54776 Federal Register / Vol. 76, No. 171 / Friday, September 2, 2011 / Notices 

dose reconstruction efforts performed 

for this program; and (c) upon request 

by the Secretary, HHS, advising the 

Secretary on whether there is a class of 

employees at any Department of Energy 

facility who were exposed to radiation 

but for whom it is not feasible to 

estimate their radiation dose, and on 

whether there is a reasonable likelihood 

that such radiation doses may have 

endangered the health of members of 

this class. The Subcommittee on 

Procedures Review was established to 

aid the ABRWH in carrying out its duty 

to advise the Secretary, HHS, on dose 

reconstructions. The Subcommittee on 

Procedures Review is responsible for 

overseeing, tracking, and participating 

in the reviews of all procedures used in 

the dose reconstruction process by the 

NIOSH Division of Compensation 

Analysis and Support (DCAS) and its 

dose reconstruction contractor. 

Matters To Be Discussed: The agenda 

for the Subcommittee meeting includes 

discussion of the following ORAU and 

OCAS procedures: ORAUT–RPRT–0044 

(‘‘Analysis of Bioassay Data with a 

Significant Fraction of Less-Than 

Results’’), OCAS TIB–0013 (‘‘Special 

External Dose Reconstruction 

Considerations for Mallinckrodt 

Workers’’), OTIB–0019 (‘‘Analysis of 

Coworker Bioassay Data for Internal 

Dose Assignment’’), OTIB–0021 

(External Coworker Dosimetry Data for 

the X–10 Site), OTIB–0029 (‘‘Internal 

Dosimetry Coworker Data for Y–12’’), 

OTIB–0047 (‘‘External Radiation 

Monitoring at the Y–12 Facility During 

the 1948–1949 Period’’), OTIB–0049 

(‘‘Estimating Doses for Plutonium 

Strongly Retained in the Lung’’), OTIB– 

0052 (‘‘Parameters to Consider When 

Processing Claims for Construction 

Trade Workers’’), OTIB–0054 (‘‘Fission 

and Activation Product Assignment for 

Internal Dose-Related Gross Beta and 

Gross Gamma Analyses’’), and OTIB– 

0070 (‘‘Dose Reconstruction During 

Residual Radioactivity Periods at 

Atomic Weapons Employer Facilities’’); 

and a continuation of the commentresolution process for other dose 

reconstruction procedures under review 

by the Subcommittee. 

The agenda is subject to change as 

priorities dictate. 

This meeting is open to the public. In 

the event an individual wishes to 

provide comments, written comments 

must be submitted prior to the meeting. 

Any written comments received will be 

provided at the meeting and should be 

submitted to the contact person below 

in advance of the meeting. 

Contact Person for More Information: 

Theodore Katz, Executive Secretary, 

NIOSH, CDC, 1600 Clifton Road, 

Mailstop E–20, Atlanta, Georgia 30333, 

Telephone: (513) 533–6800, Toll Free: 1 

(800) CDC–INFO, E-mail dcas@cdc.gov. 

The Director, Management Analysis 

and Services Office, has been delegated 

the authority to sign Federal Register 

notices pertaining to announcements of 

meetings and other committee 

management activities, for both the 

Centers for Disease Control and 

Prevention, and the Agency for Toxic 

Substances and Disease Registry. 

Dated: August 29, 2011. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. 2011–22501 Filed 9–1–11; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10390 and 

10409] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services. 

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) 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; Title of 

Information Collection: Hospice 

Voluntary Quality Data Reporting 

Program; Use: Section 1814(i)(5) of the 

Social Security Act (Act) added by 

section 3004 of Patient Protection and 

Affordable Care Act, Public Law 111– 

148, enacted on March 23, 2010 

(Affordable Care Act), authorizes the 

Secretary to establish a quality reporting 

program for hospices. Section 

1814(i)(5)(A)(i) of the Act requires that 

the Secretary, beginning with FY 2014, 

reduce the market basket update by 2 

percentage points for any hospice that 

does not comply with the quality data 

submission requirements with respect to 

that fiscal year. 

To meet the quality reporting 

requirements for hospices, as set forth in 

the proposed Hospice Wage Index for 

Fiscal Year 2012 rule, we propose that 

there shall be a voluntary hospice 

quality reporting cycle which will 

consist of data collection cycle 

beginning on October 1, 2011 and 

continuing through December 31, 2011. 

This data shall be reported to CMS by 

no later than January 31, 2012. There 

shall be a mandatory hospice quality 

reporting cycle which will consist of 

data collected from October 1, 2012 

through December 31, 2012. This data 

shall be reported to CMS by no later 

than April 1, 2013. Thereafter, it is 

proposed that all subsequent hospice 

quality reporting cycles will be based on 

the calendar-year basis(that is, January 

1, 2013 through December 31, 2013 for 

determination of the Hospice market 

basket increase factor for each Hospice 

in FY 2015, etc.). 

We are requesting an initial approval 

of a data collection instrument entitled 

‘‘Quality Data Submission Form’’ that 

hospice providers will use to submit 

quality measures data to CMS during 

the proposed voluntary reporting period 

of 10/01/2011 through 12/31/2011. This 

form shall be used by hospices to report 

quality data pertaining to one structural 

measure, which is entitled: Participation 

in a Quality Assessment and 

Performance Improvement (QAPI) 

Program that Includes at Least Three 

Quality Indicators Related to Patient 

Care. Form Number: CMS–10390 (OMB 

0938–New); Frequency: Occasionally; 

Affected Public: Private Sector: Business 

or other for-profit and not-for-profit 

institutions; Number of Respondents: 

3,531; Total Annual Responses: 3,531; 

Total Annual Hours: 883. (For policy 

questions regarding this collection 

contact Robin Dowell at 410–786–0060. 

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

2. Type of Information Collection 

Request: New collection; Title of 

Information Collection: Long Term Care 

Hospital (LCTH) Quality Reporting 

Program—Pressure Ulcer Measure Data 

Set; Use: Section 3004 of the Affordable 

Care Act authorizes the establishment of 

a new quality reporting program for 

Long Term Care Hospitals (LTCHs). 

LTCHs that fail to submit quality 

measure data may be subject to a 2 

percentage point reduction in their 


erowe on DSK5CLS3C1PROD with NOTICES
Federal Register / Vol. 76, No. 171 / Friday, September 2, 2011 / Notices 54777 

annual update to the standard Federal 

rate for discharges occurring during a 

rate year, beginning in FY 2014. One of 

the quality measures LTCHs are 

required to collect and submit data on 

is the Percent of Residents with Pressure 

Ulcers That Are New or Have Worsened. 

Currently, there are no mandatory 

standardized data sets being used in 

LTCHs. Therefore, we have created a 

new data set to be used in LTCHs, 

which incorporates data items 

contained in other, well known and 

clinically established pressure ulcer 

data sets, including but not limited to 

the Minimum Data Set 3.0 (MDS 3.0) 

and CARE data set (Continuity 

Assessment Records & Evaluation). 

Beginning on October 1, 2012, LTCHs 

will begin to use a data collection 

document entitled the ‘‘LTCH CARE 

Data Set’’ as the vehicle by which to 

collect the pressure ulcer data for the 

LTCH quality reporting program. This 

data set consists of the following 

components: (1) Pressure ulcer 

documentation; (2) selected covariates 

related to pressure ulcers; (3) patient 

demographic information; and; (4) a 

provider attestation section. The use of 

the LTCH CARE Data Set is necessary in 

order to allow CMS to collect LTCH 

quality measures data in compliance 

with Section 3004 of the Affordable 

Care Act. There are no other reasonable 

alternatives available to CMS for the 

collection and submission of pressure 

ulcer data. Form Number: CMS–10409 

(OCN: 0938–New); Frequency: 

Occasionally; Affected Public: Private 

Sector: Business or other for-profit and 

not-for-profit institutions; Number of 

Respondents: 3,531; Total Annual 

Responses: 3,531; Total Annual Hours: 

883. (For policy questions regarding this 

collection contact Caroline Gallaher at 

410–786–8705. 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. 

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 November 1, 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 llllll, Room 

C4–26–05, 7500 Security Boulevard, 

Baltimore, Maryland 21244–1850. 

Dated: August 30, 2011. 

Martique Jones, 

Director, Regulations Development Group, 

Division B, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2011–22583 Filed 9–1–11; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0556] 

Center for Devices and Radiological 

Health 510(k) Clearance Process; 

Recommendations Proposed in 

Institute of Medicine Report: ‘‘Medical 

Devices and the Public’s Health, The 

FDA 510(k) Clearance Process at 35 

Years’’; Public Meeting; 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 Friday, August 12, 2011 (76 

FR 50230). The document announced a 

public workshop entitled 

‘‘Recommendations Proposed in 

Institute of Medicine Report: ‘Medical 

Devices and the Public’s Health, The 

FDA 510(k) Clearance Process at 35 

Years.’ ’’ The document was published 

with an outdated address in the section 

entitled ‘‘Will there be transcripts of the 

meeting?’’ This document corrects that 

error. 

FOR FURTHER INFORMATION CONTACT: 

Joyce Strong, Office of Policy, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 32, Rm. 3208, 

Silver Spring, MD 20993–0002, 301– 

796–9148. 

SUPPLEMENTARY INFORMATION: In FR Doc. 

2011–20575, appearing on page 50230 

in the Federal Register of Friday, 

August 12, 2011, the following 

correction is made: 

1. On page 50231, in the second 

column, under the section entitled 

‘‘Will there be transcripts of the 

meeting?’’ the address for the Division 

of Freedom of Information is corrected 

to read ‘‘Division of Freedom of 

Information (ELEM–1029), Food and 

Drug Administration, 12420 Parklawn 

Dr., Element Bldg., Rockville, MD 

20857.’’ 

Dated: August 29, 2011. 

Nancy K. Stade, 

Deputy Director for Policy, Center for Devices 

and Radiological Health. 

[FR Doc. 2011–22475 Filed 9–1–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0002] 

Request for Nominations for Voting 

Members on a Public Advisory 

Committee; Tobacco Products 

Scientific Advisory Committee 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is requesting 

nominations for members to serve on 

the Tobacco Products Scientific 

Advisory Committee, Center for 

Tobacco Products. 

FDA has a special interest in ensuring 

that women, minority groups, and 

individuals with disabilities are 

adequately represented on advisory 

committees and, therefore, encourages 

nominations of qualified candidates 

from these groups. 

DATES: Nominations received on or 

before November 1, 2011 will be given 

first consideration for membership on 

the Tobacco Products Scientific 

Advisory Committee. Nominations 

received after November 1, 2011 will be 

considered for nomination to the 

committee if nominees are still needed. 

ADDRESSES: All nominations for 

membership should be sent 

electronically to cv@oc.fda.gov, or by 

mail to Advisory Committee Oversight 

and Management Staff, 10903 New 

Hampshire Ave., Bldg. 32, Rm. 5103, 

Silver Spring, MD 20993–0002. 

FOR FURTHER INFORMATION CONTACT: 

Regarding all nomination questions 

for membership, the primary contact is: 

Caryn Cohen, Office of Science, 

Center for Tobacco Products, Food and 

Drug Administration, 9200 Corporate 

Blvd., Rockville, MD 20850, 1–877– 

287–1373 (choose Option 4), FAX: 240– 

276–3761, TPSAC@fda.hhs.gov. 


erowe on DSK5CLS3C1PROD with NOTICES