Agency Forms Undergoing Paperwork Reduction Act Review, 52579-52580 [2022-18441]
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52579
Federal Register / Vol. 87, No. 165 / Friday, August 26, 2022 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–22–0009]
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 ‘‘National
Disease Surveillance Program—I. Case
Reports’’ 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 May 23,
2022, 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
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 Disease Surveillance
Program—I. Case Reports (OMB Control
No. 0920–0009, Exp. 08/31/2022)—
Revision—National Center for Emerging
and Zoonotic Infectious Diseases
(NCEZID), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
Surveillance of the incidence and
distribution of disease has been an
important function of the US Public
Health Service (PHS) since an 1878 Act
of Congress authorized the PHS to
collect morbidity reports. After the
Malaria Control in War Areas Program
had fulfilled its original 1942 objective
of reducing malaria transmission, its
basic tenets were carried forward and
broadened by the formation of the
Communicable Disease Center (CDC) in
1946. CDC was conceived of as a wellequipped, broadly staffed agency used
to translate facts about analysis of
morbidity and mortality statistics on
communicable diseases and through
field investigations. It was soon
recognized that control measures (such
as the DDT spraying for malaria) did not
alleviate the threat of disease
reintroduction. In 1950, the Malaria
Surveillance Program began and in
1952, the National Surveillance Program
started. Both programs were based on
the premise that diseases cannot be
diagnosed, prevented, or controlled
until existing knowledge is expanded
and new ideas developed and
implemented. The original scope of the
National Surveillance Program included
the study of malaria, murine typhus,
smallpox, psittacosis, diphtheria,
leprosy, and sylvatic plague. Over the
years, the mandate of CDC has
broadened in preventive health
activities and the surveillance systems
maintained have expanded. This
program is authorized under the Public
Health Service Act, Section 301 and 306
(42 U.S.C. 241 and 242K).
This ICR covers surveillance activities
for four, rare diseases:
1. Creutzfeldt-Jakob Disease (CJD)
2. Reye Syndrome
3. Kawasaki Syndrome
4. Acute Flaccid Myelitis
CDC requests OMB approval for an
estimated 98 annual burden hours.
There is no cost to respondents other
than their time to participate.
lotter on DSK11XQN23PROD with NOTICES1
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
Form name
Epidemiologist .................................................
Creutzfeldt-Jakob Disease (CJD) ..................
Reye Syndrome .............................................
Kawasaki Syndrome ......................................
Acute Flaccid Myelitis ....................................
10
1
20
100
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2022–18441 Filed 8–25–22; 8:45 am]
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Number of
responses per
respondent
2
1
2
4
Average
burden
per response
(in hours)
20/60
20/60
15/60
12/60
52580
Federal Register / Vol. 87, No. 165 / Friday, August 26, 2022 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–0412]
Authorization and Revocations of
Emergency Use of Certain In Vitro
Diagnostic Devices for Detection and/
or Diagnosis of COVID–19; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
issuance of one, and revocation of three,
Emergency Use Authorizations (EUAs)
(the Authorizations) issued to STS Lab
Holdco (a subsidiary of Amazon.com
Services LLC) (‘‘STS’’). FDA issued one
Authorization under the Federal Food,
Drug, and Cosmetic Act (FD&C Act), as
requested by STS, for the Amazon RealTime RT–PCR DTC Test for Detecting
SARS–CoV–2. The Authorization
contains, among other things,
conditions on the emergency use of the
authorized product. The Authorization
follows the February 4, 2020,
determination by the Secretary of Health
and Human Services (HHS) that there is
a public health emergency that has a
significant potential to affect national
security or the health and security of
U.S. citizens living abroad, and that
involves the virus that causes COVID–
19, and the subsequent declaration on
February 4, 2020, that circumstances
exist justifying the authorization of
emergency use of in vitro diagnostics for
detection and/or diagnosis of the virus
that causes COVID–19, subject to the
terms of any authorization issued under
the FD&C Act. The Authorization,
which includes an explanation of the
reasons for issuance, is listed in this
document, and further information can
be accessed on FDA’s website from the
links indicated. FDA is also announcing
the subsequent revocation of the
Authorization issued to STS for the
Amazon Real-Time RT–PCR DTC Test
for Detecting SARS–CoV–2. In addition,
FDA is announcing the revocation of the
Authorizations issued to STS for the
Amazon Multi-Target SARS–CoV–2
Real-Time RT–PCR DTC Test and
Amazon Multi-Target SARS–CoV–2
Real-Time RT–PCR Test. FDA issued
and revoked the Authorizations under
the FD&C Act. The revocations, which
include an explanation of the reasons
for each revocation, are reprinted in this
document.
DATES: The Authorization for the
Amazon Real-Time RT–PCR DTC Test
for Detecting SARS–CoV–2 was effective
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
17:46 Aug 25, 2022
Jkt 256001
May 28, 2021. The revocations for the
Amazon Real-Time RT–PCR DTC Test
for Detecting SARS–CoV–2, Amazon
Multi-Target SARS–CoV–2 Real-Time
RT–PCR DTC Test, and Amazon MultiTarget SARS–CoV–2 Real-Time RT–PCR
Test are effective as of July 19, 2022.
ADDRESSES: Submit written requests for
a single copy of the Authorization or the
revocations to the Office of
Counterterrorism and Emerging Threats,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 1, Rm.
4338, Silver Spring, MD 20993–0002.
Send one self-addressed adhesive label
to assist that office in processing your
request or include a Fax number to
which the documents may be sent. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the documents.
FOR FURTHER INFORMATION CONTACT:
Jennifer J. Ross, Office of
Counterterrorism and Emerging Threats,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 1, Rm.
4332, Silver Spring, MD 20993–0002,
301–796–8510 (this is not a toll-free
number).
SUPPLEMENTARY INFORMATION:
I. Background
Section 564 of the FD&C Act (21
U.S.C. 360bbb–3) as amended by the
Project BioShield Act of 2004 (Pub. L.
108–276) and the Pandemic and AllHazards Preparedness Reauthorization
Act of 2013 (Pub. L. 113–5) allows FDA
to strengthen the public health
protections against biological, chemical,
nuclear, and radiological agents. With
this EUA authority, FDA can help
ensure that medical countermeasures
may be used in emergencies to diagnose,
treat, or prevent serious or lifethreatening diseases or conditions
caused by biological, chemical, nuclear,
or radiological agents when there are no
adequate, approved, and available
alternatives.
II. Criteria for EUA Authorization
Section 564(b)(1) of the FD&C Act
provides that, before an EUA may be
issued, the Secretary of HHS must
declare that circumstances exist
justifying the authorization based on
one of the following grounds: (1) a
determination by the Secretary of
Homeland Security that there is a
domestic emergency, or a significant
potential for a domestic emergency,
involving a heightened risk of attack
with a biological, chemical, radiological,
or nuclear agent or agents; (2) a
determination by the Secretary of
Defense that there is a military
emergency, or a significant potential for
a military emergency, involving a
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Fmt 4703
Sfmt 4703
heightened risk to U.S. military forces,
including personnel operating under the
authority of title 10 or title 50 of the
U.S. Code, of attack with (A) a
biological, chemical, radiological, or
nuclear agent or agents; or (B) an agent
or agents that may cause, or are
otherwise associated with, an
imminently life-threatening and specific
risk to U.S. military forces; 1 (3) a
determination by the Secretary of HHS
that there is a public health emergency,
or a significant potential for a public
health emergency, that affects, or has a
significant potential to affect, national
security or the health and security of
U.S. citizens living abroad, and that
involves a biological, chemical,
radiological, or nuclear agent or agents,
or a disease or condition that may be
attributable to such agent or agents; or
(4) the identification of a material threat
by the Secretary of Homeland Security
pursuant to section 319F–2 of the Public
Health Service (PHS) Act (42 U.S.C.
247d–6b) sufficient to affect national
security or the health and security of
U.S. citizens living abroad.
Once the Secretary of HHS has
declared that circumstances exist
justifying an authorization under
section 564 of the FD&C Act, FDA may
authorize the emergency use of a drug,
device, or biological product if the
Agency concludes that the statutory
criteria are satisfied. Under section
564(h)(1) of the FD&C Act, FDA is
required to publish in the Federal
Register a notice of each authorization,
and each termination or revocation of an
authorization, and an explanation of the
reasons for the action. Under section
564(h)(1) of the FD&C Act, revisions to
an authorization shall be made available
on the FDA website. Section 564 of the
FD&C Act permits FDA to authorize the
introduction into interstate commerce of
a drug, device, or biological product
intended for use when the Secretary of
HHS has declared that circumstances
exist justifying the authorization of
emergency use. Products appropriate for
emergency use may include products
and uses that are not approved, cleared,
or licensed under section 505, 510(k),
512, or 515 of the FD&C Act (21 U.S.C.
355, 360(k), 360b, or 360e) or section
351 of the PHS Act (42 U.S.C. 262), or
1 In the case of a determination by the Secretary
of Defense, the Secretary of HHS shall determine
within 45 calendar days of such determination,
whether to make a declaration under section
564(b)(1) of the FD&C Act, and, if appropriate, shall
promptly make such a declaration.
E:\FR\FM\26AUN1.SGM
26AUN1
]]>Agencies
[Federal Register Volume 87, Number 165 (Friday, August 26, 2022)]
[Notices]
[Pages 52579-52580]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-18441]
[[Page 52579]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-22-0009]
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 ``National Disease Surveillance Program--I.
Case Reports'' 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 May 23,
2022, 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 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 Disease Surveillance Program--I. Case Reports (OMB Control
No. 0920-0009, Exp. 08/31/2022)--Revision--National Center for Emerging
and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
Surveillance of the incidence and distribution of disease has been
an important function of the US Public Health Service (PHS) since an
1878 Act of Congress authorized the PHS to collect morbidity reports.
After the Malaria Control in War Areas Program had fulfilled its
original 1942 objective of reducing malaria transmission, its basic
tenets were carried forward and broadened by the formation of the
Communicable Disease Center (CDC) in 1946. CDC was conceived of as a
well-equipped, broadly staffed agency used to translate facts about
analysis of morbidity and mortality statistics on communicable diseases
and through field investigations. It was soon recognized that control
measures (such as the DDT spraying for malaria) did not alleviate the
threat of disease reintroduction. In 1950, the Malaria Surveillance
Program began and in 1952, the National Surveillance Program started.
Both programs were based on the premise that diseases cannot be
diagnosed, prevented, or controlled until existing knowledge is
expanded and new ideas developed and implemented. The original scope of
the National Surveillance Program included the study of malaria, murine
typhus, smallpox, psittacosis, diphtheria, leprosy, and sylvatic
plague. Over the years, the mandate of CDC has broadened in preventive
health activities and the surveillance systems maintained have
expanded. This program is authorized under the Public Health Service
Act, Section 301 and 306 (42 U.S.C. 241 and 242K).
This ICR covers surveillance activities for four, rare diseases:
1. Creutzfeldt-Jakob Disease (CJD)
2. Reye Syndrome
3. Kawasaki Syndrome
4. Acute Flaccid Myelitis
CDC requests OMB approval for an estimated 98 annual burden hours.
There is no cost to respondents other than their time to participate.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per
Type of respondents Form name respondents responses per response (in
respondent hours)
----------------------------------------------------------------------------------------------------------------
Epidemiologist........................ Creutzfeldt-Jakob 10 2 20/60
Disease (CJD).
Reye Syndrome........... 1 1 20/60
Kawasaki Syndrome....... 20 2 15/60
Acute Flaccid Myelitis.. 100 4 12/60
----------------------------------------------------------------------------------------------------------------
Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2022-18441 Filed 8-25-22; 8:45 am]
BILLING CODE 4163-18-P
