[Federal Register Volume 83, Number 168 (Wednesday, August 29, 2018)]
[Notices]
[Pages 44056-44057]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-18749]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3208]


DHL Laboratories Inc.; Proposal To Withdraw Approval of a New 
Drug Application for Dextrose 5% Injection in Plastic Container; 
Opportunity for a Hearing

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration's (FDA or Agency) Center for 
Drug Evaluation and Research (CDER) is proposing to withdraw approval 
of a new drug application (NDA) for Dextrose 5% Injection in Plastic 
Container, 5 grams (g)/100 milliliters (mL), held by DHL Laboratories 
Inc., 155 Medical Science Dr., Union, SC 23979, and is announcing an 
opportunity for the holder of the NDA to request a hearing on this 
proposal. The basis for the proposal is that the holder of the NDA has 
repeatedly failed to file required annual reports for the NDA.

DATES: DHL Laboratories Inc. may submit a request for a hearing by 
September 28, 2018. Submit all data, information, and analyses upon 
which the request for a hearing relies by October 29, 2018. Submit 
electronic or written comments by October 29, 2018.

ADDRESSES: The request for a hearing may be submitted by DHL 
Laboratories Inc. by either of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
    <bullet> Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments to submit your request 
for a hearing. Comments submitted electronically to https://www.regulations.gov, including any attachments to the request for a 
hearing, will be posted to the docket unchanged.

Written/Paper Submissions

    Submit written/paper submissions as follows:
    <bullet> 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.
    <bullet> Because your request for a hearing will be made public, 
you are solely responsible for ensuring that your request does not 
include any confidential information that you or a third part 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. The request for a hearing must include the 
Docket No. FDA-2018-N-3208 for ``DHL Laboratories Inc.; Proposal to 
Withdraw Approval of a New Drug Application for Dextrose 5% Injection 
in Plastic Container; Opportunity for a Hearing.'' The request for a 
hearing will be placed in the docket and publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday.
    DHL Laboratories Inc. may submit all data and analyses upon which 
the request for a hearing relies in the same manner as the request for 
a hearing except as follows:
    <bullet> Confidential Submissions--To submit any data analyses with 
confidential information that you do not wish to be made publicly 
available, submit your data and analyses only as a written/paper 
submission. You should submit two copies total of all data and 
analyses. 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 
any decisions on this matter. 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 
or available at the Dockets Management Staff between 9 a.m. and 4 p.m., 
Monday through Friday. Submit both copies to the Dockets Management 
Staff. Any information marked as ``confidential'' will not be disclosed 
except in accordance with 21 CFR 10.20 and other applicable disclosure 
law.
    Comments Submitted by Other Interested Parties: For all comments 
submitted by other interested parties, submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
    <bullet> 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.
    <bullet> 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:
    <bullet> 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.
    <bullet> For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2018-N-3208 for ``DHL Laboratories Inc.; Proposal to Withdraw 
Approval of a New Drug Application for Dextrose 5% Injection in Plastic 
Container; Opportunity for a Hearing.'' 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.
    <bullet> 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

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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.

FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6248, Silver Spring, MD 20993-0002, 301-
796-3601.

SUPPLEMENTARY INFORMATION: The holder of an approved application to 
market a new drug for human use is required to submit annual reports to 
FDA concerning its approved application in accordance with Sec.  314.81 
(21 CFR 314.81). DHL Laboratories Inc. has failed to submit the 
required annual reports and has not responded to the Agency's request 
for submission of the reports.
    Therefore, notice is given to DHL Laboratories Inc. and to all 
other interested persons that the Director of CDER proposes to issue an 
order, under section 505(e) of the Federal Food, Drug, and Cosmetic Act 
(FD&C Act) (21 U.S.C. 355(e)), withdrawing approval of NDA 019971, 
Dextrose 5% in Plastic Container, 5 g/100 mL, and all amendments and 
supplements to it on the grounds that DHL Laboratories Inc. has failed 
to submit reports required under Sec.  314.81.
    In accordance with section 505 of the FD&C Act and part 314 (21 CFR 
part 314), DHL Laboratories Inc. is hereby provided an opportunity for 
a hearing to show why approval of NDA 019971 should not be withdrawn 
and an opportunity to raise, for administrative determination, all 
issues relating to the legal status of the drug product covered by this 
application.
    An applicant who decides to seek a hearing must file the following: 
(1) A written notice of participation and request for a hearing (see 
DATES and ADDRESSES) and (2) the data, information, and analyses relied 
on to demonstrate that there is a genuine and substantial issue of fact 
that requires a hearing (see DATES and ADDRESSES). Any other interested 
person may also submit comments on this notice. The procedures and 
requirements governing this notice of opportunity for a hearing, notice 
of participation and request for a hearing, the information and 
analyses to justify a hearing, other comments, and a grant or denial of 
a hearing are contained in Sec.  314.200 and in 21 CFR part 12.
    The failure of an applicant to file a timely written notice of 
participation and request for a hearing, as required by Sec.  314.200, 
constitutes an election by that applicant not to avail itself of the 
opportunity for a hearing concerning CDER's proposal to withdraw 
approval of the application and constitutes a waiver of any contentions 
concerning the legal status of the drug product. FDA will then withdraw 
approval of the application, and the drug product may not thereafter be 
lawfully introduced or delivered for introduction into interstate 
commerce. Any new drug product introduced or delivered for introduction 
into interstate commerce without an approved application is subject to 
regulatory action at any time.
    A request for a hearing may not rest upon mere allegations or 
denials, but must present specific facts showing that there is a 
genuine and substantial issue of fact that requires a hearing. If a 
request for a hearing is not complete or is not supported, the 
Commissioner of Food and Drugs will enter summary judgment against the 
person who requests the hearing, making findings and conclusions, and 
denying a hearing.
    All submissions under this notice of opportunity for a hearing must 
be filed in four copies. Except for data and information prohibited 
from public disclosure under 21 U.S.C. 331(j) or 18 U.S.C. 1905, the 
submissions may be seen at the Dockets Management Staff (see ADDRESSES) 
between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to 
the docket at https://www.regulations.gov.
    This notice is issued under section 505(e) of the FD&C Act and 
under authority delegated to the Director of CDER by the Commissioner 
of Food and Drugs.

    Dated: August 24, 2018.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 2018-18749 Filed 8-28-18; 8:45 am]
 BILLING CODE 4164-01-P