81 FR 68422 - Center for Devices and Radiological Health Veteran Amputee Devices; Public Workshop; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 192 (October 4, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 192 (October 4, 2016)
| Page Range | 68422-68424 | |
| FR Document | 2016-23924 |
[Federal Register Volume 81, Number 192 (Tuesday, October 4, 2016)] [Notices] [Pages 68422-68424] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-23924] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-2655] Center for Devices and Radiological Health Veteran Amputee Devices; 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 ``Center for Devices and Radiological Health Veteran Amputee Devices.'' The purpose of this workshop is to engage all stakeholders involved in the research, development, and marketing of prosthetic limb medical devices used by veteran amputees. A specific goal is to engage veteran amputees who use prosthetic limb medical devices and hear their views on these devices so that these perspectives may be considered in the total product life cycle of prosthetic limb devices. DATES: The public workshop will be held on October 31, 2016, from 9 a.m. to 4 p.m. Submit either electronic or written comments on the public workshop by November 30, 2016. ADDRESSES: The public workshop will be held at FDA's White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993. 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.'' [[Page 68423]] Instructions: All submissions received must include the Docket No. FDA-2016-N-2655 for ``Center for Devices and Radiological Health Veteran Amputee Devices.'' 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: Fabienne Santel, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3502, Silver Spring, MD 20993, 301-796- 9644, email: [email protected]. SUPPLEMENTARY INFORMATION: I. Background The Center for Devices and Radiological Health (CDRH) is committed to including views of patients on the total product life cycle of medical devices. To better understand their needs, CDRH plans to engage patients throughout our regulatory process. CDRH is interested in patients contributing their views, data, and resources to improve the total product life cycle for medical devices, reduce adverse events, and improve communication about the risks and benefits that matter most to them. Together with other centers and offices across FDA, we are testing and developing ways to engage patients and capture their views through public workshops. The CDRH Veteran Amputee Devices is one such workshop intended to engage veteran amputees, such as those patients from the Walter Reed National Military Medical Center, Warrior Clinic, who use prosthetic limb medical devices. II. Topics for Discussion at the CDRH Veteran Amputee Devices Public Workshop Topics to be discussed at the public workshop include, but are not limited to the following: Introduce the CDRH Total Product life Cycle (TPLC) for prosthetic limb devices. A focus group to obtain information on priorities for upper-limb prosthetics from the perspective of upper-limb amputees. Presentations from prosthetic limb device manufacturer. Question and answer session where patients, their caregivers and other interested parties have an opportunity to present their views and ask questions about the total product life cycle of medical devices. Registration: Registration is free and available on a first-come, first-served basis. Persons interested in attending the CDRH Veteran Amputee Devices public workshop must register online by October 24, 2016. Early registration is recommended because facilities are limited and, therefore, FDA may limit the number of participants from each organization. If time and space permit, onsite registration on the day of the public workshop will be begin at 8 a.m. If you need special accommodations due to a disability, please contact Susan Monahan, Center for Devices and Radiological Health, Office of Communication, Education (OCE), 301-796-5661 email: [email protected] no later than October 17, 2016. To register for the public workshop, please visit FDA's Medical Devices News & Events--Workshops & Conferences calendar at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this meeting/public workshop from the posted events list.) Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone number. Those without Internet access should contact Fabienne Santel to register (see FOR FURTHER INFORMATION CONTACT). 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. The Webcast link will be available on the registration Web page after October 21, 2016. Organizations are requested to view using one connection per location. 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 http://www.adobe.com/go/connectpro_overview. FDA has verified the Web site addresses in this document, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time. Requests for Oral Presentations: This public workshop includes a public comment session and topic-focused sessions. During online registration, you may indicate if you wish to present during a public comment session or participate in a specific session, and which topics you wish to address. FDA has included general topics in this document. FDA will do its best to accommodate requests to make public comments or give presentations during the focused sessions. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations, and request time for a joint presentation, or submit requests for designated representatives to participate in the focused sessions. FDA will determine the amount of time allotted to each presenter and the approximate time each oral presentation is to begin, and will select and notify participants by October 17, 2016. All requests to make oral presentations must be received by October 10, 2016. If selected for presentation, any presentation materials must be emailed to Fabienne Santel (see FOR FURTHER INFORMATION CONTACT) no later than October 28, 2016. If you are a manufacturer and wish to have a display table, please submit this [[Page 68424]] request by October 17, 2016. Space is limited; therefore, FDA will select and notify manufacturers by October 24, 2016. No commercial or promotional material will be permitted to be presented or distributed at the public workshop. FDA is holding this public workshop to obtain views from patients on prosthetic limb devices so that these perspectives may be considered in the total product life cycle of prosthetic limb medical devices. 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 patient workshop is November 30, 2016. Transcripts: Please be advised that as soon as a transcript is available, it will be accessible at http://www.regulations.gov. It may be viewed at the Division of Dockets Management (see ADDRESSES). 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. A link to the transcripts will also be available approximately 45 days after the public workshop on the Internet at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list). Dated: September 26, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-23924 Filed 10-3-16; 8:45 am] BILLING CODE 4164-01-P
![68422 Federal Register / Vol. 81, No. 192 / Tuesday, October 4, 2016 / Notices
representatives, employers, and other parties that provide income to
noncustodial parents.
ANNUAL BURDEN ESTIMATES
Number of Average
Number of Total burden
Instrument responses per burden hours
respondents hours
respondent per response
Income withholding order/notice (Courts, private attorneys, custodial parties 3,699,790 1.00 5 minutes ....... 308,316
or their representatives).
Income withholding orders/termination of employment/income status (Em- 1,207,484 9.694 2 minutes ....... 390,178
ployers and other income providers).
Electronic income withholding orders/termination of employment/income 9,596 136.38 3 seconds ...... 1,090
status (Employers and other income providers).
Estimated Total Annual Burden Hours .................................................... ........................ ........................ ........................ 699,585
In compliance with the requirements DEPARTMENT OF HEALTH AND You may submit comments as
of the Paperwork Reduction Act of 1995 HUMAN SERVICES follows:
(Pub. L. 104–13, 44 U.S.C. Chap 35), the Electronic Submissions
Administration for Children and Food and Drug Administration
Families is soliciting public comment Submit electronic comments in the
[Docket No. FDA–2016–N–2655] following way:
on the specific aspects of the
information collection described above. Center for Devices and Radiological • Federal eRulemaking Portal: http://
Copies of the proposed collection of Health Veteran Amputee Devices; www.regulations.gov. Follow the
information can be obtained and Public Workshop; Request for instructions for submitting comments.
comments may be forwarded by writing Comments Comments submitted electronically,
to the Administration for Children and including attachments, to http://
Families, Office of Planning, Research AGENCY: Food and Drug Administration, www.regulations.gov will be posted to
and Evaluation, 330 C Street SW., HHS. the docket unchanged. Because your
Washington DC 20201. Attn: ACF ACTION: Notice of public workshop; comment will be made public, you are
Reports Clearance Officer. Email request for comments. solely responsible for ensuring that your
comment does not include any
address: infocollection@acf.hhs.gov. All
SUMMARY: The Food and Drug confidential information that you or a
requests should be identified by the title Administration (FDA) is announcing the third party may not wish to be posted,
of the information collection. following public workshop entitled such as medical information, your or
The Department specifically requests ‘‘Center for Devices and Radiological anyone else’s Social Security number, or
comments on: (a) Whether the proposed Health Veteran Amputee Devices.’’ The confidential business information, such
collection of information is necessary purpose of this workshop is to engage as a manufacturing process. Please note
for the proper performance of the all stakeholders involved in the that if you include your name, contact
functions of the agency, including research, development, and marketing information, or other information that
whether the information shall have of prosthetic limb medical devices used identifies you in the body of your
practical utility; (b) the accuracy of the by veteran amputees. A specific goal is comments, that information will be
agency’s estimate of the burden of the to engage veteran amputees who use posted on http://www.regulations.gov.
proposed collection of information; (c) prosthetic limb medical devices and • If you want to submit a comment
the quality, utility, and clarity of the hear their views on these devices so that with confidential information that you
information to be collected; and (d) these perspectives may be considered in do not wish to be made available to the
ways to minimize the burden of the the total product life cycle of prosthetic public, submit the comment as a
collection of information on limb devices. written/paper submission and in the
respondents, including through the use DATES: The public workshop will be manner detailed (see ‘‘Written/Paper
of automated collection techniques or held on October 31, 2016, from 9 a.m. Submissions’’ and ‘‘Instructions’’).
other forms of information technology. to 4 p.m. Submit either electronic or
Written/Paper Submissions
Consideration will be given to written comments on the public
comments and suggestions submitted workshop by November 30, 2016. Submit written/paper submissions as
ADDRESSES: The public workshop will follows:
within 60 days of this publication.
be held at FDA’s White Oak Campus, • Mail/Hand delivery/Courier (for
Robert Sargis, 10903 New Hampshire Ave., Bldg. 31 written/paper submissions): Division of
Reports Clearance Officer. Conference Center, the Great Room (Rm. Dockets Management (HFA–305), Food
[FR Doc. 2016–23865 Filed 10–3–16; 8:45 am] 1503), Silver Spring, MD 20993. and Drug Administration, 5630 Fishers
BILLING CODE 4184–01–P Entrance for the public meeting Lane, Rm. 1061, Rockville, MD 20852.
participants (non-FDA employees) is • For written/paper comments
mstockstill on DSK3G9T082PROD with NOTICES
through Building 1 where routine submitted to the Division of Dockets
security check procedures will be Management, FDA will post your
performed. For parking and security comment, as well as any attachments,
information, please refer to http://www. except for information submitted,
fda.gov/AboutFDA/WorkingatFDA/ marked and identified, as confidential,
BuildingsandFacilities/WhiteOak if submitted as detailed in
CampusInformation/ucm241740.htm. ‘‘Instructions.’’
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![68424 Federal Register / Vol. 81, No. 192 / Tuesday, October 4, 2016 / Notices
request by October 17, 2016. Space is 1995 (the PRA), Federal Agencies are Instructions: All submissions received
limited; therefore, FDA will select and required to publish notice in the must include the Docket No. FDA–
notify manufacturers by October 24, Federal Register concerning each 2016–N–2976 for ‘‘Agency Information
2016. No commercial or promotional proposed collection of information, Collection Activities; Proposed
material will be permitted to be including each proposed extension of an Collection; Comment Request;
presented or distributed at the public existing collection of information, and Information From United States Firms
workshop. to allow 60 days for public comment in and Processors That Export to the
FDA is holding this public workshop response to the notice. This notice European Union.’’ Received comments
to obtain views from patients on solicits comments on reporting will be placed in the docket and, except
prosthetic limb devices so that these requirements in implementing the lists for those submitted as ‘‘Confidential
perspectives may be considered in the of United States (U.S.) firms/processors Submissions,’’ publicly viewable at
total product life cycle of prosthetic exporting shell eggs, game meat and http://www.regulations.gov or at the
limb medical devices. In order to permit game meat products, gelatin, and Division of Dockets Management
the widest possible opportunity to collagen to the European Union (the between 9 a.m. and 4 p.m., Monday
obtain public comment, FDA is EU). through Friday.
soliciting either electronic or written DATES: Submit either electronic or • Confidential Submissions—To
comments on all aspects of the public written comments on the collection of submit a comment with confidential
workshop topics. The deadline for information by December 5, 2016. information that you do not wish to be
submitting comments related to this ADDRESSES: You may submit comments made publicly available, submit your
patient workshop is November 30, 2016. as follows: comments only as a written/paper
Transcripts: Please be advised that as submission. You should submit two
soon as a transcript is available, it will Electronic Submissions
copies total. One copy will include the
be accessible at http:// Submit electronic comments in the information you claim to be confidential
www.regulations.gov. It may be viewed following way: with a heading or cover note that states
at the Division of Dockets Management • Federal eRulemaking Portal: http:// ‘‘THIS DOCUMENT CONTAINS
(see ADDRESSES). A transcript will also www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ The
be available in either hardcopy or on instructions for submitting comments. Agency will review this copy, including
CD–ROM, after submission of a Comments submitted electronically, the claimed confidential information, in
Freedom of Information request. The including attachments, to http:// its consideration of comments. The
Freedom of Information office address is www.regulations.gov will be posted to second copy, which will have the
available on the Agency’s Web site at the docket unchanged. Because your claimed confidential information
http://www.fda.gov. A link to the comment will be made public, you are redacted/blacked out, will be available
transcripts will also be available solely responsible for ensuring that your
for public viewing and posted on http://
approximately 45 days after the public comment does not include any
www.regulations.gov. Submit both
workshop on the Internet at http:// confidential information that you or a
copies to the Division of Dockets
www.fda.gov/MedicalDevices/ third party may not wish to be posted,
Management. If you do not wish your
NewsEvents/WorkshopsConferences/ such as medical information, your or
name and contact information to be
default.htm. (Select this public anyone else’s Social Security number, or
made publicly available, you can
workshop from the posted events list). confidential business information, such
provide this information on the cover
as a manufacturing process. Please note
Dated: September 26, 2016. sheet and not in the body of your
that if you include your name, contact
Leslie Kux, comments and you must identify this
information, or other information that
Associate Commissioner for Policy. identifies you in the body of your information as ‘‘confidential.’’ Any
[FR Doc. 2016–23924 Filed 10–3–16; 8:45 am] comments, that information will be information marked as ‘‘confidential’’
BILLING CODE 4164–01–P posted on http://www.regulations.gov. will not be disclosed except in
• If you want to submit a comment accordance with 21 CFR 10.20 and other
with confidential information that you applicable disclosure law. For more
DEPARTMENT OF HEALTH AND do not wish to be made available to the information about FDA’s posting of
HUMAN SERVICES public, submit the comment as a comments to public dockets, see 80 FR
written/paper submission and in the 56469, September 18, 2015, or access
Food and Drug Administration manner detailed (see ‘‘Written/Paper the information at: http://www.fda.gov/
Submissions’’ and ‘‘Instructions’’). regulatoryinformation/dockets/
[Docket No. FDA–2016–N–2976]
default.htm.
Written/Paper Submissions
Agency Information Collection Docket: For access to the docket to
Activities; Proposed Collection; Submit written/paper submissions as read background documents or the
Comment Request; Information From follows: electronic and written/paper comments
United States Firms and Processors • Mail/Hand delivery/Courier (for received, go to http://
That Export to the European Union written/paper submissions): Division of www.regulations.gov and insert the
Dockets Management (HFA–305), Food docket number, found in brackets in the
AGENCY: Food and Drug Administration, and Drug Administration, 5630 Fishers heading of this document, into the
HHS. Lane, Rm. 1061, Rockville, MD 20852. ‘‘Search’’ box and follow the prompts
• For written/paper comments
mstockstill on DSK3G9T082PROD with NOTICES
ACTION: Notice. and/or go to the Division of Dockets
submitted to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
SUMMARY: The Food and Drug Management, FDA will post your
1061, Rockville, MD 20852.
Administration (FDA or we) is comment, as well as any attachments,
announcing an opportunity for public except for information submitted, FOR FURTHER INFORMATION CONTACT: FDA
comment on the proposed collection of marked and identified, as confidential, PRA Staff, Office of Operations, Food
certain information by the Agency. if submitted as detailed in and Drug Administration, Three White
Under the Paperwork Reduction Act of ‘‘Instructions.’’ Flint North, 10A63, 11601 Landsdown
VerDate Sep<11>2014 19:01 Oct 03, 2016 Jkt 241001 PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 E:\FR\FM\04OCN1.SGM 04OCN1](https://thefederalregister.org/doc/81_FR_68614/page/3.svg)
Document Created: 2016-10-04 03:04:01
Document Modified: 2016-10-04 03:04:01
| 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. | |
| Dates | The public workshop will be held on October 31, 2016, from 9 a.m. to 4 p.m. Submit either electronic or written comments on the public workshop by November 30, 2016. | |
| Contact | Fabienne Santel, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3502, Silver Spring, MD 20993, 301-796- 9644, email: [email protected] | |
| FR Citation | 81 FR 68422 |
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