Post-Approval Studies 2012 Workshop: Design, Methodology, and Role in Evidence Appraisal Throughout the Total Product Life Cycle; Public Workshop; Request for Comments, 50514-50515 [2012-20469]

Download as PDF 50514 Federal Register / Vol. 77, No. 162 / Tuesday, August 21, 2012 / Notices worldwide, without further payment or consideration. HHS/CDC claims an irrevocable, royalty-free, non-exclusive worldwide license to use, copy for use, distribute, display publicly, create derivative works, and license others to do so for the purpose of the Dare to Prepare challenge and/or for the purpose of raising awareness for preparedness. Compliance With Rules and Contacting Contest Winners Finalists and the Contest Winners must comply with all terms and conditions of these Official Rules. Winning is contingent upon fulfilling all requirements herein. The finalists will be notified by email after points have been totaled and winners determined. Awards may be subject to Federal income taxes, and the Department of Health and Human Services will comply with the Internal Revenue Service withholding and reporting requirements, where applicable. 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Participation in this Contest constitutes a contestants’ full and unconditional agreement to abide by the Contest’s Official Rules found at www.Challenge.gov. Authority: 15 U.S.C. 3719. Dated: August 14, 2012. Tanja Popovic, Deputy Associate Director for Science, Centers for Disease Control and Prevention. [FR Doc. 2012–20485 Filed 8–20–12; 8:45 am] BILLING CODE 4163–18–P pmangrum on DSK3VPTVN1PROD with NOTICES Liability The Contestant/Submitter agrees to assume any and all risks and waive claims against the Federal Government and its related entities, except in the case of willful misconduct, for any injury, death, damage, or loss of property (including any damage that may result from a virus, malware, etc. to HHS/CDC systems utilized to upload photos), revenue, or profits, whether direct, indirect, or consequential, arising from their participation in the competition, whether the injury, death, damage, or loss arises through negligence or otherwise. The Contestant/Submitter shall be liable for, and shall indemnify and hold harmless the Government against, all actions or claims for any claim, demand, judgment, or other allegation arising from alleged violation of an individual’s trademark, copyright, or other legally protected interest in videos submitted to CDC. VerDate Mar<15>2010 15:31 Aug 20, 2012 Jkt 226001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–N–0891] Post-Approval Studies 2012 Workshop: Design, Methodology, and Role in Evidence Appraisal Throughout the Total Product Life Cycle; Public Workshop; Request for Comments AGENCY: Food and Drug Administration, HHS. Notice of public workshop; request for comments. ACTION: The Food and Drug Administration (FDA) is announcing the following public workshop entitled ‘‘Post-Approval Studies 2012 Workshop: Design, Methodology, and Role in Evidence Appraisal Throughout the Total Product Life Cycle.’’ The topics of SUMMARY: PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 discussion will include lessons learned from previous experiences with postapproval studies, improvement of implementation strategies for postapproval studies, best practices, and innovative methodologies for evidence appraisal. Date and Time: The public workshop will be held on August 30, 2012, from 8 a.m. to 5 p.m. Location: The public workshop will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993. 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 https:// www.fda.gov/AboutFDA/ WorkingatFDA/BuildingsandFacilities/ WhiteOakCampusInformation/ ucm241740.htm. Contact Persons: Nilsa Loyo-Berrios, Center for Devices and Radiological Health (CDRH), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3214, Silver Spring, MD 20993, 301–796–8528, email: Nilsa.Loyo-Berrios @fda.hhs.gov or Danica Marinac-Dabic, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4110, Silver Spring, MD 20993, 301–796– 6689, email: Danica.MarinacDabic@fda.hhs.gov. Registration: Registration is free and available on a first-come, first-served basis. Persons interested in attending this public workshop must register online by 5 p.m. on August 23, 2012. Early registration is recommended because facilities are limited and, therefore, FDA may limit the number of participants from each organization. Onsite registration will not be available on the day of the public workshop. If you need special accommodations due to a disability, please contact Cindy Garris, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg., 66, Rm. 4321, Silver Spring, MD 20993, 301–796–5861, email: Cynthia.garris@fda.hhs.gov. To register for the public workshop, please visit FDA’s Medical Devices News & Events—Workshops & Conferences calendar at https:// www.fda.gov/MedicalDevices/ NewsEvents/WorkshopsConferences/ default.htm. (Select this public workshop from the posted events list.) Please provide complete contact information for each attendee, including name, title, affiliation, address, email, E:\FR\FM\21AUN1.SGM 21AUN1 pmangrum on DSK3VPTVN1PROD with NOTICES Federal Register / Vol. 77, No. 162 / Tuesday, August 21, 2012 / Notices and telephone number. Those without Internet access should contact Nilsa Loyo-Berrios to register (see Contact Persons). Registrants will receive confirmation after they have been accepted. You will be notified if you are on a waiting list. Streaming Webcast of the Public Workshop: This public workshop will also be Webcast. Persons interested in viewing the Webcast must register online by 5 p.m. on August 28, 2012. Early registration is recommended because Webcast connections are limited. Organizations are requested to register all participants, but to view using one connection per location. Web cast participants will be sent technical system requirements after registration and will be sent connection access information after August 23, 2012. If you have never attended a Connect Pro event before, test your connection at https://collaboration.fda.gov/common/ help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program, visit https://www.adobe.com/ go/connectpro_overview. (FDA has verified the Web site addresses in this document, but FDA is not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register.) Comments: FDA is holding this public workshop to provide an update and obtain stakeholders input on postapproval studies ordered at the time of device approval. In order to permit the widest possible opportunity to obtain public comment, FDA is soliciting either electronic or written comments on all aspects of the public workshop topics. The deadline for submitting comments related to this public workshop is September 30, 2012. Regardless of attendance at the public workshop, interested persons may submit either written comments regarding this document to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852 or electronic comments to https://www.regulations.gov. It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. In addition, when responding to specific questions as outlined in section II of this document, please identify the question you are addressing. 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 https:// www.regulations.gov. Transcripts: Please be advised that as soon as a transcript is available, it will VerDate Mar<15>2010 15:31 Aug 20, 2012 Jkt 226001 50515 be accessible at https:// www.regulations.gov. It may be viewed at the Division of Dockets Management (see Comments). A transcript will also be available in either hardcopy or on CD–ROM, after submission of a Freedom of Information request. Written requests are to be sent to the Division of Freedom of Information (ELEM– 1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857. A link to the transcripts will also be available approximately 45 days after the public workshop on the Internet at https:// www.fda.gov/MedicalDevices/ NewsEvents/WorkshopsConferences/ default.htm (Select this public workshop from the posted events list). SUPPLEMENTARY INFORMATION: best practices and improvement of PAS implementation strategies, (3) PAS impact on public health and medical device innovation, and (4) opportunities for innovative uses of PAS data. I. Background Post-approval studies (PAS) are imposed as conditions of approval for some class III devices regulated under premarket approval (PMA) regulations and are an important public health tool for developing additional evidence on device performance in the postmarket setting. In order for PAS to be most effective, studies must be well-designed, scientifically sound, meaningful and feasible, and must provide complete and timely information. PMA conditions of approval studies are constructed to ask for specific, detailed data in a subsequent PAS relating to unanswered questions in premarket data. However, there are often opportunities for leveraging the design and conduct of PAS, enhancing its utility to other important stakeholders. In addition to the direct role of PMA holders, the role of other public health partners is expanding, as evidenced by a number of efforts external to CDRH that are directly or indirectly involved in collecting and analyzing data relevant to estimating medical device use and risk and in communicating risk to target populations. To ensure a successful PAS program, CDRH, regulated industry, clinical researchers, and other stakeholders must remain well-informed and engaged in continuous dialogue regarding the design, implementation, reporting, and use of PAS and the resultant data. Further, it is the Center’s desire to ensure this dialogue results in studies that maximize the public health impact by producing data that is informative to a range of stakeholders. Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. II. Topics for Discussion at the Public Workshop We intend to discuss a large number of issues at the workshop, including, but not limited to the following: (1) PAS within the Total Product Life Cycle, (2) PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 Dated: August 15, 2012. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2012–20469 Filed 8–20–12; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; Translational Research. Date: September 19, 2012. Time: 11:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: Michele L. Barnard, Ph.D., Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health, Room 753, 6707 Democracy Boulevard, Bethesda, MD 20892–2542, (301) 594–8898, barnardm@extra.niddk.nih.gov. Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; Diabetes Ancillary Studies. Date: October 10, 2012. Time: 2:00 p.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 20892, (Telephone Conference Call). Contact Person: D.G. Patel, Ph.D., Scientific Review Officer, Review Branch, DEA, NIDDK, National Institutes of Health, Room 756, 6707 Democracy Boulevard, E:\FR\FM\21AUN1.SGM 21AUN1

Agencies

[Federal Register Volume 77, Number 162 (Tuesday, August 21, 2012)]
[Notices]
[Pages 50514-50515]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-20469]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0891]


Post-Approval Studies 2012 Workshop: Design, Methodology, and 
Role in Evidence Appraisal Throughout the Total Product Life Cycle; 
Public Workshop; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
following public workshop entitled ``Post-Approval Studies 2012 
Workshop: Design, Methodology, and Role in Evidence Appraisal 
Throughout the Total Product Life Cycle.'' The topics of discussion 
will include lessons learned from previous experiences with post-
approval studies, improvement of implementation strategies for post-
approval studies, best practices, and innovative methodologies for 
evidence appraisal.
    Date and Time: The public workshop will be held on August 30, 2012, 
from 8 a.m. to 5 p.m.
    Location: The public workshop will be held at the FDA White Oak 
Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great 
Room (Rm. 1503), Silver Spring, MD 20993. 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 https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    Contact Persons: Nilsa Loyo-Berrios, Center for Devices and 
Radiological Health (CDRH), Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 3214, Silver Spring, MD 20993, 301-796-
8528, email: Nilsa.Loyo-Berrios @fda.hhs.gov or Danica Marinac-Dabic, 
Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4110, Silver 
Spring, MD 20993, 301-796-6689, email: Danica.Marinac-Dabic@fda.hhs.gov.
    Registration: Registration is free and available on a first-come, 
first-served basis. Persons interested in attending this public 
workshop must register online by 5 p.m. on August 23, 2012. Early 
registration is recommended because facilities are limited and, 
therefore, FDA may limit the number of participants from each 
organization. Onsite registration will not be available on the day of 
the public workshop.
    If you need special accommodations due to a disability, please 
contact Cindy Garris, Center for Devices and Radiological Health, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg., 66, Rm. 4321, 
Silver Spring, MD 20993, 301-796-5861, email: 
Cynthia.garris@fda.hhs.gov.
    To register for the public workshop, please visit FDA's Medical 
Devices News & Events--Workshops & Conferences calendar at https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. 
(Select this public workshop from the posted events list.) Please 
provide complete contact information for each attendee, including name, 
title, affiliation, address, email,

[[Page 50515]]

and telephone number. Those without Internet access should contact 
Nilsa Loyo-Berrios to register (see Contact Persons). Registrants will 
receive confirmation after they have been accepted. You will be 
notified if you are on a waiting list.
    Streaming Webcast of the Public Workshop: This public workshop will 
also be Webcast. Persons interested in viewing the Webcast must 
register online by 5 p.m. on August 28, 2012. Early registration is 
recommended because Webcast connections are limited. Organizations are 
requested to register all participants, but to view using one 
connection per location. Web cast participants will be sent technical 
system requirements after registration and will be sent connection 
access information after August 23, 2012. If you have never attended a 
Connect Pro event before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get 
a quick overview of the Connect Pro program, visit https://www.adobe.com/go/connectpro_overview. (FDA has verified the Web site 
addresses in this document, but FDA is not responsible for any 
subsequent changes to the Web sites after this document publishes in 
the Federal Register.)
    Comments: FDA is holding this public workshop to provide an update 
and obtain stakeholders input on post-approval studies ordered at the 
time of device approval. In order to permit the widest possible 
opportunity to obtain public comment, FDA is soliciting either 
electronic or written comments on all aspects of the public workshop 
topics. The deadline for submitting comments related to this public 
workshop is September 30, 2012.
    Regardless of attendance at the public workshop, interested persons 
may submit either written comments regarding this document to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852 or electronic comments 
to https://www.regulations.gov. It is only necessary to send one set of 
comments. Identify comments with the docket number found in brackets in 
the heading of this document. In addition, when responding to specific 
questions as outlined in section II of this document, please identify 
the question you are addressing. 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 https://www.regulations.gov.
    Transcripts: Please be advised that as soon as a transcript is 
available, it will be accessible at https://www.regulations.gov. It may 
be viewed at the Division of Dockets Management (see Comments). A 
transcript will also be available in either hardcopy or on CD-ROM, 
after submission of a Freedom of Information request. Written requests 
are to be sent to the Division of Freedom of Information (ELEM-1029), 
Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., 
Rockville, MD 20857. A link to the transcripts will also be available 
approximately 45 days after the public workshop on the Internet at 
https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm (Select this public workshop from the posted events list).

SUPPLEMENTARY INFORMATION: 

I. Background

    Post-approval studies (PAS) are imposed as conditions of approval 
for some class III devices regulated under premarket approval (PMA) 
regulations and are an important public health tool for developing 
additional evidence on device performance in the postmarket setting. In 
order for PAS to be most effective, studies must be well-designed, 
scientifically sound, meaningful and feasible, and must provide 
complete and timely information. PMA conditions of approval studies are 
constructed to ask for specific, detailed data in a subsequent PAS 
relating to unanswered questions in premarket data. However, there are 
often opportunities for leveraging the design and conduct of PAS, 
enhancing its utility to other important stakeholders. In addition to 
the direct role of PMA holders, the role of other public health 
partners is expanding, as evidenced by a number of efforts external to 
CDRH that are directly or indirectly involved in collecting and 
analyzing data relevant to estimating medical device use and risk and 
in communicating risk to target populations. To ensure a successful PAS 
program, CDRH, regulated industry, clinical researchers, and other 
stakeholders must remain well-informed and engaged in continuous 
dialogue regarding the design, implementation, reporting, and use of 
PAS and the resultant data. Further, it is the Center's desire to 
ensure this dialogue results in studies that maximize the public health 
impact by producing data that is informative to a range of 
stakeholders.

II. Topics for Discussion at the Public Workshop

    We intend to discuss a large number of issues at the workshop, 
including, but not limited to the following: (1) PAS within the Total 
Product Life Cycle, (2) best practices and improvement of PAS 
implementation strategies, (3) PAS impact on public health and medical 
device innovation, and (4) opportunities for innovative uses of PAS 
data.

    Dated: August 15, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-20469 Filed 8-20-12; 8:45 am]
BILLING CODE 4160-01-P

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