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]

Download as PDF 44628 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 http:// 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 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-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]


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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: 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 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