SORN Publication

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the aggregation and analysis of patient
safety events.
The Patient Safety Act authorizes the
listing of PSOs, which are entities or
component organizations whose
mission and primary activity are to
conduct activities to improve patient
safety and the quality of health care
delivery. HHS issued the Patient Safety
Rule to implement the Patient Safety
Act. AHRQ administers the provisions
of the Patient Safety Act and Patient
Safety Rule relating to the listing and
operation of PSOs. The Patient Safety
Rule authorizes AHRQ to list as a PSO
an entity that attests that it meets the
statutory and regulatory requirements
for listing. A PSO can be ‘‘delisted’’ if
it is found to no longer meet the
requirements of the Patient Safety Act
and Patient Safety Rule, when a PSO
chooses to voluntarily relinquish its
status as a PSO for any reason, or when
a PSO’s listing expires. Section 3.108(d)
of the Patient Safety Rule requires
AHRQ to provide public notice when it
removes an organization from the list of
PSOs.
AHRQ has accepted a notification of
proposed voluntary relinquishment
from the Institute for Safe Medication
Practices (ISMP) to voluntarily
relinquish its status as a PSO.
Accordingly, the Institute for Safe
Medication Practices (ISMP), P0009,
was delisted effective at 12:00 Midnight
ET (2400) on August 17, 2020. Institute
for Safe Medication Practices (ISMP) has
patient safety work product (PSWP) in
its possession. The PSO will meet the
requirements of section 3.108(c)(2)(i) of
the Patient Safety Rule regarding
notification to providers that have
reported to the PSO and of section
3.108(c)(2)(ii) regarding disposition of
PSWP consistent with section
3.108(b)(3). According to section
3.108(b)(3) of the Patient Safety Rule,
the PSO has 90 days from the effective
date of delisting and revocation to
complete the disposition of PSWP that
is currently in the PSO’s possession.
More information on PSOs can be
obtained through AHRQ’s PSO website
at http://www.pso.ahrq.gov.

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[Docket No. CDC–2020–0088]

Privacy Act of 1974; System of
Records
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice of a new system of
records.
AGENCY:

Virginia L. Mackay-Smith,
Associate Director.

In accordance with the
requirements of the Privacy Act of 1974,
as amended, the Department of Health
and Human Services (HHS) is
establishing a new system of records to
be maintained by the Centers for Disease
Control and Prevention, 09–20–0180,
‘‘Electronic Import Permit Program
Portal (eIPP Portal).’’ The system of
records will be used by CDC to monitor
the importation of infectious biological
agents, infectious substances, and
vectors of human disease.
DATES: The modified system of records
is applicable August 27, 2020, subject to
a 30-day period in which to comment
on the routine uses. Written comments
must be received on or before
September 28, 2020.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2020–
0088 by any of the following methods:
• Federal eRulemaking Portal: http://
www.regulations.gov. Follow the
instructions for submitting comments.
• Mail: Beverly Walker, Chief Privacy
Officer, CDC Privacy Unit,
CyberSecurity Program Office (CSPO),
Centers for Disease Control and
Prevention, 4770 Buford Hwy., Mailstop
S101, Atlanta, GA 30341.
Instructions: All submissions received
must include the agency name and
Docket Number. All relevant comments
received will be posted without change
to https://regulations.gov, including any
personal information provided.
Therefore, do not include any
information in your comment or
supporting materials that you consider
confidential or inappropriate for public
disclosure. For access to the docket to
read background documents or
comments received, go to https://
www.regulations.gov.

[FR Doc. 2020–18877 Filed 8–26–20; 8:45 am]

FOR FURTHER INFORMATION CONTACT:

BILLING CODE 4160–90–P

Beverly Walker, Chief Privacy Officer,
CDC Privacy Unit, CyberSecurity
Program Office (CSPO), Centers for
Disease Control and Prevention, 4770
Buford Hwy., Mailstop S101, Atlanta,
GA 30341. Telephone: 770–488–8524.

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SUMMARY:

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SUPPLEMENTARY INFORMATION:

I. Background on the CDC Import
Permit Program
Under the authority of Section 361 of
the Public Health Service Act (PHS Act)
(42 U.S.C. 264), the HHS Secretary
makes and enforces such regulations as
in his/her judgment are necessary to
prevent the introduction, transmission,
or spread of communicable diseases
from foreign countries into the U.S.
states or territories. For purposes of
carrying out and enforcing such
regulations, the HHS Secretary may
authorize a variety of public health
measures, including inspection,
fumigation, disinfection, sanitation, pest
extermination, destruction of animals or
articles found to be sources of
dangerous infection to human beings,
and other measures. The Foreign
Quarantine regulations (42 CFR part 71)
set forth provisions to prevent the
introduction, transmission, and spread
of communicable disease from foreign
countries into the United States. Part 71,
Subpart F (Importations) contains
provisions governing the importation of
infectious biological agents, infectious
substances, and vectors (42 CFR 71.54),
including requiring persons to obtain a
permit issued by the CDC before
importing, or distributing after import,
any of these materials. The purpose of
the import permit requirement and
permitting process is to prevent the
introduction, transmission, or spread of
communicable diseases from foreign
countries into the U.S. states or
territories. Before issuing an import
permit, the CDC Division of Select
Agents and Toxins, Import Permit
Program (CDC/IPP) reviews the
application to ensure the applicant has
appropriate safety measures in place for
importing and working safely with the
applicable infectious biological agent(s),
substance(s), and/or vector(s).
Regulations of the U.S. Department of
Transportation apply to such materials
while in transit in the U.S. states and
territories.
II. New System of Records 09–20–0180
The proposed new system of records,
‘‘Electronic Import Permit Program
Portal (eIPP Portal),’’ will cover records
about individual applicants, which the
CDC/IPP maintains in the new eIPP
Portal information technology (IT)
system for the purpose of overseeing—
and issuing permits allowing—the
importation of infectious biological
agents, infectious substances, and
vectors of human disease as outlined in
the import permit regulations at 42 CFR
71.54. The eIPP Portal IT system is a
single web-based information

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management system that will track
permit applications submitted to and
permits issued by CDC/IPP. It will allow
the regulated community to submit the
applications and engage in related
information exchanges with CDC/IPP
electronically via a single web portal.
This will enable the regulated
community to interact with CDC/IPP
more efficiently, allow for faster
processing of permit applications, and
reduce program burdens and reliance on
labor-intensive and paper-based
processes.
A report on the new system of records
was sent to Congress and OMB in
accordance with 5 U.S.C. 552a(r).
Dated: August 21, 2020.
Suzi Connor,
Chief Information Officer, Centers for Disease
Control and Prevention.
SYSTEM NAME AND NUMBER:

Electronic Import Permit Program
Portal (eIPP Portal), 09–20–0180.
SECURITY CLASSIFICATION:

Unclassified.
SYSTEM LOCATION:

The address of the HHS component
responsible for this system of records is:
Division of Select Agents and Toxins
(DSAT), Center for Preparedness and
Response, Centers for Disease Control
and Prevention (CDC), 1600 Clifton Rd.
NE, Atlanta, GA 30329.
SYSTEM MANAGER(S):

The System Manager is: Director,
Division of Select Agents and Toxins
(DSAT), Center for Preparedness and
Response, MS A–46, CDC, 1600 Clifton
Rd. NE, Atlanta, GA 30329, (404) 718–
2000, [email protected].
AUTHORITY FOR MAINTENANCE OF THE SYSTEM:

Public Health Service Act, Section
361, ‘‘Regulations to Control
Communicable Diseases’’ (42 U.S.C.
264).

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The purpose of this system of records
is to support CDC/IPP’s oversight of,
and permitting process for, the
importation and any subsequent
distribution of infectious biological
agents, infectious substances, and
vectors of human disease into the
United States, the purpose of which is
to prevent the introduction,
transmission, or spread of
communicable diseases from foreign
countries into the states or possessions.
CATEGORIES OF INDIVIDUALS COVERED BY THE
SYSTEM:

The records in the system will cover
those individuals who apply for an

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CATEGORIES OF RECORDS IN THE SYSTEM:

The system of records will include the
following categories of records. The
three applications are forms approved
by the Office of Management and
Budget (OMB).
• Application for Permit to Import
Biological Agents and Vectors of Human
Disease into the United States. An
applicant submits this application to
CDC/IPP to request a permit for the
importation, and any subsequent
distribution after importation, of
infectious biological agents, infectious
substances, or vectors of human disease.
• Application for Permit to Import or
Transfer Live Bats. An applicant
submits this application to CDC/IPP to
request a permit for the importation,
and any subsequent distribution after
importation, of live bats.
• Application for Permit to Import
Infectious Human Remains into the
United States. An applicant submits this
application to CDC/IPP to request a
permit for the importation of human
remains or body parts that contain
biological agents, infectious substances,
or vectors of human disease.
• Import Permit. CDC/IPP issues a
permit on an approved application,
allowing the applicant to import
biological agents and vectors of human
disease human remains or body parts
that contain biological agents, infectious
substances, or vectors of human disease
or live bats.
• Documentation of Inspection. CDC/
IPP may inspect an applicant’s or
importer’s premises to ensure
compliance with the import permit
regulations. As part of the inspection
process, the applicant may need to
respond to written requests from DSAT.
DSAT has not developed standardized
forms for this documentation.
RECORD SOURCE CATEGORIES:

PURPOSE(S) OF THE SYSTEM:

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import permit from CDC/IPP under 42
CFR 71.54.

The applicant will be the source of
most information in the records. CDC/
IPP will be the source of certain
information in the permits, tracking
records, and inspection records.
ROUTINE USES OF RECORDS MAINTAINED IN THE
SYSTEM, INCLUDING CATEGORIES OF USERS AND
PURPOSES OF SUCH USES:

In addition to other disclosures
authorized directly in the Privacy Act at
5 U.S.C. 552a(b)(1) and (2) and (4)
through (11), HHS may disclose records
about a subject individual from this
system of records to parties outside HHS
as described in these routine uses,
without the individual’s prior written
consent.

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1. Records may be disclosed to
contractors engaged to assist CDC/IPP
with performing the functions listed in
the Purpose section above. Contractors
are required to maintain Privacy Act
safeguards with respect to such records.
2. Records may be disclosed to state
health departments, other public health
agencies, cooperating medical
authorities, or federal law enforcement
agencies to effectively manage outbreaks
and conditions of public health
significance.
3. Information may be disclosed to the
Department of Justice (DOJ) or to a court
or other adjudicative body in litigation
or other proceedings when:
a. HHS or any of its component
thereof, or
b. any employee of HHS acting in the
employee’s official capacity, or
c. any employee of HHS acting in the
employee’s individual capacity where
the DOJ or HHS has agreed to represent
the employee, or
d. the United States Government, is a
party to the proceeding or has an
interest in such proceeding and, by
careful review, HHS determines that the
records are both relevant and necessary
to the proceeding.
4. Disclosure may be made to a
congressional office from the record of
an individual in response to a verified
inquiry from the congressional office
made at the written request of that
individual.
5. Where a record, either alone or in
conjunction with other information,
indicates a violation or potential
violation of law, whether civil, criminal,
or regulatory in nature, and whether
arising by general statute or by
regulation, rule, or order issued
pursuant thereto, the relevant records in
the system of records may be referred,
as a routine use, to agency concerned,
whether federal, state, Tribal, local,
territorial, or foreign, charged with the
responsibility of investigating or
prosecuting such violation or charged
with enforcing or implementing the
statute, rule, regulation, or order issued
pursuant thereto.
6. For the purpose of combatting
fraud, waste, and abuse, records may be
disclosed to a relevant federal agency or
instrumentality of any governmental
jurisdiction within or under the control
of the United States for the purpose of
investigating potential fraud, waste, or
abuse.
7. Records may be disclosed to
representatives of the National Archives
and Records Administration (NARA) in
records management inspections
conducted pursuant to 44 U.S.C. 2904
and 2906.

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8. Records may be disclosed to
appropriate agencies, entities, and
persons when (1) HHS suspects or has
confirmed that there has been a breach
of the system of records, (2) HHS has
determined that as a result of the
suspected or confirmed breach there is
a risk of harm to individuals, HHS
(including its information systems,
programs, and operations), the federal
government, or national security, and
(3) the disclosure made to such
agencies, entities, and persons is
reasonably necessary to assist in
connection with HHS’s efforts to
respond to the suspected or confirmed
breach or to prevent, minimize, or
remedy such harm.
9. Records may be disclosed to
another federal agency or federal entity,
when HHS determines that information
from this system of records is
reasonably necessary to assist the
recipient agency or entity in (1)
responding to a suspected or confirmed
breach or (2) preventing, minimizing, or
remedying the risk of harm to
individuals, the recipient agency or
entity (including its information
systems, programs, and operations), the
federal government, or national security,
resulting from a suspected or confirmed
breach.
POLICIES AND PRACTICES FOR STORAGE OF
RECORDS:

The records will be maintained
electronically, but paper printouts may
be generated.
POLICIES AND PRACTICES FOR RETRIEVAL OF
RECORDS:

The records will be retrieved by the
applicant’s name or assigned permit
number.

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POLICIES AND PRACTICES FOR RETENTION AND
DISPOSAL OF RECORDS:

The records will be retained for 10
years in compliance with the records
retention schedule requirements, or
until such time as the records are no
longer needed for litigation or other
records purposes, in accordance with
CDC/IPP disposition schedule DAA–
0441–2019–0001. Records will be
transferred to a Federal Records Center
for storage when no longer in active use.
Final disposition of records stored
offsite at the Federal Records Center
will be accomplished by a controlled
process requesting final disposition
approval from the HHS record owner
prior to any destruction to ensure the
records are not needed for litigation or
other records purposes.

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ADMINISTRATIVE, TECHNICAL, AND PHYSICAL
SAFEGUARDS:

Safeguards will conform to the HHS
Information Security and Privacy
Program, https://www.hhs.gov/ocio/
securityprivacy/index.html, the HHS
Information Security and Privacy Policy
(IS2P), and applicable federal laws,
rules and policies, including: The EGovernment Act of 2002, which
includes the Federal Information
Security Management Act of 2002
(FISMA), 44 U.S.C. 3541–3549, as
amended by the Federal Information
Security Modernization Act of 2014, 44
U.S.C. 3551–3558; all pertinent National
Institutes of Standards and Technology
(NIST) publications; and OMB Circular
A–130, Managing Information as a
Strategic Resource.
ADMINISTRATIVE AND TECHNICAL SAFEGUARDS:

• Security measures will be
implemented on government computers
to control unauthorized access to the
system. Attempts to gain access by
unauthorized individuals will be
automatically recorded and reviewed by
IPP on a regular basis. The individuals
permitted to access these records will be
limited to staff (FTEs and contractors
having security clearances at T3 (NonCritical Sensitive positions requiring
Secret clearance) or T4 (Non-Sensitive
High Risk (Public Trust)) levels) who
have responsibility for conducting
regulatory oversight.
• Protection for computerized records
will include programmed verification of
valid user identification code and
password prior to logging on to the
system; mandatory password changes,
limited log-ins, virus protection,
encryption, firewalls, and intrusion
detection systems, and user rights/file
attribute restrictions. The password
protection will impose username and
password log-in requirements to prevent
unauthorized access. Each user name
will be assigned limited access rights to
files and directories at varying levels to
control file sharing. There will be
routine daily backup procedures, and
backup files will be securely stored offsite. Security controls will be reviewed
on an ongoing basis.
• Knowledge of individual tape
passwords will be required to access
backups, and access to the system will
be limited to users obtaining prior
supervisory approval. To avoid
inadvertent data disclosure, a special
additional procedure will be performed
to ensure that all Privacy Act data are
removed from computer hard drives.
Additional safeguards may also be built
into the program by the system analyst
as warranted by the sensitivity of the
data set.

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• FTEs and contractor employees
who maintain records will be instructed
in specific procedures to protect the
security of records, and will be required
to check with the system manager prior
to making disclosure of data. When
individually identifiable data are being
used in a room, admittance at either
federal or contractor sites will be
restricted to specifically authorized
personnel.
• Appropriate Privacy Act provisions
and breach notification provisions will
be included in applicable contracts, and
the CDC Project Director, contract
officers, and project officers will oversee
compliance with these requirements.
Upon completion of a contract, all data
will be either returned to federal
government or destroyed, as specified
by the contract.
• Records that are eligible for
destruction will be disposed of using
destruction methods prescribed by NIST
SP 800–88. Hard copy records will be
placed in a locked container or
designated secure storage area while
awaiting destruction. Records will be
destroyed in a manner that precludes its
reconstruction, such as secured cross
shredding. Utilizing the HHS Security
Rule Guidance Material found at https://
www.hhs.gov/hipaa/for-professionals/
security/guidance/index.html,
electronic information will be deleted or
overwritten using Department of
Defense National Institute of Standards
and Technology/General Services
Administration (NIST/GSA) approved
overwriting software that wipes the
entire physical disk and not just the
virtual disk. In addition, the physical
destruction will be obtained by using a
National Security Agency/Central
Security Service (NSA/CSS) approved
degaussing device.
PHYSICAL SAFEGUARDS:

• Paper records (i.e., hard copy
printouts) will be maintained in locked
cabinets in secured rooms through
electronic access in a restricted access
location that is controlled by an
electronic cardkey system that is limited
to staff who have responsibility for
conducting regulatory oversight.
Electronic data files will be encrypted
using Federal Information Processing
Standards Publication (FIPS) 140–2, and
will be stored in a restricted access
location. The computer room will be
protected by an automatic sprinkler
system and numerous automatic sensors
(e.g., water, heat, smoke, etc.) which
will be monitored, and a proper mix of
portable fire extinguishers will be
located throughout the computer room.
Computer workstations, lockable

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personal computers, and automated
records will be located in secured areas.

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

RECORD ACCESS PROCEDURES:

Food and Drug Administration

An individual seeking access to
records about that individual in this
system of records must submit a written
access request to the System Manager,
identified in the ‘‘System Manager’’
section of this SORN. The request must
contain the requester’s full name,
address, and signature, and permit
number if known. To verify the
requester’s identity, the signature must
be notarized or the request must include
the requester’s written certification that
the requester is the individual who the
requester claims to be and that the
requester understands that the knowing
and willful request for or acquisition of
a record pertaining to an individual
under false pretenses is a criminal
offense subject to a fine of up to $5,000.
An accounting of disclosures that have
been made of the record, if any, may
also be requested.
CONTESTING RECORD PROCEDURES:

An individual seeking to amend a
record about that individual in this
system of records must submit an
amendment request to the System
Manager identified in the ‘‘System
Manager’’ section of this SORN,
containing the same information
required for an access request. The
request must include verification of the
requester’s identity in the same manner
required for an access request; must
reasonably identify the record and
specify the information contested, the
corrective action sought, and the
reasons for requesting the correction;
and should include supporting
information to show how the record is
inaccurate, incomplete, untimely, or
irrelevant.
NOTIFICATION PROCEDURES:

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An individual who wishes to know if
this system of records contains records
about that individual should submit a
notification request to the System
Manager identified in the ‘‘System
Manager’’ section of this SORN. The
request must contain the same
information required for an access
request, and must include verification of
the requester’s identity in the same
manner required for an access request.
EXEMPTIONS PROMULGATED FOR THE SYSTEM:

None.
HISTORY:

None.
[FR Doc. 2020–18805 Filed 8–26–20; 8:45 am]
BILLING CODE 4163–18–P

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[Docket No. FDA–2020–D–0938]

Evaluating Cancer Drugs in Patients
With Central Nervous System
Metastases; Draft Guidance for
Industry; Availability
AGENCY:

Food and Drug Administration,

HHS.
ACTION:

Notice of availability.

The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled
‘‘Evaluating Cancer Drugs in Patients
with Central Nervous System
Metastases.’’ This draft guidance
document provides recommendations
regarding the design of clinical trials of
drugs and biological products regulated
by the Center for Drug Evaluation and
Research (CDER) and the Center for
Biologics Evaluation and Research
(CBER) that are intended to support
product labeling describing the
antitumor activity in patients with
central nervous system (CNS)
metastases from solid tumors originating
outside the CNS. The draft guidance
includes study design recommendations
regarding the patient population,
available therapy, prior therapies,
assessment of CNS disease, study
endpoints, and leptomeningeal disease.
DATES: Submit either electronic or
written comments on the draft guidance
by October 26, 2020, to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
SUMMARY:

Electronic Submissions
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

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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
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2020–D–0938 for ‘‘Evaluating Cancer
Drugs in Patients with Central Nervous
System Metastases.’’ Received
comments 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.
• 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

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