34538 Federal Register / Vol. 79, No. 116 / Tuesday, June 17, 2014 / Notices 

economics, information systems, law, 

ethics, business, or public policy; and, 

(7) in representing the interests of 

patients and consumers of health care. 

42 U.S.C. 299c(c)(2). Individuals are 

particularly sought with experience and 

success in activities specified in the 

summary above. 

DATES: Nominations should be received 

on or before 60 days after date of 

publication. 

ADDRESSES: Nominations should be sent 

to Ms. Karen Brooks, AHRQ, 540 

Gaither Road, Room 3006, Rockville, 

Maryland 20850. Nominations may also 

be emailed to Karen.Brooks@

ahrq.hhs.gov. 

FOR FURTHER INFORMATION CONTACT: Ms. 

Karen Brooks, AHRQ, at (301) 427– 

1801. 

SUPPLEMENTARY INFORMATION: 42 U.S.C. 

299e provides that the Secretary shall 

appoint to the National Advisory 

Council for Healthcare Research and 

Quality twenty one appropriately 

qualified individuals. At least seventeen 

members shall be representatives of the 

public and at least one member shall be 

a specialist in the rural aspects of one 

or more of the professions or fields 

listed in the above summary. In 

addition, the Secretary designates, as ex 

officio members, representatives from 

other Federal agencies, principally 

agencies that conduct or support health 

care research, as well as Federal officials 

the Secretary may consider appropriate. 

42 U.S.C. 299c(c)(3). The Council meets 

in the Washington, DC, metropolitan 

area, generally in Rockville, Maryland, 

approximately three times a year to 

provide broad guidance to the Secretary 

and AHRQ’s Director on the direction of 

and programs undertaken by AHRQ. 

Seven individuals will be selected 

presently by the Secretary to serve on 

the Council beginning with the meeting 

in the spring of 2015. Members 

generally serve 3-year terms. 

Appointments are staggered to permit 

an orderly rotation of membership. 

Interested persons may nominate one 

or more qualified persons for 

membership on the Council. Selfnominations are accepted. Nominations 

shall include: (1) A copy of the 

nominee’s resume or curriculum vitae; 

and (2) a statement that the nominee is 

willing to serve as a member of the 

Council. Selected candidates will be 

asked to provide detailed information 

concerning their financial interests, 

consultant positions and research grants 

and contracts, to permit evaluation of 

possible sources of conflict of interest. 

Please note that once you are 

nominated, AHRQ may consider your 

nomination for future positions on the 

Council. Federally registered lobbyists 

are not permitted to serve on this 

advisory board pursuant to the 

Presidential Memorandum entitled 

‘‘Lobbyists on Agency Boards and 

Commissions’’ dated June 10, 2010, and 

the Office of Management and Budget’s 

‘‘Final Guidance on Appointment of 

Lobbyists to Federal Boards and 

Commissions,’’ 76 Fed. Reg. 61756 

(October 5, 2011). 

The Department seeks a broad 

geographic representation. In addition, 

AHRQ conducts and supports research 

concerning priority populations, which 

include: low-income groups; minority 

groups; women; children; the elderly; 

and individuals with special health care 

needs, including individuals with 

disabilities and individuals who need 

chronic care or end-of-life health care. 

See 42 U.S.C. 299(c). Nominations of 

persons with expertise in health care for 

these priority populations are 

encouraged. 

Dated: May 29 2014. 

Richard Kronick, 

AHRQ Director. 

[FR Doc. 2014–14081 Filed 6–16–14; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Scientific Information Request on 

Diagnosis and Treatment of Myalgic 

Encephalomyelitis/Chronic Fatigue 

Syndrome (ME/CFS) 

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 

Diagnosis and Treatment of Myalgic 

Encephalomyelitis/Chronic Fatigue 

Syndrome (ME/CFS), 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 17, 2014. 

ADDRESSES: Online submissions: http:// 

effectivehealthcare.AHRQ.gov/

index.cfm/submit-scientificinformation-packets/. 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 Diagnosis and 

Treatment of Myalgic 

Encephalomyelitis/Chronic Fatigue 

Syndrome (ME/CFS). 

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 Diagnosis and Treatment 

of Myalgic Encephalomyelitis/Chronic 

Fatigue Syndrome (ME/CFS), 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=displayproduct&productID

=1906#8766. 

This notice is to notify the public that 

the EHC program would find the 

following information on Diagnosis and 

Treatment of Myalgic 

Encephalomyelitis/Chronic Fatigue 

Syndrome (ME/CFS). 

• A list of completed studies your 

company has sponsored for this 

indication. In the list, indicate whether 

results are available on 


tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 116 / Tuesday, June 17, 2014 / Notices 34539 

ClinicalTrials.gov along with the 

ClinicalTrials.gov trial number. 

• For completed studies that do not 

have results on ClinicalTrials.gov, 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. 

• 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 Program. 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 Effective Health 

Care 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://effectivehealth

care.AHRQ.gov/search-for-guidesreviews-and-reports/

?pageaction=displayproduct&

productID=1906#8766. 

Key Questions (KQs) 

1. What methods are available to 

clinicians to diagnose ME/CFS and how 

do the use of these methods vary by 

patient subgroups? 

A. What are widely accepted 

diagnostic methods and what conditions 

are required to be ruled out or excluded 

before assigning a diagnosis of ME/CFS? 

B. What is the accuracy and 

concordance of diagnostic methods? 

C. What harms are associated with 

diagnosing ME/CFS? 

2. What are the (a) benefits and (b) 

harms of therapeutic interventions for 

patients with ME/CFS and how do they 

vary by patient subgroups? 

A. What are the characteristics of 

responders and non-responders to 

interventions? 

PICOTS (Population, Intervention, 

Comparator(s), Outcomes, Timing, 

Setting) 

Population(s) 

1. Include: 

A. For KQ 1: Symptomatic adults (aged 

18 years or older) with fatigue 

B. For KQ 2: Adults aged 18 years or 

older, with ME/CFS, without other 

underlying diagnosis 

2. Exclude: 

A. Children and adolescents 

B. Patients with other underlying 

diagnosis 

Interventions 

1. Include: 

A. For KQ1: Case definitions: e.g., 

Fukada/CDC, Canadian, International 

and others 

For KQ2: symptom-based medication 

management (immune modulators, 

beta blockers, antidepressants, 

anxiolytics, stimulants), forms of 

counseling and behavior therapy, 

graded exercise programs, 

complementary and alternative 

medicine (acupuncture, relaxation, 

massage, or other), and 

transcutaneous electrical nerve 

stimulation. 

Comparators 

1. Include: 

A. For KQ1: Diagnostic accuracy studies 

and diagnostic concordance studies 

with comparators 

B. For KQ2: Placebo or no treatment/

usual care, other active interventions 

(including combination therapies and 

head-to-head trials) 

Outcomes 

1. Include: 

A. For KQ1: Sensitivity, specificity, 

positive predictive value, negative 

predictive value, positive likelihood 

ratio, negative likelihood ratio, C 

statistic (AUROC), net reclassification 

index; concordance, any potential 

harm from diagnosis (such as 

psychological harms, labeling, risk 

from diagnostic test, misdiagnosis, 

other) 

B. For KQ2: Overall function (i.e., 36- 

item Short Form Survey [SF–36]), 

quality of life, days spent at work/

school, proportion working full or 

part time, fatigue (Multidimensional 

Fatigue Inventory [MFI] or similar), 

adverse effects of interventions, 

withdrawals and withdrawals due to 

adverse events, rates of adverse events 

due to interventions 

Timing 

1. Include: 12 weeks or longer 

Setting 

1. Include: Clinical settings 

Dated: June 3, 2014. 

Richard Kronick, 

AHRQ Director. 

[FR Doc. 2014–14084 Filed 6–16–14; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare and Medicaid 

Services 

Privacy Act of 1974; Report of New 

System of Records 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), Department 

of Health and Human Services (HHS). 

ACTION: Notice of New System of 

Records (SOR). 

SUMMARY: In accordance with the 

requirements of the Privacy Act of 1974, 

we are proposing to establish a new 

SOR, titled ‘‘CMS Encounter Data 

System (EDS)’’, System No. 09–70–0506. 

CMS intends to collect encounter data, 

or data on each item or service delivered 

to enrollees of Medicare Advantage 

(MA) plans offered by MA organizations 

as defined at Title 42, Code of Federal 

Regulation (CFR), § 422.4. Pursuant to 

42 CFR 422.310, each MA organization 

must submit encounter data to CMS that 

is used to determine the risk adjustment 

factors for payment, updating the risk 

adjustment model, calculating Medicare 

Disproportionate Share Hospital (DSH) 

percentages, Medicare coverage 

purposes, and quality review and 

improvement activities. Encounter data 

will be collected and maintained in the 

EDS. 

Under the authority granted in 

Section 1115 of the Social Security Act 

(the Act), CMS is authorized to conduct 

experimental, pilot or demonstration 


tkelley on DSK3SPTVN1PROD with NOTICES