HHS Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated to the Public. II. Scope and Applicability of Guidelines

10/01/2002

FDA is a scientific regulatory agency that regulates one trillion dollars worth of consumer goods each year. This amounts to more than 20 percent of all consumer spending. FDA regulates most food that we eat, all prescription drug and over-the-counter drug products that we take, and all medical devices that we use. For foods, we ensure that products are safe, wholesome, sanitary, and properly labeled. For drugs, we ensure the products are both safe and effective for use; and for medical devices, there is a reasonable assurance of their safety and effectiveness. We also are responsible for ensuring that electronic and radiation-emitting equipment, such as x-ray machines, microwave ovens, and metal detectors, are safe for use. We certify and inspect annually all mammography facilities. We regulate animal feed and most animal drugs. We ensure that cosmetics are labeled honestly and cause no harm. Our regulatory activities include inspection and surveillance of marketed products, standard setting, bioresearch monitoring, and human subject protection. We also conduct research in support of our regulatory programs.

FDA, which employs about 10,000 people, is organized primarily by centers:

  • Center for Biologics Evaluation and Research (CBER)
  • Center for Devices and Radiological Health (CDRH)
  • Center for Drug Evaluation and Research (CDER)
  • Center for Food Safety and Applied Nutrition (CFSAN)
  • Center for Veterinary Medicine (CVM)
  • National Center for Toxicological Research (NCTR)
  • Office of the Commissioner (OC)
  • Office of Regulatory Affairs (ORA)
  • Center for Tobacco Products (CTP)

Our Office of the Ombudsman, which is responsible for monitoring complaints regarding information dissemination and our response to those complaints, resides in the Office of the Commissioner.

As described in detail in the paragraphs that follow, we disseminate many different types of information to a wide variety of audiences, including the regulated industry, health care professionals and organizations, consumers, patients, other governmental agencies, and international organizations and agencies. Information dissemination is an important part of our mission to promote and protect the public health. FDA recognizes that public access to high quality information is critical to achieving this mission and public input, in turn, improves the quality of the information we disseminate.

Because of the nature of this information, our goal has been and remains to ensure that all the information we disseminate meets the high standards of quality (including objectivity, utility, and integrity) described in the OMB and HHS Guidelines. As discussed in detail in Section V, we have established several policies, standards, and processes to ensure the quality of the information we make available to the public. FDA also will ensure that information collected under the Paperwork Reduction Act of 1995, 44 U.S.C. chapter 35, will be collected, maintained, and used in a manner consistent with the OMB and HHS Guidelines and this guidance document. With the following specific exceptions, the OMB Guidelines apply to most categories of FDA-disseminated information (see discussion in following sections):

  1. Documents relating to internal FDA procedures
  2. Internal government correspondence
  3. Correspondence with individuals that is not normally made public
  4. Press releases (unless they contain new substantive information not covered by previous information dissemination)
  5. Archival records
  6. Distributions intended to be limited to subpoenas or adjudicative documents including findings and determinations made in the course of an administrative proceeding pursuant to 21 CFR Parts 10, 12, 13, 14, 15, 16, 17 and 19.
  7. Scientific publications that only contain the views of the authors and are not used to support an official agency position
  8. Responses to requests for information under the Freedom of Information Act (FOIA), the Privacy Act, the Federal Advisory Committee Act, or other similar laws.

In the pages that follow, we describe the types of information we disseminate (Section III), the methods we use to disseminate this information (Section IV), and the quality assurance policies, standards, and processes that have been put in place to ensure the quality of the information we distribute (Section V). Some of the information described below may include information that falls under one of the types of information specifically excluded above. To the extent that information in one of the categories listed below includes information listed in one of the exceptions, the OMB Guidelines do not apply. In Section VI, we discuss the procedures to be used by persons who want to request that information we have disseminated be corrected. Section VII discusses the types of information we have identified to be influential according to the OMB Guidelines and the principles we apply to information that will be disseminated regarding risks to human health, safety, and the environment. The principles that are used have been adapted from the quality principles applied by Congress to risk information pursuant to the Safe Drinking Water Act Amendments of 1996 (42 U.S.C. 300g-1(b)(3)(A) and (B)). Section VIII describes some special circumstances that may apply to certain information dissemination activities.

The pre-dissemination review described in the HHS guidelines only applies to information disseminated on or after October 1, 2002. The administrative mechanism for correction applies to information that the agency disseminates on or after October 1, 2002, regardless of when the agency first disseminated the information.