22324 Federal Register / Vol. 77, No. 72 / Friday, April 13, 2012 / Notices 

contained in their draft International 

Classification for Patient Safety (ICPS). 

Commenting on Common Formats 

Hospital 1.2 

To allow for greater participation by 

the private sector in the subsequent 

development of the Common Formats, 

AHRQ engaged the NQF, a non-profit 

organization focused on health care 

quality, to solicit comments and advice 

to guide the further refinement of the 

Common Formats. The NQF then 

convenes an expert panel to review the 

comments received and provide 

feedback. The NQF began this process 

with feedback on AHRQ’s 0.1 Beta 

release of the Common Formats in 2008. 

Based upon the expert panel’s feedback, 

AHRQ, in conjunction with the PSWG, 

revises and refines the Common 

Formats. 

The Agency is specifically interested 

in obtaining feedback from both the 

private and public sectors on the new 

Common Formats—Hospital Version 1.2 

to guide the improvement of the 

formats. Information on how to 

comment and provide feedback on the 

Common Formats—Hospital Version 

1.2, is available at the NQF Web site for 

Common Formats: http:// 

www.Quality.forum.ORG/projects/ 

commonformats.aspx. 

The process for updating and refining 

the formats will continue to be an 

iterative one. Future versions of the 

Common Formats will be developed for 

ambulatory settings, such as ambulatory 

surgery centers and physician and 

practitioner offices. More information 

on the Common Formats can be 

obtained through AHRQ’s PSO Web site: 

http://www.PSO.AHRQ.gov/index.html. 

Dated: April 5, 2012. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 2012–8743 Filed 4–12–12; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Correction—Solicitation for 

Nominations for Members of the U.S. 

Preventive Services Task Force 

(USPSTF) 

The original date of publication for 

this Federal Register notice was March 

28, 2012, Volume 77, Number 60, pages 

18823–18825. On this publication, 

Gloria Washington’s email address is 

incorrect in two places of page 18824 

under subheadings ADDRESSES: and FOR

FURTHER INFORMATION CONTACT:. The 

correct email address for Gloria 

Washington is: USPSTFmember

nominations@AHRQ.HHS.GOV 

Dated: April 4, 2012. 

Carolyn M. Clancy, 

Director. 

[FR Doc. 2012–8737 Filed 4–12–12; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Scientific Information Request on 

Treatment of Tinnitus 

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 cochlear implants, 

sound masking devices, hearing aids, 

and transcranial magnetic stimulation 

medical devices. Scientific information 

is being solicited to inform our 

Comparative Effectiveness Review of 

Evaluation and Treatment of Tinnitus, 

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 14, 2012. 

ADDRESSES: Online submissions: 

http://effectivehealthcare.AHRQ.gov/ 

index.cfm/submitscientific-informationpackets/. 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. 

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 

evaluation and treatment of tinnitus. 

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 treatment of 

tinnitus, 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.effectivehealthcare.AHRQ.

gov/index.cfm/search-for-guidesreviews-and-reports/?pageaction=

displayproduct&productid=811#4755. 

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 


pmangrum on DSK3VPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 72 / Friday, April 13, 2012 / Notices 22325 

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/. 

Key Question (KQ) 1 and PICOTS 

(Populations, Interventions, 

Comparators, Outcomes, Timing, and 

Setting) 

In patients with symptoms of tinnitus 

(e.g., ringing in the ears, whooshing 

sounds, etc.) what is the comparative 

effectiveness of methods used to 

identify patients for further evaluation 

or treatment? 

Population(s) 

Adult patients presenting with 

symptoms of tinnitus (e.g., ringing in 

the ears, whooshing sounds, etc.) 

Note: ‘‘Adults’’ for all KQs will 

include individuals 18 years of age and 

older. 

Interventions 

Direct observation or observation of 

sound with stethoscope; referral to a 

health professional with expertise on 

managing tinnitus (i.e., otolaryngologist, 

audiologist, neurologist, mental health 

professional; administration of scales/ 

questionnaires to assess severity [e.g., 

Tinnitus Handicap Inventory, Tinnitus 

Reaction Questionnaire, Tinnitus 

Functional Index, Visual Analog Scale, 

and Tinnitus Severity Index, etc.]) 

Comparators 

Different clinical evaluation methods 

used to characterize a diagnosis and 

measure severity of subjective 

idiopathic tinnitus. 

Outcomes 

Final outcome: No treatment; need for 

specialized treatment (e.g., audiology, 

otolaryngology, neurology, mental 

health care); extent of intervention. 

Timing or followup 

No restrictions. 

Setting 

Primary care; specialty care 

(audiology, otolaryngology, neurology, 

mental health care). 

Key Question 2 and PICOTS 

In adults with subjective idiopathic 

(non-pulsatile) tinnitus, what is the 

comparative effectiveness (and/or 

potential harms) of medical/surgical, 

sound treatment/technological, or 

psychological/behavioral intervention 

(including combinations of 

interventions)? 

Population(s) 

Adult patients with a diagnosis of 

subjective idiopathic (non-pulsatile) 

tinnitus (who are sufficiently bothered 

by tinnitus that they seek a treatment 

intervention) 

Note: For KQs 2 and 3, adults 

diagnosed with unilateral and/or 

pulsatile tinnitus need to be evaluated 

for other medical conditions (such as 

acoustic neuromas). Our review will 

include only those cases in which a 

medically serious underlying pathology 

as the source of the tinnitus has already 

been ruled out. 

Interventions 

Any treatment/therapy used to 

reduce/help cope with tinnitus 

including but not limited to: 

• Medical/Surgical 

• Pharmacological treatments 

• Tricyclic antidepressants (e.g., 

amitriptyline, nortriptyline, and 

trimipramine) 

• Selective serotonin-reuptake 

inhibitors: Fluoxetine and 

paroxetine 

• Other: Trazodone; anxiolytics (e.g., 

alprazolam); vasodilators and 

vasoactive substances (e.g., 

prostaglandin El); intravenous 

lidocaine; gabapentin; Botox 

(botulinum toxin type A); and 

pramipexole) 

• Laser treatments 

• TMJ treatment: Dental orthotics and 

self-care; surgery 

• Transcranial magnetic stimulation 

• Complementary and alternative 

medicine therapies: G. biloba 

extracts; acupuncture; hyperbaric 

oxygen therapy; and diet, lifestyle, 

and sleep modifications (caffeine 

avoidance, exercise) 

• Sound Treatments/Technologies 

• Hearing aids 

• Cochlear implants 

• Sound generators/maskers (both 

wearable and stationary) 

• Neuromonics 

• Tinnitus Retraining Therapy 

• Psychological/Behavioral 

• Cognitive behavioral therapy 

• Biofeedback 

• Education 

• Relaxation therapies 

• Progressive Tinnitus Management 

• Combination therapies 

• Any combination of tinnitus 

interventions (e.g., pharmacological 

treatment with cognitive behavioral 

therapy) 

Comparators 

Placebo; no treatment; wait list; 

treatment as usual; other intervention/ 

treatment. 

Outcomes 

• Final outcomes 

1. Sleep disturbance 

2. Discomfort 

3. Anxiety 

4. Depression 

5. Self-reported loudness 

6. Quality of life 

• Adverse effects 

1. Worsening of tinnitus 

2. Sedation 

3. Surgical complications 

Timing or followup 

No restrictions. 

Setting 

Primary care; specialty care 

(audiology, otolaryngology, neurology, 

and mental health care). 

Key Question 3 and PICOTS 

For adults with subjective idiopathic 

tinnitus, what prognostic factors, patient 

characteristics, and/or symptom 

characteristics affect final treatment 

outcomes? 

Population(s) 

Adults with a diagnosis of subjective 

idiopathic tinnitus (sufficiently 

bothered by tinnitus that they are 

seeking a treatment intervention). 

Interventions 

Any treatment/therapy used to 

reduce/help cope with tinnitus 

including but not limited to those 

described in KQ 2. 

Comparators 

• Prognostic factors: Length of time to 

treatment after onset, audiological 

factors (degree and type of hearing 

loss, hyperacusis, loudness 

tolerance, masking criteria, etc.), 

head injury, anxiety, mental health 

disorders, and duration of tinnitus 

• Patient characteristics: Age, gender, 

race, medical or mental health 


pmangrum on DSK3VPTVN1PROD with NOTICES
22326 Federal Register / Vol. 77, No. 72 / Friday, April 13, 2012 / Notices 

comorbidities, socioeconomic 

factors, noise exposure 

(environmental, recreational and 

work-related [including active and 

past military duty, and 

occupational hazards), involvement 

in litigation, third-party coverage 

• Symptom characteristics: Origin/ 

presumed etiology of tinnitus, 

ototoxicity, tinnitus duration since 

onset, subcategory of tinnitus, 

severity of tinnitus 

Outcomes 

• Final outcomes 

1. Time until improvement 

2. Sleep disturbance 

3. Discomfort 

4. Anxiety 

5. Depression 

6. Self-reported loudness 

7. Quality of life 

8. Return to ‘‘normal’’ work 

• Adverse effects 

1. Worsening of tinnitus 

2. Sedation 

3. Surgical complications 

Timing or Followup 

No restrictions. 

Setting 

Primary care; specialty care 

(audiology, otolaryngology, neurology, 

mental health). 

Dated: April 4, 2012 

Carolyn M. Clancy, 

Director, AHRQ. 

[FR Doc. 2012–8740 Filed 4–12–12; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Disease, Disability, and Injury 

Prevention and Control Special 

Emphasis Panel (SEP): Initial Review 

The meeting announced below 

concerns Extension of the World Trade 

Center Health Registry (U50) Request for 

Applications (RFA), OH12–001, initial 

review. 

In accordance with Section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), the Centers for Disease 

Control and Prevention (CDC) 

announces the aforementioned meeting: 

Time and Date: 1 p.m.–2 p.m., May 16, 

2012 (Closed). 

Place: National Institute of Occupational 

Safety and Health (NIOSH), 2400 Century 

Parkway, NE., Atlanta, Georgia 30345, 

Telephone: (866) 918–5441. 

Status: The meeting will be closed to the 

public in accordance with provisions set 

forth in Section 552b(c) (4) and (6), Title 5 

U.S.C., and the Determination of the Director, 

Management Analysis and Services Office, 

CDC, pursuant to Public Law 92–463. 

Matters To Be Discussed: The meeting will 

include the initial review, discussion, and 

evaluation of applications received in 

response to ‘‘Extension of the World Trade 

Center Health Registry (U50) RFA OH12– 

001’’ 

Contact Person for More Information: 

George Bockosh, M.S., Scientific Review 

Officer, CDC/NIOSH, 626 Cochrans Mill 

Road, Mailstop P–05, Pittsburgh, 

Pennsylvania 15236, Telephone: (412) 386– 

6465 AND Joan Karr, Ph.D., Scientific Review 

Officer, CDC/NIOSH 1600 Clifton Road, NE., 

Mailstop E–74, Atlanta, Georgia 30333, 

Telephone: (404) 498–2506. 

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: April 5, 2012. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. 2012–8886 Filed 4–12–12; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Board of Scientific Counselors, 

National Center for Health Statistics, 

(BSC, NCHS) 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), the Centers for Disease 

Control and Prevention (CDC), National 

Center for Health Statistics (NCHS) 

announces the following meeting of the 

aforementioned committee: 

Times and Dates: 11 a.m.–5:30 p.m., May 

17, 2012. 

8:30 a.m.–1 p.m., May 18, 2012. 

Place: NCHS Headquarters, 3311 Toledo 

Road, Hyattsville, Maryland 20782. 

Status: This meeting is open to the public; 

however, visitors must be processed in 

accordance with established federal policies 

and procedures. For foreign nationals or nonUS citizens, pre-approval is required (please 

contact Gwen Mustaf, (301) 458–4500, 

glm4@cdc.gov or Virginia Cain, 

vcain@cdc.gov at least 10 days in advance for 

requirements). All visitors are required to 

present a valid form of picture identification 

issued by a state, federal or international 

government. As required by the Federal 

Property Management Regulations, Title 41, 

Code of Federal Regulation, Subpart 101– 

20.301, all persons entering in or on Federal 

controlled property and their packages, 

briefcases, and other containers in their 

immediate possession are subject to being xrayed and inspected. Federal law prohibits 

the knowing possession or the causing to be 

present of firearms, explosives and other 

dangerous weapons and illegal substances. 

The meeting room accommodates 

approximately 100 people. 

Purpose: This committee is charged with 

providing advice and making 

recommendations to the Secretary, 

Department of Health and Human Services; 

the Director, CDC; and the Director, NCHS, 

regarding the scientific and technical 

program goals and objectives, strategies, and 

priorities of NCHS. 

Matters To Be Discussed: The agenda will 

include welcome remarks by the Director, 

NCHS; the initiation of the review of the 

Office of Research and Methodology; a 

discussion of vital statistics and an open 

session for comments from the public. 

Requests to make oral presentations should 

be submitted in writing to the contact person 

listed below. All requests must contain the 

name, address, telephone number, and 

organizational affiliation of the presenter. 

Written comments should not exceed five 

single-spaced typed pages in length and must 

be received by April 30, 2012. 

The agenda items are subject to change as 

priorities dictate. 

Contact Person for More Information: 

Virginia S. Cain, Ph.D., Director of 

Extramural Research, NCHS/CDC, 3311 

Toledo Road, Room 7208, Hyattsville, 

Maryland 20782, telephone (301) 458–4500, 

fax (301) 458–4020. 

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: April 5, 2012. 

Elaine L. Baker, 

Management Analysis and Services Office, 

Centers for Disease Control and Prevention. 

[FR Doc. 2012–8887 Filed 4–12–12; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Privacy Act of 1974, as Amended by 

Public Law 100–503; Notice of a 

Computer Matching Program 

AGENCY: Office of Financial Services 

(OFS), Office of Administration (OA), 

ACF, HHS. 

ACTION: Request for public comment on 

the Public Assistance Reporting 

Information System (PARIS) notice of a 

computer matching program between 

the Department of Veterans Affairs and 


pmangrum on DSK3VPTVN1PROD with NOTICES