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

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 EdelKindwall 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 on 

types of projects where the EdelKindwall Tables have been used, (2) 

Published and unpublished reports and 

findings 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 


srobinson on DSK4SPTVN1PROD with 
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 


srobinson on DSK4SPTVN1PROD with