Government Regulation and Science

Sue AltmeyerElectronic Services Librarian

Federal Regulations re Research:

Federal Grant Writing 2 CFR Part 215, 220, 225, 230

Human Subjects 45 CFR 46 (Health & Human Services), 21 CFR 50, 56 (FDA), 59 CFR 690 (NSF)

Animal Subjects CFR Title 9, Chapter 1, Subchapter A;

OSHA 29 CFR Part 1910 – Ventilation, Noise, Hazardous Materials, Protective Equipment,etc

EPA/FDA/ Nuclear Regulatory Commission

eg. 40 CFR Part 60, subpart CE re. Emission Guidelines for Medical Waste Incinerators; Toxic Substance Control Act Good Laboratory Practices, 40 CFR part 792; Pesticides Good Laboratory Practices 40 CFR Part 160; FDA Good Laboratory Practices 21 CFR Part 58

Regulations re Research, contd

Patents, Trademarks, Copyrights

CFR Title 37

Tax Regs re Nonprofits

• Revenue Regs –re nonprofits, ex 29 CFR §1.501(c)(3)-1

National Science Foundation

• 45 CFR parts 601-690

• independent agency promoting science and engineering through research programs and education

CFR is Arranged by Agency

Discipline Dept./Agency

Health Sciences Dept. Health & Human Services, specifically FDA, Medicare & Medicaid, Center for Disease Control & Prevention; Social Security; FTC & DOJ (Antitrust); Dept Labor - ERISA (Health Insurance)

-Speech/Hearing Dept Education

Anthropology Dept Interior

Physics Dept of Energy, NASA, Fed Aviation Admin

Discipline Dept./Agency

Environmental Science/

Biology

EPA, Dept Agriculture, Dept Energy, Dept Interior – Fish & Wildlife Service, Dept Commerce - Natl Oceanic & Atmospheric Admin

Computer Science FCC, FTC

Health Sciences Regulations

• Title 21, Food & Drugs

• Title 42, Public Health – includes Medicare and Medicaid regs

• Title 45, Public Welfare

Ex. HIPAA – 45 CFR Part 160, Subparts E& A of Part 164

• ERISA –ex. HIPAA portability 29 C.F.R. § 2590.702 (f)

Discipline Regulations

-Speech/Hearing Example - 34 CFR part 396, Interpreters

Anthropology 43 CFR Part 10, Native American Graves; 36 CFR Part 296 –Protection of Archaeological Resources, public lands

Physics Title 10 CFR – Energy, Title 14 – Aeronautics & Space

Discipline Regulations

Biology/Environmental Science

CFR Title 40 EPA, Title 7 Agriculture, Title 9 Animals, Title 10 Energy, Title 18 Conservation of Power & Water Resources, Title 50 Wildlife & Fisheries

Computer Science Regulations

• 16 CFR part 312, Children’s Online Privacy Protection

• 16 CFR part 316 CAN Spam• 16 CFR part 435 – Mail Order/Telephone Order

Merchandise rule• 16 CFR part 313 – Privacy of Consumer

Financial Information• 37 CFR part 380 - payments for the public

performance of sound recordings in certain digital transmissions

• 47 CFR, part 69, access charges

State Regulations

• Health care – licensing, certifying medical institutions, health insurance, Medicaid, health codes, malpractice

Ohio Health Regulations• Department of Health OAC 3701 et seq.; • State Certificate of Need Review Board OAC 3702 et seq.; • Commission on Minority Health OAC 3704 et seq.; • Dept of Insurance OAC 3901 et seq.; • Ohio Board of Nursing OAC 4723 et seq.; • State Medical Board OAC 4731 et seq.• Bd of Speech Language Pathology and Audiology OAC 4753• Other Ohio state health-related boards also in the 4730s-

4760s Chapters of the OAC. • OAC 5122 – Department of Mental Health• OAC 5101:3 - Medicaid

Some Ohio Regs re. Research/Laboratories

• Fire Code – OAC 1301:7

• Building Code – OAC 4101:1

• Worker’s Comp – OAC 4123

• Worker’s Comp - Division of Safety & Hygiene – OAC 4123:1

Ohio RegulationsPhysics OAC 4901 – Public Utilities, 5501-

Transportation, 1501:53 – Solar, Wind & Hydrothermal Energy, 3701:1 Radiation Control, 3734 Low-level Radioactive Waste, 4161 Underground Gas Storage Bd Review

Environment/Biology

OAC 901, Dept Agriculture; 1501, Dept Natural Resources; 3745 Ohio EPA; 6121 Water Development Authority, 3705 Air Quality Development Authority, 3717 Ohio Uniform Food Safety Code

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Computer Science

Deceptive trade practices – 109:4-3; Telecommunications 4901:1-7-12

(statutes – ORC 2913.421 re spam, ORC 1306.02 – electronic signatures)

Anthropology OAC 149-1-02 Archaeological Investigations on public lands, registry of archaeological landmarks; 122:19 Historic Preservation Tax Credits

Finding Federal Regulations

• E-CFR – Code of Federal Regulations. Free, Searchable, only one day out of date

• CFR updated by Federal Register.

• Federal Register free on FEDSYS - Search or Browse

Tracking Federal Regulations

• OpenRegulations.org. Track regulations with RSS feeds and make comments

• Justia Regulation Tracker Track proposed regs via RSS feeds

State Regulations

• Ohio Administrative Code

• Updated by Register of Ohio

• American Law Sources Online or Findlaw - Cases and Codes – links to Administrative Codes of other states

Agency Websites

• Good places to find regulations

• A-Z Index of U.S. Government Depts. & Agencies

• USA.gov: State Agencies by Topic