Federal Register / Vol. 76, No. 6 / Monday, January 10, 2011 / Notices 1435 

• Mail: NIOSH Docket Office, Robert 

A. Taft Laboratories, MS–C34, 4676 

Columbia Parkway, Cincinnati, OH 

45226. 

• Facsimile: (513) 533–8285. 

• E-mail: nioshdocket@cdc.gov. 

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. A complete electronic docket 

containing all comments submitted will 

be available on the NIOSH Web page at 

http://www.cdc.gov/niosh/docket, and 

comments will be available in writing 

by request. NIOSH includes all 

comments received without change in 

the docket, including any personal 

information provided. 

FOR FURTHER INFORMATION CONTACT: 

Lauralynn Taylor McKernan, NIOSH, 

Robert A Taft Laboratories, MS–C32, 

4676 Columbia Parkway, Cincinnati, OH 

45226, telephone: (513) 533–8542. 

SUPPLEMENTARY INFORMATION: 2,3- 

pentanedione is an alpha-diketone that 

has received attention as a substitute for 

diacetyl. 2,3-pentanedione is 

structurally very similar to diacetyl 

since 2,3-pentanedione is a 5-carbon 

alpha-diketone and diacetyl is a 4- 

carbon alpha-diketone. Published 

reports on the toxicity of 2,3- 

pentanedione are currently only in 

abstract form but suggest that in rats 2,3- 

pentanedione causes airway epithelial 

damage similar to that produced by 

diacetyl (Hubbs et al. 2010b; Morgan et 

al. 2010). Preliminary data also suggest 

that, under certain conditions, both 

diacetyl and 2,3-pentanedione can cause 

changes in the central nervous system 

(Hubbs et al. 2010a). Additional alphadiketones of interest include, but are not 

limited to, those used in food 

manufacturing such as 2,3-hexanedione 

and 2,3-heptanedione (Kreiss et al. 

2010). 

NIOSH seeks to obtain materials, 

including published and unpublished 

reports and research findings, to 

evaluate the possible health risks of 

occupational exposure to 2,3- 

pentanedione and other alpha-diketones 

used as diacetyl substitutes. Examples 

of requested information include, but 

are not limited to, the following: 

(1) Identification of industries or 

occupations in which exposures to 2,3- 

pentanedione, and other alphadiketones used as diacetyl substitutes 

may occur; 

(2) Trends in the production and use 

of 2,3-pentanedione, and other alphadiketones; 

(3) Description of work tasks and 

scenarios with a potential for exposure 

to 2,3-pentanedione, and other alphadiketones used as diacetyl substitutes; 

(4) Workplace exposure measurement 

data in various types of industries and 

jobs where 2,3-pentanedione, and other 

alpha-diketones are used; 

(5) Case reports or other health 

information demonstrating potential 

health effects in workers exposed to 2,3- 

pentanedione, and other alphadiketones; 

(6) Research findings from in vitro and 

in vivo toxicity studies; 

(7) Information on control measures 

(e.g., engineering controls, work 

practices, personal protective 

equipment) being taken to minimize 

worker exposure to 2,3-pentanedione, 

and other alpha-diketones used as 

diacetyl substitutes; 

(8) Educational materials for worker 

safety and training on the safe handling 

of 2,3-pentanedione and other alphadiketones; and 

(9) Data pertaining to the feasibility of 

establishing a REL for 2,3-pentanedione, 

and other alpha-diketones. 

References 

Hubbs, A. F., Cumpston, A., Goldsmith, W. 

T., Battelli, L. A., Kashon, M. L., Jackson, 

M. C., Frazer, D. G., Fedan, J. S., 

Goravanahally, M. P., and Sriram, K. 

(2010a). Acute central neurotoxicity of 

inhaled alpha-diketon butter flavoring 

compounds in the rat brain. Vet Path 47(6), 

57S. 

Hubbs, A. F., Moseley, A. E., Goldsmith, W. 

T., Jackson, M. C., Kashon, M. L., Battelli, 

L. A., Schwegler-Berry, D., Goravanahally, 

M. P., Frazer, D., Fedan, J. S., Kreiss, K., 

and Castranova, V. (2010b). Airway 

epithelial toxicity of the flavoring agent, 

2,3-pentanedione. The Toxicologist: 

Supplement to Toxicological Sciences 

114(1), 319. 

Kreiss, K., Day, G. A., Cummings, K. J., and 

Kullman, G. (2010). Diacetul substitutes in 

bakery product manufacture Am J Respir 

Crit Care Med 181(1), A4650. 

Morgan, D. L., Kirby, P. J., Price, H. C., 

Bosquet, R. W., Taylor, G. J., Gage, N., and 

Flake, G. P. (2010). Inhalation toxicity of 

acetyl proprionyl in rats and mice. The 

Toxicologist: Supplement to Toxicological 

Sciences 114(1), 316. 

John Howard, 

Director, National Institute for Occupational 

Safety and Health, Centers for Disease Control 

and Prevention. 

[FR Doc. 2011–274 Filed 1–7–11; 8:45 am] 

BILLING CODE 4163–19–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10142 and CMS– 

R–262] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, HHS. 

In compliance with the requirement 

of section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995, the 

Centers for Medicare & Medicaid 

Services (CMS), Department of Health 

and Human Services, is publishing the 

following summary of proposed 

collections for public comment. 

Interested persons are invited to send 

comments regarding this burden 

estimate or any other aspect of this 

collection of information, including any 

of the following subjects: (1) The 

necessity and utility of the proposed 

information collection for the proper 

performance of the Agency’s function; 

(2) the accuracy of the estimated 

burden; (3) ways to enhance the quality, 

utility, and clarity of the information to 

be collected; and (4) the use of 

automated collection techniques or 

other forms of information technology to 

minimize the information collection 

burden. 

1. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: CY 2012 Bid 

Pricing Tool (BPT) for Medicare 

Advantage (MA) Plans and Prescription 

Drug Plans (PDP); Use: Under the 

Medicare Prescription Drug, 

Improvement, and Modernization Act of 

2003 (MMA), and implementing 

regulations at 42 CFR, Medicare 

Advantage organizations (MAO) and 

Prescription Drug Plans are required to 

submit an actuarial pricing ‘‘bid’’ for 

each plan offered to Medicare 

beneficiaries for approval by CMS. 

MAOs and PDPs use the Bid Pricing 

Tool (BPT) software to develop their 

actuarial pricing bid. The information 

provided in the BPT is the basis for the 

plan’s enrollee premiums and CMS 

payments for each contract year. The 

tool collects data such as medical 

expense development (from claims data 

and/or manual rating), administrative 

expenses, profit levels, and projected 

plan enrollment information. By statute, 

completed BPTs are due to CMS by the 

first Monday of June each year. CMS 

reviews and analyzes the information 

provided on the Bid Pricing Tool. 


srobinson on DSKHWCL6B1PROD with NOTICES
1436 Federal Register / Vol. 76, No. 6 / Monday, January 10, 2011 / Notices 

Ultimately, CMS decides whether to 

approve the plan pricing (i.e., payment 

and premium) proposed by each 

organization. Form Number: CMS– 

10142 (OMB#: 0938–0944); Frequency: 

Yearly; Affected Public: Business or 

other for-profits and not-for-profit 

institutions; Number of Respondents: 

550; Total Annual Responses: 4,950; 

Total Annual Hours: 148,500. (For 

policy questions regarding this 

collection contact Diane Spitalnic at 

410–786–5745. For all other issues call 

410–786–1326.) 

2. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: CY 2012 Plan 

Benefit Package (PBP) Software and 

Formulary Submission; Under the 

Medicare Modernization Act (MMA), 

Medicare Advantage (MA) and 

Prescription Drug Plan (PDP) 

organizations are required to submit 

plan benefit packages for all Medicare 

beneficiaries residing in their service 

area. The plan benefit package 

submission consists of the Plan Benefit 

Package (PBP) software, formulary file, 

and supporting documentation, as 

necessary. MA and PDP organizations 

use the PBP software to describe their 

organization’s plan benefit packages, 

including information on premiums, 

cost sharing, authorization rules, and 

supplemental benefits. They also 

generate a formulary to describe their 

list of drugs, including information on 

prior authorization, step therapy, 

tiering, and quantity limits. 

Additionally, CMS uses the PBP and 

formulary data to review and approve 

the plan benefit packages proposed by 

each MA and PDP organization. 

CMS requires that MA and PDP 

organizations submit a completed PBP 

and formulary as part of the annual 

bidding process. During this process, 

organizations prepare their proposed 

plan benefit packages for the upcoming 

contract year and submit them to CMS 

for review and approval. Refer to the 

supporting document ‘‘Appendix B’’ for 

a list of changes. Form Number: CMS– 

R–262 (OMB#: 0938–0763); Frequency: 

Yearly; Affected Public: Business or 

other for-profits and not-for-profit 

institutions; Number of Respondents: 

651; Total Annual Responses: 6,159; 

Total Annual Hours: 45,407. (For policy 

questions regarding this collection 

contact Kristy Holtje at 410–786–2209. 

For all other issues call 410–786–1326.) 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, access CMS Web Site 

address at http://www.cms.hhs.gov/ 

PaperworkReductionActof1995, or 

E-mail your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov, or call the 

Reports Clearance Office on (410) 786– 

1326. 

To be assured consideration, 

comments and recommendations for the 

proposed information collections must 

be received by the OMB desk officer at 

the address below, no later than 5 p.m. 

on February 9, 2011, OMB, Office of 

Information and Regulatory Affairs, 

Attention: CMS Desk Officer. Fax 

Number: (202) 395–6974. E-mail: 

OIRA_submission@omb.eop.gov. 

Martique Jones, 

Director, Regulations Development DivisionB, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2011–243 Filed 1–7–11; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB Review; 

Comment Request 

Title: Tracking of Participants in the 

Early Head Start Research and 

Evaluation Project. 

OMB No.: New Collection. 

Billing Accounting Code (BAC): 

418422 (G994426). 

Description: The Administration for 

Children and Families (ACE) within the 

Department of Health and Human 

Services (HHS) will conduct tracking of 

children/families who participated in 

the Early Head Start Research and 

Evaluation Project (EHSREP). The 

purpose of tracking these participants is 

to maintain up-to-date contact 

information for the children/families in 

the event that the Administration for 

Children and Families (ACE) determines 

that a future follow-up to the EHSREP 

will take place. 

The EHSREP is a longitudinal study 

originally designed to meet 1994 

requirement for a national evaluation of 

the Early Head Start program. 3001 

children and families in 17 sites were 

randomly assigned either to the program 

group (allowed to enroll in EHS), or to 

the control group (precluded from 

enrolling in EHS, although they could 

receive other services in the 

community). Child and family 

assessments were conducted when 

children were 14 months old, 24 months 

old, 36 months old, in the spring prior 

to kindergarten entry, and again in the 

spring of the sixth year of formal 

schooling (5th grade for most children). 

If the decision is made to follow the 

sample through high school, it is 

important to maintain contact with the 

participants so that response rates at 

follow-up points will be maximized. 

Telephone interviews will be conducted 

in order to update the respondent’s 

location and contact information. This 

information will be collected from 

parents or guardians in the spring of 

2011. 

Respondents: Treatment and control 

group members in the Early Head Start 

Research and Evaluation Project. 

ANNUAL BURDEN ESTIMATES

Instrument 

Annual 

number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total annual 

burden hours 

Tracking Interview ............................................................................................ 2700 1 .25 675 

3rd Party Contacts ........................................................................................... 200 1 .05 10 

Estimated Total Annual Burden 

Hours: 685. 

Additional Information 

Copies of the proposed collection may 

be obtained by writing to the 

Administration for Children and 

Families, Office of Planning, Research 

and Evaluation, 370 L’Enfant 

Promenade, SW., Washington, DC 

20447, Attn: OPRE Reports Clearance 

Officer. All requests should be 

identified by the title of the information 

collection. E-mail address: 

OPREinfocollection@acf.hhs.gov. 


srobinson on DSKHWCL6B1PROD with NOTICES