Agency Information Collection Activities: Proposed Collection; Comment Request, 80820-80821 [2010-32197]

Download as PDF mstockstill on DSKH9S0YB1PROD with NOTICES 80820 Federal Register / Vol. 75, No. 246 / Thursday, December 23, 2010 / Notices the approximate time requested for the presentation. Oral comments made at the public meeting must also be submitted to the NIOSH Docket Office in writing in order to be considered by the Agency. Request for Information: NIOSH seeks to obtain materials, including published and unpublished reports and research findings, to evaluate the possible health risks of occupational exposure to carbon nanotubes and nanofibers. Examples of requested information include, but are not to be limited to: (1) Identification of industries or occupations in which exposures to carbon nanotubes and nanofibers can occur; (2) Trends in the production and use of carbon nanotubes and nanofibers; (3) Exposure measurement data; (4) Case reports or other health information demonstrating possible health effects in workers exposed to carbon nanotubes or nanofibers; (5) Reports of experimental in vivo and in vitro studies that provide evidence of a dose-relationship between exposure to carbon nanotubes and nanofibers and biological activity; (6) Reports of experimental data on the airborne characteristics of carbon nanotubes or nanofibers, including information on the amounts that are inhalable and respirable; (7) Criteria and rationale for including workers in a medical surveillance and screening program; (8) Description of work practices and engineering controls used to reduce or prevent workplace exposure to carbon nanotubes and nanofibers; and (9) Educational materials for worker safety and training on the safe handling of carbon nanotubes and nanofibers. ADDRESSES: Written comments or requests to attend or present at the meeting, identified by docket number NIOSH–161–A, may be submitted by any of the following ways: • 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, 4676 Columbia Parkway, Room 111, Cincinnati, OH 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 VerDate Mar<15>2010 18:06 Dec 22, 2010 Jkt 223001 the docket, including any personal information provided. All electronic comments should be formatted as Microsoft Word. Please make reference to docket number NIOSH 161–A. FOR FURTHER INFORMATION CONTACT: Ralph D. Zumwalde, NIOSH, Robert A. Taft Laboratories MS–C32, 4676 Columbia Parkway, Cincinnati, OH 45226, telephone (513) 533–8320. Dated: December 13, 2010. Tanja Popovic, Deputy Associate Director for Science, Centers for Disease Control and Prevention. [FR Doc. 2010–32328 Filed 12–22–10; 8:45 am] BILLING CODE 4163–19–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS–R–153] 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: Reinstatement with change of a previously approved collection; Title of Information Collection: Medicaid Drug Utilization Review (DUR) Annual Report; Use: The DUR program is required to assure that prescriptions are appropriate, medically necessary and are not likely to result in adverse medical results. Each State DUR program must consist of prospective drug use review, retrospective drug use review, data assessment of drug use AGENCY: PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 against predetermined standards, and ongoing educational outreach activities. In addition, States are required to submit an annual DUR program report that includes a description of the nature and scope of State DUR activities. Over the years, technology has changed as has the practice of the pharmacy. Therefore, CMS has revised the old survey vehicle to more fully address the current practices and areas of concern with the Medicaid Pharmacy Programs. Form Number: CMS–R–153 (OMB#: 0938–0659); Frequency: Annually; Affected Public: State, Local, or Tribal Governments; Number of Respondents: 51; Total Annual Responses: 51; Total Annual Hours: 20,298. (For policy questions regarding this collection contact Madlyn Kruh at 410–786–3239. 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 January 24, 2011: OMB, Office of Information and Regulatory Affairs, Attention: CMS Desk Officer. Fax Number: (202) 395–6974. E-mail: OIRA_submission@omb.eop.gov. Dated: December 17, 2010. Martique Jones, Director, Regulations Development Division-B, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2010–32196 Filed 12–22–10; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier CMS–10367] Agency Information Collection Activities: Proposed Collection; 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 AGENCY: E:\FR\FM\23DEN1.SGM 23DEN1 mstockstill on DSKH9S0YB1PROD with NOTICES Federal Register / Vol. 75, No. 246 / Thursday, December 23, 2010 / Notices Centers for Medicare & Medicaid Services (CMS) 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 functions; (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: New collection (Request for a new OMB Control Number); Title of Information Collection: Medicaid State Plan Preprint for Use by States When Implementing Section 6505 of the [Patient Protection and] Affordable Care Act; Use: [The] CMS has developed a Medicaid State Plan Preprint for use by States and specific to support the January 1, 2011, mandate of the prohibition on payments outside of the United States. The Preprint follows the format and requested information from prior preprints provided to the States by CMS and provides a placeholder and assurance of compliance with section 1902(a) of the Social Security Act; Form Number: CMS–10367 (OMB#: 0938– NEW); Frequency: Occasionally; Affected Public: State, Local, or Tribal Governments; Number of Respondents: 56; Total Annual Responses: 56; Total Annual Hours: 5. (For policy questions regarding this collection contact Carla Ausby at 410–786–2153. 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 at https://www.cms.hhs.gov/ PaperworkReductionActof1995, or email 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. In commenting on the proposed information collections please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted in one of the following ways by February 22, 2011: 1. Electronically. You may submit your comments electronically to https:// www.regulations.gov. Follow the VerDate Mar<15>2010 18:06 Dec 22, 2010 Jkt 223001 instructions for ‘‘Comment or Submission’’ or ‘‘More Search Options’’ to find the information collection document(s) accepting comments. 2. By regular mail. You may mail written comments to the following address: CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention: Document Identifier/OMB Control Number, Room C4–26–05, 7500 Security Boulevard, Baltimore, Maryland 21244–1850. Dated: December 17, 2010. Martique Jones, Director, Regulations Development DivisionB, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2010–32197 Filed 12–22–10; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–N–0266] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Study of Clinical Efficacy Information in Professional Labeling and Direct-to-Consumer Print Advertisements for Prescription Drugs; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction. The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of December 3, 2010 (75 FR 75477). The document announced a proposed collection of information that has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (the PRA). The document was published with an error. FDA, upon further review, realized that 3 comments had been submitted in response to the 60day notice and the responses to those comments are included in this notice. This document corrects that error. FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50–400B, Rockville, MD 20850, 301– 796–3792, Elizabeth.Berbakos@fda.hhs.gov. SUMMARY: In FR Doc. 2010–30385, appearing on page 75480, in the Federal Register of Friday, SUPPLEMENTARY INFORMATION: PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 80821 December 3, 2010, the following correction is made: On page 75480, in the third column, the last sentence in the sixth complete paragraph states that no comments were received on the paperwork burden for the 60-day notice that published in the Federal Register of June 16, 2010 (75 FR 34142). FDA is correcting that statement to read: Three comments were received that expressed support for the research and recommended minor improvements to the study. The responses to those comments are included in the following paragraphs. (Comment 1) Several of this comment’s suggestions have already been incorporated into our study design. Specifically, we agree that the study design should include the variables of age, education, ethnicity, race, health literacy, and whether the respondent is currently being treated with a prescription drug, and have included them in the questionnaire. Also, we have contracted with an organization that produces realistic ads and stimuli to ensure that we will show respondents realistic materials. Another question from this comment was the presentation of our manipulations. To clarify, the specific format of the presentation will be text only. We are investigating the use of charts and other visuals in another study (FDA–2009–N–0263 (January 5, 2010), ‘‘Presentation of Quantitative Effectiveness and Risk Information to Consumers in Direct-to-Consumer (DTC) Broadcast and Print Advertisements for Prescription Drugs,’’ OMB control number 0910–0663.) Because all of the respondents in the current study will see the information in the same format, this will not compromise our ability to answer the current research questions. The comment also recommends expanding the physician study to include all health care professionals who have the ability to prescribe (i.e., nurse practitioners and physician assistants). This is a good idea, but it changes our research question from how physicians use labels to how prescribers use labels. These groups vary in education and may vary in experience and training in how to interpret and use clinical trial data. Because we do not have a sample size that is large enough to analyze differences between these groups, we will limit the sample to physicians in this study. Finally, the comment recommends that FDA publish findings from the preliminary study related to the current project, ‘‘Mental Models Study of Health Care Providers’ Understanding of Prescription Drug Effectiveness’’ (FDA– 2008–N–0589; April 3, 2009). We agree E:\FR\FM\23DEN1.SGM 23DEN1

Agencies

[Federal Register Volume 75, Number 246 (Thursday, December 23, 2010)]
[Notices]
[Pages 80820-80821]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-32197]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier CMS-10367]


Agency Information Collection Activities: Proposed Collection; 
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

[[Page 80821]]

Centers for Medicare & Medicaid Services (CMS) 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 functions; (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: New collection (Request 
for a new OMB Control Number); Title of Information Collection: 
Medicaid State Plan Preprint for Use by States When Implementing 
Section 6505 of the [Patient Protection and] Affordable Care Act; Use: 
[The] CMS has developed a Medicaid State Plan Preprint for use by 
States and specific to support the January 1, 2011, mandate of the 
prohibition on payments outside of the United States. The Preprint 
follows the format and requested information from prior preprints 
provided to the States by CMS and provides a placeholder and assurance 
of compliance with section 1902(a) of the Social Security Act; Form 
Number: CMS-10367 (OMB: 0938-NEW); Frequency: Occasionally; 
Affected Public: State, Local, or Tribal Governments; Number of 
Respondents: 56; Total Annual Responses: 56; Total Annual Hours: 5. 
(For policy questions regarding this collection contact Carla Ausby at 
410-786-2153. 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 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.
    In commenting on the proposed information collections please 
reference the document identifier or OMB control number. To be assured 
consideration, comments and recommendations must be submitted in one of 
the following ways by February 22, 2011:
    1. Electronically. You may submit your comments electronically to 
https://www.regulations.gov. Follow the instructions for ``Comment or 
Submission'' or ``More Search Options'' to find the information 
collection document(s) accepting comments.
    2. By regular mail. You may mail written comments to the following 
address: CMS, Office of Strategic Operations and Regulatory Affairs, 
Division of Regulations Development, Attention: Document Identifier/OMB 
Control Number, Room C4-26-05, 7500 Security Boulevard, Baltimore, 
Maryland 21244-1850.

    Dated: December 17, 2010.
Martique Jones,
Director, Regulations Development Division-B, Office of Strategic 
Operations and Regulatory Affairs.
[FR Doc. 2010-32197 Filed 12-22-10; 8:45 am]
BILLING CODE 4120-01-P
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