DHHS Eagle graphic
ASL Header
Mission Nav Button Division Nav Button Grants Nav Button Testimony Nav Button Other Links Nav Button ASL Home Nav Button
US Capitol Building
HHS Home
Contact Us
dot graphic Testimony bar

This is an archive page. The links are no longer being updated.

Statement for the Record on Paperwork Elimination Act of 1995
Food and Drug Administration
U.S. Department of Health and Human Services

Before the House Committee on Small Business, Subcommittee on Government Programs
March 27, 1996

Mr. Chairman and Members of the Subcommittee:

The Food and Drug Administration (FDA) appreciates the opportunity to submit this statement for the record. In keeping with the theme you set for the hearing, this statement will focus on FDA's efforts providing for the electronic submission and dissemination of data and our comments on your legislative proposal, H.R. 2715, the Paperwork Elimination Act of 1995.

As you know, FDA's primary statutory mandates are in the Federal Food, Drug, and Cosmetic Act, the Public Health Service Act and the Fair Packaging and Labeling Act. Our mission under these statutes is to protect, promote and enhance the public health by implementing statutory provisions designed to ensure that food is safe and otherwise not adulterated or misbranded; that human and veterinary drugs, human biological products and medical devices are safe and effective; that cosmetics are safe; and that electronic product radiation is properly controlled. FDA-regulated products must be truthfully and accurately labeled and in compliance with all applicable laws and regulations.

While FDA principally serves the general public in its health and safety mission, FDA also recognizes it has responsibilities to the industries that it regulates. Industry demands speedier product approvals to help offset the large sums of research dollars expended to develop new products. The public demands timely access to medical innovations, especially life-saving innovations, but without sacrificing health and safety. FDA sees its mission as meeting both these goals simultaneously. We are using new information technology to better serve the regulated industry which develops the innovative products welfare charged with reviewing and the consuming public which rightfully expects timely access to new or improved products but with the same assurances of their safety and effectiveness as they have come to expect from the FDA.

Congress recognized the need for FDA to adopt modern technologies in 1987 when it added Section 711 to the Food, Drug, and Cosmetic Act directing FDA to "automate appropriate activities of the Food and Drug Administration to ensure timely review of activities regulated under this Act." In 1993, Vice President Gore's National Performance Review (NPR) recognized the power of information technology to reinvent government and reengineer agency practices to increase the speed and efficiency of government functions. The NPR set an objective of expanded use of new technologies and telecommunications to create an "electronic government." And last May, when he signed the Paperwork Reduction Act of 1995 (PRA), President Clinton reemphasized his commitment to reducing the paperwork burden through the use of new technology when he said:

Today, I want to add another dimension to this effort: From this point forward, I want all of our agencies to provide for the electronic submission of every new Government form or demonstrate to OMB why it cannot be done that way. The old way will still be available, but I think once people see how fast and efficient electronic filing can be, we'll see less paperwork and more of these. So, we're trying to do our part to act in good faith the way these Members of Congress intended the executive branch to act.


FDA is using a strategic approach to address the challenges of implementing information technology for the 21st Century. To keep our information systems as flexible and up-to-date as possible, FDA tries to keep its computer systems environment one that is open to evolving technologies. We have an Information Systems Architecture initiative which concentrates on the development of a common information technology infrastructure throughout the Agency. Our objective is to take full advantage of the evolving capabilities offered by information technologies and electronic communication to facilitate information exchange between the FDA, industry, and the public. More readily accessible information; easy-to-use systems interfaces; and fully integrated databases, information systems, and analytical tools will combine to enhance the productivity of FDA personnel and facilitate the exchange of information with industry and the public, for both programmatic and administrative purposes.

While many of the factors that influence FDA's environment will change over the next decade, one thing will not change: the Agency is and will continue to be an information-intensive organization. FDA must collect, analyze, and maintain significant amounts of data collected from pre-market approval and post-market surveillance of regulated products.

Our systems serve both big and small business -- we try to make any system we develop accessible to both. It is FDA's objective to provide the most efficient information systems we can to lighten the reporting burden on business as well as consumers.


FDA's information activities often serve multiple communities simultaneously. However to provide some order in presenting our activities, we will categorize some of our recent activities by the primary client group affected: consumers and users of regulated products, industry generally, and small business specifically.


INTERNET HOME PAGE. The FDA Home Page is an agency initiative, designed to improve the efficiency and effective dissemination of information via the Internet. For example, guidance documents to assist in development of food additive petitions are available through the home page, as is information on food, cosmetics, human and animal drugs, biologics, medical devices and radiological health products. In addition, FDA is beginning to receive information from both industry and the general public via Internet, and is exploring ways to institutionalize and optimize use of this technology.

ADVERSE EVENTS REPORTING. The MEDWATCH program, an upgrade and enhancement of earlier systems, was introduced in June 1993 to enhance the effectiveness of postmarketing surveillance of all medical products regulated by the FDA, e.g., drugs and biologics as well as medical devices and special nutritional products such as medical foods, dietary supplements, and infant formulas. The program has four general goals: 1) to increase awareness of drug- and device induced disease, 2) to clarify what should (and should not) be reported to the agency, 3) to make it easier to report, and 4) to provide regular feedback to the health care community about safety issues involving medical products. The MEDWATCH program is supported by more than 100 organizations - representing health professionals and industry - which have signed on as MEDWATCH partners to help achieve these goals.

To facilitate reporting, there is a one-page, postage-paid, voluntary form for health professionals who choose to report directly to the agency and/or the manufacturer. A 24-hour toll-free number (1-800-FDA-1088) is also available for health professionals to report by phone, to request forms either via fax or mail, or to obtain a copy of the FDA Desk Guide to Adverse Event and Product Problem Reporting, which includes examples of events to report, completed sample forms, and also blank forms with instructions. Providers may also report to the FDA electronically (on-line) by calling 1-800-FDA-7737, or fax a report on 1-800-FDA-0178. Currently the majority of adverse events reports are received via the manufacturers in computer print-out form that have to be re-entered into FDA's data system. The Adverse Events Reporting System (AERS) is an effort to strengthen the database systems and processes of our postmarket surveillance programs. To support the database, we will encourage and facilitate electronic reporting of adverse events by industry and health care providers. The AERS initiative will provide a database of adverse events information and enhanced evaluation capabilities.


VIDEO TELECONFERENCING. Video teleconferencing enhances communications with regulated industry, especially between the product sponsor and the FDA reviewers during the review process. Several small manufacturers have taken advantage of this new technology which allows both parties to see and hear each other during the session in addition to allowing them to modify a submission interactively. This system also provides a medium for training Agency and industry personnel.

FORMS AVAILABILITY. FDA is Participating in efforts of our parent Department of Health and Human Services, currently in the conceptual stage, to make forms accessible via the Internet. This system will give industry direct access to a library of forms they currently must solicit either verbally or in writing.

NEW DRUG AND BIOLOGIC APPLICATIONS. FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have for years been exploring electronic submissions of portions of new drug applications, including data sets and data summaries. CDER has received over a hundred electronic submissions. With the passage of the Prescription Drug User Fee Act of 1992 (PDUFA) Congress established specific goals for reducing the time it takes to review new drug and biologic product applications. Despite the progress made with electronic submissions, the current process for reviewing applications is time-consuming and paper intensive. With money obtained from user fees, the agency has begun the Submission Management and Review Tracking (SMART) Program. SMART currently supports CBER and CDER through several pilot projects. The program will facilitate submission of product applications electronically, and will improve the Agency's ability to process, track, and archive submission data. SMART will provide automated tools to help managers in making informed decisions, determine the status of applications, and assess the efficiency of the review process, and to assist reviewers in accessing, analyzing, sharing, and producing relevant information.

ELECTRONIC RECORDS AND SIGNATURES. In the Federal Register of August 31, 1994, FDA proposed regulations that would define the circumstances which would permit the agency to accept electronic records, electronic signatures, and handwritten signatures executed to electronic records as equivalent to paper records and handwritten signatures executed on paper. These regulations would apply to all records required under FDA regulations (Chapter I, Title 21 of the Code of Federal Regulations). Under the proposed rule, firms could choose to use electronic forms of recordkeeping for records they are required to maintain. Firms could also submit data to the agency electronically when the agency has announced its ability to accept such electronic submissions.

The intended effect of this proposed rule is to promote the optional use of electronic maintenance and submission of information, reduce paperwork burdens, improve data reliability, and enhance agency efficiency and responsiveness in a manner that is compatible with FDA's ability to promote, protect and enhance the public health. This is a significant rule that we are working hard to finalize.


IMPORT SURVEILLANCE. Import brokers are mainly small businesses. Operational and Administrative System for Import Support (OASIS) is an automated system designed to facilitate inspection and clearance of imported products regulated by FDA. The amount of paper import brokers provide to FDA as part of the entry process was reduced by 85% through application of information systems technology. A 1995 cost/benefit study by Booz-Allen and Hamilton shows that the import industry will save more than $1.2 billion over the period from 1994 through 2001 because of paperwork reduction and expediting of the entry process.

In February 1996, 80 percent of all shipments of FDA-REGULATED products processed in the electronic system received a final clearance within minutes after the electronic data was submitted. These short clearance times are a great improvement over the one, two or more days that it took to clear products before automation. This system also allows FDA to focus its scarce resources on those import shipments that are suspected of not meeting regulatory requirements.

ELECTRONIC MEDICAL DEVICE APPLICATIONS. Based on results of a pilot study begun in 1994, the Center for Devices and Radiological Health (CDRH) has started accepting medical device applications in electronic form for Premarket Notifications (so-called 510k's), Premarket Approval (PMA) Applications, and Investigational Device Exemptions (IDE). The applications were developed specifically with the small manufacturer in mind. They do not require expensive, sophisticated equipment. Already a dozen such applications have been processed. one medical device manufacturer has estimated a 20% savings in document submittal time resulting from this approach.

SMALL PURCHASES. Our Office of Facilities, Acquisitions, and Central Services has initiated a pilot project using electronic data interchange (EDI) for product acquisition, soliciting small businesses, receiving quotations and awarding purchase orders electronically for a small number of requirements.

TOLL FREE NUMBERS. 1-800 telephone numbers as well as FAX-on-DEMAND and FLASH FAX, are being used in various programs throughout the agency to expedite information exchange with consumers, health professionals, and the industry. Each of the Agency's thirteen 800 numbers has a target constituency and purpose. Examples include: the Seafood Safety Hotline, MEDWATCH mentioned earlier, the Advisory Committee Hotline, the orphan Product Development Information Line, and lines providing assistance in the areas of drugs, medical devices, biologics and general consumer information. Using these technologies to disseminate information to over a half million callers each year has significantly reduced the paperwork burden on the Agency.


What follows is a short case study of how the agency is changing and adapting its services to industry to keep pace with the rapid change of technology. This chronicles efforts of the Division of Small Manufacturers Assistance in FDA's Center for Devices and Radiological Health (CDRH), to assure that any use of new technologies is of advantage to the small device manufacturer.

ELECTRONIC DOCKET. In 1994 CDRH established an Electronic Docket which includes publicly available documents such as guidance memoranda, talk papers, and press releases. A comparison of accesses to the Electronic Docket with the Public (paper) Docket found the Electronic Docket to be considerably more popular, with thousands of accesses a month on the Electronic Docket, compared to tens of accesses to the public docket. These findings resulted in discontinuation of the paper docket. The major advantage of the electronic docket was the addition of 510k application status listings. Small manufacturers no longer had to telephone a reviewer to find out the status of their Premarket Notification (510k) but could find out via simple access from a personal computer.

CDRH INTERNET ROME PAGE. With the introduction of the Internet CDRH decided to convert the Electronic Docket to make that same information available on CDRH's Home Page on the World Wide Web. The advantage to the small manufacturer is that more information is available in a more easily searchable manner. Statistics show that this mechanism is now taking precedence over the Electronic Docket, which may be phased out in the near future.

In summary, as demonstrated by the listing of alternative technologies and the case study, while many of the factors that influence FDA's environment will change over the next decade, one thing will not change: the Agency is and will continue to be an information-intensive organization. FDA must collect, analyze, and maintain significant amounts of data from pre-market approval and post-market surveillance of regulated products. The judicious implementation of alternative technologies will be an absolute necessity for the agency to gain the efficiencies needed to enhance our services to the public and the regulated industry within the budget constraints of the foreseeable future.


We have one technical comment. In Section 5(a) of the proposed legislation, the words "when appropriate" should be inserted before the semicolon. This change is consistent with the wording of the other sections of the proposed legislation and is necessary because, in some cases, electronic maintenance, submission, or disclosure of information would not serve the purposes of the Food, Drug, and Cosmetic Act and its regulations; for example, it is important that FDA be able to continue to require that low acid canned foods be physically marked with a can code. This is critical in the event of a manufacturing or handling failure that requires the identification of potentially hazardous product.

If we may paraphrase, the stated purpose of H.R. 2715 is to promote the sponsorship and use of alternative information technologies to: (1) minimize the burden of federal paperwork demands on small businesses, and (2) more effectively enable Federal Agencies to achieve the purpose of the Paperwork Reduction Act. As you saw from the list of highlights above, FDA has been working for many years to incorporate alternative information technologies in our system. As you know, these types of changes do not happen quickly. They take planning and money. For a number of years, the agency has been investing some of our scarce resources in this large effort to take firmer control of the many demands being made on us. It is not clear what additional impetus the provisions of H.R. 2715 would provide. We are already moving in the direction envisioned by H.R. 2715 propelled by the needs of our clients for more information provided as quickly as possible, the budgetary constraints of our times demanding that we seek more efficient means of fulfilling our mission, and encouraged by Section 711 of the FDC Act, the National Performance Review and most recently by the President's own statement.

Thank you again for giving us the opportunity to present our views on this important topic.

Privacy Notice (www.hhs.gov/Privacy.html) | FOIA (www.hhs.gov/foia/) | What's New (www.hhs.gov/about/index.html#topiclist) | FAQs (answers.hhs.gov) | Reading Room (www.hhs.gov/read/) | Site Info (www.hhs.gov/SiteMap.html)