[Federal Register Volume 83, Number 116 (Friday, June 15, 2018)]
[Notices]
[Pages 27996-27998]
[FR Doc No: 2018-12824]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-1788]

Intravascular Catheters, Wires, and Delivery Systems With
Lubricious Coatings--Labeling Considerations; Draft Guidance for
Industry and Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of the draft guidance entitled ``Intravascular
Catheters, Wires, and Delivery Systems with Lubricious Coatings--
Labeling Considerations.'' This draft guidance addresses labeling
considerations for devices containing lubricious coatings that are used
in the vasculature. The purpose of this draft guidance is to provide
recommendations for information to be included in device labeling, as
submitted in premarket applications (PMAs) or premarket notification
submissions (510(k)s) for class III and class II devices, to enhance
the consistency of information across these product areas as well as to
promote the safe use of these devices in clinical settings. This draft
guidance is not final nor is it in effect at this time.

DATES: Submit either electronic or written comments on the draft
guidance by August 14, 2018 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2018-D-1788 for ``Intravascular Catheters, Wires, and Delivery
Systems with Lubricious Coatings--Labeling Considerations.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    An electronic copy of the draft 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 draft guidance document entitled
``Intravascular Catheters, Wires, and Delivery Systems with Lubricious
Coatings--Labeling Considerations'' 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: Leigh Anderson, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2656, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Hydrophilic- and/or hydrophobic-coated devices have been used for
more than 20 years in minimally invasive diagnostic and therapeutic
cerebrovascular, cardiovascular, and peripheral vascular procedures.
Although these devices may offer patient benefits, evidence indicates
that the coating may separate from intravascular devices in some
circumstances. FDA has received and analyzed information concerning
serious adverse events associated with hydrophilic and/or hydrophobic
coatings separating (e.g., peeling, flaking, shedding, delaminating, or
sloughing off) from intravascular medical devices.
    FDA has not concluded that any specific manufacturer or brand of
these devices is associated with higher risks than others. The cause of
coating separation is multifactorial, and can be associated with
factors including device design, manufacturing, and use. Current FDA
analysis suggests that use-related issues may be mitigated through
proper device selection, preparation, and other labeling considerations
that are addressed within this draft guidance.
    This draft guidance addresses labeling considerations for devices
containing lubricious coatings used in the vasculature. The purpose of
this draft

guidance is to provide recommendations for information to be included
in device labeling, as submitted in PMAs or 510(k)s for class III and
class II devices, to enhance the consistency of coating information
across these product areas as well as to promote the safe use of these
devices in clinical settings.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on
``Intravascular Catheters, Wires, and Delivery Systems with Lubricious
Coatings--Labeling Considerations.'' 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. This guidance is not subject to Executive
Order 12866.

III. Electronic Access

    Persons interested in obtaining a copy of the draft 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 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This draft
guidance document is also available at https://www.regulations.gov.
Persons unable to download an electronic copy of ``Intravascular
Catheters, Wires, and Delivery Systems with Lubricious Coatings--
Labeling Considerations'' may send an email request to [email protected] to receive an electronic copy of the document.
Please use the document number 16016 to identify the guidance you are
requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. 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 part 807, subpart E have been
approved under OMB control number 0910-0120; the collections of
information in 21 CFR part 814, subparts A through E have been approved
under OMB control number 0910-0231; and the collections of information
in 21 CFR part 801 have been approved under OMB control number 0910-
0485.

    Dated: June 8, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12824 Filed 6-14-18; 8:45 am]
BILLING CODE 4164-01-P


September 6, 2007

By Email

FOIA Officer

FOIA and Privacy Branch

Office of Environmental Information

United States Environmental Protection Agency

1200 Pennsylvania Avenue, N.W. (2822T)

Washington, D.C. 20460

<EMAIL_ADDRESS>
Re:  	Freedom of Information Act Request For Documents Pertaining to the
Identification of Facilities That May Burn Emission Comparable Fuels
(ECF)

Dear FOIA Officer:

	Pursuant to the Freedom of Information Act (FOIA), 5 U.S.C. §552, I
hereby request the following records relating to the proposed Expansion
of RCRA Comparable Fuel Exclusion, 72 Fed. Reg. 33284, June 15, 2007.

	Specifically, I request the following information:

The identification of all industrial facilities for which EPA has
received information indicating that the facilities may utilize the
proposed comparable fuel exclusion for emission comparable fuel;

The location of all industrial facilities for which EPA has received
information indicating that the facilities may utilize the proposed
comparable fuel exclusion for emission comparable fuel; and

The estimated quantity of emission comparable fuel that may be used by
such industrial facilities.

	I understand that in late 2003, EPA received the results of a survey
conducted by the American Chemistry Council (ACC).  The voluntary ACC
membership survey of waste generation and management indicated that
approximately 190,000 tons per year of additional waste fuels could
potentially be used by its members if such fuels were excluded under
revisions to the current comparable fuels exclusion.  72  Fed. Reg.
33287.  Although EPA stated that the ACC Survey data was a “primary
data source” used in its analysis for the 2007 comparable fuels
rulemaking, the survey data are not included in the record for this
rulemaking.  72 Fed. Reg. 33320.  The only document relating to the ACC
survey in the record is a 3-page summary that does not provide
information regarding the nature, identification or location of the
industries.  See EPA-HQ-RCRA-2005-0017-0021.  Thus the docket does not
contain pertinent information about the industries that may potentially
burn the hazardous wastes that EPA seeks to exempt in this rulemaking.

	I respectfully request that you waive all fees in connection with this
request as provided by 5 U.S.C. §552(a)(4)(A)(iii) and 5 C.F.R.
§1303.70.  Earthjustice is a national, nonprofit 501(c)(3) organization
with no commercial interest in obtaining the requested information.
Instead we intend to use the requested information to better understand
the activities of the U.S. EPA with respect to the proposed rule,
Expansion of RCRA Comparable Fuel Exclusion, 72 Fed. Reg. 33284 et seq.

	Disclosure of the information requested in this Freedom of Information
Request is in the public interest and thus eligible for a fee waiver
pursuant to 5 U.S.C. 552(e)(4)(A)(ii)(1994 Supp. IV 1998).   Disclosure
of the requested information is likely to contribute significantly to
public understanding of the operations or activities of the government
and is not in the commercial interest of the requester.   We have
received fee waivers under FOIA from EPA and other federal agencies in
the past.  This is because Earthjutice has, since 1971, promoted the
public interest through the enforcement of federal environmental laws
and the advancement of policies that provide enhanced environmental
protection.

In the event that your Office denies a fee waiver, please send a written
explanation for the denial but continue to produce documents until the
fee reaches $150.

Please produce the requested records on a rolling basis, as the
materials are located.  Records pertaining to the first request of this
letter can likely be identified immediately, and we therefore request
that these “Conflict of Interest and Bias Questionnaires” be
produced as soon as possible.  At no time should the Office’s search
for, or deliberations concerning, any records requested herein delay the
production of other records that the Office has already elected to
produce.

If you regard any of the requested records to be exempt from required
disclosure under FOIA, we request that you disclose them nevertheless;
as such disclosure would serve the public interest of educating
citizens.  See 10 C.F.R. §1004.1 (authorizing disclosure of documents
exempt from FOIA disclosure where such disclosure is in the public
interest).

In addition, should you invoke a FOIA exemption regarding any of the
requested records, we request that you release any segregable portions
of such records that are left after the exempted material has been
redacted from the records we are seeking.

I appreciate your help in obtaining the requested information. As
provided in FOIA, we expect a reply within twenty working days.  5
U.S.C. §552(a)(6)(A)(iii); 5 C.F.R. §1303.10(c).

Please send the requested records by regular mail to Lisa Evans,
Earthjustice, 21 Ocean Avenue, Marblehead, MA 01945 or transmit the
documents electronically to<EMAIL_ADDRESS>  If you find that
this request is unclear in any way, please do not hesitate to contact me
by phone at<PHONE_NUMBER>

Thank you in advance for your prompt attention to this matter.  I look
forward to your  reply.

Sincerely,

/s/ Lisa Evans

Lisa Evans

Attorney

cc:  Mary Jackson, OSW

Earthjustice FOIA  Request		Page   PAGE  3  of   NUMPAGES  3

21 Ocean Ave., Marblehead, MA 01945

T.<PHONE_NUMBER>  F.<PHONE_NUMBER>  E.   HYPERLINK
<EMAIL_ADDRESS><EMAIL_ADDRESS>
 W: www.earthjustice.org


[Federal Register Volume 85, Number 239 (Friday, December 11, 2020)]
[Notices]
[Page 80119]
[FR Doc No: 2020-27303]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-2197]

VistaPharm, Inc., et al.; Withdrawal of Approval of 10
Abbreviated New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of 10 abbreviated new drug applications (ANDAs)
from multiple applicants. The applicants notified the Agency in writing
that the drug products were no longer marketed and requested that the
approval of the applications be withdrawn.

DATES: Approval is withdrawn as of January 11, 2021.

FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676, Silver Spring, MD 20993-0002, 240-
402-6980<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The applicants listed in the table have
informed FDA that these drug products are no longer marketed and have
requested that FDA withdraw approval of the applications under the
process described in Sec.  314.150(c) (21 CFR 314.150(c)). The
applicants have also, by their requests, waived their opportunity for a
hearing. Withdrawal of approval of an application or abbreviated
application under Sec.  314.150(c) is without prejudice to refiling.

------------------------------------------------------------------------
        Application No.                  Drug               Applicant
------------------------------------------------------------------------
ANDA 040323...................  Prednisolone Syrup, 15  VistaPharm,
                                 milligrams (mg)/5       Inc., 7265
                                 milliliters (mL).       Ulmerton Rd.,
                                                         Largo, FL 33771
ANDA 075782...................  Valproic Acid Syrup,     Do.
                                 250 mg/5 mL.
ANDA 076188...................  Fosinopril Sodium       Upsher-Smith
                                 Tablets, 10 mg, 20      Laboratories,
                                 mg, and 40 mg.          LLC, 6701
                                                         Evenstad Dr.,
                                                         Maple Grove, MN
                                                         55369
ANDA 076189...................  Mirtazapine Tablets,     Do.
                                 15 mg, 30 mg, and 45
                                 mg.
ANDA 077537...................  Glyburide Tablets,      Aurobindo Pharma
                                 1.25 mg, 2.5 mg, and    USA, Inc., 279
                                 5 mg.                   Princeton-
                                                         Hightstown Rd.,
                                                         East Windsor,
                                                         NJ 08520
ANDA 077672...................  Stavudine Capsules, 15   Do.
                                 mg, 20 mg, 30 mg, and
                                 40 mg.
ANDA 085055...................  Tylenol W/Codeine No.   Janssen
                                 1 (acetaminophen and    Pharmaceuticals
                                 codeine phosphate)      , Inc., 1000
                                 Tablets, 300 mg; 7.5    U.S. Route 202,
                                 mg.                     P.O. Box 300,
                                Tylenol W/Codeine No.    Raritan NJ
                                 2 (acetaminophen and    08869
                                 codeine phosphate)
                                 Tablets, 300 mg; 15
                                 mg.
                                Tylenol W/Codeine No.
                                 3 (acetaminophen and
                                 codeine phosphate)
                                 Tablets, 300 mg; 30
                                 mg.
                                Tylenol W/Codeine No.
                                 4 (acetaminophen and
                                 codeine phosphate)
                                 Tablets, 300 mg; 60
                                 mg.
ANDA 087266...................  Lindane Shampoo, 1%...  Olta
                                                         Pharmaceuticals
                                                         Corp. (an Akorn
                                                         Company), 1925
                                                         West Field Ct.,
                                                         Suite 300, Lake
                                                         Forest, IL
                                                         60045
ANDA 087313...................  Lindane Lotion, 1%....   Do.
ANDA 089003...................  Phenytoin Sodium        Fresenius Kabi
                                 Injection, 50 mg/mL.    USA, LLC, Three
                                                         Corporate Dr.,
                                                         Lake Zurich, IL
                                                         60047
------------------------------------------------------------------------

    Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of
January 11, 2021. Approval of each entire application is withdrawn,
including any strengths and dosage forms inadvertently missing from the
table. Introduction or delivery for introduction into interstate
commerce of products without approved new drug applications violates
section 301(a) and (d) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 331(a) and (d)). Drug products that are listed in the table that
are in inventory on January 11, 2021 may continue to be dispensed until
the inventories have been depleted or the drug products have reached
their expiration dates or otherwise become violative, whichever occurs
first.

    Dated: December 8, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-27303 Filed 12-10-20; 8:45 am]
BILLING CODE 4160-01-P