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
Q

Workplace Substance Abuse Program

A

Dept of Energy, applies to all contractors and DOE reactor sites

Must conduct drug tests, provide substance abuse training, and have disciplinary policy

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26
Q

International Traffic in Arms Regulations (ITAR) - coverage?

A

Defense articles & technical data
Defense services
Goods, software, or info designed primarily for military use

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27
Q

SBIR 3 phases

A

1: $150k total costs, 6 months, feasibility study
2: $1mil total costs, 2 years, R&D effort
3: not SBIR funded, commercializations efforts

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28
Q

Americans with Disabilities Act

A

1990
Applies to all agreements
Must be flowed down to all recipients with 25+ employees

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29
Q

Age Discrimination Act

A

1975

Prohibits unreasonable age discrimination

31
Q

Tools of the Trade

A

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
Q

STTR objective

A

Promote small business - academic partnerships and innovation

33
Q

Walsh Healey Public Contracts Act

A

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
Q

Drug Free Workplace Act

A

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
Q

Lobbying Disclosure Act

A

1995
aka Simpson-Craig Amendment
Professional lobbyists must disclose activities and who hired them

37
Q

Trade secrets - definition

A

Protects confidential & proprietary information from being disclosed
Can cover things that can’t be patented or copyrighted (customer lists)

38
Q

Bath-Dole Act

A

1980
Allows awardee to retain IP
Govt gets no exclusive, nontransferable, irrevocable, paid-up license for global use

39
Q

STTR effort requirements

A

None

40
Q

Small Business Act

A

1953
PL85-536
Created Small Business Administration
Promised small businesses a fair portion of federal grants & contracts

43
Q

Work for hire

A

Copyright concept

Commissioner of work may have claim to copyright

43
Q

Copyright - protection process

A

Occurs at creation
Automatic coverage -notice not required
Must file within 5 years to preserve rights

44
Q

Federal Grant & Cooperative Agreement Act

A

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
Q

Fly America Act - 3 exceptions

A
  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
Q

Trade secrets - laws governing

A

Uniform trade secrets act (1979): 47 states adopted uniform rules; civil penalties
Economic Espionage Act (1996): criminal penalties

47
Q

Copyright - definition

A

Vests with authors of original works

Work must be creative, in fixed/tangible form of expression

48
Q

Truth and Negotiations Act

A

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
Q

Trademark - definition

A

Words/slogans/designs used in product marketing

Covers service mark (services) and trademarks (products)

50
Q

SBIR

A

Small Business Innovation Research

51
Q

STTR eligibility

A

Located in US
<500 employees
Majority US owned

53
Q

Trade secrets - protection process

A

No registration required

54
Q

Patent - protection process

A

Provisional : 1 year

U.S. utility: 20 years

55
Q

SBIR eligibility

A

50% US-owned business

56
Q

FDP

A

Federal Demonstration Project

57
Q

Institutional Biosafety Committee (IBC)

A

Mandated under NIH guidelines

Report to Federal Office of Biotechnology Activities

58
Q

SBIR objective

A

Promote small businesses and innovation

59
Q

Licensing

A
Allow others to use patented goods
Exclusive license
Non exclusive license
End user license (software)
Annual fee; upfront fee; royalties
60
Q

Non-Delinquency Act

A

Org that is indebted to the U.S. Govt cannot receive grants

60
Q

Federal Demonstration Project

A

Partnership between govt and research organizations to streamline research administration.
A-110 expanded authorities & Subaward template are FDP results

60
Q

SBIR effort requirement

A

Phase 1: 2/3 work must be done by PI

Phase 2: 1/2 work must be done by PI

61
Q

Radiation Safety Committee

A

Register with Nuclear Radiation Commission (NRC)

Must have Radiation Safety Officer, management representative, & personnel with radiation experience

62
Q

Foreign Assets Control Regulations (FACR) coverage

A

Regulates travel abroad, transactions with foreign individuals/entities, transactions in certain countries, & export/import of goods

63
Q

Freedom of Information Act

A

1966

Allows citizens to obtain federal records

65
Q

3 major differences between STTR & SBIR

A

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
Q

Byrd Amendment

A

1989
Bans hiring lobbyists with federal funds
Requires grant- seekers to disclose lobbyists hired with non-federal funds

66
Q

Buy American Act

A

Micro purchase threshold: $2,500

Establishes a preference for American made goods meeting threshold whenever possible

66
Q

STTR

A

Small Business Technology Transfer

66
Q

STTR phases

A

1: $100k total costs, 1 year, feasibility
2: $750k total costs, 2 years, R&D
3: not funded by STTR

66
Q

Occupational Safety & Health Act

A

1970

Created OSHA and workplace safety standards

68
Q

Materials covered under Biosafety regulations

A
  1. rDNA
  2. Pathogens
  3. Vertebrate animal infectious agents
  4. Human gene therapy materials
  5. Bloodborne pathogens
  6. Select agents
69
Q

Patent - definition

A

Legal right to exclude others from making product
Public disclosure can jeopardize patent
Must be Novel, Non-Obvious, and have clear Utility

70
Q

NIH under Freedom of Information Act

A

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
Q

Export Administration Regulations (EAR) fall under which office/dept?

A

Department of Commerce, Bureau of Industry & Security (BIS)