81 FR 44628 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 131 (July 8, 2016)

Page Range		44628-44629
FR Document		2016-16152

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.

Federal Register, Volume 81 Issue 131 (Friday, July 8, 2016)

[Federal Register Volume 81, Number 131 (Friday, July 8, 2016)]
[Notices]
[Pages 44628-44629]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-16152]


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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 http://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: [email protected].

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 http://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

44628 Federal Register / Vol. 81, No. 131 / Friday, July 8, 2016 / Notices

Medical Devices; Third-Party Review a request for accreditation to FDA. efficiency of 510(k) review for low- to
Under the Food and Drug Accredited third-party reviewers have moderate-risk devices.
Administration Modernization Act— the ability to review a manufacturer’s Respondents to this information
OMB Control Number 0910–0375— 510(k) submission for selected devices. collection are businesses or other for-
Extension After reviewing a submission, the profit organizations.
reviewer will forward a copy of the FDA receives an average of one
Section 210 of the Food and Drug 510(k) submission, along with the application for accreditation for third-
Administration Modernization Act reviewer’s documented review and party review per year. According to
(FDAMA) established section 523 of the recommendation, to FDA. Third-party FDA’s data, the number of 510(k)s
Federal Food, Drug, and Cosmetic Act reviewers should maintain records of submitted for third-party review is
(21 U.S.C. 360m), directing FDA to their 510(k) reviews and a copy of the approximately 260 annually, which is
accredit persons in the private sector to 510(k) for a reasonable period of time, 26 annual reviews per each of the 10
review certain premarket notifications usually a period of 3 years. accredited reviewers. Third-party
(510(k)s). Participation in this third- This information collection will allow reviewers are required to keep records
party review program by accredited FDA to continue to implement the of their review of each submission.
persons is entirely voluntary. A third accredited person review program FDA estimates the burden of this
party wishing to participate will submit established by FDAMA and improve the collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Activity responses per burden per Total hours
respondents responses
respondent response

Requests for accreditation ................................................... 1 1 1 24 24
510(k) reviews conducted by accredited third parties ......... 10 26 260 40 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 Average
Number of Total annual
Activity records per burden per Total hours
recordkeepers records
recordkeeper recordkeeping

510(k) reviews ...................................................................... 10 26 260 10 2,600
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Dated: July 1, 2016. Elemental Impurities. The purpose of WhiteOakCampusInformation/
Leslie Kux, the public workshop is to elaborate key ucm241740.htm.
Associate Commissioner for Policy. aspects of the ICH Guideline Q3D: FOR FURTHER INFORMATION CONTACT:
[FR Doc. 2016–16158 Filed 7–7–16; 8:45 am] Guideline on Elemental Impurities in Amanda Roache, Food and Drug
BILLING CODE 4164–01–P
order facilitate a harmonized Administration, 10903 New Hampshire
interpretation and implementation by Ave., Bldg. 51, Rm. 1176, Silver Spring,
industry and regulators. It is not MD 20993, 301–796–4548, email:
DEPARTMENT OF HEALTH AND intended to provide additional guidance Amanda.Roache@fda.hhs.gov.
HUMAN SERVICES beyond the scope of Q3D. The meeting
SUPPLEMENTARY INFORMATION: The ICH
will take place on the FDA campus and
Food and Drug Administration also be broadcast on the Web allowing brings together regulatory authorities
participants to join in person or via the and pharmaceutical industry to discuss
[Docket No. FDA–2016–N–0001] scientific and technical aspects of drug
Web.
registration. The ICH’s mission is to
Regional Public Workshop on the DATES: The public workshop will be achieve greater harmonization
International Council for held on August 22 and 23, from 9 a.m. worldwide to ensure that safe, effective,
Harmonization of Technical to 5 p.m., EST. See the SUPPLEMENTARY and high quality medicines are
Requirements for Pharmaceuticals for INFORMATION section for information on developed and registered in the most
Human Use Q3D Implementation of how to register. resource-efficient manner. The ICH Q3D
Guideline for Elemental Impurities; ADDRESSES: The public workshop will Guideline was developed by the ICH to
Public Workshop be held at 10903 New Hampshire Ave., provide a global policy for limiting
Bldg. 31, Rm. 1503B/C, Silver Spring, elemental impurities qualitatively and
asabaliauskas on DSK3SPTVN1PROD with NOTICES

AGENCY: Food and Drug Administration,
HHS. MD 20993. The entrance for the public quantitatively in drug products and
ACTION: Notice of public workshop. workshop participants (non-FDA ingredients. Following finalization of
employees) is through Building 1 where this Guideline, an Implementation
SUMMARY: The Food and Drug routine security check procedures will Working Group was established to
Administration (FDA) is announcing a be performed. For parking and security develop a comprehensive training
public workshop entitled: Regional information, please refer to http:// program and supporting documents
Public Workshop on ICH Q3D www.fda.gov/AboutFDA/ sponsored by ICH to ensure the proper
Implementation of Guideline for WorkingatFDA/BuildingsandFacilities/ interpretation and effective utilization

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Federal Register / Vol. 81, No. 131 / Friday, July 8, 2016 / Notices 44629

by industry and regulators alike to accommodations because of a disability, 0002. Send one self-addressed adhesive
enable a harmonized and smooth please contact Amanda Roache (see FOR label to assist that office in processing
implementation of Q3D on a global FURTHER INFORMATION CONTACT) at least 7 your request or include a fax number to
basis. days before the meeting. which the Authorization may be sent.
The U.S. regional workshop is Dated: July 1, 2016. See the SUPPLEMENTARY INFORMATION
intended to clarify key aspects of ICH section for electronic access to the
Leslie Kux,
Q3D: Guideline on Elemental Impurities Authorization.
by elaborating on those key topics. It Associate Commissioner for Policy.
[FR Doc. 2016–16152 Filed 7–7–16; 8:45 am] FOR FURTHER INFORMATION CONTACT:
will include: (1) A discussion of how to Carmen Maher, Office of
apply Q3D concepts to routes of BILLING CODE 4164–01–P
Counterterrorism and Emerging Threats,
administration, not addressed in Q3D, Food and Drug Administration, 10903
(2) justification for elemental impurity New Hampshire Ave., Bldg. 1, Rm.
levels higher than an established DEPARTMENT OF HEALTH AND
HUMAN SERVICES 4347, Silver Spring, MD 20993–0002,
permissible daily exposure (PDE) (3) 301–796–8510 (this is not a toll free
application of Q3D concepts to number).
determine safe levels of elements not Food and Drug Administration
included in Q3D, (4) discussion of the [Docket No. FDA–2016–N–1486] SUPPLEMENTARY INFORMATION:
rationale for limits on large volume I. Background
parenterals, (5) elaboration of the Authorization of Emergency Use of an
concepts outlined in the Q3D Sections In Vitro Diagnostic Device for Section 564 of the FD&C Act (21
on Risk Assessment and Control of Detection of Zika Virus; Availability U.S.C. 360bbb–3) as amended by the
Elemental Impurities and (6) options for Project BioShield Act of 2004 (Pub. L.
AGENCY: Food and Drug Administration, 108–276) and the Pandemic and All-
converting between PDEs and HHS.
concentrations. Hazards Preparedness Reauthorization
In addition, case studies may be ACTION: Notice. Act of 2013 (Pub. L. 113–5) allows FDA
presented to illustrate the concepts to strengthen the public health
SUMMARY: The Food and Drug protections against biological, chemical,
described previously, and frequently Administration (FDA) is announcing the
asked questions will be discussed. The nuclear, and radiological agents. Among
issuance of an Emergency Use other things, section 564 of the FD&C
presentation of the material will follow Authorization (EUA) (the Authorization)
the modules that are available on the Act allows FDA to authorize the use of
for an in vitro diagnostic device for an unapproved medical product or an
ICH Web site, www.ich.org, and will detection of the Zika virus in response
include time for questions and unapproved use of an approved medical
to the Zika virus outbreak in the product in certain situations. With this
discussion. Breakout sessions will be Americas. FDA issued this
provided to discuss key topics and EUA authority, FDA can help assure
Authorization under the Federal Food, that medical countermeasures may be
provide feedback to participants. Drug, and Cosmetic Act (the FD&C Act),
Material will be presented by members used in emergencies to diagnose, treat,
as requested by Hologic, Inc. The or prevent serious or life-threatening
of the ICH Q3D Implementation Authorization contains, among other
Working Group. The agenda for the diseases or conditions caused by
things, conditions on the emergency use biological, chemical, nuclear, or
workshop will be made available on the of the authorized in vitro diagnostic
internet at http://www.fda.gov/Drugs/ radiological agents when there are no
device. The Authorization follows the adequate, approved, and available
NewsEvents/ucm498553.htm.
February 26, 2016, determination by the alternatives.
Registration: If you wish to attend this
Secretary of Health and Human Services Section 564(b)(1) of the FD&C Act
meeting, visit the following Web site to
register: https://www.eventbrite.com/e/ (HHS) that there is a significant provides that, before an EUA may be
regional-public-workshop-on-ich-q3d- potential for a public health emergency issued, the Secretary of HHS must
implementation-of-guideline-for- that has a significant potential to affect declare that circumstances exist
elemental-impurities-tickets- national security or the health and justifying the authorization based on
25492458630. Please register by August security of U.S. citizens living abroad one of the following grounds: (1) A
15, 2016. If you are unable to attend the and that involves Zika virus. On the determination by the Secretary of
meeting in person, you can register to basis of such determination, the Homeland Security that there is a
view a live Webcast on the meeting. You Secretary of HHS declared on February domestic emergency, or a significant
will be asked to indicate in your 26, 2016, that circumstances exist potential for a domestic emergency,
registration if you plan to attend in justifying the authorization of involving a heightened risk of attack
person or via the Webcast. Your emergency use of in vitro diagnostic with a biological, chemical, radiological,
registration must also contain your tests for detection of Zika virus and/or or nuclear agent or agents; (2) a
complete contact information, including diagnosis of Zika virus infection, subject determination by the Secretary of
name, title, affiliation, address, email to the terms of any authorization issued Defense that there is a military
address, and phone number. under the FD&C Act. The Authorization, emergency, or a significant potential for
Registrations may be limited, so early which includes an explanation of the a military emergency, involving a
registration is recommended. reasons for issuance, is reprinted in this heightened risk to U.S. military forces of
Registration is free and will be on a first- document. attack with a biological, chemical,
asabaliauskas on DSK3SPTVN1PROD with NOTICES

come, first-served basis. However, the DATES: The Authorization is effective as radiological, or nuclear agent or agents;
number of participants from each of June 17, 2016. (3) a determination by the Secretary of
organization may be limited based on ADDRESSES: Submit written requests for HHS that there is a public health
space limitations. Registrants will single copies of the EUA to the Office emergency, or a significant potential for
receive confirmation once they have of Counterterrorism and Emerging a public health emergency, that affects,
been accepted. Onsite registration on Threats, Food and Drug Administration, or has a significant potential to affect,
the day of the meeting will be based on 10903 New Hampshire Ave., Bldg. 1, national security or the health and
space availability. If you need special Rm. 4338, Silver Spring, MD 20993– security of U.S. citizens living abroad,

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Document Created: 2016-07-08 00:17:26
Document Modified: 2016-07-08 00:17:26

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 August 22 and 23, from 9 a.m. to 5 p.m., EST. See the SUPPLEMENTARY INFORMATION section for information on how to register.
Contact		Amanda Roache, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1176, Silver Spring, MD 20993, 301-796-4548, email: [email protected]
FR Citation		81 FR 44628

81 FR 44628 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 131 (July 8, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration