60d FRN - Public Comment

President
Maureen O'Leary, PhD, CBSP
Dartmouth College
37 Dewey Field Road, Suite 6216
Hanover, NH 03755
603-646-1762
maureen.o'[email protected]

President-Elect
Patrick Condreay, PhD, RBP
pc Biosafety Consulting Services, LLC
P.O. Box 1106
Carrboro, NC 27510
919-649-4971
[email protected]

Secretary
Krista Murray, RBP, CBSP
University of Delaware
222 Chapel Street, 132 GSB
Newark, DE 19716
302-831-1433
[email protected]

Treasurer
James Klenner, MSc, MPH, MPA, RBP, CBSP
Indiana University—Purdue University Indianapolis
980 Indiana Avenue, Room 4428
Indianapolis, IN 46202
317-274-2830
[email protected]

Past-President
Melissa Morland, MS, MBA, RBP, CBSP
University of Maryland—Baltimore
714 West Lombard Street
Baltimore, MD 21201
410-706-7845
[email protected]

Councilors
Kelly J. Flint, RBP, CBSP, SM(NRCM) (17)
Julie A. Johnson, PhD, CBSP (Pro Tem 17)

February 23, 2017
Leroy A. Richardson
Information Collection Review Office
Centers for Disease Control and Prevention
1600 Clifton Road NE., MS-D74
Atlanta, Georgia 30329
RE: Proposed Data Collection Submitted for Public Comment and
Recommendations, Docket No. CDC-2016-0125
Dear Mr. Richardson,
ABSA International welcomes the opportunity to review the proposed
revision of the CDC information collection project entitled “Possession,
Use, and Transfer of Select Agents and Toxins” published December 30,
2016. ABSA International provides a critical expertise for this topic as
many of its members are extensively involved in implementing the
Federal Select Agent Program (FSAP) and fulfilling certain roles therein.
ABSA International has reviewed the draft “APHIS/CDC Form 3 Incident
Notification and Reporting (Theft/Loss/Release)” and the draft
“APHIS/CDC Guidance Document for Reporting Potential Theft, Loss,
Release, or Occupational Exposure”. The specific comments provided
respond to category “(c) ways to enhance the quality, utility, and clarity of
the information collected” in the Federal Register notice.
ABSA International appreciates efforts by the CDC to reduce the
regulatory burden and provision of the draft information collection tool
and guidance. The comments in the attached table are respectfully offered
for your consideration.
Sincerely,

David Gillum, MS, RBP (18)
Barbara Owen, RBP, CBSP, SM(NRCM) (18)

2017 Biosafety Conference Chairpersons
Exhibitors Advisory Committee
Brandon Rosendahl

Maureen O’Leary, PhD, CBSP
President, ABSA International

Local Arrangements Committee
Jennifer Gaudioso, PhD
Scientific Program Committee
Betsy Matos, PhD, RBP

Executive Director
Edward J. Stygar, III, MBA, CAE
[email protected]

Attachment

ABSA International Technical and Regulatory Review Committee
Comments Table
Comments on: • CDC: Proposed Data Collection Submitted for Public Comment and
Recommendations. • Incident Notification and Reporting APHIS/CDC Form 3 Draft.
•APHIS/CDC Guidance Document for Reporting Potential Theft, Loss, Release, or
Occupational Exposure.

Deadline: 14 February 2017

Document Citation/Number: 81 FR 96456
https://www.federalregister.gov/documents/2016/12/30/20
16-31739/proposed-data-collection-submitted-for-publiccomment-and-recommendations

Table 1: General Comments
Instructions: Use this table to make general comments about the document content or related issues. Add rows as needed.
General comment

Comment (justification for change)

Proposed change

Proposal to address each comment submitted

Table 2: Specific Comments
Instructions: Use this table to make comments specific to each recommendation in the document
Form 3 or Guidance
Drafts,
Section and Name

Form 3 Block, or
Guidance Page

Type of comment
ge = general
te = technical
ed = editorial

Form 3 Section AEntity Information

Block 7

ed

Comment (justification for change)

Proposed change

Laboratory supervisor should be removed, all Name of Responsible Official (or ARO):
communication should be through the RO (or
ARO) and not a lab manager. This ensures
that the RO is apprised of all situations in the
laboratory as they are occurring.

Page 1 of 2

Proposal to address
comment submitted

The Guidance document refers to listing the laboratory supervisor if
the entity is not registered. Recommend adding as subtext "(see
Guidance document if entity is not registered)". The term "laboratory
supervisor" is too vague in how it is used across various entities.
The Guidance document can explain that the person listed should be
equivalent in responsibility to the RO or ARO. This person may have
a different title than laboratory supervisor.

Form 3 or Guidance
Drafts,
Section and Name

Form 3 Block, or
Guidance Page

Type of comment
ge = general
te = technical
ed = editorial

Form 3 Section E Report of Release

Block 3

ge

The list of types of PPE worn is very generic,
a space is suggested for a "Description of
PPE" below the list. In doing this a more
specific answer can be provided such as "
Tyvek suit with PAPR and double gloves",
thus better assisting in the exposure risk
assessment.

Add a line for Description of PPE after the list The Guidance document refers to listing the laboratory supervisor if
the entity is not registered. Recommend adding as subtext "(see
Guidance document if entity is not registered)". The term "laboratory
supervisor" is too vague in how it is used across various entities.
The Guidance document can explain that the person listed should be
equivalent in responsibility to the RO or ARO. This person may have
a different title than laboratory supervisor.

Form 3 Section E Report of Release

Block 8

te

Modify question to ask if an internal incident
invesigation has been initiated to identify the
root cause versus only a review of procedures
and policies.

Modify question to "Has an internal
investigation review of laboratory procedures
and policies, been initiated to lessen the
likelihood of recurrences of incident involving
the select agents and toxin at this entity?"

te

Modify text in Guidance document, page 16, Change Block E8 title from "Internal Review"
Block E8, to reflect proposed change above in to "Internal Investigation".
Form 3 Section E Block 8.
Change first bullet to read: "Select 'yes', if an
internal investigation has been initiated to
identify the root cause and review laboratory
procedures and policies. Otherwise, select
'no'.

Guidance Page 16, Block E8
Section E - Report
of Release

Comment (justification for change)

Proposed change

Page 2 of 2

Proposal to address
comment submitted

Change prioritizes focus on how incident occurred versus whether it
was a violation of procedure or policy.