60 day FRN

11296

Federal Register / Vol. 86, No. 35 / Wednesday, February 24, 2021 / Notices
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.

FOR FURTHER INFORMATION CONTACT:

Theresa Kingsberry (202–326–3100),
Program Support Specialist, Federal
Trade Commission Premerger
Notification Office, Bureau of
Competition, Room CC–5301,
Washington, DC 20024.
By direction of the Commission.
Joel Christie,
Acting Secretary.
[FR Doc. 2021–03751 Filed 2–23–21; 8:45 am]

Kalwant Smagh,
Director, Strategic Business Initiatives Unit,
Office of the Chief Operating Officer, Centers
for Disease Control and Prevention.

BILLING CODE P

[FR Doc. 2021–03744 Filed 2–23–21; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

Centers for Disease Control and
Prevention

Agency for Toxic Substances and
Disease Registry

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Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended, and the Determination of
the Director, Strategic Business
Initiatives Unit, Office of the Chief
Operating Officer, CDC, pursuant to
Public Law 92–463. The grant
applications and the discussions could
disclose confidential trade secrets or
commercial property such as patentable
material, and personal information
concerning individuals associated with
the grant applications, the disclosure of
which would constitute a clearly
unwarranted invasion of personal
privacy.
Name of Committee: Disease,
Disability, and Injury Prevention and
Control Special Emphasis Panel (SEP)—
CE21–002: Research Grants to Develop
or Identify Effective Strategies to
Prevent Overdose Involving Illicit
Stimulants and Polysubstance Use
Involving Stimulants.
Dates: June 15–16, 2021.
Times: 8:30 a.m.–5:00 p.m., EDT.
Place: Videoconference.
Agenda: To review and evaluate grant
applications.
FOR FURTHER INFORMATION CONTACT:
Mikel Walters, Ph.D., Scientific Review
Officer, National Center for Injury
Prevention and Control, CDC, 4770
Buford Highway NE, Mailstop F–63,
Atlanta, Georgia 30341, Telephone (404)
639–0913, [email protected].
The Director, Strategic Business
Initiatives Unit, Office of the Chief
Operating Officer, Centers for Disease
Control and Prevention, has been

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[60Day–20–0051; Docket No. ATSDR–2020–
0005]

Proposed Data Collection Submitted
for Public Comment and
Recommendations
Agency for Toxic Substances
and Disease Registry (ATSDR),
Department of Health and Human
Services (HHS).
ACTION: Notice with comment period.
AGENCY:

The Agency for Toxic
Substances and Disease Registry
(ATSDR), 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
Chemical Exposures (ACE)
Investigations.’’ The purpose of ACE
Investigations is to focus on performing
rapid epidemiological assessments to
assist state, regional, local, or tribal
health departments (the requesting
agencies) to respond to or prepare for
acute environmental incidents.
DATES: ATSDR must receive written
comments on or before April 26, 2021.
ADDRESSES: You may submit comments,
identified by Docket No. ATSDR–2020–
0005 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
SUMMARY:

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Docket Number. ATSDR 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.

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
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:

Proposed Project
Assessment of Chemical Exposures
(ACE) Investigations (OMB Control No.
0923–0051)—Reinstatement with

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Federal Register / Vol. 86, No. 35 / Wednesday, February 24, 2021 / Notices

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Change—Agency for Toxic Substances
and Disease Registry (ATSDR).
Background and Brief Description
The Agency for Toxic Substances and
Disease Registry (ATSDR) is requesting
a three-year Paperwork Reduction Act
(PRA) clearance for the Revision of
‘‘Assessment of Chemical Exposures
(ACE) Investigations’’ information
collection request (ICR) (OMB Control
No. 0923–0051; Expiration Date 03/31/
2021). ATSDR conducts ACE
Investigations to assist state and local
health departments after acute
environmental incidents.
ATSDR has successfully completed
five investigations to date using this
valuable mechanism. ATSDR would like
to continue these impactful information
collections. A brief summary of recent
information collections approved under
this tool includes the following:
• During 2015, in U.S. Virgin Islands
there was a methyl bromide exposure
incident at a condominium resort
severely injuring a family and causing
symptoms in the first responders to the
incident. ATSDR interviewed all
potentially exposed persons who stayed
or worked at the resort to look for signs
of exposure. Under this ACE
investigation, ATSDR raised awareness
among pest control companies that
methyl bromide is currently prohibited
in homes and other residential settings.
Additionally, ATSDR raised awareness
among clinicians about the toxicologic
syndrome caused by exposure to methyl
bromide and the importance of notifying
first responders immediately when they
have encountered contaminated
patients.
• During 2016, the ACE Team
conducted a rash investigation in Flint,
Michigan. Persons who were exposed to
Flint municipal water and had current
or worsening rashes were surveyed and
referred to free dermatologist screening
if desired. Findings revealed that when
the city was using water from the Flint
River, there were large swings in
chorine, pH, and hardness, which could
be one possible explanation for the
eczema-related rashes.
• During 2016, the ACE Team also
conducted a follow-up investigation for
people who were referred to a
dermatologist in the first Flint
investigation. The follow-up interviews
resulted in improvements in medical
exam and referral processes that were
still on-going at the time.
The ACE Investigations have focused
on performing rapid epidemiological
assessments to assist state, regional,
local, or tribal health departments (the
requesting agencies) to respond to or
prepare for acute chemical releases.

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The main objectives for performing
these rapid assessments are to:
• Characterize exposure and acute
health effects of the affected community
to inform health officials and the
community;
• Identify needs (i.e., medical, mental
health, and basic) of those exposed
during the incidents to aid in planning
interventions in the community;
• Determine the sequence of events
responsible for the incident so that
actions can be taken to prevent future
incidents;
• Assess the impact of the incidents
on the emergency response and health
services use and share lessons learned
for use in hospital, local, and state
planning for environmental incidents;
and
• Identify cohorts that may be
followed and assessed for persistent
health effects resulting from
environmental releases.
Because each incident is different, it
is not possible to predict in advance
exactly what type of, and how many
respondents will be consented and
interviewed to effectively evaluate the
incident. Respondents typically include,
but are not limited to, emergency
responders such as police, fire,
hazardous material technicians,
emergency medical services, and
personnel at hospitals where patients
from the incident were treated.
Incidents may occur at businesses or in
the community setting; therefore,
respondents may also include business
owners, managers, workers, customers,
community residents, and those passing
through the affected area.
The multidisciplinary ACE Team
consisting of staff from ATSDR, the
Centers for Disease Control and
Prevention (CDC), and the requesting
agencies will be collecting data. ATSDR
has developed a quickly tailored series
of draft survey forms used in the field
to collect data that will meet the goals
of the investigation. ATSDR collections
will be administered based on time
permitted and urgency. For example, it
is preferable to administer the General
Survey to as many respondents as
possible. However, if there are time
constraints, the shorter Household
Survey or the former ACE Short Form,
now modified as the Epidemiologic
Contact Assessment Symptom Exposure
(Epi CASE) Survey, may be
administered instead. The individual
surveys collect information about
exposure, acute health effects, health
services use, medical history, needs
resulting from the incident,
communication during the release,
health impact on children, and
demographic data. Hospital personnel

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11297

are asked about the surge, response and
communication, decontamination, and
lessons learned.
Depending on the situation, data
collected by face-to-face interviews,
telephone interviews, written surveys,
mailed surveys, or on-line surveys can
be collected. Medical charts may also be
considered for review. In rare situations,
an investigation might involve
collection of clinical specimens.
ATSDR is proposing to increase the
utility of this Generic ICR in response to
stakeholder requests. We would like to
expand the ACE toolkit to be more
inclusive of other types of
environmental incidents affecting the
community and which fall under
ATSDR’s mandate and, at times, the
mandates of our partners in the CDC’s
National Center for Environmental
Health (NCEH) and the National Center
for Occupational Safety and Health
(NIOSH). In addition to acute chemical
releases, we propose to include
radiological and nuclear incidents,
explosions, natural disasters, and other
environmental incidents.
We propose revisions to select
information collection forms, which
will be deployed using handheld
devices whenever possible to reduce
burden, and to adjust the number of
responses and time per response for
several forms. A new brief Eligibility
Screener (900 responses per year; 30
hours) will be added prior to
administering consent for our surveys.
The Epi CASE Survey, formerly the ACE
Short Form, has been modified for the
expanded scope of eligible incidents
requested (1,000 responses per year; 250
hours). To reduce time burden, there
will be new field data entry screens and
deletion of unused questions for the
General Survey (800 responses per year;
333 hours), the Household Survey (120
responses per year; 20 hours) and for the
Hospital Survey (40 responses per year;
17 hours). We are retaining the Medical
Chart Abstraction Form (250 responses
per year; 125 hours) but are removing
the Veterinary Chart Abstraction Form
as it has not been used in the past.
ATSDR anticipates up to four ACE
investigations per year. We are
requesting approval for 3,110 annual
responses (increase of 1,820 responses
per year) and for 775 annual hours
(increase of 184 hours per year).
Participation in ACE investigations is
voluntary and there are no anticipated
costs to respondents other than their
time.

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11298

Federal Register / Vol. 86, No. 35 / Wednesday, February 24, 2021 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent

Number of
respondents

Total
burden
(in hr)

Form name

Residents, first responders, business
owners, employees, customers.

Eligibility Screener ............................
Epi CASE Survey .............................
General Survey ................................
Household Survey ............................
Hospital Survey ................................
Medical Chart Abstraction Form ......

900
1,000
800
120
40
25

1
1
1
1
1
10

2/60
15/60
25/60
10/60
25/60
30/60

30
250
333
20
17
125

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

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

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

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

775

Residents ..........................................
Hospital staff .....................................
Staff from state, local, or tribal health
agencies.
Total ...........................................

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2021–03703 Filed 2–23–21; 8:45 am]
BILLING CODE 4163–18–P

received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
Electronic Submissions

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0672]

Agency Information Collection
Activities; Proposed Collection;
Comment Request; Prominent and
Conspicuous Mark of Manufacturers
on Single-Use Devices
AGENCY:

Food and Drug Administration,

HHS.
ACTION:

Notice.

The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on reprocessed,
single-use device labeling.
DATES: Submit either electronic or
written comments on the collection of
information by April 26, 2021.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before April 26,
2021. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of April 26, 2021. Comments
SUMMARY:

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Average
burden per
response
(in hr)

Type of respondent

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Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and

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identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2011–N–0672 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Prominent and Conspicuous Mark of
Manufacturers on Single-Use Devices.’’
Received comments, those filed in a
timely manner (see ADDRESSES), will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://

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