Federal Register Notice

56616

Federal Register / Vol. 85, No. 178 / Monday, September 14, 2020 / Notices

(NCEH), Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
The CDC is requesting a three-year
Paperwork Reduction Act (PRA)
clearance for a Revision to an
information collection request (ICR) for
a research program focused on
identifying the environmental causes of
foodborne illness and improving
environmental public health practice.
This research program is conducted by
the Environmental Health Specialists
Network (EHS-Net), a collaborative
project of the CDC, U.S. Food and Drug
Administration (FDA), U.S. Department
of Agriculture (USDA), and eight state
and local public health programs
(California; Tennessee; Minnesota;
Rhode Island; New York; New York
City, NY; Southern Nevada Health
District, NV; and Harris County, TX).
This ICR aims to assess whether an
educational intervention will result in

Although approved in 2018, NCEH
and its program partners needed to
prioritize other data collections over
this study, and then had to delay the
current study due to the COVID–19
pandemic. NCEH partners provided
feedback to refine this research protocol,
revise the ICR, and plan to begin this
study in 2021. NCEH is requesting
approval for revisions which fall into
three categories: (1) Changes to comply
with the 2018 Revised Common Rule
and 21st Century Cures Act; (2) changes
to strengthen the study, based on recent
experience and stakeholder feedback;
and (3) changes to respond to the
COVID–19 pandemic.
NCEH is requesting a revised PRA
clearance for 715 responses per year and
for a time burden of 206 hours per year.
These changes result in a decrease of
1,412 responses and 146 hours per year
relative to the 2018 PRA clearance.
There is no cost to the respondents
other than their time.

either the development or enhancement
of restaurant ill worker policies. This
will be accomplished by interviewing
restaurant managers, surveying workers,
and observing restaurant practices in
320 randomly selected and assigned
restaurants in the EHS-Net catchment
area. Burden hours would be associated
with the restaurant staff for the time to
answer questions about their restaurant.
There would be two to three site visits
depending upon which group the
restaurants were assigned to, that is, the
intervention or the control group. An
initial visit will be used to observe
baseline conditions and to provide the
intervention only to the restaurants
selected to receive it. A second visit will
be used to determine if the policies had
changed and to introduce the
intervention to the control restaurants
(if it is deemed successful), and a final
follow up visit to the control restaurants
that received the intervention on the
second visit.

ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent

Number of
respondents

Total burden
(in hr)

Form name

Restaurant Managers (Intervention
Restaurants).
Manager Informed Consent and
Interview Form.
Restaurant Managers (Control Restaurants).
Manager Informed Consent and
Interview Form.
Health Department Workers (Intervention Restaurants).
Health Department Workers (Control
Restaurants).

Manager Recruiting Script ...............

119

1

3/60

53 .....................................................

2

20/60

35

Manager Recruiting Script ...............

119

1

3/60

53 .....................................................

3

20/60

53

Restaurant Environment Observation Form.
Restaurant Environment Observation Form.

53

2

30/60

53

53

2

30/60

53

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

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

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

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

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

206

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2020–20215 Filed 9–11–20; 8:45 am]

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–20–1080; Docket No. CDC–2020–
0098]

BILLING CODE 4163–18–P

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:
khammond on DSKJM1Z7X2PROD with NOTICES

Average
burden per
response
(in hr)

Type of respondent

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:

VerDate Sep<11>2014

17:51 Sep 11, 2020

Jkt 250001

PO 00000

Frm 00045

Fmt 4703

Sfmt 4703

6

6

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 HIV Outpatient Study (HOPS).
The Centers for Disease Control and
Prevention is requesting a three-year
extension to the previously approved
project to continue collecting
standardized HIV clinical and
behavioral data at private HIV care
practices and university based U.S.
clinics participating in the HOPS.
CDC must receive written
comments on or before November 13,
2020.

DATES:

E:\FR\FM\14SEN1.SGM

14SEN1

Federal Register / Vol. 85, No. 178 / Monday, September 14, 2020 / Notices
You may submit comments,
identified by Docket No. CDC–2020–
0098 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.
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:
404–639–7118; 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

khammond on DSKJM1Z7X2PROD with NOTICES

ADDRESSES:

VerDate Sep<11>2014

17:51 Sep 11, 2020

Jkt 250001

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
HIV Outpatient Study (HOPS) (OMB
Control No. 0920–1080, Exp. 09/30/
2021)—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 requests a three-year
approval for the HIV Outpatient Study
data collection activity. The HIV
Outpatient Study (HOPS) is a
prospective longitudinal cohort of HIVinfected outpatients at eight well
established private HIV care practices
and university-based U.S. clinics, in
Tampa, Florida; Washington, DC; Stony
Brook, New York; Chicago, Illinois;
Denver, Colorado; and Philadelphia,
Pennsylvania. Clinical data are
abstracted on an ongoing basis from the
medical records of adult HIV-infected
HOPS study participants, who also
complete an optional telephone/Webbased behavioral assessment as part of
their annual clinic visit, which on
average takes about seven minutes.
Before enrolling in this study, all
potential study participants will
undergo an informed consent process
(including signing of a written informed
consent) which is estimated to take 15
minutes.
The core areas of HOPS research
extending through the present HIV
treatment era include; (i) monitoring
death rates and causes of death, (ii)
characterizing the optimal patient
management strategies to reduce HIV
related morbidity and mortality (e.g.,
effectiveness of antiretroviral therapies
and other clinical interventions), (iii)
monitoring of sexual and drug use
behaviors to inform Prevention with
Positives, and (iv) investigating
disparities in the HIV care continuum
by various demographic factors.
In recent years, the HOPS has been
instrumental in bringing attention to
emerging issues in chronic HIV
infection with actionable opportunities
for prevention, including cardiovascular
disease, fragility fractures, renal and
hepatic disease, and cancers. The HOPS

PO 00000

Frm 00046

Fmt 4703

Sfmt 4703

56617

remains an important source for
multiyear trend data concerning
conditions and behaviors for which data
are not readily available elsewhere,
including: rates of opportunistic
illnesses, rates of comorbid conditions
(e.g., hypertension, obesity, diabetes)
and antiretroviral drug resistance.
Data will be collected through
medical record abstraction by trained
abstractors and by telephone or internet
based, computer-assisted interviews at
eight funded study sites in six U.S.
cities. Collection of data abstracted from
patient medical records provides data in
five general categories: Demographics
and risk behaviors for HIV infection;
symptoms; diagnosed conditions
(definitive and presumptive);
medications prescribed (including dose,
duration, and reasons for stopping); all
laboratory values, including CD4+ Tlymphocyte (CD4+) cell counts, plasma
HIV–RNA determinations, and
genotype, phenotype, and trophile
results. Data on visit frequency, AIDS,
and death are acquired from the clinic
chart. Data collected using a brief
Telephone Audio-Computer Assisted
Self-Interview (T–ACASI) survey or an
identical Web-based Audio-Computer
Assisted Self-Interview (ACASI)
include: Age, sex at birth, use of alcohol
and drugs, cigarette smoking, adherence
to antiretroviral medications, types of
sexual intercourse, condom use, and
disclosure of HIV status to partners.
We anticipate that 450 new HOPS
study participants will be recruited
annually into the HOPS from a pool of
HIV-infected individuals currently in
HIV-care at the nine aforementioned
clinics (50 patients per site). Patients are
approached during one of their routine
clinic visits to participate in the HOPS.
Patients interested in participating in
the HOPS are given detailed information
about the nature of the study and
provided with written informed consent
that must be completed prior to
enrollment. The 450 newly enrolled
participants each year will be added to
the database of existing participants
such that approximately 2,500
participants will be seen in the HOPS
each year. Medical record abstractions
will be completed on all HOPS
participants and impose no direct
burden on HOPS study participants.
Participation of respondents is
voluntary. There is no cost to the
respondents other than their time.

E:\FR\FM\14SEN1.SGM

14SEN1

56618

Federal Register / Vol. 85, No. 178 / Monday, September 14, 2020 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Form name

HOPS study Patients ........................
HOPS Study Patients .......................

Behavioral survey .............................
Consent form ....................................

2,500
450

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

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

405

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2020–20214 Filed 9–11–20; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Board of Scientific Counselors, Center
for Preparedness and Response
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice of meeting.
AGENCY:

In accordance with the
Federal Advisory Committee Act, the
CDC announces the following meeting
for the Board of Scientific Counselors,
Center for Preparedness and Response,
(BSC, CPR). This is a virtual meeting
that is open to the public, limited only
by the number of net conference access
available, which is 500. Pre-registration
is required by accessing the link at
https://cdc.zoomgov.com/webinar/
register/WN_bV_
Jrvp4QZGHZFao0moqPg.
DATES: The meeting will be held on
October 26, 2020, from 12:30 p.m. to
3:30 p.m., EDT.
ADDRESSES: Zoom Virtual Meeting. If
you wish to attend the virtual meeting,
please pre-register by accessing the link
at https://cdc.zoomgov.com/webinar/
register/WN_bV_
Jrvp4QZGHZFao0moqPg.
Instructions to access the Zoom
virtual meeting will be provided in the
link following registration.
FOR FURTHER INFORMATION CONTACT:
Dometa Ouisley, Office of Science and
Public Health Practice, Centers for
Disease Control and Prevention, 1600
Clifton Road NE, Mailstop-H21–6,
Atlanta, Georgia 30329–4027,
Telephone: (404) 639–7450; Facsimile:
(404) 471–8772; Email:
[email protected].
SUPPLEMENTARY INFORMATION:
SUMMARY:

khammond on DSKJM1Z7X2PROD with NOTICES

Number of
respondents

Type of respondent

VerDate Sep<11>2014

17:51 Sep 11, 2020

Jkt 250001

Purpose: This Board is charged with
providing advice and guidance to the
Secretary, Department of Health and
Human Services (HHS), the Assistant
Secretary for Health (ASH), the Director,
Centers for Disease Control and
Prevention (CDC), and the Director,
Center for Preparedness and Response
(CPR), concerning strategies and goals
for the programs and research within
CPR, monitoring the overall strategic
direction and focus of the CPR Divisions
and Offices, and administration and
oversight of peer review for CPR
scientific programs. For additional
information about the Board, please
visit: https://www.cdc.gov/cpr/bsc/
index.htm.
Matters To Be Considered: The agenda
will include discussions on updates
from the CPR Director and Division
Directors, CPR Strategic Planning and
Science Agenda, and CPR BSC Polio
Containment Workgroup (PCWG)
Updates. Agenda items are subject to
change as priorities dictate.
The Director, Strategic Business
Initiatives Unit, Office of the Chief
Operating Officer, Centers for Disease
Control and Prevention, has been
delegated the authority to sign Federal
Register notices pertaining to
announcements of meetings and other
committee management activities, for
both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Kalwant Smagh,
Director, Strategic Business Initiatives Unit,
Office of the Chief Operating Officer, Centers
for Disease Control and Prevention.
[FR Doc. 2020–20187 Filed 9–11–20; 8:45 am]
BILLING CODE 4163–18–P

PO 00000

Number of
responses per
respondent
1
1

Average
burden per
response
(in hr)

Total
burden
(in hr)

7/60
15/60

292
113

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
A National Elastomeric Half Mask
Respirator (EHMR) Strategy for Use in
Healthcare Settings During an
Infectious Disease Outbreak/Pandemic
National Institute for
Occupational Safety and Health
(NIOSH) of the Centers for Disease
Control and Prevention (CDC),
Department of Health and Human
Services (HHS).
ACTION: Request for information and
comment.
AGENCY:

The National Institute for
Occupational Safety and Health
(NIOSH) of the Centers for Disease
Control and Prevention (CDC), within
the Department of Health and Human
Services (HHS), announces this request
for information regarding the
deployment and use of elastomeric halfmask respirators in healthcare settings
and emergency medical services (EMS)
organizations during the COVID–19
crisis.
DATES: Comments must be received
October 14, 2020.
ADDRESSES: Responses should be
submitted to Dr. Lee Greenawald,
NIOSH, 626 Cochrans Mill Road,
Building 141, Pittsburgh, PA 15236, or
[email protected].
FOR FURTHER INFORMATION CONTACT: Lee
Greenawald, NIOSH, 626 Cochrans Mill
Road, Building 141, Pittsburgh, PA
15236; phone: (412) 386–6465 (not a
toll-free number, email: ppeconcerns@
cdc.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:

Public Participation
Informational submissions in
response to this request for information
(RFI) are due no later than October 14,
2020. Please limit informational
submissions for each of the two sections
to five pages or less (for a total of 10
pages or less).
NIOSH will not respond to individual
informational submissions or publish

Frm 00047

Fmt 4703

Sfmt 4703

E:\FR\FM\14SEN1.SGM

14SEN1