Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry: Use of Serological Tests To Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components for Transfusion, 19062-19063 [2017-08306]
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19062
Federal Register / Vol. 82, No. 78 / Tuesday, April 25, 2017 / Notices
purity and potency) beyond the
manufacturer’s labeled expiration date
so the replacement of stockpiled
product could be deferred. This
document, once finalized, will provide
guidance to government stakeholders on
testing to extend the shelf life (i.e.,
expiration date) under section 564A(b)
of the FD&C Act (21 U.S.C. 360bbb–
3a(b)) of stockpiled doxycycline tablets
and capsules for public health
emergency preparedness and response
purposes for an anthrax emergency.
The draft guidance applies to both
doxycycline monohydrate and
doxycycline hyclate tablets and
capsules equivalent to 50 mg and 100
mg of doxycycline that are indicated for
PEP or treatment of inhalational
anthrax. Where doxycycline is
mentioned throughout this guidance, it
is meant to include both the hyclate and
monohydrate forms of the drug that are
indicated for PEP or treatment of
inhalational anthrax.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on ‘‘Extending Expiration Dates of
Doxycycline Tablets and Capsules in
Strategic Stockpiles.’’ It does not
establish any rights for any person and
is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information that
are subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collection of
information has been approved under
OMB control number 0910–0595.
III. Electronic Access
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Dated: April 19, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–08326 Filed 4–24–17; 8:45 am]
[Docket No. FDA–2013–N–0868]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guidance for
Industry: Use of Serological Tests To
Reduce the Risk of Transmission of
Trypanosoma cruzi Infection in Whole
Blood and Blood Components for
Transfusion
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or we) is
announcing that a proposed collection
of information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995
(the PRA).
DATES: Fax written comments on the
collection of information by May 25,
2017.
SUMMARY:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0681. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A63, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Guidance for Industry: Use of
Serological Tests To Reduce the Risk of
Transmission of Trypanosoma cruzi
Infection in Whole Blood and Blood
Components Intended for Transfusion
OMB Control Number 0910–0681—
Extension
The guidance document implements
the donor screening recommendations
for the FDA-approved serological test
BILLING CODE 4164–01–P
17:42 Apr 24, 2017
Food and Drug Administration
SUPPLEMENTARY INFORMATION:
Persons with access to the Internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
VerDate Sep<11>2014
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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systems for the detection of antibodies
to T. cruzi. The use of the donor
screening tests are to reduce the risk of
transmission of T. cruzi infection by
detecting antibodies to T. cruzi in
plasma and serum samples from
individual human donors, including
donors of Whole Blood and blood
components intended for transfusion.
The guidance recommends that
establishments that manufacture Whole
Blood and blood components intended
for transfusion should notify consignees
of all previously collected in-date blood
and blood components to quarantine
and return the blood components to
establishments or to destroy them
within 3 calendar days after a donor
tests repeatedly reactive by a licensed
test for T. cruzi antibody. When
establishments identify a donor who is
repeatedly reactive by a licensed test for
T. cruzi antibodies and for whom there
is additional information indicating risk
of T. cruzi infection, such as testing
positive on a licensed supplemental test
(when such test is available) or until
such test is available, information that
the donor or donor’s mother resided in
an area endemic for Chagas disease
(Mexico, Central and South America) or
as a result of other medical diagnostic
testing of the donor indicating T. cruzi
infection, we recommend that the
establishment notify consignees of all
previously distributed blood and blood
components collected during the
lookback period and, if blood and blood
components were transfused, encourage
consignees to notify the recipient’s
physician of record of a possible
increased risk of T. cruzi infection.
Respondents to this information
collection are establishments that
manufacture Whole Blood and blood
components intended for transfusion.
We believe that the information
collection provisions in the guidance for
establishments to notify consignees and
for consignees to notify the recipient’s
physician of record in the guidance do
not create a new burden for respondents
and are part of usual and customary
business practices. Since the end of
January 2007, a number of blood centers
representing a large proportion of U.S.
blood collections have been testing
donors using a licensed assay. We
believe these establishments have
already developed standard operating
procedures for notifying consignees and
for the consignees to notify the
recipient’s physician of record.
The guidance also refers to previously
approved collections of information
found in FDA regulations. The
collections of information in 21 CFR
601.12 have been approved under OMB
control number 0910–0338; the
E:\FR\FM\25APN1.SGM
25APN1
Federal Register / Vol. 82, No. 78 / Tuesday, April 25, 2017 / Notices
collections of information in 21 CFR
606.100, 606.121, 606.122,
606.160(b)(ix), 606.170(b), 610.40, and
630.40 have been approved under OMB
control numbers 0910–0116 and 0910–
0795; the collections of information in
21 CFR 606.171 have been approved
under OMB control number 0910–0458.
In the Federal Register of November
7, 2016 (81 FR 78170), we published a
60-day notice requesting public
comment on the proposed extension of
this collection of information. No
comments were received in response to
the notice.
Dated: April 18, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–08306 Filed 4–24–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–0001]
Sentinel Training at the Food and Drug
Administration; Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing the following public
workshop entitled ‘‘Sentinel Training at
FDA.’’ The purpose of the public
workshop is to provide training to
understand the kinds of questions that
can be asked using health care claims
data generally and within the FDA
Sentinel System specifically, allowing
an understanding of the capabilities of
the Sentinel System.
DATES: The public workshop will be
held on July 10, 2017, from 10 a.m. to
4 p.m.
ADDRESSES: The public workshop will
be held at FDA’s White Oak Campus,
10903 New Hampshire Ave., Bldg. 31,
Rm. 1503 (the Great Room), Silver
Spring, MD 20993. Entrance for the
public workshop participants (non-FDA
employees) is through Building 1 where
routine security check procedures will
be performed. For parking and security
information, please refer to https://
www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm.
FOR FURTHER INFORMATION CONTACT:
Kayla Garvin, Food and Drug
Administration, 10903 New Hampshire
asabaliauskas on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:42 Apr 24, 2017
Jkt 241001
Avenue, Bldg. 51, Rm. 6314, Silver
Spring, MD 20993, 301–796–7578,
Kayla.Garvin@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The Sentinel Initiative began in 2008
as a multiyear effort to create a national
electronic system for monitoring the
performance of FDA-regulated medical
products. The Sentinel Initiative is
FDA’s response to the Food and Drug
Administration Amendments Act of
2007 (FDAAA) requirement that FDA
work with public, academic, and private
entities to develop a system to obtain
information from existing electronic
health care data from multiple sources
to assess the safety of FDA approved
medical products.
The Sentinel System uses a
distributed data approach in which Data
Partners maintain physical and
operational control over electronic
health care data in their existing
environments. The distributed approach
is achieved by using a standardized data
structure referred to as the Sentinel
Common Data Model. Data Partners
transform their data locally in
accordance with the Common Data
Model, which enables them to execute
standardized computer programs that
run identically at each Data Partner site.
Data Partners are able to review the
results of the queries before sending
them back to the Sentinel Operations
Center. Queries are distributed and
results are returned through a secure
portal to preserve privacy.
II. Topics for Discussion at the Public
Workshop
This full-day seminar, targeting
clinical researchers and others without
direct experience using health care
claims data, will provide an overview of
data that are and are not available in the
Sentinel Distributed Database, the
Sentinel Common Data Model, and a
description of the distributed tools
available to work with the data. This
seminar will help those in attendance
understand the kinds of questions that
can be asked using health care claims
data generally and within the Sentinel
System specifically. Attendees will
leave with an understanding of the
capabilities of the Sentinel System. The
Sentinel System can help the public,
academia, and private entities better
understand potential safety issues
associated with FDA-approved medical
products. Importantly, users can get
responses to their questions in a matter
of weeks, as compared to months, or
even longer using traditional
surveillance methods.
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19063
III. Participating in the Public
Workshop
Registration: To register for the public
workshop, please visit the following
Web site: https://www.eventbrite.com/e/
sentinel-training-at-food-and-drugadministration-registration32503315291. Please provide required
contact information for each attendee,
including name, title, affiliation, and
email.
Registration is free and based on
space availability, with priority given to
early registrants. Early registration is
recommended because seating is
limited; therefore, FDA may limit the
number of participants from each
organization. If time and space permit,
onsite registration on the day of the
public workshop will be provided
beginning at 9 a.m.
If you need special accommodations
due to a disability, please contact Kayla
Garvin no later than June 30, 2017.
Streaming Webcast of the public
workshop: This public workshop will
also be Webcast at: https://
collaboration.fda.gov/
sentineltraining2017/.
If you have never attended a Connect
Pro event before, test your connection at
https://collaboration.fda.gov/common/
help/en/support/meeting_test.htm. To
get a quick overview of the Connect Pro
program, visit https://www.adobe.com/
go/connectpro_overview. FDA has
verified the Web site addresses in this
document, as of the date this document
publishes in the Federal Register, but
Web sites are subject to change over
time.
Transcripts: Please be advised that
transcripts will not be available.
Dated: April 19, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–08302 Filed 4–24–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1393]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Patent Term
Restoration, Due Diligence Petitions,
Filing, Format, and Content of
Petitions
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
E:\FR\FM\25APN1.SGM
Notice.
25APN1
]]>Agencies
[Federal Register Volume 82, Number 78 (Tuesday, April 25, 2017)]
[Notices]
[Pages 19062-19063]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-08306]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0868]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Guidance for
Industry: Use of Serological Tests To Reduce the Risk of Transmission
of Trypanosoma cruzi Infection in Whole Blood and Blood Components for
Transfusion
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is announcing
that a proposed collection of information has been submitted to the
Office of Management and Budget (OMB) for review and clearance under
the Paperwork Reduction Act of 1995 (the PRA).
DATES: Fax written comments on the collection of information by May 25,
2017.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0681.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North,
10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Guidance for Industry: Use of Serological Tests To Reduce the Risk of
Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood
Components Intended for Transfusion
OMB Control Number 0910-0681--Extension
The guidance document implements the donor screening
recommendations for the FDA-approved serological test systems for the
detection of antibodies to T. cruzi. The use of the donor screening
tests are to reduce the risk of transmission of T. cruzi infection by
detecting antibodies to T. cruzi in plasma and serum samples from
individual human donors, including donors of Whole Blood and blood
components intended for transfusion. The guidance recommends that
establishments that manufacture Whole Blood and blood components
intended for transfusion should notify consignees of all previously
collected in-date blood and blood components to quarantine and return
the blood components to establishments or to destroy them within 3
calendar days after a donor tests repeatedly reactive by a licensed
test for T. cruzi antibody. When establishments identify a donor who is
repeatedly reactive by a licensed test for T. cruzi antibodies and for
whom there is additional information indicating risk of T. cruzi
infection, such as testing positive on a licensed supplemental test
(when such test is available) or until such test is available,
information that the donor or donor's mother resided in an area endemic
for Chagas disease (Mexico, Central and South America) or as a result
of other medical diagnostic testing of the donor indicating T. cruzi
infection, we recommend that the establishment notify consignees of all
previously distributed blood and blood components collected during the
lookback period and, if blood and blood components were transfused,
encourage consignees to notify the recipient's physician of record of a
possible increased risk of T. cruzi infection.
Respondents to this information collection are establishments that
manufacture Whole Blood and blood components intended for transfusion.
We believe that the information collection provisions in the guidance
for establishments to notify consignees and for consignees to notify
the recipient's physician of record in the guidance do not create a new
burden for respondents and are part of usual and customary business
practices. Since the end of January 2007, a number of blood centers
representing a large proportion of U.S. blood collections have been
testing donors using a licensed assay. We believe these establishments
have already developed standard operating procedures for notifying
consignees and for the consignees to notify the recipient's physician
of record.
The guidance also refers to previously approved collections of
information found in FDA regulations. The collections of information in
21 CFR 601.12 have been approved under OMB control number 0910-0338;
the
[[Page 19063]]
collections of information in 21 CFR 606.100, 606.121, 606.122,
606.160(b)(ix), 606.170(b), 610.40, and 630.40 have been approved under
OMB control numbers 0910-0116 and 0910-0795; the collections of
information in 21 CFR 606.171 have been approved under OMB control
number 0910-0458.
In the Federal Register of November 7, 2016 (81 FR 78170), we
published a 60-day notice requesting public comment on the proposed
extension of this collection of information. No comments were received
in response to the notice.
Dated: April 18, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-08306 Filed 4-24-17; 8:45 am]
BILLING CODE 4164-01-P
