BREAKING: Some USDA Documents Back Online

The U.S. Department of Agriculture (USDA) has reported that some of the enforcement actions documents from the Animal Care Information Service (ACIS) have been reposted to the agency’s website.

As NABR reported, on February 3 USDA’s Animal and Plant Health Inspection Service (APHIS) removed from its website “inspection reports, regulatory correspondence, research facility annual reports, and enforcement records that have not received final adjudication.” Several animal rights groups, including People for the Ethical Treatment of Animals (PETA), the Beagle Freedom Project (BFP), Physicians Committee for Responsible Medicine (PCRM), Born Free USA, Massachusetts Society for the Prevention of Cruelty to Animals, and an Animal Law & Policy Fellow at Harvard Law School filed a lawsuit against the department demanding that the database be restored. The Humane Society of the United States (HSUS) was preparing to file a lawsuit. Just this week, 101 members of the House of Representatives wrote to President Donald Trump (R) expressing concerns with the removal of the database requesting that it be reinstated.

To read USDA’s statement regarding the restoration of the database, please click here.

New Federal Legislation Would Require Broad Reporting of Animal Use Data

Representative Ken Calvert (R-CA) has introduced H.R. 816, the Federal Accountability in Chemical Testing (FACT) Act. The bill would amend the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) Authorization Act of 2000 and would add a requirement that federal agencies must “include a description of the progress on the development, validation, acceptance, and utilization of alternative test methods (including animal use data by species, number, and test type) for toxicological testing conducted, supported, or required.” In short, Calvert’s bill would require the addition of animal census information for all research species (including rodents) to be included in the biannual ICCVAM report. The legislation would appear to represent an additional reporting requirement for federal agencies. Agencies affected include: USDA, DOD, DOE, Department of Interior, DOT, EPA, FDA, NIH, OSHA and the Agency for Toxic Substances and Disease Registry. The impact of this legislation likely extends beyond federal agencies, as a number of them require animal testing to be conducted outside the agency.

The introduction of the bill was stirred by the White Coat Waste Project (WCW), an animal activist organization that aims to end the use of animals in federally funded research. WCW is engaging with Republican members of Congress by claiming taxpayers could save money by eliminating animal research at the federal level. According to WCW’s website, its approach is to “drain the swamp: cut government spending that hurts animals and taxpayers.”

At the time of this writing, the bill has acquired 13 cosponsors: Representatives Ed Royce (R-CA), Vern Buchanan (R-FL), Mike Bishop (R-MI), Dina Titus (D-NV), Betty McCollum (D-MN), Tom Marino (R-PA), Lucille Roybal-Allard (D-CA), Raul Grijalva (D-AZ), Earl Blumenauer (D-OR), Peter DeFazio (D-OR), Mike Quigley (D-IL), Eliot Engel (D-NY) and Julia Brownley (D-CA). The bill has been referred to the House Energy and Commerce Committee and will remain alive until the end of the legislative session in December of 2018. For the full bill text, click here.

HHS Secretary Confirmed by Senate Earlier Today

The U.S. Senate has confirmed Representative Tom Price (R-GA) to be U.S. Secretary of Health and Human Services. Despite efforts by Democrats to delay his confirmation process, he was confirmed early Friday morning by a vote of 52-47.

Sonny Perdue, President Trump’s nomination for U.S. Secretary of Agriculture, will soon be vetted by the Senate Agriculture Committee, although a date for the hearing is yet to be determined. Perdue, a small business owner and veterinarian by training, would oversee a federal department that implements a broad range of programs including USDA’s enforcement of the Animal Welfare Act.

Watch your inbox, visit www.NABR.org, or follow us on Twitter for updates from NABR about Perdue’s confirmation process.

USDA’s APHIS Removes Enforcement Action Database; Information Still Available Through FOIA

UPDATED - February 9, 2017

On Friday, February 3, 2017, the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) notified stakeholders that during the last year it had “conducted a comprehensive review of the information it posts on its website” and “will remove from its website inspection reports, regulatory correspondence, research facility annual reports, and enforcement records that have not received final adjudication.”  The move impacts information related to research facilities subject to the Animal Welfare Act and entities subject to the Horse Protection Act.

APHIS indicated that such records can be requested under the Freedom of Information Act (FOIA) and will be released when authorized and in a manner consistent with the FOIA and Privacy Act.  NABR members attempting to access information on the APHIS website will notice changes including deactivation of the Animal Care Search Tool known as ACIS. The only information currently available on the website is a list by name and state of licensed and registered facilities.

The APHIS website changes have been widely reported by news media as an “abrupt removal” of information and animal rights groups have speculated that the changes may be driven by the new administration.

However, it is more likely the changes are related to a federal lawsuit filed by individuals and organizations involved with the horse industry in a February 2016 filing against USDA in the U.S. District Court for the Northern District of Texas (Contender Farms vs. USDA). The lawsuit alleges that APHIS’ publication of enforcement actions is unlawful, misleading and falsely identifies thousands of people who never received notice of an alleged violation, never had a USDA complaint filed against them and were never afforded the opportunity for a formal hearing as “violators.”

In reviewing the information currently available to NABR, the net result of this action appears to be that all of the information available on the USDA website related to inspection and annual reports will still be available to anyone who files a FOIA request with the personally identifying information redacted. FOIA requests can be filed here: https://efoia-pal.usda.gov/palMain.aspx.

UPDATE - February 9, 2017

NABR supports transparency for information that serves the public good. Historically we have found USDA enforcement data extremely valuable in tracking and analyzing animal use trends in research. We hope the USDA can strike the proper balance between protecting personal privacy and informing the public as expeditiously as possible.

NABR will continue to report as new information becomes available. Please continue to check your email, visit www.NABR.org or follow us on Twitter.

Your Voice Matters: Contact the President and Congress Today

As we reported last week to our membership, the new Congress has already begun business in Washington for its 2017-2019 legislative session. A total of 55 new Freshman Members of Congress from states and districts across the country are now settling-in to legislate on a full slate of issues, including those that impact biomedical research with animal studies.

In order to introduce these new lawmakers to NABR, its membership, and the various issues facing the future of biomedical research, NABR has sent a welcome letter (log-in required) to them and the rest of the 115th Congress. NABR encourages you to do the same. If you'd like to voice your support for biomedical research in this upcoming Congress and Presidential Administration, please click here to send a pre-written letter to the President, Vice President, both of your Senators, your Congressperson and the U.S. Department of Agriculture. This is a tiny investment of your time that will pay significant dividends in terms of educating policy makers about the irreplaceable value of humane animal research.

Please continue to check your email and www.NABR.org for the latest news from NABR and be sure to follow NABR on Twitter to get breaking news instantly.

BREAKING NEWS: Dr. Francis Collins to Continue as NIH Director for Now

According to the Washington Post, the National Institutes of Health (NIH) announced late yesterday that Dr. Francis Collins, the current director of the NIH, will remain on the job at least temporarily.

An NIH spokesperson said that Dr. Collins has been “held over by the Trump administration,” however it is unclear whether President Donald Trump (R) will formally reappoint him or if he will serve until a possible permanent director is selected. President Trump has asked some 50 senior members of the Obama Administration to stay on to assist in the transition.

Others rumored to be possible candidates for the top post at NIH have been physician and U.S. Representative Andy Harris (R-MD), biotech billionaire Patrick Soon-Shiong and Geoffrey Ling, former biotech director of the Defense Advanced Research Projects Agency (DARPA).

Dr. Collins, a geneticist, became director of the NIH in August of 2009. Because he was confirmed by the Senate during the Obama Administration he would not need to be reconfirmed if brought onboard by President Trump.

For more information on this breaking news, please see the coverage by the Washington Post, Science, and Nature.

As always, for the latest in news impacting the biomedical research community, please visit www.NABR.org or follow us on Twitter.

BREAKING NEWS: Governor Sonny Perdue Nominated as Agriculture Secretary

Former Georgia Governor Sonny Perdue (R), was nominated today by President-elect Donald Trump (R) to serve as the 31st U.S. Secretary of Agriculture.

A veterinarian by training, Perdue would be responsible for overseeing a federal department that implements a broad range of programs in the areas of farming, natural resources, food safety, animal health, trade and nutrition, to name a few. Of utmost importance to the animal research community is USDA’s enforcement of the Animal Welfare Act.

Perdue is a small business owner and native of Bonaire, Georgia and he served as Governor from 2003 to 2011 where he focused on reducing government waste, improving education and reforming state government. Prior to becoming Governor, he earned his Doctorate of Veterinary Medicine degree in 1971 from the University of Georgia and served several terms in the Georgia State Senate.

Agriculture Secretary is the last Cabinet-level position to be nominated by the President-elect. There has not yet been any indication when Perdue’s confirmation hearing will be scheduled.

NABR Submits Comments to FDA on GLP Proposed Rule

Last August, the Food and Drug Administration (FDA) published a proposed rule the in the Federal Register (Vol. 81, No. 164) titled, “Good Laboratory Practice for Nonclinical Laboratory Studies” [Docket No. FDA–2010–N–0548]. FDA has proposed amending the current regulations to require a complete quality system approach which they refer to as a GLP Quality System.

The proposed system would be required for safety and toxicity studies to support applications or submissions to the FDA. Proposed changes that would impact animal research facilities include additional management responsibilities, changes to SOP procedures and changes to address the management of multisite nonclinical laboratory studies.

NABR submitted comments to the FDA this afternoon, expressing concern that creating additional rules would be redundant with existing regulations and confusing for researchers, as research facilities are already governed by numerous other animal welfare requirements. A copy of our comments can be found here and NABR members are encouraged to use them as a basis for filing their own at regulations.gov. Comments must be submitted by January 21, 2017.

Senate Confirmation Hearings Set to Begin Soon for HHS Secretary

The Senate Health, Education, Labor and Pensions (HELP) Committee is scheduled to hold a hearing on Wednesday, January 18 to consider the nomination of Representative Tom Price (R-GA) as Secretary of Health and Human Services (HHS).

Before any appointed Cabinet member can be confirmed, the Senate must hold a hearing with the committee that has jurisdiction over the agency related to the position; in this case, the HELP committee has jurisdiction of the Secretary of HHS. Following this hearing, on a date yet to be determined, the Senate Finance Committee will hold a hearing in which they are expected to vote to send the confirmation to the Senate floor. A final vote to confirm Price as Secretary will occur on the Senate floor. According to Roll Call, “it is the Finance Committee that has primary responsibility for the Health and Human Services nomination, since it has jurisdiction over taxes and entitlement programs like Medicare and Medicaid.”

President-elect Donald Trump has at the time of this writing not announced a selection for Agriculture Secretary or Director of the National Institutes of Health (NIH). Please watch for updates from NABR throughout the nomination and confirmation process.

Hill Action on ‘Cures’ and CR

21st Century Cures Act

SUMMARY:

The 21st Century Cures Act is a major health care and research reform package with strong bipartisan support passed by Congress today, December 7, 2016. According to The Hill, it is expected to be signed into law by the President very quickly. Passage of the Act is considered a victory for biomedical researchers, pharmaceutical companies and patients. In addition to mental health and opioid addiction aid and provisions affecting patients, the Act contains several features important to the biomedical research community, including measures intended to advance research and expedite approval for lifesaving cures.

Highlights of the “Cures” Act include an authorization for increased funding for the National Institutes of Health (NIH), acceleration of the Food and Drug Administration (FDA) drug approval process, and prioritization for the development of innovation projects that support research discovery at the NIH and FDA. It also provides for the review of regulations and policies affecting researchers using animal models, with an emphasis on reducing administrative and regulatory burden.

The Act authorizes the following funding for biomedical research, although actual appropriations are still required and may vary annually.

 
KEY AUTHORIZATIONS:

  • $4.796 billion of funding for the National Institutes of Health (FY 2017-2026)
  • $1.8 billion for cancer research (FY 2017-2023)
  • $1.511 billion for BRAIN (FY 2017-2026)
  • $1.455 billion for the Precision Medicine Initiative (FY 2017-2026)
  • $500 million of funding for the FDA (FY 2018-2026)
  • $30 million for regenerative medicine research using adult stem cells (FY 2017-2020)

 

AWARD OF RESEARCH GRANTS:

The Act simplifies the application and approval process for researchers and reduces burdens on recipients.

Specifically, the Act provides for the following provisions related to NIH grants—

  • Implement measures to reduce burdens on the monitoring of subrecipients of grants, including an exemption from subrecipient monitoring or the implementation of alternative grant structures which remove the need for such monitoring.
  • Establish considerations to modify the timelines for the reporting of financial conflicts of interest and ensure they are appropriate for the award.
  • Avoid duplication of procedures and requirements between the agency and the department, requiring the Secretary of Health & Human Services (HHS) and the Director of the NIH to evaluate expenditure reporting to minimize burdens on funding recipients.
  • Creates the “Next Generation of Researchers Initiative” to foster a new crop of investigators. The Initiative will promote research independence and increase opportunities for funding and mentorship, and will enhance workforce diversity for young researchers.

 

DRUG APPROVAL PROCESS:

FDA is granted authority by the Emergency Use Authorization (EUA) to strengthen the nation’s response to chemical, biological, radiological, or nuclear (CBRN) threats through the use of unapproved medical products. 21st Century Cures clarifies this authorization by allowing the use of conditionally approved medications. It also expands the use of these unapproved countermeasures to animal drugs and animals.

 
REDUCTION OF REGULATORY BURDEN:

The Act aims to reduce administrative and regulatory burden for biomedical researchers. Two other bills (H.R. 5583 and S. 2742) were previously introduced in the 114th Congress to alleviate regulatory burden in research, but no action was taken. The language of the “Cures” Act states in Sec. 2034, page 69 that not later than 2 years after enactment, “the NIH Director shall collaborate with the Agriculture Secretary and Food and Drugs Commissioner to complete a review of the policies and regulations for the care and use of laboratory animals. As appropriate, they shall revise and reduce burden placed on investigators, while protecting research animals and maintaining the integrity and credibility of research findings.”

The Director of the NIH shall seek input of experts and shall—

  • “Identify ways to ensure such regulations and policies are not inconsistent, overlapping, or unnecessarily duplicative, including with respect to inspection and review requirements by Federal agencies and accrediting associations;
  • Take steps to eliminate or reduce identified inconsistencies, overlap, or duplication among such regulations and policies; and
  • Take other actions, as appropriate, to improve the coordination of regulations and policies with respect to research with laboratory animals.”

The Act also provides for a review by research funding agencies regarding the policies covering the disclosure of financial conflicts of interest and make any revisions necessary to harmonize these policies.

 
RESEARCH POLICY BOARD:

One year after enactment, a research policy board will be established to advise government officials about the effects of regulations on researchers. The board will consist of the Administrator of the Office of Information and Regulatory Affairs of the Office of Management and Budget, the Director of the Office of Science and Technology Policy, the Secretary of HHS, the Director of the National Science Foundation, and other secretaries and directors that support or regulate scientific research, as well as 9 and 12 members from nonprofit scientific organizations. The board will conduct assessments of regulatory policies and offer suggestions for improvement. The board will then submit a report to selected federal offices and Congressional committees containing their formal recommendations.

Continuing Resolution

The House Appropriations Committee has introduced a continuing resolution (CR) that will fund the government at its current spending levels through April 28, 2017. The current $1.07 trillion budget cap level will be maintained.

The CR will provide $872 million for biomedical research in 2017, which serves as the first installment of National Institutes of Health (NIH) funding in the 21st Century Cures Act, a landmark healthcare reform bill passed today by the Senate that is headed to the President’s desk for his signature. Of this funding, $352 million will be allocated to the NIH for innovation purposes, $500 million to states for grants to tackle opioid abuse and addiction, and $20 million to the Food and Drug Administration to modernize regulations.

As stated in Section 1001 of the CR, allocations for 2017 NIH innovation funds are broken down as follows:

  • $300 million for cancer research
  • $40 million for the Precision Medicine Initiative
  • $10 million for BRAIN
  • $2 million for regenerative medicine research using adult stem cells

In addition, the CR provides disaster assistance and relief for those affected by contaminated drinking water such as the Flint, Michigan community. It also provides funding to the Defense and State Departments to combat terrorism, as well as a waiver for the requirement that the Secretary of Defense be a civilian for 7 years before being nominated and confirmed as Secretary of Defense.

The bill is being reviewed by the House Rules Committee this afternoon. It is expected that the House will vote on Thursday, followed by a Senate vote on Friday. The CR must be passed by both chambers and signed by the President before December 9th which is when the current spending bill expires.

Please continue to check your email and www.NABR.org for the latest news from NABR. Please also follow NABR on Twitter to get breaking news instantly.

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