[Federal Register Volume 71, Number 186 (Tuesday, September 26, 2006)]
[Pages 56151-56152]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-15706]



Centers for Disease Control and Prevention

The National Institute for Occupational Safety and Health (NIOSH) 
of the Centers for Disease Control and Prevention (CDC) Announcement 
Opportunity for Businesses To Partner With National Institute for 
Occupational Safety and Health (NIOSH) on a Research Project To 
Evaluate the Reusability of Disposable Filtering Facepiece Respirators 
(FFR) Used for Protection Against Infectious Aerosols

    Authority: 29 U.S.C. Sections 651 et seq.

AGENCY: The National Institute for Occupational Safety and Health 
(NIOSH), Centers for Disease Control and Prevention (CDC).

ACTION: Notice.


SUMMARY: The National Personal Protective Technology Laboratory 
(NPPTL), NIOSH, is conducting research to determine the reusability of 
filtering facepiece respirators (FFR) exposed to infectious aerosols. 
One aim of this research is to address whether NIOSH-certified FFR are 
suitable for reuse after decontamination. NIOSH proposes to study the 
effects of decontaminating a diverse array of FFR including NIOSH-
certified N95, P100, and N95 filtering facepiece respirator/surgical 
mask. This project will also study the survivability of a simulant 
influenza virus on FFR. NIOSH plans to include in the research study 
some of the respirator models that have been stockpiled by the U.S 
government to be used in the event of an influenza pandemic. NIOSH also 
plans to include models that have head straps versus those that do not 
have head straps, as well as models with and without exhalation valves.
    Through this announcement, NIOSH is seeking to identify FFR 
products or prototypes that possess anti-viral or other novel 
technologies that disinfect or sterilize infectious aerosols (e.g., 
viruses) as part of their materials of construction. Program funding 
constraints may limit the number of candidate respirators that may be 
included in the research program. NIOSH will give consideration to the 
incorporation of novel anti-viral technologies into this research study 
using the following hierarchy for selection of candidate FFR products 
and prototypes: (1) The FFR proposed for consideration in this study 
are commercially available and are currently certified to meeting 42 
CFR part 84 requirements, (2) the FFR proposed for consideration is in 
the process of being certified by NIOSH to meet 42 CFR part 84 
requirements, (3) the FFR proposed for consideration are either a 
prototype or a commercially available product that has not been 
submitted to NIOSH for certification and the manufacturer submitting 
the letter of interest has received NIOSH certification for other 
respiratory protection products, and (4) the FFR prototype contains a 
unique technology for disinfecting or sterilizing infectious aerosol 
particles trapped on the exterior surface of the FFR and complements 
the diversity of technologies already considered in the research 
    Candidate companies will be evaluated based on their capability to 
achieve the identified criteria in sufficient quantities for testing. 
Candidates selected could be requested to enter into a Cooperative 
Research and Development Agreement (CRADA). This announcement does not 
obligate NIOSH to enter into a contractual agreement with any 
respondents. NIOSH reserves the right to establish a partnership based 
on scientific analysis and capabilities found by way of this 
announcement or other searches, if determined to be in the best 
interest of the government.

DATES: Submit letters of interest within 30 days after the date of 
publication of this notice in the Federal Register.

ADDRESSES: Interested manufacturers should submit a letter of interest 
with information about their capabilities to: NIOSH, National Personal 
Protection Technology Laboratory, P.O. Box 18070, 626 Cochrans Mill 
Road, Attn: Jonathan Szalajda, Pittsburgh, PA 15236, E-mail address: 
[email protected].

SUPPLEMENTARY INFORMATION: CDC recommends the use of disposable N95, 
N99, or N100 filtering facepiece particulate respirators (FFR) as the 
minimum level of respiratory protection against transmission of 
influenza virus. During a respirator shortage, it is important to 
consider whether a previously worn FFR can be used again. Reuse 
guidelines in the NIOSH Guide to the Selection and Use of Particulate 
Respirators Certified under 42 CFR 84 recommend reuse based on loading 
of the filter and functioning of the respirator. Hospital settings tend 
to have relatively low concentrations of particulates, but the 
potential for infectious agents exists. Thus, reuse is more dependent 
upon infection control procedures than on respirator loading 
considerations. Respirators exposed to viruses are considered to be 
potentially harmful because of the possibility for the respirator to 
act as a fomite and the potential for the viral particle to become 
dislodged during a sneeze/cough or from rough handling. Thus, 
respirators worn in the presence of a potentially infected patient or 
co-worker should be disposed of as infectious waste, and touching of 
the outside of the respirator should be avoided.
    In January, 2006, the Department of Health and Human Services asked 
the Institute of Medicine (IOM) to convene a committee to conduct an 
assessment of measures that can be taken that would permit the reuse of 
disposable N95 particulate filtering respirators in healthcare settings 
and to report the status of current knowledge about the need and 
development of reusable N95 respirators for healthcare providers and 
the general public. Some of the key recommendations from that study 
were that research studies should be conducted to (1) understand the 
efficacy of simple decontamination methods that could be used without 
negative effects on respirator integrity; and (2) understand the risks 
associated with handling a respirator that has been used for protection 
against a viral threat (e.g., study the likelihood that the exterior 
surface of the respirator might harbor pathogenic microorganisms and 
thus serve as a fomite).
    This research project addresses the major research gaps related to 
the reusability of filtering facepiece respirators (FFR) during an 
influenza pandemic. NIOSH/NPPTL plans to conduct a variety of tasks in 
this research project, including: (1) Determining the effect of 
decontamination on FFR filtration

[[Page 56152]]

performance; (2) Development of a standardized test protocol for 
measuring the efficacy of a decontamination procedure for FFR; (3) 
Measure the survivability of a virus simulant trapped on FFR; (4) 
Measurement of the reaerosolization of a trapped virus simulant on FFR; 
(5) Assess the efficacy of various decontamination methods suitable for 
FFR; (6) Determine the effects of decontamination on the FFR fit; and 
(7) produce a final report that could be used to issue guidance 
documents on FFR reuse.

FOR FURTHER INFORMATION CONTACT: Jonathan Szalajda, telephone 412-386-
6627, or e-mail [email protected].

    Dated: September 19, 2006.
James D. Seligman,
Chief Information Officer, Centers for Disease Control and Prevention.
 [FR Doc. E6-15706 Filed 9-25-06; 8:45 am]