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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 is 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 to respond to a collection of
information, search data sources, and
complete and review the collection of
information; and to transmit or
otherwise disclose the information.
Proposed Project
Possession, Use, and Transfer of
Select Agents and Toxins (42 CFR 73)
(OMB Control No. 0920–0576, exp. 12/
31/2018)—Revision—Office of Public
Health Preparedness and Response
(OPHPR), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
Subtitle A of the Public Health
Security and Bioterrorism Preparedness

and Response Act of 2002, (42 U.S.C.
262a), requires the United States
Department of Health and Human
Services (HHS) to regulate the
possession, use, and transfer of
biological agents or toxins that have the
potential to pose a severe threat to
public health and safety (select agents
and toxins). Subtitle B of the Public
Health Security and Bioterrorism
Preparedness and Response Act of 2002
(which may be cited as the Agricultural
Bioterrorism Protection Act of 2002), (7
U.S.C. 8401), requires the United States
Department of Agriculture (USDA) to
regulate the possession, use, and
transfer of biological agents or toxins
that have the potential to pose a severe
threat to animal or plant health, or
animal or plant products (select agents
and toxins). The HHS Secretary
delegated the responsibility for
promulgating and implementing select
agent regulations found at 42 CFR part
73 to CDC Division of Select Agents and
Toxins (DSAT). The Animal and Plant
Health Inspection Service (APHIS)/
Agriculture Select Agent Services
(AgSAS) was delegated responsibility by
USDA for select agent regulations (7
CFR part 331, and 9 CFR part 121). The
Federal Select Agent Program (FSAP) is
the collaboration of the DSAT and
AgSAS to administer the select agent
regulations in a manner to minimize the
administrative burden on persons
subject to the select agent regulations.
Accordingly, CDC and APHIS have

adopted an identical system to collect
information for the possession, use, and
transfer of select agents and toxins.
CDC is requesting OMB approval to
revise the collected information under
the select agent regulations through the
use of the APHIS/CDC Form 3 (Report
of Theft, Loss, or Release of Select
Agents and Toxins). The Report of
Theft, Loss, or Release of Select Agent
and Toxin form (42 CFR 73.19(a),(b))
must be completed by an individual or
an entity whenever the individual or
entity experiences a theft, loss, or
release of a select agent or toxin.
CDC is proposing to revise the form to
further clarify what needs to be reported
as a ‘‘release’’ and ‘‘loss’’ and additional
fields to assist with categorizing the
type of release (e.g., spill within
secondary containment, occupational
exposure, possible breach of facility
containment, etc.), type of exposure,
and the understanding of safety and
security risk levels relative to human
illness. Estimated average time to
complete this form is one hour.
The total estimated annualized
burden for this collection was
calculated using data obtained from the
FSAP database and is estimated as 430
hours. Information will be collected via
fax, email and hard copy mail from
respondents. Upon OMB approval, CDC
will continue use of the revised form
through November 2018. There is no
cost to the respondents.

ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent

Average
burden per
response
(in hours)

Total burden
hours

Form name

73.19 Section .................

Report of Theft, Loss, or Release of Select
Agents and Toxins.

215

1

2

430

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

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

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

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

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

430

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.

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

[FR Doc. 2016–31739 Filed 12–29–16; 8:45 am]

[60Day–17–1074; Docket No. CDC–2016–
0123]

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Number of
respondents

Type of respondents

Centers for Disease Control and
Prevention

Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).

AGENCY:

ACTION:

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Notice with comment period.

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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 the revision of the
information collection entitled
‘‘Colorectal Cancer Control Program
(CRCCP) Monitoring Activities.’’ The
change to the collection will include a

SUMMARY:

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redesigned survey and a redesigned
clinic-level data collection template.
DATES: Written comments must be
received on or before February 28, 2017.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2016–
0123 by any of the following methods:
• Federal eRulemaking Portal:
Regulations.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: [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

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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
Colorectal Cancer Control Program
(CRCCP) Monitoring Activities—(OMB
Control No. 0920–1074, exp. 6/30/
2018)—Revision—National Center for
Chronic Disease Prevention and Health
Promotion (NCCDPHP), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
CDC is requesting a revision of the
information collection approved under
OMB Control Number 0920–1074. Based
on feedback from grantees and internal
subject matter experts, CDC proposes
use of a revised annual grantee survey
instrument, as well as a revised cliniclevel data collection template. The
number of respondents will also
decrease from 31 to 30 grantees. Total
estimated annualized burden will
decrease. OMB approval is requested for
three years.
Colorectal cancer (CRC) is the second
leading cause of death from cancer in
the United States among cancers that
affect both men and women. CRC
screening has been shown to reduce
incidence of and death from the disease.
Screening for CRC can detect disease
early when treatment is more effective
and prevent cancer by finding and
removing precancerous polyps. Of
individuals diagnosed with early stage
CRC, more than 90% live five or more
years. Despite strong evidence
supporting screening, only 65% of
adults currently report being up-to-date
with CRC screening as recommended by
the U.S. Preventive Services Task Force,

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with more than 22 million age-eligible
adults estimated to be untested. To
reduce CRC morbidity, mortality, and
associated costs, use of CRC screening
tests must be increased among ageeligible adults with the lowest CRC
screening rates.
CDC’s Colorectal Cancer Control
Program (CRCCP) currently provides
funding to 30 grantees under
‘‘Organized Approaches to Increase
Colorectal Cancer Screening’’ (CDC–
RFA–DP15–1502). CRCCP grantees
include state governments or bona-fide
agents, universities, and tribal
organizations. The purpose of the
cooperative agreement program is to
increase CRC screening rates among an
applicant defined target population of
persons 50–75 years of age within a
partner health system serving a defined
geographical area or disparate
population. The CDC significantly
redesigned the CRCCP in 2015. The
CRCCP has two components.
Component 1: Funding for component
1 is limited to partnerships with health
systems to implement up to four priority
evidence-based interventions (EBIs)
described in the Guide to Community
Preventive Services as well as other
supporting strategies. Grantees must
implement at least two EBIs in each
partnering health system. All 30 CRCCP
grantees received Component 1 funding.
Component 2: Funding for component
2 is used by grantees to provide direct
screening and follow-up clinical
services for a limited number of
individuals aged 50–64 in the program’s
priority population who are
asymptomatic, at average risk for CRC,
have inadequate or no health insurance
for CRC screening, and are low income.
Six of the 30 CRCCP grantees received
Component 2 funding.
Two forms of data collection have
been implemented to assess program
processes and outcomes. In Program
Year 1, the annual grantee survey
monitored grantee program
implementation, including (1) program
management, (2) implementation of the
EBIs and Supporting Activities (SAs) (3)
health information technology (IT), (4)
partnerships, (5) data use, (6) training
and technical assistance (TA), and (7)
clinical service delivery (for programs
receiving Component 2 funding only).
Clinic-level data collection assessed
CRCCP’s primary outcome of interest—
CRC screening rates within partner
health systems—by measuring the
following components: (1) Partner
health system, clinic, and patient
population characteristics, (2) reporting
period (for screening rates), (3) Chart
review screening rate data, (4)
Electronic Health Record (EHR)

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Federal Register / Vol. 81, No. 251 / Friday, December 30, 2016 / Notices
screening rate, and (5) Priority evidencebased EBIs and SAs. CRCCP grantees
collected and reported CRCCP cliniclevel information for all partnering
health system primary care clinic sites.
For Program Years 2–5, based on
feedback from grantees, CDC proposes
use of updated data collection
instruments. Specifically, CDC plans to
implement a revised CRCCP annual
grantee survey that eliminates survey
items related to implementation of EBIs
and SAs as these data are more

assistance needs. In addition, data
collected will inform program
improvement and help identify
successful activities that need to be
maintained, replicated, or expanded.
OMB approval is requested for three
years. The number of grantees decreased
from 31 grantees in program year one to
30 grantees in program year two. In
addition, the total estimated annualized
burden hours have decreased from 210
to 204 hours. There are no costs to
respondents other than their time.

accurately reported at the clinic level.
Conversely, CDC plans to implement a
revised CRCCP clinic-level data
collection template that includes
additional data variables related to
implementation of EBIs and SAs, as
well as monitoring and evaluation
activities, at the clinic level.
Redesigned data elements will enable
CDC to better gauge progress in meeting
CRCCP program goals and monitor
implementation activities, evaluate
outcomes, and identify grantee technical

ESTIMATED ANNUALIZED BURDEN HOURS
Average
burden per
response
(in hours)

Total burden
(in hours)

Form name

CRCCP Grantees .............................

CRCCP Annual Grantee Survey ......
CRCCP Clinic-level Information Collection Template.

30
30

1
12

24/60
32/60

12
192

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

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

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

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

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

204

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. 2016–31740 Filed 12–29–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Electronic Filing of Certain Import Data
Into the Document Image System
Through the Automated Commercial
Environment
Centers for Disease Control and
Prevention, Department of Health and
Human Services.
ACTION: Notice.
AGENCY:

Through publication of this
notice, the Centers for Disease Control
and Prevention (CDC) located within the
Department of Health and Human
Services (HHS) announces a new policy
and guidance for the electronic
submission of data related to the
importation of CDC-regulated items in
the International Trade Data System
(ITDS). Certain data, forms, and
documents required to be submitted to
HHS/CDC will be submitted through the
U.S. Customs and Border Protection
(CBP)’s Automated Commercial
Environment (ACE) system, using the
Document Image System (DIS). This
electronic process will replace certain

SUMMARY:

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Number of
responses per
respondent

Number of
respondents

Type of respondent

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paper-based processes in keeping with
Federal policy and improve operations
to further assist HHS/CDC’s mission to
protect public health.
DATES: This action is effective December
30, 2016.
FOR FURTHER INFORMATION CONTACT: For
information regarding this Notice:
Ashley A. Marrone, J.D., Division of
Global Migration and Quarantine,
Centers for Disease Control and
Prevention, 1600 Clifton Road NE., MS–
E03, Atlanta, GA 30329. For information
regarding CDC operations related to this
Notice: Kendra Stauffer, D.V.M.,
Division of Global Migration and
Quarantine, Quarantine and Border
Health Services Branch, Importations
and Animal Contact Team, Centers for
Disease Control and Prevention, 1600
Clifton Road NE., MS–E28, Atlanta, GA
30345. Either may also be reached by
telephone 404–498–1600 or email
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
On February 19, 2014, the President
signed Executive Order 13659,
Streamlining the Export/Import Process
for America’s Businesses (79 FR 10655),
that requires the completion and
government-wide utilization by
December 31, 2016 of the International
Trade Data System (ITDS) and
establishes a two-tiered governance
process to oversee its implementation.
Once fully implemented, ITDS, through
the Automated Commercial
Environment (ACE), will allow
importers to submit the data required by

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U.S. Customs and Border Protection and
its Partner Government Agencies (PGAs)
relating to the import or export of cargo
through a ‘‘single window’’ concept.
CBP has developed ACE as the single
window for the trade community to
transmit electronically all required
cargo-related information.
This notice announces HHS/CDC’s
updated policy concerning the
electronic transmission of HHS/CDC
permits, forms, and documents using
CBP’s Document Image System (DIS).
This DIS capability will satisfy the
HHS/CDC data and electronic document
requirements for any entry filed
electronically in ACE and enable the
trade community to have a CBPmanaged single window for the
electronic submission of data and
documents required by HHS/CDC
during the cargo importation and review
process. The list of PGA forms and
documents, including documents
required by HHS/CDC, which may be
transmitted using DIS may be found at
http://www.cbp.gov/trade/ace/features
under the DIS tab by clicking on the
‘‘ACE PGA Forms List’’ hyperlink in the
‘‘References’’ column. The HHS/CDC
permits, forms, and documents listed in
the ACE PGA Forms List are those
eligible to be transmitted using DIS.
II. Current HHS/CDC Paper-Based
Procedures
Under current applicable HHS/CDC
policy and operations, the importation
of HHS/CDC-regulated commodities
into the customs territory of the United
States typically requires the submission

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