3818 Federal Register / Vol. 79, No. 15 / Thursday, January 23, 2014 / Notices 

D. Pregnant women 

E. The elderly (age greater than or 

equal to 65 years) 

II. What factors modify the test 

performance and comparative test 

performance of available diagnostic tests 

in these populations? 

KQ 2 

What is the comparative effectiveness 

of alternative diagnostic tests, alone or 

in combination, for patients with RLQ 

pain and suspected acute appendicitis? 

I. For the populations listed under 

Key Question 1a, what is the effect of 

alternative testing strategies on 

diagnostic thinking, therapeutic 

decision making, clinical outcomes, and 

resource utilization? 

II. What factors modify the 

comparative effectiveness of testing for 

patients with RLQ pain and suspected 

acute appendicitis? 

KQ 3 

What are the harms of diagnostic tests 

per se, and what are the treatmentrelated harms of test-directed treatment 

for tests used to diagnose RLQ pain and 

suspected acute appendicitis? 

PICOTS (Population, Interventions, 

Comparators, Outcomes, Timing, 

Setting) 

Population(s) 

I. Patients with acute RLQ abdominal 

pain (less than or equal to 7 days 

duration) for whom appendicitis is 

considered in the differential diagnosis 

II. Separate analyses will be 

performed for the following 

populations: 

A. Children (age less than 18 years); 

additional analyses will be performed 

for younger children (less than 2 years 

and 2–5 years of age) 

B. Adults (age greater than or equal to 

18 years) 

C. Non pregnant women of 

reproductive age 

D. Pregnant women 

E. Elderly (age greater than or equal to 

65 years) 

Interventions 

I. Diagnostic tests (alone or in 

combination) for diagnosing 

appendicitis 

A. Clinical signs (e.g., psoas sign, 

obturator sign, Rovsing sign, McBurney 

sign) 

B. Clinical symptoms (e.g., fever, 

migrating pain, guarding) 

C. Laboratory tests (e.g., white blood 

cell count, C-reactive protein 

concentration, left shift) 

D. Clinical prediction or decision 

rules (e.g., Alvarado score, Pediatric 

Appendicitis Score, other predictive 

models) 

E. Imaging tests (e.g., US; 

multidetector or helical CT with or 

without contrast administered orally, 

rectally, or intravenously; MRI with or 

without contrast; abdominal X-ray) 

F. Nuclear imaging studies 

G. Diagnostic laparoscopy 

Comparators 

Alternative tests or test combinations 

(as listed above), clinical observation 

Outcomes 

I. Test performance (e.g., sensitivity, 

specificity, accuracy, proportion of 

‘‘negative’’ appendectomies) using 

pathology or clinical followup as the 

reference standard 

II. Intermediate outcomes 

A. Impact on diagnostic thinking (e.g., 

change in diagnosis after testing; change 

in subsequent diagnostic approach after 

obtaining initial test results) 

B. Impact on therapeutic decision 

making (e.g., change in treatment plan 

after testing; time from admission to 

surgery) 

III. Final health or patient-centered 

outcomes 

A. Bowel perforation (ruptured 

appendix) 

B. Fistula formation 

C. Infectious complications (abscess 

formation, peritonitis, sepsis, stump 

appendicitis) 

D. Delay in diagnosis (time from 

presentation to definitive diagnosis; 

time from presentation to initiation of 

treatment; time from presentation to 

resolution of pain) 

E. Length of hospital stay 

F. Fetal/maternal outcomes (for 

pregnant women; including premature 

labor, pregnancy loss, fetal morbidity, 

fetal mortality, maternal morbidity, 

maternal mortality) 

G. Mortality 

IV. Adverse effects of intervention(s) 

A. Direct harms of testing (e.g., harms 

from exposure to ionizing radiation, 

allergic reactions/kidney injury caused 

by contrast agents) 

B. Harms of test-directed treatment 

(indirect) 

Timing 

Studies will be considered regardless 

of duration of followup. 

Setting 

All health care settings will be 

considered. 

Dated: January 14, 2014. 

Richard Kronick, 

AHRQ Director. 

[FR Doc. 2014–01241 Filed 1–22–14; 8:45 am] 

BILLING CODE 4160–90–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–R–308 and 

CMS–10508] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

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 

(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 

a second opportunity for public 

comment on the notice. Interested 

persons are invited to send comments 

regarding the burden estimate or any 

other aspect of this collection of 

information, including any of the 

following subjects: (1) the necessity and 

utility of the proposed information 

collection for the proper performance of 

the agency’s functions; (2) the accuracy 

of the estimated burden; (3) ways to 

enhance the quality, utility, and clarity 

of the information to be collected; and 

(4) the use of automated collection 

techniques or other forms of information 

technology to minimize the information 

collection burden. 

DATES: Comments on the collection(s) of 

information must be received by the 

OMB desk officer by February 24, 2014. 

ADDRESSES: When commenting on the 

proposed information collections, 

please reference the document identifier 

or OMB control number. To be assured 

consideration, comments and 

recommendations must be received by 

the OMB desk officer via one of the 

following transmissions: 

OMB, Office of Information and 

Regulatory Affairs, Attention: CMS Desk 

Officer, Fax Number: (202) 395–5806 

OR Email: OIRA_ 

submission@omb.eop.gov. 

To obtain copies of a supporting 

statement and any related forms for the 

proposed collection(s) summarized in 

this notice, you may make your request 

using one of following: 

1. Access CMS’ Web site address at 

http://www.cms.hhs.gov/

PaperworkReductionActof1995. 

2. Email your request, including your 

address, phone number, OMB number, 


sroberts on DSK5SPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 15 / Thursday, January 23, 2014 / Notices 3819 

and CMS document identifier, to 

Paperwork@cms.hhs.gov. 

3. Call the Reports Clearance Office at 

(410) 786–1326. 

FOR FURTHER INFORMATION CONTACT: 

Reports Clearance Office at (410) 786– 

1326 

SUPPLEMENTARY INFORMATION: Under the 

Paperwork Reduction Act of 1995 (PRA) 

(44 U.S.C. 3501–3520), federal agencies 

must obtain approval from the Office of 

Management and Budget (OMB) for each 

collection of information they conduct 

or sponsor. The term ‘‘collection of 

information’’ is defined in 44 U.S.C. 

3502(3) and 5 CFR 1320.3(c) and 

includes agency requests or 

requirements that members of the public 

submit reports, keep records, or provide 

information to a third party. Section 

3506(c)(2)(A) of the PRA (44 U.S.C. 

3506(c)(2)(A)) requires federal agencies 

to publish a 30-day notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension or 

reinstatement of an existing collection 

of information, before submitting the 

collection to OMB for approval. To 

comply with this requirement, CMS is 

publishing this notice that summarizes 

the following proposed collection(s) of 

information for public comment: 

1. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: State Children’s 

Health Insurance Program and 

Supporting Regulations; Use: States 

must submit title XXI plans and 

amendments for approval by the 

Secretary. We use the plan and its 

subsequent amendments to determine if 

the state has met the requirements of 

title XXI. Information provided in the 

state plan, state plan amendments, and 

from the other information we are 

collecting will be used by advocacy 

groups, beneficiaries, applicants, other 

governmental agencies, providers 

groups, research organizations, health 

care corporations, health care 

consultants. States will use the 

information collected to assess state 

plan performance, health outcomes and 

an evaluation of the amount of 

substitution of private coverage that 

occurs as a result of the subsidies and 

the effect of the subsidies on access to 

coverage. Form Number: CMS–R–308 

(OCN: 0938–0841); Frequency: Yearly, 

Once, and Occasionally; Affected 

Public: State, Local, or Tribal 

Governments; Number of Respondents: 

56; Total Annual Responses: 400; Total 

Annual Hours: 1,473,817. (For policy 

questions regarding this collection 

contact Judith Cash at 410–786–4473). 

2. Type of Information Collection 

Request: New collection (Request for a 

new OMB control number); Title of 

Information Collection: Evaluation of 

the Rural Community Hospital 

Demonstration (RCHD); Use: Section 

10313 of the Affordable Care Act of 

2010 (ACA) extended and expanded the 

Rural Community Hospital 

Demonstration (RCHD). Originally 

authorized under the Medicare 

Prescription Drug, Improvement, and 

Modernization Act of 2003 (MMA), the 

RCHD provides enhanced 

reimbursement for inpatient services to 

small rural hospitals that do not qualify 

as critical access hospitals (CAHs). The 

RCHD is intended to increase the 

capability of these hospitals to meet the 

health care needs of rural beneficiaries 

in their service areas. As a 

demonstration, the RCHD aims to 

provide information that can be used to 

assess the feasibility and advisability of 

establishing a new category of rural 

community hospitals for reimbursement 

policy. As of January 2013, 23 hospitals 

from 11 states are participating in the 

RCHD. This number includes seven 

hospitals continuing from the original 

demonstration as authorized under the 

MMA and 15 new hospitals that joined 

under the expansion authorized under 

the ACA. 

For the original demonstration, the 

MMA required a Report to Congress six 

months after the end of the 

demonstration, a requirement 

unchanged by the ACA. An initial 

evaluation was conducted between 2007 

and 2011 toward preparing for a Report 

to Congress and focused on the 17 

hospitals that had participated at some 

point between October 2004 and March 

2011. Findings from this evaluation 

were reported to the Centers for 

Medicare and Medicaid Services (CMS) 

in the Interim Evaluation Report of the 

Rural Community Hospital 

Demonstration (an unpublished report). 

The current five-year evaluation of the 

RCHD will extend and build on the 

prior evaluation and produce the Report 

to Congress required by the MMA. It 

will assess the impact of the RCHD in 

meeting its goals: to enable hospitals to 

achieve community benefits such as 

improved services for their communities 

(especially Medicare beneficiaries), 

meet their individual strategic goals, 

and improve the financial solvency and 

viability of the participating hospitals. 

In addition, the evaluation will 

determine if it is feasible and advisable 

to create a new payment category of 

rural hospitals. To achieve this 

objective, the evaluation will examine 

how RCHD hospitals responded to 

payment options and assess how the 

costs to Medicare under RCHD compare 

to existing alternative payment options. 

The evaluation will also summarize 

the characteristics of the markets served 

by RCHD hospitals, including 

beneficiaries’ proximity to inpatient 

providers and competition among 

providers in the area. The information 

will be used to assess the implications 

of expanding the RCHD payment system 

to hospitals in various market 

environments. In addition, the 

evaluation will examine the potential 

costs of expanding the RCHD payment 

methodology, accounting for alternative 

approaches to targeting rural hospitals. 

Form Number: CMS–10508 (OCN: 

0938–NEW); Frequency: Annually; 

Affected Public: State, Local or Tribal 

Governments, Private sector (Business 

or other for-profit and Not-for-profit 

organizations); Number of Respondents: 

57; Total Annual Responses: 101; Total 

Annual Hours: 245. (For policy 

questions regarding this collection 

contact Woolton Lee at 410–786–4942.) 

Dated: January 16, 2014. 

Martique Jones, 

Deputy Director, Regulations Development 

Group, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2014–01208 Filed 1–22–14; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–N–1064] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Application for 

Participation in the Medical Device 

Fellowship Program 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by February 

24, 2014. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 


sroberts on DSK5SPTVN1PROD with NOTICES