36514 Federal Register / Vol. 79, No. 124 / Friday, June 27, 2014 / Notices 

company name (if any), and ‘‘Notice– 

CECANF–2014–03’’ on your attached 

document. 

• Mail: Commission to Eliminate 

Child Abuse and Neglect Fatalities, c/o 

General Services Administration, 

Agency Liaison Division, 1800 F St. 

NW., Room 7003D, Washington, DC 

20006. 

Instructions: Please submit comments 

only and cite ‘‘Notice–CECANF–2014– 

03’’ in all correspondence related to this 

notice. All comments received will be 

posted without change to http://

www.regulations.gov, including any 

personal and/or business confidential 

information provided. 

FOR FURTHER INFORMATION CONTACT: Visit 

the CECANF Web site at https://

eliminatechildabusefatalities.sites.usa.

gov/. Or contact Ms. Patricia Brincefield, 

Communications Director, at 202–818– 

9596, 1800 F St. NW., Room 7003D, 

Washington, DC 20006. 

SUPPLEMENTARY INFORMATION: 

Background: CECANF was 

established to develop a national 

strategy and recommendations for 

reducing fatalities resulting from child 

abuse and neglect. 

Agenda: The purpose of the meeting 

is for Commission members to gather 

information to better understand the 

extent of, and risks associated with, 

child abuse and neglect fatalities. The 

Commission will hear from researchers 

regarding strategies for improving 

national data and preventing fatalities; 

learn more about the federal policy 

framework for addressing these 

fatalities; gain a better understanding of 

confidentiality issues and possible 

solutions; and hear about child welfare, 

law enforcement, health, and public 

health strategies for addressing the issue 

of child abuse and neglect fatalities. 

Attendance at the Meeting: 

Individuals interested in attending the 

meeting in person must register in 

advance because of limited space. To 

register to attend in person or by phone, 

please go to https://www.surveymonkey.

com/s/7JCP6W9 and follow the 

prompts. Detailed meeting minutes will 

be posted within 90 days of the meeting. 

Interested members of the public may 

listen to the CECANF discussion by 

calling 1–866–928–2008, and entering 

pass code 556476. Members of the 

public will not have the opportunity to 

ask questions or otherwise participate in 

the meeting. 

However, members of the public 

wishing to comment should follow the 

steps detailed under the heading 

addresses in this publication or contact 

us via the CECANF Web site at https:// 

eliminatechildabusefatalities.sites.usa.

gov/contact-us/. 

Dated: June 23, 2014. 

Patricia Brincefield, 

CECANF Communications Director. 

[FR Doc. 2014–15054 Filed 6–26–14; 8:45 am] 

BILLING CODE 6820–34–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Scientific Information Request on 

Interventions To Improve Appropriate 

Antibiotic Use for Acute Respiratory 

Tract Infections 

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 

the public. Scientific information is 

being solicited to inform our review of 

Interventions to Improve Appropriate 

Antibiotic Use for Acute Respiratory 

Tract Infections, 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 will improve the 

quality of this review. AHRQ is 

conducting this systematic review 

pursuant to Section 1013 of the 

Medicare Prescription Drug, 

Improvement, and Modernization Act of 

2003, Public Law 108–173, and Section 

902(a) of the Public Health Service Act, 

42 U.S.C. 299a(a). 

DATES: Submission Deadline on or 

before July 28, 2014. 

ADDRESS: Online submissions: http://

effectivehealthcare.AHRQ.gov/index.

cfm/submit-scientific-informationpackets/. Please select the study for 

which you are submitting information 

from the list to upload your documents. 

Email submissions: SIPS@epc-src.org. 

Print Submissions 

Mailing Address 

Portland VA Research Foundation, 

Scientific Resource Center, ATTN: 

Scientific Information Packet 

Coordinator, PO Box 69539, Portland, 

OR 97239. 

Shipping Address (FedEx, UPS, etc.) 

Portland VA Research Foundation, 

Scientific Resource Center, ATTN: 

Scientific Information Packet 

Coordinator, 3710 SW. U.S. Veterans 

Hospital Road, Mail Code: R&D 71, 

Portland, OR 97239. 

FOR FURTHER INFORMATION CONTACT: 

Ryan McKenna, Telephone: 503–220– 

8262 ext. 58653 or Email: SIPS@epcsrc.org. 

SUPPLEMENTARY INFORMATION: The 

Agency for Healthcare Research and 

Quality has commissioned the Effective 

Health Care (EHC) Program Evidencebased Practice Centers to complete a 

review of the evidence for Interventions 

to Improve Appropriate Antibiotic Use 

for Acute Respiratory Tract Infections. 

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 requesting information 

from the public (e.g., details of studies 

conducted). We are looking for studies 

that report on Interventions to Improve 

Appropriate Antibiotic Use for Acute 

Respiratory Tract Infections, including 

those that describe adverse events. The 

entire research protocol, including the 

key questions, is also available online 

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

search-for-guides-reviews-and-reports/

?pageaction=display

product&productID=1913. 

This notice is to notify the public that 

the EHC Program would find the 

following information on Interventions 

to Improve Appropriate Antibiotic Use 

for Acute Respiratory Tract Infections 

helpful: 

• A list of completed studies that 

your company has sponsored for this 

indication. In the list, indicate whether 

results are available on 

ClinicalTrials.gov along with the 

ClinicalTrials.gov trial number. 

• For completed studies that do not 

have results on ClinicalTrials.gov, 

please provide a summary, including 

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 follow-up/withdrawn/

analyzed, effectiveness/efficacy, and 

safety results. 

• A list of ongoing studies your 

company has sponsored for this 

indication. In the list, please provide the 

ClinicalTrials.gov trial number or, if the 

trial is not registered, the protocol for 

the study including a study number, the 

study period, design, methodology, 

indication and diagnosis, proper use 

instructions, inclusion and exclusion 

criteria, and primary and secondary 

outcomes. 


wreier-aviles on DSK5TPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 124 / Friday, June 27, 2014 / Notices 36515 

• Description of whether the above 

studies constitute ALL Phase II and 

above clinical trials sponsored by your 

company for this indication and an 

index outlining the relevant information 

in each submitted file. 

Your contribution is very beneficial to 

the EHC Program. Since the contents of 

all submissions will be made available 

to the public upon request, materials 

submitted must be publicly available or 

can be made public. Materials that are 

considered confidential; marketing 

materials; study types not included in 

the review; or information on 

indications not included in the review 

cannot be used by the EHC Program. 

This is a voluntary request for 

information, and all costs for complying 

with this request must be borne by the 

submitter. 

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 systematic review will answer the 

following questions. This information is 

provided as background. AHRQ is not 

requesting that the public provide 

answers to these questions. The entire 

research protocol is also available 

online at: http://effectivehealthcare.

AHRQ.gov/search-for-guides-reviewsand-reports/?pageaction=display

product&productID=1913. 

The Key Questions 

Key Question 1 

For patients with an acute respiratory 

tract infection (RTI) and no clear 

indication for antibiotic treatment, what 

is the comparative effectiveness of 

particular strategies in improving the 

appropriate prescription or use of 

antibiotics compared with other 

strategies or standard care? 

I. Does the comparative effectiveness 

of strategies differ according to how 

appropriateness is defined? 

II. Does the comparative effectiveness 

of strategies differ according to the 

intended target of the strategy (i.e., 

clinicians, patients, and both)? 

III. Does the comparative effectiveness 

of strategies differ according to patient 

characteristics, such as type of Rh, signs 

and symptoms (nature and duration), 

when counting began for duration of 

symptoms, previous medical history 

(e.g., frailty, comorbidity), prior RTIs, 

and prior use of antibiotics, age, 

ethnicity, socioeconomic status, and 

educational level attained? 

IV. Does the comparative effectiveness 

of strategies differ according to clinician 

characteristics, such as specialty, 

number of years in practice, type of 

clinic organization, geographic region, 

and population served? 

V. Does the comparative effectiveness 

differ according to the diagnostic 

method or definition used, the 

clinician’s perception of the patient’s 

illness severity, or the clinician’s 

diagnostic certainty? 

VI. Does the comparative effectiveness 

differ according to various background 

contextual factors, such as the time of 

year, known patterns of disease activity 

(e.g., an influenza epidemic, a pertussis 

outbreak), system-level characteristics, 

or whether the intervention was locally 

tailored? 

Key Question 2 

For patients with an acute RTI and no 

clear indication for antibiotic treatment, 

what is the comparative effect of 

particular strategies on antibiotic 

resistance and medical complications 

(including mortality and adverse effects 

of receiving or not receiving antibiotics) 

compared with other strategies or 

standard care? 

I. Does the comparative effect of 

strategies differ according to the 

intended target of the strategy (i.e., 

clinicians, patients, and both)? 

II. Does the comparative effect of 

strategies differ according to patient 

characteristics, such as type of RTI, 

signs and symptoms (nature and 

duration), when counting began for 

duration of symptoms, previous medical 

history (e.g., frailty, comorbidity), prior 

RTIs, prior use of antibiotics, age, 

ethnicity, socioeconomic status, and 

educational level attained? 

III. Does the comparative effect of 

strategies differ according to clinician 

characteristics, such as specialty, 

number of years in practice, type of 

clinic organization, geographic region, 

and population served? 

IV. Does the comparative effectiveness 

differ according to the diagnostic 

method or definition used, the 

clinician’s perception of the patient’s 

illness severity, or the clinician’s 

diagnostic certainty? 

V. Does the comparative effect differ 

according to various background 

contextual factors, such as the time of 

year, known patterns of disease activity 

(e.g., an influenza epidemic, a pertussis 

outbreak), whether the intervention was 

locally tailored, system-level 

characteristics, or the source of the 

resistance data (i.e., population versus 

study sample)? 

Key Question 3 

For patients with an acute RTI and no 

clear indication for antibiotic treatment, 

what is the comparative effect of 

particular strategies on other clinical 

outcomes (e.g., hospitalization, health 

care utilization, patient satisfaction) 

compared with other strategies or 

standard care? 

I. Does the comparative effect of 

strategies differ according to the 

intended target of the strategy (i.e., 

clinicians, patients, and both)? 

II. Does the comparative effect of 

strategies differ according to patient 

characteristics, such as type of RTI, 

signs and symptoms (nature and 

duration), when counting began for 

duration of symptoms, previous medical 

history (e.g., frailty, comorbidity), prior 

RTIs, prior use of antibiotics, age, 

ethnicity, socioeconomic status, and 

educational level attained? 

III. Does the comparative effect of 

strategies differ according to clinician 

characteristics, such as specialty, 

number of years in practice, type of 

clinic organization, geographic region, 

and population served? 

IV. Does the comparative effectiveness 

differ according to the diagnostic 

method or definition used, the 

clinician’s perception of the patient’s 

illness severity, or the clinician’s 

diagnostic certainty? 

V. Does the comparative effect differ 

according to various background 

contextual factors, such as the time of 

year, known patterns of disease activity 

(e.g., an influenza epidemic, a pertussis 

outbreak), whether the intervention was 

locally tailored or system-level 

characteristics? 

Key Question 4 

For patients with an acute Rh I and no 

clear indication for antibiotic treatment, 

what is the comparative effect of 

particular strategies on achieving 

intended intermediate outcomes, such 

as improved knowledge regarding use of 

antibiotics for acute RTIs (clinicians 

and/or patients), improved shared 

decision making regarding the use of 

antibiotics, and improved clinician 

skills for appropriate antibiotic use (e.g., 

communication appropriate for patients’ 

literacy level and/or cultural 

background)? 

Key Question 5 

What are the comparative non-clinical 

adverse effects of strategies for 

improving the appropriate use of 

antibiotics for acute RTIs (e.g., increased 

time burden on clinicians, patients, 

clinic staff)? 

The following inclusion/exclusion 

criteria reflect input from key 

informants, public comments, AHRQ 

and the TEP. 


wreier-aviles on DSK5TPTVN1PROD with NOTICES
36516 Federal Register / Vol. 79, No. 124 / Friday, June 27, 2014 / Notices 

PICOTS (Population, Interventions, 

Comparators, Outcomes, Timing, 

Setting) 

Populations 

I. Adult and pediatric patients with an 

acute RTI and no clear indication for 

antibiotic treatment. Respiratory tract 

infections of interest include: acute 

bronchitis; otitis media; sore throat/

pharyngitis/tonsillitis; rhinitis; sinusitis; 

cough and common cold. 

II. Parents of pediatric patients with 

acute RTI and no clear indication for 

antibiotic treatment. 

III. Healthy adults and/or children 

without a current acute RTI, who may 

develop an acute RTI in the future. 

IV. Clinicians and others who care for 

patients with acute RTI in outpatient 

settings. 

V. Groups whose attendance policies 

may indirectly affect the use of 

antibiotics, such as employers or school 

officials. 

Interventions 

Any strategy for improving 

appropriate use of antibiotics when not 

indicated for acute RTI, which may fall 

into various categories, including: 

I. Educational, behavioral and 

psychological interventions that target 

clinicians, patients, or both. 

II. Strategies to improve 

communication between clinicians and 

patients, such as those designed to 

improve shared decision making. 

III. Clinical strategies, such as delayed 

prescribing of antibiotics, clinical 

prediction rules, use of risk assessment 

or diagnostic prediction, use of nonantibiotic alternatives, or use of relevant 

point-of-care (POC) diagnostic tests. 

A. EPC will include any POC test that 

is available and used in primary care 

settings for diagnostic purposes with the 

ability to provide results within a 

reasonable period (e.g. during the clinic 

visit). Examples include inflammatory 

tests (e.g., procalcitonin, c-reactive 

protein [CRP], white blood cell, etc.), 

rapid multiplex polymerase chain 

reaction (PCR) tests used to rule in/out 

organisms (e.g. rapid strep test, 

influenza, RSV), routine diagnostic 

tests, such as chest x-ray, pulse 

oximetry, and blood gasses, when they 

are specifically evaluated as an 

intervention for improving antibiotic 

use. 

IV. System level strategies, such as 

clinician reminders (paper-based or 

electronic), clinician audit and 

feedback, financial or regulatory 

incentives for clinicians or patients, 

antimicrobial stewardship programs, 

pharmacist review. 

V. Multifaceted approaches that 

include numerous elements of one or 

more of the above strategies. 

Comparators 

I. Different strategies for improving 

appropriate use of antibiotics when not 

indicated for acute RTI. 

II. Standard care without a strategy for 

improving appropriate use of 

antibiotics. 

Outcomes 

Key Question 1 

• Increased appropriate prescription of 

antibiotics (primary outcome) 

• Increased appropriate use of 

antibiotics (primary outcome) 

Note: Studies may vary in how 

appropriateness is defined or determined. We 

will accept and record any definition of 

appropriateness. We will group together 

studies that use similar definitions of 

appropriateness and categorize the different 

groups based on concordance with (e.g., high, 

medium, low) select clinical practice 

guidelines (e.g., AAP, ACCP, AAFP). We will 

then evaluate whether the comparative 

effectiveness of strategies differ across 

categories. We may also find that overall 

reduction in antibiotic prescription or use is 

reported, without a determination of 

appropriateness. While this is not a direct 

measure of the primary outcomes, we will 

report these as indirect measures of the 

impact of the intervention. 

Key Question 2 

• Mortality 

• Antibiotic resistance 

• Medical complications 

• Adverse drug effects, including 

clostridium difficile infections 

Key Question 3 

• Admission to hospital 

• Clinic visits (Index, return and 

subsequent episodes), ED visits 

• Time to return to work and/or school 

• Patient satisfaction 

• Quality of life 

• Improvement in patient symptoms, 

speed of improvement 

• Use of non-antibiotic treatments, such 

as over-the-counter medications 

• Utilization of vaccinations 

• Quality metrics 

Key Question 4 

Intermediate outcomes, such as 

improved knowledge regarding use of 

antibiotics for acute RTI (clinician 

and/or patient), or improved shared 

decision making 

Key Question 5 

Adverse effects of the strategy, such as 

increased time burden on clinicians, 

sustainability of intervention (e.g. 

measures of continued effectiveness 

over time), diagnostic resource use 

associated with POC testing, 

diagnostic coding (e.g. ICD billing 

codes) according to desired action 

(prescribe/not prescribe) 

Timing 

Any duration of follow-up. 

Setting 

I. Outpatient care settings including 

institutional settings 

II. Emergency care settings 

III. Other settings, such as school or 

workplace 

Study Design 

We will prioritize comparative studies 

with concurrent control groups (e.g. 

randomized controlled trial, prospective 

and retrospective cohort studies 

including database studies). For areas in 

which direct comparative evidence is 

lacking, we will include before-after 

studies, with or without a control group 

and with or without repeated measures. 

Dated: June 16 2014. 

Richard Kronick, 

AHRQ Director. 

[FR Doc. 2014–14962 Filed 6–26–14; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifiers: CMS–10526, CMS– 

2540–10, CMS–265–11, CMS–10106 and 

CMS–R–235] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, HHS. 

ACTION: Notice. 

SUMMARY: The Centers for Medicare & 

Medicaid Services (CMS) is announcing 

an opportunity for the public to 

comment on CMS’ intention to collect 

information from the public. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information (including each proposed 

extension or reinstatement of an existing 

collection of information) and to allow 

60 days for public comment on the 

proposed action. Interested persons are 

invited to send comments regarding our 

burden estimates or any other aspect of 

this collection of information, including 

any of the following subjects: (1) The 

necessity and utility of the proposed 


wreier-aviles on DSK5TPTVN1PROD with NOTICES