DRAFT_FDA SOW Library Resources_09162024.pdf

DRAFT Statement of Work FDA Library Resources

September 16, 2024

Introduction

The U.S. Food and Drug Administration (FDA), is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics and products that emit radiation.

The FDA Library is well-respected as an invaluable aid to delivering credible, timely information from scientific and health literature to FDA scientists because it always makes available knowledge resources, publications, references and research services in support of the FDA mission. This portfolio availability is made possible through the 24/7 access to library support services to all of FDA staff through a secure access network with IP authentication. This portfolio provided is made possible via purchases from domestic and foreign serial publishers of journals (electronic and print) as well as databases. The objective of this Blanket Purchase Agreement (BPA) is to acquire the necessary library resources through a streamlined ordering process.

The FDA Library is seeking for services for a BPA from qualified vendors to act on its behalf to renew and/or purchase subscriptions for journals, books, databases, and training in online and/or print formats. The vendor will be responsible for paying each renewal and/or purchase on the FDA Library’s behalf. When publishers require signatures on license agreements, the vendor will work with FDA’s contracting office to append the license to the contract.

Objectives

The objective is to consolidate orders from various publishers purchased through other procurement methods into one all-encompassing contract. The Contractor shall process new and renewal orders on behalf of the FDA Library in any of these formats: print, print plus online or online only formats.

Resources must be accessible through an online tracking system, integrate with current FDA subscriptions and comply with security regulations. Accessibility shall not require any client installed software. FDA Library staff will provide a list of resources which will include the titles of print and electronic journals, electronic books, databases, training resources, and subscription charges including an Electronic Funds Transfer account with the University of Connecticut for document delivery/interlibrary loan.

Scope

1. The Contractor shall provide all facilities, equipment, and supplies for the placement of new and renewal subscriptions and shall pay publishers in local currencies where required based on accurate international exchange rates for publishers.

2. The Contractor shall provide the review and incorporation of subscription license agreements into call orders, which includes receipt of agreement, sending to the FDA COR and Contracting Officer for legal review and working with the Contracting Officer to process the call order modification. The resulting call order modification will include the license agreement.

3. The Contractor shall assure continued access to previously subscribed content from publishers whenever possible and ensure that access to content from subscriptions placed in previous years is retained. For subscriptions which have lapsed or payment questions, the Contractor shall provide proof of payment to publishers to get the physical or electronic subscription reinstated immediately and have all back issues provided to the Library, unless otherwise directed in a call order. Costs associated with lapsed and duplicate subscriptions shall be included in the Contractor’s applicable service fee. The contractor shall provide administrative services for each subscription for up to three months after the subscription expires, i.e. the publication of the last issue covered by the subscription period.

4. The Contractor shall provide Government access to an online tracking system with accurate, up-to-date and complete information accessible to its customers 24 /7 with at least a 99% average reliability and at least an 85% reliability of all titles in the RPF title list. Through a user-friendly interface it must include a claiming interface and complete bibliographic data. If a title is not in the database, it shall be added to the database within 48 hours after the Contractor receives a request for a serial subscription. The database must have the ability to run sortable reports in Excel format.

5. The Contractor shall resolve problems which arise from ordering online subscriptions with publishers. These problems include, but are not limited to, incorrect tiers ordered, invoice discrepancies and payment, broken links, IP issues, incorrect username and/or passwords, lost access and licensing issues. Lost access problem reports must be addressed within 24 hours of submission.

6. The Contractor shall ensure that the FDA Library can generate claims for missing issues online through Electronic Data Interchange (EDI), via the library’s integrated library system.

7. Standards Connect/ANSI – FDA supports the requirements of the National Technology Transfer and Advancement Act (NTTAA), which became law in March 1996, and OMB Directive A-119. These documents direct Federal agencies with respect to their use of private sector standards and conformity assessment practices. Their objective is for Federal agencies to adopt private sector standards, wherever possible, in lieu of creating proprietary, non-consensus standards. In addition, the use of voluntary consensus standards by our regulated industry is increasing and is anticipated to continue to increase further to support product safety, least burdensome regulatory submissions and global harmonization. FDA staff need to have access to consensus standards as part of product review, surveillance, and enforcement activities at the Agency.

The vendor will maintain the portfolio of standards currently available to FDA from the Statement of Work (SOW) including the following standards Developing Organizations (SDOs): ANSI, BSI, CLSI, IEEE, ISA, ISO, IEC, ASME, ADA, RESNA, ASTM, ASQ, ASA, AAMI, and PDA. This permits FDA negotiate any additional SDOs that we identify. FDA employees will be able to obtain any standard from the included SDOs at his/her desk by direct download from their computer or other electronic resources capable of accessing the online database subscription. The vendor will also provide access to single copies of standards not in the portfolio for a total price up to the amount specified in the order’s

SOW.

Task Areas

1. Purchase New and Renewal Orders of Library Resources /Coordinate Delivery of Hard Copy

Resources/Provide Access to electronic Resources.

All electronic subscriptions must be ordered and priced for institutional-wide access. Authorized users shall consist of all staff FDA employees. Access is provided through a secure network.

The Contractor shall obtain pricing from publishers and providers that provide discounts for multi-year subscriptions where applicable and where the discount is documented.

The government must be eligible for certain discounts offered by publishers. If so, the government must be charged the lowest of the available prices. The service or discount offered by the contractor must be to this actual subscription price paid by the FDA. The service fee shall be included in the price proposal submitted to the Contracting Officer (CO) for the call order. The contractor will obtain proper invoices based on the FDA-specific portfolios. If publisher quotes are available, the contractor shall work with publishers to obtain those based on FDA specific criteria.

The Contractor shall process new and renewal orders on behalf of the FDA Library for selected library resources in any of these formats: print, print plus online, or online only formats. Print formats will be ordered when that is the only format available, or when the publisher requires the subscription to be bundled with online. Title subscriptions may be procured by orders via the respective publisher(s) or combined into one bundled order. The Contractor will notify the publisher within 5 working days when customer change of address occurs.

The contractor shall enter all new or renewal orders within five working days after receipt of the call order or receipt of the reviewed title list, whichever is later. Delays are allowed only by written agreement.

Some resources will be one-time purchases with perpetual access. Electronic books generally are available as a subscription or one-time purchase, with an annual service fee. Journal orders must be available to be reviewed and placed within 30 days after award of the contract. All users will receive access to electronic resources through FDA’s secure network. All electronic online subscriptions shall be priced for FDA-wide access, unless otherwise noted by FDA. All of FDA’s licenses are based on 4,500 full time employees.

If the publisher will not accept the order without prior payment, the Contractor shall send out such payment within that same 24-hour period.

If orders become a rush due to the contractor’s delay, the contractor shall pay for the order and shall absorb any additional fee because of its delay in timely and accurately processing the order. Under no circumstance shall the FDA be responsible for the extra cost of orders that become rush due to the contractor’s failure to place the order(s) timely. Other rush orders for subscriptions must be accepted at no extra charge and processed within 24 hours after the order is placed.

FDA headquarters is in Silver Spring, MD. FDA staff is located world-wide. As such, the Contractor shall handle delivery of print journals to multiple ship-to addresses, when the Government requires it.

The Contractor shall work with publishers to obtain quotes based on FDA-specific portfolios and to obtain proper invoices. The contractor shall maintain records and provide reporting to show the amount spent, amount projected, and balance/deficit for each subscription account in the system.

The Contractor shall have the ability to accept orders for new subscriptions at any time during the year, publisher permitting.

FDA must have the ability to generate claims for missing issues online through EDI (Electronic Data Interface).

2. Pay Publisher Invoices/Handle License Agreements

2.1 At any time during the year, the Contractor shall pay publisher subscription order invoices that the FDA Library places with the Contractor within two (2) weeks after the Contractor receives a publisher’s invoice in accordance with the terms of the award document. The Contractor shall submit an electronic invoice for processing to the FDA Vendor Payments team with a courtesy copy provided to the COR and Contracting Officer. The Contractor shall provide proof of payment within 48 hours after paying a publisher’s invoice.

2.2 The Contractor must have the ability to verify payment of invoices with information provider/publisher to the correct FDA account within 48 hours of subscription and payment. The use of standard currency conversion rates will be used when processing invoices in foreign currency. If rate used on invoice to customer differs markedly from rate found using a standard online converter, a clear explanation must be provided.

2.2 The Contractor shall obtain license agreements, as applicable and include any license agreements with the invoices submitted to FDA. If a license agreement is received after the award of the BPA, a modification to the award will be completed once the license agreement is vetted by the Contracting Officer and the FDA Legal Office.

2.3 The Contractor shall, without additional compensation, correct errors and reconcile discrepancies on invoices and submit revised invoices.

2.4 All licenses will be forwarded to FDA within 10 days of subscription purchase.

3. Subscription Management and Tracking System

3.1 The Contractor shall ensure that FDA Library subscription resource data is accessible through an online tracking system and integrated with current FDA systems. The online tracking system must comply with security regulations. Electronic access shall be activated by the Contractor when the Government places a call order. The Contractor shall troubleshoot any access issues with the publishers.

3.2 The Contractor shall provide access to an online tracking system with accurate, up-to-date, and complete information available twenty-four (24) hours a day, seven (7) days a week. It must contain metadata records for all biomedical journals and databases common to a large research organization to include records for at least 85% of the titles listed in the BPA. The system shall have a 99% reliability average. Restrictions for institutional subscribers must be clearly stated.

3.3 The online tracking system must have complete metadata on all journals considered for acquisition (if a title is not in the database, it must be added within 2 business days). The metadata must include, at a minimum, the following information:

title publisher

ISSN

EISSN

country of publication publication frequency Subscription period subscription package membership (ebundle) combined with a list of the titles included available format volume price % increase in price from past year invoice-item number/date bill to/ship to Address account number charged customer subscriber number (assigned by publisher) restrictions or terms for institutional subscriptions clearly noted (i.e., Online only, print only) subscription status – (i.e. irregular, discontinued, slow publication) purchase mechanism

3.4 The online tracking system must be able to

• Interface with the customer’s integrated library system using standard EDI transfer or a future standard which would be developed and adopted

• Provide ability for customer to generate claims online via EDI

• Export and/or synchronize all fields on all titles within all orders using standard protocols into a commercial or open source electronic resources management system.

• Generate sortable reports (MS EXCEL) to several access points listed in section 3.3 in any combination as needed.

• Generate sortable reports of titles contained within subscription packages, including the access points listed in section 3.3

• Provide ability for customer to export reports in Excel format

• Ability to capture, store and report all bibliographic and financial transactions ordered by the

Library for the previous five (5) years.

• Provide clear and accurate customer order history through title searches.

• Generate sortable title reports contained within subscription packages.

• Provide online access to subscription payment data

• Ability to support transmission of purchase orders and invoices electronically

• Provide address fields with maximum flexibility with at least 5 lines and 30 characters per line

4. BPA Management

4.1 Alerts - The Contractor shall provide, at least monthly, a variety of alerts and email reports to notify library staff of changes to subscription mix, including, but not limited to, changes in format, delayed issues, publication mergers, online availability, or discontinued titles.

4.2 Review List – Every year, by August 1st, the Contractor shall provide a review list of library resources that includes the data elements in Section 3.3 (above) along with renewal quotes from the publishers.

4.3 Reports

a. Subscription Comparison Index Report – In October, or upon request, the Contractor shall provide a cost comparison report covering a three (3)-year period in an Excel spreadsheet for all subscriptions at the title level and sortable by any field.

b. Renewal Report – The Contractor shall provide a monthly renewal report of all subscriptions based upon actual or estimated pricing for the following year.

c. Regular title updates – The Contractor shall provide updates at least monthly on serial titles including data such as delayed issues, title changes, publisher changes, publication mergers, cessations, online availability status and direct order requirements.

d. On Demand Reports - for current orders showing registration instructions, library specific IP’s, third party platform requirements, access models, URL for registration and license.

e. The Contractor shall provide a report that lists all subscriptions with package and title level metadata, vendor/provider metadata, and subscription periods of performance upon request.

4.4 Database - The Contractor shall maintain a current database of publisher point-of-contact information that can be used for correspondence (quotes, license agreements) and made available in the tracking system.

4.5 Customer Service Access - The Contractor shall have a dedicated representative who has the authority to resolve account problems available from Monday through Frida 9:00 AM to 5:00 PM, EST/EDT. Responses to requests shall be provided within one (1) business day of receipt of the request.

The Contractor is responsible for the professional quality and technical accuracy of all facets of work covering subscription ordering, processing and invoicing.

4.6 Post Award Conference - The Contractor shall participate in a post-award conference, which will be scheduled after the Call Order is awarded. The COR will coordinate scheduling of the post-award conference with the Contractor.

4.7 Training - The Contractor shall provide FDA Library personnel with training on the online tracking resources within 30 days of the award.

Period of Performance

The period of performance is for January 1, 2025 through January 31, 2030.

Delivery

1. All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract number and contractor name. The contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition. Specific deliverables (resources, publications, etc.) will be specified in the call orders issued under this BPA.

2. Deliver invoices to the Contacting Office Representative and the Financial Management Office

a. Each invoice shall be submitted for each subscription order and for each title at the agreed upon price with evidence of prior payment to the publisher.

3. Provide account based access to the Subscription Management and tracking system.

4. Call order #5 title/package list – see attached package and title spreadsheets.

5. ODC CLIN (not to exceed $450,000.00) will be included to cover unforeseen subscription changes that occur when titles change publishers or when additional titles are found to be within scope and necessary for the FDA mission.