Replaces MOU No. 225-05-3000

MEMORANDUM OF UNDERSTANDING BETWEEN THE
U.S. FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
AND U.S. NATIONAL LIBRARY OF MEDICINE
NATIONAL INSTITUTES OF HEALTH
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

 

I. Purpose:

The purpose of this agreement is assign responsibilities to the Food and Drug Administration (FDA) and National Library of Medicine (NLM) for the distribution of Structured Product Labeling (SPL) documents.

II. Background: 

FDA is authorized to enforce the Federal Food, Drug, and Cosmetic Act (the Act) as amended (21 U.S.C. 301, et seq.).  In fulfilling its responsibilities under the Act, FDA, among other things, directs its activities toward promoting and protecting the public health by assuring the safety, efficacy, and security of drugs, veterinary products, and medical devices and the safety and security of foods, dietary supplements, cosmetics, and radiological products.  FDA also has responsibility for regulating the manufacturing, marketing and distribution of tobacco products to protect the public health and to reduce tobacco use by minors. To accomplish its mission, FDA must stay abreast of the latest developments in research and communicate with stakeholders about complex scientific and public health issues. The partnership with NLM described in this memorandum will greatly contribute to FDA’s mission.

This agreement is needed to ensure that SPL documents such as the content of labeling and indexing are readily available to health information providers in their most up-to-date form as part of the DailyMed Initiative.  The DailyMed Initiative is a partnership between the FDA and the National Library of Medicine (NLM).  Drug manufacturers and distributors provide information about their products to FDA in SPL format, in fulfillment of their obligations for drug listing and certain other regulatory submissions to FDA.  SPL is structured information about a product contained in an XML file.  FDA will index the product information using SPL documents, but will not change the content submitted by drug manufacturers or distributors. Any new or changed SPL documents for a product will be transmitted from the FDA to the NLM each business day.  NLM will maintain the up-to-date SPL documents in an electronic repository.  This repository will be accessible for download at no cost from a publicly available web site.  Healthcare information suppliers will be able to use the information from this repository in their computer systems, allowing access to providers, patients, and the public to reliable, up-to-date information on the products they use.

NLM is the world's largest medical library. The Library collects materials and provides information and research services in all areas of biomedicine and health care. The National Library of Medicine

•  assists the advancement of medical and related sciences through the collection, dissemination, and exchange of information important to the progress of medicine and health;
• serves as a national information resource for medical education, research, and service activities of Federal and private agencies, organizations, and institutions;
• serves as a national information resource for the public, patients, and families by providing electronic access to reliable health information issued by the National Institutes of Health and other trusted sources;
• publishes in print and electronically guides to health sciences information in the form of catalogs, bibliographies, indexes, and online databases;
• provides support for medical library development and for training of biomedical librarians and other health information specialists;
• conducts and supports research in methods for recording, storing, retrieving, preserving, and communicating health information;
• creates information resources and access tools for molecular biology, biotechnology, toxicology, environmental health, and health services research, and
• provides technical consultation services and research assistance.
   

III. Substance of Agreement and Roles and Responsibilities  

The FDA agrees to transmit new or changed SPL documents for a product each business day.  The NLM agrees to make the transmitted SPL documents available the next business day for download by the public at no cost in an electronic repository. The FDA will transmit only those SPL documents it deems acceptable for posting; however, in the event of an error, the FDA may notify the NLM to refrain from posting one or more SPL documents from a transmission that has been received but not yet posted to the repository.

Name and Address of Participating Parties

 A. Food and Drug Administration
  10903 New Hampshire Ave
  Silver Spring, Maryland 20993

 B. National Library of Medicine
  National Institute of Health
  8600 Rockville Pike
  Bethesda, Maryland  20894

IV. General Provisions:  

This is an internal government agreement between FDA and National Library of Medicine and does not confer any rights or benefits to any person or Partner.

V. Resource Obligations: 

This MOU represents the broad outline of the FDA and NLM’s present intent to enter specific agreements for collaborative efforts in areas of mutual interest to FDA and the NLM.  All activities undertaken through the MOU are subject to the availability of personnel, resources, and funds.  This MOU replaces MOU No. 225-05-3000. It does not affect or supersede any existing or future agreements or arrangements among the FDA and NLM.  This MOU does not create binding, enforceable obligations against any Party.  This MOU and all associated agreements will be subject to the applicable policies, rules, regulations, and statutes under which FDA and NLM operate.

VI. Liaison Officers:

A. Contacts for FDA
  
Lonnie Smith
SPL Coordinator
10903 New Hampshire Ave
Silver Spring, MD  20993
  
B. Contacts for NLM

Stuart J. Nelson, MD, FACMI
Head, Medical Subject Headings
BG 1 Dem RM 202G  MSC 4879
6701 Democracy Blvd
Bethesda, MD 20892-4879

Each Party may designate new liaisons at any time by notifying the other Party's administrative liaison in writing.  If, at any time, an individual designated as a liaison under this agreement becomes unavailable to fulfill those functions, the Parties will name a new liaison within 2 weeks and notify the other Party through the designated administrative liaison.

Term, Termination, and Modification:

The agreement becomes effective upon signature of both parties and will continue without expiration.  It may be modified by mutual consent or terminated by either party upon 120 days written notice.

APPROVED AND ACCEPTED FOR NATIONAL LIBRARY OF MEDICINE
Betsy Humphreys
Deputy Director
National Library of Medicine
Date:05/25/2012

APPROVED AND ACCEPTED FOR U.S. FOOD AND DRUG ADMINISTRATION
Jesse Goodman, M.D., M.P.H.
Chief Scientist
Deputy Commissioner for Science and Public Health
Date:05/30/2012