### 74193 Federal Register / Vol. 77, No. 240 / Thursday, December 13, 2012 / Notices

Availability

This notice announces the availability of three new and seven updated final toxicological profiles of priority hazardous substances prepared by ATSDR. The following final toxicological profiles were made available to the public on December 7, 2012. These documents are available at the ATSDR Web site: www.atsdr.cdc.gov/toxprofiles/ index.asp

.
Toxicological profile CAS No.

1. Acrylamide ........................ 79–06–1 2. 1,3-Butadiene ................... 106–99–0 3. Cadmium .......................... 7440–43–9 4. Carbon Monoxide ............. 630–08–0 5. Chromium ......................... 7440–47–3 6. 1,4-Dioxane ...................... 123–91–1 7. Manganese ....................... 7439–96–5 8. Phosphate Ester Flame

Retardants ......................... 78–51–3 126–73–8 126–71–6 115–86–6 13674–84–5 13674–87–8

115–96–8 9. Radon ............................... 10043–92–2 10. Vanadium ....................... 7440–62–2

The final profiles are also available through the U.S. Department of Commerce, National Technical Information Service (NTIS), 5285 Port Royal Road, Springfield, Virginia 22161, telephone 1–800–553– 6847. These profiles are available for a fee as determined by NTIS.

Dated: December 6, 2012. Ken Rose, Director, Office of Policy, Planning and Evaluation, National Center for Environmental Health/ Agency for Toxic Substances and Disease Registry.
[FR Doc. 2012–30087 Filed 12–12–12; 8:45 am]

**BILLING CODE 4163–70–P**

**DEPARTMENT OF HEALTH AND HUMAN SERVICES** 

**Centers for Disease Control and Prevention (CDC)** 

**[CDC–2012–0012; NIOSH–254]**

**Request for Information on Edel Kindwall Caisson Tables for**  **Preventing Decompression Illness in Construction Workers** 

**AGENCY :**  National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). **ACTION :**  Notice of public comment period.

**SUMMARY :**  The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) invites comments and information on decompression tables used for protecting tunneling (caisson) workers from developing decompression illnesses.

Public Comment Period: Comments must be received by March 29, 2013.

**ADDRESSES :**  Written comments, identified by CDC–2012–0012 and docket number NIOSH–254, may be submitted by any of the following methods:

• Federal erulemaking portal: http:// www.regulations.gov. Follow the instructions for submitting comments.

• Mail: NIOSH Docket Office, Robert A. Taft Laboratories, MS–C34, 4676 Columbia Parkway, Cincinnati, OH
45226.

• Email: nioshdocket@cdc.gov

. All information received in response to this notice will be available for public examination and copying at the NIOSH Docket Office, 4676 Columbia Parkway, Cincinnati, Ohio 45226. The document and instructions for submitting comments can be found at: http:// www.regulations.gov. NIOSH includes all comments received without change in the docket, including any personal information provided. All electronic comments should be formatted as Microsoft Word. Please make reference to CDC 2012–0012 and docket number NIOSH–254.

**FOR FURTHER INFORMATION CONTACT :**  Frank J. Hearl, PE, Chief of Staff, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention, Patriots Plaza, Suite 9200, 395 E St. SW., Washington, DC 20201. Telephone: (202) 245–0625 (this is not a toll-free number).

**SUPPLEMENTARY INFORMATION :**  High pressure tunneling operations are used for some underground infrastructure projects. Compressed air is used to prevent seepage of water or to stabilize unstable soil conditions. Caisson work (a water-tight structure that allows underwater construction to be performed) can also involve elevated pressure worksites. This hyperbaric environment created by ambient pressure and compressed air effects exposes caisson and tunnel workers to the risks of decompression sickness (DCS) such as the ‘‘bends.’’ DCS is related to intravascular or extravascular bubbles formed during reduction of environmental pressure (decompression). The release of nitrogen bubbles into blood or tissues can result in obstruction of blood flow or pressure effects. Clinical manifestations of DCS include (but are not limited to) joint pain (‘‘bends’’), lytic lesions of bones (dysbaric osteonecrosis), cutaneous disorders (cutis marmorata), spinal cord and brain disorders (stroke, paralysis, paresthesias, bladder dysfunction, etc.), and cardiopulmonary disorders (shortness of breath ‘‘chokes’’), arterial gas embolism.

In order to prevent DCS, workers in higher hyperbaric environments must be safely brought back to the non-work environmental ambient pressure (decompressed) in decompression areas.

Decompression tables generally utilize stepwise (staged) progressions of gradually decreasing pressure at varying time intervals based on work exposure pressures and length of work shift.

In 1971, the Washington State Decompression Tables that were used in multiple states became the federal code enforced by the Occupational Health and Safety Administration (OSHA) and remain, unchanged, as the decompression tables in force today. The maximum worksite pressures allowed by OSHA (1926 Subpart S, Appendix A) and addressed by the OSHA decompression tables is 50 pounds per square inch (psi) (

∼ 3.45 bar gauge) [1]. They are considered inadequate for ‘‘efficiently eliminating nitrogen from the body’’ at pressures in excess of 36.5 psi [2].

The Edel-Kindwall Caisson Tables were developed for NIOSH in 1981. They are based on advances in hyperbaric research and are considered to be more protective of worker health than the OSHA tables. As a result, these tables have been used for variances to the OSH standard. NIOSH is making these tables more easily accessible to construction users by posting them to a new Web page at the NIOSH Web site
at http://www.cdc.gov/NIOSH/topics/ Decompression/.

However, the Edel-Kindwall tables are inadequate for dealing with pressures greater than 50 psi. Many modern projects using Tunnel Boring Machines involve pressures greater than 50 psi. There is a need for up-to-date decompression tables.

NIOSH is thus requesting information on the following: (1) Information ontypes of projects where the EdelKindwall Tables have been used, (2) Published and unpublished reports andfindings relating to the use of the EdelKindwall Tables, including information on possible health effects or lack of observed health health effects in tunnel/ caisson workers who were


### 74194 Federal Register / Vol. 77, No. 240 / Thursday, December 13, 2012 / Notices

decompressed with data from the EdelKindwall Tables,(3) Information on related control measures (e.g., engineering controls, work practices, personal protective equipment) in use in workplaces where decompression is required, and (4) Information on alternative tables and approaches being used to protect tunneling workers from higher pressures greater than 50 psi.

References

1. Hamilton RW, Bill Kay E. (2008) Boring deep tunnels. Third conference on U.S.- Japan panel on aerospace-diving physiology & technology and hyperbaric medicine. 2. Downs GJ, Kindwall EP. (1986) Aseptic necrosis in caisson workers: A new set of decompression tables. Aviat Space & Environ Med 57:569–574.

Dated: December 4, 2012. John Howard, Director, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention.
[FR Doc. 2012–30080 Filed 12–12–12; 8:45 am]

**BILLING CODE 4163–19–P**

**DEPARTMENT OF HEALTH AND HUMAN SERVICES** 

**Centers for Disease Control and Prevention** 

**[Docket Number NIOSH–238]**

**Issuance of Final Guidance Publication**

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

**ACTION :**  Notice of issuance of final guidance publication.

**SUMMARY :**  The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), announces the availability of the following publication: NIOSH Alert entitled ‘‘Preventing Occupational Respiratory Disease from Exposures Caused by Dampness in Office Buildings, Schools, and Other Nonindustrial Buildings’’ [2013–102].

**ADDRESSES :**  This document may be obtained at the following link:

• Web site: http://www.cdc.gov/ niosh/docs/2013-102/

. **FOR FURTHER INFORMATION CONTACT :**  Michelle R. Martin, M.S., NIOSH/CDC, 1095 Willowdale Road, Morgantown, WV 26505, telephone (304) 285–5734, email mrmartin1@cdc.gov

. Dated: December 4, 2012. John Howard, Director, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention.
[FR Doc. 2012–30081 Filed 12–12–12; 8:45 am]

**BILLING CODE 4163–19–P**

**DEPARTMENT OF HEALTH AND HUMAN SERVICES** 

**Food and Drug Administration**

**[Docket No. FDA–2012–D–0429]**

**Agency Information Collection Activities; Submission for Office of**  **Management and Budget Review; Comment Request; Guidance on**  **Meetings With Industry and Investigators on the Research and**  **Development of Tobacco Products**

**AGENCY :**  Food and Drug Administration, HHS.

**ACTION :**  Notice.

**SUMMARY :**  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 review and clearance under the Paperwork Reduction Act of 1995.

**DATES :**  Fax written comments on the collection of information by January 14,
2013.

**ADDRESSES :**  To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202–395–7285, or emailed to oira

_ submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–NEW and title ‘‘Guidance on Meetings With Industry and Investigators on the Research and Development of Tobacco Products.’’ Also, include the FDA docket number found in brackets in the heading of this document.

**FOR FURTHER INFORMATION CONTACT :**  Daniel Gittleson, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50– 400B, Rockville, MD 20850, 301–796– 5156, Daniel.Gittleson@fda.hhs.gov.

**SUPPLEMENTARY INFORMATION :**  In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Guidance on Meetings With Industry and Investigators on the Research and Development of Tobacco Products— (OMB Control Number 0910–NEW)

This guidance is intended to assist tobacco manufacturers, importers, researchers, and investigators, and their representatives who seek meetings with staff of FDA’s Center for Tobacco Products (CTP) relating to their plans to conduct research to inform the regulation of tobacco products or support the development or marketing of tobacco products. This guidance does not pertain to other types of meetings or meeting requests with CTP staff. The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Pub. L. 111–31) offers tobacco product manufacturers several pathways to obtain an order from FDA to authorize the marketing of a tobacco product before it may be introduced or delivered into interstate commerce. To provide assistance with these pathways to market particular products, FDA will meet with tobacco product manufacturers, importers, researchers, and investigators (or their representatives) where appropriate. This guidance is intended to assist persons who seek guidance relating to their research to inform the regulation of tobacco products, or to support the development or marketing of tobacco products. In the guidance, the Agency discusses, among other things:

• What information DA recommends persons include in such a meeting request;

• How and when to submit such a request; and

• What information FDA recommends persons submit prior to such a meeting.

In the Federal Register of May 25, 2012 (77 FR 31368), FDA published a 60-day notice requesting public comment on the proposed collection of information. FDA received one response containing PRA-related comments.. The comment indicated that the guidance should clarify that meeting request times will vary depending on the type of submission to be discussed and the meeting information package requirements should be tailored to the submission type.

In response, the estimated burden hours for both meeting requests and meeting information package requirements have been calculated by FDA and are based on an average number of hours for each type of submission over a 3-year period. The meeting information requirements are also averaged together and are not individually split into submission types