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

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,


### 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 isannouncing 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 I NTERNATIONAL 

### E MERGENCY 

### R ESPONSE 

### CASE AND 

### CONTACT 

### S URVEILLANCE 

### 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


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

A—CDC I NTERNATIONAL 

### E MERGENCY 

### R ESPONSE 

### CASE AND 

### CONTACT 

### S URVEILLANCE 

### 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—G ENERIC 

### C LEARANCE FOR 

### ‘‘H OUSEHOLD 

### T RANSMISSION 

### S URVEYS IN 

### W EST 

### A FRICA 

### : P UBLIC 

### H EALTH 

### R ESPONSE 

### 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—‘‘N ATIONAL 

### D ISEASE 

### S URVEILLANCE 

### P ROGRAM 

### III—CDC S UPPORT FOR 

### CASE 

### I NVESTIGATION 

### , CONTACT 

### T RACING



### , AND 

### CASE 

### R EPORTS

### ’’

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 forHealthcare Workers with Direct Patient Contact. 600 15 10/60 1,500

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


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

C—‘‘N ATIONAL 

### D ISEASE 

### S URVEILLANCE 

### P ROGRAM 

### III—CDC S UPPORT FOR 

### CASE 

### I NVESTIGATION 

### , CONTACT 

### T RACING



### , AND 

### CASE 

### R EPORTS

### ’’—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 E MERGENCY 

### O PERATIONS 

### C ENTER 

### C LINICAL 

### I NQUIRIES

### ’’

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 Re**  **Approval 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