We make a large number of documents and information available to a variety of audiences. The major types, with examples of each, are provided here.
Public Communications About Risk
As part of our mission to protect the public health and safety, we provide the public with a wide variety of information on risk, including information on food safety and the risks involved with using medical products. Some examples of our communications are listed here.
- Consumer advice and fact sheets (for example, News Release No. 0020.01, January 2001 provides advice to consumers to reduce the risk of illness from foodborne Listeria monocytogenes)
- "Dear Health Care Professional" letters (for example, Agency August 2001 letter to health care professionals warning about rhabdomyolsis, a serious, potentially fatal adverse effect of all statin drugs)
- Public health and safety alerts (for example, "FDA Announces New Alcohol Warnings for Pain Relievers and Fever Reducers," October 1998; "Seniors and Food Safety -- Preventing Foodborne Illness," May 1999; "Learning About Lasik Eye Surgery," on the Internet; "FDA Patient Safety News," a video targeting hospitals; "Tips and Warnings for Consumers About Buying Medicines and Medical Products Online," on the Internet; "An Important Message for Pregnant Women and Women of Childbearing Age About the Risk of Mercury in Fish," March 2001; "FDA Public Health Notification: Reducing Radiation Risk from Computed Tomography for Pediatric and Small Adult Patients," November 2001)
- FDA Talk Papers (for example, FDA Announces Availability of Vibrioparahaemolyticus Risk Assessment, January 18, 2001)
- Various subject matter brochures intended for consumers. Some are produced as low-literacy brochures aimed at consumers with no more than a fifth-grade reading level. Some are also produced in other languages, particularly in Spanish. Some are mailed directly to specific audiences; some are disseminated at large professional meetings (for example, "Reprocessing of Single-Use Medical Devices by Hospitals" (November 2000), "Buying Contact Lenses on the Internet, by Phone, or by Mail" (August 2001)).
- Posters are distributed to health clinics and schools with consumer information on FDA-related health issues.
Like many Federal agencies, we engage in rulemaking. This process includes publishing a proposed rule and explanatory material in the Federal Register, obtaining public comment, and publishing a final rule and response to the comments. Some examples include:
- Additional Criteria for Classifying Over the Counter Drugs as Generally Recognized as Safe and Effective and Not Misbranded, a final rule that published on January 23, 2002
- Medical Devices; Device Tracking, a final rule that published on February 8, 2002
- State Certification of Mammography Facilities, a final rule that published on February 6, 2002
- Implantation or Injectable Dosage Form New Animal Drugs: Trenbolone and Estradiol; a final rule that published on February 7, 2002
- Foreign Establishment Registration and Listing, a final rule that published on November 27, 2001
- Substances Affirmed as Generally Recognized as Safe: Menhaden Oil; a proposed rule that published on February 26, 2002
- Hazard Analysis and Critical Control Point (HACCP): Procedures for the Safe and Sanitary Processing and Importing of Juice; a final rule that published on January 19, 2001
As part of the rulemaking process, we may also publish advanced notice of proposed rulemaking documents (ANPRs) and direct final rules.
When we evaluate applications for approval to market medical products, we produce reviews of the data collected, analyzed, and submitted by applicants. On approval of drugs2, we compile our reviews into an approval package that provides the basis for the Agency clearance of a decision to approve a product. To provide as much information as possible to health care practitioners and consumers so they can make informed decisions about treatment, we make the medical product approval packages, including generic drug approvals, available on the Internet. An approval package can range from 100 to more than 1,000 pages, redacted to remove confidential and trade secret information. Contents usually include individual discipline reviews; correspondence between the company and FDA; administrative documents; and labeling. For example, the package for Clarinex [desloratadine], an antihistamine to treat seasonal allergic rhinitis, was approved on December 21, 2001. We posted the 500-page package on the Internet on February 12, 2002.
We also post on the Internet, for animal drug products, an FOI summary of the approval and for device premarket approvals, a detailed summary of safety and effectiveness, the approval order, and the draft labeling.
Food and Color Additives
When we evaluate applications for premarket approval of food additives and color additives, we produce reviews of the data and analyses submitted by the applicant. For direct food additives and color additives, we publish a final rule in the Federal Register explaining the basis for Agency approval of the product and issuance of a regulation in the U.S. Code of Federal Regulations. For other food additives, we announce their approval via Internet listings that are updated at least monthly. In all cases, the published listings include specifications and use limitations necessary to ensure the safe use of the product. In addition, the documents and information that form the basis for Agency approvals are available under the Freedom of Information Act.
Guidance and Regulatory Assistance
We develop guidance and other policy documents usually with input from the public, to assist industry, consumers, hospitals, reviewers, and other health care related organizations and individuals interested in our statutes and regulations. In addition, we provide procedural guidance to our field offices. In compliance with our policy involving good guidance practices, under 21 CFR 10.115, we publish notices announcing the availability of guidances in the Federal Register, and make the guidances available in the public docket and on the Internet. Some examples of guidances are provided here:
- Guidance to Hospitals, Nursing Homes, and Other Health Care Organizations -- FDA Public Advisory on the risks of death and injury related to medical gas mix-ups (April 2001)
- Small Business Compliance Guides -- guidances to help small businesses; required by the Regulatory Flexibility Act (5 U.S.C. 602) for all rulemakings that will have a significant impact on small entities (for example, Sterility Requirement for Aqueous-Based Drug Products for Oral Inhalation -- Small Entity Compliance Guide, November 2001)
- Formal Dispute Resolution: Appeals Above the Division Level (March 2001)
- Food Security Guidance (January 2002)
- Food Code; 2001 Revision (December 2001)
- Guidance for Industry: Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing, VICH GL23
- Guidance on Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals (August 2000)
- The Policy Guidance Help System (January 2000; revised November 2001) -- a computerized system containing all Mammography Quality Standards Act regulations and final guidance (Internet and as a stand-alone downloadable program)
- CDRH develops "Plain Talk" guidance on how to comply with our regulations and provides a unique interactive Website called "Device Advice" to answer specific device related questions.
- Compliance Policy Guides are issued to the field offices to ensure that our regulations and policies are followed consistently. These Compliance Policy Guides are made public and treated as guidances.
- Regulatory Procedures Manual provides FDA procedural guidance and instruction for use by FDA and the public. The manual is publicly available and is treated as guidance.
We also develop reports on a variety of topics. Some examples include:
- Managing the Risks From Medical Product Use -- Report to the FDA Commissioner from the Task Force on Risk Management (May 1999)
- Prescription Drug Marketing Act of 1987 -- Report to Congress (June 2001)
- FDA Fiscal Year 2002 Congressional Budget Request (annual report)
- Import Detentions Reports (IDRs) -- IDRs provide information on the products detained by the Agency (that is, products for which our District Offices have issued a "Notice of Detention and Hearing"). The IDR is generated from data collected by FDA's Operational and Administrative System for Import Support (OASIS) and is updated monthly and is posted on the FDA website for a period of time (on the average of 12 months). Archived data are not available on the Internet but is available under the Freedom of Information Act.
- FDA Enforcement Report -- Published weekly, this online publication contains information on recalls and other actions taken in connection with Agency regulatory activities.
- Mammography Facility Adverse Event Report -- an annual report of adverse actions taken against mammography facilities issued to help health professionals and consumers in evaluating the performance of their mammography facilities
Citizen Petitions and Responses
When citizens petition the FDA to address an issue, we write a response to the petitioner explaining our position. Although these responses are letters addressed to individuals or organizations, the petitions and our responses are made available through the public docket and often on the Internet. In recent years, we have responded to an average of 250 citizen petitions per year. For example, on February 15, 2002, we issued a response to a petitioner asking us to refrain from approving a generic version of an antibiotic (Ceftin) if the generic drug product's active ingredient were wholly or partially in crystalline form.
Press Items and Publications
The Agency releases much information through the press and related media. Some examples include:
- News releases (for example, HHS and USDA Release Listeria monocytogenes Risk Assessment and Listeria monocytogenes Action Plan, Release No. 0020.01, January 18, 2001; Cape May Foods Recalls Chopped Clams Because of Possible Health Risk, January 15, 2002)
- FDA Consumer Magazine (bimonthly magazine targeting consumers) and reprints of selected feature articles from FDA Consumer.
- FDA Veterinarian (bimonthly newsletter targeting veterinarians and the food animal industry)
- Frequently Asked Questions: What Can I Do to Protect Myself from Food Poisoning? (Internet only)