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Regulatory Update, July 2016

Friday, July 1, 2016

NIH Guidelines Amended

In the April 15, 2016 Federal Register, the National Institutes of Health (NIH) Office of Science Policy (OSP) announced it was amending portions of the NIH Guidelines for Research Involving Recombinant or Syn­thetic Nucleic Acid Molecules (NIH Guide­lines) in order to provide investigators with biosafety guidance regarding the standards for containment of non-human primates (NHP) in biosafety level (BL) 4 laboratories and to make such guidance consistent with the expectations articulated in the Centers for Disease Control and Prevention (CDC)/ NIH Biosafety in Microbiological and Bio­medical Laboratories, 5th edition (BMBL).

The NIH Guidelines will now allow hous­ing of NHP in open caging in a dedicated animal holding room provided that there are two physical barriers between that ani­mal holding room and non-containment space within the laboratory. Further, the an­imal holding room should have negative air pressure with respect to any adjacent non-containment corridors, and there should be specific decontamination protocols in place before the door to the animal holding room is opened to allow for the periodic transfer of new animals into the room. These amend­ments do not change the current contain­ment requirements in the NIH Guidelines, but rather offer an alternative for achieving primary containment without compromis­ing safety. In addition, the recertification requirement for biosafety cabinets in BL4 laboratories is updated in recognition of the technological standards for modern biosafe­ty cabinets. The NIH OSP is also updating the validation requirements for equipment responsible for centralized heat decontami­nation of liquid effluents in laboratories working with large animals.

The first three editions of the BMBL and the NIH Guidelines were consistent in their approach to requiring primary contain­ment for animal work in BL4 containment laboratories. However, in the early 1990s, the BMBL was amended and the fourth edi­tion stated that animals housed in BL4 suit laboratories (i.e., laboratories in which Class III cabinets are not used; instead person­nel wear positive pressure protective suits) should be housed in a primary containment system (such as open cages covered with fil­tered bonnets and opened in laminar flow hoods or other equivalent containment sys­tems). This language has remained in the current 5th edition BMBL. With the change in the BMBL, primary containment caging was arguably preferred but no longer re­quired under BL4 containment. In contrast, the NIH Guidelines have always required primary containment caging for all animals in BL4 laboratories.

NHP are social animals and require en­vironmental enrichment. Researchers in several American BL4 laboratories engaged in NHP research approached the NIH OSP with concerns that primary containment caging in BL4 laboratories hindered the creation of an environment that allowed animals to benefit from adequate social in­teraction. Also, based on risk assessments and experiences comparing several primary containment caging systems, the research­ers concluded that primary containment caging may actually create new hazards for laboratory workers. These findings included interference with observation of the ani­mals from outside the room, which led to more frequent entries into the BL4 animal room to monitor the animals. The exacerba­tion of cramped working conditions created by the additional barriers required by some containment systems increased the diffi­culty of working in inflated pressure suits as well as the potential for damage to the suits. In addition, investigators stated that current BL4 laboratory designs incorporate sophisticated engineering systems, which provide biosafety protection in a dedicated animal room equivalent to the primary containment caging required under the NIH Guidelines.

The Federal Register notice indicated the sections of the NIH Guidelines that were changed and provided a detailed descrip­tion of the changes that were made. These amendments to the NIH Guidelines were implemented immediately upon publication in the Federal Register. The changes were developed after extensive consultation with biosafety experts, directors of and principal investigators in BL4 facilities working with NHP, and CDC’s Division of Select Agent and Toxins leadership at a March 28, 2014 public workshop and further discussion at a June 11, 2014 Recombinant DNA Advisory Committee (RAC) public meeting.

FDA Final Guidance on Clinical Trials for Nail Fungus

In the March 7, 2016 Federal Register, the FDA announced the availability of the guidance titled “Medical Devices and Clinical Trial Design for the Treatment or Improvement in the Appearance of Fun­gally-Infected Nails.” This guidance pro­vided recommendations regarding clinical trial design for medical devices intended to provide improvement in the appearance of nails affected by onychomycosis or to treat onychomycosis (fungal nail infection). This document makes final the draft that was made available for public comment on Jan­uary 27, 2015.

Interested parties may submit electronic or written comments on final guidance at any time. The FDA may consider those com­ments for future revisions. Submit com­ments as instructed above and identify them with Docket No. FDA-2014-D-1849.


The Regulatory Update is excerpted from Re­search Practitioner, Volume 17 Number 04, July-August 2016.

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