Agency Forms Undergoing Paperwork Reduction Act Review, 30318-30320 [2021-11872]
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Federal Register / Vol. 86, No. 107 / Monday, June 7, 2021 / Notices
FEDERAL COMMUNICATIONS
COMMISSION
[OMB 3060–0188; FRS 30456]
Information Collection Being Reviewed
by the Federal Communications
Commission Under Delegated
Authority
Federal Communications
Commission.
ACTION: Notice and request for
comments.
AGENCY:
As part of its continuing effort
to reduce paperwork burdens, and as
required by the Paperwork Reduction
Act of 1995 (PRA), the Federal
Communications Commission (FCC or
Commission) invites the general public
and other Federal agencies to take this
opportunity to comment on the
following information collection(s).
Comments are requested concerning:
Whether the proposed collection of
information is necessary for the proper
performance of the functions of the
Commission, including whether the
information shall have practical utility;
the accuracy of the Commission’s
burden estimate; ways to enhance the
quality, utility, and clarity of the
information collected; ways to minimize
the burden of the collection of
information on the respondents,
including the use of automated
collection techniques or other forms of
information technology; and ways to
further reduce the information
collection burden on small business
concerns with fewer than 25 employees.
The FCC may not conduct or sponsor a
collection of information unless it
displays a currently valid Office of
Management and Budget (OMB) control
number. No person shall be subject to
any penalty for failing to comply with
a collection of information subject to the
PRA that does not display a valid OMB
control number.
DATES: Written comments should be
submitted on or before August 6, 2021.
If you anticipate that you will be
submitting comments but find it
difficult to do so within the period of
time allowed by this notice, you should
advise the contacts below as soon as
possible.
SUMMARY:
Direct all PRA comments to
Cathy Williams, FCC, via email to PRA@
fcc.gov and to Cathy.Williams@fcc.gov.
FOR FURTHER INFORMATION CONTACT: For
additional information about the
information collection, contact Cathy
Williams at (202) 418–2918.
SUPPLEMENTARY INFORMATION:
OMB Control Number: 3060–0188.
khammond on DSKJM1Z7X2PROD with NOTICES
ADDRESSES:
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Title: Call Sign Reservation and
Authorization System, FCC Form 380.
Form Number: FCC Form 380.
Type of Review: Extension of a
currently approved collection.
Respondents: Business or other forprofit, Not-for-profit institutions; and
State, local, or tribal government.
Number of Respondents and
Responses: 1,600 respondents; 1,600
responses.
Estimated Hours per Response: 0.166–
0.25 hours.
Frequency of Response: On occasion
reporting requirements.
Total Annual Burden: 333 hours.
Total Annual Cost: $162,000.
Obligation to Respond: Required to
obtain or retain benefits. The statutory
authority for this collection is contained
in Sections 154(i) and 303 of the
Communications Act of 1934, as
amended.
Nature and Extend of Confidentiality:
There is need for confidentiality with
this collection of information.
Privacy Impact Assessment: No
impact(s).
Needs and Uses: The information
collection requirements contained in 47
CFR 73.3550 provide that all requests
for new or modified call signs be made
via the on-line call sign reservation and
authorization. The Commission uses an
on-line system, FCC Form 380, for the
electronic preparation and submission
of requests for the reservation and
authorization of new and modified call
signs. Access to the call sign reservation
and authorization system is made by
broadcast licensees and permittees, or
by persons acting on their behalf, via the
internet’s World Wide Web. This online, electronic call sign system enables
users to determine the availability and
licensing status of call signs; to request
an initial, or change an existing, call
sign; and to determine and submit more
easily the appropriate fee, if any.
Because all elements necessary to make
a valid call sign reservation are
encompassed within the on-line system,
this system prevents users from filing
defective or incomplete call sign
requests. The electronic system also
provides greater certitude, as a selected
call sign is effectively reserved as soon
as the user has submitted its call sign
request. This electronic call sign
reservation and authorization system
has significantly improved service to all
radio and television broadcast station
licensees and permittees.
Federal Communications Commission.
Marlene Dortch,
Secretary, Office of the Secretary.
[FR Doc. 2021–11828 Filed 6–4–21; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–21–20PE]
Agency Forms Undergoing Paperwork
Reduction Act Review
In accordance with the Paperwork
Reduction Act of 1995, the Centers for
Disease Control and Prevention (CDC)
has submitted the information
collection request titled Operational
Readiness Review 2.0 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 June 23,
2020 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
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
E:\FR\FM\07JNN1.SGM
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Federal Register / Vol. 86, No. 107 / Monday, June 7, 2021 / Notices
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
Operational Readiness Review 2.0—
Existing Information Collection in Use
Without an OMB Control Number—
Center for Preparedness and Response
(CPR), Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
To help evaluate the country’s public
health emergency preparedness and
response capacity, the Centers for
Disease Control and Prevention’s
Division of State and Local Readiness
(DSLR) administers the Public Health
Emergency Preparedness (PHEP)
cooperative agreement. The PHEP
program is a critical source of funding
for 62 state, local, and territorial
jurisdictions, including four major
metropolitan areas (Chicago, Los
Angeles County, New York City, and
Washington, DC) to build and
strengthen their ability to respond to
and recover from public health
emergencies.
The Operational Readiness Review
(ORR) is a rigorous, evidence-based
assessment used to evaluate PHEP
recipients’ planning and operational
functions. The previous version of the
ORR evaluated a jurisdiction’s ability to
execute a large emergency response
requiring medical countermeasure
(MCM) distribution and dispensing. The
purpose of the new ORR 2.0 is to
expand measurement and evaluation to
all 15 Public Health Emergency
Preparedness and Response
Capabilities, which serve as national
standards for public health
preparedness planning. The capabilities
are: 1—Community Preparedness, 2—
Community Recovery, 3—Emergency
Operations Coordination, 4—Emergency
Public Information and Warning, 5—
Fatality Management, 6—Information
Sharing, 7—Mass Care, 8—Medical
Countermeasure Dispensing and
Administration, 9—Medical Materiel
Management and Distribution, 10—
Medical Surge, 11—Nonpharmaceutical
Intervention, 12—Public Health
Laboratory Testing, 13—Public Health
Surveillance and Epidemiological
Investigation, 14—Responder Safety and
Health, and 15—Volunteer
Management. These capabilities serve as
national standards for public health
preparedness planning.
The ORR 2.0 will have three modules:
Descriptive, planning, and operational,
which will allow DSLR to analyze the
data for the development of descriptive
statistics and to monitor the progress of
each recipient towards performance
goals. The four major metropolitan areas
have additional reporting requirements
that are incorporated into the
operational module. The intended
outcome of the ORR 2.0 is to assist CDC
in identifying strengths and challenges
facing preparedness programs across the
nation, and to identify opportunities for
improvement and further technical
support.
Information will be collected from
respondents using the new Operational
Readiness Review (ORR) 2.0 platform,
but a backup paper option is available
for jurisdictions that require it.
Information collected from respondents
is a requirement of the PHEP
Cooperative Agreement for participants
to receive funding. CDC requests a
three-year approval for this information
collection. The total annualized burden
estimate is 3,055 hours. There is no cost
to respondents other than their time.
ESTIMATED ANNUALIZED BURDEN HOURS
Form name
All PHEP Awardees: State, local, territorial, and metropolitan area jurisdictions.
Descriptive Module: Jurisdictional
structure sheet.
Critical contact sheet (CCS) ............
Jurisdictional data sheet (JDS) ........
Partner planning sheet ....................
Workforce development and training
Planning Module: Capability 1 .........
Capability 2 ......................................
Capability 3 ......................................
Capability 4 ......................................
Capability 5 ......................................
Capability 6 ......................................
Capability 7 ......................................
Capability 8 ......................................
Capability 9 ......................................
Capability 10 ....................................
Capability 11 ....................................
Capability 12 ....................................
Capability 13 ....................................
Capability 14 ....................................
Capability 15 ....................................
Operations Module: Ops 1 ..............
Ops 2 ...............................................
Tabletop exercise (TTX) ..................
Partner role (Par1) ...........................
Access and functional needs exercise accommodations or actions
(Par2).
Joint exercise with emergency management and health care coalitions (Par3).
All PHEP Awardees: State, local, territorial, and metropolitan area jurisdictions.
khammond on DSKJM1Z7X2PROD with NOTICES
Number of
respondents
Type of respondent
All PHEP Awardees: State, local, territorial, and metropolitan area jurisdictions.
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Number of
responses per
respondent
Avg. burden
per response
(in hours)
62
1
3
62
62
62
62
62
62
62
62
62
62
62
62
62
62
62
62
62
62
62
62
62
62
62
62
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
3
3
1
1
1
80/60
2.5
8
1.5
1
1
2
1.5
2.5
1
2
3
195/60
2
1.5
1.5
2.5
1.5
75/60
20/60
15/60
1.5
15/60
0.5
62
1
6/60
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Federal Register / Vol. 86, No. 107 / Monday, June 7, 2021 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Type of respondent
PHEP Awardees: Major Metropolitan Area Jurisdictions.
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2021–11872 Filed 6–4–21; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–P–2317]
Determination That QUELICIN
PRESERVATIVE FREE
(Succinylcholine Chloride) Injection, 20
Milligrams/Milliliter, 50 Milligrams/
Milliliter, and 100 Milligrams/Milliliter,
Was Not Withdrawn From Sale for
Reasons of Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) has
determined that QUELICIN
PRESERVATIVE FREE (succinylcholine
chloride) Injection, 20 milligrams (mg)/
milliliter (mL), 50 mg/mL, and 100 mg/
mL, was not withdrawn from sale for
reasons of safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for QUELICIN
PRESERVATIVE FREE (succinylcholine
chloride) Injection, 20 mg/mL, 50 mg/
mL, and 100 mg/mL, if all other legal
and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT:
Nikki Mueller, Center for Drug
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SUMMARY:
VerDate Sep<11>2014
17:36 Jun 04, 2021
Vaccination of critical workforce
(functional exercise, full-scale exercise, or incident).
Vaccination of critical workforce
(point of dispensing/dispensing/
vaccination clinic setup).
Vaccination of critical workforce (immunization information system).
Five-year distribution FSE OR fiveyear pandemic influenza full-scale
exercise.
Facility setup drill .............................
Site activation drill ............................
Staff notification and assembly drill
Dispensing throughput drill ..............
Five-year dispensing full-scale exercise or incident.
Five-year dispensing full-scale exercise for each point of dispensing
site exercised.
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6280,
Silver Spring, MD 20993–0002, 301–
796–3601, Nicole.Mueller@fda.hhs.gov.
In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products under an
ANDA procedure. ANDA applicants
must, with certain exceptions, show that
the drug for which they are seeking
approval contains the same active
ingredient in the same strength and
dosage form as the ‘‘listed drug,’’ which
is a version of the drug that was
previously approved. ANDA applicants
do not have to repeat the extensive
clinical testing otherwise necessary to
gain approval of a new drug application
(NDA).
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is known generally as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are removed from the list if the
Agency withdraws or suspends
approval of the drug’s NDA or ANDA
for reasons of safety or effectiveness or
if FDA determines that the listed drug
was withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
SUPPLEMENTARY INFORMATION:
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Number of
responses per
respondent
Number of
respondents
Form name
Avg. burden
per response
(in hours)
62
1
12/60
62
1
12/60
62
1
12/60
62
1
0.5
4
4
4
4
4
1
1
1
1
1
45/60
1
1
12/60
6/60
4
1
6/60
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
QUELICIN PRESERVATIVE FREE
(succinylcholine chloride) Injection, 20
mg/mL, 50 mg/mL, and 100 mg/mL, is
the subject of NDA 008845, held by
Hospira, Inc., and initially approved on
May 1, 1953. QUELICIN
PRESERVATIVE FREE is indicated as an
adjunct to general anesthesia, to
facilitate tracheal intubation, and to
provide skeletal muscle relaxation
during surgery or mechanical
ventilation.
Baxter Healthcare Corp. submitted a
citizen petition dated December 21,
2020 (Docket No. FDA–2020–P–2317),
under 21 CFR 10.30, requesting that the
Agency determine whether QUELICIN
PRESERVATIVE FREE (succinylcholine
chloride) Injection, 20 mg/mL, 50 mg/
mL, and 100 mg/mL, was withdrawn
from sale for reasons of safety or
effectiveness.
After considering the citizen petition
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that QUELICIN
PRESERVATIVE FREE (succinylcholine
chloride) Injection, 20 mg/mL, 50 mg/
mL, and 100 mg/mL, was not
withdrawn for reasons of safety or
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07JNN1
]]>Agencies
[Federal Register Volume 86, Number 107 (Monday, June 7, 2021)]
[Notices]
[Pages 30318-30320]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-11872]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-21-20PE]
Agency Forms Undergoing Paperwork Reduction Act Review
In accordance with the Paperwork Reduction Act of 1995, the Centers
for Disease Control and Prevention (CDC) has submitted the information
collection request titled Operational Readiness Review 2.0 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 June 23, 2020 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 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
[[Page 30319]]
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
Operational Readiness Review 2.0--Existing Information Collection
in Use Without an OMB Control Number--Center for Preparedness and
Response (CPR), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
To help evaluate the country's public health emergency preparedness
and response capacity, the Centers for Disease Control and Prevention's
Division of State and Local Readiness (DSLR) administers the Public
Health Emergency Preparedness (PHEP) cooperative agreement. The PHEP
program is a critical source of funding for 62 state, local, and
territorial jurisdictions, including four major metropolitan areas
(Chicago, Los Angeles County, New York City, and Washington, DC) to
build and strengthen their ability to respond to and recover from
public health emergencies.
The Operational Readiness Review (ORR) is a rigorous, evidence-
based assessment used to evaluate PHEP recipients' planning and
operational functions. The previous version of the ORR evaluated a
jurisdiction's ability to execute a large emergency response requiring
medical countermeasure (MCM) distribution and dispensing. The purpose
of the new ORR 2.0 is to expand measurement and evaluation to all 15
Public Health Emergency Preparedness and Response Capabilities, which
serve as national standards for public health preparedness planning.
The capabilities are: 1--Community Preparedness, 2--Community Recovery,
3--Emergency Operations Coordination, 4--Emergency Public Information
and Warning, 5--Fatality Management, 6--Information Sharing, 7--Mass
Care, 8--Medical Countermeasure Dispensing and Administration, 9--
Medical Materiel Management and Distribution, 10--Medical Surge, 11--
Nonpharmaceutical Intervention, 12--Public Health Laboratory Testing,
13--Public Health Surveillance and Epidemiological Investigation, 14--
Responder Safety and Health, and 15--Volunteer Management. These
capabilities serve as national standards for public health preparedness
planning.
The ORR 2.0 will have three modules: Descriptive, planning, and
operational, which will allow DSLR to analyze the data for the
development of descriptive statistics and to monitor the progress of
each recipient towards performance goals. The four major metropolitan
areas have additional reporting requirements that are incorporated into
the operational module. The intended outcome of the ORR 2.0 is to
assist CDC in identifying strengths and challenges facing preparedness
programs across the nation, and to identify opportunities for
improvement and further technical support.
Information will be collected from respondents using the new
Operational Readiness Review (ORR) 2.0 platform, but a backup paper
option is available for jurisdictions that require it. Information
collected from respondents is a requirement of the PHEP Cooperative
Agreement for participants to receive funding. CDC requests a three-
year approval for this information collection. The total annualized
burden estimate is 3,055 hours. There is no cost to respondents other
than their time.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Avg. burden
Type of respondent Form name Number of responses per per response
respondents respondent (in hours)
----------------------------------------------------------------------------------------------------------------
All PHEP Awardees: State, local, Descriptive Module: 62 1 3
territorial, and metropolitan area Jurisdictional
jurisdictions. structure sheet.
Critical contact sheet 62 1 80/60
(CCS).
Jurisdictional data 62 1 2.5
sheet (JDS).
Partner planning sheet.. 62 1 8
Workforce development 62 1 1.5
and training.
All PHEP Awardees: State, local, Planning Module: 62 1 1
territorial, and metropolitan area Capability 1. 62 1 1
jurisdictions. Capability 2............
Capability 3............ 62 1 2
Capability 4............ 62 1 1.5
Capability 5............ 62 1 2.5
Capability 6............ 62 1 1
Capability 7............ 62 1 2
Capability 8............ 62 1 3
Capability 9............ 62 1 195/60
Capability 10........... 62 1 2
Capability 11........... 62 1 1.5
Capability 12........... 62 1 1.5
Capability 13........... 62 1 2.5
Capability 14........... 62 1 1.5
Capability 15........... 62 1 75/60
All PHEP Awardees: State, local, Operations Module: Ops 1 62 3 20/60
territorial, and metropolitan area Ops 2................... 62 3 15/60
jurisdictions.
Tabletop exercise (TTX). 62 1 1.5
Partner role (Par1)..... 62 1 15/60
Access and functional 62 1 0.5
needs exercise
accommodations or
actions (Par2).
Joint exercise with 62 1 6/60
emergency management
and health care
coalitions (Par3).
[[Page 30320]]
Vaccination of critical 62 1 12/60
workforce (functional
exercise, full-scale
exercise, or incident).
Vaccination of critical 62 1 12/60
workforce (point of
dispensing/dispensing/
vaccination clinic
setup).
Vaccination of critical 62 1 12/60
workforce (immunization
information system).
Five-year distribution 62 1 0.5
FSE OR five-year
pandemic influenza full-
scale exercise.
PHEP Awardees: Major Metropolitan Area Facility setup drill.... 4 1 45/60
Jurisdictions. Site activation drill... 4 1 1
Staff notification and 4 1 1
assembly drill.
Dispensing throughput 4 1 12/60
drill.
Five-year dispensing 4 1 6/60
full-scale exercise or
incident.
Five-year dispensing 4 1 6/60
full-scale exercise for
each point of
dispensing site
exercised.
----------------------------------------------------------------------------------------------------------------
Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2021-11872 Filed 6-4-21; 8:45 am]
BILLING CODE 4163-18-P
