Regional Public Workshop on the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use Q3D Implementation of Guideline for Elemental Impurities; Public Workshop, 44628-44629 [2016-16152]
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Federal Register / Vol. 81, No. 131 / Friday, July 8, 2016 / Notices
Medical Devices; Third-Party Review
Under the Food and Drug
Administration Modernization Act—
OMB Control Number 0910–0375—
Extension
Section 210 of the Food and Drug
Administration Modernization Act
(FDAMA) established section 523 of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360m), directing FDA to
accredit persons in the private sector to
review certain premarket notifications
(510(k)s). Participation in this thirdparty review program by accredited
persons is entirely voluntary. A third
party wishing to participate will submit
a request for accreditation to FDA.
Accredited third-party reviewers have
the ability to review a manufacturer’s
510(k) submission for selected devices.
After reviewing a submission, the
reviewer will forward a copy of the
510(k) submission, along with the
reviewer’s documented review and
recommendation, to FDA. Third-party
reviewers should maintain records of
their 510(k) reviews and a copy of the
510(k) for a reasonable period of time,
usually a period of 3 years.
This information collection will allow
FDA to continue to implement the
accredited person review program
established by FDAMA and improve the
efficiency of 510(k) review for low- to
moderate-risk devices.
Respondents to this information
collection are businesses or other forprofit organizations.
FDA receives an average of one
application for accreditation for thirdparty review per year. According to
FDA’s data, the number of 510(k)s
submitted for third-party review is
approximately 260 annually, which is
26 annual reviews per each of the 10
accredited reviewers. Third-party
reviewers are required to keep records
of their review of each submission.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Requests for accreditation ...................................................
510(k) reviews conducted by accredited third parties .........
1
10
1
26
1
260
24
40
24
10,400
Total ..............................................................................
........................
........................
........................
........................
10,424
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
Activity
510(k) reviews ......................................................................
1 There
[FR Doc. 2016–16158 Filed 7–7–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0001]
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Regional Public Workshop on the
International Council for
Harmonization of Technical
Requirements for Pharmaceuticals for
Human Use Q3D Implementation of
Guideline for Elemental Impurities;
Public Workshop
Food and Drug Administration,
HHS.
ACTION:
10
Total annual
records
26
260
Average
burden per
recordkeeping
Total hours
10
2,600
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: July 1, 2016.
Leslie Kux,
Associate Commissioner for Policy.
AGENCY:
Number of
records per
recordkeeper
Notice of public workshop.
The Food and Drug
Administration (FDA) is announcing a
public workshop entitled: Regional
Public Workshop on ICH Q3D
Implementation of Guideline for
SUMMARY:
VerDate Sep<11>2014
17:00 Jul 07, 2016
Jkt 238001
Elemental Impurities. The purpose of
the public workshop is to elaborate key
aspects of the ICH Guideline Q3D:
Guideline on Elemental Impurities in
order facilitate a harmonized
interpretation and implementation by
industry and regulators. It is not
intended to provide additional guidance
beyond the scope of Q3D. The meeting
will take place on the FDA campus and
also be broadcast on the Web allowing
participants to join in person or via the
Web.
DATES: The public workshop will be
held on August 22 and 23, from 9 a.m.
to 5 p.m., EST. See the SUPPLEMENTARY
INFORMATION section for information on
how to register.
ADDRESSES: The public workshop will
be held at 10903 New Hampshire Ave.,
Bldg. 31, Rm. 1503B/C, Silver Spring,
MD 20993. The 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/
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
WhiteOakCampusInformation/
ucm241740.htm.
FOR FURTHER INFORMATION CONTACT:
Amanda Roache, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 1176, Silver Spring,
MD 20993, 301–796–4548, email:
Amanda.Roache@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The ICH
brings together regulatory authorities
and pharmaceutical industry to discuss
scientific and technical aspects of drug
registration. The ICH’s mission is to
achieve greater harmonization
worldwide to ensure that safe, effective,
and high quality medicines are
developed and registered in the most
resource-efficient manner. The ICH Q3D
Guideline was developed by the ICH to
provide a global policy for limiting
elemental impurities qualitatively and
quantitatively in drug products and
ingredients. Following finalization of
this Guideline, an Implementation
Working Group was established to
develop a comprehensive training
program and supporting documents
sponsored by ICH to ensure the proper
interpretation and effective utilization
E:\FR\FM\08JYN1.SGM
08JYN1
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 81, No. 131 / Friday, July 8, 2016 / Notices
by industry and regulators alike to
enable a harmonized and smooth
implementation of Q3D on a global
basis.
The U.S. regional workshop is
intended to clarify key aspects of ICH
Q3D: Guideline on Elemental Impurities
by elaborating on those key topics. It
will include: (1) A discussion of how to
apply Q3D concepts to routes of
administration, not addressed in Q3D,
(2) justification for elemental impurity
levels higher than an established
permissible daily exposure (PDE) (3)
application of Q3D concepts to
determine safe levels of elements not
included in Q3D, (4) discussion of the
rationale for limits on large volume
parenterals, (5) elaboration of the
concepts outlined in the Q3D Sections
on Risk Assessment and Control of
Elemental Impurities and (6) options for
converting between PDEs and
concentrations.
In addition, case studies may be
presented to illustrate the concepts
described previously, and frequently
asked questions will be discussed. The
presentation of the material will follow
the modules that are available on the
ICH Web site, www.ich.org, and will
include time for questions and
discussion. Breakout sessions will be
provided to discuss key topics and
provide feedback to participants.
Material will be presented by members
of the ICH Q3D Implementation
Working Group. The agenda for the
workshop will be made available on the
internet at https://www.fda.gov/Drugs/
NewsEvents/ucm498553.htm.
Registration: If you wish to attend this
meeting, visit the following Web site to
register: https://www.eventbrite.com/e/
regional-public-workshop-on-ich-q3dimplementation-of-guideline-forelemental-impurities-tickets25492458630. Please register by August
15, 2016. If you are unable to attend the
meeting in person, you can register to
view a live Webcast on the meeting. You
will be asked to indicate in your
registration if you plan to attend in
person or via the Webcast. Your
registration must also contain your
complete contact information, including
name, title, affiliation, address, email
address, and phone number.
Registrations may be limited, so early
registration is recommended.
Registration is free and will be on a firstcome, first-served basis. However, the
number of participants from each
organization may be limited based on
space limitations. Registrants will
receive confirmation once they have
been accepted. Onsite registration on
the day of the meeting will be based on
space availability. If you need special
VerDate Sep<11>2014
17:00 Jul 07, 2016
Jkt 238001
accommodations because of a disability,
please contact Amanda Roache (see FOR
FURTHER INFORMATION CONTACT) at least 7
days before the meeting.
Dated: July 1, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–16152 Filed 7–7–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–1486]
Authorization of Emergency Use of an
In Vitro Diagnostic Device for
Detection of Zika Virus; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
issuance of an Emergency Use
Authorization (EUA) (the Authorization)
for an in vitro diagnostic device for
detection of the Zika virus in response
to the Zika virus outbreak in the
Americas. FDA issued this
Authorization under the Federal Food,
Drug, and Cosmetic Act (the FD&C Act),
as requested by Hologic, Inc. The
Authorization contains, among other
things, conditions on the emergency use
of the authorized in vitro diagnostic
device. The Authorization follows the
February 26, 2016, determination by the
Secretary of Health and Human Services
(HHS) that there is a significant
potential for a public health emergency
that has a significant potential to affect
national security or the health and
security of U.S. citizens living abroad
and that involves Zika virus. On the
basis of such determination, the
Secretary of HHS declared on February
26, 2016, that circumstances exist
justifying the authorization of
emergency use of in vitro diagnostic
tests for detection of Zika virus and/or
diagnosis of Zika virus infection, subject
to the terms of any authorization issued
under the FD&C Act. The Authorization,
which includes an explanation of the
reasons for issuance, is reprinted in this
document.
DATES: The Authorization is effective as
of June 17, 2016.
ADDRESSES: Submit written requests for
single copies of the EUA to the Office
of Counterterrorism and Emerging
Threats, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 1,
Rm. 4338, Silver Spring, MD 20993–
SUMMARY:
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
44629
0002. Send one self-addressed adhesive
label to assist that office in processing
your request or include a fax number to
which the Authorization may be sent.
See the SUPPLEMENTARY INFORMATION
section for electronic access to the
Authorization.
FOR FURTHER INFORMATION CONTACT:
Carmen Maher, Office of
Counterterrorism and Emerging Threats,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 1, Rm.
4347, Silver Spring, MD 20993–0002,
301–796–8510 (this is not a toll free
number).
SUPPLEMENTARY INFORMATION:
I. Background
Section 564 of the FD&C Act (21
U.S.C. 360bbb–3) as amended by the
Project BioShield Act of 2004 (Pub. L.
108–276) and the Pandemic and AllHazards Preparedness Reauthorization
Act of 2013 (Pub. L. 113–5) allows FDA
to strengthen the public health
protections against biological, chemical,
nuclear, and radiological agents. Among
other things, section 564 of the FD&C
Act allows FDA to authorize the use of
an unapproved medical product or an
unapproved use of an approved medical
product in certain situations. With this
EUA authority, FDA can help assure
that medical countermeasures may be
used in emergencies to diagnose, treat,
or prevent serious or life-threatening
diseases or conditions caused by
biological, chemical, nuclear, or
radiological agents when there are no
adequate, approved, and available
alternatives.
Section 564(b)(1) of the FD&C Act
provides that, before an EUA may be
issued, the Secretary of HHS must
declare that circumstances exist
justifying the authorization based on
one of the following grounds: (1) A
determination by the Secretary of
Homeland Security that there is a
domestic emergency, or a significant
potential for a domestic emergency,
involving a heightened risk of attack
with a biological, chemical, radiological,
or nuclear agent or agents; (2) a
determination by the Secretary of
Defense that there is a military
emergency, or a significant potential for
a military emergency, involving a
heightened risk to U.S. military forces of
attack with a biological, chemical,
radiological, or nuclear agent or agents;
(3) a determination by the Secretary of
HHS that there is a public health
emergency, or a significant potential for
a public health emergency, that affects,
or has a significant potential to affect,
national security or the health and
security of U.S. citizens living abroad,
E:\FR\FM\08JYN1.SGM
08JYN1
]]>Agencies
[Federal Register Volume 81, Number 131 (Friday, July 8, 2016)]
[Notices]
[Pages 44628-44629]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-16152]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0001]
Regional Public Workshop on the International Council for
Harmonization of Technical Requirements for Pharmaceuticals for Human
Use Q3D Implementation of Guideline for Elemental Impurities; 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: Regional Public Workshop on ICH Q3D Implementation
of Guideline for Elemental Impurities. The purpose of the public
workshop is to elaborate key aspects of the ICH Guideline Q3D:
Guideline on Elemental Impurities in order facilitate a harmonized
interpretation and implementation by industry and regulators. It is not
intended to provide additional guidance beyond the scope of Q3D. The
meeting will take place on the FDA campus and also be broadcast on the
Web allowing participants to join in person or via the Web.
DATES: The public workshop will be held on August 22 and 23, from 9
a.m. to 5 p.m., EST. See the SUPPLEMENTARY INFORMATION section for
information on how to register.
ADDRESSES: The public workshop will be held at 10903 New Hampshire
Ave., Bldg. 31, Rm. 1503B/C, Silver Spring, MD 20993. The 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: Amanda Roache, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1176, Silver
Spring, MD 20993, 301-796-4548, email: Amanda.Roache@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The ICH brings together regulatory
authorities and pharmaceutical industry to discuss scientific and
technical aspects of drug registration. The ICH's mission is to achieve
greater harmonization worldwide to ensure that safe, effective, and
high quality medicines are developed and registered in the most
resource-efficient manner. The ICH Q3D Guideline was developed by the
ICH to provide a global policy for limiting elemental impurities
qualitatively and quantitatively in drug products and ingredients.
Following finalization of this Guideline, an Implementation Working
Group was established to develop a comprehensive training program and
supporting documents sponsored by ICH to ensure the proper
interpretation and effective utilization
[[Page 44629]]
by industry and regulators alike to enable a harmonized and smooth
implementation of Q3D on a global basis.
The U.S. regional workshop is intended to clarify key aspects of
ICH Q3D: Guideline on Elemental Impurities by elaborating on those key
topics. It will include: (1) A discussion of how to apply Q3D concepts
to routes of administration, not addressed in Q3D, (2) justification
for elemental impurity levels higher than an established permissible
daily exposure (PDE) (3) application of Q3D concepts to determine safe
levels of elements not included in Q3D, (4) discussion of the rationale
for limits on large volume parenterals, (5) elaboration of the concepts
outlined in the Q3D Sections on Risk Assessment and Control of
Elemental Impurities and (6) options for converting between PDEs and
concentrations.
In addition, case studies may be presented to illustrate the
concepts described previously, and frequently asked questions will be
discussed. The presentation of the material will follow the modules
that are available on the ICH Web site, www.ich.org, and will include
time for questions and discussion. Breakout sessions will be provided
to discuss key topics and provide feedback to participants. Material
will be presented by members of the ICH Q3D Implementation Working
Group. The agenda for the workshop will be made available on the
internet at https://www.fda.gov/Drugs/NewsEvents/ucm498553.htm.
Registration: If you wish to attend this meeting, visit the
following Web site to register: https://www.eventbrite.com/e/regional-public-workshop-on-ich-q3d-implementation-of-guideline-for-elemental-impurities-tickets-25492458630. Please register by August 15, 2016. If
you are unable to attend the meeting in person, you can register to
view a live Webcast on the meeting. You will be asked to indicate in
your registration if you plan to attend in person or via the Webcast.
Your registration must also contain your complete contact information,
including name, title, affiliation, address, email address, and phone
number. Registrations may be limited, so early registration is
recommended. Registration is free and will be on a first-come, first-
served basis. However, the number of participants from each
organization may be limited based on space limitations. Registrants
will receive confirmation once they have been accepted. Onsite
registration on the day of the meeting will be based on space
availability. If you need special accommodations because of a
disability, please contact Amanda Roache (see FOR FURTHER INFORMATION
CONTACT) at least 7 days before the meeting.
Dated: July 1, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-16152 Filed 7-7-16; 8:45 am]
BILLING CODE 4164-01-P
