HHS Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated to the Public. IX. References

10/01/2002

Clinger-Cohen Act of 1996.
Code of Federal Regulations (CFR), Title 21, Parts 5, 10, 50, 56, 58, 312, and 314.
Computer Fraud and Abuse Act of 1986.
Computer Security Act of 1987.
Consolidated Appropriations Act, 2001 (Public Law 106-554), Appendix C -- H.R. 5658.
HHS Automated Information Systems Security Program Handbook (Release 2.0), May 1994.
FDA guidance, Formal Dispute Resolution: Appeals Above the Division Level, February 2000.
FDA guidance, Medical Device Appeals and Complaints: Guidance on Dispute Resolution, February 1998.
FDA guidance, Resolving Scientific Disputes Concerning the Regulation of Medical Devices, a Guide to Use of the Medical Devices Dispute Resolution Panel, July 2001.
FDA Internet world Wide Web Site Guidelines, rev. March 23, 2001.
FDA Staff Manual Guide 3250.17,Data Security\Data Integrity.
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).
Federal Managers Financial Integrity Act.
Food and Drug Administration Modernization Act of 1995 (Public Law 105-115).
Freedom of Information Act and Electronic Freedom of Information Act Amendments (5 U.S.C. 552).
Government Information Security Reform Act (GISRA).
ICH guidance, E2B Guidance on Data Elements for Transmission of Individual Case Safety Reports, January 1998.
NIST Special Publication 800-14, Generally Accepted Principles and Practices for Securing Information Technology Systems, September 1996.
Office of Management and Budget (OMB) Circular A-130, Appendix III, Management of Federal Information Resources, rev. February 1996.
Public Health Service Act (42 U.S.C. 201 et seq.).
Regulatory Flexibility Act (5 U.S.C. 601-612).
Safe Drinking Water Act Amendments (Public Law 104-182).
Treasury and General Government Appropriations Act, 2001.