Guidelines for Ensuring the Quality of Information Disseminated to the Public
F. � Food and Drug Administration
This guidance provides the information quality guidelines for the Food and Drug Administration (FDA) requested under the Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by Federal Agencies (OMB Guideline). 1 The OMB Guidelines implement section 515 of the Treasury and General Government Appropriations Act for Fiscal Year 2001 (Pub. L. 106-554; H.R. 5658). The OMB Guidelines direct agencies to issue their own information quality guidelines ensuring and maximizing the quality, objectivity, utility, and integrity of information, including statistical information, disseminated by the agency. This guidance is part of the U.S. Department of Health and Human Services (HHS) implementation plan developed to comply with the OMB Guidelines. The principles described in the HHS plan and OMB guidance are incorporated by reference into this guidance.
This guidance describes the nature of the information disseminated by the FDA and explains FDA's standards, policies, and procedures for ensuring the quality of the information it disseminates. The guidance also explains the administrative mechanisms that are in place to enable persons to seek and obtain correction of information maintained and disseminated by the FDA that they believe does not comply with the OMB and HHS Guidelines and this guidance.
I. � Agency Mission
The Agency's mission, as defined in Section 406 of the Food and Drug Administration (FDA) Modernization Act of 1997, is as follows:
The Administration shall --
II. � Scope and Applicability of Guidelines
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:
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):
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.
III. � Types of Information Disseminated
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.
As part of the rulemaking process, we may also publish advanced notice of proposed rulemaking documents (ANPRs) and direct final rules.
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.
IV. � Types of Dissemination Methods
Transparency is one of the Agency's key goals. It is critical that our audience understand what we do, how we do what we do, and why we do something. Because our audience is so diverse, we use a variety of media to disseminate public health and safety information. Some examples are provided here:
V. � Agency Quality Assurance Policies, Standards, and Processes
As described in the HHS Implementation Plan, as one of the HHS operating divisions, we have established a number of quality assurance policies, standards, and processes for ensuring the quality of the information we disseminate to the public. Our documents undergo a rigorous review and clearance evaluation according to pre-established procedures, documented in our regulations and guidances.
Generally, Agency documents are cleared as follows:
In addition to these clearance procedures, we use a number of mechanisms to ensure the quality of the information we disseminate. FDA reviews the quality (including the objectivity, utility, and integrity) of information before it is disseminated and treats information quality as integral to every step of the development of information, including its creation, collection, maintenance, and dissemination. Quality, as defined in the OMB Guidelines, encompasses (1) utility, the usefulness of the information to its intended users, including the public; (2) objectivity, whether information is being presented in an accurate, clear, complete, and unbiased manner; and (3) integrity, the information is protected from unauthorized access or revision.
We developed our good guidance practice (GGP) policy as a result of public request. Congress later enacted the policy into law, and we codified our GGP policy in our regulations at 21 CFR 10.115. The GGPs describe our procedures for developing, issuing, and using guidance documents and include detailed procedures on how members of the public can suggest areas for guidance development, submit drafts of proposed guidance documents, and request the revision or withdrawal of an existing guidance document. We also maintain a guidance Agenda, which is a list of guidances we are planning to develop in the coming year. We post the list on the Internet and publish it annually in the Federal Register. We publish the Agenda to keep the public up-to-date on guidance development plans and solicit input from the public on what guidances are needed.
In addition, we are subject to the Freedom of Information Act and the Electronic Freedom of Information Act Amendments (5 U.S.C. 552), which provide for the dissemination of information to members of the public and posting on the Internet certain information that is, or is likely to be, responsive to multiple information requests.
In accordance with the Regulatory Flexibility Act (5 U.S.C. 602), the General Services Administration publishes a semiannual regulatory agenda describing the regulatory actions being developed. The Secretary welcomes comments on this agenda and suggestions for improvements and initiatives.
We also take steps to ensure that our regulatory decisions are based on objective information. If we rely on information submitted to us by third parties in support of an application for product approval or in a rulemaking proceeding, we make sure that this information meets the appropriate standards for quality and objectivity. We have a number of regulations and guidances that set standards for the generation of information in support of regulatory decisions. For example, the supporting data may be generated in new research using good laboratory practices (GLPs)3, in clinical studies subject to Good Clinical Practices (GCPs)4, in reviews of existing information obtained primarily from peer-reviewed scientific literature, or obtained from surveys based on widely accepted scientific survey techniques. Interpretations of quantitative results of Agency studies are commonly subjected to statistical analyses. Even though we may be unable to fully disclose the information on which our actions are based because it has been submitted by a third party with a proprietary interest in maintaining its confidentiality, we make special efforts to ensure that the information submitted meets these standards for objectivity and is of high quality.
The methods by which we ensure the objectivity of the information for some of our major regulatory activities are described here.
We develop regulations and guidance documents to help ensure that the data submitted to us result from the best available studies, that the studies are conducted in accordance with sound and objective scientific practices, and that the data are collected using scientifically accepted methods. For example, FDA regulations specify the format and content of the clinical studies that are submitted in support of an application to market a new drug product. They specify how the data are to be collected and the types of analyses that are to be performed. In the case of biological products, we have developed guidance on the format and content of reports on clinical studies that are submitted to the Agency. Other FDA guidances provide detailed descriptions of appropriate methodologies, analyses, and procedures.
Since the early 1990s, we have been involved in an intensive international effort to harmonize technical requirements for the conduct of studies in support of marketing applications and the content and format of applications with the goal of allowing the submission of a common application for marketing around the world. The International Conference on Harmonisation for Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) brings together scientific experts from different countries to develop a consensus on the appropriate requirements. We also are engaged in international activities in the device, food, and animal drug areas. For example, International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Products (VICH) is the veterinary counterpart to ICH. The Global Harmonization Task Force (GHTF) is working to harmonize device regulations and guidance. The Codex Alimentarius committees are working to harmonize international food regulations. Many agreements reached are then embodied in regulations issued through notice-and-comment rulemaking and in guidance documents that describe in more detail appropriate ways to comply with the regulations. As a result of these efforts, most of our actions on product approval applications are consistent with international standards for data collection and quality of analysis.
We also are in the process of developing good review practices (GRPs) for drug reviews with the goal of making our drug product review process consistent across all divisions in the Center for Drug Evaluation and Research. A major emphasis of the GRP project is to ensure that the reviews we make available to the public are consistently formatted and clearly written so interested individuals can access important health and safety information.
We frequently consult with scientific experts on product approval applications and broader issues. We have 31 standing Advisory Committees5, whom we routinely consult on whether the data in particular applications are sufficient to support an approval decision. As noted above, we incorporate our approval decisions into drug approval packages and device summaries of safety and effectiveness that contain our analyses of the submitted data. These packages and summaries do not include confidential commercial, trade secret, and other information exempt from disclosure when we place them on the Internet.
We collect information to support our food safety activities through many sources, including research, risk assessment, inspection and surveillance, peer-reviewed literature, and advisory committee opinions. We conduct in-house research on a variety of food safety topics and also fund a substantial amount of extramural research every year. The Center for Food Safety and Applied Nutrition (CFSAN) participates in collaborative research on processing and packaging through the National Center for Food Safety and Technology, which is a consortium of government, industry, and academia, and we coordinate food safety research activities through a cooperative program with the University of Maryland. Topics of both internal and external research interest are determined by CFSAN's 3-year research plan. This plan is developed in conjunction with other federal agencies to prioritize our research to inform our most critical food safety efforts and to avoid duplication of effort.
We also gather information for certain food safety activities through risk assessment. Risk assessments are a very useful tool for evaluating the benefits of pursuing various rulemaking strategies. To date, we have conducted or been involved in four risk assessments related to food safety. We conducted a joint risk assessment with USDA on Salmonella Enteritidis in shell eggs that was published in 1998. More recently, we published risk assessments on the Public Health Impact of Vibrio parahaemolyticus in Raw Molluscan Shellfish and the Relative Risk to Public Health from Foodborne Listeria monocytogenes Among Selected Ready-to-Eat Foods. We also intend to use the risk assessment model developed for USDA by Harvard University on bovine spongiform encephalopathy to determine the risk reduction outcomes of various rulemaking efforts we are considering.
We gather data for FDA food safety activities through use of surveys designed for specific purposes and advisory committee opinions. The surveys include the Health and Diet Survey and the Total Diet Study, both of which are used in our development of safety and exposure assessments for various compounds. When information is not available through research or literature, we have several advisory committees that are able to render expert opinions on particular matters. These committees include the National Advisory Committee on Microbiological Criteria for Foods, which considers a variety of food safety issues for FDA and USDA, and FDA's Transmissible Spongiform Encephalopathy Advisory Committee (TSEAC), which specifically considers issues related to TSE diseases. Finally, our food safety activities are informed through the participation of FDA scientists in a variety of professional organizations such as Codex Alimentarius, International Commission on Microbiological Specifications for Foods, Institute of Food Technologists, American Society for Microbiology, the International Association for Food Protection, Society for Toxicology, American Chemical Society, the National Academy of Sciences, International Life Sciences Institute, and editorial review boards of several publications including Journal of Food Protection and Journal of Food Science.
A separate system is used to monitor the safety of vaccines after approval. The Vaccine Adverse Events Reporting System (VAERS) is a cooperative program for vaccine safety of the FDA and the Centers for Disease Control and Prevention (CDC). VAERS is a postmarketing safety surveillance program, collecting information about adverse events that occur after the administration of U.S. licensed vaccines. Other systems are in place to monitor the quality of manufacturing of drugs and biological products and blood related products.
Adverse events related to either product problems or issues associated with the use of the device are reported by both manufacturers and device users. Although both the manufacturing and user communities have mandatory reporting requirements for device-related problems, this surveillance system is virtually a passive system that depends on the reporter to recognize an event and follow through in reporting. This passive surveillance system is augmented by a more active reporting network composed of hospitals and other health care facilities, where reporting is encouraged and supported through educational activities and feedback. Adverse event reports are immediately triaged to quickly identify problems that require urgent attention; all reports are then reviewed by clinical analysts and others with appropriate expertise to decide if further follow-up is needed.
Adverse event reports related to animal drugs are maintained in a separate database, the Center for Veterinary Medicine's adverse drug event reporting system (ADERS). This database is used to identify adverse effects not detected during pre-market testing of FDA-approved animal drugs and to monitor the performance of drugs not approved for use in animals. The ADERS depends upon the detection of an adverse clinical event by veterinarians and animal owners, the attribution of the clinical event to the use of a particular drug ("suspect" drug), and the reporting of the ADE either to the manufacturer of the suspected drug or directly to FDA. Data from these ADE reports are reviewed, coded and entered into the computerized ADERS.
The ADE for veterinary drugs generates current information on the safety and efficacy of veterinary drugs. These data expand the knowledge base used in animal drug approvals and ultimately contribute to reducing the risks associated with veterinary medical products. Summary information from this system is available to support decisions about disseminating information on product safety.
Each FDA Center and Office also uses several strategies to ensure the quality (including objectivity) of its extramural research and the accuracy of data collected in association with these studies. For example, study protocols may be developed collaboratively by principal investigators and program officials. A project advisory group (PAG) consisting of experts who oversee extramural research projects in a particular field may be appointed.
To ensure the data are accurate and timely, FDA monitors research progress at the project level on a recurring basis. FDA quality assurance staff assess experiments that fall within the scope of FDA's Good Laboratory practice guidelines for compliance. Additionally, agency scientists publish research manuscripts, book chapters, and abstracts in recognized, peer-reviewed scientific journals. FDA's research findings are also presented at national and international scientific meetings, many of which are sponsored or co-sponsored by FDA. Many FDA scientists also serve on international scientific advisory boards.
All data submitted for inclusion in our systems must be accompanied by information about origin, sensitivity, reliability, and the date of most recent revision. We have systems in place to ensure that data modifications are accomplished in a managed and controlled manner and that all information is protected from unauthorized access, revision, corruption, or falsification.
Transactions affecting sensitive or valuable information can only be processed if the originating individual or system has been validated as authorized to submit such transactions. Additionally, transactions must be initiated only through source documents or computerized messages in which the originating individual or system is clearly identified. All transactions intended for input into a multi-user production computer system must first be subjected to reasonableness checks, edit checks, and/or validation checks.
Transactions that fail such checks must either be:
Management has established and maintains preventive and detective security measures that ensure that our information is protected from undetected alteration. All rejected input transactions are placed in a suspense file and listed in exception reports until they are successfully resubmitted for processing. Resubmission and corrections are subject to the same validation procedures that original input transactions receive. Management reviews the reasonableness and accuracy of all changes to internal records. If a client or customer brings record errors to our attention, an investigation of the errors is initiated promptly.
The Office of Public Affairs provides guidance to the Agency on best communications principles and practices to help assure that public messages are accurate, understandable and consistent with current Agency policies. The quality, objectivity, utility and integrity of information posted on the FDA Internet is assured by the internal clearance process used to clear printed documents.
VI. � Agency Administrative Complaint Procedures
If you request a correction of any information disseminated by us, we would appreciate it if you clearly designate the request as a request for correction of information under this guidance and the OMB and HHS Guidelines. You should use the following format for your request:
Food and Drug Administration
5600 Fishers Lane
Room 14B03, HF-7
Rockville, MD 20857
FDA regulations at 21 CFR 10.75 provide a mechanism for any interested person (a person who submits a petition, comment, or objection, or otherwise asks to participate in an informal or formal administrative proceeding or court action) to obtain formal review of any Agency decision or action by raising the matter with the supervisor of the employee who made the decision. These procedures can be used to submit an initial complaint about an FDA information dissemination. If the issue is not resolved at the primary supervisory level, the interested person may request that the matter be reviewed at the next higher supervisory level. This process may continue throughout the Agency's chain of command, through the centers to the Commissioner of the FDA.
Regulations for dispute resolution during the application review process (21 CFR 312.48; 314.103; and 814.42 (d), 814.46(c), 814.112(b), and 808.25 (e)) specify procedures similar to those outlined above. CDRH also established a Medical Devices Dispute Resolution Panel to hear scientific disputes. Regulations for CDER and CBER also provide that a sponsor may request that we seek the advice of outside experts. In addition, we may refer major issues to an appropriate advisory committee for its recommendations (�� 312.48(c)(3) and 314.103(c)(3)).
Several guidances explaining the dispute resolution process also are available:
Finally, 21 CFR 5.200 provides for the establishment of an Agency ombudsman. We have established an Ombudsman Office within the Office of the Commissioner, and each center has identified or is identifying an ombudsman. Information about when and how to contact an Agency or center ombudsman can be found on our Internet site7. We encourage interested parties who may be reluctant to contact a program person in a specific program, division, office or center to feel free to contact a center or Agency ombudsman.
Existing public comment procedures for rule-makings and other formal agency actions already provide well established procedural safeguards that allow affected persons to raise information quality issues on a timely basis. Accordingly, FDA will use these existing procedures to respond to information quality complaints that arise in this process.
In cases where the agency disseminates a study, analysis, or other information prior to the final agency action or information product, requests for correction will be considered prior to the final agency action or information product in those cases where in the agency's judgment issuing an earlier response would not unduly delay issuance of the agency action or information product and the complainant has shown a reasonable likelihood of suffering actual harm from the agency's dissemination if the agency does not resolve the complaint prior to the final agency action or information product.
You should be aware that you bear the "burden of proof" with respect to your request for correction.
VII. � Influential Scientific, Financial, and Statistical Information
As illustrated by the number and types of information we disseminate and the variety of methods we use to disseminate them, it is clear that we strive for a high degree of transparency with regard to all of our information dissemination activities. The OMB Guidelines, however, apply special quality standards to the dissemination of information that is considered influential. Such information must meet high standards of transparency of the data and methods used to facilitate the reproducibility of such information by third parties. As defined below, influential scientific, financial and statistical information that FDA disseminates will meet the high standards in the OMB Guidelines for such information.
For purposes of this guidance, influential information is defined as disseminated information that results from or is used in support of agency actions that are expected to have an annual effect on the economy of $100 million or more or will adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local or tribal governments or communities. It should be noted that the definition applies to "information" itself, not to decisions that the information may support. Even if a decision or action by FDA is itself very important, a particular piece of information supporting it may or may not be "influential."
Two examples of what FDA considers to be influential information follow.
If information that meets the criteria for influential information is disseminated, the OMB Guidelines provide that it must meet certain higher standards of transparency and methods to facilitate the reproducibility of information by qualified third parties. When we disseminate information, but particularly in those cases involving influential information, we strive to ensure that the information is accurate and unbiased, as well as substantially reproducible and replicable. This goal is accomplished by using reliable data sources and sound analytical techniques, and by employing a high degree of transparency about the data, methods, measures, assumptions and limitations used to develop the information to facilitate reproducibility by third parties. Our goal is to provide a clear explanation of the assumptions and data upon which we base our conclusions, the criteria used to determine the suitability of the data for use, the methods used in our analysis, and the conclusions we have drawn.
Because of legal obligations to maintain the confidentiality of data supplied by third parties, there may be instances when original or supporting data may not be available to the public. In such cases, we will disclose the specific data sources used and the specific quantitative methods and assumptions employed. We will also conduct especially rigorous robustness checks of any models used in the analysis and the analytic results so that there will be a high degree of confidence in the results.
Biases, if any, will be revealed. All assumptions used in the analysis, the scientific rationale, and data used to estimate the impact of the various factors influencing the analysis should be clearly stated. This ensures that biases will be eliminated or minimized and that any introduced biases will be clearly identified.
Clarity includes ensuring the information disseminated is clear and understandable. When detailed technical information is needed to provide sufficient information so that a qualified third party could reproduce the analysis, the resulting document may be lengthy and difficult the public to understand. One approach that can provide additional transparency in such cases is to develop an interpretative summary document as a companion to the technical analysis. The summary document can provide a non-technical explanation of the data, process, results, and conclusions in a manner that the public can understand. As discussed under "Objectivity," we have a strong commitment to writing all our new documents in plain English. As we revise and update existing documents, we will ensure that they are written in plain English. Our goal is to make our written communications more understandable.
A participatory process should be used. The process for generating information defined as influential should be transparent. One approach is to invite public comment on the information to be disseminated and encourage stakeholders to submit scientific data and information that can be used in preparing the information. As appropriate, we will solicit advice and opinions of advisory committees as well as peer review from experts within and outside of the agency. To the extent practicable under confidentiality laws, we will strive to make supporting data and analyses available to the public for technical review and comment. This can be accomplished by posting the information on our web pages and providing printed copies as requested.
The OMB Guidelines provide that in addition to the ordinary standards for utility, objectivity, and integrity that apply to dissemination of information, special considerations must be taken into account in certain risk assessments, i.e., those that provide the basis for the dissemination of influential information. The Guidelines state that "With regard to analysis of risks to human health, safety, and the environment maintained or disseminated by the agencies, agencies shall either adopt or adapt the quality principles applied by Congress to risk information used and disseminated pursuant to the Safe Drinking Water Act Amendments of 1996 (SDWA) (42 U.S.C. 300g-1(b)(3)(A) and (B)).
The SDWA risk assessment principles are as follows:
Many of our actions are based on scientific experts' judgments using available data, are essentially qualitative, and are generally carried out for non-cancer-causing hazards. Such assessments provide useful answers in most instances that are sufficient for regulatory purposes, and much more elaborate, quantitative estimates extrapolating beyond the data are unnecessary. For example, we may issue regulations on submission requirements for product approval applications, electronic submission of product labeling, or periodic reporting by manufacturers of adverse events from drugs; devices; and biologics, including blood, vaccines, and tissues. Regulations like these do not always lend themselves to the types of quantitative risk assessments contemplated by the Safe Drinking Water Act principles.
Other actions are based on research and supporting data that are generated outside FDA. For example, most product approval actions are based on scientific studies conducted by sponsors seeking marketing approval in accordance with our regulations and guidance documents. Our regulations and guidance documents describe sound scientific practices for conducting human and animal studies of medical products and analyzing the resulting data. Most information in these studies is considered confidential commercial information and is closely held by the sponsors. As a result, formal peer-review of the data is rare. However, for certain drug approval applications, the safety and/or effectiveness information is presented to scientific advisory committees for recommendations. Evaluations of food safety and nutritional data are also presented to scientific advisory committees.
As a result, we have adapted the general principles for risk assessments from the SDWA to fit these situations. The principles we intend to apply to risk assessments involving the dissemination of influential information affecting product approval actions or regulations that do not lend themselves to quantitative risk assessment are as follows:
In situations requiring a quantitative risk assessment, we generally follow basic risk assessment principles in the NAS paradigm of 1983. Our needs for quantitative risk assessments range over a wide variety of hazards including physical hazards encountered during use of a medical device, food chemical residues, and antimicrobial resistance genes in bacteria. Thus, we also ascribe to the statement from NAS when it revisited the risk assessment process in 1994 (Science and Judgment in Risk Assessment, NAS 1994): "Risk assessment is not a single process, but a systematic approach to organizing and analyzing scientific knowledge and information. "In each of the areas we regulate, we apply risk assessment practices to the specific task that are widely accepted among relevant domestic and international public health agencies.
For quantitative risk assessments in support of the dissemination of influential information, FDA intends to apply the following principles:
VIII. � Special Considerations for Agency Dissemination
Under certain circumstances, we may need to disseminate information without fully applying the principles for ensuring the quality, objectivity, utility and integrity of the information outlined above. Even in these cases, however, FDA intends to use its internal review process to evaluate the data received and the information it plans to disseminate to ensure to the degree practicable the accuracy, objectivity, and transparency of the relevant information, and will entertain requests for correction after the exigent circumstances have passed. The specific situations where this may occur are as follows:
As mentioned above, in all such special circumstances, the Agency will be particularly careful to use its internal review processes to the extent practicable when considering the dissemination of relevant information to the public.
IX. � References
Clinger-Cohen Act of 1996.
Last revised: November 12, 2003