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- USDA
(United States Department of Agriculture)— All institutions
housing species covered by the animal welfare act are required
to be registered with the USDA and file annual reports of
animal use. Veterinary Medical Officers from the Animal
and Plant Health Inspection Service (APHIS, REAC, AC) conduct
unannounced inspections of HMS facilities to determine compliance
with the Animal Welfare Act The Harvard Medical School USDA
registration number is 14-R-0019 and the Brigham & Women's
USDa Registration Number is 14-R-0092.
- PHS/OLAW
Assurance of Compliance (Public Health Service, National
Institutes of Health, Office for Laboratory Animal Welfare)
— All institutions receiving Federal funds for research
purposes must have an approved assurance of compliance on
file with OLAW. This Assurance of Compliance is renewed
every 5 years by the institutional and annual reports are
filed. The Harvard Medical School Assurance of Compliance
Number is A-3431-01.
- FDA GLP
(Food and Drug Administration, Good Laboratory Practice)
— Compliance with GLPs is required for nonclinical
safety studies that support or are intended to support applications
for research or marketing permits for products regulated
by the FDA. The regulations are listed in the Code of Federal
Regulations, Title 21 CFR Part 58 and define the minimal
standards necessary for conducting a GLP study. The application
of these regulations is intended to assure the quality and
integrity of safety data. (http://www.access.gpo.gov/nara/cfr/waisidx_99/21cfr58_99.html)
- DEA (United
States Department of Justice, Drug Enforcement Administration)
21 USC 824 and 958, Sections 304 and 1008 of the Controlled
Substance Act of 1970 — A Federal DEA registration
is required for all institutional veterinarians for clinical
treatment of research animals. Individual investigators
requiring controlled substances for research purposes are
expected to obtain their own license. Licence applications
are available at the
U.S Department of Justice, Drug Enforcement Administration,
Diversion Control Program.
- The Commonwealth
of Massachusetts
- Department
of Public Health, Division of Food and Drugs (MGL,
Chapter 94C. ) — MA controlled substance registration
is required for institutional veterinarian for clinical
treatment of research animals. This license if renewed
every 3 years. As with the Federal DEA license all individual
investigators requiring controlled substances for research
purposes are expected to obtain their own state license.
- Division
of Fisheries and Wildlife (MGL, Chapter 131 and
CML 321, Part 2.12.) — A non-Commercial Class 4
Propagator's License required for all institutions to
possess, propagate, maintain, buy, and have in possession
for non-commercial purposes birds, mammals, reptiles
and/or amphibians protected by the above mentioned codes
and laws. The license is renewed annually and the required
fee is paid by the Institution.
- US Department
of the Interior Fish and Wildlife Services (50 CFR,
Parts 10-14, 17, 21, and 23) — A license is required
for the possession of wildlife. Individual forms are required
for each importation/exportation across state lines.
- MPHS/MSPCA
(Massachusetts
Society for the Prevention of Cruelty to Animals) Commonwealth
of Massachusetts, Department of Public Health, Division
of Food and Drugs.( MGL, Chapter 140, Sec 174d ) —
A license is required by all institutions using dogs and
cats in research and education; this license is renewed
annually by the institution and annual reports of animal
usage are filed. The Commonwealth of Massachusetts has empowered
the Massachusetts Society for the Prevention of Cruelty
to Animals (MSPCA) to inspect all licensed institutions
and enforce animal welfare laws. Harvard Medical School
is subject to unscheduled inspections.
- City of Cambridge
Public Health Department, Office of the Commissioner
of Laboratory Animals — Ordinance for the Care
and Use of Laboratory Animals enforced by the Commissioner
of Laboratory Animals (ordinance No. 2453, Article IV.)
Institutions shall be registered, inspected and provide
animal use data as requested to Commissioner; annual reports
and fees (based on average daily animal population) are
paid by the Institution.
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