83 FR 7052 - Pediatric Medical Device Development; Public Meeting; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 33 (February 16, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 33 (February 16, 2018)
| Page Range | 7052-7054 | |
| FR Document | 2018-03215 |
[Federal Register Volume 83, Number 33 (Friday, February 16, 2018)] [Notices] [Pages 7052-7054] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-03215] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-0404] Pediatric Medical Device Development; Public Meeting; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting; request for comments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public meeting entitled ``Pediatric Medical Device Development.'' The purpose of the public meeting is to identify strategies to enhance the medical device ecosystem to cultivate development and innovation of devices that serve the unique needs of pediatric populations. (The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines pediatric patients, for medical device purposes, as age 21 years or younger at the time of diagnosis or treatment and specifies categories of pediatric subpopulations.) Topics for discussion will include ways to improve research infrastructure and research networks to facilitate the conduct of clinical studies of pediatric devices, extrapolation, use of postmarket registries and data to increase pediatric medical device [[Page 7053]] labeling, assistance to medical device manufacturers in developing devices for pediatric populations, and identifying barriers to pediatric device development and incentives to address such barriers. DATES: The public meeting will be held on August 13 and August 14, 2018, from 9 a.m. to 5 p.m. Submit either electronic or written comments on this public meeting by September 14, 2018. See the SUPPLEMENTARY INFORMATION section for registration information. ADDRESSES: The public meeting will be held at FDA's White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, Rm. 1503 (the Great Room), Silver Spring, MD 20993-0002. 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 https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm. You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before September 14, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of September 14, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, 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.'' Instructions: All submissions received must include the Docket No. FDA-2018-N-0404 for ``Pediatric Medical Device Development; Public Meeting; Request for Comments.'' Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 https://www.regulations.gov. Submit both copies to the Dockets Management Staff. 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: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Victoria Wagman, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5562, Silver Spring, MD 20993, 301-796- 6581, [email protected]. SUPPLEMENTARY INFORMATION: I. Background For more than a decade, legislative changes and regulatory process improvements have been implemented to facilitate development of medical devices that serve the unique needs of pediatric populations. The FD&C Act defines pediatric patients, for medical device purposes, as age 21 years or younger at the time of diagnosis or treatment and specifies categories of pediatric subpopulations (see section 520(m)(6)(E) of the FD&C Act (21 U.S.C. 360j(m)(6)(E))). Nevertheless, children and those who care for them continue to have limited medical device options. FDA seeks to identify opportunities to support development and innovation of medical devices designed and labeled for children. Engaging in such opportunities will not only serve children and their families but optimize the medical device ecosystem for all. The Agency invites all stakeholders, including representatives from the medical device industry, academia, recipients of funding under section 305 of the Pediatric Medical Device Safety and Improvement Act of 2007, medical provider organizations, and organizations and individuals representing patients and consumers to collaborate with us in addressing this important public health issue (See Pub. L. 110-85; 42 U.S.C. 282 note). FDA guidance documents entitled ``Premarket Assessment of Pediatric Medical Devices,'' ``Providing Information about Pediatric Uses of Medical Devices,'' and ``Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices,'' provide background information regarding pediatric medical device development (Refs. 1 to 3). [[Page 7054]] II. Topics for Discussion at the Public Meeting As mandated by section 502(d) of the FDA Reauthorization Act of 2017 (FDARA), this FDA meeting on the development and labeling of pediatric medical devices is being convened with representatives from the medical device industry, academia, recipients of funding under section 305 of the Pediatric Medical Device Safety and Improvement Act of 2007, medical provider organizations, and organizations representing patients and consumers (see Pub. L. 110-85; 42 U.S.C. 282 note). As directly outlined in FDARA, the meeting shall include consideration of ways to: (1) Improve research infrastructure and research networks to facilitate the conduct of clinical studies of devices for pediatric populations that would result in the approval or clearance, and labeling of medical devices for such populations; (2) appropriately use extrapolation under section 515A(b) of the FD&C Act (21 U.S.C. 360e-1(b)); (3) enhance the appropriate use of postmarket registries and data to increase pediatric medical device labeling; (4) increase FDA assistance to medical device manufacturers in developing devices for pediatric populations that are approved or cleared, and labeled, for their use; and (5) identify current barriers to pediatric device development and incentives to address such barriers. A detailed agenda will be posted on the following website in advance of the workshop at https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. Select this event from the list of items provided. III. Participating in the Public Meeting Registration: To register for the public meeting, 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, and telephone number. Registration is free, and in-person attendance is based on space availability, with priority given to early registrants. Persons interested in attending this public meeting must register by August 6, 2018, 3 p.m. Eastern Time. Early registration is recommended because seating is limited; therefore, FDA may limit the number of participants from each organization. Registrants will receive confirmation when they have been accepted. If time and space permit, onsite registration on the day of the public workshop will be provided beginning at 7:30 a.m. We will let registrants know if registration closes before the day of the public meeting. If you need special accommodations due to a disability, please contact Peggy Roney at the Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5231, Silver Spring, MD 20993-0002, 301-796-5671, [email protected], no later than June 1, 2018. Requests for Oral Presentations: During online registration, you may indicate if you wish to present during a public comment session and which topic(s) you wish to address. FDA will do its best to accommodate requests to make public comments. 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. We encourage persons who are interested in making an oral presentation during a public comment session to indicate their intent on the registration form by 3 p.m. Eastern Time on June 29, 2018. Based on the number of applicants for oral presentations, FDA will distribute the available time equally among all presenters and inform selected presenters of the public presentation agenda by July 6, 2018. If selected for presentation, any presentation materials must be emailed to Victoria Wagman at [email protected] no later than July 13, 2018. No commercial or promotional material will be permitted to be presented or distributed at the public meeting. Streaming Webcast of the public meeting: This public meeting will also be webcast. The webcast link will be available on the registration web page after August 6, 2018. Please visit FDA's Medical Devices News & Events--Workshops & Conferences calendar (https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm) and select this event from the list of items provided. Organizations are requested to register all participants but 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 https://www.adobe.com/go/connectpro_overview. FDA has verified the website addresses in this document as of the date this document publishes in the Federal Register, but websites are subject to change over time. Transcripts: Please be advised that as soon as a transcript of the public meeting is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff (see ADDRESSES). A link to the transcript will also be available on the internet at https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list.) IV. References The following references are on display at the Dockets Management Staff (see ADDRESSES) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at https://www.regulations.gov. 1. FDA's guidance for Industry and FDA Staff: ``Premarket Assessment of Pediatric Medical Devices,'' available at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089742.pdf. 2. FDA's guidance for Industry and FDA Staff: ``Providing Information about Pediatric Uses of Medical Devices,'' available at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM339465.pdf. 3. FDA's guidance for Industry and FDA Staff: ``Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices,'' available at https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm444591.pdf. Dated: February 12, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-03215 Filed 2-15-18; 8:45 am] BILLING CODE 4164-01-P
![7052 Federal Register / Vol. 83, No. 33 / Friday, February 16, 2018 / Notices
‘‘THIS DOCUMENT CONTAINS whether their human medical product for any person and is not binding on
CONFIDENTIAL INFORMATION.’’ The will be regulated as a drug, a device, a FDA or the public. You can use an
Agency will review this copy, including biologic, or a combination product, and alternative approach if it satisfies the
the claimed confidential information, in which FDA medical product Agency requirements of the applicable statutes
its consideration of comments. The Center (CDER, CBER, or CDRH) will and regulations. This guidance is not
second copy, which will have the regulate it, if it is a non-combination subject to Executive Order 12866.
claimed confidential information product, or will have the primary
II. Paperwork Reduction Act of 1995
redacted/blacked out, will be available jurisdiction for the premarket review
for public viewing and posted on and regulation of the product, if it is a This guidance refers to previously
https://www.regulations.gov. Submit combination product. approved collections of information
both copies to the Dockets Management There are two ways that a sponsor can found in FDA regulations. These
Staff. If you do not wish your name and receive such a feedback from OCP. One collections of information are subject to
contact information to be made publicly option is to submit an RFD to receive a review by the Office of Management and
available, you can provide this formal, binding determination for the Budget (OMB) under the Paperwork
information on the cover sheet and not sponsor’s product with respect to Reduction Act of 1995 (44 U.S.C. 3501–
in the body of your comments and you classification and/or center assignment 3520). The collections of information in
must identify this information as that may be changed under conditions this guidance regarding how to prepare
‘‘confidential.’’ Any information marked specified in section 563 of the Federal a Pre-RFD have been approved under
as ‘‘confidential’’ will not be disclosed Food, Drug, and Cosmetic Act (21 U.S.C. OMB control number 0910–0845.
except in accordance with 21 CFR 10.20 360bbb–2) and 21 CFR 3.9 in the III. Electronic Access
and other applicable disclosure law. For regulations. The RFD process is codified
in 21 CFR part 3, and OCP has issued Persons with access to the internet
more information about FDA’s posting
a guidance about this process (see ‘‘How may obtain the document at https://
of comments to public dockets, see 80
to Write a Request for Designation’’ at www.fda.gov/RegulatoryInformation/
FR 56469, September 18, 2015, or access
https://www.fda.gov/ Guidances/ucm534661.htm.
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/2015- RegulatoryInformation/Guidances/ Dated: February 12, 2018.
23389.pdf. ucm126053.htm). A second more Leslie Kux,
Docket: For access to the docket to flexible option is for a sponsor to submit Associate Commissioner for Policy.
read background documents or the an inquiry to OCP to receive a [FR Doc. 2018–03230 Filed 2–15–18; 8:45 am]
electronic and written/paper comments preliminary jurisdictional assessment,
BILLING CODE 4164–01–P
received, go to https:// which is not binding.
www.regulations.gov and insert the Many sponsors seek to utilize a more
docket number, found in brackets in the flexible, approachable way to interact DEPARTMENT OF HEALTH AND
heading of this document, into the with OCP and the medical product HUMAN SERVICES
‘‘Search’’ box and follow the prompts Agency Centers, to obtain feedback from
and/or go to the Dockets Management the Agency before submitting a Food and Drug Administration
Staff, 5630 Fishers Lane, Rm. 1061, marketing application to the Agency.
Over time, these informal methods of [Docket No. FDA–2018–N–0404]
Rockville, MD 20852.
You may submit comments on any obtaining feedback have become
Pediatric Medical Device Development;
guidance at any time (see 21 CFR increasingly customary with sponsors,
Public Meeting; Request for Comments
10.115(g)(5)). and for some, even preferable to the
Submit written requests for a single formal RFD process. Accordingly, FDA AGENCY: Food and Drug Administration,
copies of this guidance entitled ‘‘How to is enhancing the transparency and HHS.
Prepare a Pre-Request for Designation consistency of such interaction, which ACTION: Notice of public meeting;
(Pre-RFD)’’ to the Office of Combination will now be called the ‘‘Pre-Request for request for comments.
Products, Food and Drug Designation (Pre-RFD) Program.’’
This guidance describes this SUMMARY: The Food and Drug
Administration, 10903 New Hampshire Administration (FDA, the Agency, or
structured process with clear
Ave., Bldg. 32, Rm. 5129, Silver Spring, we) is announcing the following public
recommendations for sponsors wishing
MD 20993–0002. Send one self- meeting entitled ‘‘Pediatric Medical
to submit Pre-RFDs. It also provides the
addressed adhesive label to assist that Device Development.’’ The purpose of
process for review of Pre-RFDs by FDA
office in processing your request. See the public meeting is to identify
staff, the general timeframes for
the SUPPLEMENTARY INFORMATION section strategies to enhance the medical device
sponsors to receive feedback from OCP,
for electronic access to the guidance ecosystem to cultivate development and
and the process for scheduling
document. innovation of devices that serve the
teleconferences and meetings in relation
FOR FURTHER INFORMATION CONTACT: to a Pre-RFD. unique needs of pediatric populations.
Leigh Hayes, Office of Combination FDA carefully considered the (The Federal Food, Drug, and Cosmetic
Products, Food and Drug comments received on the draft Act (FD&C Act) defines pediatric
Administration, 10903 New Hampshire guidance, and, where appropriate, has patients, for medical device purposes, as
Ave., Bldg. 32, Rm. 5129, Silver Spring, revised the guidance to reflect such age 21 years or younger at the time of
MD 20993–0002, 301–796–8930. comments. FDA encourages diagnosis or treatment and specifies
SUPPLEMENTARY INFORMATION: stakeholders to contact OCP if they have categories of pediatric subpopulations.)
daltland on DSKBBV9HB2PROD with NOTICES
additional questions. Topics for discussion will include ways
I. Background This guidance is being issued to improve research infrastructure and
Since its establishment on December consistent with FDA’s good guidance research networks to facilitate the
24, 2002, OCP has served as a resource practices regulation (21 CFR 10.115). conduct of clinical studies of pediatric
for sponsors at various stages of The guidance represents the Agency’s devices, extrapolation, use of
development of their products. current thinking on how to prepare a postmarket registries and data to
Sponsors often seek OCP feedback on Pre-RFD. It does not establish any rights increase pediatric medical device
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![7054 Federal Register / Vol. 83, No. 33 / Friday, February 16, 2018 / Notices
II. Topics for Discussion at the Public number of participants from each go/connectpro_overview. FDA has
Meeting organization. Registrants will receive verified the website addresses in this
As mandated by section 502(d) of the confirmation when they have been document as of the date this document
FDA Reauthorization Act of 2017 accepted. If time and space permit, publishes in the Federal Register, but
(FDARA), this FDA meeting on the onsite registration on the day of the websites are subject to change over time.
public workshop will be provided Transcripts: Please be advised that as
development and labeling of pediatric
beginning at 7:30 a.m. We will let soon as a transcript of the public
medical devices is being convened with
registrants know if registration closes meeting is available, it will be accessible
representatives from the medical device
before the day of the public meeting. at https://www.regulations.gov. It may
industry, academia, recipients of
If you need special accommodations be viewed at the Dockets Management
funding under section 305 of the due to a disability, please contact Peggy Staff (see ADDRESSES). A link to the
Pediatric Medical Device Safety and Roney at the Center for Devices and transcript will also be available on the
Improvement Act of 2007, medical Radiological Health, Food and Drug internet at https://www.fda.gov/
provider organizations, and Administration, 10903 New Hampshire MedicalDevices/NewsEvents/
organizations representing patients and Ave., Bldg. 32, Rm. 5231, Silver Spring, WorkshopsConferences/default.htm.
consumers (see Pub. L. 110–85; 42 MD 20993–0002, 301–796–5671, (Select this public workshop from the
U.S.C. 282 note). Peggy.Roney@fda.hhs.gov, no later than
As directly outlined in FDARA, the posted events list.)
June 1, 2018.
meeting shall include consideration of Requests for Oral Presentations: IV. References
ways to: (1) Improve research During online registration, you may The following references are on
infrastructure and research networks to indicate if you wish to present during a display at the Dockets Management Staff
facilitate the conduct of clinical studies public comment session and which (see ADDRESSES) and are available for
of devices for pediatric populations that topic(s) you wish to address. FDA will viewing by interested persons between
would result in the approval or do its best to accommodate requests to 9 a.m. and 4 p.m., Monday through
clearance, and labeling of medical make public comments. Individuals and Friday; they are also available
devices for such populations; (2) organizations with common interests are electronically at https://
appropriately use extrapolation under urged to consolidate or coordinate their www.regulations.gov.
section 515A(b) of the FD&C Act (21 presentations, and request time for a
U.S.C. 360e–1(b)); (3) enhance the 1. FDA’s guidance for Industry and FDA
joint presentation, or submit requests for Staff: ‘‘Premarket Assessment of Pediatric
appropriate use of postmarket registries designated representatives to participate Medical Devices,’’ available at https://
and data to increase pediatric medical in the focused sessions. We encourage www.fda.gov/downloads/MedicalDevices/
device labeling; (4) increase FDA persons who are interested in making an DeviceRegulationandGuidance/
assistance to medical device oral presentation during a public GuidanceDocuments/ucm089742.pdf.
manufacturers in developing devices for comment session to indicate their intent 2. FDA’s guidance for Industry and FDA
pediatric populations that are approved on the registration form by 3 p.m. Staff: ‘‘Providing Information about Pediatric
or cleared, and labeled, for their use; Eastern Time on June 29, 2018. Based Uses of Medical Devices,’’ available at
and (5) identify current barriers to https://www.fda.gov/downloads/
on the number of applicants for oral MedicalDevices/DeviceRegulation
pediatric device development and presentations, FDA will distribute the andGuidance/GuidanceDocuments/
incentives to address such barriers. available time equally among all UCM339465.pdf.
A detailed agenda will be posted on presenters and inform selected 3. FDA’s guidance for Industry and FDA
the following website in advance of the presenters of the public presentation Staff: ‘‘Leveraging Existing Clinical Data for
workshop at https://www.fda.gov/ agenda by July 6, 2018. If selected for Extrapolation to Pediatric Uses of Medical
MedicalDevices/NewsEvents/ presentation, any presentation materials Devices,’’ available at https://www.fda.gov/
WorkshopsConferences/default.htm. must be emailed to Victoria Wagman at ucm/groups/fdagov-public/@fdagov-meddev-
Select this event from the list of items Victoria.wagman@fda.hhs.gov no later gen/documents/document/ucm444591.pdf.
provided. than July 13, 2018. No commercial or Dated: February 12, 2018.
III. Participating in the Public Meeting promotional material will be permitted Leslie Kux,
to be presented or distributed at the
Registration: To register for the public Associate Commissioner for Policy.
public meeting.
meeting, please visit FDA’s Medical Streaming Webcast of the public [FR Doc. 2018–03215 Filed 2–15–18; 8:45 am]
Devices News & Events—Workshops & meeting: This public meeting will also BILLING CODE 4164–01–P
Conferences calendar at https:// be webcast. The webcast link will be
www.fda.gov/MedicalDevices/ available on the registration web page
NewsEvents/WorkshopsConferences/ after August 6, 2018. Please visit FDA’s DEPARTMENT OF HEALTH AND
default.htm. (Select this public Medical Devices News & Events— HUMAN SERVICES
workshop from the posted events list.) Workshops & Conferences calendar
Please provide complete contact Food and Drug Administration
(https://www.fda.gov/MedicalDevices/
information for each attendee, including NewsEvents/WorkshopsConferences/ [Docket Nos. FDA–2016–E–2512 and FDA–
name, title, affiliation, address, email, default.htm) and select this event from 2016–E–2511]
and telephone number. the list of items provided. Organizations
Registration is free, and in-person are requested to register all participants Determination of Regulatory Review
attendance is based on space but view using one connection per Period for Purposes of Patent
daltland on DSKBBV9HB2PROD with NOTICES
availability, with priority given to early location. Extension; COTELLIC
registrants. Persons interested in If you have never attended a Connect AGENCY: Food and Drug Administration,
attending this public meeting must Pro event before, test your connection at HHS.
register by August 6, 2018, 3 p.m. https://collaboration.fda.gov/common/ ACTION: Notice.
Eastern Time. Early registration is help/en/support/meeting_test.htm. To
recommended because seating is get a quick overview of the Connect Pro SUMMARY: The Food and Drug
limited; therefore, FDA may limit the program, visit https://www.adobe.com/ Administration (FDA or the Agency) has
VerDate Sep<11>2014 19:24 Feb 15, 2018 Jkt 244001 PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 E:\FR\FM\16FEN1.SGM 16FEN1](https://thefederalregister.org/doc/83_FR_7085/page/3.svg)
Document Created: 2018-02-16 00:55:43
Document Modified: 2018-02-16 00:55:43
| 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 meeting; request for comments. | |
| Dates | The public meeting will be held on August 13 and August 14, 2018, from 9 a.m. to 5 p.m. Submit either electronic or written comments on this public meeting by September 14, 2018. See the SUPPLEMENTARY INFORMATION section for registration information. | |
| Contact | Victoria Wagman, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5562, Silver Spring, MD 20993, 301-796- 6581, [email protected] | |
| FR Citation | 83 FR 7052 |
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