60 Day FRN

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
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:

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

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SUMMARY:

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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: [email protected].
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

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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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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
Form name

General Public ...............

A1—Viral Hemorrhagic Fever Case Investigation
Form (English).
A2—Viral Hemorrhagic Fever Case Investigation
Form (French).
A3—Viral Hemorrhagic Fever Case Investigation
Short Form (English).
A4—Viral Hemorrhagic Fever Case Investigation
Short Form (French).
A5—Viral Hemorrhagic Fever Contact Listing
Form (English).
A6—Viral Hemorrhagic Fever Contact Listing
Form (French).
A7—Viral Hemorrhagic Fever Contact Tracing
Follow-Up Form (English).
A8—Viral Hemorrhagic Fever Contact Tracing
Follow-Up Form (French).
A9—Ebola Virus Disease Case Contact Questionnaire (English).
A10—Ebola Virus Disease Case Contact Questionnaire (French).
A11—Ebola Outbreak Response Sexual Transmission Adult Case Investigation Form
(English).
A12—Ebola Outbreak Response Sexual Transmission Adult Case Investigation Form
(French).
A13—Healthcare Worker Ebola Virus Disease
Exposure Report—West Africa (CDC–WHO)
(English).
A14—Healthcare Worker Ebola Virus Disease
Exposure Report—West Africa (CDC–WHO)
(French).

General Public ...............
General Public ...............
General Public ...............
General Public ...............
General Public ...............
General Public ...............
General Public ...............
General Public ...............
General Public ...............
General Public ...............

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Number of
respondents

Type of respondents

General Public ...............
Healthcare Workers or
Proxy.
Healthcare Workers or
Proxy.

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Number of
responses per
respondent

Average
burden per
response
(in hours)

Total burden
(in hours)

13,650

1

20/60

4,550

7,350

1

20/60

2,450

5,850

1

10/60

975

3,150

1

10/60

525

19,500

1

15/60

4,875

10,500

1

15/60

2,625

195,000

1

63/60

204,750

105,000

1

63/60

110,250

195,000

1

5/60

16,250

105,000

1

5/60

8,750

500

1

30/60

250

300

1

30/60

150

1,950

1

30/60

975

1,050

1

30/60

525

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

Healthcare
Proxy.
Healthcare
Proxy.
Healthcare
Proxy.
Healthcare
Proxy.

Workers or
Workers or
Workers or
Workers or

Total ........................

Number of
respondents

Form name

A15—Healthcare Worker Ebola Virus Investigation Questionnaire (Liberia).
A16—Healthcare Worker Ebola Virus Disease
Exposure Report (Sierra Leone).
A17—Health Facility Assessment and Case
Finding Survey (English).
A18—Health Facility Assessment and Case
Finding Survey (French).
..............................................................................

Average
burden per
response
(in hours)

Number of
responses per
respondent

Total burden
(in hours)

400

1

30/60

200

400

1

30/60

200

3,900

1

30/60

1,950

2,100

1

30/60

1,050

........................

........................

........................

361,300

B—GENERIC CLEARANCE FOR ‘‘HOUSEHOLD TRANSMISSION SURVEYS IN WEST AFRICA: PUBLIC HEALTH RESPONSE
EVALUATIONS’’
Number of
respondents

Type of respondents

Form name

Case-patients or caregiver (as proxy).
Heads of household ......

B1—Initial Questionnaire for Case-Patients—
SAMPLE FORM.
B2—Questionnaire for Ebola-affected Households—SAMPLE FORM.
B3—Questionnaire for Investigation of Household Contacts of Ebola-infected Case-patients—SAMPLE FORM.
B4—Contact
Exit
Questionnaire—SAMPLE
FORM.
B5—Patient
Laboratory
Record—SAMPLE
FORM.

Household contacts of
case-patient.
Household contacts of
case-patient.
Laboratory analyst and
project staff.
Total ........................

..............................................................................

Average
burden per
response
(in hours)

Number of
responses per
respondent

Total burden
(in hours)

357

1

20/60

119

357

1

20/60

119

3,570

1

30/60

1,785

3,570

1

5/60

298

573

1

5/60

48

........................

........................

........................

2,369

C—‘‘NATIONAL DISEASE SURVEILLANCE PROGRAM III—CDC SUPPORT FOR CASE INVESTIGATION, CONTACT TRACING,
AND CASE REPORTS’’
Form name

General Public—Case ...

C1—Ebola Virus Disease Case Investigation
Form—United States.
C2—Symptom Monitoring Form ..........................
C3—Ebola Virus Disease Person Under Investigation (PUI) Form.

General Public—Case ...
General Public—Person
Under Investigation
(PUI).
General Public—Person
Under Investigation
(PUI).
General Public—Contact
General Public—Contact
Healthcare Workers .......

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Number of
respondents

Type of respondents

Healthcare Workers .......
Laboratory Personnel ....
Laboratory Personnel ....
Environmental Services
Personnel.
Environmental Services
Personnel.

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Number of
responses per
respondent

Average
burden per
response
(in hours)

Total burden
(in hours)

15

1

30/60

8

15
300

57
1

5/60
10/60

72
50

C2—Symptom Monitoring Form ..........................

300

42

5/60

1,050

C4—Ebola Virus Disease Contact Tracing
Form—United States.
C2—Symptom Monitoring Form ..........................
C5—Ebola Virus Disease Tracking Form for
Healthcare Workers with Direct Patient Contact.
C2—Symptom Monitoring Form ..........................
C6—Ebola Tracking Form for Laboratory Personnel.
C2—Symptom Monitoring Form ..........................
C7—Ebola Tracking Form for Environmental
Services Personnel.
C2—Symptom Monitoring Form ..........................

105

1

10/60

18

105
600

42
15

5/60
10/60

368
1,500

600
600

57
15

5/60
10/60

2,850
1,500

600
600

57
15

5/60
10/60

2,850
1,500

600

57

5/60

2,850

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C—‘‘NATIONAL DISEASE SURVEILLANCE PROGRAM III—CDC SUPPORT FOR CASE INVESTIGATION, CONTACT TRACING,
AND CASE REPORTS’’—Continued
Type of respondents

State, Territorial, and
Local Public Health
Authorities and Their
Delegates.
Total ........................

Average
burden per
response
(in hours)

Number of
responses per
respondent

Number of
respondents

Form name

Total burden
(in hours)

C8—Daily and Weekly Report ............................

15

42

10/60

105

..............................................................................

........................

........................

........................

14,721

D—‘‘CDC EMERGENCY OPERATIONS CENTER CLINICAL INQUIRIES’’
Type of respondents

State and Local Health
Departments.
Clinicians and Other
Providers.
Total ........................

420

1

15/60

105

D1—Clinical Inquiries Database ..........................

800

1

15/60

200

..............................................................................

........................

........................

........................

305

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.

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

DATES:

Effective Date: This notice is
effective from March 27, 2015 to March
29, 2021.

BILLING CODE 4163–18–P

FOR FURTHER INFORMATION CONTACT:

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

Kathleen Todd, 410–786–3385.
SUPPLEMENTARY INFORMATION:

Centers for Medicare & Medicaid
Services

I. Background and Legislative
Authority

[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
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice.
AGENCY:

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

SUMMARY:
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Total burden
(in hours)

D1—Clinical Inquiries Database ..........................

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.

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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.

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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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