Legal Basics for Working at CDC/ATSDR: What You Need to Know and Why You Should Care Module 1 HHS Office of the Genera

1. Legal Basics for Working at CDC/ATSDR: What You Need to Know and Why You Should CareModule 1HHS Office of the General CounselCDC/ATSDR (404)639-7200

2. Module 1 • Introduction to CDC’s Office of the General Counsel • CDC’s Authorities • Federal Appropriations Law • Paperwork Reduction Act • Federal Records Act • Copyright Act

3. Office of the General Counsel (OGC) CDC/ATSDR Program Attorneys Paula Kocher, Deputy Associate General Counsel Deborah Tress, Principal Senior Attorney Mary Armstrong Mark Kashdan Kenya Ford Alice Kelley Joe Foster Kevin Malone Sudevi Ghosh Robert McGolerick Eva Holland Jim Misrahi James Holt Leslie Page-Taylor Heather Horton Katy Runyan Emily Howell Joanna Stettner Michael Rafky

4. Office of the General CounselRegion IV (Atlanta) Attorneys Marie Ransley Murray Kampf Robert Nerthling Jocelyn Cerrito • EEO • Personnel Litigation • Contracts http://intranet.cdc.gov/ogc/default.htm

5. Services Provided by OGC • Legal Advice • Interpret Statutory and Regulatory Authority • Assist in Rulemaking Dockets and Federal Register Notices • Review Documents for Legal Sufficiency • Program Announcements • Letters • MOUs/MOAs • Policy Statements • Contact Point for Government and Private Attorneys • Assist DOJ in Civil Litigation and Criminal Prosecutions

6. CDC’s Authorities for Conducting Public Health Activities CDC’s underlying authorities for conducting public health activities and furthering its mission include, but are not limited to: • The Public Health Service Act • The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 • Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), as amended by the Superfund Amendments and Reauthorization Act (SARA) • Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA) • Federal Mine Safety and Health Acts of 1969 and 1977   • Occupational Safety and Health Act of 1970 • Appropriation Laws

7. CDC’s Authorities for Conducting Public Health Activities Key Points: • CDC must have the legal authority to do whatever activity it wants to do • Contact: OGC

8. Authorization laws establish, continue or modify federal programs and are a prerequisite for Congress to appropriate budget authority for programs Appropriations laws provide the actual funding for federal programs Federal Appropriations LawAuthorizing Legislation vs. Appropriations Laws

9. Federal Appropriations Law Key Points: • Graduate School/USDA course in Federal Appropriations Law (offered multiple times each year) • Contact: OGC

10. Paperwork Reduction Act The purpose of the Paperwork Reduction Act is to reduce the federal burden on the public and maximize the practical utility and public benefit of any information that is collected by the federal government

11. The Paperwork Reduction Act and OMB Clearance • A data collection requires OMB approval when: • It involves 10 or more respondents in any 12-month period (both domestic and international) AND • It involves the use of identical questions, identical reporting or recordkeeping requirements, or asking respondents to provide the same level of information on the same subject AND • The federal government is sponsoring the data collection (such as a contract or cooperative agreement)

12. The Paperwork Reduction Act Key Points: • Applies to questions asked: • In writing • Electronically • Through phone calls • In-person interviews • Contact: Maryam Daneshvar (404-639-4604)

13. Federal Records Act What are Federal Records? Documentary material, regardless of format, created or received in the course of federal business CDC Record Control Schedule: Examples Administrative records: 5 Years Epidemiological case studies: 20 Years Final reports/studies/publications: Permanent

14. Federal Records Act Key Points: • Records belong to CDC, not to individuals • Contact: Mary Wilson (404-498-1552)

15. Copyright Act • Copyright is a form of protection provided by federal law for original works of authorship • Applies to literary works, including books, magazines, journals and newspapers, as well as photographs, videos, artistic and other intellectual work • Protected regardless of the media in which they are created or reproduced (e.g. electronic works are also protected)

16. Copyright Act“Fair Use” • Federal copyright law permits, for certain purposes, the “fair use” of copyrighted material, i.e., use without the copyright owner’s permission • Many Government uses of copyrighted materials for internal purposes are “fair”; however, the Government IS SUBJECT to copyright infringement • Copyright protection is not available for works prepared by an officer or employee of the United States Government as part of that person’s official duties

17. Copyright Act Key Points: • Generally, in lieu of signing a publisher’s copyright form or book contract, CDC authors should use CDC’s standard copyright form or standard book agreement • Contact: OGC

18. Office of the General Counsel Paula Kocher (404-639-7200) The Paperwork Reduction Act/OMB Clearance Maryam Daneshvar (404-639-4604) Records Management Mary Wilson (404-498-1552) Contact Information for Important CDC Offices

19. Questions?OGC: 404-639-7200

20. Legal Basics for Working at CDC/ATSDR: What You Need to Know and Why You Should CareModule 2HHS Office of the General CounselCDC/ATSDR (404)639-7200

21. Module 2 • Privacy Laws • Privacy Act • HIPAA Privacy Rule • Assurance of Confidentiality laws • Open Government Laws • Freedom of Information Act (FOIA) • Federal Advisory Committee Act (FACA)

22. Privacy Act • Pertains only to records retrieved by a personal identifier • Generally permits access to personal information only by the person to whom the records pertain

23. Privacy Act: Common Exceptions • If disclosure required under FOIA • Routine use as defined by the agency • At written request of head of federal agency for law enforcement purposes • To GAO, if requested as part of an audit • GAO Contact: Alyce Burton (404-639-7243) • Court order

24. Privacy Act Key Points: • The Privacy Act does 2 main things: • Protects an individual’s privacy • Provides an individual access to his own information contained in a Privacy Act system of records • CDC must maintain in its records only such information about individual as is relevant and necessary to accomplish the purpose of the agency • Contact: OGC

25. The HIPAA Privacy Rule • Regulation provides protection for the privacy of certain individually identifiable health data (“protected health information”)

26. The HIPAA Privacy Rule • The Privacy Rule expressly permits disclosures without individual authorization to public health authorities authorized by law to receive such information to perform public health activities

27. Key Points: CDC is not a covered entity. Therefore CDC is not required to comply with the Privacy Rule. CDC protects individually identifiable health information pursuant to other Federal laws (e.g. FOIA and the Privacy Act), but NOT pursuant to HIPAA CDC may receive PHI from covered entities, because CDC is a public health authority authorized by law to receive such information for public health purposes. Covered entities MAY, but ARE NOT REQUIRED to, provide PHI to CDC Contact: Gail Horlick (404-639-4613) The HIPAA Privacy Rule

28. Certificates and Assurances of Confidentiality Key Points: • 308(d)—specifically for CDC—protects the confidentiality of individuals AND institutions • 301(d) is used mostly for grants and cooperative agreements funded by CDC • Contact: Cheryl Coble (404-639-4791)

29. Freedom of Information Act (FOIA) • Permits access to all records kept by CDC unless an exemption applies • “Records” includes drafts, phone messages, marginal notes • Records must be in control of CDC at time of request

30. FOIA Exemptions • 1) Classified information • 2) Internal personnel rules and practices by the agency • 3) Records protected from release by other statutes • 4) Trade secrets, commercial or financial information that is privileged or confidential • 5) Inter or intra agency memoranda which would not be available by law to a party in litigation by the agency • 6) Personal privacy of individuals • 7) Information compiled for law enforcement purposes • 8) Bank examining data used by those supervising financial institutions • 9) Geological or geophysical information concerning wells

31. FOIA: OPENNESS PREVAILS • On January 21, 2009, President Obama issued a Memorandum related to FOIA. The President stated: • “In the face of doubt, openness prevails . . . all agencies should adopt a presumption in favor of disclosure.” • “The Government should not keep information confidential merely because public officials might be embarrassed by disclosures.” • “The presumption of disclosure also means that agencies should take affirmative steps to make information public.”

32. FOIA: OPENNESS PREVAILS • On March 19, 2009 the Attorney General issued new guidelines governing FOIA. The Guidelines: • Encourage agencies to release records in part whenever they cannot be released in full. • The Department of Justice will only defend a denial of a FOIA request if: • The agency reasonably foresees that disclosure would harm an interest protected by one of the statutory exemptions, or • Disclosure is prohibited by law.

33. FOIA Key Points: • Records include e-mails! • Contact: Lynn Armstrong (404-639-7270)

34. Federal Advisory Committee Act (FACA) • Law requires legal chartering of advisory committees • Meetings must be open and advertised in Federal Register • Committee membership must be balanced • Mistakes in procedure can result in lawsuits against agency • Does not usually apply to individual consultant meetings

35. FACA Key Points: • Think about FACA if a group is composed—even partially—of private sector persons for the purpose of giving consensus advice to the Federal Government • Contact: Elizabeth Millington (404-498-3494)

36. Office of the General Counsel Paula Kocher (404-639-7200) HIPAA Gail Horlick (404-639-4613) Freedom of Information Act Lynn Armstrong (404-639-7270) GAO Coordinator Alyce Burton (404-639-7243) Certificates and Assurances of Confidentiality Cheryl Coble (404-639-4791) FACA Elizabeth Millington (404-498-3494) Contact Information for Important CDC Offices

37. Questions?OGC: 404-639-7200

38. Legal Basics for Working at CDC/ATSDR:What You Need to Know and Why You Should CareModule 3HHS Office of the General CounselCDC/ATSDR (404)639-7200

39. Module 3 Ethics • Standards of Conduct • Outside Activities • Conflicts of Interest • Co-sponsorships/Collaborations

40. Employee Standards of Conduct • Standards of Conduct are set out in 5 C.F.R. Pt. 2635 (for all Federal employees) and 45 C.F.R. Pt. 73 (for all HHS employees) • The Standards of Conduct include, among other things: • Limits on the acceptance of gifts • Post-Federal employment rules • Policies on outside activities • New supplemental standards (5 C.F.R. Pts. 5501 and 5502) established 2/3/05

41. Employee Standards of Conduct Key Points: • AllFederal government Executive Branch employees must follow the Standards of Conduct • Contact: Teresa Walker-Mason (404-639-5003)

42. Outside Activities • Outside Activities: paid or unpaid work outside the scope of federal employment • Prior approval is required for certain Outside Activities using form HHS-520 • HHS-520 must be renewed annually • An annual accounting of ALL outside activities must be submitted via form HHS-521

43. Outside Activities Key Points: • Generally, outside activities which require advance approval include (but are not limited to) the following: • Writing, editing, or publishing that relates to official duties • Teaching or lecturing that relates to official duties • All professional services, including outside CLINICAL practice • Service on boards or committees • Contact: Teresa Walker-Mason (404-639-5003)

44. Conflicts of Interest • What constitutes a criminal conflict of interest? • Employees cannot participate in Government matters that can affect their own or imputed financial interests (18 U.S.C. § 208)

45. Conflicts of Interest Key Points: • Resolve Conflicts through: • Divestiture • Reassignment • Waiver/Authorization • Recusal • Contact: Teresa Walker-Mason (404-639-5003)

46. Co-sponsorship/Collaboration • Co-sponsorship: the joint development of a conference, seminar, symposium, educational program, public information campaign, or similar event related to the mission of CDC by CDC and one or more non-federal entities • Collaboration: a voluntary interaction between CDC and one or more private sector organizations in which both parties work together to carry out their missions; basis for the interaction not found in statutory or other law

47. Co-sponsorship/Collaboration Key Points: • Guidance documents: • CDC’s Co-Sponsorship Policy (MASO) • CDC Guidance on Collaboration with the Private Sector (MASO) • OGC Ethics Division Guidance (OGC) • NCHM Partnership Toolkit • Contact: OGC

48. Office of the General Counsel Paula Kocher (404-639-7200) Ethics and Conflicts of Interest Teresa Walker-Mason (404-639-5003) Contact Information for Important CDC Offices

49. Questions?OGC: 404-639-7200

50. What You Need to Know and Why You Should Care Module 4HHS Office of the General CounselCDC/ATSDR (404)639-7200 Legal Basics for Working at CDC/ATSDR: Legal Basics for Working at CDC/ATSDR: