Document ID: FDA-2015-N-3172-0001
Agency: fda
Document Type: Notice
Title: Osteoporosis Drug Development; Public Workshop; Request for
Comments
Posted Date: 2015-09-10T04:00Z

[Federal Register Volume 80, Number 175 (Thursday, September 10, 2015)]
[Notices]
[Pages 54567-54568]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-22784]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-3172]

Osteoporosis Drug Development; Public Workshop; Request for 
Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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    The Food and Drug Administration's (FDA or Agency) Division of 
Bone, Reproductive, and Urologic Products in the Center for Drug 
Evaluation and Research is announcing a public workshop entitled 
``Osteoporosis Drug Development: Moving Forward.'' The purpose of this 
workshop is to seek input from experts on scientific issues important 
to clinical development of drugs and therapeutic biologics intended to 
treat osteoporosis. During the workshop, attendees will discuss 
potential surrogate endpoints and the endpoints' ability to predict 
clinical benefit.
    Date and Time: The workshop will be held on November 4, 2015, from 
8 a.m. to 5 p.m. Registration to attend the workshop must be received 
by October 21, 2015. See the SUPPLEMENTARY INFORMATION section for 
information on how to register for this workshop. Submit electronic or 
written comments by October 7, 2015.
    Location: The workshop will be held at the FDA White Oak Campus, 
10903 New Hampshire Ave., Bldg. 31 Conference Center, in Sections B and 
C of the Great Room (Rm. 1503), Silver Spring, MD 20993-0002. Entrance 
for the workshop participants (non-FDA employees) is through Building 
1, where routine security check procedures will be performed. For more 
information on parking and security procedures, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    Contact Person: Samantha Bell, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
22, Rm. 5379, Silver Spring, MD 20993-0002, 301-796-9687, email: 
Samantha.Bell@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing a public workshop entitled ``Osteoporosis Drug 
Development: Moving Forward.'' The Agency will engage experts in 
osteoporosis to address challenging issues related to osteoporosis drug 
development. Workshop sessions will include discussions on the 
indication language, target populations for treatment and prevention of 
osteoporosis, and phase 3 clinical trial design issues. The afternoon 
discussion session will focus on surrogate endpoints for fracture and 
the requirements for validation of a surrogate endpoint. This workshop 
is part of the Agency's program to facilitate the development of 
surrogate endpoints, clinical endpoints, and other scientific methods 
for predicting clinical benefit, in accordance with section 901 of the 
Food and Drug Administration Safety and Innovation Act, signed into law 
on July 9, 2012, which is titled ``Enhancement of Accelerated Patient 
Access to New Medical Treatments.''

II. Participation in the Public Workshop

A. Registration and Requests for Oral Presentations

    There is no fee to attend the public workshop, but attendees should 
register in advance. Space is limited and registration will be on a 
first-come, first-served basis. Persons interested in attending this 
workshop must register online at Osteoporosis_Workshop@fda.hhs.gov on 
or before October 21, 2015. When registering, please provide complete 
contact information for each attendee, including name, title, 
affiliation, address, email address, and telephone number. For those 
without Internet access, please contact Samantha Bell (see Contact 
Person) to register. If you need special accommodations due to a 
disability, please contact Samantha Bell (see Contact Person) at least 
7 days in advance.
    The afternoon session will have an open public hearing. Interested 
persons may present data, information, or views, orally or in writing, 
on issues related to osteoporosis drug development. Those individuals 
interested in making formal oral presentations should notify the 
contact person and submit the following information on or before 
October 21, 2015: A brief statement of the general nature of the 
evidence or arguments

[[Page 54568]]

they wish to present, the names and addresses of proposed participants, 
and an indication of the approximate time requested to make their 
presentation. Oral presentations from the public will be scheduled 
between approximately 2 p.m. and 3 p.m. Time allotted for each 
presentation may be limited. If the number of registrants requesting to 
speak is greater than can be reasonably accommodated during the 
scheduled open public hearing session, FDA may conduct a lottery to 
determine the speakers for the scheduled open public hearing session. 
The contact person will notify interested persons regarding their 
requests to speak by October 28, 2015.

B. Comments

    Regardless of whether you attend this meeting, you can submit 
either electronic comments regarding this public workshop to http://www.regulations.gov or written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852. All comments should be identified with 
the docket number found in brackets in the heading of this document and 
must be received by December 29, 2015. Received comments may be seen in 
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday, and will be posted to the docket at http://www.regulations.gov.

C. Transcripts

    Transcripts of the workshop will be available for review at the 
Division of Dockets Management (see Comments) and at http://www.regulations.gov approximately 30 days after the workshop. A 
transcript will also be available in either hardcopy or on CD-ROM, 
after submission of a Freedom of Information request. The Freedom of 
Information office address is available on the Agency's Web site at 
http://www.fda.gov.

    Dated: September 3, 2015
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-22784 Filed 9-9-15; 8:45 am]
 BILLING CODE 4164-01-P