presentations should be limited to 15 minutes.
The purpose of the meeting is to obtain comments from individuals regarding potential chemical and biological respiratory protection standards and guidelines that NIOSH is developing in collaboration with SBCCOM and NIST.
After reviewing the requests for presentations, NIOSH will notify each presenter by mail or telephone of the approximate time that his or her oral presentation is scheduled to begin. If a participant is not present when his or her presentation is scheduled to begin, the remaining participants will be heard in order. At the conclusion of the meeting, an attempt will be made to allow presentations by any scheduled participants who missed their assigned times. Attendees who wish to speak but did not submit a request for the opportunity to make presentations may be given this opportunity at the conclusion of the meeting, at the discretion of the presiding officer.
SUMMARY: The Agencies will provide information to attendees concerning the progress of their collaborative efforts and their current understanding of chemical, biological, and radiological respiratory protection issues including threats or hazards, and the developmental status of chemical and biological standards and guidelines. Participants will be given an opportunity to ask questions of Agencies' representatives, and to present individual comments that they wish to have considered.
Background
Due to the recognition that terrorism is a national domestic security issue, municipal, state, and national guard responder groups, particularly those in locations considered potential targets, have been developing response and consequence management plans. The federal Interagency Board for Equipment Standardization and Interoperability (IAB) has worked to identify personal protective equipment that is already available on the market for responders' use. The IAB has identified the development of standards or guidelines for respiratory protection equipment as a top priority. NIOSH, NIST, National Fire Protection Association and the Occupational Safety and Health Administration have entered into a Memorandum of Understanding defining each agency or organization's role in developing, establishing and enforcing standards or guidelines for responders' respiratory protective devices. NIST has initiated Interagency Agreements with NIOSH and SBCCOM to aid in the development of appropriate respiratory protection standards or guidelines, NIOSH has the lead in developing standards or guidelines to test, evaluate and approve respirators.
Specific Discussion and Comment Topics
NIOSH, SBCCOM, and NIST are holding this meeting to present their progress in assessing respiratory protection needs of responders to chemical, biological, and radiological incidents. The Agencies will present their methods or models for developing hazard and exposure estimates, and their status in evaluating test methods and performance standards that may be applicable as future chemical and biological respirator standards or guidelines. Participants are invited to provide their individual comments on these topics and to identify additional information that will help in developing respiratory standards and guidelines.
The Agencies have evaluated threat and vulnerability assessments and other associated documents to gain understanding of probable terrorism agents including chemical warfare agents, biological warfare agents, and toxic industrial materials. A summary of the findings will be presented at the meeting for discussion and comment by the attendees.
There are multiple classes of respirators having various operational parameters. The Agencies are currently aware that the domestic preparedness community is purchasing self-contained breathing apparatus (SCBA), and full facepiece powered and non-powered air-purifying respirators to equip response teams for which there are no NIOSH chemical/biological respirator approval standards. NIOSH and SBCCOM are in the process of develaping chemical and biological respiratory protection standards and guidelines, and will present pertinent information for each class of respirator. The Agencies will discuss potential tests and test parameters being considered for each respirator class.
For SCBA, the parameters are system and component agent permeation testing and laboratory protection level testing, For air-purifying respirators, the same parameters are being considered plus challenge concentrations, breakthrough and end-point concentrations, breathing flow rates, hot and cold temperature function, human wear factors, assessment of current respirator technologies, etc. The status of NIOSH and SBCCOM in these efforts will be presented at the meeting, Participants are invited to pravide individual comment on these and other performance, quality, or operational parameters that should be considered. Comments on the topics 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 513-533-8456, fax 513/543-8230. Comments may also be submitted by e-mail to; NIOCINDOCKET@CDC.GOV. E-mail attachments should be formatted as WordPerfect 6/7/8/9, or Microsoft Word. Comments should be submitted to NIOSH no later than May 31, 2001, and should reference docket number, NIOSH—002, in the subject heading.
FOR FURTHER INFORMATION CONTACT: John M. Dower or Ray Wells, NIOSH, 1095 Willowdale Road, Morgantown, West Virginia 26505-2888, telephone 304/ 285-5907, fax 304/285-6030 and/or Email: respcert@cdc.gov. or Mr. Wayne Davis, Product Director for Respiratory Protection, Project Manager for Nuclear, Biological and Chemical Defense Systems, SBCCOM, 5183 Blackhawk Road, Aberdeen Proving Ground, MD 24010-5424, ATTN: AMSSB-PM-RNN- P/ Mr. Wayne Davis, telephone 410 436-1776, fax 410 436-4185 and/or Wayne.davis@sbecom.apgea.army.mil.
The Director, Management Analysis and Services office has been delegated the authority to sign Federal Register notices pertaining ta announcements of meetings and other committee management activities for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry.
Dated: March 15, 2001.
John Burckhardt,
Acting Director, Management Analysis and Office, Centers for Disease Control and Prevention.
[FR Doc. 01-6977 Filed 2-20-01; 8:45 am]
BILLING CODE 4162-18-P
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 01D-0086]
Draft Guidance for Industry: Disclosing Information Provided to Advisory Committees in Connection With Open Advisory Committee Meetings Related to the Testing or Approval of Biologic Products and Convened by the Center for Biologics Evaluation and Research; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
