81 FR 96007 - Identification and Characterization of the Infectious Disease Risks of Human Cells, Tissues, and Cellular and Tissue-Based Products; Public Workshop

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 250 (December 29, 2016)

Page Range		96007-96008
FR Document		2016-31628

The Food and Drug Administration (FDA) is announcing a public workshop entitled ``Identification and Characterization of the Infectious Disease Risks of Human Cells, Tissues, and Cellular and Tissue-based Products.'' The purpose of the public workshop is to have a scientific discussion of the current methods available for identifying and characterizing infectious disease risks associated with human cells, tissues, and cellular and tissue-based products (HCT/Ps).

Federal Register, Volume 81 Issue 250 (Thursday, December 29, 2016)

[Federal Register Volume 81, Number 250 (Thursday, December 29, 2016)]
[Notices]
[Pages 96007-96008]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-31628]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]


Identification and Characterization of the Infectious Disease 
Risks of Human Cells, Tissues, and Cellular and Tissue-Based Products; 
Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
workshop entitled ``Identification and Characterization of the 
Infectious Disease Risks of Human Cells, Tissues, and Cellular and 
Tissue-based Products.'' The purpose of the public workshop is to have 
a scientific discussion of the current methods available for 
identifying and characterizing infectious disease risks associated with 
human cells, tissues, and cellular and tissue-based products (HCT/Ps).

DATES: The public workshop will be held on February 8, 2017, from 8:30 
a.m. to 4:30 p.m., and February 9, 2017, from 8:30 a.m. to 12:30 p.m. 
See the SUPPLEMENTARY INFORMATION section for registration date and 
information.

ADDRESSES: The public workshop will be held at the Wiley Auditorium 
located in the Harvey H. Wiley Federal Building, 5100 Campus Dr., 
College Park, MD 20740.

FOR FURTHER INFORMATION CONTACT: Monica Kapoor, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 3111C, Silver Spring, MD 20993, 
[email protected]; or Stacey Rivette, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Avenue, Bldg. 71, Rm. 3109B, Silver Spring, MD 20993, 
[email protected] with the subject line titled ``HCT/P 
Workshop.''

SUPPLEMENTARY INFORMATION:

I. Background

    Transplantation of HCT/Ps represents an area of medicine important 
for saving and/or enhancing the lives of millions of individuals every 
year. In order to assure the safety of patients receiving HCT/P 
transplants, FDA issued regulations to prevent the introduction, 
transmission, or spread of communicable diseases by HCT/Ps under part 
1271 (21 CFR part 1271) (May 25, 2004; 69 FR 29786). These regulations 
became effective on May 25, 2005. The regulations under part 1271, 
subpart C, contain the requirements for

[[Page 96008]]

tissue establishments for determining HCT/P donor eligibility. These 
requirements include the need to screen and test potential donors of 
HCT/Ps for relevant communicable disease agents and diseases (RCDADs).
    The regulations under part 1271, subpart C, list the following 
RCDADs for all cells and tissues: Human immunodeficiency virus, types 1 
and 2; hepatitis B virus; hepatitis C virus; human transmissible 
spongiform encephalopathy; and Treponema pallidum. These regulations 
also list human T-lymphotropic virus type I and type II as RCDADs for 
viable, leukocyte- rich cells and tissues. For reproductive cells or 
tissues, a disease agent or disease of the genitourinary tract includes 
Chlamydia trachomatis and Neisseria gonorrhea. In addition, the 
regulations under part 1271, subpart C, recognize that over time as new 
infectious diseases emerge there would be the need to designate 
additional RCDADs. The regulations describe the criteria for 
identifying new RCDADs. These criteria include that the disease or 
disease agent is potentially transmissible by a HCT/P: Either it has 
sufficient incidence and/or prevalence to affect the donor population; 
or if it were released in a manner to place potential donors at risk 
that it could be fatal or life-threatening, and that there were 
appropriate screening and legally marketed screening tests available 
for it. However, the regulations under part 1271, subpart C, do not 
specify the deliberative and scientific processes necessary to apply 
the criteria.
    This workshop will describe currently available scientific methods 
to characterize both epidemiologic and biological features of emerging 
diseases and disease agents, and discuss their potential use in 
evaluating HCT/P infectious diseases risks for the purpose of 
identifying new RCDADs for the purposes of the HCT/P regulatory 
framework. Assessing the overall risk of a particular disease agent or 
disease to recipients of HCT/Ps requires consideration of multiple 
factors, including the presence of the disease agent or disease in the 
HCT/P donor population, potential for transmission by an HCT/P, and the 
potential morbidity or mortality in the recipient. In many cases, 
information for one or more of these factors may be limited or 
incomplete.

II. Topics for Discussion at the Public Workshop

    The workshop is intended as a scientific discussion regarding the 
current methods available to identify and characterize infectious 
disease risks related to HCT/Ps. Topics discussed will include: (1) 
Estimating disease incidence and/or prevalence in the potential HCT/P 
donor population, (2) assessing the potential transmissibility of a 
disease by HCT/Ps, and (3) understanding the capabilities of current 
screening and testing methodologies. The workshop will also include 
discussion on how available information can be used to characterize the 
overall infectious disease risks posed by HCT/Ps.

III. Participating in the Public Workshop

    Registration: To register for the public workshop, please visit the 
following Web site at https://www.eventbrite.com/e/identification-and-characterization-of-hctp-infectious-disease-risks-public-workshop-registration-24465329459. Please provide complete contact information 
for each attendee, including name, title, affiliation, address, email, 
and telephone.
    Registration is free and based on space availability, with priority 
given to early registrants. Persons interested in attending this public 
workshop must register by February 6, 2017. Early registration is 
recommended because seating is limited; therefore, FDA may limit the 
number of participants from each organization. Registrants will receive 
confirmation once they have been accepted. Attendance for this workshop 
is in-person only. FDA will post the agenda approximately 5 days before 
the workshop at http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm490175.htm.
    If you need special accommodations because of disability, please 
contact Monica Kapoor or Stacey Rivette no later than 7 days in advance 
of the meeting by email at [email protected] with the 
subject line titled ``HCT/P Workshop.''
    Transcripts: Please be advised that as soon as a transcript of the 
public workshop is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852. A link to the transcript will also be 
available on the Internet at http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm525001.html.

    Dated: December 23, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-31628 Filed 12-28-16; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 250 / Thursday, December 29, 2016 / Notices 96007

• the statement ‘‘Not for resale,’’ and, We estimate that annually a total of The draft guidance also references
if the repackaged radiopharmaceutical is approximately 2 outsourcing facilities registration, adverse event reporting,
distributed by an outsourcing facility (‘‘No. of Respondents’’ in table 1, row 1) product reporting, and current good
other than pursuant to a prescription for will each design, test, and produce manufacturing practices (CGMP)
an individual identified patient, the approximately 5 different labels (‘‘No. of requirements for outsourcing facilities.
statement ‘‘Office Use Only’’; and Disclosures per Respondent’’ in table 1, The collection of information for
• a list of the active and inactive row 1) for a total of 10 labels that outsourcing facility registration has
ingredients, unless such information is include the information described been approved by the Office of
included on the label for the container previously (including directions for use) Management and Budget (OMB) under
from which the individual units are (‘‘Total Annual Disclosures’’ in table 1, OMB control number 0910–0777 (79 FR
removed, as described in this document. row 1). We also estimate that designing, 69859, November 24, 2014). The
Another condition in the draft testing, and producing each label will collection of information for adverse
guidance is that the label on the event reporting by outsourcing facilities
take approximately 0.5 hours for each
container from which the individual has been approved by OMB under OMB
repackaged radiopharmaceutical
units are removed for administration control number 0910–0800 (80 FR
(secondary packaging, e.g., the bag, box, (‘‘Average Burden Hours per 60917, October 8, 2015). In the Federal
or other package in which the Disclosure’’ in table 1, row 1). The Register of August 1, 2016 (81 FR
repackaged products are distributed) provision to add the statement http:// 50523), FDA estimated the burden
includes the active and inactive www.fda.gov/medwatch and 1–800– resulting from outsourcing facility
ingredients, if the immediate product FDA–1088 is not included in this electronic drug product reporting. In the
label is too small to include this burden estimate because it is not Federal Register of July 2, 2014 (79 FR
information, and directions for use, considered a collection of information 37743), FDA estimated the burden
including, as appropriate, dosage and under the PRA because the information resulting from outsourcing facility
administration, and the following is ‘‘originally supplied by the Federal compliance with CGMP requirements.
information to facilitate adverse event Government to the recipient for the The total estimated third-party
reporting: http://www.fda.gov/ purpose of disclosure to the public’’ (5 disclosure burden resulting from the
medwatch and 1–800–FDA–1088. CFR 1320.3(c)(2)). draft guidance is as follows:
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN
Number of
Number of disclosures Total annual Average burden
Repackaging by outsourcing facilities Total hours
respondents per disclosures per disclosure
respondent

Designing, testing, and producing each label on imme- 2 5 10 .5 (30 minutes) .... 5
diate containers, packages and/or outer containers.
There are no capital costs or operating and maintenance costs associated with this collection of information.

III. Electronic Access ACTION: Notice of public workshop. Evaluation and Research, Food and
Persons with access to the Internet Drug Administration, 10903 New
SUMMARY: The Food and Drug Hampshire Ave., Bldg. 71, Rm. 3111C,
may obtain the draft guidance at either Administration (FDA) is announcing a
http://www.fda.gov/Drugs/Guidance Silver Spring, MD 20993,
public workshop entitled ‘‘Identification CBERPublicEvents@fda.hhs.gov; or
ComplianceRegulatoryInformation/ and Characterization of the Infectious
Guidances/default.htm or https:// Stacey Rivette, Center for Biologics
Disease Risks of Human Cells, Tissues, Evaluation and Research, Food and
www.regulations.gov. and Cellular and Tissue-based Drug Administration, 10903 New
Dated: December 22, 2016. Products.’’ The purpose of the public Hampshire Avenue, Bldg. 71, Rm.
Leslie Kux, workshop is to have a scientific 3109B, Silver Spring, MD 20993,
Associate Commissioner for Policy. discussion of the current methods CBERPublicEvents@fda.hhs.gov with the
[FR Doc. 2016–31512 Filed 12–28–16; 8:45 am] available for identifying and subject line titled ‘‘HCT/P Workshop.’’
characterizing infectious disease risks
BILLING CODE 4164–01–P SUPPLEMENTARY INFORMATION:
associated with human cells, tissues,
and cellular and tissue-based products I. Background
DEPARTMENT OF HEALTH AND (HCT/Ps).
Transplantation of HCT/Ps represents
HUMAN SERVICES DATES: The public workshop will be an area of medicine important for saving
held on February 8, 2017, from 8:30 a.m. and/or enhancing the lives of millions
Food and Drug Administration to 4:30 p.m., and February 9, 2017, from of individuals every year. In order to
8:30 a.m. to 12:30 p.m. See the assure the safety of patients receiving
[Docket No. FDA–2016–N–0001] SUPPLEMENTARY INFORMATION section for HCT/P transplants, FDA issued
asabaliauskas on DSK3SPTVN1PROD with NOTICES

registration date and information. regulations to prevent the introduction,
Identification and Characterization of ADDRESSES: The public workshop will
the Infectious Disease Risks of Human transmission, or spread of
be held at the Wiley Auditorium located communicable diseases by HCT/Ps
Cells, Tissues, and Cellular and in the Harvey H. Wiley Federal
Tissue-Based Products; Public under part 1271 (21 CFR part 1271)
Building, 5100 Campus Dr., College (May 25, 2004; 69 FR 29786). These
Workshop Park, MD 20740. regulations became effective on May 25,
AGENCY: Food and Drug Administration, FOR FURTHER INFORMATION CONTACT: 2005. The regulations under part 1271,
HHS. Monica Kapoor, Center for Biologics subpart C, contain the requirements for

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Document Created: 2016-12-29 01:59:14
Document Modified: 2016-12-29 01:59:14

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice of public workshop.
Dates		The public workshop will be held on February 8, 2017, from 8:30 a.m. to 4:30 p.m., and February 9, 2017, from 8:30 a.m. to 12:30 p.m. See the SUPPLEMENTARY INFORMATION section for registration date and information.
Contact		Monica Kapoor, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3111C, Silver Spring, MD 20993, [email protected]; or Stacey Rivette, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 71, Rm. 3109B, Silver Spring, MD 20993, [email protected] with the subject line titled ``HCT/P Workshop.''
FR Citation		81 FR 96007

81 FR 96007 - Identification and Characterization of the Infectious Disease Risks of Human Cells, Tissues, and Cellular and Tissue-Based Products; Public Workshop

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 250 (December 29, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration