81 FR 54102 - Premarket Notification Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgery; Guidance for Industry and Food and Drug Administration Staff; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 157 (August 15, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 157 (August 15, 2016)
| Page Range | 54102-54104 | |
| FR Document | 2016-19402 |
[Federal Register Volume 81, Number 157 (Monday, August 15, 2016)] [Notices] [Pages 54102-54104] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-19402] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2014-D-0218] Premarket Notification Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgery; Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Premarket Notification (510(k)) Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgery.'' FDA has developed this guidance document to assist industry in preparing premarket notification (510(k)) submissions for bipolar electrosurgical vessel sealers intended for use in general surgery. DATES: Submit either electronic or written comments on this guidance at any time. General comments on Agency guidance documents are welcome at any time. ADDRESSES: 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''). [[Page 54103]] 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.'' Instructions: All submissions received must include the Docket No. FDA-2014-D-0218 for ``Premarket Notification (510(k)) Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgery.'' 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. An electronic copy of the guidance document is available for download from the Internet. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written requests for a single hard copy of the guidance document entitled ``Premarket Notification (510(k)) Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgery'' to the Office of the Center Director, Guidance and Policy Development, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request. FOR FURTHER INFORMATION CONTACT: Jismi Johnson, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1524, Silver Spring, MD 20993-0002, 301-796-6424. SUPPLEMENTARY INFORMATION: I. Background FDA has developed this guidance document to assist industry in preparing premarket notification (510(k)) submissions for bipolar electrosurgical vessel sealers intended for use in general surgery. These devices are designed to seal isolated blood and lymphatic vessels for hemostasis (as an alternative to ties) through the use of high- frequency electrical current between two electrodes in close proximity. The scope of this document is limited to the class II electrosurgical devices and accessories classified under 21 CFR 878.4400, Electrosurgical cutting and coagulation device and accessories. This generic type of device includes bipolar vessel sealing instruments, associated electrosurgical generators, and accessories for use in open and minimally invasive general surgical procedures. This guidance is intended only to address bipolar electrosurgical vessel sealers that have general indications for use in general surgery. In the Federal Register of March 24, 2014 (79 FR 16009), FDA announced the availability of the draft guidance. Interested persons were invited to comment by June 23, 2014. Four sets of comments were received. FDA reviewed and considered all the public comments received and revised sections of the guidance, where applicable. II. Significance of Guidance This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on Premarket Notification (510(k)) Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgery. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. III. Electronic Access Persons interested in obtaining a copy of the guidance may do so by downloading an electronic copy from the Internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance documents are also available at http://www.regulations.gov. Persons unable to download an electronic copy of ``Premarket Notification (510(k)) Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgery'' may send an email request to [email protected] to receive an electronic copy of the document. Please use the document number 1300048 to identify the guidance you are requesting. IV. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR 807, subpart E have been approved under OMB control number 0910- 0120; the collections of information in 21 CFR part 820 have been approved under OMB control number 0910-0073; the collections of information in 21 CFR part 801 have been approved under OMB control number 0910-0485; the collections of information in 21 CFR part 58 have been approved under OMB control number 0910-0119; and the collections of information in the guidance document ``Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff'' have been [[Page 54104]] approved under OMB control number 0910-0756. Dated: August 9, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-19402 Filed 8-12-16; 8:45 am] BILLING CODE 4164-01-P
![54102 Federal Register / Vol. 81, No. 157 / Monday, August 15, 2016 / Notices
will be accepted for current vacancies growers should send a letter stating that DEPARTMENT OF HEALTH AND
effective with this notice. interest to the FDA contact (see FOR HUMAN SERVICES
DATES: Any industry organization FURTHER INFORMATION CONTACT) within
interested in participating in the 30 days of publication of this document Food and Drug Administration
selection of an appropriate nonvoting (see DATES). Within the subsequent 30
member to represent the interests of days, FDA will send a letter to each [Docket No. FDA–2014–D–0218]
tobacco growers must send a letter organization that has expressed an
stating that interest to FDA by interest, attaching a complete list of all Premarket Notification Submissions
September 14, 2016 (see sections I and such organizations, and a list of all for Bipolar Electrosurgical Vessel
II of this document for further details). nominees along with their current Sealers for General Surgery; Guidance
Concurrently, nomination materials for for Industry and Food and Drug
résumés. The letter will also state that
prospective candidates should be sent to Administration Staff; Availability
it is the responsibility of the interested
FDA by September 14, 2016. organizations to confer with one another AGENCY: Food and Drug Administration,
ADDRESSES: All statements of interest and to select a candidate, within 60 HHS.
from industry organizations interested days after the receipt of the FDA letter,
in participating in the selection process ACTION: Notice of availability.
to serve as the nonvoting member to
should be sent to Caryn Cohen (see FOR
represent the interests of tobacco SUMMARY: The Food and Drug
FURTHER INFORMATION CONTACT). All
growers for the committee. The Administration (FDA or Agency) is
nominations for nonvoting industry
interested organizations are not bound announcing the availability of the
representatives should be submitted
by the list of nominees in selecting a guidance entitled ‘‘Premarket
electronically by accessing the FDA
candidate. However, if no individual is Notification (510(k)) Submissions for
Advisory Committee Membership
selected within 60 days, the Bipolar Electrosurgical Vessel Sealers
Nomination Portal at: https://
Commissioner will select the nonvoting for General Surgery.’’ FDA has
www.accessdata.fda.gov/scripts/
member to represent the interests of developed this guidance document to
FACTRSPortal/FACTRS/index.cfm or by
tobacco growers. assist industry in preparing premarket
mail to Advisory Committee Oversight
notification (510(k)) submissions for
and Management Staff, Food and Drug III. Application Procedure bipolar electrosurgical vessel sealers
Administration, 10903 New Hampshire
intended for use in general surgery.
Ave., Bldg. 32, Rm. 5103, Silver Spring, Individuals may self-nominate and/or
MD 20993–0002. Information about DATES: Submit either electronic or
an organization may nominate one or
becoming a member of an FDA advisory more individuals to serve as a nonvoting written comments on this guidance at
committee can also be obtained by any time. General comments on Agency
member to represent the interests of
visiting FDA’s Web site at: http:// guidance documents are welcome at any
tobacco growers. Contact information,
www.fda.gov/AdvisoryCommittees/ time.
current curriculum vitae, and the name
default.htm. of the committee of interest should be ADDRESSES: You may submit comments
FOR FURTHER INFORMATION CONTACT: sent to the FDA Advisory Committee as follows:
Caryn Cohen, Office of Science, Center Membership Nomination Portal (see Electronic Submissions
for Tobacco Products, Food and Drug ADDRESSES) within 30 days of
Administration, Center for Tobacco Submit electronic comments in the
publication of this document (see following way:
Products, Document Control Center, DATES). FDA will forward all
Bldg. 71, Rm. G335, 10903 New • Federal eRulemaking Portal: http://
nominations to the organizations www.regulations.gov. Follow the
Hampshire Ave., Silver Spring, MD expressing interest in participating in
20993–0002, 1–877–287–1373 (choose instructions for submitting comments.
the selection process for the committee. Comments submitted electronically,
Option 5), email: TPSAC@fda.hhs.gov. (Persons who nominate themselves as including attachments, to http://
SUPPLEMENTARY INFORMATION: The nonvoting industry representatives will www.regulations.gov will be posted to
Agency intends to add nonvoting not participate in the selection process.) the docket unchanged. Because your
industry representatives to the following
FDA seeks to include the views of comment will be made public, you are
advisory committee:
women, and men, members of all racial solely responsible for ensuring that your
I. Tobacco Products Scientific Advisory and ethnic groups, and individuals with comment does not include any
Committee and without disabilities on its advisory confidential information that you or a
The Tobacco Products Scientific committees and, therefore encourages third party may not wish to be posted,
Advisory Committee (the Committee) nominations of appropriately qualified such as medical information, your or
advises the Commissioner of Food and candidates from these groups. anyone else’s Social Security number, or
Drugs (the Commissioner) or designee in confidential business information, such
This notice is issued under the as a manufacturing process. Please note
discharging responsibilities related to
Federal Advisory Committee Act (5 that if you include your name, contact
the regulation of tobacco products. The
U.S.C. app. 2) and 21 CFR part 14, information, or other information that
Committee reviews and evaluates safety,
relating to advisory committees. identifies you in the body of your
dependence, and health issues relating
to tobacco products and provides Dated: August 9, 2016. comments, that information will be
posted on http://www.regulations.gov.
sradovich on DSK3GMQ082PROD with NOTICES
appropriate advice, information, and Janice M. Soreth,
recommendations to the Commissioner. • If you want to submit a comment
Acting Associate Commissioner, Special
Medical Programs.
with confidential information that you
II. Selection Procedure do not wish to be made available to the
[FR Doc. 2016–19312 Filed 8–12–16; 8:45 am]
Any industry organization interested public, submit the comment as a
in participating in the selection of an BILLING CODE 4164–01–P written/paper submission and in the
appropriate nonvoting member to manner detailed (see ‘‘Written/Paper
represent the interests of tobacco Submissions’’ and ‘‘Instructions’’).
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![54104 Federal Register / Vol. 81, No. 157 / Monday, August 15, 2016 / Notices
approved under OMB control number SUPPLEMENTARY INFORMATION: current project plan, as the NCMHI
0910–0756. Intended Recipient of the Award: The advances system changes and new
Dated: August 9, 2016. American Academy of Pediatrics. initiatives at the community, state, and
Amount of Non-Competitive Awards: national levels, building on community
Leslie Kux,
$600,000. partnerships to support family-centered
Associate Commissioner for Policy. Period of Supplemental Funding: 7/1/ medical home implementation for all
[FR Doc. 2016–19402 Filed 8–12–16; 8:45 am] 2016–6/30/2017 and 7/1/2017–6/30/ children and youth, particularly those
BILLING CODE 4164–01–P 2018. underrepresented and from diverse
CFDA Number: 93.110. communities (Goal 3).
Authority: Social Security Act, Title
DEPARTMENT OF HEALTH AND V, sections 501(a)(1)(D) and 501(a)(2), In 2013, following objective review of
HUMAN SERVICES (42 U.S.C. 701(a)(1)(D) and 701(a)(2)). its application, HRSA awarded the
Justification: The White House Rural NCMHI cooperative agreement to the
Health Resources and Services Council initiated the Rural IMPACT American Academy of Pediatrics (AAP),
Administration project to support improved well-being a nonprofit, tax-exempt organization
and upward economic mobility of under Internal Revenue Code 501(c)(3).
Notice of Single-Award Deviation From In 2015, HRSA awarded a $300,000
children in rural and tribal
Competition Requirements for the supplement to the NCMHI cooperative
communities. Ideally, systems and
National Center for Medical Home agreement to allow the AAP to build on
services are designed to meet family’s
Implementation Cooperative its existing work under the cooperative
needs, and are linked together so that
Agreement families can access them seamlessly agreement to implement and spread the
AGENCY: Health Resources and Services through universal ‘‘no wrong door’’ medical home model in Rural IMPACT
Administration, HHS. intake processes and shared referral project communities, thereby advancing
ACTION: Notice of Single-Award networks. Components of the Rural the well-being of children in those
Deviation from Competition IMPACT project include Healthy Start, communities.
Requirements for the National Center for Early Head Start, Head Start, Home From August 2015 to June 2016, AAP,
Medical Home Implementation Visiting, WIC, Medical Home, Quality as part of the NCMHI cooperative
Cooperative Agreement. Child Care Education Job Training and agreement, established an expert
income and nutrition supports such as workgroup and operational structure to
SUMMARY: HRSA announces the award TANF cash assistance, Supplemental guide the initiative; developed and
of a supplement in the amount of Security Income, and the Supplemental issued a solicitation and scoring
$300,000 per year for two years for the Nutrition Assistance Program. The goal process, and conducted a review of
National Center for Medical Home of Rural IMPACT is to ensure the applications to make recommendations
Implementation (NCMHI) Cooperative healthy development of at-risk children for participating communities. Since the
Agreement cooperative agreement. The and increase the education and identification of ten rural and tribal
purpose of the NCMHI cooperative employment opportunities of their communities, the AAP has provided
agreement, as stated in the funding parents, thereby improving the well- technical assistance to support their
opportunity announcement, is to: (1) being of families. efforts to develop and begin
Support a national resource and Rural IMPACT project continues to be implementing two-generation service
assistance effort to implement and a high priority of the White House Rural delivery models to address the needs of
spread the medical home model to all Council, and support for the ten Rural both vulnerable children and their
children and youth, particularly IMPACT communities will continue to parents.
children with special health care needs be an interagency effort including, in
From July 2016 to June 2018, the ten
(CSHCN), children who are vulnerable addition to HHS, the Departments of
participating communities will
and/or medically underserved, and Agriculture, Education, Labor, and the
implement their action plans. Ongoing
pediatric populations served by state Corporation for National and
support is needed to assist the
public health programs, MCHB and Community Service.
communities in implementation as well
HRSA; and (2) support activities of the The purpose of the NCMHI
as evaluation, sustainability, and
Healthy Tomorrows Partnership for cooperative agreement, as stated in the
dissemination of information. This
Children Program (HTPCP) grantees to funding opportunity announcement, is
supplement will provide additional
improve children’s health through to: (1) Support a national resource and
funds, through the NCMHI cooperative
innovative community-based efforts, assistance effort to implement and
agreement, to provide technical
and community and statewide spread the medical home model to all
assistance to the Rural IMPACT
partnerships among professionals in children and youth, particularly
communities as they employ two-
health, education, social services, children with special health care needs
generation strategies to more effectively
government, and business. The (CSHCN), children who are vulnerable
support children living in poverty in
supplement will permit the American and/or medically underserved, and
rural communities, including the
Academy of Pediatrics (AAP), the pediatric populations served by state
implementation and spread of the
cooperative agreement awardee, during public health programs, MCHB and
family-centered medical home model of
the budget periods of 7/1/2016–6/30/ HRSA; and (2) support activities of the
health care.
2017 and 7/1/2017–6/30/2018, to Healthy Tomorrows Partnership for
provide technical assistance to the Rural Children Program (HTPCP) grantees to FOR FURTHER INFORMATION CONTACT:
sradovich on DSK3GMQ082PROD with NOTICES
IMPACT communities as they employ improve children’s health through Marie Y. Mann, MD, MPH, FAAP,
two-generation strategies to more innovative community-based efforts, Division of Services for Children with
effectively support children living in and community and statewide Special Health Needs, Maternal and
poverty in rural communities, including partnerships among professionals in Child Health Bureau, Health Resources
the implementation and spread of the health, education, social services, and Services Administration, 5600
family-centered medical home model of government, and business. The Rural Fishers Lane, Room 13–103, Rockville,
health care. IMPACT Project activities align with the Maryland 20857; MMann@hrsa.gov.
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Document Created: 2016-08-13 02:22:05
Document Modified: 2016-08-13 02:22:05
| 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 availability. | |
| Dates | Submit either electronic or written comments on this guidance at any time. General comments on Agency guidance documents are welcome at any time. | |
| Contact | Jismi Johnson, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1524, Silver Spring, MD 20993-0002, 301-796-6424. | |
| FR Citation | 81 FR 54102 |
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