83 FR 63516 - Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 236 (December 10, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 236 (December 10, 2018)
| Page Range | 63516-63518 | |
| FR Document | 2018-26626 |
[Federal Register Volume 83, Number 236 (Monday, December 10, 2018)] [Notices] [Pages 63516-63518] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-26626] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-4395] Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice; establishment of a public docket; request for comments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing a forthcoming public advisory committee meeting of the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee (Committee). The general function of the Committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document. DATES: The meeting will be held on February 12, 2019, from 8 a.m. to 6:30 p.m. ADDRESSES: Hilton Washington, DC North/Gaithersburg; Salons A, B, C, and D; 620 Perry Pkwy., Gaithersburg, MD 20877. The hotel's telephone number is 301-977-8900; additional information available online at: https://www3.hilton.com/en/hotels/maryland/hilton-washington-dc-north-gaithersburg-GAIGHHF/index.html. Answers to [[Page 63517]] commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm. FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2018-N-4395. The docket will close on February 11, 2019. Submit either electronic or written comments on this public meeting by February 11, 2019. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before February 11, 2019. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of February 11, 2019. 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. Comments received on or before January 27, 2019, will be provided to the Committee. Comments received after that date will be taken into consideration by FDA. You may submit comments as follows: 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-4395 for ``The Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; 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.'' FDA 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 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 the 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, September18, 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: Evella Washington, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G640, Silver Spring, MD 20993-0002, [email protected], 301-796-6683, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check FDA's website at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. SUPPLEMENTARY INFORMATION: Agenda: On February 12, 2019, the Committee will discuss and make recommendations regarding the safety and effectiveness of surgical mesh placed transvaginally in the anterior vaginal compartment to treat pelvic organ prolapse. FDA is convening this meeting to seek expert opinion on the evaluation of the risks and benefits of these devices. The Committee will be asked to provide scientific and clinical input on assessing the effectiveness, safety, and benefit/risk of mesh placed transvaginally in the anterior vaginal compartment, as well as identifying the appropriate patient population and physician training needed for these devices. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's website after the meeting. Background material is available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the [[Page 63518]] appropriate advisory committee meeting link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before February 5, 2019. Oral presentations from the public will be scheduled on February 12, 2019, between approximately 8:15 a.m. and 9:15 a.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before January 28, 2019. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by January 29, 2019. Persons attending FDA's advisory committee meetings are advised that FDA is not responsible for providing access to electrical outlets. For press inquiries, please contact the Office of Media Affairs at [email protected] or 301-796-4540. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Artair Mallett at [email protected] or 301-796-9638, at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: December 3, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-26626 Filed 12-7-18; 8:45 am] BILLING CODE 4164-01-P
![63516 Federal Register / Vol. 83, No. 236 / Monday, December 10, 2018 / Notices
management. These activities aim to research into improved outcomes for held by webinar to minimize burden on
produce tangible outputs such as individuals and populations exposed to the participants.
research findings on WTC-related disasters such as, but not limited to, the These focus groups are necessary to
conditions, healthcare protocols, peer- 9/11 attacks. In the formative stage of gather background information on the
reviewed publications, quality our assessment, we propose to hold a relationship between different
assessment reports, and member and series of focus groups with different stakeholders and the WTCHP that will
provider education products. Finally, stakeholder groups to explore their complement data gathered during more
the model anticipates short-, perspectives on translational research in detailed interviews with stakeholders in
intermediate-, and long-term the context of the WTCHP. The focus the interviews that will take place 6–12
measurement of outcomes and serves as groups will each consist of a well- months later. Specific topics to be
a communication tool for program defined stakeholder group, and will last addressed in the focus groups will
planning and evaluation. approximately two hours. Focus group include: Conceptualizations of research
In 2016, NIOSH contracted with the discussions will be held in-person or by and ‘‘translational research;’’ relevance
RAND Corporation to conduct an telephone or webinar format. Depending of WTCHP research topics, potential
independent evaluation of the WTCHP on the timing of OMB approval, RAND gaps, and stakeholder priorities,
RTC model including the research anticipates conducting focus groups including responsiveness to regulatory
investments to date and the shortly after, most likely in the winter/ issues; uses and usefulness of WTCHP
effectiveness with which the Program early spring of 2019. If this occurs, research; barriers to conduct and use of
translates its research to different results will be analyzed in the spring of WTCHP research; and understanding of
stakeholder groups. RAND was selected 2019. If the timing of OMB approval and perspectives on the relevance and
given the project team’s expertise with coincides with one of the twice-yearly usefulness of the Research-to-Care
similar assessments and NIOSH’s NIOSH-sponsored research meetings in model.
requirement for an objective analysis. NYC, RAND plans to hold in-person OMB approval is requested for one
This work will ultimately provide focus groups with the stakeholder year. The total estimated burden in
guidance for the WTCHP on strategic groups in attendance (NIOSH and hours is 220. Participation is voluntary
directions, as well as produce new principal investigators, typically); the and there are no costs to the respondent
knowledge about the translation of remainder of the focus groups will be other than their time.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per
Type of respondents Form name responses per
respondents response
respondent (in hours)
Principal Investigators of WTCHP-Funded Focus Group Discussion Guide and Brief 30 1 2
Research. Demographic Survey.
Leadership from WTC Clinical Centers of Ex- Focus Group Discussion Guide and Brief 20 1 2
cellence and Other Stakeholders. Demographic Survey.
WTC Health Registry staff .............................. Focus Group Discussion Guide and Brief 10 1 2
Demographic Survey.
Clinicians Caring for WTCHP Members ......... Focus Group Discussion Guide and Brief 20 1 2
Demographic Survey.
WTCHP Responders and Survivors (State/ Focus Group Discussion Guide and Brief 15 1 2
local govt). Demographic Survey.
WTCHP Responders and Survivors (private Focus Group Discussion Guide and Brief 15 1 2
citizens). Demographic Survey.
Jeffrey M. Zirger, DEPARTMENT OF HEALTH AND Gynecology Devices Panel of the
Acting Lead, Information Collection Review HUMAN SERVICES Medical Devices Advisory Committee
Office, Office of Scientific Integrity, Office (Committee). The general function of the
of Science, Centers for Disease Control and Food and Drug Administration Committee is to provide advice and
Prevention. recommendations to the Agency on
[FR Doc. 2018–26633 Filed 12–7–18; 8:45 am] [Docket No. FDA–2018–N–4395] FDA’s regulatory issues. The meeting
BILLING CODE 4163–18–P will be open to the public. FDA is
Obstetrics and Gynecology Devices establishing a docket for public
Panel of the Medical Devices Advisory comment on this document.
Committee; Notice of Meeting; DATES: The meeting will be held on
Establishment of a Public Docket; February 12, 2019, from 8 a.m. to 6:30
Request for Comments p.m.
AGENCY: Food and Drug Administration, ADDRESSES: Hilton Washington, DC
HHS. North/Gaithersburg; Salons A, B, C, and
ACTION: Notice; establishment of a D; 620 Perry Pkwy., Gaithersburg, MD
public docket; request for comments. 20877. The hotel’s telephone number is
301–977–8900; additional information
SUMMARY: The Food and Drug available online at: https://www3.hilton.
Administration (FDA) is announcing a com/en/hotels/maryland/hilton-
forthcoming public advisory committee washington-dc-north-gaithersburg-
meeting of the Obstetrics and GAIGHHF/index.html. Answers to
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![63518 Federal Register / Vol. 83, No. 236 / Monday, December 10, 2018 / Notices
appropriate advisory committee meeting DEPARTMENT OF HEALTH AND Open: 2:00 p.m. to 4:00 p.m.
link. HUMAN SERVICES Agenda: To review the Division’s scientific
and planning activities.
Procedure: Interested persons may Place: National Institutes of Health,
National Institutes of Health
present data, information, or views, Natcher Conference Center (Building 45),
orally or in writing, on issues pending National Institute of Diabetes and Conference Room E1/E2, 45 Center Drive,
before the committee. Written Bethesda, MD 20892.
Digestive and Kidney Diseases; Notice Contact Person: Karl F. Malik, Ph.D.,
submissions may be made to the contact of Meetings Director, Division of Extramural Activities,
person on or before February 5, 2019.
Pursuant to section 10(d) of the National Institutes of Diabetes and Digestive
Oral presentations from the public will and Kidney Diseases, 6707 Democracy Blvd.
be scheduled on February 12, 2019, Federal Advisory Committee Act, as
Room 7329, MSC 5452, Bethesda, MD 20892,
between approximately 8:15 a.m. and amended, notice is hereby given of (301) 594–4757, malikk@niddk.nih.gov.
9:15 a.m. Those individuals interested meetings of the National Diabetes and
Name of Committee: National Diabetes and
in making formal oral presentations Digestive and Kidney Diseases Advisory Digestive and Kidney Diseases Advisory
should notify the contact person and Council. Council, Kidney, Urologic and Hematologic
submit a brief statement of the general The meetings will be open to the Diseases.
nature of the evidence or arguments public as indicated below, with Date: January 16, 2019.
attendance limited to space available. Open: 1:00 p.m. to 2:15 p.m.
they wish to present, the names and
Individuals who plan to attend and Agenda: To review the Division’s scientific
addresses of proposed participants, and and planning activities.
need special assistance, such as sign
an indication of the approximate time Place: National Institutes of Health,
language interpretation or other
requested to make their presentation on Natcher Conference Center (Building 45),
reasonable accommodations, should
or before January 28, 2019. Time Conference Room F1/F2, 45 Center Drive,
notify the Contact Person listed below Bethesda, MD 20892.
allotted for each presentation may be
in advance of the meeting. Closed: 2:30 p.m. to 4:00 p.m.
limited. If the number of registrants The meetings will be closed to the
requesting to speak is greater than can Agenda: To review and evaluate grant
public in accordance with the applications.
be reasonably accommodated during the provisions set forth in sections Place: National Institutes of Health,
scheduled open public hearing session, 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Natcher Conference Center (Building 45),
FDA may conduct a lottery to determine as amended. The grant applications and Conference Room F1/F2, 45 Center Drive,
the speakers for the scheduled open the discussions could disclose Bethesda, MD 20892.
public hearing session. The contact confidential trade secrets or commercial Contact Person: Karl F. Malik, Ph.D.,
person will notify interested persons Director, Division of Extramural Activities,
property such as patentable material, National Institutes of Diabetes and Digestive
regarding their request to speak by and personal information concerning
January 29, 2019. and Kidney Diseases, 6707 Democracy Blvd.
individuals associated with the grant Room 7329, MSC 5452, Bethesda, MD 20892,
Persons attending FDA’s advisory applications, the disclosure of which (301) 594–4757, malikk@niddk.nih.gov.
committee meetings are advised that would constitute a clearly unwarranted Name of Committee: National Diabetes and
FDA is not responsible for providing invasion of personal privacy. Digestive and Kidney Diseases Advisory
access to electrical outlets. Name of Committee: National Diabetes and Council, Digestive Diseases and Nutrition.
Digestive and Kidney Diseases Advisory Date: January 16, 2019.
For press inquiries, please contact the Open: 1:00 p.m. to 2:30 p.m.
Office of Media Affairs at fdaoma@ Council.
Date: January 16, 2019. Agenda: To review the Division’s scientific
fda.hhs.gov or 301–796–4540. and planning activities.
Open: 8:30 a.m. to 12:00 p.m.
FDA welcomes the attendance of the Agenda: To present the Director’s Report Place: National Institutes of Health,
public at its advisory committee and other scientific presentations. Natcher Conference Center (Building 45),
Place: National Institutes of Health, Conference Room D, 45 Center Drive,
meetings and will make every effort to Bethesda, MD 20892.
accommodate persons with disabilities. Natcher Conference Center (Building 45),
Conference Room E1/E2, 45 Center Drive, Closed: 2:30 p.m. to 4:00 p.m.
If you require accommodations due to a Agenda: To review and evaluate grant
Bethesda, MD 20892.
disability, please contact Artair Mallett Closed: 1:00 p.m. to 4:30 p.m. applications.
at artair.mallett@fda.hhs.gov or 301– Agenda: To review and evaluate grant Place: National Institutes of Health,
796–9638, at least 7 days in advance of applications. Natcher Conference Center (Building 45),
the meeting. Place: National Institutes of Health, Conference Room D, 45 Center Drive,
Natcher Conference Center (Building 45), Bethesda, MD 20892.
FDA is committed to the orderly Conference Room E1/E2, 45 Center Drive, Contact Person: Karl F. Malik, Ph.D.,
conduct of its advisory committee Bethesda, MD 20892. Director, Division of Extramural Activities,
meetings. Please visit our website at Contact Person: Karl F. Malik, Ph.D., National Institutes of Diabetes and Digestive
https://www.fda.gov/ Director, Division of Extramural Activities, and Kidney Diseases, 6707 Democracy Blvd.
AdvisoryCommittees/ National Institutes of Diabetes and Digestive Room 7329, MSC 5452, Bethesda, MD 20892,
AboutAdvisoryCommittees/ and Kidney Diseases, 6707 Democracy Blvd. (301) 594–4757, malikk@niddk.nih.gov.
ucm111462.htm for procedures on Room 7329, MSC 5452, Bethesda, MD 20892, Any interested person may file written
(301) 594–4757, malikk@niddk.nih.gov. comments with the committee by forwarding
public conduct during advisory
Name of Committee: National Diabetes and the statement to the Contact Person listed on
committee meetings. this notice. The statement should include the
Digestive and Kidney Diseases Advisory
Notice of this meeting is given under Council, Diabetes, Endocrinology and name, address, telephone number and when
the Federal Advisory Committee Act (5 Metabolic Diseases. applicable, the business or professional
U.S.C. app. 2). Date: January 16, 2019. affiliation of the interested person.
Closed: 1:00 p.m. to 2:00 p.m. In the interest of security, NIH has
Dated: December 3, 2018. Agenda: To review and evaluate grant instituted stringent procedures for entrance
Leslie Kux, applications. onto the NIH campus. All visitor vehicles,
Place: National Institutes of Health, including taxicabs, hotel, and airport shuttles
Associate Commissioner for Policy.
Natcher Conference Center (Building 45), will be inspected before being allowed on
[FR Doc. 2018–26626 Filed 12–7–18; 8:45 am] Conference Room E1/E2, 45 Center Drive, campus. Visitors will be asked to show one
BILLING CODE 4164–01–P Bethesda, MD 20892. form of identification (for example, a
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Document Created: 2018-12-08 00:21:28
Document Modified: 2018-12-08 00:21:28
| 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; establishment of a public docket; request for comments. | |
| Dates | The meeting will be held on February 12, 2019, from 8 a.m. to 6:30 p.m. | |
| Contact | Evella Washington, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G640, Silver Spring, MD 20993-0002, [email protected], 301-796-6683, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check FDA's website at https://www.fda.gov/ AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. | |
| FR Citation | 83 FR 63516 |
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