CRA Exam - Jodi Flashcards

0
Q

Anti-Kickback Act

A

1936
(Aka Copeland Anti-Kickback Act)
Prohibits building/construction contractor from making employees give up compensation to which they are entitled (can’t require kickbacks)

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1
Q

Title IX

A

1972 (part of Education Amendments)

Prohibits exclusion by sex by any program with federal funds

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2
Q

Rehabilitation act

A

1973
Requires affirmative action
Prohibits discrimination by those with $10k+ in federal funds
Must file assurance that federally-funded activities will be available to handicapped individuals

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3
Q

Civil Rights Act

A

1964

Prohibits discrimination on basis of race, sex, color, or national origin

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4
Q

Anti-Kickback Statute

A

1986
Prohibits the exchange (or offer of) anything of value to reward referral of federal health care program benefits
Prosecuted under False Claims Act (civil & criminal)

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5
Q

False Claims Act

A

1863 (amended repeatedly)
Individuals may bring QUI TAM actions (private citizen makes allegations on behalf of the government - whistleblowers)
Whistleblower gets ~15-20% of settlement

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6
Q

Stark Law

A

Stark I: 1992
Stark II: 1993
Stark III: 2007
Prohibits referral of Medicare & Medicaid patients if the physician has a financial relationship with that organization

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7
Q

Fair Labor Standards Act

A
1938
Established the 40-hour workweek
National minimum wage
1.5x overtime pay for certain jobs
Prohibits most child employment
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8
Q

Trademark - protection process

A

Common law: rights granted with 1st use of symbol
Federal registration: protects from intentional and unintentional infringement; filed upon 1st inter-state use; 10 year term, renewable; expires when no longer in use

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9
Q

Debarment & suspension

A

Codified in CFAR subpart 9.4

DHHS implements as outlined in GPS

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11
Q

International Traffic in Arms Regulations (ITAR) - department and office?

A

Department of State, Directorate of Defense Trade Controls

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12
Q

Contract Work Hours and Safety Standards

A

1962
Applies to federal contracts over $100k
Must pay laborers 1.5x for overtime
Sets safety standards

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13
Q

Fundamental Research Exemption

A

Applies to research where results are ordinarily published (covers only data - not the shipment of actual goods).

  1. Educational exclusion
  2. Employment exclusion
  3. Public domain (ITAR) or publicly available (EAR)
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14
Q

USA PATRIOT Act

A

2001
Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism Act
Prohibits providing material support to terrorists (including select agents)

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15
Q

Export Administration Regulations (EAR) - coverage?

A

Anti boycott provisions

Goods, software, & technology that is mostly civilian in nature but may include military applications

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16
Q

Shelby Amendment

A

1999
Amends Freedom of Information (FOI)Act
Amends A-110 to require that “all data produced under an award” is covered by FOI (except trade secrets, etc.)

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17
Q

Davis-Bacon Act

A

1931
Applies to contractors doing $2k+ in construction/repair under federal funds
Must pay laborers at least the local prevailing wage; weekly pay

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18
Q

Procurement Integrity Act

A

Prohibits contractor pricing or bid info before contract is awarded
Govt employees working on $10million+ contracts cannot be hired by contractor (or take consultancy) for 1 year

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19
Q

Federal Financial Assistance Management Improvement Act

A

1999
PL106-107
Simplify grant application process
Grants.gov was chosen to be the portal for all govt grants with DHHS being the managing partner

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20
Q

Chemical Hygiene Safety Committee

A

Chemical Safety Hygiene Plan:

  1. Chemical Hygiene Officer (must be employee)
  2. Material Data Safety Sheets must be available to employees
  3. Measures to minimize exposure
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21
Q

Deemed export

A

Any export that is released to a foreign national - either in the US or abroad

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22
Q

Drug Free Schools & Communities Act

A

1989
Schools must have plan re: drug use & possession
Biennial review of plan & enforcement required

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23
Q

Foreign Assets Control Regulations (FACR) - office & agency?

A

Office of Foreign Assets Control (OFAC), under Department of Treasury

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24
Q

Fly America Act (definition)

A

Must use US flag carriers for travel bought with US funds

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25
Workplace Substance Abuse Program
Dept of Energy, applies to all contractors and DOE reactor sites Must conduct drug tests, provide substance abuse training, and have disciplinary policy
26
International Traffic in Arms Regulations (ITAR) - coverage?
Defense articles & technical data Defense services Goods, software, or info designed primarily for military use
27
SBIR 3 phases
1: $150k total costs, 6 months, feasibility study 2: $1mil total costs, 2 years, R&D effort 3: not SBIR funded, commercializations efforts
28
Americans with Disabilities Act
1990 Applies to all agreements Must be flowed down to all recipients with 25+ employees
29
Age Discrimination Act
1975 | Prohibits unreasonable age discrimination
31
Tools of the Trade
Under export control rules, a laptop (including mass-marketed software) is exempt from regs as long as it comes back to US in 1 year, will be in employee possession, and has no confidential data
32
STTR objective
Promote small business - academic partnerships and innovation
33
Walsh Healey Public Contracts Act
1936 Federal contractors ($10k+) must pay 1.5x for hours worked over 40 hours/week Restricts employment of children & prisoners Sets basic health & safety standards
34
Drug Free Workplace Act
1988 Employers must provide written notice to employees of drug-free workplace policy Exceptions: work outside US, law enforcement undercover agents, & when inconsistent with international obligations
35
Lobbying Disclosure Act
1995 aka Simpson-Craig Amendment Professional lobbyists must disclose activities and who hired them
37
Trade secrets - definition
Protects confidential & proprietary information from being disclosed Can cover things that can't be patented or copyrighted (customer lists)
38
Bath-Dole Act
1980 Allows awardee to retain IP Govt gets no exclusive, nontransferable, irrevocable, paid-up license for global use
39
STTR effort requirements
None
40
Small Business Act
1953 PL85-536 Created Small Business Administration Promised small businesses a fair portion of federal grants & contracts
43
Work for hire
Copyright concept | Commissioner of work may have claim to copyright
43
Copyright - protection process
Occurs at creation Automatic coverage -notice not required Must file within 5 years to preserve rights
44
Federal Grant & Cooperative Agreement Act
1977 PL95-224 Defines grants, contracts, and when to use them Grants are not for procurement (grants transfer a thing of value [money] from the govt to recipient to carry out public purpose
45
Fly America Act - 3 exceptions
1. Will extend travel time by 24+ hours 2. Will result in a foreign layover of 6+ hours or extends flying time by 6+ hours 3. Trips under 2 hours that would be 2x longer on US carrier
46
Trade secrets - laws governing
Uniform trade secrets act (1979): 47 states adopted uniform rules; civil penalties Economic Espionage Act (1996): criminal penalties
47
Copyright - definition
Vests with authors of original works | Work must be creative, in fixed/tangible form of expression
48
Truth and Negotiations Act
1962 Requires disclosure by contractors regarding pricing (must submit fair, accurate and reasonable prices) Threshold level at which detailed pricing info is required (was $500k, but now ~$700k)
48
Trademark - definition
Words/slogans/designs used in product marketing | Covers service mark (services) and trademarks (products)
50
SBIR
Small Business Innovation Research
51
STTR eligibility
Located in US <500 employees Majority US owned
53
Trade secrets - protection process
No registration required
54
Patent - protection process
Provisional : 1 year | U.S. utility: 20 years
55
SBIR eligibility
50% US-owned business
56
FDP
Federal Demonstration Project
57
Institutional Biosafety Committee (IBC)
Mandated under NIH guidelines | Report to Federal Office of Biotechnology Activities
58
SBIR objective
Promote small businesses and innovation
59
Licensing
``` Allow others to use patented goods Exclusive license Non exclusive license End user license (software) Annual fee; upfront fee; royalties ```
60
Non-Delinquency Act
Org that is indebted to the U.S. Govt cannot receive grants
60
Federal Demonstration Project
Partnership between govt and research organizations to streamline research administration. A-110 expanded authorities & Subaward template are FDP results
60
SBIR effort requirement
Phase 1: 2/3 work must be done by PI | Phase 2: 1/2 work must be done by PI
61
Radiation Safety Committee
Register with Nuclear Radiation Commission (NRC) | Must have Radiation Safety Officer, management representative, & personnel with radiation experience
62
Foreign Assets Control Regulations (FACR) coverage
Regulates travel abroad, transactions with foreign individuals/entities, transactions in certain countries, & export/import of goods
63
Freedom of Information Act
1966 | Allows citizens to obtain federal records
65
3 major differences between STTR & SBIR
1: SBIR has PI effort requirements 2: STTR requires 40% of work to be done by small business and 30% by partner research institute 3: SBIR requires the PI to be primarily employed by the small business
66
Byrd Amendment
1989 Bans hiring lobbyists with federal funds Requires grant- seekers to disclose lobbyists hired with non-federal funds
66
Buy American Act
Micro purchase threshold: $2,500 | Establishes a preference for American made goods meeting threshold whenever possible
66
STTR
Small Business Technology Transfer
66
STTR phases
1: $100k total costs, 1 year, feasibility 2: $750k total costs, 2 years, R&D 3: not funded by STTR
66
Occupational Safety & Health Act
1970 | Created OSHA and workplace safety standards
68
Materials covered under Biosafety regulations
1. rDNA 2. Pathogens 3. Vertebrate animal infectious agents 4. Human gene therapy materials 5. Bloodborne pathogens 6. Select agents
69
Patent - definition
Legal right to exclude others from making product Public disclosure can jeopardize patent Must be Novel, Non-Obvious, and have clear Utility
70
NIH under Freedom of Information Act
Will not release salary info, details on unfounded projects, personal details (SS#, birthdays), details about pending or non-federal support, refs to unpublished data, patentable info, grant scores, reviewer comments
70
Export Administration Regulations (EAR) fall under which office/dept?
Department of Commerce, Bureau of Industry & Security (BIS)