[Federal Register Volume 65, Number 129 (Wednesday, July 5, 2000)]
[Notices]
[Page 41472]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-16849]



[[Page 41472]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


National Institute for Occupational Safety and Health; Approval 
of Respiratory Devices Used to Protect Workers in Hazardous 
Environments

AGENCY: Centers for Disease Control and Prevention (CDC), National 
Institute for Occupational Safety and Health (NIOSH), Department of 
Health and Human Services (DHHS).

ACTION: Notice of public meetings concerning quality assurance and 
administrative approval requirements for respiratory protective 
devices.

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DATES: August 8, 2000, 9 a.m.-5 p.m., in the Washington DC Area. August 
16, 2000, 9 a.m.-5 p.m., in the San Francisco, CA Area.

PLACES:   
Washington DC Area--Quality Hotel & Suites; Courthouse Plaza, Jefferson 
Room, 1200 N. Courthouse Road, Arlington, VA 22201. Phone: 1-888-987-
2555 or 703-524-4000. Phone by July 21, 2000 to receive the NIOSH group 
rate of $118.00.
San Francisco, CA Area--Embassy Suites, Ambassador Ballroom, 150 Anza 
Boulevard, Burlingame, California 94010. Phone: 650-340-0327. Phone by 
July 24, 2000 to receive the NIOSH group rate of $164.00.

    The meetings will be open to the public, limited only by the space 
available. Each meeting room accommodates approximately 120 people.
    Requests to make presentations at the public meetings should be 
mailed to the NIOSH Docket Officer, Robert A. Taft Laboratories, M/S 
C34, 4676 Columbia Parkway, Cincinnati, Ohio 45226, telephone 513-533-
8450, fax 513-533-8285, or e-mail to [email protected] on or before 
July 30, 2000.
SUMMARY: The National Institute for Occupational Safety and Health 
(NIOSH) is in the process of developing a proposed rule on the quality 
assurance and administrative requirements for the approval of 
respirators and is seeking individual stakeholder input for this 
process. The purpose of these meetings is to provide an opportunity for 
an exchange of information between the Agency and respirator 
manufacturers, industry representatives, labor representatives, and 
others with an interest in respiratory protection. Attendees will be 
given an opportunity to ask questions; submit verbal and written 
comments they wish to have included in the regulatory record; and 
provide individual input into potential changes to the applicable 
regulations and policies.

Discussion and Comment Topics

    NIOSH has not determined the final content of its proposed 
rulemaking but is considering the regulatory actions listed below. 
NIOSH is specifically asking for comments on these proposed actions, 
but would also welcome comments on additional areas that the commenters 
believe may need to be addressed.

NIOSH is Considering

    (1) Proposing quality assurance requirements for the approval 
holder's manufacturing process that are consistent with international 
standards, specifically the International Organization for Standards 
(ISO) 9000 guidelines. These international standards would be 
supplemented by respirator-specific quality measures.
    (2) Proposing new quality requirements, such as mandatory pre-
approval audits for new manufacturing sites, more stringent quality 
sampling plans, critical classification of defects for all types of 
respirators, and records retention schedules;
    (3) Proposing to enhance quality monitoring activities by NIOSH by 
increasing the frequency of both site and product audits, requiring an 
approval holder to supply free product audit samples for product 
audits, requiring approval holders to self-audit their product and 
present those results to NIOSH, accepting ISO certification in lieu of 
a NIOSH-performed site audit, employing contract laboratories to do 
certain tests for the approval program, and requiring the approval 
holder to report all customer complaints and non-compliance findings to 
NIOSH; and
    (4) Implementing a new fee structure to recover costs of approval 
application processing (approximately a 2.5 times increase over the 
current application fees), approval records maintenance (a new annual 
fee of approximately $36 per approval), and auditing costs (a new 
charge computed based on the hourly rate of government personnel 
[approximately $50 per hour] plus expenses) for the chargeable services 
received by the applicant or approval holder.
    Comments on the concepts presented in this notice should be mailed 
to the NIOSH Docket Office, Robert A. Taft Laboratories, M/S C34, 4676 
Columbia Parkway, Cincinnati, Ohio 45226, telephone 513-533-8450, fax 
513-533-8285. Comments may also be submitted by e-mail to: 
[email protected]. E-mail attachments should be formatted as 
WordPerfect 6/7/8/9 or Microsoft Word. Submitted comments should 
reference docket number, NIOSH-001, in the subject heading.

FOR FURTHER INFORMATION CONTACT: Matt Bowyer or Roland BerryAnn, NIOSH, 
1095 Willowdale Road, Morgantown, West Virginia 26505-2888, telephone 
304-285-5907, fax 304-285-6030 and/or E-mail:[email protected].
    In addition to these public meetings, NIOSH invites individuals, 
organizations and companies to meet with the staff of its Respirator 
Branch. Requests for such meetings should be made on or before July 31, 
2000 to Matt Bowyer or Roland BerryAnn. NIOSH will prepare summaries of 
these meetings and place them in the regulatory docket.

Linda Rosenstock,
Director, National Institute for Occupational Safety and Health, 
Centers for Disease Control and Prevention.
[FR Doc. 00-16849 Filed 7-3-00; 8:45 am]
BILLING CODE 4160-18-P