Pharmaceutical Distribution Supply Chain Pilot Projects; Reopening of Comment Period; Request for Information, 31874-31875 [2019-14147]

Download as PDF jspears on DSK30JT082PROD with NOTICES 31874 Federal Register / Vol. 84, No. 128 / Wednesday, July 3, 2019 / Notices Cardinal Health Regulatory Sciences submitted a citizen petition dated January 31, 2019 (Docket No. FDA– 2019–P–1366), under 21 CFR 10.30, requesting that the Agency determine whether CLAFORAN (cefotaxime sodium) for injection, 500 mg/vial, 1 g/ vial, 2 g/vial and 10 g/vial, was withdrawn from sale for reasons of safety or effectiveness. After considering the citizen petition and reviewing Agency records and based on the information we have at this time, FDA has determined under § 314.161 that CLAFORAN (cefotaxime sodium) for injection, 500 mg/vial, 1 g/ vial, 2 g/vial and 10 g/vial was not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that CLAFORAN (cefotaxime sodium) for injection, 500 mg/vial, 1 g/ vial, 2 g/vial and 10 g/vial was withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of CLAFORAN (cefotaxime sodium) for injection, 500 mg/vial, 1 g/vial, 2 g/vial and 10 g/vial from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. We have found no information that would indicate that this drug product was withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list CLAFORAN (cefotaxime sodium) for injection, 500 mg/vial, 1 g/ vial, 2 g/vial and 10 g/vial, in the ‘‘Discontinued Drug Product List’’ section of the Orange Book. The ‘‘Discontinued Drug Product List’’ delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. FDA will not begin procedures to withdraw approval of approved ANDAs that refer to this drug product. Additional ANDAs for this drug product may also be approved by the Agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. If FDA determines that labeling for this drug product should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling. Dated: June 27, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–14172 Filed 7–2–19; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 19:23 Jul 02, 2019 Jkt 247001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–N–3208] DHL Laboratories Inc.; Withdrawal of Approval of a New Drug Application for Dextrose 5% Injection in Plastic Container, 5 Grams/100 Milliliters AGENCY: Food and Drug Administration, concerning the legal status of the drug product. Therefore, under these findings, approval of NDA 019971, and all amendments and supplements thereto, is hereby withdrawn as of July 3, 2019. Dated: June 27, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–14137 Filed 7–2–19; 8:45 am] BILLING CODE 4164–01–P HHS. ACTION: Notice. The Food and Drug Administration (FDA) is withdrawing approval of new drug application (NDA) 019971 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. The basis for the withdrawal is that the holder of the NDA has repeatedly failed to file required annual reports for the NDA. DATES: Approval is withdrawn as of July 3, 2019. 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 § 314.81 (21 CFR 314.81). In the Federal Register of August 29, 2018 (83 FR 44056), FDA published a notice offering an opportunity for a hearing (NOOH) on a proposal to withdraw approval of NDA 019971 because DHL Laboratories Inc. had failed to submit required annual reports for the NDA. DHL Laboratories Inc. did not respond to the NOOH. Failure to file a written notice of participation and request for hearing as required by § 314.200 (21 CFR 314.200) constitutes an election by the holder of the NDA not to make use of the opportunity for a hearing concerning the proposal to withdraw approval of the NDA and a waiver of any contentions concerning the legal status of the drug product. FDA is withdrawing approval of NDA 019971 for Dextrose 5% Injection in Plastic Container, 5 g/100 mL. FDA finds that DHL Laboratories Inc. has repeatedly failed to submit reports required by § 314.81. In addition, under § 314.200, FDA finds DHL Laboratories Inc. has waived any contentions SUMMARY: PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–N–1114] Pharmaceutical Distribution Supply Chain Pilot Projects; Reopening of Comment Period; Request for Information AGENCY: Food and Drug Administration, HHS. Notice; reopening of comment period; request for information. ACTION: The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the notices (requests for information) that published in the Federal Register of April 15, 2016, and April 28, 2017. FDA is requesting comments regarding issues related to utilizing the product identifier for product tracing, improving the technical capabilities of the supply chain, and identifying system attributes that are necessary to implement the requirements established under the Drug Supply Chain Security Act (DSCSA). The information gathered from reopening of the comment period will allow supply chain stakeholders to share information about relevant piloting activities that are conducted outside of FDA’s DSCSA Pilot Project Program to inform DSCSA implementation by FDA and supply chain stakeholders. DATES: FDA is reopening the comment period on the notices (requests for information) published April 15, 2016 (81 FR 22279), and April 28, 2017 (82 FR 19737). Submit either electronic or written comments by June 28, 2022. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before June 28, 2022. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of June 28, 2022. Comments received by mail/hand delivery/courier SUMMARY: E:\FR\FM\03JYN1.SGM 03JYN1 Federal Register / Vol. 84, No. 128 / Wednesday, July 3, 2019 / Notices (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. 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’’). jspears on DSK30JT082PROD with NOTICES 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– 2016–N–1114 for ‘‘Pharmaceutical Distribution Supply Chain Pilot Projects; Reopening of Comment Period; Request for Information.’’ 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. VerDate Sep<11>2014 19:23 Jul 02, 2019 Jkt 247001 • 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/201523389.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: Daniel Bellingham, Office of Compliance, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002, 301–796–3130, DSCSAPilotProjects@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: FDA is interested in comments regarding past or present pilot projects related to enhancing the safety and security of the pharmaceutical distribution supply chain; this may include information related to piloting activities that are conducted outside of FDA’s DSCSA Pilot Project Program. Stakeholders that may be interested in responding to this request for information include manufacturers, repackagers, wholesale distributors, dispensers, State and PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 31875 Federal authorities, solution providers, standards organizations, and other interested persons. FDA is particularly interested in learning about the practices, processes, and systems that supply chain stakeholders have used or considered using in such pilot projects. This includes, but is not limited to, information about the following: • Utilizing the product identifier for tracing of a product, which may include verification of the product identifier of a product, including the use of aggregation and inference; • Technical capabilities of each supply chain sector to develop and implement the systems and processes needed to utilize the product identifier to enhance the tracing of a product; or • System attributes that are necessary to implement the requirements established under the DSCSA. Interested persons are requested to provide any other relevant information that may inform FDA’s implementation of the requirements for enhanced product tracing and verification under the DSCSA. FDA is reopening the comment period for the requests for information for 3 years, until June 28, 2022. The Agency believes that a 3-year comment period allows adequate time for interested persons to submit new, additional, or updated comments on these important issues as they work to implement requirements under the DSCSA. Dated: June 27, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–14147 Filed 7–2–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2019–P–0692] Determination That THAM Solution (Tromethamine) Injectable, 3.6 Grams/ 100 Milliliters, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) has determined that THAM Solution (tromethamine) injectable, 3.6 grams (g)/ 100 milliliters (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new SUMMARY: E:\FR\FM\03JYN1.SGM 03JYN1

Agencies

[Federal Register Volume 84, Number 128 (Wednesday, July 3, 2019)]
[Notices]
[Pages 31874-31875]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-14147]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-1114]


Pharmaceutical Distribution Supply Chain Pilot Projects; 
Reopening of Comment Period; Request for Information

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; reopening of comment period; request for information.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
reopening the comment period for the notices (requests for information) 
that published in the Federal Register of April 15, 2016, and April 28, 
2017. FDA is requesting comments regarding issues related to utilizing 
the product identifier for product tracing, improving the technical 
capabilities of the supply chain, and identifying system attributes 
that are necessary to implement the requirements established under the 
Drug Supply Chain Security Act (DSCSA). The information gathered from 
reopening of the comment period will allow supply chain stakeholders to 
share information about relevant piloting activities that are conducted 
outside of FDA's DSCSA Pilot Project Program to inform DSCSA 
implementation by FDA and supply chain stakeholders.

DATES: FDA is reopening the comment period on the notices (requests for 
information) published April 15, 2016 (81 FR 22279), and April 28, 2017 
(82 FR 19737). Submit either electronic or written comments by June 28, 
2022.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before June 28, 2022. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of June 28, 2022. Comments received 
by mail/hand delivery/courier

[[Page 31875]]

(for written/paper submissions) will be considered timely if they are 
postmarked or the delivery service acceptance receipt is on or before 
that date.

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-2016-N-1114 for ``Pharmaceutical Distribution Supply Chain Pilot 
Projects; Reopening of Comment Period; Request for Information.'' 
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 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: Daniel Bellingham, Office of 
Compliance, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 
301-796-3130, [email protected].

SUPPLEMENTARY INFORMATION: FDA is interested in comments regarding past 
or present pilot projects related to enhancing the safety and security 
of the pharmaceutical distribution supply chain; this may include 
information related to piloting activities that are conducted outside 
of FDA's DSCSA Pilot Project Program. Stakeholders that may be 
interested in responding to this request for information include 
manufacturers, repackagers, wholesale distributors, dispensers, State 
and Federal authorities, solution providers, standards organizations, 
and other interested persons. FDA is particularly interested in 
learning about the practices, processes, and systems that supply chain 
stakeholders have used or considered using in such pilot projects. This 
includes, but is not limited to, information about the following:
     Utilizing the product identifier for tracing of a product, 
which may include verification of the product identifier of a product, 
including the use of aggregation and inference;
     Technical capabilities of each supply chain sector to 
develop and implement the systems and processes needed to utilize the 
product identifier to enhance the tracing of a product; or
     System attributes that are necessary to implement the 
requirements established under the DSCSA.
    Interested persons are requested to provide any other relevant 
information that may inform FDA's implementation of the requirements 
for enhanced product tracing and verification under the DSCSA.
    FDA is reopening the comment period for the requests for 
information for 3 years, until June 28, 2022. The Agency believes that 
a 3-year comment period allows adequate time for interested persons to 
submit new, additional, or updated comments on these important issues 
as they work to implement requirements under the DSCSA.

    Dated: June 27, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-14147 Filed 7-2-19; 8:45 am]
BILLING CODE 4164-01-P

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