80 FR 54567 - Osteoporosis Drug Development; Public Workshop; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 175 (September 10, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 175 (September 10, 2015)
| Page Range | 54567-54568 | |
| FR Document | 2015-22784 |
[Federal Register Volume 80, Number 175 (Thursday, September 10, 2015)] [Notices] [Pages 54567-54568] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-22784] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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: [email protected]. 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 [email protected] 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
![Federal Register / Vol. 80, No. 175 / Thursday, September 10, 2015 / Notices 54567
In the Federal Register of October 23, RegulatoryInformation/Guidances/ Ave., Bldg. 22, Rm. 5379, Silver Spring,
2013 (78 FR 63219), FDA published a default.htm. MD 20993–0002, 301–796–9687, email:
notice announcing the availability of a Dated: September 4, 2015. Samantha.Bell@fda.hhs.gov.
draft guidance entitled ‘‘Q3D Elemental Leslie Kux, SUPPLEMENTARY INFORMATION:
Impurities.’’ The notice gave interested
Associate Commissioner for Policy. I. Background
persons an opportunity to submit
[FR Doc. 2015–22835 Filed 9–9–15; 8:45 am] FDA is announcing a public
comments by December 23, 2013.
BILLING CODE 4164–01–P workshop entitled ‘‘Osteoporosis Drug
After consideration of the comments
received and revisions to the guidance, Development: Moving Forward.’’ The
a final draft of the guidance was Agency will engage experts in
DEPARTMENT OF HEALTH AND osteoporosis to address challenging
submitted to the ICH Steering
HUMAN SERVICES issues related to osteoporosis drug
Committee and endorsed by the three
participating regulatory agencies on Food and Drug Administration development. Workshop sessions will
December 16, 2014. include discussions on the indication
The guidance establishes permitted [Docket No. FDA–2015–N–3172] language, target populations for
daily exposures for 24 elements in drug treatment and prevention of
Osteoporosis Drug Development; osteoporosis, and phase 3 clinical trial
products and provides for a risk-based
Public Workshop; Request for design issues. The afternoon discussion
approach to assessing the likelihood
Comments session will focus on surrogate
that elemental impurities with
established permitted daily exposures AGENCY: Food and Drug Administration, endpoints for fracture and the
will be present in a pharmaceutical HHS. requirements for validation of a
product. In response to comments on surrogate endpoint. This workshop is
ACTION: Notice of public workshop;
the draft guidance, several changes were part of the Agency’s program to
request for comments.
made to the final guidance including facilitate the development of surrogate
clarifying the scope, reevaluation of The Food and Drug Administration’s endpoints, clinical endpoints, and other
some permitted daily exposures based (FDA or Agency) Division of Bone, scientific methods for predicting
on new toxicology data, simplification Reproductive, and Urologic Products in clinical benefit, in accordance with
of the classification scheme for the Center for Drug Evaluation and section 901 of the Food and Drug
elemental impurities, and clarifying the Research is announcing a public Administration Safety and Innovation
examples to illustrate certain concepts workshop entitled ‘‘Osteoporosis Drug Act, signed into law on July 9, 2012,
within the guidance. Development: Moving Forward.’’ The which is titled ‘‘Enhancement of
This guidance is being issued purpose of this workshop is to seek Accelerated Patient Access to New
consistent with FDA’s good guidance input from experts on scientific issues Medical Treatments.’’
practices regulation (21 CFR 10.115). important to clinical development of II. Participation in the Public
The guidance represents the current drugs and therapeutic biologics Workshop
thinking of FDA on Q3D elemental intended to treat osteoporosis. During
impurities. It does establish any rights the workshop, attendees will discuss A. Registration and Requests for Oral
for any person and is not binding on potential surrogate endpoints and the Presentations
FDA or the public. You can use an endpoints’ ability to predict clinical There is no fee to attend the public
alternative approach if it satisfies the benefit. workshop, but attendees should register
requirements of the applicable statutes Date and Time: The workshop will be in advance. Space is limited and
and regulations. held on November 4, 2015, from 8 a.m. registration will be on a first-come, first-
to 5 p.m. Registration to attend the served basis. Persons interested in
II. Comments
workshop must be received by October attending this workshop must register
Interested persons may submit either 21, 2015. See the SUPPLEMENTARY online at Osteoporosis_Workshop@
electronic comments regarding this INFORMATION section for information on fda.hhs.gov on or before October 21,
document to http://www.regulations.gov how to register for this workshop. 2015. When registering, please provide
or written comments to the Division of Submit electronic or written comments complete contact information for each
Dockets Management (see ADDRESSES). It by October 7, 2015. attendee, including name, title,
is only necessary to send one set of Location: The workshop will be held affiliation, address, email address, and
comments. Identify comments with the at the FDA White Oak Campus, 10903 telephone number. For those without
docket number found in brackets in the New Hampshire Ave., Bldg. 31 Internet access, please contact Samantha
heading of this document. Received Conference Center, in Sections B and C Bell (see Contact Person) to register. If
comments may be seen in the Division of the Great Room (Rm. 1503), Silver you need special accommodations due
of Dockets Management between 9 a.m. Spring, MD 20993–0002. Entrance for to a disability, please contact Samantha
and 4 p.m., Monday through Friday, and the workshop participants (non-FDA Bell (see Contact Person) at least 7 days
will be posted to the docket at http:// employees) is through Building 1, where in advance.
www.regulations.gov. routine security check procedures will The afternoon session will have an
be performed. For more information on open public hearing. Interested persons
III. Electronic Access
parking and security procedures, please may present data, information, or views,
mstockstill on DSK4VPTVN1PROD with NOTICES
Persons with access to the Internet refer to http://www.fda.gov/AboutFDA/ orally or in writing, on issues related to
may obtain the document at http:// WorkingatFDA/BuildingsandFacilities/ osteoporosis drug development. Those
www.regulations.gov, http:// WhiteOakCampusInformation/ individuals interested in making formal
www.fda.gov/Drugs/Guidance ucm241740.htm. oral presentations should notify the
ComplianceRegulatoryInformation/ Contact Person: Samantha Bell, contact person and submit the following
Guidances/default.htm, or http:// Center for Drug Evaluation and information on or before October 21,
www.fda.gov/BiologicsBloodVaccines/ Research, Food and Drug 2015: A brief statement of the general
GuidanceCompliance Administration, 10903 New Hampshire nature of the evidence or arguments
VerDate Sep<11>2014 17:28 Sep 09, 2015 Jkt 235001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 E:\FR\FM\10SEN1.SGM 10SEN1](https://thefederalregister.org/doc/80_FR_54742/page/1.svg)
![54568 Federal Register / Vol. 80, No. 175 / Thursday, September 10, 2015 / Notices
they wish to present, the names and DEPARTMENT OF HEALTH AND I. Background
addresses of proposed participants, and HUMAN SERVICES FDA is announcing the availability of
an indication of the approximate time draft GFI #231 entitled ‘‘Distributor
requested to make their presentation. Food and Drug Administration Labeling for New Animal Drugs.’’
Oral presentations from the public will ‘‘Distributor labeling’’ refers to the
be scheduled between approximately 2 [Docket No. FDA–2015–D–3056] labeling of an approved new animal
p.m. and 3 p.m. Time allotted for each drug marketed by a distributor who
presentation may be limited. If the Distributor Labeling for New Animal distributes the product under its own
number of registrants requesting to Drugs; Draft Guidance for Industry; label or proprietary name. Unlike the
speak is greater than can be reasonably Availability approved labeling, which the Center for
accommodated during the scheduled Veterinary Medicine reviews as part of
AGENCY: Food and Drug Administration,
open public hearing session, FDA may a NADA/ANADA approval process to
HHS.
conduct a lottery to determine the ensure the safe and effective use of the
speakers for the scheduled open public ACTION: Notice. drug and compliance with the Federal
hearing session. The contact person will Food, Drug, and Cosmetic Act (the
SUMMARY: The Food and Drug FD&C Act) and its implementing
notify interested persons regarding their Administration (FDA) is announcing the regulations, distributor labeling does not
requests to speak by October 28, 2015. availability of a draft guidance for ordinarily go through a premarket
B. Comments industry (GIF) #231 entitled ‘‘Distributor approval process.
Labeling for New Animal Drugs.’’ This FDA regulations (21 CFR 514.80)
Regardless of whether you attend this draft guidance discusses FDA’s current require that distributor labeling be
meeting, you can submit either thinking with respect to the factors it identical to the labeling approved in the
electronic comments regarding this considers in determining whether to NADA/ANADA, except for a different
public workshop to http:// take regulatory action against distributor and suitable proprietary name and the
www.regulations.gov or written labeling for a new animal drug that name and address of the distributor
comments to the Division of Dockets differs from the labeling approved as preceded by an appropriate qualifying
Management (HFA–305), Food and Drug part of a New Animal Drug Application phrase. These requirements are meant to
Administration, 5630 Fishers Lane, Rm. or Abbreviated New Animal Drug ensure that distributor labeling complies
1061, Rockville, MD 20852. All Application (NADA/ANADA) in ways with the requirements of the FD&C Act
comments should be identified with the other than those permitted by and its implementing regulations and to
docket number found in brackets in the regulation. prevent distributor label products from
heading of this document and must be reaching the market with labeling that
DATES: Although you can comment on compromises the safe and effective use
received by December 29, 2015. any guidance at any time (see 21 CFR of the new animal drug.
Received comments may be seen in the 10.115(g)(5)), to ensure that the Agency
Division of Dockets Management considers your comment on this draft II. Significance of Guidance
between 9 a.m. and 4 p.m., Monday guidance before it begins work on the This level 1 draft guidance is being
through Friday, and will be posted to final version of the guidance, submit issued consistent with FDA’s good
the docket at http:// either electronic or written comments guidance practices regulation (21 CFR
www.regulations.gov. on the draft guidance by November 9, 10.115). The draft guidance, when
2015. finalized, will represent the current
C. Transcripts thinking of FDA on distributor labeling
ADDRESSES: Submit written requests for for new animal drugs. It does not
Transcripts of the workshop will be single copies of the draft guidance to the
available for review at the Division of establish any rights for any person and
Policy and Regulations Staff (HFV–6), is not binding on FDA or the public.
Dockets Management (see Comments) Center for Veterinary Medicine, Food You can use an alternative approach if
and at http://www.regulations.gov and Drug Administration, 7519 Standish it satisfies the requirements of the
approximately 30 days after the Pl., Rockville, MD 20855. Send one self- applicable statutes and regulations.
workshop. A transcript will also be addressed adhesive label to assist that
available in either hardcopy or on CD– office in processing your requests. See III. Paperwork Reduction Act of 1995
ROM, after submission of a Freedom of the SUPPLEMENTARY INFORMATION section This draft guidance refers to
Information request. The Freedom of for electronic access to the draft previously approved collections of
Information office address is available guidance document. information found in FDA regulations.
on the Agency’s Web site at http:// Submit electronic comments on the These collections of information are
www.fda.gov. draft guidance to http:// subject to review by the Office of
Dated: September 3, 2015 www.regulations.gov. Submit written Management and Budget (OMB) under
comments to the Division of Dockets the Paperwork Reduction Act of 1995
Leslie Kux,
Management (HFA–305), Food and Drug (44 U.S.C. 3501–3520). The collections
Associate Commissioner for Policy. Administration, 5630 Fishers Lane, Rm. of information in § 514.80 have been
[FR Doc. 2015–22784 Filed 9–9–15; 8:45 am] 1061, Rockville, MD 20852. approved under OMB control number
BILLING CODE 4164–01–P
FOR FURTHER INFORMATION CONTACT:
0910–0284.
mstockstill on DSK4VPTVN1PROD with NOTICES
Dorothy McAdams, Center for IV. Comments
Veterinary Medicine, Division of Interested persons may submit either
Surveillance (HFV–210), Food and Drug electronic comments regarding this
Administration, 7519 Standish Pl., document to http://www.regulations.gov
Rockville, MD 20855, 240–402–5763, or written comments to the Division of
email: dorothy.mcadams@fda.hhs.gov. Dockets Management (see ADDRESSES).
SUPPLEMENTARY INFORMATION: It is only necessary to send one set of
VerDate Sep<11>2014 17:28 Sep 09, 2015 Jkt 235001 PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 E:\FR\FM\10SEN1.SGM 10SEN1](https://thefederalregister.org/doc/80_FR_54742/page/2.svg)
Document Created: 2015-12-15 10:03:45
Document Modified: 2015-12-15 10:03:45
| 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; request for comments. | |
| FR Citation | 80 FR 54567 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR