture in cooperation with Fonner Park management has quarantined the horses located at Fonner Park. Horses located in the Red Barn (where the affected horses were stabled) will not be allowed to race at present time. Racing will continue at Fonner Park with the horses located in the other barns on the premises.
EHM is the neurological form of Equine Herpes Virus (EHV-1). Cases of the diseases have been confirmed at several locations around the country, many of them at horse race tracks or events where horses are co-mingled.
"It is of utmost importance that horse owners and facility managers take appropriate precautions to prevent the spread of this disease," said Dr. Hughes. "Vigilance is especially important in situations where horses can come into contact with each other. There can be a high susceptibility to the disease where we have horses co-mingling from different regions or states."
The disease is spread through direct or indirect contact with infected horses, so Dr. Hughes encourages operators of horse shows and exhibitions to review their biosecurity plans and minimize the opportunity for horses to have direct or indirect contact with each other. Indirect contact includes the use of shared water and feed sources, as well as the use of shared equipment. In addition, Dr. Hughes said he recommends horse owners planning to travel to shows and exhibitions contact the venue prior to transporting their horses to inquire about entrance requirements for the event.
Biosecurity measures horse owners should take at their own operations include requiring individuals to wash their hands before and after contact with each horse, disinfecting boots and changing clothes that come into contact with horses other than their own.
"If possible, horse owners should avoid contact with other people's horses, and isolate horses returning from shows or exhibitions for 3 to 4 weeks," said Dr. Hughes. "Owners who will be co-mingling their horses also should consider contacting their veterinarian to discuss their horses' current vaccination status and weigh the benefits of vaccination."
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5. Arizona: Rabies confirmed in Nogales domestic horse, 1st case in nearly seven years
Posted by Press Release
Outbreak News Today
April 19, 2016
The Arizona Department of Agriculture confirmed Monday that a domestic horse owned in the Nogales area tested positive for rabies. The horse was hospitalized but did not respond to treatment and was later euthanized.
"While rabies among domestic animals is extremely rare with this being the first case in almost 7 years, we are reminded of the importance of keeping our animals' vaccinations current," said Dr. Susan Gale, acting state veterinarian.
"The rabies vaccination protects our pets from this infectious disease and vaccinating pets protects people." Rabies affects the nervous system causing animals to act strangely. Cattle and horses should be vaccinated annually to protect against rabies.
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6. Register Now for U.S.-Canada Regulatory Cooperation Council Meeting May 4-5 in Washington, D.C.
USDA Animal and Plant Health Inspection Service Bulletin
April 19, 2016
Dear RCC stakeholders:
We invite you to participate in the U.S.-Canada Regulatory Cooperation Council Stakeholder Meeting, to be held at the Embassy of Canada in Washington, D.C. on May 4-5 2016.
Please indicate your attendance at this two-day event by registering at the following link http://www.us-can-rcc-ccr.com/. A registration confirmation will follow via e-mail within two business days. We encourage you to sign up early as registrations will be accepted on a first-come-first-served basis due to space limitations.
In the fall of 2014, the United States and Canada released a Joint Forward Plan for regulatory cooperation. That plan called for bilateral senior-level discussions on regulatory cooperation. The objective of the May 4-5sessions is to provide a single venue for senior regulators to get together with stakeholders and discuss areas of opportunity over the short-medium term. U.S. and Canadian senior officials will be seeking stakeholder views on regulated sectors and related opportunities for efforts between regulators.
The program agenda* provides additional information, including logistical details, for the event. As noted in the agenda, during the afternoon of May 4th and throughout the day on May 5th, stakeholders are invited to meet with U.S. and Canadian regulatory officials to identify and discuss new opportunities for regulatory cooperation between the two countries.
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7. FDA Announces 2016 Public Meetings and Comment Period on Reauthorization of Two Animal Drug User Fee Programs
FDA/CVM Update
April 19, 2016
The U.S. Food and Drug Administration will hold public meetings to offer opportunity for discussion on the proposed reauthorization of the Animal Drug User Fee Act (ADUFA) and Animal Generic Drug User Fee Act (AGDUFA). The FDA is also providing the opportunity for the public to comment on the user fee programs and make suggestions regarding features that FDA should propose for the next ADUFA and AGDUFA programs. Interested parties can share their comments at the meeting or by submitting them to the public docket electronically or by mail as described below.
ADUFA and AGDUFA give the FDA the authority to collect user fees that provide funding to support the new animal drug and generic new animal drug review processes, respectively. These resources support the FDA's responsibility to review these drugs for safety and effectiveness and to enhance the timeliness and predictability of application reviews. These programs expire on September 30, 2018. Without new legislation reauthorizing these programs, FDA will no longer have the authority to collect user fees to help fund the new animal drug and generic new animal drug review processes.
Date and Time
May 16, 2016
9 a.m. to 12 p.m.: ADUFA public meeting
1 p.m. to 4 p.m.: AGDUFA public meeting
Location
Food and Drug Administration - Center for Veterinary Medicine
7519 Standish Place, 3rd Floor, Room A
Rockville, MD 20855
Registration and Public Comment
Registration to attend these public meetings is free and available on a first-come, first-served basis. Early registration is recommended due to limited seating. Onsite registration on the day of the public meetings will be based on space availability. If you wish to attend and/or present at one or both public meetings, please register by email to cvmadufa@fda.hhs.gov by May 4, 2016. Additional information about registration is available at the following links:
Notice of Public Meeting; Animal Drug User Fee Act; Request for Comments
Notice of Public Meeting; Animal Generic Drug User Fee Act; Request for Comments
If attendees need special accommodations due to a disability, please contact Cassie Ravo at Cassie.Ravo@fda.hhs.gov or 240-402-6866 at least seven days before the meeting.
Public comments will be accepted through December 1, 2017, electronically via the Federal eRulemaking Portal http://www.regulations.gov, or in writing to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm 1061, Rockville, MD 20952. All comment submissions received must reference Docket No. FDA-2011-N-0656 for ADUFA, and Docket No. FDA-2011-N-0655 for AGDUFA. Comments received by June 16, 2016 suggesting changes to the program will be published online.
Confidential Submissions -To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. For detailed instructions, refer to
Notice of Public Meeting; Animal Drug User Fee Act; Request for Comments
Notice of Public Meeting; Animal Generic Drug User Fee Act; Request for Comments
We are also issuing two notices to request that public stakeholders notify FDA of their intent to participate in periodic consultation meetings on reauthorization of the ADUFA and AGDUFA programs. The Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires that FDA consult with a range of stakeholders--including patient and consumer advocacy groups, veterinary professionals, and scientific and academic experts--in developing recommendations for the next ADUFA and AGDUFA programs, and hold discussions with these stakeholders at least once every 4 months during FDA's negotiations with the regulated industry. The purpose of these requests for notification is to ensure continuity and progress in these regular discussions by establishing consistent stakeholder representation.
If you intend to participate in continued periodic stakeholder consultation meetings regarding AGDUFA reauthorization, please submit notification by email to: cvmagdufa@fda.hhs.gov by May 16, 2016. If you intend to participate in continued periodic stakeholder consultation meetings regarding ADUFA reauthorization, please submit notification by email to: cvmadufa@fda.hhs.gov by May 16, 2016. Your email should contain complete contact information for each attendee, including name, title, affiliation, address, email address, telephone number, and notice of any special accommodations required due to a disability. Stakeholders will receive confirmation and additional information about the first meeting after FDA receives this notification.
Animal Generic Drug User Fee Act; Stakeholder Consultation Meetings on the Animal Generic Drug User Fee Act Reauthorization; Request for Notification of Stakeholder Intention to Participate
[ See Pre-Pub: https://s3.amazonaws.com/public-inspection.federalregister.gov/2016-09152.pdf ]
Animal Drug User Fee Act; Stakeholder Consultation Meetings on the Animal Drug User Fee Act Reauthorization; Request for Notification of Stakeholder Intention to Participate
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