Agency Information Collection Activities: Submission for OMB Review; Comment Request, 1435-1436 [2011-243]

Download as PDF 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 NIOSH seeks to obtain materials, including published and unpublished reports and research findings, to evaluate the possible health risks of occupational exposure to 2,3pentanedione and other alpha-diketones used as diacetyl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 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 https://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 Annual number of respondents Instrument srobinson on DSKHWCL6B1PROD with NOTICES Tracking Interview ............................................................................................ 3rd Party Contacts ........................................................................................... Estimated Total Annual Burden Hours: 685. Additional Information Copies of the proposed collection may be obtained by writing to the VerDate Mar<15>2010 18:19 Jan 07, 2011 Jkt 223001 2700 200 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 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 Number of responses per respondent 1 1 Average burden hours per response .25 .05 Total annual burden hours 675 10 identified by the title of the information collection. E-mail address: OPREinfocollection@acf.hhs.gov. E:\FR\FM\10JAN1.SGM 10JAN1

Agencies

[Federal Register Volume 76, Number 6 (Monday, January 10, 2011)]
[Notices]
[Pages 1435-1436]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-243]


-----------------------------------------------------------------------

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.

[[Page 1436]]

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 https://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 Division-B, Office of Strategic 
Operations and Regulatory Affairs.
[FR Doc. 2011-243 Filed 1-7-11; 8:45 am]
BILLING CODE 4120-01-P

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.