### 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


### 54777 Federal Register / Vol. 76, No. 171 / Friday, September 2, 2011 / Notices

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.