Federal Register / Vol. 80, No. 59 / Friday, March 27, 2015 / Notices 16405 

Dated: March 23, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–07009 Filed 3–26–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60Day–15–15UX: Docket No. CDC–2015– 

0011] 

Proposed Data Collection Submitted 

for Public Comment and 

Recommendations 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (HHS). 

ACTION: Notice with comment period. 

SUMMARY: The Centers for Disease 

Control and Prevention (CDC), as part of 

its continuing efforts to reduce public 

burden and maximize the utility of 

government information, invites the 

general public and other Federal 

agencies to take this opportunity to 

comment on proposed and/or 

continuing information collections, as 

required by the Paperwork Reduction 

Act of 1995. This notice invites 

comment on ‘‘Continuing and New 

International and U.S. Data Collections 

from the 2014 CDC Ebola Virus Disease 

Emergency Response’’. Under the 

current 60-day Federal Register Notice, 

the CDC is announcing its intention to 

seek three-year OMB approval to 

continue several Ebola-related 

information collections beyond their 

current emergency expiration dates and 

to conduct newly proposed information 

collections within international borders 

of Ebola-affected West African countries 

and within the domestic borders of 

State, Territorial and Local (STL) public 

health authorities in the U.S. These 

existing ‘‘source’’ information 

collections and new information 

collection requests (ICRs) will be 

submitted under four ‘‘destination’’ 

ICRs for Office of Management and 

Budget (OMB) approval. 

DATES: Written comments must be 

received on or before May 26, 2015. 

ADDRESSES: You may submit comments, 

identified by Docket No. CDC–2015– 

0011, by any of the following methods: 

• Federal eRulemaking Portal: 

Regulation.gov. Follow the instructions 

for submitting comments. 

• Mail: Leroy A. Richardson, 

Information Collection Review Office, 

Centers for Disease Control and 

Prevention, 1600 Clifton Road NE., MS– 

D74, Atlanta, Georgia 30329. 

Instructions: All submissions received 

must include the agency name and 

Docket Number. All relevant comments 

received will be posted without change 

to Regulations.gov, including any 

personal information provided. For 

access to the docket to read background 

documents or comments received, go to 

Regulations.gov. 

Please note: All public comment 

should be submitted through the 

Federal eRulemaking portal 

(Regulations.gov) or by U.S. mail to the 

address listed above. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the information collection plan and 

instruments, contact the Information 

Collection Review Office, Centers for 

Disease Control and Prevention, 1600 

Clifton Road NE., MS–D74, Atlanta, 

Georgia 30329; phone: 404–639–7570; 

Email: omb@cdc.gov. 

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. In addition, the PRA also 

requires Federal agencies to provide a 

60-day notice in the Federal Register 

concerning each proposed collection of 

information, including each new 

proposed collection, each proposed 

extension of existing collection of 

information, and each reinstatement of 

previously approved information 

collection before submitting the 

collection to OMB for approval. To 

comply with this requirement, we are 

publishing this notice of a proposed 

data collection as described below. 

Comments are invited on: (a) Whether 

the proposed collection of information 

is necessary for the proper performance 

of the functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected; (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology; and (e) estimates of capital 

or start-up costs and costs of operation, 

maintenance, and purchase of services 

to provide information. Burden means 

the total time, effort, or financial 

resources expended by persons to 

generate, maintain, retain, disclose or 

provide information to or for a Federal 

agency. This includes the time needed 

to review instructions; to develop, 

acquire, install and utilize technology 

and systems for the purpose of 

collecting, validating and verifying 

information, processing and 

maintaining information, and disclosing 

and providing information; to train 

personnel and to be able to respond to 

a collection of information, to search 

data sources, to complete and review 

the collection of information; and to 

transmit or otherwise disclose the 

information. 

Proposed Project 

Continuing and New International 

and U.S. Data Collections from the 2014 

CDC Ebola Virus Disease Emergency 

Response—New—National Center for 

Emerging and Zoonotic Infectious 

Diseases (NCEZID), Centers for Disease 

Control and Prevention (CDC). 

Background and Brief Description 

The international outbreak of Ebola 

virus disease (EVD) in West Africa 

began March 10, 2014. The initial cases 

were from southern Guinea, near its 

rural border with Liberia and Sierra 

Leone. Highly mobile populations 

contributed to increasing waves of 

person-to-person transmission of EVD 

that occurred in multiple countries in 

West Africa. The Centers for Disease 

Control and Prevention (CDC) 

Emergency Operations Center (EOC) 

was activated on July 9, 2014, to help 

coordinate technical assistance and 

control activities with international 

partners and to deploy teams of public 

health experts to the affected countries. 

The operations turned to the United 

States (U.S.) when the first imported 

case of EVD was diagnosed in Texas on 

September 30, 2014. In response, on 

October 11, 2014, the CDC Quarantine 

Stations and the Department of 

Homeland Security (DHS) Customs and 

Border Patrol (CBP) mobilized to screen, 

detect, and refer arriving travelers who 

were potential persons at risk for EVD 

to appropriate state, territorial, and local 

(STL) authorities. The CDC also 

increased its commitment to support 

STL public health authorities to combat 

and control the spread of EVD within 

their jurisdictions. 

Thus in 2014, the CDC used OMB 

emergency clearance procedures to 

initiate and expedite multiple urgently 

needed information collections in West 

Africa, at U.S. ports of entry, and within 

STL jurisdictions. These procedures 

allowed the agency to accomplish its 

primary mission on many fronts to 

quickly prevent public harm, illness, 

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16406 Federal Register / Vol. 80, No. 59 / Friday, March 27, 2015 / Notices 

and death from the uncontrolled spread 

of EVD. 

With this notice, the CDC is 

announcing its intention to seek threeyear OMB clearances to continue several 

Ebola-related information collections 

beyond their current emergency 

expiration dates and to conduct newly 

proposed information collections within 

international borders of Ebola-affected 

West African countries and within the 

domestic borders of STL public health 

authorities in the U.S. These existing 

‘‘source’’ information collections and 

new ICRs will be submitted under four 

‘‘destination’’ ICRs for OMB approval. 

On the international front, CDC seeks 

to continue to address key public health 

surveillance and medical treatment 

objectives in collaboration with West 

African ministries of health (MoHs), the 

World Health Organization (WHO), and 

other key partners. Examples of 

‘‘source’’ information collections 

include: (1) ‘‘2014 Emergency Response 

to Ebola in West Africa’’ (OMB Control 

No. 0920–1033, expiration date 4/30/

2015) which helped to establish country 

EVD surveillance systems for case 

investigations and contact tracing; and 

(2) the emergency clearance for 

‘‘Household Transmission Survey—a 

Public Health Response Evaluation in 

Western Area, Sierra Leone’’ (OMB 

Control No. 0920–1043, expiration date 

07/31/2015). This was a one-time 

investigation that will be the first of a 

new ‘‘destination’’ generic clearance ICR 

that will identify ways to improve 

established surveillance systems in 

other West African countries and 

settings. 

On the domestic front, CDC’s 

information collections will focus on 

continued support of STL public health 

authorities and healthcare providers in 

EVD infection control and notifiable 

disease reporting to the CDC. CDC 

wishes to extend OMB clearance for the 

‘‘source’’ emergency information 

collection, ‘‘Ebola Virus Disease in the 

United States: CDC Support for Case 

and Contact Investigation’’ (OMB 

Control Number 0920–1045, expiration 

date: 07/31/2015). For this, the CDC 

proposes a new ‘‘destination’’ ICR titled 

‘‘National Disease Surveillance Program 

III—CDC Support for Case 

Investigations, Contact Tracing, and 

Case Reports.’’ This new mechanism 

will be designed to allow CDC to 

conduct active disease surveillance in 

support of and at the request of STL 

authorities among respondents that may 

include the general public, workers, and 

STL authorities. 

The CDC will seek OMB approval for 

another new domestic ICR titled ‘‘CDC 

Emergency Operations Center Clinical 

Inquiries’’ an Ebola-related information 

collection currently in use without an 

OMB control number. Early in the 

response, a call center was quickly set 

up to support urgent inquiries about 

active monitoring, diagnosis, and 

clinical treatment of EVD. The clinical 

inquirers were STL authorities and 

health facilities that were notified by 

U.S. Quarantine Stations that persons 

requiring investigation and possible 

treatment for EVD were arriving in their 

respective jurisdictions and facilities. 

Although initiated by EOC Task 

Forces, the lead CDC center for the 

emergency response (based on subject 

matter, mission, and program areas) will 

sponsor these information collections. 

These information collections will align 

with their legislative authority, which is 

Section 301 of the Public Health Service 

Act (42 U.S.C. 241). 

There are no costs to the respondents 

other than their time. The total 

annualized burden requested is 378,695 

hours. 

Estimated Annualized Burden Hours 

A—CDC INTERNATIONAL EMERGENCY RESPONSE CASE AND CONTACT SURVEILLANCE SYSTEMS

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

(in hours) 

General Public ............... A1—Viral Hemorrhagic Fever Case Investigation 

Form (English).

13,650 1 20/60 4,550 

General Public ............... A2—Viral Hemorrhagic Fever Case Investigation 

Form (French).

7,350 1 20/60 2,450 

General Public ............... A3—Viral Hemorrhagic Fever Case Investigation 

Short Form (English).

5,850 1 10/60 975 

General Public ............... A4—Viral Hemorrhagic Fever Case Investigation 

Short Form (French).

3,150 1 10/60 525 

General Public ............... A5—Viral Hemorrhagic Fever Contact Listing 

Form (English).

19,500 1 15/60 4,875 

General Public ............... A6—Viral Hemorrhagic Fever Contact Listing 

Form (French).

10,500 1 15/60 2,625 

General Public ............... A7—Viral Hemorrhagic Fever Contact Tracing 

Follow-Up Form (English).

195,000 1 63/60 204,750 

General Public ............... A8—Viral Hemorrhagic Fever Contact Tracing 

Follow-Up Form (French).

105,000 1 63/60 110,250 

General Public ............... A9—Ebola Virus Disease Case Contact Questionnaire (English).195,000 1 5/60 16,250 

General Public ............... A10—Ebola Virus Disease Case Contact Questionnaire (French).105,000 1 5/60 8,750 

General Public ............... A11—Ebola Outbreak Response Sexual Transmission Adult Case Investigation Form 

(English).

500 1 30/60 250 

General Public ............... A12—Ebola Outbreak Response Sexual Transmission Adult Case Investigation Form 

(French).

300 1 30/60 150 

Healthcare Workers or 

Proxy.

A13—Healthcare Worker Ebola Virus Disease 

Exposure Report—West Africa (CDC–WHO) 

(English).

1,950 1 30/60 975 

Healthcare Workers or 

Proxy.

A14—Healthcare Worker Ebola Virus Disease 

Exposure Report—West Africa (CDC–WHO) 

(French).

1,050 1 30/60 525 

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Federal Register / Vol. 80, No. 59 / Friday, March 27, 2015 / Notices 16407 

A—CDC INTERNATIONAL EMERGENCY RESPONSE CASE AND CONTACT SURVEILLANCE SYSTEMS—Continued 

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

(in hours) 

Healthcare Workers or 

Proxy.

A15—Healthcare Worker Ebola Virus Investigation Questionnaire (Liberia).400 1 30/60 200 

Healthcare Workers or 

Proxy.

A16—Healthcare Worker Ebola Virus Disease 

Exposure Report (Sierra Leone).

400 1 30/60 200 

Healthcare Workers or 

Proxy.

A17—Health Facility Assessment and Case 

Finding Survey (English).

3,900 1 30/60 1,950 

Healthcare Workers or 

Proxy.

A18—Health Facility Assessment and Case 

Finding Survey (French).

2,100 1 30/60 1,050 

Total ........................ .............................................................................. ........................ ........................ ........................ 361,300 

B—GENERIC CLEARANCE FOR ‘‘HOUSEHOLD TRANSMISSION SURVEYS IN WEST AFRICA: PUBLIC HEALTH RESPONSE

EVALUATIONS’’ 

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

(in hours) 

Case-patients or caregiver (as proxy).B1—Initial Questionnaire for Case-Patients— 

SAMPLE FORM.

357 1 20/60 119 

Heads of household ...... B2—Questionnaire for Ebola-affected Households—SAMPLE FORM.357 1 20/60 119 

Household contacts of 

case-patient.

B3—Questionnaire for Investigation of Household Contacts of Ebola-infected Case-patients—SAMPLE FORM.3,570 1 30/60 1,785 

Household contacts of 

case-patient.

B4—Contact Exit Questionnaire—SAMPLE 

FORM.

3,570 1 5/60 298 

Laboratory analyst and 

project staff.

B5—Patient Laboratory Record—SAMPLE 

FORM.

573 1 5/60 48 

Total ........................ .............................................................................. ........................ ........................ ........................ 2,369 

C—‘‘NATIONAL DISEASE SURVEILLANCE PROGRAM III—CDC SUPPORT FOR CASE INVESTIGATION, CONTACT TRACING, 

AND CASE REPORTS’’ 

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

(in hours) 

General Public—Case ... C1—Ebola Virus Disease Case Investigation 

Form—United States.

15 1 30/60 8 

General Public—Case ... C2—Symptom Monitoring Form .......................... 15 57 5/60 72 

General Public—Person 

Under Investigation 

(PUI).

C3—Ebola Virus Disease Person Under Investigation (PUI) Form.300 1 10/60 50 

General Public—Person 

Under Investigation 

(PUI).

C2—Symptom Monitoring Form .......................... 300 42 5/60 1,050 

General Public—Contact C4—Ebola Virus Disease Contact Tracing 

Form—United States.

105 1 10/60 18 

General Public—Contact C2—Symptom Monitoring Form .......................... 105 42 5/60 368 

Healthcare Workers ....... C5—Ebola Virus Disease Tracking Form for 

Healthcare Workers with Direct Patient Contact.

600 15 10/60 1,500 

Healthcare Workers ....... C2—Symptom Monitoring Form .......................... 600 57 5/60 2,850 

Laboratory Personnel .... C6—Ebola Tracking Form for Laboratory Personnel.600 15 10/60 1,500 

Laboratory Personnel .... C2—Symptom Monitoring Form .......................... 600 57 5/60 2,850 

Environmental Services 

Personnel.

C7—Ebola Tracking Form for Environmental 

Services Personnel.

600 15 10/60 1,500 

Environmental Services 

Personnel.

C2—Symptom Monitoring Form .......................... 600 57 5/60 2,850 

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16408 Federal Register / Vol. 80, No. 59 / Friday, March 27, 2015 / Notices 

C—‘‘NATIONAL DISEASE SURVEILLANCE PROGRAM III—CDC SUPPORT FOR CASE INVESTIGATION, CONTACT TRACING, 

AND CASE REPORTS’’—Continued 

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

(in hours) 

State, Territorial, and 

Local Public Health 

Authorities and Their 

Delegates.

C8—Daily and Weekly Report ............................ 15 42 10/60 105 

Total ........................ .............................................................................. ........................ ........................ ........................ 14,721 

D—‘‘CDC EMERGENCY OPERATIONS CENTER CLINICAL INQUIRIES’’ 

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

(in hours) 

State and Local Health 

Departments.

D1—Clinical Inquiries Database .......................... 420 1 15/60 105 

Clinicians and Other 

Providers.

D1—Clinical Inquiries Database .......................... 800 1 15/60 200 

Total ........................ .............................................................................. ........................ ........................ ........................ 305 

Leroy A. Richardson 

Chief, Information Collection Review Office, 

Office of Scientific Integrity, Office of the 

Associate Director for Science, Office of the 

Director, Centers for Disease Control and 

Prevention. 

[FR Doc. 2015–07037 Filed 3–26–15; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3314–N] 

Medicare, Medicaid, and CLIA 

Programs; Announcement of the ReApproval of the American Osteopathic 

Association/Healthcare Facilities 

Accreditation Program (Formerly 

Known as the American Osteopathic 

Association) as an Accreditation 

Organization Under the Clinical 

Laboratory Improvement Amendments 

of 1988 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This notice announces the 

application of the American Osteopathic 

Association/Healthcare Facilities 

Accreditation Program (AOA/HFAP) for 

approval as an accreditation 

organization for clinical laboratories 

under the Clinical Laboratory 

Improvement Amendments of 1988 

(CLIA) program. We have determined 

that AOA/HFAP meets or exceeds the 

applicable CLIA requirements. In this 

notice, we announce the approval and 

grant AOA/HFAP deeming authority for 

a period of 6 years. 

DATES: Effective Date: This notice is 

effective from March 27, 2015 to March 

29, 2021. 

FOR FURTHER INFORMATION CONTACT: 

Kathleen Todd, 410–786–3385. 

SUPPLEMENTARY INFORMATION: 

I. Background and Legislative 

Authority 

On October 31, 1988, the Congress 

enacted the Clinical Laboratory 

Improvement Amendments of 1988 

(CLIA) (Pub. L. 100–578). CLIA 

amended section 353 of the Public 

Health Service Act. We issued a final 

rule implementing the accreditation 

provisions of CLIA on July 31, 1992 (57 

FR 33992). Under those provisions, we 

may grant deeming authority to an 

accreditation organization if its 

requirements for laboratories accredited 

under its program are equal to or more 

stringent than the applicable CLIA 

program requirements in 42 CFR part 

493 (Laboratory Requirements), subpart 

E of part 493 (Accreditation by a Private, 

Nonprofit Accreditation Organization or 

Exemption under an Approved State 

Laboratory Program), which specifies 

the requirements an accreditation 

organization must meet to be approved 

by CMS as an accreditation organization 

under CLIA. 

II. Notice of Approval of the American 

Osteopathic Association/Healthcare 

Facilities Accreditation Program (AOA/ 

HFAP) as an Accreditation 

Organization 

In this notice, we approve the 

American Osteopathic Association/

Healthcare Facilities Accreditation 

Program (AOA/HFAP) as an 

organization that may accredit 

laboratories for purposes of establishing 

their compliance with CLIA 

requirements for all specialty and 

subspecialty areas under CLIA. We have 

examined the initial AOA/HFAP 

application and all subsequent 

submissions to determine its 

accreditation program’s equivalency 

with the requirements for approval of an 

accreditation organization under 

subpart E of part 493. We have 

determined that AOA/HFAP meets or 

exceeds the applicable CLIA 

requirements. We have also determined 

that AOA/HFAP will ensure that its 

accredited laboratories will meet or 

exceed the applicable requirements in 

subparts H, I, J, K, M, Q, and the 

applicable sections of subpart R. 

Therefore, we grant AOA/HFAP 

approval as an accreditation 

organization under subpart E of part 

493, for the period stated in the DATES

section of this notice for all specialty 

and subspecialty areas under CLIA. As 

a result of this determination, any 

laboratory that is accredited by AOA/

HFAP during the time period stated in 

the DATES section of this notice will be 

deemed to meet the CLIA requirements 

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