24716 Federal Register / Vol. 77, No. 80 / Wednesday, April 25, 2012 / Notices 

disincentives to quality of care and 

enhancing regulatory oversight of 

hospitals; and a national messaging plan 

to raise awareness of HAIs among the 

hospitals and family caregivers. The 

Action Plan also delineates specific 

measures and five-year goals to focus 

efforts and track national progress in 

reducing the most prevalent infections. 

In addition, the plan intended to 

enhance collaboration with nongovernment stakeholders and partners at 

the national, regional, state, and local 

levels to strengthen coordination and 

impact of efforts. 

Recognizing the need to coordinate 

prevention efforts across healthcare 

facilities, HHS began to transition into 

the second phase (Phase Two) of the 

Action Plan in late 2009. Phase Two 

expands efforts outside of the acute care 

setting into outpatient facilities (e.g., 

ambulatory surgical centers, end-stage 

renal disease facilities). The healthcare 

and public health communities are 

increasingly challenged to identify, 

respond to, and prevent healthcareassociated infections across the 

continuum of settings where healthcare 

is delivered. The public health model’s 

population-based perspective can be 

deployed to enhance healthcareassociated infection prevention, 

particularly given the shifts in 

healthcare delivery from the acute care 

(Phase One) to ambulatory (Phase Two) 

and other settings. 

Moreover, healthcare personnel can 

acquire and transmit influenza from 

patients or transmit influenza to 

patients and other health care 

personnel. Results of several studies 

indicate that higher vaccination 

coverage among health care personnel is 

associated with lower incidence of 

nosocomial influenza, influenza-like 

illness, or mortality during influenza 

season. In addition, the proportion of 

healthcare-associated cases among 

hospitalized patients decreases as well, 

suggesting that increased staff 

vaccination can contribute to the 

decline in the number of healthcareassociated influenza cases. 

The Steering Committee drafted two 

strategies or modules that address 

healthcare-associated infection 

prevention in ambulatory surgical 

centers and end-stage renal disease 

facilities. An additional module 

addresses influenza vaccination of 

health care personnel. Similar to its 

Phase One efforts, Phase Two 

healthcare-associated infection 

reduction strategies expect to be 

executed through research and 

guideline development, implementation 

of national quality improvement 

initiatives at the provider level, and 

creation of payment policies that 

promote infection control and reduction 

in healthcare facilities. 

To assist the Steering Committee in 

obtaining broad input in the 

development of the three draft modules, 

HHS, through this request for 

information (RFI), is seeking comments 

from stakeholders and the general 

public on the revised draft National 

Action Plan to Prevent HealthcareAssociated Infections: Roadmap to 

Elimination. The revised draft can be 

found at http://www.hhs.gov/ash/ 

initiatives/hai/actionplan/index.html. 

II. Information Request 

The Office of Healthcare Quality, on 

behalf of the HHS Steering Committee 

for the Prevention of HealthcareAssociated Infections, requests input on 

the revised draft National Action Plan to 

Prevent Healthcare-Associated 

Infections: Roadmap to Elimination. 

III. Potential Responders 

HHS invites input from a broad range 

of individuals and organizations that 

have interests in preventing and 

reducing healthcare-associated 

infections. Some examples of these 

organizations include, but are not 

limited to the following: 

—General public 

—Healthcare, professional, and 

educational organizations/societies 

—Caregivers or health system providers 

(e.g., physicians, physician assistants, 

nurses, infection preventionists) 

—State and local public health agencies 

—Public health organizations 

—Foundations 

—Medicaid- and Medicare-related 

organizations 

—Insurers and business groups 

—Collaboratives and consortia. 

When responding, please self-identify 

with any of the above or other categories 

(include all that apply) and your name. 

Anonymous submissions will not be 

considered. The submission of written 

materials in response to the RFI should 

not exceed 10 pages, not including 

appendices and supplemental 

documents. Responders may submit 

other forms of electronic materials to 

demonstrate or exhibit concepts of their 

written responses, however, we request 

that comments are identified by 

Chapter, Section, and page number so 

they may be addressed accordingly. All 

comments received before the close of 

the comment period are available for 

viewing by the public, including any 

personally identifiable or confidential 

business information that is included in 

a comment. 

Dated: April 19, 2012. 

Don Wright, 

Deputy Assistant Secretary for Health. 

[FR Doc. 2012–9868 Filed 4–24–12; 8:45 am] 

BILLING CODE 4150–28–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Scientific Information Request on 

Medical Devices To Treat Otitis Media 

With Effusion 

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 otitis media with 

effusion medical devices, such as 

tympanostomy tubes and autoinflation 

devices. Scientific information is being 

solicited to inform our Comparative 

Effectiveness Review of Otitis Media 

with Effusion (OME) Treatments, 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 May 25, 2012. 

ADDRESSES:

Online submissions: http://effective

healthcare.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. 

Email 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 Email: 

ehcsrc@ohsu.edu. 


pmangrum on DSK3VPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 80 / Wednesday, April 25, 2012 / Notices 24717 

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 

otitis media with effusion treatments. 

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 

for studies that report on treatments for 

otitis media with effusion, 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://www.effective

healthcare.AHRQ.gov/index.cfm/search

-for-guides-reviews-and-reports/ 

?pageaction=displayproduct&

productid=1013#5070. 

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/follow-up/ 

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 email 

list at: http://effectivehealthcare.AHRQ.gov/

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

The Key Questions (KQs) 

KQ 1: What is the comparative 

effectiveness of the following treatment 

options (active treatments and watchful 

waiting) in affecting clinical outcomes 

or health care utilization in patients 

with OME? Clinical outcomes include 

changes in: OME signs (middle ear 

fluid) and symptoms (fullness in ear, 

difficulty in hearing), objective hearing 

thresholds, episodes of Acute Otitis 

Media (AOM), and vestibular function 

such as balance and coordination. 

Treatment options include: 

a. Tympanostomy tubes 

b. Adenoidectomy with or without 

myringotomy 

c. Myringotomy 

d. Oral or topical nasal steroids 

e. Autoinflation 

f. Complementary and alternative 

medical procedures 

g. Watchful waiting 

h. Variations in surgical technique or 

procedure 

KQ 2: What is the comparative 

effectiveness of the different treatment 

options listed in KQ 1 (active treatments 

and watchful waiting) in improving 

functional and health-related quality-oflife outcomes in patients with OME? 

Outcomes include: Hearing, speech and 

language development, auditory 

processing, academic achievement, 

attention and behavioral outcomes, 

health-related quality of life, and patient 

and parent satisfaction with care. 

KQ 3: What are the differences in 

harms or tolerability among the different 

treatment options? 

KQ 4: What are the comparative 

benefits and harms of treatment options 

in subgroups of patients with OME? 

Subgroups include: 

a. Patients of different age groups 

b. Patients of different racial/ethnic 

backgrounds 

c. Patients in different socioeconomic 

status groups 

d. Patients with comorbidities such as 

craniofacial abnormalities (e.g., cleft 

palate), Down syndrome, and existing 

speech, language, and hearing 

problems 

e. Patients with a medical history of 

AOM or OME (with and without 

clinical hearing loss) 

KQ 5: Is the comparative effectiveness 

of treatment options affected by the 

following: Health insurance coverage, 

physician specialty, type of facility of 

the treatment provider, geographic 

location, continuity of care, or prior 

inoculation with the pneumococcal 

vaccine? 

Dated: April 12, 2012. 

Carolyn M. Clancy, 

AHRQ, Director. 

[FR Doc. 2012–9818 Filed 4–24–12; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Scientific Information Request on 

Local Therapies for the Treatment of 

Stage I Non-Small Cell Lung Cancer 

and Endobronchial Obstruction Due to 

Advanced Lung Tumors 

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 Conventional TwoDimensional External Beam 

Radiotherapy (2D–EBRT), 3- 

dimensional conformal radiation 

therapy (3D–CRT), Intensity-modulated 

radiation therapy (IMRT), Stereotactic 

body radiation therapy (SBRT), Proton 

beam radiotherapy (PBR), 

Brachytherapy, Radiofrequency 

ablation, Endobronchial debridement 

and stents, and Nd-YAG Laser Therapy 

medical devices. Scientific information 

is being solicited to inform our 

Comparative Effectiveness Review of 

Local Therapies for the Treatment of 

Stage I Non-Small Cell Lung Cancer and 

Endobronchial Obstruction Due to 

Advanced Lung Tumors, 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 


pmangrum on DSK3VPTVN1PROD with NOTICES