81_FR_5488 81 FR 5467 - The Arthritis Foundation-Food and Drug Administration Accelerating Osteoarthritis Clinical Trials Workshop

81 FR 5467 - The Arthritis Foundation-Food and Drug Administration Accelerating Osteoarthritis Clinical Trials Workshop

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 21 (February 2, 2016)

Page Range5467-5468
FR Document2016-01789

Osteoarthritis is the most common form of arthritis, and occurs when the cartilage that cushions the bones of the joint break down and the bones begin to rub together. This can cause pain, swelling, and loss of motion of the joint. The Food and Drug Administration's (FDA) Center for Drug Evaluation and Research, in co- sponsorship with the Arthritis Foundation is announcing a workshop entitled, ``Accelerating OA Clinical Trials Workshop''. The purpose of the workshop is to discuss recommendations from the international Arthritis Foundation Accelerating Osteoarthritis Clinical Trial workgroup and identify next steps in forging new approaches to osteoarthritis clinical trials that may improve the likelihood of successful conduct and outcomes of these trials and lead to the development of safe and effective treatments for osteoarthritis.

Federal Register, Volume 81 Issue 21 (Tuesday, February 2, 2016) 
[Federal Register Volume 81, Number 21 (Tuesday, February 2, 2016)]
[Notices]
[Pages 5467-5468]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-01789]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]


The Arthritis Foundation--Food and Drug Administration 
Accelerating Osteoarthritis Clinical Trials Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of workshop.

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SUMMARY: Osteoarthritis is the most common form of arthritis, and 
occurs when the cartilage that cushions the bones of the joint break 
down and the bones begin to rub together. This can cause pain, 
swelling, and loss of motion of the joint. The Food and Drug 
Administration's (FDA) Center for Drug Evaluation and Research, in co-
sponsorship with the Arthritis Foundation is announcing a workshop 
entitled, ``Accelerating OA Clinical Trials Workshop''. The purpose of 
the workshop is to discuss recommendations from the international 
Arthritis Foundation Accelerating Osteoarthritis Clinical Trial 
workgroup and identify next steps in forging new approaches to 
osteoarthritis clinical trials that may improve the likelihood of 
successful conduct and outcomes of these trials and lead to the 
development of safe and effective treatments for osteoarthritis.

DATES: The workshop will be held on February 24, 2016, from 8 a.m. to 
5:30 p.m., and February 25, 2016, from 8 a.m. to 2 p.m.

ADDRESSES: The workshop will be held at the Atlanta Airport Hilton, 
1031 Virginia Ave., Atlanta, GA 30354.

FOR FURTHER INFORMATION CONTACT: Sarah Yim, Office of New Drugs, Center 
for Drug Evaluation and Research, email: [email protected]; Amanda 
Niskar, Arthritis Foundation, Inc., 1330 West Peachtree St., Atlanta, 
GA 30309, 404-964-7545, FAX: 404-965-7807, email: 
[email protected]; or Becky Bosworth, Arthritis Foundation, Inc., 
1330 West Peachtree St., Atlanta, GA 30309, 404-965-7673, email: 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    The osteoarthritis (OA) community of clinicians, physicians and 
scientists have been challenged to get new treatments to market so that 
people with OA can benefit at the point of care. The Arthritis 
Foundation and FDA are convening experts to discuss alternative 
approaches to clinical trials in OA.

[[Page 5468]]

Workshop objectives will include discussion and identification of 
promising innovations that could facilitate successful trials in OA, 
new approaches to recruitment for clinical trials, feasible and 
clinically meaningful trial endpoints, and approaches for reducing the 
time and cost of OA trials while maximizing the likelihood of success.
    Registration: There is no fee to attend the workshop, but attendees 
must register in advance. Space is very limited. Persons interested in 
attending this workshop may request to register by sending their resume 
and inquiry to [email protected]. The registration deadline is 
February 2, 2016.

II. Accommodations

    An online registration link and a meeting code will be provided 
through the registration process giving participants a reduced group 
rate for hotel accomodations, not including applicable taxes. No 
additional reservations are required. Industry and government attendees 
are responsible for the cost of their own accomodations. If you need 
special accommodations due to a disability, please contact Becky 
Bosworth at [email protected] at least 7 days in advance.

III. Transcripts

    No transcripts will be available from the event, however, the event 
will be video taped for the purposes of the Arthritis Foundation. 
Speaker presentation materials, if permitted by the presenter, will be 
available on the Arthritis Foundation Web site following the workshop.

     Dated: January 27, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-01789 Filed 2-1-16; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 21 / Tuesday, February 2, 2016 / Notices 5467 The numbers of patents submitted to information collection burden DEPARTMENT OF HEALTH AND FDA for listing in the Orange Book in associated with § 314.50(h) (citing HUMAN SERVICES 2012, 2013, and 2014 were 458, 509, § 314.53) and Forms FDA 3542 and and 617, respectively, for an annual 3542a will be approximately 5 hours Food and Drug Administration average of 528 (458 patents + 509 and 20 hours per response, respectively. [Docket No. FDA–2016–N–0001] patents + 617 patents)/3 years = 528 Dated: January 27, 2016. patents/year). Because many of these Leslie Kux, The Arthritis Foundation—Food and individual patents are included in Associate Commissioner for Policy. Drug Administration Accelerating multiple NDA submissions, there could Osteoarthritis Clinical Trials Workshop [FR Doc. 2016–01782 Filed 2–1–16; 8:45 am] be multiple declarations for a single patent. From our previous review of BILLING CODE 4164–01–P AGENCY: Food and Drug Administration, submissions, we believe that HHS. approximately 14 percent of the patents ACTION: Notice of workshop. DEPARTMENT OF HEALTH AND submitted are included in multiple NDA HUMAN SERVICES SUMMARY: Osteoarthritis is the most submissions, and thus require multiple common form of arthritis, and occurs patent declarations. Therefore, we Food and Drug Administration when the cartilage that cushions the estimate that 74 (528 patents × 14 bones of the joint break down and the percent) patents will be multiple [Docket No. FDA–2012–N–0129] bones begin to rub together. This can listings, and there will be a total of 602 cause pain, swelling, and loss of motion patents (528 patents + 74 patents = 602 Agency Information Collection of the joint. The Food and Drug patents) declared on Form FDA 3542. Activities; Announcement of Office of Administration’s (FDA) Center for Drug We approved 86, 94, and 107 NDAs in Management and Budget Approval; Evaluation and Research, in co- calendar years 2012, 2013, and 2014, General Licensing Provisions; Section sponsorship with the Arthritis respectively, of which we estimate 351(k) Biosimilar Applications Foundation is announcing a workshop based on our previous review that entitled, ‘‘Accelerating OA Clinical approximately 71 percent submitted AGENCY: Food and Drug Administration, Trials Workshop’’. The purpose of the patent information for listing in the HHS. workshop is to discuss Orange Book. The remaining NDAs ACTION: Notice. recommendations from the international submitted Form FDA 3542 as required Arthritis Foundation Accelerating and declared that there were no relevant SUMMARY: The Food and Drug Administration (FDA) is announcing Osteoarthritis Clinical Trial workgroup patents. We also approved and identify next steps in forging new approximately 101, 101, and 110 NDA that a collection of information entitled ‘‘General Licensing Provisions; Section approaches to osteoarthritis clinical supplements in FYs 2012, 2013, and trials that may improve the likelihood of 2014, respectively, for which 351(k) Biosimilar Applications’’ has been approved by the Office of successful conduct and outcomes of submission of a patent declaration these trials and lead to the development would be required. We estimate there Management and Budget (OMB) under the Paperwork Reduction Act of 1995. of safe and effective treatments for will be 200 instances (based on an osteoarthritis. average of 96 NDA approvals and 104 FOR FURTHER INFORMATION CONTACT: FDA supplement approvals per year) where PRA Staff, Office of Operations, Food DATES: The workshop will be held on an NDA holder would be affected by the and Drug Administration, 8455 February 24, 2016, from 8 a.m. to 5:30 patent declaration requirements, and Colesville Rd., COLE–14526, Silver p.m., and February 25, 2016, from 8 a.m. that each of these NDA holders would, Spring, MD 20993–0002, PRAStaff@ to 2 p.m. on average, submit 3.4 declarations (602 fda.hhs.gov. ADDRESSES: The workshop will be held patent declarations + 74 no relevant at the Atlanta Airport Hilton, 1031 SUPPLEMENTARY INFORMATION: On July 8, patent declarations)/200 instances = 3.4 Virginia Ave., Atlanta, GA 30354. 2015, the Agency submitted a proposed declarations per instance) on Form FDA collection of information entitled FOR FURTHER INFORMATION CONTACT: 3542. We filed 112, 116, and 113 NDAs ‘‘General Licensing Provisions; Section Sarah Yim, Office of New Drugs, Center in 2012, 2013, and 2014, respectively, 351(k) Biosimilar Applications’’ to OMB for Drug Evaluation and Research, and 112, 112, 156 NDA supplements in for review and clearance under 44 email: sarah.yim@fda.hhs.gov; Amanda 2012, 2013, and 2014, respectively, for U.S.C. 3507. An Agency may not Niskar, Arthritis Foundation, Inc., 1330 which submission of a patent conduct or sponsor, and a person is not West Peachtree St., Atlanta, GA 30309, declaration would be required. We required to respond to, a collection of 404–964–7545, FAX: 404–965–7807, estimate there will be 241 instances information unless it displays a email: aniskar@arthritis.org; or Becky (based on an average of 114 NDAs filed currently valid OMB control number. Bosworth, Arthritis Foundation, Inc., and 127 NDA supplements filed per OMB has now approved the information 1330 West Peachtree St., Atlanta, GA year) where an NDA holder would be collection and has assigned OMB 30309, 404–965–7673, email: affected by the patent declaration control number 0910–0719. The bbosworth@arthritis.org. requirements. We estimate, based on a approval expires on December 31, 2018. SUPPLEMENTARY INFORMATION: proportional increase from the number A copy of the supporting statement for of declarations for approved NDAs, that I. Background this information collection is available there will be an annual total of 819 on the Internet at http:// The osteoarthritis (OA) community of wgreen on DSK2VPTVN1PROD with NOTICES declarations (241 instances × 3.4 www.reginfo.gov/public/do/PRAMain. clinicians, physicians and scientists declarations per instance = 819 have been challenged to get new declarations) on Form FDA 3542a Dated: January 27, 2016. treatments to market so that people with submitted with these applications. Leslie Kux, OA can benefit at the point of care. The Based upon information provided by Associate Commissioner for Policy. Arthritis Foundation and FDA are regulated entities and other information, [FR Doc. 2016–01783 Filed 2–1–16; 8:45 am] convening experts to discuss alternative we previously estimated that the BILLING CODE 4164–01–P approaches to clinical trials in OA. VerDate Sep<11>2014 15:21 Feb 01, 2016 Jkt 238001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 E:\FR\FM\02FEN1.SGM 02FEN1

5468 Federal Register / Vol. 81, No. 21 / Tuesday, February 2, 2016 / Notices Workshop objectives will include SUMMARY: The Food and Drug including its challenges and operations. discussion and identification of Administration (FDA) is announcing The purpose of this document is to promising innovations that could that a collection of information entitled invite biologics facilities to contact facilitate successful trials in OA, new ‘‘Improving Food Safety and Defense CBER for more information if they are approaches to recruitment for clinical Capacity of the State and Local Level: interested in participating in this trials, feasible and clinically meaningful Review of State and Local Capacities’’ program. trial endpoints, and approaches for has been approved by the Office of DATES: Submit either an electronic or reducing the time and cost of OA trials Management and Budget (OMB) under written request for participation in this while maximizing the likelihood of the Paperwork Reduction Act of 1995. program by March 3, 2016. The request success. FOR FURTHER INFORMATION CONTACT: FDA should include a description of your Registration: There is no fee to attend PRA Staff, Office of Operations, Food facility relative to products regulated by the workshop, but attendees must and Drug Administration, 8455 CBER. Please specify the physical register in advance. Space is very Colesville Rd., COLE–14526, Silver address(es) of the site(s) you are limited. Persons interested in attending Spring, MD 20993–0002, PRAStaff@ offering. this workshop may request to register by fda.hhs.gov. ADDRESSES: If your biologics facility is sending their resume and inquiry to SUPPLEMENTARY INFORMATION: On interested in offering a site visit, submit AFScience@arthritis.org. The November 30, 2015, the Agency either an electronic request to http:// registration deadline is February 2, submitted a proposed collection of www.regulations.gov or a written 2016. information entitled ‘‘Improving Food request to the Division of Dockets II. Accommodations Safety and Defense Capacity of the State Management (HFA–305), Food and Drug and Local Level: Review of State and Administration, 5630 Fishers Lane, Rm. An online registration link and a Local Capacities’’ to OMB for review 1061, Rockville, MD 20852. If you meeting code will be provided through and clearance under 44 U.S.C. 3507. An previously responded to earlier requests the registration process giving Agency may not conduct or sponsor, to participate in this program and you participants a reduced group rate for and a person is not required to respond continue to be interested in hotel accomodations, not including to, a collection of information unless it participating, please renew your request applicable taxes. No additional displays a currently valid OMB control through a submission to the Division of reservations are required. Industry and number. OMB has now approved the Dockets Management. government attendees are responsible information collection and has assigned FOR FURTHER INFORMATION CONTACT: for the cost of their own accomodations. OMB control number 0910–0726. The Cynthia Whitmarsh, Division of If you need special accommodations approval expires on January 31, 2019. A Manufacturers Assistance and Training, due to a disability, please contact Becky copy of the supporting statement for this Center for Biologics Evaluation and Bosworth at bbosworth@arthritis.org at information collection is available on Research, Food and Drug least 7 days in advance. the Internet at http://www.reginfo.gov/ Administration, 10903 New Hampshire III. Transcripts public/do/PRAMain. Ave., Bldg. 71, Rm. G112, Silver Spring, No transcripts will be available from Dated: January 27, 2016. MD 20993–0002, 240–402–8010, FAX: the event, however, the event will be Leslie Kux, 301–595–1243, email: video taped for the purposes of the Industry.Biologics@fda.hhs.gov. Associate Commissioner for Policy Arthritis Foundation. Speaker SUPPLEMENTARY INFORMATION: [FR Doc. 2016–01785 Filed 2–1–16; 8:45 am] presentation materials, if permitted by BILLING CODE 4164–01–P I. Background the presenter, will be available on the CBER regulates certain biological Arthritis Foundation Web site following products including blood and blood the workshop. DEPARTMENT OF HEALTH AND products, vaccines, and cellular, tissue, Dated: January 27, 2016. HUMAN SERVICES and gene therapies. CBER is committed Leslie Kux, to advancing the public health through Food and Drug Administration Associate Commissioner for Policy. innovative activities that help ensure [FR Doc. 2016–01789 Filed 2–1–16; 8:45 am] [Docket No. FDA–2016–N–0275] the safety, effectiveness, and availability BILLING CODE 4164–01–P of biological products to patients. To Regulatory Site Visit Training Program support this primary goal, CBER has AGENCY: Food and Drug Administration, initiated various training and DEPARTMENT OF HEALTH AND HHS. development programs, including HUMAN SERVICES ACTION: Notice. programs to further enhance performance of its compliance staff, Food and Drug Administration SUMMARY: The Food and Drug regulatory review staff, and other Administration’s (FDA’s) Center for relevant staff. CBER seeks to [Docket No. FDA–2012–N–0145] Biologics Evaluation and Research continuously enhance and update (CBER) is announcing an invitation for review efficiency and quality, and the Agency Information Collection participation in its Regulatory Site Visit quality of its regulatory efforts and Activities; Announcement of Office of Training Program (RSVP). This training interactions, by providing CBER staff Management and Budget Approval; program is intended to give CBER with a better understanding of the wgreen on DSK2VPTVN1PROD with NOTICES Improving Food Safety and Defense regulatory review, compliance, and biologics industry and its operations. Capacity of the State and Local Level: other relevant staff an opportunity to Further, CBER seeks to enhance: (1) Its Review of State and Local Capacities visit biologics facilities. These visits are understanding of current industry AGENCY: Food and Drug Administration, intended to allow CBER staff to directly practices and regulatory impacts and HHS. observe routine manufacturing practices needs and (2) communication between and to give CBER staff a better CBER staff and industry. CBER initiated ACTION: Notice. understanding of the biologics industry, its RSVP in 2005. Through these annual VerDate Sep<11>2014 15:21 Feb 01, 2016 Jkt 238001 PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 E:\FR\FM\02FEN1.SGM 02FEN1


Document Created: 2016-02-02 00:31:42
Document Modified: 2016-02-02 00:31:42
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of workshop.
DatesThe workshop will be held on February 24, 2016, from 8 a.m. to 5:30 p.m., and February 25, 2016, from 8 a.m. to 2 p.m.
ContactSarah Yim, Office of New Drugs, Center for Drug Evaluation and Research, email: [email protected]; Amanda Niskar, Arthritis Foundation, Inc., 1330 West Peachtree St., Atlanta, GA 30309, 404-964-7545, FAX: 404-965-7807, email: [email protected]; or Becky Bosworth, Arthritis Foundation, Inc., 1330 West Peachtree St., Atlanta, GA 30309, 404-965-7673, email: [email protected]
FR Citation81 FR 5467 
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