Public Meeting on the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of public meeting; request for comments.

SUMMARY:

The Food and Drug Administration (FDA or Agency) is announcing a regional public meeting entitled “U.S. Food and Drug Administration and Health Canada Joint Public Consultation on International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).” The meeting will take place on the FDA campus and also be broadcast on the Internet. The goal of this meeting is to provide information and receive comments on the ICH, as well as information related to the upcoming ICH meetings in Lisbon, Portugal, in June 2016. The topics to be discussed in the regional public meeting are the topics for discussion at the forthcoming ICH Assembly Meeting. The purpose of this regional public meeting is to solicit public input prior to the next Assembly and Expert Working Group meetings in Lisbon, Portugal, scheduled for June 11 through 16, 2016, at which the discussion of the topics underway and ICH reforms will continue to progress.

DATES:

The public meeting will be held on May 6, 2016, from 9 a.m. to 12 p.m., EST. Registration to attend the Webcast and requests for oral presentations must be received by May 4, 2016. Interested persons may submit either electronic or written comments to the public docket (see ADDRESSES) by June 6, 2016.

ADDRESSES:

The public meeting will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center (Rm. 1503A), Silver Spring, MD 20993-0002. Entrance for the public meeting 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.

You may submit comments as follows:

Electronic Submissions

Submit electronic comments in the following way:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov.
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions.”)

Written/Paper Submissions

Submit written/paper submissions as follows:

• Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

Instructions: All submissions received must include the Docket No. FDA-2016-N-1112 for “The U.S. Food and Drug Administration and Health Canada Joint Public Consultation on International Council on Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; Public Meeting.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.

Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Amanda Roache, Food and Drug Administration, Center for Drug Evaluation and Research, 10903 New Hampshire Ave., Bldg. 51, Rm. 1176, Silver Spring MD, 20993, 301-796-4548, Amanda.Roache@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

The ICH, formerly known as the International Conference on Harmonisation, was established in 1990 as a joint regulatory/industry project to improve, through harmonization, the efficiency of the process for developing and registering new medicinal products in Europe, Japan, and the United States without compromising the regulatory obligations of safety and effectiveness. In 2015, the ICH was reformed to make the ICH a true global initiative that expands beyond the previous ICH members. More involvement from regulators around the world is expected, as they will join their counterparts from Europe, Japan, the United States, Canada, and Switzerland as ICH Regulatory Members. The reforms build on a 25-year track record of successful delivery of harmonized guidelines for global pharmaceutical development, and their regulation. Additionally, the reforms strengthen ICH as the leading platform for global pharmaceutical regulatory harmonization, and brings together in a transparent manner all key regulatory authorities and industry stakeholders.

In recent years, many important initiatives have been undertaken by regulatory authorities and industry associations to promote international harmonization of regulatory requirements. FDA has participated in many meetings designed to enhance harmonization and is committed to seeking scientifically based harmonized technical procedures for pharmaceutical development. One of the goals of harmonization is to identify and then reduce differences in technical requirements for medical product development among regulatory Agencies. ICH was organized to provide an opportunity for harmonization initiatives to be developed with input from both regulatory and industry representatives. Members of the ICH Management Committee include the European Union; the European Federation of Pharmaceutical Industries Associations; the Japanese Ministry of Health, Labor, and Welfare; the Japanese Pharmaceutical Manufacturers Association; FDA; the Pharmaceutical Research and Manufacturers of America; Health Canada; Swissmedic; the World Health Organization; and International Federation of Pharmaceutical Manufacturers and Associations (as Observers). The ICH process has achieved significant harmonization of the technical requirements for the approval of pharmaceuticals for human use in the ICH regions over the past two decades. The current ICH process and structure can be found at the following Web site: http://www.ich.org. (FDA has verified the Web site addresses as of the date this document publishes in the Federal Register, but Web sites are subject to change over time.)

II. Webcast Attendance and Participation

A. Registration

If you wish to attend this meeting, visit http://ichpublicconsult2016.eventbrite.com. Please register by May 4, 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 Webcast.

B. Requests for Oral Presentations

Interested persons may present data, information, or views orally or in writing on issues pending at the public Webcast. Public oral presentations will be scheduled between approximately 11:30 a.m. and 12 p.m. Time allotted for oral presentations may be limited to 5 minutes. Those desiring to make oral presentations should notify Amanda Roache (see FOR FURTHER INFORMATION CONTACT) by April 29, 2016, and submit a brief statement of the general nature of the evidence or arguments they wish to present; the names and addresses, telephone number, fax, and email of proposed participants; and an indication of the approximate time requested to make their presentation. The agenda for the public Webcast will be made available on the Internet at http://www.fda.gov/Drugs/NewsEvents/ucm488618.htm.