60-day Federal Register Notice

Attachment 2 Published 60 Day FRN.pdf

Requirements for the Importation of Nonhuman Primates into the United States

60-day Federal Register Notice

OMB: 0920-0263

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Federal Register / Vol. 84, No. 235 / Friday, December 6, 2019 / Notices
submissions and may choose to redact,
or withhold, submissions containing
private or proprietary information such
as Social Security numbers, medical
information, inappropriate language, or
duplicate/near duplicate examples of a
mass-mail campaign. ATSDR will
carefully consider all comments
submitted in preparation of the final
Toxicological Profiles and may revise
the profiles as appropriate.

The Superfund Amendments and
Reauthorization Act of 1986 (SARA) [42
U.S.C. 9601 et seq.] amended the
Comprehensive Environmental
Response, Compensation, and Liability
Act of 1980 (CERCLA or Superfund) [42
U.S.C. 9601 et seq.] by establishing
certain requirements for ATSDR and the
U.S. Environmental Protection Agency
(EPA) regarding the hazardous
substances most commonly found at
facilities on the CERCLA National
Priorities List (NPL). Among these
statutory requirements is a mandate for
the Administrator of ATSDR to prepare
toxicological profiles for each substance
included on the priority list of
hazardous substances [also called the
Substance Priority List (SPL)]. This list
identifies 275 hazardous substances that
ATSDR and EPA have determined pose
the most significant potential threat to
human health. The SPL is available
online at www.atsdr.cdc.gov/spl.
In addition, CERCLA provides ATSDR
with the authority to prepare
toxicological profiles for substances not
found on the SPL. CERCLA authorizes
ATSDR to establish and maintain an
inventory of literature, research, and
studies on the health effects of toxic
substances (CERCLA Section
104(i)(1)(B); 42 U.S.C. 9604(i)(1)(B)); to
respond to requests for health
consultations (CERCLA Section
104(i)(4); 42 U.S.C. 9604(i)(4)); and to
support the site-specific response
actions conducted by the agency.
Availability

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These Draft Toxicological Profiles will
be available online at http://
www.atsdr.cdc.gov/ToxProfiles and at
www.regulations.gov, Docket No.
ATSDR–0008.
Pamela I. Protzel Berman,
Director, Office of Policy, Partnerships and
Planning, Agency for Toxic Substances and
Disease Registry.
[FR Doc. 2019–26361 Filed 12–5–19; 8:45 am]
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Centers for Disease Control and
Prevention
[60Day–20–0263; Docket No. CDC–2019–
0110]

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:

Legislative Background

VerDate Sep<11>2014

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

Jkt 250001

The Centers for Disease
Control and Prevention (CDC), as part of
its continuing effort to reduce public
burden and maximize the utility of
government information, invites the
general public and other Federal
agencies the opportunity to comment on
a proposed and/or continuing
information collection, as required by
the Paperwork Reduction Act of 1995.
This notice invites comment on
Requirements for the Importation of
Nonhuman Primates into the United
States. This information collection
contains the reporting and
documentation requirements for
registered importers of nonhuman
primates, as outlined in 42 Code of
Federal Regulations part 71.53
Requirements for importers of
nonhuman primates.
DATES: CDC must receive written
comments on or before February 4,
2020.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2019–
0110 by any of the following methods:
• Federal eRulemaking Portal:
Regulations.gov. Follow the instructions
for submitting comments.
• Mail: Jeffrey M. Zirger, 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. CDC will post, without
change, all relevant comments to
Regulations.gov.
SUMMARY:

Please note: Submit all comments through
the Federal eRulemaking portal
(regulations.gov) or by U.S. mail to the
address listed above.

To
request more information on the
proposed project or to obtain a copy of
the information collection plan and
instruments, contact Jeffrey M. Zirger, of
the Information Collection Review
Office, Centers for Disease Control and

FOR FURTHER INFORMATION CONTACT:

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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 the OMB for approval. To
comply with this requirement, we are
publishing this notice of a proposed
data collection as described below.
The OMB is particularly interested in
comments that will help:
1. Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
2. Evaluate the accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
3. Enhance the quality, utility, and
clarity of the information to be
collected; and
4. Minimize the burden of the
collection of information on those who
are to respond, including through the
use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submissions
of responses.
5. Assess information collection costs.
Proposed Project
Requirements for the Importation of
Nonhuman Primates into the United
States (OMB Control No. 0920–0263,
Exp. 08/31/2020)—Revision—National
Center for Emerging and Zoonotic
Infectious Diseases (NCEZID), Centers
for Disease Control and Prevention
(CDC).
Background and Brief Description
Under the 42 CFR 71.53, CDC collects
information pertaining to importers and
imported nonhuman primates. This
information collection enables CDC to
evaluate compliance with pre-arrival of
shipment notification requirements, to
investigate the number and species of
imported nonhuman primates, and to

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Federal Register / Vol. 84, No. 235 / Friday, December 6, 2019 / Notices

determine if adequate measures are
being taken for the prevention of
exposure to persons and animals during
importation.
Since May 1990, CDC has monitored
the arrival and/or uncrating of certain
shipments of non-human primates
imported in to the United States. In
February 2013, CDC promulgated two
regulations pertaining to the
importation of nonhuman primates. The
first rule, Establishment of User Fees for
Filovirus Testing of Nonhuman Primate
Liver Samples, outlines a process by
which importers can send liver tissues
to CDC from primates that die during
importation from reasons other than
trauma (2/12/2013, Vol.78, No. 29,
p.9828). CDC performs these tests due to
the absence of a private sector option.

The second rule, Requirements for
Importers of Nonhuman Primates,
consolidates into 42 CFR 71.53 the
requirements previously found in 42
CFR part 71.53 with those found in the
Special Permit to Import Cynomolgus,
African Green, or Rhesus Monkeys into
the United States (2/15/2013, Vol. 78,
No. 32/p. 11522). It also rescinded the
six-month special-permit requirements
for cynomolgus, African green, and
rhesus monkeys and extended the time
period for registration/permit renewal
from 180 days to two years, reducing
much of the respondent burden. CDC
feels these regulatory changes and
reporting requirements balance the
public health risks posed by the
importation of nonhuman primates with

the burden imposed on regulating their
importation.
All registered importers of nonhuman primates are required by 42 CFR
part 71.53 to maintain certain disease
control procedures and keep certain
records. Standard business practices
likely dictate that importers already
keep records on the origin,
transportation, and disposition of the
nonhuman primates. Thus, CDC asks for
information which should already be
maintained by the importers and need
only be assembled and reported. The
estimate of burden hours and costs
reflects assembling and reporting only.
CDC requests approval for an estimated
185 annual burden hours. There is no
cost to respondents other than their
time.

ESTIMATED ANNUALIZED BURDEN HOURS
Type of
respondent
Nonhuman Primate Importer.
Nonhuman Primate Importer.
Nonhuman Primate Importer.
Nonhuman Primate Importer.
Nonhuman Primate Importer.
Nonhuman Primate Importer.
Nonhuman Primate Importer.
Nonhuman Primate Importer.
Nonhuman Primate Importer.
Total ........................

Number of
responses per
respondent

Number of
respondents

Form name/CFR reference

CDC 75.10A Application for Registration as an
Importer of Nonhuman Primates (New Importer).
CDC 75.10A Application for Registration as an
Importer of Nonhuman Primates (Re-Registration).
71.53(g)(1)(iii) and (h) Documentation and
Standard Operating Procedures (no form)
(New Importer).
71.53(g)(1)(iii) and (h) Documentation and
Standard Operating Procedures (no form)
(Registered Importer).
Recordkeeping and reporting requirements for
importing NHPs: Notification of shipment arrival 71.53(n) (no form).
Statements regarding the health of the
nonhuman primates during travel and CDC
quarantine (42 CFR 71.53(m) (no form).
Statements, including necropsy reports, about
the nonhuman primates upon their release
from CDC quarantine. (42 CFR 71.53(m)(no
form).
Quarantine release 71.53(l)(no form) ..................

1

10/60

1

12

1

10/60

2

1

1

10

10

12

1

30/60

6

25

6

15/60

38

25

6

15/60

38

25

3

15/60

19

25

6

15/60

38

71.53 (v) Form: Filovirus Diagnostic Specimen
Submission Form for Non-human Primate Materials.

10

10

20/60

33

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

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

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

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

185

[FR Doc. 2019–26371 Filed 12–5–19; 8:45 am]
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Total burden
hours

1

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
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Average
burden per
response
(in hours)

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Federal Register / Vol. 84, No. 235 / Friday, December 6, 2019 / Notices

Centers for Disease Control and
Prevention
[60Day–20–1193; Docket No. CDC–2019–
0105]

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 effort to reduce public
burden and maximize the utility of
government information, invites the
general public and other Federal
agencies the opportunity to comment on
a proposed and/or continuing
information collection, as required by
the Paperwork Reduction Act of 1995.
This notice invites comment on a
proposed information collection project
titled Assessment of Technical
Assistance and Training (TTA)
Approaches to Accelerate
Comprehensive Cancer Control
Outcomes. CDC is requesting to collect
information about TTA offered using
case studies and a web-based survey to
assess whether a specific cooperative
agreement has been implemented as
intended, and has contributed to
National Comprehensive Cancer Control
Program (NCCCP) awardees’
achievements in program goals and
outcomes.

SUMMARY:

CDC must receive written
comments on or before February 4,
2020.

DATES:

You may submit comments,
identified by Docket No. CDC–2019–
0105 by any of the following methods:
• Federal eRulemaking Portal:
Regulations.gov. Follow the instructions
for submitting comments.
• Mail: Jeffrey M. Zirger, 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. CDC will post, without
change, all relevant comments to
Regulations.gov.

lotter on DSKBCFDHB2PROD with NOTICES

ADDRESSES:

Please note: Submit all comments through
the Federal eRulemaking portal
(regulations.gov) or by U.S. mail to the
address listed above.

VerDate Sep<11>2014

17:22 Dec 05, 2019

Jkt 250001

To
request more information on the
proposed project or to obtain a copy of
the information collection plan and
instruments, contact Jeffrey M. Zirger,
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 the OMB for approval. To
comply with this requirement, we are
publishing this notice of a proposed
data collection as described below.
The OMB is particularly interested in
comments that will help:
1. Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
2. Evaluate the accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
3. Enhance the quality, utility, and
clarity of the information to be
collected; and
4. Minimize the burden of the
collection of information on those who
are to respond, including through the
use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submissions
of responses.
5. Assess information collection costs.
FOR FURTHER INFORMATION CONTACT:

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

Proposed Project
Assessment of Technical Assistance
and Training (TTA) Approaches to
Accelerate Comprehensive Cancer
Control Outcomes (OMB Control No.
0920–1193)—Reinstatement with
Change—National Center for Chronic
Disease Prevention and Health
Promotion (NCCDPHP), Centers for
Disease Control and Prevention (CDC).

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Background and Brief Description
Cancer is the second leading cause of
death in the United States, and health
care costs for cancer care are expected
to rise to $158 billion by 2020.
Addressing this public health problem
requires primary prevention, early
detection and treatment, support for
cancer survivors, and a reduction in
health disparities. Providing support to
state, tribal, territorial and local
organizations to implement evidencebased strategies has the potential to
impact population-level cancer
outcomes and reduce the burden of
cancer.
The Centers for Disease Control and
Prevention’s (CDC) National
Comprehensive Cancer Control Program
(NCCCP) has been a primary funder for
state and community-based cancer
control interventions since its inception
in the late 1990s. The program supports
states and communities in developing a
comprehensive approach to cancer
prevention and control that includes
supporting an infrastructure for state,
local, and population-based
interventions and multi-sectoral
partnerships and coalitions. Currently,
NCCCP supports 66 cancer control
program grantees including programs in
all 50 states, the District of Columbia,
and in a number of tribes, tribal
organizations, and U.S. Associated
Pacific Islands/territories. In addition,
CDC’s Office on Smoking and Health
(OSH) also has worked to build state
health department infrastructure and
capacity to conduct coordinated
comprehensive tobacco prevention and
control activities which contribute to
cancer health outcomes.
In striving to build capacity and
maximize the impact of CDC’s funded
programs, CDC has focused on
developing and implementing
innovative programs to enhance TTA
delivered to NCCCP awardees. CDC
funds two awardees under a cooperative
agreement—Provision of Technical
Assistance and Training to Assure
Comprehensive Cancer Control
Outcomes (DP18–1805). DP18–1805
awardees are charged with developing
and delivering high-quality TTA for
NCCCP funded programs, coalition
members, and partners focused on
improving implementation of evidencebased strategies for cancer prevention
and control. The TTA activities DP18–
1805 awardees implement include; (1)
conducting needs assessments, (2)

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