83 FR 44056 - DHL Laboratories Inc.; Proposal To Withdraw Approval of a New Drug Application for Dextrose 5% Injection in Plastic Container; Opportunity for a Hearing
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 168 (August 29, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 168 (August 29, 2018)
| Page Range | 44056-44057 | |
| FR Document | 2018-18749 |
[Federal Register Volume 83, Number 168 (Wednesday, August 29, 2018)] [Notices] [Pages 44056-44057] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-18749] [[Page 44056]] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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: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: 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. 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: 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: Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2018-N-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. 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 [[Page 44057]] 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.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: 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
![44056 Federal Register / Vol. 83, No. 168 / Wednesday, August 29, 2018 / Notices
DEPARTMENT OF HEALTH AND third part may not wish to be posted, third party may not wish to be posted,
HUMAN SERVICES such as medical information, your or such as medical information, your or
anyone else’s Social Security number, or anyone else’s Social Security number, or
Food and Drug Administration confidential business information, such confidential business information, such
[Docket No. FDA–2018–N–3208] as a manufacturing process. The request as a manufacturing process. Please note
for a hearing must include the Docket that if you include your name, contact
DHL Laboratories Inc.; Proposal To No. FDA–2018–N–3208 for ‘‘DHL information, or other information that
Withdraw Approval of a New Drug Laboratories Inc.; Proposal to Withdraw identifies you in the body of your
Application for Dextrose 5% Injection Approval of a New Drug Application for comments, that information will be
in Plastic Container; Opportunity for a Dextrose 5% Injection in Plastic posted on https://www.regulations.gov.
Hearing Container; Opportunity for a Hearing.’’ • If you want to submit a comment
The request for a hearing will be placed with confidential information that you
AGENCY: Food and Drug Administration, in the docket and publicly viewable at do not wish to be made available to the
HHS. https://www.regulations.gov or at the public, submit the comment as a
ACTION: Notice. Dockets Management Staff between 9 written/paper submission and in the
a.m. and 4 p.m., Monday through manner detailed (see ‘‘Written/Paper
SUMMARY: The Food and Drug Friday. Submissions’’ and ‘‘Instructions’’).
Administration’s (FDA or Agency) DHL Laboratories Inc. may submit all
Center for Drug Evaluation and Research Written/Paper Submissions
data and analyses upon which the
(CDER) is proposing to withdraw request for a hearing relies in the same Submit written/paper submissions as
approval of a new drug application manner as the request for a hearing follows:
(NDA) for Dextrose 5% Injection in except as follows: • Mail/Hand delivery/Courier (for
Plastic Container, 5 grams (g)/100 • Confidential Submissions—To written/paper submissions): Dockets
milliliters (mL), held by DHL submit any data analyses with Management Staff (HFA–305), Food and
Laboratories Inc., 155 Medical Science confidential information that you do not Drug Administration, 5630 Fishers
Dr., Union, SC 23979, and is wish to be made publicly available, Lane, Rm. 1061, Rockville, MD 20852.
announcing an opportunity for the submit your data and analyses only as • For written/paper comments
holder of the NDA to request a hearing a written/paper submission. You should submitted to the Dockets Management
on this proposal. The basis for the submit two copies total of all data and Staff, FDA will post your comment, as
proposal is that the holder of the NDA analyses. One copy will include the well as any attachments, except for
has repeatedly failed to file required information you claim to be confidential information submitted, marked and
annual reports for the NDA. with a heading or cover note that states identified, as confidential, if submitted
DATES: DHL Laboratories Inc. may ‘‘THIS DOCUMENT CONTAINS as detailed in ‘‘Instructions.’’
submit a request for a hearing by CONFIDENTIAL INFORMATION.’’ The Instructions: All submissions received
September 28, 2018. Submit all data, Agency will review this copy, including must include the Docket No. FDA–
information, and analyses upon which the claimed confidential information, in 2018–N–3208 for ‘‘DHL Laboratories
the request for a hearing relies by its consideration of any decisions on Inc.; Proposal to Withdraw Approval of
October 29, 2018. Submit electronic or this matter. The second copy, which a New Drug Application for Dextrose
written comments by October 29, 2018. will have the claimed confidential 5% Injection in Plastic Container;
ADDRESSES: The request for a hearing information redacted/blacked out, will Opportunity for a Hearing.’’ Received
may be submitted by DHL Laboratories be available for public viewing and comments, those filed in a timely
Inc. by either of the following methods: posted on https://www.regulations.gov manner (see ADDRESSES), will be placed
or available at the Dockets Management in the docket and, except for those
Electronic Submissions Staff between 9 a.m. and 4 p.m., submitted as ‘‘Confidential
Submit electronic comments in the Monday through Friday. Submit both Submissions,’’ publicly viewable at
following way: copies to the Dockets Management Staff. https://www.regulations.gov or at the
• Federal eRulemaking Portal: Any information marked as Dockets Management Staff between 9
https://www.regulations.gov. Follow the ‘‘confidential’’ will not be disclosed a.m. and 4 p.m., Monday through
instructions for submitting comments to except in accordance with 21 CFR 10.20 Friday.
submit your request for a hearing. and other applicable disclosure law. • Confidential Submissions—To
Comments submitted electronically to Comments Submitted by Other submit a comment with confidential
https://www.regulations.gov, including Interested Parties: For all comments information that you do not wish to be
any attachments to the request for a submitted by other interested parties, made publicly available, submit your
hearing, will be posted to the docket submit comments as follows: comments only as a written/paper
unchanged. submission. You should submit two
Electronic Submissions copies total. One copy will include the
Written/Paper Submissions Submit electronic comments in the information you claim to be confidential
Submit written/paper submissions as following way: with a heading or cover note that states
follows: • Federal eRulemaking Portal: ‘‘THIS DOCUMENT CONTAINS
• Mail/Hand delivery/Courier (for https://www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ The
written/paper submissions): Dockets instructions for submitting comments. Agency will review this copy, including
Comments submitted electronically, the claimed confidential information, in
sradovich on DSK3GMQ082PROD with NOTICES
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers including attachments, to https:// its consideration of comments. The
Lane, Rm. 1061, Rockville, MD 20852. www.regulations.gov will be posted to second copy, which will have the
• Because your request for a hearing the docket unchanged. Because your claimed confidential information
will be made public, you are solely comment will be made public, you are redacted/blacked out, will be available
responsible for ensuring that your solely responsible for ensuring that your for public viewing and posted on
request does not include any comment does not include any https://www.regulations.gov. Submit
confidential information that you or a confidential information that you or a both copies to the Dockets Management
VerDate Sep<11>2014 17:04 Aug 28, 2018 Jkt 244001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 E:\FR\FM\29AUN1.SGM 29AUN1](https://thefederalregister.org/doc/83_FR_44224/page/1.svg)
![Federal Register / Vol. 83, No. 168 / Wednesday, August 29, 2018 / Notices 44057
Staff. If you do not wish your name and An applicant who decides to seek a Dated: August 24, 2018.
contact information to be made publicly hearing must file the following: (1) A Janet Woodcock,
available, you can provide this written notice of participation and Director, Center for Drug Evaluation and
information on the cover sheet and not request for a hearing (see DATES and Research.
in the body of your comments and you ADDRESSES) and (2) the data, [FR Doc. 2018–18749 Filed 8–28–18; 8:45 am]
must identify this information as information, and analyses relied on to BILLING CODE 4164–01–P
‘‘confidential.’’ Any information marked demonstrate that there is a genuine and
as ‘‘confidential’’ will not be disclosed substantial issue of fact that requires a
except in accordance with 21 CFR 10.20 hearing (see DATES and ADDRESSES). Any DEPARTMENT OF HEALTH AND
and other applicable disclosure law. For other interested person may also submit HUMAN SERVICES
more information about FDA’s posting comments on this notice. The
of comments to public dockets, see 80 procedures and requirements governing National Institutes of Health
FR 56469, September 18, 2015, or access
this notice of opportunity for a hearing,
the information at: https://www.gpo.gov/ Center for Scientific Review; Notice of
notice of participation and request for a
fdsys/pkg/FR-2015-09-18/pdf/2015- Closed Meeting
hearing, the information and analyses to
23389.pdf.
Docket: For access to the docket to justify a hearing, other comments, and
a grant or denial of a hearing are Pursuant to section 10(d) of the
read background documents or the Federal Advisory Committee Act, as
electronic and written/paper comments contained in § 314.200 and in 21 CFR
part 12. amended, notice is hereby given of the
received, go to https:// following meeting.
www.regulations.gov and insert the The failure of an applicant to file a
docket number, found in brackets in the timely written notice of participation The meeting will be closed to the
heading of this document, into the and request for a hearing, as required by public in accordance with the
‘‘Search’’ box and follow the prompts § 314.200, constitutes an election by that provisions set forth in sections
and/or go to the Dockets Management applicant not to avail itself of the 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
Staff, 5630 Fishers Lane, Rm. 1061, opportunity for a hearing concerning as amended. The grant applications and
Rockville, MD 20852. CDER’s proposal to withdraw approval the discussions could disclose
FOR FURTHER INFORMATION CONTACT: of the application and constitutes a confidential trade secrets or commercial
Florine P. Purdie, Center for Drug waiver of any contentions concerning property such as patentable material,
Evaluation and Research, Food and the legal status of the drug product. FDA and personal information concerning
Drug Administration, 10903 New will then withdraw approval of the individuals associated with the grant
Hampshire Ave., Bldg. 51, Rm. 6248, application, and the drug product may applications, the disclosure of which
Silver Spring, MD 20993–0002, 301– not thereafter be lawfully introduced or would constitute a clearly unwarranted
796–3601. delivered for introduction into interstate invasion of personal privacy.
SUPPLEMENTARY INFORMATION: The commerce. Any new drug product Name of Committee: Center for Scientific
holder of an approved application to introduced or delivered for introduction Review Special Emphasis Panel PAR Panel:
market a new drug for human use is into interstate commerce without an Mechanisms and Consequences of Sleep
required to submit annual reports to approved application is subject to Disparities.
FDA concerning its approved regulatory action at any time. Date: September 25–26, 2018.
application in accordance with § 314.81 Time: 7:00 p.m. to 4:00 p.m.
(21 CFR 314.81). DHL Laboratories Inc. A request for a hearing may not rest
Agenda: To review and evaluate grant
has failed to submit the required annual upon mere allegations or denials, but applications.
reports and has not responded to the must present specific facts showing that Place: National Institutes of Health, 6701
Agency’s request for submission of the there is a genuine and substantial issue Rockledge Drive, Bethesda, MD 20892,
reports. of fact that requires a hearing. If a (Virtual Meeting).
Therefore, notice is given to DHL request for a hearing is not complete or Contact Person: Jane A Doussard-
Laboratories Inc. and to all other is not supported, the Commissioner of Roosevelt, Ph.D., Scientific Review Officer,
interested persons that the Director of Food and Drugs will enter summary Center for Scientific Review, National
CDER proposes to issue an order, under judgment against the person who Institutes of Health, 6701 Rockledge Drive,
section 505(e) of the Federal Food, Drug, requests the hearing, making findings Room 3184, MSC 7848, Bethesda, MD 20892,
and Cosmetic Act (FD&C Act) (21 U.S.C. and conclusions, and denying a hearing. (301) 435–4445, doussarj@csr.nih.gov.
355(e)), withdrawing approval of NDA All submissions under this notice of (Catalogue of Federal Domestic Assistance
019971, Dextrose 5% in Plastic opportunity for a hearing must be filed Program Nos. 93.306, Comparative Medicine;
Container, 5 g/100 mL, and all in four copies. Except for data and 93.333, Clinical Research, 93.306, 93.333,
amendments and supplements to it on information prohibited from public 93.337, 93.393–93.396, 93.837–93.844,
the grounds that DHL Laboratories Inc. disclosure under 21 U.S.C. 331(j) or 18 93.846–93.878, 93.892, 93.893, National
has failed to submit reports required U.S.C. 1905, the submissions may be Institutes of Health, HHS)
under § 314.81. seen at the Dockets Management Staff Dated: August 22, 2018.
In accordance with section 505 of the
(see ADDRESSES) between 9 a.m. and 4 Natasha M. Copeland,
FD&C Act and part 314 (21 CFR part
p.m., Monday through Friday, and will Program Analyst, Office of Federal Advisory
314), DHL Laboratories Inc. is hereby
sradovich on DSK3GMQ082PROD with NOTICES
be posted to the docket at https:// Committee Policy.
provided an opportunity for a hearing to
show why approval of NDA 019971 www.regulations.gov. [FR Doc. 2018–18652 Filed 8–28–18; 8:45 am]
should not be withdrawn and an This notice is issued under section BILLING CODE 4140–01–P
opportunity to raise, for administrative 505(e) of the FD&C Act and under
determination, all issues relating to the authority delegated to the Director of
legal status of the drug product covered CDER by the Commissioner of Food and
by this application. Drugs.
VerDate Sep<11>2014 17:04 Aug 28, 2018 Jkt 244001 PO 00000 Frm 00043 Fmt 4703 Sfmt 9990 E:\FR\FM\29AUN1.SGM 29AUN1](https://thefederalregister.org/doc/83_FR_44224/page/2.svg)
Document Created: 2018-08-29 00:12:48
Document Modified: 2018-08-29 00:12:48
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| 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. | |
| 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. | |
| FR Citation | 83 FR 44056 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR