48158 Federal Register / Vol. 77, No. 156 / Monday, August 13, 2012 / Notices 

http://ManagingMeds.Challenge.gov and 

register (Registration is free) or log in 

with an existing ChallengePost account. 

After a Contestant signs up, a 

confirmation email will be sent to the 

email address provided. The Contestant 

must use the confirmation email to 

verify his or her email address. The 

registered Contestant will then be able 

to enter a Submission. 

2. On http:// 

ManagingMeds.Challenge.gov, click 

‘‘Accept this challenge’’ to register your 

interest in participating. This step 

ensures that you will receive important 

challenge updates. 

3. Create a video and ensure the 

following (please read the Official Rules 

on http://ManagingMeds.Challenge.gov 

for complete requirements): 

a. Your video must demonstrate how 

technology can be used to help you take 

your meds as prescribed. 

b. Your video encourages viewers to 

visit www.HealthIT.gov to learn more 

about using technology to improve your 

health. 

c. Your video is no longer than 2 

minutes. 

4. Confirm that you have read and 

agreed to the Official Rules. 

• The title of the Video; 

• A link to the Video on 

YouTube.com or Vimeo.com (the Video 

should be no longer than 2 minutes); 

• A text description of your use of 

health IT to improve medication 

management, and a transcript of the 

words spoken in the video; 

• A transcript of the words spoken or 

sung in the video; 

• Uploaded consent forms for 

everyone who appears in the video 

regardless of age. 

All individuals that appear in a Video 

must complete and sign the Video 

Consent Form. If a minor appears in the 

Video, the minor’s parent/legal guardian 

must also sign the Video Consent Form. 

A Submission will not be considered 

complete and eligible to win prizes 

without a completed Video Consent 

Form being uploaded from all 

individuals that appear in the Video. All 

completed Video Consent Forms must 

include a handwritten signature, and be 

scanned, combined in to a single file 

(ZIP, PDF, or doc), and uploaded on the 

submission form on 

BloodPressure.Challenge.gov. 

AMOUNT OF THE PRIZE

Winner Prize Quantity 

First Prize ................. $3,000 1 

Second Prize ............ 2,000 1 

Third Prize ................ 1,000 1 

Honorable Prize ........ 500 2 

AMOUNT OF THE PRIZE—Continued 

Winner Prize Quantity 

Popular Choice ......... 500 1 

Basis Upon Which Winner Will Be 

Selected 

Videos will be judged based on the 

following criteria (to be equally 

weighted): 

1. Quality of the Idea (Includes 

elements such as the relevance and 

originality of your use of health IT). 

2. Potential Impact on health IT 

adoption (Includes whether the video is 

compelling, instructive, and easy to 

follow so that others can perform 

similar activities using health 

technology). 

The five (5) Contestants whose 

Submissions earn the highest overall 

score will win, respectively, the prizes 

identified below in Section 8. In the 

event of a tie, winners will be selected 

based on their score on the criteria 

described in (3), then (2), and then (1). 

If there is still a tie then the winner will 

be selected based on a vote by the 

judging panel. 

Dated: August 3, 2012. 

Erin Poetter, 

Consumer e-Health Policy Analyst, Office of 

Consumer e-Health,Office of the National 

Coordinator for Health Information 

Technology (ONC), Office of the Secretary 

(OS). 

[FR Doc. 2012–19775 Filed 8–10–12; 8:45 am] 

BILLING CODE 4150–45–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10390] 

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: 

Hospice Quality Reporting Program; 

Use: Section 1814(i)(5) of the Social 

Security Act (the Act) added by section 

3004 of the 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 

for hospices. Section 1814(i)(5)(A)(i) of 

the Act requires 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. 

The Hospice Quality Data Submission 

Form was created for hospice providers 

to collect specified quality data and 

submit that data to CMS, for the data 

collection period starting October 1, 

2012, through December 31, 2012, and 

continuing on a calendar year thereafter. 

Webinar training on data collection and 

data submission has been and will 

continue to be provided by CMS. Use of 

the Hospice Quality Data Submission 

Form is necessary in order for hospices 

to submit the quality data specified for 

the Hospice Quality Reporting Program. 

Form Number: CMS–10390 (OCN: 

0938–1153); Frequency: Yearly; Affected 

Public: Individuals and households; 

Number of Respondents: 3632; Total 

Annual Responses: 7264; Total Annual 

Hours: 657,392. (For policy questions 

regarding this collection contact Robin 

Dowell at 410–786–0060. 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 

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. 

To be assured consideration, 

comments and recommendations for the 

proposed information collections must 

be received by the OMB desk officer at 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 77, No. 156 / Monday, August 13, 2012 / Notices 48159 

the address below, no later than 5 p.m. 

on September 12, 2012. 

OMB, Office of Information and 

Regulatory Affairs, Attention: CMS 

Desk Officer, Fax Number: (202) 395– 

6974, Email: 

OIRA_submission@omb.eop.gov. 

Dated: August 7, 2012. 

Martique Jones, 

Director, Regulations Development Group, 

Division B, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2012–19689 Filed 8–10–12; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Tribal Consultation Meeting 

AGENCY: Office of Head Start (OHS), 

Administration for Children and 

Families, HHS. 

ACTION: Notice of meeting. 

SUMMARY: Pursuant to the Improving 

Head Start for School Readiness Act of 

2007, notice is hereby given of a oneday Tribal Consultation Session to be 

held between the Department of Health 

and Human Services, Administration for 

Children and Families, Office of Head 

Start leadership and the leadership of 

Tribal Governments operating Head 

Start (including Early Head Start) 

programs. The purpose of this 

Consultation Session is to discuss ways 

to better meet the needs of American 

Indian and Alaska Native children and 

their families, taking into consideration 

funding allocations, distribution 

formulas, and other issues affecting the 

delivery of Head Start services in their 

geographic locations. 

DATES: October 15, 2012 and October 17, 

2012. 

ADDRESSES: 2012 Office of Head Start 

Tribal Consultation Session will be held 

at the following locations: Monday, 

October 15, 2012—Portland, Oregon— 

Westin Portland, 750 SW Alder Street, 

Portland, OR 97205; and Wednesday, 

October, 17, 2012—Anchorage, Alaska— 

Hilton Anchorage Hotel, 500 West Third 

Avenue, Anchorage, AK 99501. 

FOR FURTHER INFORMATION CONTACT: Ann 

Linehan, Deputy Director, Office of 

Head Start, email 

Ann.Linehan@acf.hhs.gov or phone 

(202) 205–8579. Additional information 

and online meeting registration is 

available at http://www.headstart

resourcecenter.org. 

SUPPLEMENTARY INFORMATION: The 

Department of Health and Human 

Services (HHS) announces Office of 

Head Start (OHS) Tribal Consultations 

for leaders of Tribal Governments 

operating Head Start and Early Head 

Start programs in Region X and in 

Alaska. The Consultation Session for 

Region X will take place Monday, 

October 15, 2012, in Portland, Oregon. 

The Consultation Session for the State 

of Alaska will take place Wednesday, 

October 17, 2012, in Anchorage, Alaska, 

immediately preceding the annual 

Alaska Federation of Natives 

convention. As much as possible, OHS 

Tribal Consultations are scheduled in 

conjunction with other Tribal Leader 

events. This is done in an effort to 

minimize the financial and travel 

burden for participants. 

The agenda for the scheduled OHS 

Tribal Consultations will be organized 

around the statutory purposes of Head 

Start Tribal Consultations related to 

meeting the needs of AI/AN children 

and families, taking into consideration 

funding allocations, distribution 

formulas, and other issues affecting the 

delivery of Head Start services in their 

geographic locations. In addition, OHS 

will share actions taken and in progress 

to address the issues and concerns 

raised in 2011 OHS Tribal 

Consultations. 

Tribal leaders and designated 

representatives interested in submitting 

written testimony or proposing specific 

agenda topics for the Oklahoma City 

Consultation Session should contact 

Ann Linehan at 

Ann.Linehan@acf.hhs.gov. Proposals 

must be submitted at least three days in 

advance of the session and should 

include a brief description of the topic 

area, along with the name and contact 

information of the suggested presenter. 

The Consultation Session will be 

conducted with elected or appointed 

leaders of Tribal Governments and their 

designated representatives (42 U.S.C. 

9835, Section 640(l)(4)(A)). Designees 

must have a letter from the Tribal 

Government authorizing them to 

represent the tribe. The letter should be 

submitted at least three days in advance 

of the Consultation Session to Ann 

Linehan at (202) 205–9721 (fax). Other 

representatives of tribal organizations 

and Native nonprofit organizations are 

welcome to attend as observers. 

A detailed report of the Consultation 

Session will be prepared and made 

available within 90 days of the 

Consultation Session to all Tribal 

Governments receiving funds for Head 

Start and Early Head Start programs. 

Tribes wishing to submit written 

testimony for the report should send 

testimony to Ann Linehan at 

Ann.Linehan@acf.hhs.gov either prior to 

the Consultation Session or within 30 

days after the meeting. 

Oral testimony and comments from 

the Consultation Session will be 

summarized in each report without 

attribution, along with topics of concern 

and recommendations. Hotel and 

logistical information for the 

Consultation Session has been sent to 

tribal leaders via email and posted on 

the Head Start Resource Center Web site 

at http://www.headstartresource

center.org. 

Dated: July 23, 2012. 

Yvette Sanchez Fuentes, 

Director, Office of Head Start. 

[FR Doc. 2012–19587 Filed 8–10–12; 8:45 am] 

BILLING CODE 4184–40–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–D–0523] 

Draft Guidance for Industry and Food 

and Drug Administration Staff; Refuse 

To Accept Policy for 510(k)s; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the draft guidance 

entitled ‘‘Refuse to Accept Policy for 

510(k)s.’’ The purpose of this document 

is to explain the procedures and criteria 

FDA intends to use in determining 

whether a premarket notification 

(510(k)) submission is administratively 

complete, which determines whether it 

should be accepted for substantive 

review. This guidance is applicable to 

510(k)s reviewed in the Center for 

Devices and Radiological Health (CDRH) 

and the Center for Biologics Evaluation 

and Research (CBER). This draft 

guidance is not final nor is it in effect 

at this time. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by September 27, 

2012. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance 

document entitled ‘‘Refuse to Accept 

Policy for 510(k)s’’ to the Division of 

Small Manufacturers, International and 

Consumer Assistance, Center for 

mstockstill on DSK4VPTVN1PROD with NOTICES