Research Determination

Print Date: 6/17/24

Title:

Import Permit Applications (42 CFR 71.54) (OMB Control No. 0920-0199)

Project Id:

0900f3eb823c2299

Accession #:

-ORR-6/12/24-c2299

Project Contact:

Albert D Garcia

Organization:

ORR

Status:

Project In Progress

Intended Use:

Project Determination

Estimated Start Date:

06/12/2024

Estimated Completion Date:

06/30/2034

CDC/ATSDR HRPO/IRB Protocol #:
0920-0199

OMB Control #:

Determinations
Determination

Justification

Completed

Entered By & Role

6/12/24

Garcia_Albert D. (asg9) CIO HSC

Not Research / Other
HSC:
Does NOT Require HRPO
Review

45 CFR 46.102(l)
Other - regulatory compliance

PRA:

PRA Applies

ICRO:
PRA Applies

OMB Approval date: 8/13/21
OMB Expiration date: 8/31/24

6/14/24

Garcia_Albert D. (asg9) OMB / PRA

6/17/24

Zirger_Jeffrey (wtj5) ICRO Reviewer

Description & Funding
Description
Priority:

Standard

Priority Justification:
CDC Priority Area for this Project:

Not selected

Determination Start Date:

06/12/24

Description:

Section 361 of the Public Health Service Act (42 U.S.C. 264), as amended, authorizes that the Secretary of Health and Human
Services (HHS) 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 Centers for Disease Control and
Prevention#s Import Permit Program (IPP) regulates the importation of infectious biological agents, infectious substances, and
vectors of human disease into the United States. Prior to issuing an import permit, IPP reviews all applications to ensure that
entities have appropriate safety measures in place for working safely with these imported materials.

IMS/CIO/Epi-Aid/Lab-Aid/Chemical Exposure
Submission:

No

IMS Activation Name:

Not selected

Submitted through IMS Clearance Matrix:

Not selected

Primary Scientific Priority:

Not selected

Secondary Scientific Priority (s):

Not selected

Task Force Responsible:

Not selected

CIO Emergency Response Name:

Not selected

Epi-Aid Name:

Not selected

Lab-Aid Name:

Not selected

Assessment of Chemical Exposure Name:

Not selected

Goals/Purpose

Objective:

The goal of the study is to support Section 361 of the Public Health Service (PHS) Act (42 U.S.C. 264) and prevents 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.
The Centers for Disease Control and Prevention#s Import Permit Program (IPP) regulates the importation of infectious biological
agents, infectious substances, and vectors of human disease into the United States. Prior to issuing an import permit, IPP reviews
all applications to ensure that entities have appropriate safety measures in place for working safely with these imported materials.

Does your project measure health disparities among No
populations/groups experiencing social, economic,
geographic, and/or environmental disadvantages?:
Does your project investigate underlying
contributors to health inequities among populations
/groups experiencing social, economic, geographic,
and/or environmental disadvantages?:

No

Does your project propose, implement, or evaluate
an action to move towards eliminating health
inequities?:

No

Activities or Tasks:

New Collection of Information, Data, or Biospecimens

Target Populations to be Included/Represented:

General US Population

Tags/Keywords:

Biological Control Agents

CDC's Role:

Activity originated and designed by CDC staff, or conducted at the specific request of CDC, or CDC staff will approve study design
and data collection as a condition of any funding provided

Method Categories:

Survey

Methods:

# The subpopulation to be studied are those academic institutions and biomedical centers, commercial manufacturing facilities,
federal, state, and local laboratories, including clinical and diagnostic laboratories, research facilities, exhibition facilities, and
educational facilities to request a permit for the importation, and any subsequent distribution after importation, of biological agents,
infectious substances, or vectors of human disease. The subpopulation are those 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.

Collection of Info, Data or Biospecimen:

# The method used to collect data/information is an electronic data collection system that uses electronic forms, which are available
on the Centers for Disease Control and Prevention#s Import Permit website at https://www.cdc.gov/cpr/ipp/applications/index.htm.

Expected Use of Findings/Results and their impact:

# The intended use of the study is to fulfill the requirements promulgated by Health and Human Services under 42 CFR 71.54.

Could Individuals potentially be identified based on
Information Collected?

Yes

Will PII be captured (including coded data)?

Yes

Does CDC have access to the identifiers (including
coded data)?:

Yes

Is this project covered by an Assurance of

No

Confidentiality?
Does this activity meet the criteria for a Certificate
of Confidentiality (CoC)?

No

Is there a formal written agreement prohibiting the
release of identifiers?

No

Funding

Funding yet to be added .....

HSC Review

HSC Attributes
Other - regulatory compliance

Yes

Regulation and Policy
Do you anticipate this project will need IRB review
by the CDC IRB, NIOSH IRB, or through reliance on
an external IRB?

No

Estimated number of study participants

Population - Children

Protocol Page #:

Population - Minors

Protocol Page #:

Population - Prisoners

Protocol Page #:

Population - Pregnant Women

Protocol Page #:

Population - Emancipated Minors

Protocol Page #:

Suggested level of risk to subjects
Do you anticipate this project will be exempt
research or non-exempt research

Requested consent process waviers
Informed consent for adults

No Selection

Children capable of providing assent

No Selection

Parental permission

No Selection

Alteration of authorization under HIPAA Privacy
Rule

No Selection

Requested Waivers of Documentation of Informed Consent
Informed consent for adults

No Selection

Children capable of providing assent

No Selection

Parental permission

No Selection

Consent process shown in an understandable language
Reading level has been estimated

No Selection

Comprehension tool is provided

No Selection

Short form is provided

No Selection

Translation planned or performed

No Selection

Certified translation / translator

No Selection

Translation and back-translation to/from target
language(s)

No Selection

Other method

No Selection

Clinical Trial
Involves human participants

No Selection

Assigned to an intervention

No Selection

Evaluate the effect of the intervention

No Selection

Evaluation of a health related biomedical or
behavioral outcome

No Selection

Registerable clinical trial

No Selection

Other Considerations
Exception is requested to PHS informing those
bested about HIV serostatus

No Selection

Human genetic testing is planned now or in the
future

No Selection

Involves long-term storage of identfiable biological
specimens

No Selection

Involves a drug, biologic, or device

No Selection

Conducted under an Investigational New Drug
exemption or Investigational Device Exemption

No Selection

Institutions & Staff
Institutions

Will you be working with an outside Organization or Institution? No
Institutions yet to be added .....

Staff
Staff
Member

SIQT Exp.
Date

CITI Biomedical
Exp. Date

CITI Social & Behavioral
Exp. Date

Albert
Garcia

07/18/2025

10/31/2021

09/15/2026

Data

CITI Good Clinical Practice
Exp. Date

Staff Role

Email

Phone

Organization

CoInvestigator

asg9@cdc.
gov

404-6397139

OFFICE OF READINESS AND
RESPONSE

DMP
Proposed Data Collection Start Date:

6/12/24

Proposed Data Collection End Date:

6/30/34

Proposed Public Access Level:

Non-Public

Non-Public Details:
Reason For Not Releasing Data:

Other - No utility outside federal gov

Public Access Justification:

Data is for internal use only to fulfill the requirements promulgated by Health and Human Services under 42 CFR 71.54. The data
has no utility for the public

How Access Will Be Provided for Data:

Access will not be provided to the public.

Plans for Archival and Long Term Preservation:

The information is kept in a database which consists of permitted entities importing or subsequently transferring biological agents,
infectious substances and vectors of human disease. This database is safeguarded; paper records are kept in locked files.
Electronic data files are password protected and stored in a restricted access location. Only a small number of staff within DRSC
has access to the information, and disclosure of information is stringently limited. To comply with the Office of Management and
Budget (OMB) Memoranda (M) 07-16, Safe-guarding Against and Responding to the Breach of Personally Identifiable Information,
the at-tached Federal Register notice was published on August 27, 2020 for the System of Record No-tice entitled, ##Electronic
Import Permit Program Portal (eIPP Portal)#

Spatiality

Spatiality (Geographic Locations) yet to be added .....

Dataset
Dataset
Title

Dataset
Description

Dataset yet to be added...

Supporting Info

Data Publisher
/Owner

Public Access
Level

Public Access
Justification

External
Access URL

Download
URL

Type of Data
Released

Collection
Start Date

Collection End
Date

Supporting Info
Current

CDC Staff
Member and
Role
Zirger_Jeffrey
(wtj5)
ICRO Reviewer

Date Added

Description

Supporting Info Type

Supporting Info

06/17/2024

NOA 0920-0199 (2024)

Notice of Action

NOA 0920-0199_2021.pdf