[Federal Register Volume 87, Number 152 (Tuesday, August 9, 2022)]
[Notices]
[Pages 48487-48488]
[FR Doc No: 2022-17059]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-1608]

Vaccines and Related Biological Products 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.

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SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Vaccines and Related
Biological Products Advisory Committee (VRBPAC). The general function
of the committee is to provide advice and recommendations to FDA on
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 virtually on September 22, 2022, from
8:30 a.m. to 5 p.m. Eastern Time.

ADDRESSES: Please note that due to the impact of this COVID-19
pandemic, all meeting participants will be joining this advisory
committee meeting via an online teleconferencing platform. The online
web conference meeting will be available at the following link on the
day of the meeting: https://youtu.be/vrahKrbyJaU.
    FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2022-N-1608. The docket will close on
September 21, 2022. Either electronic or written comments on this
public meeting must be submitted by September 21, 2022. Please note
that late, untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of September 21, 2022. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.
    Comments received on or before September 14, 2022, will be provided
to the committee. Comments received after September 14, 2022, and by
September 21, 2022, will be taken into consideration by FDA. In the
event that the meeting is cancelled, FDA will continue to evaluate any
relevant applications or information, and consider any comments
submitted to the docket, as appropriate.
    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-2022-N-1608 for ``Vaccines and Related Biological Products Advisory
Committee (VRBPAC); 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,<PHONE_NUMBER>.
     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.govinfo.gov/content/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,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Sussan Paydar or Prabhakara Atreya,
Center for Biologics Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, Silver Spring, MD
20993-0002,<PHONE_NUMBER>, [email protected]; or FDA Advisory
Committee Information Line, 1-800-741-8138<PHONE_NUMBER> 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 the 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: The meeting presentations will be heard, viewed, captioned,
and recorded through an online teleconferencing platform. On September
22, 2022, the committee will meet in open session to discuss BLA 125739
from Rebiotix Inc., for a product REBYOTA (Fecal Microbiota, Live),
with a requested indication to ``reduce the recurrence of
Clostridioides difficile infection (CDI) in adults following antibiotic
treatment for recurrent Clostridioides difficile infection.''
    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 time 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 appropriate advisory committee meeting link. The meeting
will include slide presentations with audio components to allow the
presentation of materials in a manner that most closely resembles an
in-person advisory committee meeting.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
All electronic and written submissions submitted to the Dockets (see
ADDRESSES) on or before September 14, 2022, will be provided to the
committee. Comments received after September 14, 2022, and by September
21, 2022, will be taken into consideration by FDA. Oral presentations
from the public will be scheduled between approximately 1:50 p.m. and
2:50 p.m. Eastern Time. 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, along with their names, email addresses, and direct contact
phone numbers of proposed participants, on or before 12 p.m. Eastern
Time on September 14, 2022. 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 6 p.m.
Eastern Time September 16, 2022.
    For press inquiries, please contact the Office of Media Affairs at
[email protected] or<PHONE_NUMBER>.
    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 Sussan Paydar or Prabhakara Atreya (see FOR FURTHER INFORMATION
CONTACT) 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: August 1, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-17059 Filed 8-8-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: June 28, 2010 (Volume 75, Number 123)]
[Notices]
[Page 36780-36781]
[DOCID:fr28jn10-153]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2010-0006; Notice 1]

Notice of Receipt of Petition for Decision that Nonconforming
2000 East Lancs Lolyne Double Decker Bus Mounted on Volvo B7L Chassis
is Eligible for Importation

AGENCY: National Highway Traffic Safety Administration, DOT.

ACTION: Notice of receipt of petition.

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SUMMARY: This document announces receipt by the National Highway
Traffic Safety Administration (NHTSA) of a petition for a decision that
2000 East Lancs Lolyne double decker buses mounted on Volvo B7L chasses
that were not originally manufactured to comply with all applicable
Federal Motor Vehicle Safety Standards (FMVSS) are eligible for
importation into the United States because they have safety features
that comply with, or are capable of being altered to comply with, all
such standards.

DATES: The closing date for comments on the petition is July 28, 2010.

ADDRESSES: Comments should refer to the docket and notice numbers above
and be submitted by any of the following methods:
     Federal eRulemaking Portal: Go to http://
www.regulations.gov. Follow the online instructions for submitting
comments.
     Mail: Docket Management Facility: U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., West Building Ground
Floor, Room W12-140, Washington, DC 20590-0001
     Hand Delivery or Courier: West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue, SE., between 9 a.m. and 5 p.m. ET,
Monday through Friday, except Federal holidays.
     Fax:<PHONE_NUMBER>.
    Instructions: Comments must be written in the English language, and
be no greater than 15 pages in length, although there is no limit to
the length of necessary attachments to the comments. If comments are
submitted in hard copy form, please ensure that two copies are
provided. If you wish to receive confirmation that your comments were
received, please enclose a stamped, self-addressed postcard with the
comments. Note that all comments received will be posted without change
to http://www.regulations.gov, including any personal information
provided. Please see the Privacy Act heading below.
    Privacy Act: Anyone is able to search the electronic form of all
comments received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78).
    How to Read Comments submitted to the Docket: You may read the
comments received by Docket Management at the address and times given
above. You may also view the documents from the Internet at http://
www.regulations.gov. Follow the online instructions for

accessing the dockets. The docket ID number and title of this notice
are shown at the heading of this document notice. Please note that even
after the comment closing date, we will continue to file relevant
information in the Docket as it becomes available. Further, some people
may submit late comments. Accordingly, we recommend that you
periodically search the Docket for new material.

FOR FURTHER INFORMATION CONTACT: Coleman Sachs, Office of Vehicle
Safety Compliance, NHTSA<PHONE_NUMBER>).

SUPPLEMENTARY INFORMATION:

Background

    Under 49 U.S.C. 30141(a)(1)(B), a motor vehicle that was not
originally manufactured to conform to all applicable FMVSS, and has no
substantially similar U.S.-certified counterpart, shall be refused
admission into the United States unless NHTSA has decided that the
motor vehicle has safety features that comply with, or are capable of
being altered to comply with, all applicable FMVSS based on destructive
test data or such other evidence as NHTSA decides to be adequate.
    Petitions for eligibility decisions may be submitted by either
manufacturers or importers who have registered with NHTSA pursuant to
49 CFR part 592. As specified in 49 CFR 593.7, NHTSA publishes notices
in the Federal Register for each petition that it receives, and affords
interested persons an opportunity to comment on the petitions. At the
close of the comment period, NHTSA decides, on the basis of the
petitions and any comments that it has received, whether the vehicle(s)
is eligible for importation. The agency then publishes their decision
in the Federal Register.
    J.K. Technologies, LLC, of Baltimore, Maryland (J.K.) (Registered
Importer 90-006) has petitioned NHTSA to decide whether nonconforming
2000 East Lancs Lolyne double decker buses mounted on Volvo B7L chasses
are eligible for importation into the United States.
    J.K. submitted information with its petition intended to
demonstrate that non-U.S. certified 2000 East Lancs Lolyne double
decker buses mounted on Volvo B7L chasses, as originally manufactured,
conform to many FMVSS, or are capable of being altered to conform to
those standards.
    Specifically, the petitioner claims that non-U.S. certified 2000
East Lancs Lolyne double decker buses mounted on Volvo B7L chasses, as
originally manufactured, comply with Standard Nos. 102 Transmission
Shift Lever Sequence, Starter Interlock, and Transmission Braking
Effect, 103 Windshield Defrosting and Defogging Systems, 104 Windshield
Wiping and Washing Systems, 106 Brake Hoses, 111 Rearview Mirrors, 119
New Pneumatic Tires for Vehicles other than Passenger Cars, 121 Air
Brake Systems, 124 Accelerator Control Systems, 205 Glazing Materials,
207 Seating Systems, 209 Seat Belt Assemblies, 210 Seat Belt Assembly
Anchorages, 217 Bus Emergency Exits and Window Retention and Release,
and 302 Flammability of Interior Materials.
    With regard to Standard No. 121 Air Brake Systems, the petition
asserts: ``All elements of the braking system comply with the
applicable FMVSS 121 requirements.'' Because it is aware that Volvo
Buses has not, to date, manufactured any buses for sale in the United
States or certified any buses as complying with all applicable FMVSS,
NHTSA is concerned that the brake system on the vehicles that are the
subject of the petition may not, in fact, have been originally
manufactured to comply with all requirements of Standard No. 121. As a
consequence, the agency is soliciting specific comments with respect to
this issue.
    Petitioner also contends that the vehicle is capable of being
altered to meet the following standards, in the manners indicated:
    Standard No. 101 Controls and Displays: modification of: (a) The
speedometer face so that speed is displayed in miles per hour; (b) the
low pressure warning system dash placards for the primary and secondary
braking systems; and (c) the safety belt telltale lamp label to ensure
that the controls and displays meet the requirements of this standard.
    Standard No. 108 Lamps, Reflective Devices and Associated
Equipment: installation of the following U.S.-conforming model
components: (a) Front sidemarker lamps; (b) headlamps; (c) tail lamps
with integral rear side marker lamps; (d) clearance lamps; and (e) side
mounted reflectors in place of existing nonconforming reflectors.
    Standard No. 120 New Pneumatic Tires for Vehicles Other than
Passenger Cars: installation of a tire information placard.
    Standard No. 208 Occupant Crash Protection: Installation of an
audible seat belt warning system to meet the requirements of this
standard.
    All comments received before the close of business on the closing
date indicated above will be considered, and will be available for
examination in the docket at the above addresses both before and after
that date. To the extent possible, comments filed after the closing
date will also be considered. Notice of final action on the petition
will be published in the Federal Register pursuant to the authority
indicated below.

    Authority:  49 U.S.C. 30141(a)(1)(A) and (b)(1); 49 CFR 593.8;
delegations of authority at 49 CFR 1.50 and 501.8.

    Issued on: June 21, 2010.
Claude H. Harris,
Director, Office of Vehicle Safety Compliance.
[FR Doc. 2010-15552 Filed 6-25-10; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register Volume 78, Number 246 (Monday, December 23, 2013)]
[Notices]
[Pages 77444-77445]
[FR Doc No: 2013-30516]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP14-25-000]

Natural Gas Pipeline Company of America LLC; Stingray Pipeline
Company, L.L.C.; Notice of Application

    Take notice that on December 4, 2013, Natural Gas Pipeline Company
of America LLC (Natural), 3250 Lacey Road, 7th Floor, Downers Grove,
Illinois 60515-7918 and Stingray Pipeline Company, L.L.C. (Stingray),
110 Louisiana Street, Suite 3300, Houston, Texas 77002, filed a joint
application in Docket No. CP14-25-000 pursuant to section 7(b) and
section7(c) of the Natural Gas Act (NGA), and Part 157 of the
Commission's regulations, for a certificate of public convenience and
necessity requesting: (1) Approval for Natural to abandon by sale to
Stingray the offshore, West Cameron 148 Lateral, the West Cameron 148
Platform, related appurtenances, and the onshore Compressor Station 701
land; (2) approval for Natural to abandon by sale to Stingray the
offshore, West Cameron 144 Lateral, the West Cameron 144 Meter and
related appurtenances; (3) to abandon Natural's Rate Schedule X-50, the
long term lease for the aforementioned facilities and land; and (4) a
certificate of public convenience and necessity for Stingray to acquire
from Natural, and to own and operate the above listed facilities and
land, all as more fully set forth in the application which is on file
with the Commission and open for public inspection. The filing may also
be viewed on the web at http://www.ferc.gov using the ``eLibrary''
link. Enter the docket number excluding the last three digits in the
docket number field to access the document. For assistance, contact
FERC at<EMAIL_ADDRESS>or call toll-free,<PHONE_NUMBER> or
TTY,<PHONE_NUMBER>.
    Any questions regarding the applications should be directed Bruce
H. Newsome, Vice President, Natural Gas Pipeline Company of America
LLC, 3250 Lacey Road, 7th Floor, Downers Grove, Illinois 60515-7918,
telephone:<PHONE_NUMBER>, or email<EMAIL_ADDRESS>or
to Cynthia Roney, Manager, Regulatory Compliance, Stingray Pipeline
Company, L.L.C., 1100 Louisiana, Suite 3300, Houston, Texas 77002,
telephone:<PHONE_NUMBER>, or email<EMAIL_ADDRESS>    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice the Commission staff will either:
Complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding; or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or EA for this
proposal. The filing of the EA in the Commission's public record for
this proceeding or the issuance of a Notice of Schedule for
Environmental Review will serve to notify federal and state agencies of
the timing for the completion of all necessary reviews, and the
subsequent need to complete all federal authorizations within 90 days
of the date of issuance of the Commission staff's FEIS or EA.
    There are two ways to become involved in the Commission's review of

this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date stated below, file with the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit 7 copies of filings made with the Commission and must mail a
copy to the applicant and to every other party in the proceeding. Only
parties to the proceeding can ask for court review of Commission orders
in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commenter's will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with he Commission's environmental review process.
Environmental commenter's will not be required to serve copies of filed
documents on all other parties. However, the non-party commentary, will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and ill not have the right to seek court
review of the Commission's final order.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFiling'' link
at http://www.ferc.gov. Persons unable to file electronically should
submit an original and 5 copies of the protest or intervention to the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426. See, 18 CFR 385.2001(a)(1)(iii) and the instructions on the
Commission's Web site under the ``e-Filing'' link.
    Comment Date: 5:00 p.m. Eastern Time on January 7, 2014.

    Dated: December 17, 2013.
Kimberly D. Bose,
Secretary.
[FR Doc. 2013-30516 Filed 12-20-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 216 (Friday, November 7, 2014)]
[Notices]
[Pages 66387-66388]
[FR Doc No: 2014-26443]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2014-0970]

National Maritime Security Advisory Committee; Vacancies

AGENCY: Coast Guard, DHS.

ACTION: Request for applications.

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SUMMARY: The Coast Guard seeks applications for membership on the
National Maritime Security Advisory Committee. The National Maritime
Security Advisory Committee provides advice and makes recommendations
on national maritime security matters to the Secretary of Homeland
Security via the Commandant of the United States Coast Guard.

DATES: Applicants must submit a cover letter and resume in time to
reach Mr.

Ryan Owens, the Alternate Designated Federal Officer, no later than
December 31, 2014.

ADDRESSES: Send your cover letter and resume indicating the membership
category for which you are applying via one of the following methods:
     Email<EMAIL_ADDRESS>Subject line: The National
Maritime Security Advisory Committee;
     Fax:<PHONE_NUMBER>, ATTN: Mr. Ryan Owens, National Maritime
Security Maritime Advisory Committee, Alternate Designated Federal
Officer; or
     Mail: Send your completed application packets to: Mr. Ryan
Owens, National Maritime Security Advisory Committee, Alternate
Designated Federal Officer, CG-FAC, U.S. Coast Guard, 2703 Martin
Luther King Jr. Avenue SE., Washington, DC 20593, Stop 7501,
Washington, DC 20593-7501.

FOR FURTHER INFORMATION CONTACT: Mr. Ryan Owens, Commandant (CG-FAC),
National Maritime Security Advisory Committee, Alternate Designated
Federal Officer, U.S. Coast Guard Headquarters, 2703 Martin Luther King
Jr. Avenue SE., Washington, DC 20593, Stop 7501, Washington, DC 20593-
7501<EMAIL_ADDRESS>Phone:<PHONE_NUMBER>, Fax:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The National Maritime Security Advisory
Committee is an advisory committee established in accordance with the
provisions of the Federal Advisory Committee Act, Title 5 United States
Code, Appendix. The National Maritime Security Advisory Committee
advises, consults with, and makes recommendations to the Secretary via
the Commandant of the Coast Guard on matters relating to national
maritime security.
    The full Committee normally meets at least two times per fiscal
year. Working group meetings and teleconferences are held more
frequently, as needed. The Committee may also meet for extraordinary
purposes.
    We will consider applications for seven positions. Current members
are eligible to serve an additional term of office but must re-apply in
accordance with this notice.
    Applicants with experience in the following sectors of the marine
transportation industry with at least five years' practical experience
in their field are encouraged to apply:
     at least one individual who represents the interests of
the port authorities;
     at least one individual who represents the interests of
the facilities' owners or operators;
     at least one individual who represents the interests of
the terminal owners or operators;
     at least one individual who represents the interests of
the vessel owners or operators;
     at least one individual who represents the interests of
the maritime labor organizations;
     at least one individual who represents the interests of
State and local governments; and
     at least one individual who represents the interests of
the maritime industry.
    Due to the nature of National Maritime Security Advisory Committee
business, National Maritime Security Advisory Committee members are
required to apply for, obtain, and maintain a government national
security clearance at the Secret level. The Coast Guard will sponsor
and assist candidates with this process. Each member serves for a term
of three years. While attending meetings or when otherwise engaged in
Committee business, members may be reimbursed for travel and per diem
expenses as permitted under applicable Federal travel regulations.
However, members will not receive any salary or other compensation for
their service on the National Maritime Security Advisory Committee.
    The Department of Homeland Security does not discriminate in
selection of Committee members on the basis of race, color, religion,
sex, national origin, political affiliation, sexual orientation, gender
identity, marital status, disability and genetic information, age,
membership in an employee organization, or other non-merit factor. The
Department of Homeland Security strives to achieve a widely diverse
candidate pool for all of its recruitment actions.
    To visit our online docket, go to http://www.regulations.gov, enter
the docket number for this notice (USCG-2014-0970) in the Search box,
and click ``Search.'' Please do not post your resume on this site. Note
that during the vetting process, applicants may be asked to provide
date of birth and social security number.

    Dated: November 3, 2014.
J. C. Burton,
Captain, U.S. Coast Guard, Director of Inspections and Compliance.
[FR Doc. 2014-26443 Filed 11-6-14; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 86, Number 31 (Thursday, February 18, 2021)]
[Notices]
[Page 10127]
[FR Doc No: 2021-03298]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4509-DR; Docket ID FEMA-2021-0001]

North Dakota; Amendment No. 2 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of North Dakota (FEMA-4509-DR), dated April 1, 2020, and
related determinations.

DATES: This change occurred on January 20, 2021.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) hereby gives notice that pursuant to the authority vested in the
Administrator, under Executive Order 12148, as amended, Nancy J.
Dragani, of FEMA is appointed to act as the Federal Coordinating
Officer for this disaster.
    This action terminates the appointment of Lee K. dePalo as Federal
Coordinating Officer for this disaster.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Robert J. Fenton,
Senior Official Performing the Duties of the Administrator, Federal
Emergency Management Agency.
[FR Doc. 2021-03298 Filed 2-17-21; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register: August 11, 2008 (Volume 73, Number 155)]
[Notices]
[Page 46618-46619]
[DOCID:fr11au08-59]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

August 6, 2008.
    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

    Docket Numbers: RP03-36-033.
    Applicants: Dauphin Island Gathering Partners.
    Description: Dauphin Island Gathering Partners submits the Thirty-
Eighth Revised Sheet 9 to FERC Gas Tariff, First Revised Volume 1, to
be effective 8/4/08.
    Filed Date: 08/04/2008.
    Accession Number: 20080805-0115.
    Comment Date: 5 p.m. Eastern Time on Monday, August 18, 2008.

    Docket Numbers: RP06-200-046.
    Applicants: Rockies Express Pipeline LLC.
    Description: Rockies Express Pipeline, LLC submits Second Revised
Sheet 8B et al. to FERC Gas Tariff, Second Revised Volume 1.
    Filed Date: 08/01/2008.
    Accession Number: 20080804-0219.
    Comment Date: 5 p.m. Eastern Time on Wednesday, August 13, 2008.
    Docket Numbers: RP06-569-006. RP07-376-003. RP01-245-028.
    Applicants: Transcontinental Gas Pipe Line Corp.
    Description: Transcontinental Gas Pipe Line Corp forwards a DVD
that contains their Report of Refund.
    Filed Date: 08/01/2008.
    Accession Number: 20080804-0220.
    Comment Date: 5 p.m. Eastern Time on Wednesday, August 13, 2008.
    Docket Numbers: RP08-481-000.
    Applicants: Texas Gas Transmission. LLC.
    Description: Texas Gas Transmission, LLC submits Fourth revised
Sheet 240 to FERC Gas Tariff, Second Revised Volume 1.
    Filed Date: 08/01/2008.
    Accession Number: 20080804-0227.
    Comment Date: 5 p.m. Eastern Time on Wednesday, August 13, 2008.

    Docket Numbers: RP08-482-000.
    Applicants: Natural Gas Pipeline Company of America.
    Description: Natural Gas Pipeline Company of America, LLC submits
First Revised Sheet 32 to FERC Gas Tariff, Seventh Revised Volume 1.
    Filed Date: 08/01/2008.
    Accession Number: 20080804-0226.
    Comment Date: 5 p.m. Eastern Time on Wednesday, August 13, 2008.

    Docket Numbers: RP08-483-000.
    Applicants: Trailblazer Pipeline Company LLC.
    Description: Trailblazer Pipeline Co, LLC submits First Revised
Sheet 5 et al. to FERC Gas Tariff, Fourth Revised Volume 1.
    Filed Date: 08/01/2008.
    Accession Number: 20080804-0225.
    Comment Date: 5 p.m. Eastern Time on Wednesday, August 13, 2008.

    Docket Numbers: RP08-484-000.
    Applicants: Colorado Interstate Gas Company.
    Description: Colorado Interstate Gas Co submits Sixth Revised Sheet
320 to its FERC Gas Tariff, First Revised Volume 1.
    Filed Date: 08/01/2008.
    Accession Number: 20080804-0224.
    Comment Date: 5 p.m. Eastern Time on Wednesday, August 13, 2008.

    Docket Numbers: RP08-485-000.
    Applicants: Cimarron River Pipeline, LLC.
    Description: Cimarron River Pipeline, LLC submits First Revised
Sheet 500 to FERC Gas Tariff, Original Volume 1.
    Filed Date: 08/01/2008.
    Accession Number: 20080804-0223.
    Comment Date: 5 p.m. Eastern Time on Wednesday, August 13, 2008.

    Docket Numbers: RP08-486-000.
    Applicants: Horizon Pipeline Company, L.L.C.
    Description: Horizon Pipeline Company, LLC submits Fifth Revised
Sheet 5 to FERC Gas Tariff, Original Volume 1.
    Filed Date: 08/01/2008.
    Accession Number: 20080804-0222.
    Comment Date: 5 p.m. Eastern Time on Wednesday, August 13, 2008.

    Docket Numbers: RP08-487-000.
    Applicants: East Tennessee Natural Gas, LLC.
    Description: East Tennessee Natural Gas, LLC submits Second Revised
Sheet 313 et al. to FERC Gas Tariff, Third Revised Volume 1.
    Filed Date: 08/01/2008.
    Accession Number: 20080804-0221.
    Comment Date: 5 p.m. Eastern Time on Wednesday, August 13, 2008.

    Docket Numbers: RP08-488-000.
    Applicants: Maritimes & Northeast Pipeline, L.L.C.
    Description: Maritimes & Northeast Pipeline, LLC submits Second
Revised Sheet 300 to FERC Gas Tariff, First Revised Volume 1, and
effective 9/4/08 under RP08-488.
    Filed Date: 08/04/2008.
    Accession Number: 20080805-0101.
    Comment Date: 5 p.m. Eastern Time on Monday, August 18, 2008.

    Docket Numbers: CP06-5-010.
    Applicants: Empire Pipeline Inc.
    Description: Empire Pipeline Inc., submits Original Sheet No. 0 et
al. to FERC Gas Tariff, Original Volume No. 1, to be effective 11/1/08.
    Filed Date: 08/01/2008.
    Accession Number: 20080805-0096.
    Comment Date: 5 p.m. Eastern Time on Friday, August 15, 2008.

    Docket Numbers: CP07-417-001.
    Applicants: Texas Gas Transmission, LLC.
    Description: Texas Gas Transmission, LLC submits Original Sheet 35A
et al. to FERC Gas Tariff, Second Revised Volume No. 1.

    Filed Date: 08/01/2008.
    Accession Number: 20080805-0215.
    Comment Date: 5 p.m. Eastern Time on Friday, August 15, 2008.

    Docket Numbers: CP08-17-001.
    Applicants: Cimarron River Pipeline, LLC.
    Description: Cimarron River Pipeline, LLC submits its proposed FERC
Gas Tariff, Original Volume No. 1, to be effective 9/1/08.
    Filed Date: 08/01/2008.
    Accession Number: 20080805-0120.
    Comment Date: 5 p.m. Eastern Time on Friday, August 15, 2008.
    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. Protests will be considered by the Commission in
determining the appropriate action to be taken, but will not serve to
make protestants parties to the proceeding. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://
www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St. NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please e-mail<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. E8-18454 Filed 8-8-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: May 30, 2008 (Volume 73, Number 105)]
[Rules and Regulations]
[Page 31027-31033]
[DOCID:fr30my08-9]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 878

[Docket No. FDA-2006-P-0140] (formerly Docket No. 2006P-0071)

General and Plastic Surgery Devices; Reclassification of the
Tissue Adhesive for Topical Approximation of Skin Device

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is reclassifying the
device type, tissue adhesive for the topical approximation of skin,
from class III (premarket approval) into class II (special controls).
Tissue adhesives for non-topical uses remain in class III and continue
to require premarket approval applications (PMAs). FDA is proposing
this reclassification in accordance with the Federal Food, Drug, and
Cosmetic Act (the act). Elsewhere in this issue of the Federal
Register, FDA is announcing the availability of a guidance document
entitled ``Class II Special Controls Guidance Document: Tissue Adhesive
for the Topical Approximation of Skin'' that will serve as the special
control for the reclassified device type.

DATES: This final rule is effective June 30, 2008.

FOR FURTHER INFORMATION CONTACT: George J. Mattamal, Center for Devices
and Radiological Health (HFZ-410), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Regulatory Authorities

    The act, as amended by the Medical Device Amendments of 1976 (the
1976 amendments) (Public Law 94-295), the Safe Medical Devices Act of
1990 (SMDA) (Public Law 101-629), and the Food and Drug Administration
Modernization Act of 1997 (FDAMA) (Public Law 105-115), among other
amendments, established a comprehensive system for the regulation of
medical devices intended for human use. Section 513 of the act (21
U.S.C. 360c) established three categories (classes) of devices,
depending on the regulatory controls needed to provide reasonable
assurance of their safety and effectiveness. The three categories of
devices are class I (general controls), class II (special controls),
and class III (premarket approval).
    The 1976 amendments broadened the definition of ``device'' in
section 201(h) of the act (21 U.S.C. 321(h)) to include certain
articles that were once regulated as drugs. Under the 1976 amendments,
Congress classified all transitional devices, i.e., those devices
previously regulated as new drugs, into class III. SMDA amended section
520(l) of the act (21 U.S.C. 360j(l)) to direct FDA to collect certain
safety and effectiveness information from the manufacturers of
transitional devices still remaining in class III to determine whether
the devices should be reclassified into class II (special controls) or
class I (general controls). The legislative history of the SMDA
reflects congressional concern that many transitional devices were not
appropriately regulated in class III (H. Rept. 808, 101st Cong., 2d
sess. 26-27 (1990); S. Rept. 513, 101st Cong., 2d sess. 27 (1990)).
    Accordingly, in the Federal Register of November 14, 1991 (56 FR
57960), FDA issued an order under section 520(l)(5)(A) of the act,
requiring manufacturers of transitional devices to submit to FDA a
summary of and a citation to any information known or otherwise
available to them respecting the devices, including adverse safety or
effectiveness information, that had not

been submitted under section 519 of the act (21 U.S.C. 360i).
Manufacturers were to submit the summaries and citations to FDA by
January 13, 1992. By notice published in the Federal Register of March
10, 1992 (57 FR 8462), FDA extended the reporting period to March 31,
1992.
    Section 520(l)(5)(B) of the act provides that, after the issuance
of an order requiring manufacturers to submit any information known or
otherwise available respecting the devices, but before December 1,
1992, FDA was to publish regulations either leaving transitional class
III devices in class III or reclassifying them into class I or II.
Subsequently, as permitted by section 520(l)(5)(C) of the act, in the
Federal Register of November 30, 1992 (57 FR 56586), the agency
published a notice extending the period for issuing such regulations
until December 1, 1993, but did not publish the regulations before
December 1, 1993.

II. Regulatory Background of the Device

    Transitional devices, those devices formerly regulated as drugs,
were classified into class III by the statute and premarket approval
was immediately required (section 520(l) of the act). The Federal
Register of December 16, 1977 (42 FR 63472), identified certain
transitional devices and stated the following: ``The lists contained in
this notice may not be an exhaustive inventory of products subject to
section 520(l) of the act.'' This notice did not specifically list
``Tissue Adhesives.'' The investigational new drug (IND) and new drug
applications (NDAs) for transitional devices were shortly thereafter
transferred to FDA's Center for Devices and Radiological Health
(formerly the Bureau of Medical Devices). Applications for tissue
adhesives were included in this transfer. In a January 19, 1982,
preamble to a proposed rule classifying other devices (47 FR 2810),
``tissue adhesive for use in general surgery,'' was identified as a
transitional device, but listed under injectable silicone. Since
enactment of the 1976 amendments, FDA has approved several PMAs and PMA
supplements authorizing the commercial distribution of tissue adhesives
in the United States.

III. Description of the Device

    FDA has referred to this device type, under review for
reclassification, in previous notices as ``tissue adhesive for use in
general surgery''; however, FDA is now revising the name and
identification to more accurately identify the device type. The device,
reclassified into class II, would be:
    Tissue adhesive for the topical approximation of skin. A tissue
adhesive for the topical approximation of skin is a device intended for
topical closure of surgical incisions, including laparoscopic
incisions, and simple traumatic lacerations that have easily
approximated skin edges. Tissue adhesives for the topical approximation
of skin may be used in conjunction with, but not in place of, deep
dermal stitches.
    FDA is also issuing the following identification for the devices
that will remain in class III:
    A tissue adhesive for non-topical use, including adhesives intended
for use in the embolization of brain arteriovenous malformation or
ophthalmic surgery, is a device used for adhesion of internal tissues
and vessels.

IV. Recommendation of the Panel

    On February 9, 2006, Regulatory & Clinical Research Institute, Inc.
(RCRI), Minneapolis, MN, submitted a petition (Docket No. 2006P-0071)
to FDA to reclassify tissue adhesive for soft tissue approximation from
``Class III to Class II (special controls)'' (Ref. 1). On May 15, 2006,
the petitioner amended its petition to include several references from
the scientific literature cited in the original petition (Ref. 2). On
July 18, 2006, the petitioner again amended its petition to clarify
that the use it was proposing for reclassification was only the topical
approximation of skin (Ref. 3).
    In response to the petition, FDA consulted with the FDA's General
and Plastic Surgery Devices Panel (the Panel), regarding
reclassification of this device type. The Panel discussed the device
type at an August 25, 2006, public meeting and unanimously recommended
that the tissue adhesive for the topical approximation of skin be
reclassified from class III into class II. The Panel also recommended
that a class II guidance document, which the Panel thought should
include several voluntary consensus standards, be the special control
for the device. The Panel based the recommendations on the information
provided by FDA; the presentations to the panel by the petitioner,
other manufacturers, and FDA; the Panel's deliberations at the meeting;
and the Panel's personal experience with the use of devices for the
topical approximation of skin. The Panel did not consider the
reclassification of any other use of tissue adhesives.
    Accordingly, in the Federal Register of July 3, 2007 (72 FR 36398),
FDA issued a proposed rule to reclassify the device, tissue adhesive
for the topical approximation of skin, from class III (premarket
approval) into class II (special controls). Tissue adhesive for non-
topical uses would remain in class III and continue to require PMAs.

V. Comments

    FDA invited interested persons to comment on the proposed rule by
September 4, 2007. FDA received two comments on the proposed rule. The
following is a summary of the comments and FDA's responses. Elsewhere
in this issue of the Federal Register, portions of the comments which
address only the draft guidance document are addressed in the notice of
availability announcing the special controls guidance document.
    (Comment 1) One comment supported the reclassification of tissue
adhesives. The comment noted that the tissue adhesives approved by FDA
have had a long history of safety. The comment suggested that tissue
adhesives made of other cyanoacrylates with different alkyl groups may
have additional benefits for patients. The comment also said that bench
testing is more useful than clinical testing to evaluate substantial
equivalence due to the many uncontrolled variables. The comment said
that manufacturers of new tissue adhesives should be permitted to
market their devices through a premarket notification if they are able
to demonstrate that their devices are substantially equivalent to the
marketed predicate devices.
    (Response) FDA agrees that these type devices should be
reclassified and intends that manufacturers who are able to demonstrate
substantial equivalence to marketed devices within the reclassified
generic type will be permitted to market their devices.
    (Comment 2) One comment objected that FDA improperly designated the
tissue adhesive for the topical approximation of skin as a transitional
device. The comment said that the tissue adhesive for the topical
approximation of skin does not meet the definition of a transitional
device in section 520(l) of the act. The comment noted that an NDA for
a tissue adhesive was submitted before the enactment of the 1976
amendments but was subsequently withdrawn before the enactment date.
The comment said that, in order for the device to be a transitional
device, it is necessary for an IND to have been in effect or for an NDA
to have been pending or approved on the enactment date. The comment
said that tissue adhesives are devices automatically classified into
class III under section 513(f)(1) of the act.
    (Response) Section 520(l)(1)(B) provides that a device is a
transitional

device if ``an application [under section 505(b) of the act was filed
on or before the enactment date [of the Medical Device Amendments of
1976] and with respect to which no order of approval or refusing to
approve had been issued on such date* * *.'' The comment agrees that an
application was filed before the enactment date. It is also clear that
no order of approval or refusing to approve had been issued before the
enactment date. The plain words of the statute do not require that an
application be pending on the date of enactment. As noted previously,
FDA published a document on January 19, 1982 identifying, among other
devices, tissue adhesives as transitional devices. FDA did not receive
any objections to this designation until the comment on this proposed
rule. Furthermore, even if the device would be considered a
postamendments device under section 513(f) of the act, the procedures
that FDA followed would be sufficient to reclassify the device. FDA did
not follow ``truncated procedures'' to reclassify the device under the
transitional device provisions. FDA referred the petition to an
advisory panel that made a recommendation after holding an open public
meeting. FDA published the panel recommendation along with the proposed
rule and provided interested persons 60 days to comment on the
proposal. The criteria for reclassifying a device into class II are
identical for transitional devices under section 520(l) of the act and
postamendments devices under section 513(f) of the act.
    (Comment 3) One comment said that FDA failed to instruct the panel
on the appropriate legal standard for reclassification. The comment
said that the panel transcript and briefing memorandum show that FDA
did not instruct the panel that a reclassification recommendation must
be based on valid scientific evidence.
    (Response) FDA disagrees. The panel was instructed properly. FDA
conducts training sessions prior to the panel meeting for panel members
before they undertake their duties. Training for panels considering the
reclassification of a transitional device type consists of procedures
for the reclassification of a device type, including a transitional
device type, and the appropriate regulatory controls for each class of
device. Moreover, it is FDA's responsibility to make reclassification
decisions after receiving a panel recommendation. In accordance with
Sec.  860.7(c)(1) (21 CFR 860.7(c)(1)) the agency relied on valid
scientific evidence in determining that special controls, in addition
to general controls, would provide reasonable assurance of the safety
and effectiveness of the device.
    (Comment 4) One comment said that FDA did not identify an
appropriate generic type of device that could be reclassified. The
comment said that existing tissue adhesives are significantly different
in composition and could not be combined into a single generic type of
device. The comment also said there is insufficient publicly available
formulation and manufacturing information to establish a generic type
of device. Finally, the comments said that even minor differences in
product composition can affect the performance of the device.
    (Response) FDA disagrees with this comment. The FDA classification
regulations (21 CFR 860.3(i)) define generic type of device as ``a
grouping of devices that do not differ significantly in purpose,
design, materials, energy source, function, or any other feature
related to safety and effectiveness, and for which similar regulatory
controls are sufficient to provide reasonable assurance of safety and
effectiveness.'' It is not necessary that devices be identical in order
to fit within the same generic type. FDA believes that there is
sufficient publicly available information from currently marketed
tissue adhesives to show that they do not differ significantly in
design, materials, and function and that similar regulatory controls
are sufficient to provide reasonable assurance of their safety and
effectiveness. A manufacturer who wishes to market a new device will
need to show in a premarket notification that its device is
substantially equivalent in safety and effectiveness to a marketed
predicate device.
    (Comment 5) Two comments said that there was insufficient valid
scientific evidence to support the reclassification. One comment noted
that three of the articles submitted are not reports of prospective
clinical trials. The comment described one of the articles as a general
discussion of tissue adhesives, the second article as a brief
description of one facility's 6-month experience with tissue adhesives,
and the third article as a retrospective review of eight different
clinical studies. The comment further said the 6 FDA-designated
representative articles that discuss prospective clinical studies
involve limited numbers of subjects with a total of 60 to 100 subjects
in each study.
    (Response) FDA disagrees with this comment. FDA regulations (Sec.
860.7(b)(2)) define valid scientific evidence as:
    ``* * *evidence from well-controlled investigations, partially
controlled studies, studies and objective trials without matched
controls, well-documented case histories conducted by qualified
experts, and reports of significant human experience with a marketed
device, from which it can fairly and responsibly be concluded by
qualified experts that there is reasonable assurance of the safety and
effectiveness of a device under its conditions of use. The evidence
required may vary according to the characteristics of the device, its
conditions of use, the existence and adequacy of warnings and other
restrictions, and the extent of experience with its use. Isolated case
reports, random experience, reports lacking sufficient details to
permit scientific evaluation, and unsubstantiated opinions are not
regarded as valid scientific evidence to show safety or effectiveness*
* *.''
    FDA believes that the evidence on the record falls within this
definition of valid scientific evidence. The shortcomings of the
information alleged by the comment do not take this information out of
the category of valid scientific evidence. Literature available to FDA
and the Panel included over 1,500 published articles that reported on
the use of multiple adhesives in over 5,900 procedures (over 5,500
patients), with more than half evaluated in prospective randomized
trials. The study protocols included primary endpoints such as
cosmesis, dehiscence, and healing time for the topical skin
approximations. As defined in Sec.  860.7(c)(2), randomized prospective
trials and peer-reviewed literature constitute valid scientific
evidence.
    (Comment 6) One comment said that the performance parameters for
the device described in the proposal are incomplete. The comment said
that missing performance parameters include adherence and endurance
(how long the product will remain intact once applied); the ability to
potentiate infection; the ability to maintain a microbial barrier; and
how the skin reacts to the stabilizing agents. The comment also said
that publicly available scientific literature does not yield ranges of
values that would constitute acceptable performance on required tests
to demonstrate that performance parameters are met.
    (Response) FDA disagrees with this comment. FDA believes that the
FDA recommendations for premarket notifications in the special controls
guidance as well as general controls will adequately address all
appropriate performance parameters. Manufacturers who are proposing the
introduction of a new tissue adhesive will need to demonstrate
substantial equivalence to a

legally marketed predicate device in all safety and effectiveness
aspects before FDA will issue a substantial equivalence order. All
manufacturers submitting 510(k)s will need to demonstrate the
performance characteristics of the device related to adhesive strength,
(i.e., tensile strength, shear strength, peel adhesion strength, and
impact strength); hydrolytic degradation (i.e., the amount of
formulation additives, monomer impurities, and degradation products);
heat of polymerization; shelf life; and biocompatibility. FDA believes
that these performance characteristics will directly or indirectly
address the performance parameters identified in the comment. Where
these performance characteristics are shown sufficiently different from
currently legally marketed devices, the special controls guidance
document indicates that FDA may conclude additional animal testing or
clinical assessment is necessary, see sections 10, ``Animal Testing,''
and 11, ``Clinical Studies.''
    (Comment 7) A comment said that FDA has failed to fully identify
the risks to health presented by these devices. A comment said that FDA
unduly relied upon Medical Device Reports (MDRs) to identify the risks
to health and that the MDR system is inadequate to fully identify the
risks. A comment said that risks not identified include pain, stinging,
or burning upon application, delayed wound healing or tissue toxicity,
patients picking off the adhesive, and necrosis.
    All of these effects are intrinsic to the risk of adverse tissue
reaction and chemical burns except for patient ``picking off
adhesive.'' Although foreseeable, it is not intended for patients to
``pick off'' the adhesive and therefore is not considered a risk to
health associated with the intended or otherwise correct use of the
device. A comment further said that the risks identified by FDA are not
supported by valid scientific evidence because they are developed from
the MDR system.
    (Repsonse) FDA disagrees with this comment. FDA believes that it
has fully identified the significant risks to health presented by these
devices. As noted in the proposal, FDA did not rely solely upon the MDR
reports to identify the risks to health presented by these devices. FDA
also considered the information presented in the petition,
presentations at the panel meeting, and the panel recommendation.
    (Comment 8) A comment also said that the proposed special controls
are inadequate to eliminate or mitigate the risks associated with
tissue adhesives. A comment also said that FDA did not present
sufficient valid scientific evidence to support the proposed special
controls because almost half of the articles relate to a single device
and, therefore, cannot support reclassification of a generic type of
device.
    (Response) FDA disagrees with the comment. FDA believes that a
premarket notification that adequately addresses the recommendations of
the special control guidance and adherence to the general controls of
the act will mitigate the risks to health associated with these devices
and provide reasonable assurance of the safety and effectiveness of the
device. In the premarket notification review process, FDA will assure
that the device intended for marketing is at least as safe and
effective as the legally marketed predicate device. FDA believes that
there is adequate valid scientific evidence on the record about all
legally marketed tissue adhesives to establish and reclassify a generic
type of device. Although many of the articles relate to a single
device, there is substantial evidence concerning other marketed devices
and that evidence, as well as the remainder of the evidence on the
record, provides adequate valid scientific evidence to reclassify a
generic type of device.
    (Comment 9) One comment stated that bench testing as described in
the special controls guidance document is more informative and
introduces fewer variables than do animal or clinical studies in
evaluating these devices.
    (Response) FDA agrees, in general, that animal studies and clinical
trials for these devices may not be the most appropriate means to
evaluate these devices. FDA intends to request animal or clinical data
only when appropriate.
    (Comment 10) One comment asked whether the device is subject to
current good manufacturing practices (CGMPs).
    (Response) When the device is reclassified into class II, it
remains subject to the requirements of good manufacturing practices
(GMPs) under the Quality System Regulation in part 820 (21 CFR part
820). For more information on the scope of applicability of the Quality
System Regulation, please see Sec.  820.1, Scope.
    (Comment 11) One comment said the bench testing using American
Society for Testing and Materials (ASTM) methods described in the
guidance does not correlate to device performance in the clinical
setting because the ASTM methods do not include acceptance criteria.
    (Response) Although FDA agrees these methods do not include
acceptance criteria, FDA disagrees with the premise that these methods
are inadequate. The methods described in these standards allow direct
comparison of performance characteristics between devices. For those
devices where the data demonstrate equivalent performance
characteristics, no additional clinical testing would be necessary.
Where the performance characteristics are shown by bench testing to be
sufficiently different from those of currently legally marketed
devices, the special controls guidance document indicates that FDA may
conclude additional animal testing or clinical assessment is necessary.
See sections 10. Animal Testing and 11. Clinical Studies.
    (Comment 12) One comment suggested that heat of polymerization
studies recommended in the guidance are not appropriate for materials
that cure by non-exothermic mechanisms. The second part of the comment
said that FDA should set an upper limit on the amount of heat generated
by exothermic mechanisms because of the possibility of burns.
    (Response) FDA agrees, in part, with this comment. Heat of
polymerization studies are not appropriate methods for evaluating the
performance characteristics of materials that cure by non-exothermic
mechanisms. As stated in section 5 of the special controls guidance
document, a manufacturer proposing to use materials that cure by non-
exothermic mechanisms will need to identify the risks specific to those
devices by conducting a risk analysis and will need to address the
risks identified. FDA disagrees with the second part of the comment.
FDA has set no upper threshold for the heat of polymerization because
FDA believes the unique properties of each material approved to date
require a case-by-case evaluation of the heat generated by
polymerization. Addressing this property is intrinsic to addressing the
risk of chemical burns, which is one of the risks to health identified
in the special controls guidance document.
    (Comment 13) One comment said that testing the applicator based on
the force to express and that moisture vapor transmission testing are
not relevant. The comment also suggested that, depending on the design
of the applicator and its components, applicator functionality may be a
more relevant test.
    (Response) FDA agrees and has revised the guidance accordingly.
    (Comment 14) A comment said that clinical trials are necessary to
effectively evaluate critical performance parameters. One comment said
that the record fails to reveal any new valid

scientific evidence that demonstrates a diminished need for clinical
testing.
    (Response) FDA generally disagrees with the comment. In accordance
with the ``least burdensome'' provision of section 513(i)(1)(D) of the
act, FDA believes that the special controls guidance document
recommends the submission of the minimum information that is necessary
to making substantial equivalence determinations. In some cases,
submission of reports from bench and animal testing and conformance to
designated standards may be sufficient to demonstrate substantial
equivalence. FDA also states in the special controls guidance that it
may recommend the submission of clinical evidence in a premarket
notification if the proposed device is dissimilar to the legally
marketed predicate device in material formulation, technology, or
intended use.
    FDA believes that new information includes information developed as
a result of a re-evaluation of the data before the agency when the
device was originally classified, as well as information not presented,
not available, or not developed at that time. (See e.g., Holland Rantos
v. United States Department of Health, Education, and Welfare, 587 F.2d
1173, 1174 n.1 (D.C. Cir. 1978); Upjohn v. Finch, 422 F.2d 944 (6th
Cir. 1970); Bell v. Goddard, 366 F.2d 177 (7th Cir. 1966).) Re-
evaluation of the data previously before the agency is an appropriate
basis for subsequent regulatory action where the re-evaluation is made
in light of newly available regulatory authority (see Bell v. Goddard,
supra, 366 F.2d at 181; Ethicon, Inc. v. FDA, 762 F.Supp. 382, 389-91
(D.D.C. 1991)), or in light of changes in ``medical science.'' (See
Upjohn v. Finch, supra, 422 F.2d at 951.) FDA believes that the
information in the reclassification petition together with information
presented at the panel meeting and the history of use of the device as
known to the panel and FDA is sufficient new information to justify the
reclassification.
    (Comment 15) One comment said that the premarket notification and
GMP requirements will not provide reasonable assurance of the safety
and effectiveness of these devices. The comment said that there is no
coherent generic type of device that would permit meaningful
substantial equivalence comparisons and determinations. The comment
also said the premarket notification review process does not afford the
same level of manufacturing review as the premarket approval process.
    (Response) FDA disagrees with this comment. FDA believes that the
premarket notification process, in conjunction with the special
controls guidance document and the general controls of the act,
including the GMP requirements, will provide reasonable assurance of
the safety and effectiveness of the device. A manufacturer will need to
show in a premarket notification that the device it intends to market
is at least as safe and effective as a legally marketed predicate
device. This provides a device to which meaningful comparisons can be
made. While the premarket notification review process does not include
a pre-clearance GMP inspection, manufacturers of new tissue adhesive
devices will still be required to be in compliance with the GMP
requirements at all times.
    (Comment 16) One comment noted that tissue adhesives have been
considered significant risk devices under the investigational device
exemption rule (21 CFR 812.3(m)). The comment expressed concern that
reclassification into class II would result in these devices being
considered non-significant risk devices and expose patients in studies
involving newly developed tissue adhesives to risks without adequate
protection.
    (Response) Reclassification of these devices into class II is not
inconsistent with the designation of these devices as significant risk
devices under the investigational device exemption regulations. In the
special controls guidance document, FDA states: ``If a clinical study
is needed to demonstrate substantial equivalence (i.e., conducted prior
to obtaining 510(k) clearance of the device), the study must be
conducted under the Investigational Device Exemptions (IDE) regulation,
21 CFR Part 812. FDA generally believes that this device is a
significant risk device as defined in 21 CFR 812.3(m). In addition to
the requirement of having an FDA-approved IDE, sponsors of such trials
must comply with the regulations governing institutional review boards
(21 CFR Part 56) and informed consent (21 CFR Part 50).''

VI. Risks to Health

    After considering the information in the petition, the information
presented at the Panel meeting, the Panel's recommendation, and MDRs,
FDA has evaluated the risks to health associated with use of the tissue
adhesive for the topical approximation of skin and determined that the
following risks to health are associated with its use.

A. Unintentional Bonding or Product Leaks into Eyes

    Without adequate protection of the patient's eye, the adhesive may
inadvertently leak onto the eyelids when tissue adhesive is used on the
skin near the patient's eye, for example on the brow or forehead. If
this occurs, this can lead to sealing the eyelids shut and can require
surgical intervention to remove the adhesive and any bound skin.

B. Wound Dehiscence

    Wound dehiscence, the subsequent separation of the edges of the
wound, i.e., incision or laceration, during recovery is a risk of all
surgical procedures and treatments of traumatic wounds. Complications,
which include re-sealing the wound and surgical revision of the wound
with adhesive or sutures, can arise as a result of wound dehiscence.
These complications have the potential to delay the patient's recovery.

C. Adverse Tissue Reaction and Chemical Burns

    Tissue adhesive may be associated with adverse tissue reactions,
including allergy, inflammation, foreign body reactions, erythema
(redness), granuloma, and the exacerbation of asthma. In addition,
fumes given off by the adhesive before or during polymerization can
cause chemical burns.

D. Infection

    Infection of the skin or soft tissue is a risk to health associated
with all surgical procedures and wound treatment. If the tissue
adhesive is not properly sterilized, it may contribute to an increased
risk of infection.

E. Applicator Malfunction

    Inadequate packaging of the device or user error when opening the
packaging can result in damage to the applicator and subsequent
malfunction. If an applicator malfunctions, surgery may be extended,
resulting in additional time under anesthesia, or treatment may be
delayed. In addition, if the adhesive is packaged in a glass container,
lacerations to the user or the patient may result if the glass breaks.

F. Delayed Polymerization

    Polymerization of the adhesive may be delayed, resulting in
compromise of the wound, additional time under anesthesia, or delayed
treatment.

VII. Summary of the Reasons for the Reclassification

    FDA believes that a tissue adhesive for the topical approximation
of skin should be reclassified into class II because special controls,
in addition to general controls, would provide reasonable assurance of
the safety and effectiveness of the device. FDA believes there is
sufficient information to establish special controls to provide such
assurance. In addition to the potential risks to health associated with
use of a tissue adhesive for the topical skin approximation described
in section V of this document, there is reasonable knowledge of the
benefits of the device. Specifically, the tissue adhesive for the
topical approximation of skin may prevent extended bleeding in the
repair of surgical incisions and traumatic lacerations, promote healing
of approximated wound edges, and reduce pain and recovery time.

VIII. Special Controls

    In addition to general controls, FDA believes that the guidance
document entitled ``Class II Special Controls Guidance Document: Tissue
Adhesive for the Topical Approximation of Skin'' (the class II special
controls guidance document) is a special control adequate to address
the risks to health associated with the use of the device described in
section V of this document. FDA believes that the class II special
controls guidance document, which incorporates voluntary consensus
standards and describes labeling recommendations, in addition to
general controls, provides reasonable assurance of the safety and
effectiveness of the device. Elsewhere in this issue of the Federal
Register, FDA is publishing a notice of availability of the class II
special controls guidance document that is the special control for this
device.
    The class II special controls guidance document sets forth the
information FDA believes should be included in premarket notification
submissions (510(k)s) for the tissue adhesive for the topical
approximation of skin. FDA has identified the risks to health
associated with the use of the device in the first column of table 1 of
this document and the recommended mitigation measures identified in the
class II special controls guidance document in the second column of
table 1. FDA believes that addressing these risks to health in a 510(k)
in the manner identified in the class II special controls guidance
document, or in an acceptable alternative manner, is necessary to
provide reasonable assurance of the safety and effectiveness of the
device.

            Table 1.--Risks to Health and Mitigation Measures
------------------------------------------------------------------------
            Identified Risk              Recommended Mitigation Measures
------------------------------------------------------------------------
Unintentional bonding or product leaks   Bench testing
 into eyes                               Labeling
------------------------------------------------------------------------
Wound dehiscence                         Bench testing
                                         Shelf-life testing
                                         Animal testing
                                         Labeling
------------------------------------------------------------------------
Adverse tissue reaction and chemical     Biocompatibility
 burns                                   Animal testing
------------------------------------------------------------------------
Infection                                Bench testing
                                         Sterility
------------------------------------------------------------------------
Applicator malfunction                   Bench testing
------------------------------------------------------------------------
Delayed polymerization                   Bench testing
                                         Animal testing
------------------------------------------------------------------------

IX. FDA's Findings

    As discussed previously in this document, FDA believes the tissue
adhesive for the topical approximation of skin can be reclassified into
class II because special controls, in addition to general controls,
provide reasonable assurance of the safety and effectiveness of the
device and because there is sufficient information to establish special
controls to provide such assurance. FDA, therefore, is reclassifying
the device into class II and establishing the draft class II special
controls guidance document as a special control for the device. Tissue
adhesives for non-topical use will remain in class III and continue to
require PMAs.
    Section 510(m) of the act (21 U.S.C. 360) provides that a class II
device may be exempted from the premarket notification requirements
under section 510(k) of the act, if the agency determines that
premarket notification is not necessary to provide reasonable assurance
of the safety and effectiveness of the device. For this device, for the
reasons discussed previously, FDA believes that premarket notification
is necessary to provide reasonable assurance of safety and
effectiveness and, therefore, does not intend to exempt the device from
the premarket notification requirements.

X. Environmental Impact

    The agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

XI. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive
Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the
Unfunded Mandates Reform Act of 1995 (Public Law 104-4)). Executive
Order 12866 directs agencies to assess all costs and benefits of
available regulatory alternatives and, when regulation is necessary, to
select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The agency believes that
this final rule is not a significant regulatory action under the
Executive order.
    The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small

entities. Reclassification of this device when it is used for the
topical approximation of skin, from class III to class II, will relieve
manufacturers of the device of the cost of complying with the premarket
approval requirements in section 515 of the act (21 U.S.C. 360e).
Because reclassification will reduce regulatory costs with respect to
this device, the agency certifies that the rule will not have a
significant economic impact on a substantial number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $127 million, using the most current (2006) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
rule to result in any 1-year expenditure that would meet or exceed this
amount.

XII. Federalism

    FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. FDA has determined that the rule
does not contain policies that have substantial direct effects on the
States, on the relationship between the National Government and the
States, or on the distribution of power and responsibilities among the
various levels of government. Accordingly, the agency has concluded
that the rule does not contain policies that have federalism
implications as defined in the Executive order and, consequently, a
federalism summary impact statement is not required.

XIII. Paperwork Reduction Act of 1995

    This final rule contains no collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 is not required. Elsewhere in this
issue of the Federal Register, FDA is issuing a notice announcing the
guidance for the final rule. This guidance, ``Class II Special Controls
Guidance Document: Tissue Adhesive for the Topical Approximation of
Skin,'' references previously approved collections of information found
in FDA regulations.

XIV. References

    The following references have been placed on display in the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852 and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
    1. Regulatory & Clinical Research Institute, Inc. (RCRI),
reclassification petition, Docket No. 2006P-0071, Minneapolis, MN,
February 9, 2006.
    2. Regulatory & Clinical Research Institute, Inc.,
reclassification petition, Docket No. 2006P-0071, Minneapolis, MN,
May 15, 2006.
    3. Regulatory & Clinical Research Institute, Inc.,
reclassification petition, Docket No. 2006P-0071, Minneapolis, MN,
July 18, 2006.
    4. General and Plastic Surgery Devices Panel, transcript, pp.
199 to 207, August 25, 2006.

List of Subjects in 21 CFR Part 878

    Medical devices.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
878 is amended as follows:

PART 878--GENERAL AND PLASTIC SURGERY DEVICES

0
1. The authority citation for 21 CFR part 878 continues to read as
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. Section 878.4010 is added to subpart E to read as follows:

Sec.  878.4010  Tissue adhesive.

    (a) Tissue adhesive for the topical approximation of skin--(1)
Identification. A tissue adhesive for the topical approximation of skin
is a device intended for topical closure of surgical incisions,
including laparoscopic incisions, and simple traumatic lacerations that
have easily approximated skin edges. Tissue adhesives for the topical
approximation of skin may be used in conjunction with, but not in place
of, deep dermal stitches.
    (2) Classification. Class II (special controls). The special
control for this device is FDA's ``Class II Special Controls Guidance
Document: ``Tissue Adhesive for the Topical Approximation of Skin.''
See Sec.  878.1(e) of this chapter for the availability of this
guidance document.
    (b) Tissue adhesive for non-topical use--(1) Identification. A
tissue adhesive for non-topical use, including adhesives intended for
use in the embolization of brain arteriovenous malformation or for use
in ophthalmic surgery, is a device used foradhesion of internal tissues
and vessels.
    (2) Classification. Class III (premarket approval). As of May 28,
1976, an approval under section 515 of the act is required before this
device may be commercially distributed. See Sec.  878.3 of this
chapter.

    Dated: May 21, 2008.
Daniel G. Schultz,
Center for Devices and Radiological Health.
[FR Doc. E8-12078 Filed 5-29-08; 8:45 am]

BILLING CODE 4160-01-S