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and unpublished reports and research 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 

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. 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 

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: 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 

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 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 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 

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 

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Federal Register / Vol. 75, No. 246 / Thursday, December 23, 2010 / Notices 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 http://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 http:// 

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 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. 

SUMMARY: 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 60- 

day 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. 

SUPPLEMENTARY INFORMATION: In FR Doc. 

2010–30385, appearing on page 75480, 

in the Federal Register of Friday, 

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 

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