Federal Register / Vol. 76, No. 207 / Wednesday, October 26, 2011 / Notices 66307 

To be eligible to win a prize under 

this challenge, an individual or entity— 

(1) Shall have registered to participate 

in the competition under the rules 

promulgated by HHS; 

(2) Shall have complied with all the 

requirements under this section; 

(3) In the case of a private entity, shall 

be incorporated in and maintain a 

primary place of business in the United 

States, and in the case of an individual, 

whether participating singly or in a 

group, shall be a citizen or permanent 

resident of the United States; and 

(4) May not be a Federal entity or 

Federal employee acting within the 

scope of their employment. 

(5) Shall not be an HHS employee 

working on their applications or 

submissions during assigned duty 

hours. 

(6) Shall not be in the reporting chain 

of Dr. Howard Koh in the Office of the 

Assistant Secretary for Health. 

(7) Federal grantees may not use 

Federal funds to develop COMPETES 

Act challenge applications unless 

consistent with the purpose of their 

grant award. 

(8) Federal contractors may not use 

Federal funds from a contract to develop 

COMPETES Act challenge applications 

or to fund efforts in support of a 

COMPETES Act challenge submission. 

An individual or entity shall not be 

deemed ineligible because the 

individual or entity used Federal 

facilities or consulted with Federal 

employees during a competition if the 

facilities and employees are made 

available to all individuals and entities 

participating in the competition on an 

equitable basis. 

Challenge participants will be 

expected to sign a liability release as 

part of the contest registration process. 

The liability release will use the 

following language: 

By participating in this competition, I agree 

to assume any and all risks and waive claims 

against the Federal Government and its 

related entities, except in the case of willful 

misconduct, for any injury, death, damage, or 

loss of property, revenue, or profits, whether 

direct, indirect, or consequential, arising 

from my participation in this prize contest, 

whether the injury, death, damage, or loss 

arises through negligence or otherwise. 

Registration Process for Participants: 

Participants can register for the 

Challenge by visiting http://www.

health2challenge.org or http://www.

challenge.gov. Registration will be open 

from October 31, 2011 to March 15, 

2012. 

Amount of the Prize: 

Challenge winners will be provided 

monetary cash prizes, totaling $15,000. 

The first place winner will receive 

$10,000. The second place winner will 

receive $3,000. And the third place 

winner will receive $2,000. Winners 

will be invited to demonstrate their 

apps at the 2012 Health Promotion 

Summit in Washington, DC. 

Basis Upon Which Winner Will be 

Selected: 

Challenge submissions will be 

reviewed by a panel of judges with 

relevant expertise in health IT and in 

Healthy People 2020. Winners will be 

selected based on the following criteria: 

(1) Easy Access and Navigation. 

(2) Platform Neutrality. 

(3) User Appeal. 

(4) Innovative Design. 

(5) Broad Applicability. 

(6) Integration of Health Data. 

(7) Evidence of Co-Design and 

Collaboration. 

Judges will also award bonus points 

to submissions that align with Section 

508 of the Rehabilitation Act of 1973, 

and ones that incorporate plain 

language and health literacy principles. 

Award Approving Official: Carter 

Blakey, Acting Director, Office of 

Disease Prevention and Health 

Promotion. 

Additional Information: The Healthy 

People Web site, http://www.

HealthyPeople.gov, contains objectives, 

targets, and baseline data for all of the 

Healthy People 2020 topic areas. From 

healthypeople.gov, challenge 

participants will also be able to access 

the corresponding leading health 

indicators from the HHS Health 

Indicators Warehouse. 

Dated: October 18, 2011. 

Carter Blakey, 

Acting Director, Office of Disease Prevention 

and Health Promotion. 

[FR Doc. 2011–27681 Filed 10–25–11; 8:45 am] 

BILLING CODE 4150–32–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Scientific Information Request on 

Phototherapy for Treatment of Chronic 

Plaque Psoriasis 

AGENCY: Agency for Healthcare Research 

and Quality (AHRQ), HHS. 

ACTION: Request for scientific 

information submissions. 

SUMMARY: The Agency for Healthcare 

Research and Quality (AHRQ) is seeking 

scientific information submissions from 

manufacturers of Phototherapy medical 

devices for treatment of chronic plaque 

psoriasis. Scientific information is being 

solicited to inform our Comparative 

Effectiveness Review of Biologic and 

Nonbiologic Systemic Agents and 

Phototherapy for Treatment of Chronic 

Plaque Psoriasis, which is currently 

being conducted by the Evidence-based 

Practice Centers for the AHRQ Effective 

Health Care Program. Access to 

published and unpublished pertinent 

scientific information on this device 

will improve the quality of this 

comparative effectiveness review. 

AHRQ is requesting this scientific 

information and conducting this 

comparative effectiveness review 

pursuant to Section 1013 of the 

Medicare Prescription Drug, 

Improvement, and Modernization Act of 

2003, Public Law 108–173. 

DATES: Submission Deadline on or 

before November 25, 2011. 

ADDRESSES: Online submissions: http:// 

effectivehealthcare.AHRQ.gov/

index.cfm/submit-scientific-information

-packets/. Please select the study for 

which you are submitting information 

from the list of current studies and 

complete the form to upload your 

documents. 

E-mail submissions: ehcsrc@ohsu.edu 

(please do not send zipped files—they 

are automatically deleted for security 

reasons). 

Print submissions: Robin Paynter, 

Oregon Health and Science University, 

Oregon Evidence-based Practice Center, 

3181 SW. Sam Jackson Park Road, Mail 

Code: BICC, Portland, OR 97239–3098. 

FOR FURTHER INFORMATION CONTACT: 

Robin Paynter, Research Librarian, 

Telephone: 503–494–0147 or E-mail: 

ehcsrc@ohsu.edu. 

SUPPLEMENTARY INFORMATION: In 

accordance with Section 1013 of the 

Medicare Prescription Drug, 

Improvement, and Modernization Act of 

2003, Public Law 108–173, the Agency 

for Healthcare Research and Quality has 

commissioned the Effective Health Care 

(EHC) Program Evidence-based Practice 

Centers to complete a comparative 

effectiveness review of the evidence for 

Biologic and Nonbiologic Systemic 

Agents and Phototherapy for Treatment 

of Chronic Plaque Psoriasis. 

The EHC Program is dedicated to 

identifying as many studies as possible 

that are relevant to the questions for 

each of its reviews. In order to do so, we 

are supplementing the usual manual 

and electronic database searches of the 

literature by systematically requesting 

information (e.g., details of studies 

conducted) from medical device 

industry stakeholders through public 

information requests, including via the 

Federal Register and direct postal and/ 

or online solicitations. We are looking 


jlentini on DSK4TPTVN1PROD with NOTICES
66308 Federal Register / Vol. 76, No. 207 / Wednesday, October 26, 2011 / Notices 

for studies that report on phototherapy 

for treatment of chronic plaque 

psoriasis, including those that describe 

adverse events, as specified in the key 

questions detailed below. The entire 

research protocol, including the key 

questions, is also available online at: 

http://effectivehealthcare.AHRQ.gov/

index.cfm/search-forouides-reviews-and

-reports/?pageaction=displayproduct&

productid=793. 

This notice is a request for industry 

stakeholders to submit the following: 

• A current product label, if 

applicable (preferably an electronic PDF 

file). 

• Information identifying published 

randomized controlled trials and 

observational studies relevant to the 

clinical outcomes. Please provide both a 

list of citations and reprints if possible. 

• Information identifying 

unpublished randomized controlled 

trials and observational studies relevant 

to the clinical outcomes. If possible, 

please provide a summary that includes 

the following elements: study number, 

study period, design, methodology, 

indication and diagnosis, proper use 

instructions, inclusion and exclusion 

criteria, primary and secondary 

outcomes, baseline characteristics, 

number of patients screened/eligible/ 

enrolled/lost to withdrawn/followup/ 

analyzed, and effectiveness/efficacy and 

safety results. 

• Registered ClinicalTrials.gov 

studies. Please provide a list including 

the ClinicalTrials.gov identifier, 

condition, and intervention. 

Your contribution is very beneficial to 

this program. AHRQ is not requesting 

and will not consider marketing 

material, health economics information, 

or information on other indications. 

This is a voluntary request for 

information, and all costs for complying 

with this request must be borne by the 

submitter. In addition to your scientific 

information please submit an index 

document outlining the relevant 

information in each file along with a 

statement regarding whether or not the 

submission comprises all of the 

complete information available. 

Please Note: The contents of all 

submissions, regardless of format, will be 

available to the public upon request unless 

prohibited by law. 

The draft of this review will be posted 

on AHRQ’s EHC program Web site and 

available for public comment for a 

period of 4 weeks. If you would like to 

be notified when the draft is posted, 

please sign up for the e-mail list at: 

http://effectivehealthcare.AHRQ.gov/

index.cfm/join-the-email-list1/. 

Key Questions 

Proposed Key Questions (KQs) were 

posted for public comments and were 

modified with consideration of the 

comments received. Since controversy 

surrounds the classification of psoriasis 

as mild or moderate-to-severe, 

moderate-to-severe disease was not 

included as an explicit inclusion 

criterion in the systematic search of the 

literature or in the comparative 

effectiveness review. As suggested in 

the public comments, we will consider 

when evaluating efficacy data whether 

patients were naı ̈ve to biologics, were 

treated previously with biologics, or 

were allowed drug holidays. Although a 

suggestion was made to evaluate 

combination therapy and to compare 

harms in patients without psoriasis or 

untreated controls with psoriasis, such 

an evaluation falls outside the scope of 

our review. We have now specified the 

measures that will be used for healthrelated quality of life in KQ. 

1. The Psoriasis Area and Severity 

Index (PAST) score will be considered 

not only as a binary outcome but as a 

continuous outcome as suggested. 

Although we had proposed the Psoriasis 

Scalp Severity Index (PSSI) and the Nail 

Psoriasis Severity Index (NAPSI) scores 

as outcomes, patient-reported 

improvement in scalp pruritus and 

scalp pain were suggested as additional 

outcomes in KQ 1; scalp pruritus and 

scalp pain are not as commonly 

reported in the literature and are less 

likely to add extra value over the bodywide assessments. We have not listed 

specific malignancies (hepatosplenic Tcell lymphoma and other lymphomas) 

and infections (tuberculosis and 

histoplasmosis) in KQ 2 as suggested to 

be more comprehensive. Weight and 

impact of neutralizing antibodies have 

been added as characteristics that will 

be evaluated in KQ 3. We did not move 

major adverse cardiovascular events 

(MACE) from final health outcomes to 

harms, because this is an outcome of the 

disease process rather than of 

therapeutic interventions. Subgroup 

analyses based on duration of followup 

were discussed with the Technical 

Expert Panelists (TEP). 

The acronyms used in the questions 

below are defined within the text and 

the list under Definitions of Terms. 

Question 1 

In patients with chronic plaque 

psoriasis, what is the comparative 

effectiveness of systemic biologic agents 

and systemic nonbiologic agents 

(between-class comparisons) or 

phototherapy when evaluating 

intermediate (plaque BSA measurement, 

PAST score, Patient’s Assessment of 

Global Improvement, PGA, and 

individual symptom improvement) and 

final health outcomes (mortality, 

HRQoL [e.g., DLQI, HAQ–DI, EQ–5D] 

and other patient-reported outcomes, 

MACE, diabetes, and psychological 

comorbidities [e.g., depression, 

suicide])? 

Question 2 

In patients with chronic plaque 

psoriasis, what is the comparative safety 

of systemic biologic agents and systemic 

nonbiologic agents (between-class 

comparisons) or phototherapy 

(hepatotoxicity [e.g., AST, ALT], 

nephrotoxicity [e.g., SCr, GFR], 

hematologic toxicity [e.g., TCP, anemia, 

neutropenia], hypertension, alteration in 

metabolic parameters [e.g., glucose, 

lipids, weight, BMI, thyroid function], 

injection site reaction, malignancy, 

infection, and study withdrawal)? 

Question 3 

In patients with chronic plaque 

psoriasis treated with systemic biologic 

therapy, systemic nonbiologic therapy, 

or phototherapy, which patient or 

disease characteristics (e.g., age, gender, 

race, weight, smoking status, psoriasis 

severity, presence or absence of 

concomitant psoriatic arthritis, disease 

duration, baseline disease severity, 

affected BSA, disease location, number 

and type of previous treatments, failure 

of previous treatments and presence of 

neutralizing antibodies) affect 

intermediate and final outcomes? 

Details regarding the specific 

therapies considered in each class of 

interventions and comparators can be 

found in Tables 1–5. There are no 

specific requirements in terms of 

followup period that will be evaluated 

in these key questions. The setting will 

include inpatient, outpatient and home 

therapy. 

Dated: October 14, 2011. 

Carolyn M. Clancy, 

Director, AHRQ. 

[FR Doc. 2011–27563 Filed 10–25–11; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Statement of Organization, Functions, 

and Delegations of Authority 

Part C (Centers for Disease Control 

and Prevention) of the Statement of 

Organization, Functions, and 

Delegations of Authority of the 


jlentini on DSK4TPTVN1PROD with NOTICES