Request for Information on 2,3-Pentanedione and Other Alpha-Diketones Used As Diacetyl Substitutes, 1434-1435 [2011-274]

Download as PDF 1434 Federal Register / Vol. 76, No. 6 / Monday, January 10, 2011 / Notices CityMatCH, and participating communities. This request is for 3-years. The original Fetal-Infant Mortality Review (FIMR) methodology was an approach designed to lead to community-level improvements in infant health outcomes. The methodology consists of four steps: Data gathering, case review, community action, and changes in community systems. The FHPM has adapted the steps of FIMR in order to evaluate and address the causes of perinatal HIV transmission. This is the first program to approach perinatal HIV prevention using a community-based systems investigation and improvement strategy. During FHPM’s first step of the methodology, cases of perinatal HIV will be identified based on a preestablished case definition, and will be prioritized for community review. Data for selected cases will be collected from a variety of sources, including medical, public health, and case management records, and then deidentified. A maternal interview will only be conducted if consent is provided by the woman. Data collection can proceed using hospital records if there is no consent for an interview. Data collected during interviews with consenting women will be de-identified. There will be no cost to participants Form name Face-to-Face Form. Maternal Interview Sites participating in FHPM ............. [FR Doc. 2011–280 Filed 1–7–11; 8:45 am] BILLING CODE 4163–18–P Centers for Disease Control and Prevention [Docket Number NIOSH–189] Request for Information on 2,3Pentanedione and Other AlphaDiketones Used As Diacetyl Substitutes National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), AGENCY: 18:19 Jan 07, 2011 ACTION: Jkt 223001 Notice of public comment period. The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) intends to evaluate the scientific data on 2,3pentanedione (CAS #600–14–6, also known as pentane-2,3-dione; acetyl propionyl) and other alpha-diketones and develop appropriate communication documents, such as a Current Intelligence Bulletin, Criteria Document and/or other informational products, and potentially establish a Recommended Exposure Limit (REL) for diacetyl substitutes. NIOSH is requesting information on the following: (1) Published and unpublished reports and findings from in vitro and in vivo toxicity studies with 2,3-pentanedione, PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 10 sites. Sites have been collecting and evaluating data on mother-to-child transmissions in their communities since 2010. Currently de-identified FHPM data is stored electronically at participating sites. This data has been collected by local health agencies for local public health action and programming. NCHHSTP also plans to launch the FIMR–HIV Data System (FHDS) in 2011, which would provide a centralized, Web-based data system that could be accessed and utilized by all participating sites and partner organizations. This Information Collection Request is being submitted since the FHDS since FHDS will be managed by CDC, thus centralizing the data and allowing aggregated analysis. NCHHSTP is considering ways to eliminate perinatal HIV transmission in the U.S., and has incorporated FHPM into a framework to do so. Data collected by FHPM will primarily serve to inform and improve local health systems in order to prevent future perinatal HIV transmissions. This data will provide a clearer picture of the systems-level strengths and weaknesses in participating communities. There will be no cost to participants other than their time. Estimated Annualized Burden Hours Number of responses per respondent 10 Department of Health and Human Services (HHS). SUMMARY: DEPARTMENT OF HEALTH AND HUMAN SERVICES srobinson on DSKHWCL6B1PROD with NOTICES Number of respondents Respondents Dated: December 30, 2010. Carol E. Walker, Acting Reports Clearance Officer, Centers for Disease Control and Prevention. VerDate Mar<15>2010 beyond their time, and women can decline to be interviewed. The maternal interview is the only portion of the project which interacts with individual patients. As is the case for all data collected by FHPM, the intent for the data is for local use to understand and improve local systems. Face-to-face interviews will average 1.5 hours in duration and will not need to be repeated, unless a woman has a second pregnancy and is selected for case review under the priority assessment, and consents to participate a second time. Each of the 10 FHPM sites will conduct 30 maternal interviews annually. The number of elements in the interview is presently being reduced. When the FIMR–HIV Data System (FHDS) is implemented (see below), each of these 10 sites will be asked to send its data to the FHDS. After the data collection phase, a multidisciplinary case review team (CRT) will conduct a regularly scheduled case review session. The recommendations and findings of the CRT will then be passed on to a Community Action Team (CAT), a diverse, broad-based group of community leaders and representatives capable of defining and initiating changes in the local systems. Since 2009, partner organizations have been funded to operate FHPM in 30 Average burden response (in hours) 1.5 Total burden (in hours) 450 and other alpha diketones, (2) information on possible health effects observed in workers exposed to 2,3pentanedione, and other alphadiketones, (3) information on workplaces and products in which 2,3pentanedione and other alpha-diketones can be found, (4) description of work tasks and scenarios with a potential for exposure to 2,3-pentanedione and other alpha-diketones, (5) workplace exposure data, and (6) information on control measures (e.g., engineering controls, work practices, personal protective equipment) that are being used in workplaces where potential exposures to 2,3-pentanedione and other alpha diketones occur. Public Comment Period: Comments must be received by February 9, 2011. You may submit comments, identified by docket number NIOSH– 189 by any of the following methods: ADDRESSES: E:\FR\FM\10JAN1.SGM 10JAN1 srobinson on DSKHWCL6B1PROD with NOTICES Federal Register / Vol. 76, No. 6 / Monday, January 10, 2011 / Notices • 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 https://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: 2,3pentanedione 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 4carbon alpha-diketone. Published reports on the toxicity of 2,3pentanedione are currently only in abstract form but suggest that in rats 2,3pentanedione 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 2,3pentanedione 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 2,3pentanedione, 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 VerDate Mar<15>2010 18:19 Jan 07, 2011 Jkt 223001 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 2,3pentanedione, 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 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 1435 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 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. AGENCY: E:\FR\FM\10JAN1.SGM 10JAN1

Agencies

[Federal Register Volume 76, Number 6 (Monday, January 10, 2011)]
[Notices]
[Pages 1434-1435]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-274]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Docket Number NIOSH-189]


Request for Information on 2,3-Pentanedione and Other Alpha-
Diketones Used As Diacetyl Substitutes

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) intends 
to evaluate the scientific data on 2,3-pentanedione (CAS 600-
14-6, also known as pentane-2,3-dione; acetyl propionyl) and other 
alpha-diketones and develop appropriate communication documents, such 
as a Current Intelligence Bulletin, Criteria Document and/or other 
informational products, and potentially establish a Recommended 
Exposure Limit (REL) for diacetyl substitutes. NIOSH is requesting 
information on the following: (1) Published and unpublished reports and 
findings from in vitro and in vivo toxicity studies with 2,3-
pentanedione, and other alpha diketones, (2) information on possible 
health effects observed in workers exposed to 2,3-pentanedione, and 
other alpha-diketones, (3) information on workplaces and products in 
which 2,3-pentanedione and other alpha-diketones can be found, (4) 
description of work tasks and scenarios with a potential for exposure 
to 2,3-pentanedione and other alpha-diketones, (5) workplace exposure 
data, and (6) information on control measures (e.g., engineering 
controls, work practices, personal protective equipment) that are being 
used in workplaces where potential exposures to 2,3-pentanedione and 
other alpha diketones occur.
    Public Comment Period: Comments must be received by February 9, 
2011.

ADDRESSES: You may submit comments, identified by docket number NIOSH-
189 by any of the following methods:

[[Page 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 https://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 
alpha-diketones 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 alpha-diketones used as diacetyl 
substitutes may occur;
    (2) Trends in the production and use of 2,3-pentanedione, and other 
alpha-diketones;
    (3) Description of work tasks and scenarios with a potential for 
exposure to 2,3-pentanedione, and other alpha-diketones 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 alpha-diketones;
    (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 alpha-diketones; 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

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