Department of Health and Human Services December 12, 2007 – Federal Register Recent Federal Regulation Documents

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 draft Current Intelligence Bulletin (CIB) entitled ``Interim Guidance on Medical Screening of Workers Potentially Exposed to Engineered Nanoparticles.'' The document and instructions for submitting comments can be found at https://www.cdc.gov/niosh/review/public/115/. Comments may be provided to the NIOSH docket, as well as given orally at the following meeting. Public Comment Period: December 14, 2007 through February 15, 2008. Public Meeting Time and Date: 9 a.m.-4 p.m., January 30, 2008. Place: Robert A. Taft Laboratories, Taft Auditorium, NIOSH, CDC, 4676 Columbia Parkway, Cincinnati, Ohio 45226. Purpose of Meeting: To discuss and obtain comments on the draft CIB ``Interim Guidance on Medical Screening of Workers Potentially Exposed to Engineered Nanoparticles.'' Special emphasis will be placed on discussion of the following: (1) Do the data support the conclusions of the document? (2) Are the conclusions appropriate in light of the current understanding of toxicological data? (3) Is medical surveillance appropriate at this time for workers with potential exposure to engineered nanoparticles; if so, what form(s) of medical surveillance are specific for such workers? (4) What are the potential benefits, adverse impacts, and limitations of medical screening of workers potentially exposed to engineered nanoparticles? (5) What are the potential benefits, adverse impacts, and limitations of establishing an exposure registry for workers exposed to engineered nanoparticles? 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 Friday, January 18, 2008. Persons wanting to provide oral comments at the meeting are requested to notify the NIOSH Docket Office no later than January 11, 2008 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 will be recorded and included in the docket. 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-115 and must be submitted by February 15, 2008 (public review closing date) to be considered by the Agency. All electronic comments should be formatted as Microsoft Word. Please make reference to docket number NIOSH-115. 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. Background: Concerns have been raised about whether workers exposed to engineered nanoparticles will be at increased risk of adverse health effects and whether medical screening or some other type of occupational health surveillance is appropriate for these workers. Although increasing evidence indicates that exposure to some engineered nanoparticles can cause adverse health effects in laboratory animals, insufficient medical evidence exists to recommend the medical screening of workers potentially exposed to engineered nanoparticles. However, NIOSH will continue to assess the scientific evidence and periodically update the guidance on medical screening. Because occupational exposure to engineered nanoparticles is likely to become more common in the future, NIOSH has recommended that employers identify the presence of engineered nanoparticles in their workplace and implement effective efforts to minimize worker exposure to these materials [NIOSH 2006]. This guidance document does not have the force and effect of the law. Contact Persons for Technical Information: Dr. Paul A. Schulte, M/S C-14, Robert A. Taft Laboratories, 4676 Columbia Parkway, Cincinnati, Ohio 45226, telephone 513/533-8302, or Ralph Zumwalde, M/S C-32, Robert A. Taft Laboratories, 4676 Columbia Parkway, Cincinnati, Ohio 45226, telephone 513/533-8320. Reference: NIOSH [2006]. Approaches to safe nanotechnology: an information exchange with NIOSH. Cincinnati, OH: Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, July 2006. Web address for this document: https://www.cdc.gov/niosh/topics/nanotech/safenano/.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for emergency processing under the Paperwork Reduction Act of 1995 (the PRA). The proposed collection of information concerns the certification to accompany human drug, biological product, and device applications or submissions.