60-day Federal Register Notice

Attachment 2a - 2024-02173-0920-0199-60-DayFRRevision.pdf

[CPR] Import Permit Applications (42 CFR 71.54)

60-day Federal Register Notice

OMB: 0920-0199

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Federal Register / Vol. 89, No. 24 / Monday, February 5, 2024 / Notices

understand needed improvements in
these systems.
The NHSS would classify HIV
infections as Stage 0 if the first positive
HIV test were within six months of a
negative HIV test. Persons who received
a diagnosis at Stage 0 (i.e., early
diagnosis) could access HIV testing
shortly after infection yet could not
benefit from biomedical and behavioral
interventions to prevent HIV infection.
The federal Ending the HIV Epidemic in
the U.S. (EHE) initiative prioritizes the
provision of HIV preexposure
prophylaxis (PrEP), syringe services
programs, treatment as prevention
efforts, and other proven
interventions—as part of the Prevent
pillar of the EHE initiative—to prevent
new HIV infections.
HIV infections are classified as Stage
3 (AIDS) by the presence of an AIDSdefining opportunistic infection or by
the lowest CD4 lymphocyte test result.
Persons with Stage 3 infection at the
time of their initial HIV diagnosis (i.e.,

late diagnosis) did not benefit from
timely receipt of testing or HIV
prevention interventions. They were
likely unaware of their infection for a
substantial length of time.
Nationally, an estimated 13.3% of
persons with HIV are unaware of their
infection, contributing to an estimated
40% of all ongoing transmission.
Increasing early diagnosis is a crucial
pillar of efforts to end HIV in the United
States. Given the continued occurrence
of HIV infections in the United States,
the barriers and gaps associated with
low uptake of HIV testing and
prevention services must be addressed
to reduce new infections and facilitate
timely diagnosis and treatment.
Individual- and systems-level factors
likely contribute to barriers and gaps in
testing and prevention. Therefore, CDC
is sponsoring this data collection to
improve understanding of barriers and
gaps associated with new infection and
late diagnosis in the era of multiple
testing modalities and prevention

options such as PrEP. These enhanced
surveillance activities will identify
actionable missed opportunities for
early diagnosis and prevention, thus
informing allocation of resources,
development and prioritization of
interventions, and evidence-based local
and national decisions to improve HIV
testing and address prevention gaps.
The changes proposed in this request
add a new qualitative data collection
activity that encompasses a new consent
form and a new data collection tool (Indepth Interview Guide) to conduct
qualitative interviews to meet prevailing
information needs and enhance the
value of SHIELD data and minor edits
to the approved SHIELD survey while
remaining within the scope of the
currently approved project purpose. The
annualized burden hours of the project
increased by 158 hours with these
additions, for a total of 3,074 annualized
burden hours. There are no costs to
respondents other than time.

ESTIMATED ANNUALIZED BURDEN HOURS
Form name

Potential Eligible Participant ...................
Potential Eligible Participant ...................
Eligible Participant ..................................
Eligible Participant ..................................
Eligible Participant ..................................
Eligible Participant ..................................
Eligible Participant ..................................
Eligible Participant ..................................
Eligible Participant ..................................
Eligible Participant ..................................

Recruitment Script English .....................................
Recruitment Script Spanish ....................................
Consent for quantitative survey—English ..............
Consent—Spanish ..................................................
Survey—English .....................................................
Survey—Spanish ....................................................
Consent for qualitative interview—English .............
Consent for qualitative interview—Spanish ............
In-depth Interview—English ....................................
In-depth Interview—Spanish ...................................

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Public Health Ethics and
Regulations, Office of Science, Centers for
Disease Control and Prevention.
[FR Doc. 2024–02172 Filed 2–2–24; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–24–0199; Docket No. CDC–2024–
0008]
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Number of
respondents

Type of respondent

Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).

AGENCY:

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ACTION:

Notice with comment period.

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
general public and other federal
agencies the opportunity to comment on
a continuing information collection, as
required by the Paperwork Reduction
Act of 1995. This notice invites
comment on a proposed information
collection project titled Import Permit.
The goal of the information collection is
to support the Public Health Service
(PHS) Act and prevent the introduction,
transmission, or spread of
communicable diseases from foreign
countries into the States or possessions,
or from one State or possession into any
other State or possession.

SUMMARY:

CDC must receive written
comments on or before April 5, 2024.

DATES:

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2,000
500
2,000
500
2,000
500
50
50
50
50

Number of
responses per
respondent
1
1
1
1
1
1
1
1
1
1

Average
burden per
response
(in hours)
15/60
15/60
5/60
5/60
50/60
50/60
5/60
5/60
90/60
90/60

You may submit comments,
identified by Docket No. CDC–2024–
0008 by either of the following methods:
• Federal eRulemaking Portal:
www.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 H21–8, Atlanta,
Georgia 30329.
Instructions: All submissions received
must include the agency name and
Docket Number. CDC will post, without
change, all relevant comments to
www.regulations.gov.
Please note: Submit all comments
through the Federal eRulemaking portal
(www.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
ADDRESSES:

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Federal Register / Vol. 89, No. 24 / Monday, February 5, 2024 / Notices
instruments, contact Jeffrey M. Zirger,
Information Collection Review Office,
Centers for Disease Control and
Prevention, 1600 Clifton Road NE, MS
H21–8, Atlanta, Georgia 30329;
Telephone: 404–639–7570; Email: omb@
cdc.gov.
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;
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; and
5. Assess information collection costs.

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Proposed Project
Import Permit Applicatons (42 CFR
71.54) (OMB Control No. 0920–0199,
Exp. 8/31/2024)—Revision—Office of
Readiness and Response (ORR), Centers
for Disease Control and Prevention
(CDC).

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Background and Brief Description
Section 361 of the Public Health
Service Act (42 U.S.C. 264), as
amended, authorizes the Secretary of
Health and Human Services to make
and enforce such regulations as are
necessary to prevent the introduction,
transmission, or spread of
communicable diseases from foreign
countries into the States or possessions,
or from one State or possession into any
other State or possession. Part 71 of
Title 42, Code of Federal Regulations
(Foreign Quarantine) sets forth
provisions to prevent the introduction,
transmission, and spread of
communicable disease from foreign
countries into the United States.
Subpart F—Importations—contains
provisions for the importation of
infectious biological agents, infectious
substances, and vectors (42 CFR 71.54);
requiring persons that import these
materials to obtain a permit issued by
the CDC. The Application for Permit to
Import Biological Agents, Infectious
Substances and Vectors of Human
Disease into the United States form is
used by laboratory facilities, such as
those operated by government agencies,
universities, and research institutions to
request a permit for the importation of
biological agents, infectious substances,
or vectors of human disease. This form
currently requests applicant and sender
contact information; description of
material for importation; facility
isolation and containment information;
and personnel qualifications. Based on
questions we have received from prior
applicants, CDC is proposing to reduce
open text questions and replace them
with more streamlined check boxes. The
goal is that this will clarify what is
being asked of applicants and will
increase efficiency and speed of
processing by reducing back and forth
communication necessary to clarify to
applicants.
The Application for Permit to Import
or Transport Live Bats form is used by
laboratory facilities such as those
operated by government agencies,
universities, research institutions, and
for educational, exhibition, or scientific
purposes to request a permit for the
importation, and any subsequent
distribution after importation, of live
bats. This form currently requests the
applicant and sender contact

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7713

information; a description and intended
use of bats to be imported; and facility
isolation and containment information.
CDC does not plan to revise this
application.
The Application for Permit to Import
Infectious Human Remains into the
United States is used by facilities that
will bury/cremate the imported cadaver
and educational facilities to request a
permit for the importation and
subsequent transfers throughout the
U.S. of human remains or body parts
that contains biological agents,
infectious substances, or vectors of
human disease. This form will request
applicant and sender contact
information; facility processing human
remains; cause of death; biosafety and
containment information; and final
destination(s) of imported infectious
human remains. CDC does not plan to
revise this application.
The Importer Certification Statement
is a new form and will be used as an
attestation by an importer stating that
they are importing only noninfectious
biological agent(s) or biological
substance(s). The noninfectious,
imported agent or substance must be
accompanied by an importer
certification statement confirming that
the material is not known to contain or
suspected of containing an infectious
biological agent or has been rendered
noninfectious. This form requests a
detailed description of the material,
statements affirming that the material is
not known or suspected to contain an
infectious biological agent, and one of
the following: (1) How the person
knows that the material does not
contain an infectious biological agent;
(2) Why there is no reason to suspect
that the material contains an infectious
biological agent; or (3) A detailed
description of how the material was
rendered noninfectious.
Annualized burden hours were
calculated based on data obtained from
CDC import permit database on the
number of permits issued on annual
basis since 2015, which is 2,000
respondents. The total estimated burden
for the data collection is 2,097. There is
an increase in burden from 1,097 hours
to 2,097 hours which reflects the new,
proposed form (Importer Certification
Statement), to this project.

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Federal Register / Vol. 89, No. 24 / Monday, February 5, 2024 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent

Application for Permit to Import Biological Agents, Infectious Substances and
Vectors of Human Disease into the
United States.
Application for Permit to Import Biological Agents, Infectious Substances and
Vectors of Human Disease into the
United States Subsequent Transfer.
Application for a Permit to Import Live
Bats.
Application for Permit to Import Infectious Human Remains into the United
States.
Importer Certification Statement .............

2,000

1

30/60

1,000

380

1

10/60

63

3

1

20/60

1

100

1

20/60

33

2,000

1

30/60

1,000

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

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

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

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

2,097

Form name

Applicants Requesting to Import Biological Agents, Infectious Substances and
Vectors.
Applicants Requesting to Import Biological Agents, Infectious Substances and
Vectors.
Applicants Requesting to Import Live
Bats.
Applicants Requesting to Import Infectious Human Remains into the United
States.
Importers of Non-infectious Materials to
the United States.
Total ..................................................

Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Public Health Ethics and
Regulations, Office of Science, Centers for
Disease Control and Prevention.
[FR Doc. 2024–02173 Filed 2–2–24; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Lead Exposure and Prevention
Advisory Committee (LEPAC); Notice
of Charter Renewal
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice of charter renewal.
AGENCY:

This gives notice under the
Federal Advisory Committee Act of
October 6, 1972, that the Lead Exposure
and Prevention Advisory Committee
(LEPAC), Centers for Disease Control
and Prevention, Department of Health
and Human Services, has been renewed
for a 2-year period through January 17,
2026.
FOR FURTHER INFORMATION CONTACT: Paul
Allwood, Ph.D., MPH, Designated
Federal Officer, National Center for
Environmental Health, Centers for
Disease Control and Prevention,
Department of Health and Human
Services, 1600 Clifton Road NE, MS
S106–5, Atlanta, Georgia 30329–4018.
Telephone (770) 488–6774; PAllwood@
cdc.gov.

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SUMMARY:

CDC is
providing notice under 5 U.S.C. 1001–

SUPPLEMENTARY INFORMATION:

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Average
burden per
response
(in hours)

Number of
respondents

Type of respondents

1014 of the renewal of the charter of the
Lead Exposure and Prevention Advisory
Committee, Centers for Disease Control
and Prevention, Department of Health
and Human Services. This charter has
been renewed for a two-year period
through January 17, 2026.
The Director, Office of Strategic
Business Initiatives, 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, Office of Strategic Business
Initiatives, Office of the Chief Operating
Officer, Centers for Disease Control and
Prevention.
[FR Doc. 2024–02179 Filed 2–2–24; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[Docket No. CDC–2024–0009; NIOSH–278]

Meeting of the Board of Scientific
Counselors, National Institute for
Occupational Safety and Health
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice of meeting and request
for comment.
AGENCY:

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Total
burden
(in hours)

In accordance with the
Federal Advisory Committee Act, the
Centers for Disease Control and
Prevention (CDC) announces the
following meeting of the Board of
Scientific Counselors, National Institute
for Occupational Safety and Health
(BSC, NIOSH). This is a virtual meeting.
It is open to the public, limited only by
the number of web conference lines (500
lines are available). Time will be
available for public comment.
DATES: The meeting will be held on
March 13, 2024, from 10 a.m. to 3:30
p.m., EDT.
Written comments must be received
on or before March 6, 2024.
ADDRESSES: If you wish to attend the
meeting, please register at the NIOSH
website at https://www.cdc.gov/niosh/
bsc/ or by telephone at (202) 245–0649
no later than March 6, 2024.
You may submit comments, identified
by Docket No. CDC–2024–0009;
NIOSH–278, by either of the methods
listed below. CDC does not accept
comments by email.
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
• Mail: Ms. Sherri Diana, NIOSH
Docket Office, National Institute for
Occupational Safety and Health, 1090
Tusculum Avenue, Mailstop C–34,
Cincinnati, Ohio 45226. Attn: Docket
No. CDC–2024–0009; NIOSH–278.
Instructions: All submissions received
must include the Agency name and
docket number. Docket number CDC–
2024–0009; NIOSH–278 will close
March 6, 2024.
FOR FURTHER INFORMATION CONTACT:
Maria Strickland, M.P.H., Designated
Federal Officer, Board of Scientific
SUMMARY:

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