Sources Sought Antimicobial Resistance.doc

General Information:

Document Type:

Sources Sought Release Date:

April 23, 2021 Response Date:

April 30, 2021 at 5:00pm local time via e-mail to Contracting Specialist Contracting Office Address:

Food and Drug Administration, Tara Hobson, Contract Specialist Description:

Antimicrobial resistance (AMR) Outreach This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition, 541990. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice.

**QUESTIONS WILL NOT BE ENTERTAINED AS A RESULT OF THIS NOTICE**

Background Antimicrobial resistance (AMR) is a global public health threat. According to the 2019 CDC Threats Report, more than 2.8 million antimicrobial-resistant infections occur in the United States each year, and more than 35,000 people die as a result. Any use of an antimicrobial drug, including use in humans and animals and horticulture, can contribute to the emergence of antimicrobial resistance. Judicious use of antimicrobials, in all settings, can help to slow the rate at which AMR develops.

Antimicrobial drugs are widely used in animals and CVM is committed to helping shape public policy regarding the judicious use of medically important antimicrobial drugs in animals. To continue our efforts to slow the development of antimicrobial resistance, CVM has implemented a five-year antimicrobial resistance plan, “Supporting Antimicrobial Stewardship in Veterinary Settings, Goals for Fiscal Years 2019-2023” with key activities for fostering antimicrobial stewardship. These key activities are organized under three goals:

1. Align antimicrobial drug product use with the principles of antimicrobial stewardship

2. Foster stewardship of antimicrobials in veterinary settings

3. Enhance monitoring of antimicrobial resistance and antimicrobial drug use in animals

To support antimicrobial stewardship, it is important to ensure antimicrobials are used judiciously in animals. This falls under CVM’s AMR strategy Goal 2, Objective 2.1: Support outreach and education by providing information on antimicrobial stewardship.

CVM believes that the concept of “antimicrobial stewardship” encompasses several important principles of judicious use that are critical to slowing the rate at which bacteria develop resistance to antimicrobial drugs. In simple terms, we believe medically important antimicrobial drugs should only be used when necessary to treat, control, or prevent disease. In addition, when such use is necessary, these antimicrobials should be used in an optimal manner under the oversight of a licensed veterinarian.

Although work continues on multiple fronts to more fully develop stewardship plans specific to various veterinary settings, we acknowledge and support the comprehensive definition developed by the American Veterinary Medical Association (AVMA) that defines antimicrobial stewardship for veterinarians to be “the actions veterinarians take individually and as a profession to preserve the effectiveness and availability of antimicrobial drugs through conscientious oversight and responsible medical decision making while safeguarding animal, public, and environmental health.”

CVM has broad authority to regulate the safety and effectiveness of animal drugs, including the authority to require certain drugs be limited to use under the oversight of licensed veterinarians. CVM’s role in overseeing activities that relate to the practice of veterinary medicine is limited, however; given that veterinarians are licensed by the states in which they practice, such oversight generally lies with state veterinary medicine licensing boards.

Other important factors such as animal husbandry and biosecurity practices can have a significant bearing on disease incidence and, in turn, on the need for antimicrobial use. CVM does not regulate animal husbandry or farming activities; however, we believe effectively implementing antimicrobial stewardship in veterinary settings requires a collaborative effort from a broad interdisciplinary set of stakeholders.

These stakeholders include drug manufacturers and distributors, feed manufacturers and distributors, veterinarians, animal producers, academic organizations, food safety advocacy groups, various federal, state, and local agencies, and other key stakeholders.

Objectives

Over the years, CVM has published several education and outreach related documents related to antimicrobial resistance. Now that some of the initial actions in CVM’s 5-year plan have been accomplished, we would like to update our messages to reflect current policies and reiterate the importance of judicious use of antimicrobials in veterinary settings.

The purpose of this contract is to develop an educational campaign to include outreach materials (video, print, audio, and social media) targeting affected stakeholders likely to use antimicrobials without veterinary oversight such as farmers or hobbyist with small numbers of sheep, goats, or backyard poultry, or farmers and ranchers in areas with limited access to veterinarians. The campaign is meant to inform farmers, ranchers and other animal care providers about the significance of antimicrobial resistance and about the importance of their role in helping to reduce its impact on human and animal health. This includes providing information on how to implement judicious use of antimicrobials by working with a veterinarian and effectively implementing antimicrobial stewardship practices. The campaign will provide the information they need to effectively implement antimicrobial stewardship in animal care/production settings by distributing materials through the media, retail stores, extension veterinarians, etc.

Scope of Work

The contractor shall be an expert on antimicrobial resistance and use of antimicrobials in animals.

The contactor shall develop an educational campaign for farmers, ranchers, and other animal health care providers including the development of materials related to the importance of good antimicrobial stewardship practices, judicious antimicrobial use in animals, and how a valid VCPR could help reduce inappropriate antimicrobial use and support animal health. Messaging may also include importance of record keeping, and concerns related to the implementation of GFI #263, “Recommendations for Sponsors of Medically Important Antimicrobial Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary Oversight All Products That Continue to be Available Over-the-Counter.” Deliverables include developing videos, species-specific training materials, bilingual brochures, posters, audio ads for radio and podcasts, etc. FDA will provide feedback throughout development, FDA policies, and assistance with messaging.

The contactor will work with FDA to identify the target audience for various types of materials. The contractor will engage in ongoing communication with key FDA staff and become familiar with current policies related to judicious use and antimicrobial resistance. Using USDA - National Agricultural Statistics Service Homepage and other demographic information on species such as sheep, goats, backyard chickens, the contractor will identify key regions or groups and develop top line messaging for the targeted audiences.

CVM believes top line messaging will aim to teach targeted audiences why judicious use in animals is important in preventing AMR and supporting human and animal health, and to persuade them make behavior changes that support judicious use when administering antimicrobials to animals, including working with a veterinarian. These messages will be expanded upon to develop educational materials to teach producers and caretakers judicious use principles and practices.

The contractor will also be responsible for providing FDA with final versions of the materials, the distribution of print materials, assuring that online materials are 508 compliant, and securing the appropriate radio space and social media ads.

Capabilities and Technical Experience:

Provide a capability statement describing how your company would meet the requirements.

Business Status:

Please provide your business size status (e.g., small business, 8(a), HUBZone, etc) and DUNS number.

Disclaimer and Important Notes:

This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation.

Responses to the sources sought shall be no longer than 10 pages.

� American Veterinary Medical Association, “Antimicrobial Stewardship Definition and Core Principles,” 2018, https://www.avma.org/KB/Policies/Pages/Antimicrobial-Stewardship-Definition-and-Core-Principles.aspx, accessed September

5, 2018.

� FDA does regulate the extralabel use of animal drugs, and such extralabel use must meet the requirements of section 512(a) of the Federal Food, Drug, and Cosmetic Act and FDA regulations at 21 CFR part 530. In implementing and enforcing the extralabel provisions of federal law, we are regulating animal drugs, not regulating the practice of veterinary medicine.

� Although FDA does not generally regulate farming activities, we do regulate food and drugs given to food-producing animals.