60 Day FRN

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Federal Register / Vol. 85, No. 65 / Friday, April 3, 2020 / Notices

from the American Medical Association
may be obtained and studied, as well as
frames that are not currently in use by
NAMCS, such as state and
organizational listings of other licensed
providers. (2) Within the National Study
of Long-Term Care Providers, additional
new frames may be sought and
evaluated and data items from home
care agencies, long-term care hospitals,
and facilities exclusively serving
individuals with intellectual/
developmental disability may be tested.
Similarly, data may be obtained from
lists compiled by states and other
organizations. Data about the facilities
as well as residents and their visits will
be investigated. (3) In the inpatient and
outpatient care settings, the National
Hospital Care Survey (NHCS) and the
National Hospital Ambulatory Medical
Care Survey (NHAMCS) may investigate
the addition of facility and patient
information especially as it relates to

insurance and electronic medical
records.
Projects under development or in the
planning stages include two projects
related to opioid use: One that will
investigate adding questions to NAMCS
on physician understanding of
guidelines for opioid use and one that
will test the validation of an algorithm
for identifying opioid-involved hospital
visits. Another study will develop a
Hospital-Based Victim Services Frame.
The National Health Care Surveys
collect critical, accurate data that are
used to produce reliable national
estimates—and in recent years (when
budget allows), state-level estimates—of
clinical services and of the providers
who delivered those services in
inpatient, outpatient, ambulatory, and
long-term care settings. The data from
these surveys are used by providers,
policy makers and researchers to
address important topics of interest,

including the quality and disparities of
care among populations, epidemiology
of medical conditions, diffusion of
technologies, effects of policies and
practice guidelines, and changes in
health care over time. Research studies
need to be conducted to improve
existing and proposed survey design
and procedures of the National Health
Care Surveys, as well as to evaluate
alternative data collection approaches
particularly due to the expansion of
electronic health record use, and to
develop new sample frames of currently
out-of-scope providers and settings of
care. There is no cost to respondents
other than their time to participate.
Average burdens are designed to cover
15–40 min interviews as well as 90minute focus groups, longer on-site
visits, and situations where
organizations may be preparing
electronic data files. The total estimated
annualized burden hours are 7,085.

TABLE 1—ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondents

Health Care Providers and Business entities
Health Care Providers, State/local government agencies, and business entities.

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2020–06947 Filed 4–2–20; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–20–0572; Docket No. CDC–2020–
0034]

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.

jbell on DSKJLSW7X2PROD with NOTICES

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

SUMMARY:

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17:45 Apr 02, 2020

Jkt 250001

Number of
respondents

Form name

Interviews, surveys,
ments (in person,
electronic mail).
Interviews, surveys,
ments (in person,
electronic mail).

6,667

1

1

focus groups, experiphone, internet, postal/

167

1

2.5

CDC must receive written
comments on or before June 2, 2020.

DATES:

You may submit comments,
identified by Docket No. CDC–20–0034
by any of the following methods:
• Federal eRulemaking Portal:
Regulations.gov. Follow the instructions
for submitting comments.

ADDRESSES:

Frm 00068

Average
burden per
response
(in hours)

focus groups, experiphone, internet, postal/

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 Possession, Use, and Transfer of
Select Agents and Toxins (42 CFR part
73). This information collection intends
to support the Public Health Safety and
Bioterrorism Preparedness and
Response Act of 2002 and ensure select
agents or toxins are managed
appropriately to prevent any threats to
human health or safety. Data will be
used to fulfill the requirements
promulgated by HHS under this part
and also subject to corresponding
regulations promulgated by USDA.

PO 00000

Number of
responses per
respondent

Fmt 4703

Sfmt 4703

• 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.
Please note: Submit all comments
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 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

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18981

Federal Register / Vol. 85, No. 65 / Friday, April 3, 2020 / Notices
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
Possession, Use, and Transfer of
Select Agents and Toxins (OMB Control
No. 0920–0576)—Revision—Center for
Preparedness and Response (CPR),
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). Accordingly, HHS and
USDA have promulgated regulations
requiring individuals or entities that
possess, use, or transfer select agents
and toxins to register with the CDC or
the Animal and Plant Health Inspection
Service (APHIS). See 42 CFR part 73, 7
CFR part 331, and 9 CFR part 121 (the
select agent regulations). The Federal
Select Agent Program (FSAP) is the
collaboration of the CDC, Division of
Select Agents and Toxins (DSAT) and
the APHIS Agriculture Select Agent
Services (AgSAS) to administer the
select agent regulations in a manner to
minimize the administrative burden on
persons subject to the select agent
regulations. The FSAP administers the
select agents regulations in close
coordination with the Federal Bureau of
Investigation’s Criminal Justice
Information Services (CJIS).
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
continue to collect information under
the select agent regulations through the
use of five forms: (1) Application for
Registration for Possession. Use, and
Transfer of Select Agents and Toxins
(APHIS/CDC Form 1); (2) Request to
Transfer Select Agents or Toxins
(APHIS/CDC Form 2); (3) Incident
Notification and Reporting (Theft, Loss,
or Release) (APHIS/CDC Form 3); (4)
Reporting the Identification of a Select
Agent or Toxin (APHIS/CDC Form 4);
and (5) Request for Exemption of Select
Agents and Toxins for an Investigational
Product (APHIS/CDC Form 5).
An entity may amend its registration
(42 CFR 73.7(h)(1)) if any changes occur

to the information previously submitted
to CDC. When applying for an
amendment to a certificate of
registration, an entity would complete
the relevant portion of the application
package (APHIS/CDC Form 1).
Besides the forms listed above, there
is no standard form for the following
information:
1. An individual or entity may request
an exclusion from the requirements of
the select agent regulations of an
attenuated strain of a select agent or a
select toxin modified to be less potent
or toxic. (42 CFR 73.3(e) and 73.4(e)).
2. Annual inspections that are
conducted by the entity must be
documented. (42 CFR 73.9(a)(6)).
3. An individual’s security risk
assessment may be expedited upon
written request by a Responsible Official
and a showing of good cause. (42 CFR
73.10(f)).
4. An individual or entity may request
approval to perform a ‘‘restricted
experiment’’ (42 CFR 73.13).
5. An individual or entity must
develop and implement a written
security plan, biosafety plan, and
incident response plan (42 CFR 73.11(a),
42 CFR 73.12(a), and 42 CFR 73.14(a)).
6. The Responsible Official at the
must ensure a record of the training for
each individual with access to select
agents and toxins and each escorted
individual is maintained (42 CFR
73.15(d)).
7. An individual or entity may appeal
a denial, revocation, or suspension of
registration. (42 CFR 73.20(a)).
8. An individual may appeal a denial,
limitation, or revocation of access
approval. (42 CFR 73.20(b)).
The total estimated annualized
burden for all data collection was
calculated using the 2018 Annual
Report of the Federal Select Agent
Program available at https://
www.selectagents.gov/
annualreport2018.html or FSAP IT
system and is estimated as 4465 hours.
Information will be collected through
FSAP IT system, fax, email and hard
copy mail from respondents. Upon OMB
approval, CDC will begin use of the
revised forms in October 2020 through
October 2023. There is no cost to the
respondents.

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ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Section

Form name

Sections 3 & 4 ......
Sections 5 & 6 ......
Sections 5 & 6 ......

Request for Exclusions ..............................................
Report of Identification of a Select Agent or Toxin ....
Request of Exemption ................................................

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Number of
responses per
respondent

1
1,181
1

E:\FR\FM\03APN1.SGM

1
1
1

03APN1

Average
burden per
response
(in hours)

Total burden
hours
1
1
1

1
1,181
1

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Federal Register / Vol. 85, No. 65 / Friday, April 3, 2020 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued

Section

Section
Section
Section
Section
Section
Section
Section
Section
Section
Section
Section
Section
Section

Number of
responses per
respondent

Average
burden per
response
(in hours)

Total burden
hours

7 ...............
7 ...............
9 ...............
10 .............
11 .............
12 .............
13 .............
14 .............
15 .............
16 .............
17 .............
19 .............
20 .............

Application for Registration ........................................
Amendment to a Certificate of Registration ...............
Documentation of self-inspection ...............................
Request for Expedited Review ...................................
Security Plan ..............................................................
Biosafety Plan ............................................................
Request Regarding a Restricted Experiment ............
Incident Response Plan .............................................
Training .......................................................................
Request to Transfer Select Agents and Toxins .........
Records ......................................................................
Notification of Theft, Loss, or Release .......................
Administrative Review ................................................

3
253
253
1
253
253
1
253
253
253
253
201
28

1
5
1
1
1
1
1
1
1
1
1
1
1

5
1
1
0.5
1
1
2
1
1
1.5
0.5
1
1

15
1,265
253
1
253
253
2
253
252
380
127
201
28

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

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

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

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

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

4465

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2020–06948 Filed 4–2–20; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–20–0995]

Agency Forms Undergoing Paperwork
Reduction Act Review

jbell on DSKJLSW7X2PROD with NOTICES

Number of
respondents

Form name

In accordance with the Paperwork
Reduction Act of 1995, the Centers for
Disease Control and Prevention (CDC)
has submitted the information
collection request titled ‘‘National
Network of Sexually Transmitted
Diseases Clinical Prevention Training
Centers’’ to the Office of Management
and Budget (OMB) for review and
approval. CDC previously published a
‘‘Proposed Data Collection Submitted
for Public Comment and
Recommendations’’ notice on November
4, 2019 to obtain comments from the
public and affected agencies. CDC did
not receive comments related to the
previous notice. This notice serves to
allow an additional 30 days for public
and affected agency comments.
CDC will accept all comments for this
proposed information collection project.
The Office of Management and Budget
is particularly interested in comments
that:
(a) Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including

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17:45 Apr 02, 2020

Jkt 250001

whether the information will have
practical utility;
(b) Evaluate the accuracy of the
agencies estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
(c) Enhance the quality, utility, and
clarity of the information to be
collected;
(d) 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 submission of
responses; and
(e) Assess information collection
costs.
To request additional information on
the proposed project or to obtain a copy
of the information collection plan and
instruments, call (404) 639–7570.
Comments and recommendations for the
proposed information collection should
be sent within 30 days of publication of
this notice to www.reginfo.gov/public/
do/PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function. Direct written
comments and/or suggestions regarding
the items contained in this notice to the
Attention: CDC Desk Officer, Office of
Management and Budget, 725 17th
Street NW, Washington, DC 20503 or by
fax to (202) 395–5806. Provide written
comments within 30 days of notice
publication.
Proposed Project
National Network of Sexually
Transmitted Diseases Clinical
Prevention Training Centers (OMB No.

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0920–0995, Expiration 05/31/2020)—
Extension—National Center for HIV/
AIDS, Viral Hepatitis, STD, and TB
Prevention (NCHHSTP), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
The Centers for Disease Control and
Prevention (CDC), Division of STD
Prevention requests an extension and
three-year approval of the currently
approved information collection request
that comprises the NNPTC Abbreviated
Health Professional Application for
Training (NNPTC Abbreviated HPAT).
This extension will allow the NNPTC
Abbreviated HPAT to continue to serve
as the official training application form
used for training activities conducted by
the Sexually Transmitted Disease (STD)
Prevention Training Centers’ (PTCs)
grantees funded by the (CDC). The PTCs
are funded by CDC/Division of STD
Prevention (DSTDP) to provide training
and capacity-building that includes
information, training, technical
assistance and technology transfer.
The PTCs offer classroom and
experiential training, web-based
training, clinical consultation, and
capacity building assistance to maintain
and enhance the capacity of health care
professionals to control and prevent
STDs and HIV. The NNPTC Abbreviated
HPAT is used to monitor and evaluate
performance and reach of grantees that
offer STD and HIV prevention training,
training assistance, and capacity
building assistance to physicians,
nurses, disease intervention specialists,
health educators, etc. During the
previously approved three-year period,
data was collected to monitor and
evaluate the performance of the NNTPC
grantees and the NNPTC program. This
data provided the NNPTC with

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