Department of Health and Human Services October 17, 2008 – Federal Register Recent Federal Regulation Documents

Declaration pursuant to section 319F-3 of the Public Health Service Act (42 U.S.C. 247d-6d) to provide targeted liability protections for pandemic countermeasures based on a credible risk that avian influenza viruses spread and evolve into strains capable of causing a pandemic of human influenza.

Declaration pursuant to section 319F-3 of the Public Health Service Act (42 U.S.C. 247d-6d) to provide targeted liability protections for Botulism countermeasures based on a credible risk that the threat of exposure to botulinum toxin(s) and the resulting disease(s) from a manmade or natural source constitutes a public health emergency.

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the following meeting and request for public comment on the Fire Fighter Fatality Investigation and Prevention Program (FFFIPP). Public Meeting Time and Date: 10 a.m.-5 p.m., CST, November 19, 2008. Place: Crowne Plaza Hotel, Chicago O'Hare, 5440 North River Road, Rosemont, Illinois 66018. Purpose of Meeting: The public meeting will seek stakeholder input on the progress and strategic goals of the NIOSH Fire Fighter Fatality Investigation and Prevention Program (FFFIPP) to ensure that the program is meeting the needs of the stakeholders, and to identify ways in which the program can be improved to increase its impact on the safety and health of fire fighters across the United States. NIOSH will compile and consider all comments received at the meeting and through the NIOSH Docket Office and use them in making decisions on how to proceed with the FFFIPP. Status: This meeting is hosted by NIOSH and will be open to the public, limited only by the space available. The meeting room will accommodate approximately 75 people. Interested parties should make hotel reservations directly with the Crowne Plaza Hotel, telephone (847) 671-6350 or (800) 972-2494 and reference the NIOSH FFFIPP Stakeholders Meeting. Interested parties should confirm their attendance to this meeting by completing a registration form on the NIOSH Web site: https://www.cdc.gov/niosh/fire/ 2008PublicMeetingRegistration.html Format of Meeting: The NIOSH Acting Director, Dr. Christine Branche, will provide opening remarks, followed by NIOSH presentations that provide an overview of the Fire Fighter Fatality Investigation and Prevention Program (FFFIPP) and summary of Program changes and improvements since March 2006. NIOSH will present and make available for stakeholder input a set of draft Strategic Goals for FFFIPP for stakeholder consideration and comment. Stakeholders who have requested an opportunity to speak prior to the meeting will present suggestions for enhancing the impact of the program and future directions. An opportunity to make oral presentations will be provided to all interested parties, given time on the agenda. Presentations will be limited to 10 minutes. The meeting will end with an interactive session providing the opportunity for clarification of stakeholder comments. Requests to make presentations at the meeting should be made by e- mail to Paul Moore, Chief, Fatality Investigations Team, e-mail PMoore@cdc.gov, telephone (304) 285-6016 or Matt Bowyer, General Engineer, e-mail MBowyer@cdc.gov, telephone (304) 285-5991, facsimile (304) 285-5774, before November 10, 2008. All requests to present should include the name, address, telephone number, relevant business affiliations of the presenter, and a brief summary of the presentation. After reviewing the requests for presentation, NIOSH FFFIPP staff will notify each presenter of the approximate time that their presentation is scheduled to begin. If a participant is not present when their presentation is scheduled to begin, the remaining participants will be heard in order. Written comments without an oral presentation are also encouraged, and should be submitted to the NIOSH Docket Office as outlined in the next section. Written comments on the usefulness of the FFFIPP and products for improving fire fighter safety and health, suggestions for enhancing the impact of the program, and comments on the draft FFFIPP strategic and programmatic goals may be submitted to the NIOSH Docket Office, Robert A. Taft Laboratories, Mailstop C34, 4676 Columbia Parkway, Cincinnati, Ohio 45226, telephone (513) 533-8303, facsimile (513) 533-8285. Comments may also be submitted via e-mail to niocindocket@cdc.gov. All electronic comments should be formatted as Microsoft Word. Comments should be submitted to NIOSH no later than December 19, 2008, and should reference the NIOSH Docket Number 063-A in the subject heading. Background: NIOSH convened a similar stakeholders' meeting in March 2006 to seek input on the progress and future directions of the FFFIPP. The input provided by stakeholders at that meeting was useful in providing insight into stakeholder needs and in helping to improve the FFFIPP. The November 2008 meeting will be held to again seek stakeholder input. Contact Person for Technical Information: Paul Moore, Chief, Fatality Investigations Team, Division of Safety Research, telephone (304) 285-6016 or Matt Bowyer, General Engineer, Fatality Investigations Team, (304) 285-5991.

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the availability of the following notice of public meeting and draft document available for public comment entitled ``NIOSH Criteria Document Update: Occupational Exposure to Hexavalent Chromium.'' The document and instructions for submitting comments can be found at https://www.cdc.gov/niosh/review/public/144/. Comments may be provided to the NIOSH docket, as well as given orally at the following meeting. Public Comment Period: October 15, 2008-January 31, 2009. Public Meeting Time and Date: 9 a.m.-4 p.m. EST, January 22, 2009. Place: Robert A. Taft Laboratories, Taft Auditorium, NIOSH, CDC, 4676 Columbia Parkway, Cincinnati, OH 45226-1998. Purpose of Meeting: To discuss and obtain comments on the draft document, ``NIOSH Criteria Document Update: Occupational Exposure to Hexavalent Chromium.'' Special emphasis will be placed on discussion of the following: 1. Are the critical studies presented clearly and adequately? 2. Do all of the presented studies use scientifically valid methods and techniques? 3. Are there additional critical studies relevant to occupational exposure to hexavalent chromium compounds that should be included? 4. Does NIOSH have a transparent and sound basis for its revised Recommended Exposure Limit for hexavalent chromium compounds? 5. Is the new NIOSH policy of providing general exposure assessment recommendations instead of a specific Action Level scientifically justified? 6. Are the NIOSH recommendations for worker protection clear and justified? 7. Are there additional recommendations for worker protection that should be included? Status: The forum will include scientists and representatives from various government agencies, industry, labor, and other stakeholders, and is open to the public, limited only by the space available. The meeting room accommodates 80 people. Due to limited space and security clearance requirements, notification of intent to attend the meeting must be made to the NIOSH Docket Office no later than January 7, 2009 for U.S. citizens, or no later than December 30, 2008 for non-U.S. citizens.* Persons wanting to provide oral comments at the meeting are requested to notify the NIOSH Docket Office no later than January 7, 2009 at (513) 533-8611 or by e-mail at nioshdocket@cdc.gov. Priority for attendance will be given to those providing oral comments. Other requests to attend the meeting will then be accommodated on a first- come basis. Unreserved walk-in attendees will not be admitted due to security clearance requirements. Persons wanting to provide oral comments will be permitted up to 20 minutes. If additional time becomes available, presenters will be notified. Oral comments given at the meeting must also be submitted to the docket in writing in order to be considered by the Agency. Written comments will also be accepted at the meeting. Written comments may also be submitted to the NIOSH Docket Office, Robert A. Taft Laboratories, 4676 Columbia Parkway, MS C-34, Cincinnati, Ohio 45226, telephone (513) 533-8611. All material submitted to the Agency should reference Docket Number NIOSH-144 and must be submitted by January 31, 2009 to be considered by the Agency. All electronic comments should be formatted as Microsoft Word. Please make reference to Docket Number NIOSH-144. All information received in response to this notice will be available for public examination and copying at the NIOSH Docket Office, Room 111, 4676 Columbia Parkway, Cincinnati, Ohio 45226. *Non-U.S. Citizens: Because of CDC Security Regulations, any non- U.S. citizen wishing to attend this meeting must provide the following information in writing to the NIOSH Docket Officer at the address below no later than December 30, 2008. This information will be transmitted to the CDC Security Office for approval. Visitors will be notified as soon as approval has been obtained. 1. Name: 2. Gender: 3. Date of Birth: 4. Place of Birth (city, province, state, country): 5. Citizenship: 6. Passport Number: 7. Date of Passport Issue: 8. Date of Passport Expiration: 9. Type of Visa: 10. U.S. Naturalization Number (if a naturalized citizen) 11. U.S. Naturalization Date (if a naturalized citizen) 12. Visitor's Organization: 13. Organization Address: 14. Organization Telephone Number: 15. Visitor's Position/Title within the Organization: Background: This draft NIOSH document provides a review of the available literature and provides an update of NIOSH policies on occupational exposure to hexavalent chromium compounds including an assessment of: (1) Critical animal, human, and in vitro studies on occupational exposure to hexavalent chromium; (2) relevant quantitative risk assessments about occupational exposure to hexavalent chromium; (3) appropriate methods for sampling and analysis of hexavalent chromium compounds in the workplace; (4) basis for the NIOSH revised Recommended Exposure Limit for hexavalent chromium compounds; and (5) other NIOSH recommendations for protecting workers from occupational exposure to hexavalent chromium. This guidance document does not have the force and effect of law. The purpose of the public review of the draft document and public meeting is to obtain public comments assessing whether: (1) This hazard identification is an accurate reflection of the available scientific studies; (2) the NIOSH recommendations for protecting workers from occupational exposure to hexavalent chromium compounds are appropriate and justified, and (3) NIOSH has a transparent and scientific basis for its revised Recommended Exposure Limit for hexavalent chromium compounds.