82_FR_19818 82 FR 19737 - Pharmaceutical Distribution Supply Chain Pilot Projects; Reopening of Comment Period; Request for Information

82 FR 19737 - Pharmaceutical Distribution Supply Chain Pilot Projects; Reopening of Comment Period; Request for Information

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 81 (April 28, 2017)

Page Range19737-19738
FR Document2017-08583

The Food and Drug Administration (FDA) is reopening the comment period for the Request for Information that appeared in the Federal Register of April 15, 2016. In the Request for Information, FDA requested 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 additional public comments will further inform the design and development of the pilot project(s) that FDA establishes under the DSCSA. FDA is reopening the comment period to receive updated comments and any new information.

Federal Register, Volume 82 Issue 81 (Friday, April 28, 2017) 
[Federal Register Volume 82, Number 81 (Friday, April 28, 2017)]
[Notices]
[Pages 19737-19738]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-08583]


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

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) is reopening the 
comment period for the Request for Information that appeared in the 
Federal Register of April 15, 2016. In the Request for Information, FDA 
requested 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 additional public 
comments will further inform the design and development of the pilot 
project(s) that FDA establishes under the DSCSA. FDA is reopening the 
comment period to receive updated comments and any new information.

DATES: FDA is reopening the comment period on the Request for 
Information published April 15, 2016 (81 FR 22279). Submit either 
electronic or written comments by April 30, 2018. Late, untimely filed 
comments will not be considered. Electronic comments must be submitted 
on or before April 30, 2018. The https://www.regulations.gov/ 
electronic filing system will accept comments until midnight Eastern 
Time at the end of April 30, 2018. Comments received by mail/hand 
delivery/courier (for written/paper submissions) will be considered 
timely if they are postmarked or the delivery service acceptance 
receipt is on or before that date.

ADDRESSES: 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/.

[[Page 19738]]

     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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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 DATES), will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://www.regulations.gov/ or at 
the Division of Dockets Management 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 Division of Dockets 
Management. 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 Division of Dockets Management, 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: In the Federal Register of April 15, 2016, 
FDA published a Request for Information with a 30-day comment period to 
request comments relating to FDA implementation of the DSCSA. To permit 
additional and update submissions, we are reopening this comment period 
and extending it for April 30, 2018. We are particularly interested in 
comments regarding past or present pilot projects related to enhancing 
the safety and security of the pharmaceutical distribution supply 
chain. Stakeholders that may be interested in responding to this 
request for information include manufacturers, repackagers, wholesale 
distributors, dispensers, State and Federal authorities, solution 
providers, and 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 each sector of the supply chain to 
comply with 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 development of a pilot project under 
the DSCSA.
    FDA is reopening the comment period for the Request for Information 
for 1 year, until April 30, 2018. The Agency believes that an 
additional comment period of 1 year will allow time for interested 
persons to submit new, additional, or updated comments on these 
important issues.

    Dated: April 19, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-08583 Filed 4-27-17; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 82, No. 81 / Friday, April 28, 2017 / Notices 19737 Application No. Drug name Active ingredient(s) Strength(s) Dosage form/route Applicant NDA 050072 ......... PENBRITIN–S ................. Ampicillin Sodium ............ EQ 125 mg Base/Vial; EQ Injectable; Injection .......... Wyeth Ayerst Labora- 250 mg Base/Vial; EQ 500 tories. mg Base/Vial; EQ 1 gram (g) Base/Vial; EQ 2 g Base/Vial; EQ 4 g Base/ Vial. NDA 050309 ......... POLYCILLIN–N ................ Ampicillin Sodium ............ EQ 125 mg Base/Vial; EQ Injectable; Injection .......... Bristol Laboratories Inc. 250 mg Base/Vial; EQ 500 mg Base/Vial; EQ 1 g Base/Vial; EQ 2 g Base/ Vial. NDA 050674 ......... VANTIN ............................ Cefpodoxime Proxetil ....... EQ 100 mg Base; EQ 200 Tablet; Oral ...................... Pharmacia and Upjohn mg Base. Co. ANDA 064170 ...... CEFAZOLIN SODIUM ..... Cefazolin Sodium ............. EQ 10 g Base/Vial; EQ 20 g Injectable; Injection .......... Fresenius Kabi USA, LLC. Base/Vial. ANDA 075406 ...... OGESTREL 0.5/50–21 .... Ethinyl Estradiol; 0.05 mg; 0.5 mg ................... Tablet; Oral-21 ................. Watson Laboratories, Inc. Norgestrel. ANDA 085106 ...... PERCOCET ..................... Acetaminophen; 325 mg; 5 mg ....................... Tablet; Oral ...................... Vintage Pharmaceuticals Oxycodone Hydro- LLC. chloride. ANDA 089351 ...... ROXICET ......................... Acetaminophen; 325 mg/5 mL; 5 mg/5 mL ..... Solution; Oral ................... West-Ward Pharma- Oxycodone Hydro- ceuticals International chloride. Ltd. ANDA 089456 ...... PERPHENAZINE ............. Perphenazine ................... 8 mg ...................................... Tablet; Oral ...................... ANI Pharmaceuticals, Inc. ANDA 089457 ...... PERPHENAZINE ............. Perphenazine ................... 16 mg .................................... Tablet; Oral ...................... Teva Pharmaceuticals USA. ANDA 089707 ...... PERPHENAZINE ............. Perphenazine ................... 2 mg ...................................... Tablet; Oral ...................... Ditto. ANDA 089708 ...... PERPHENAZINE ............. Perphenazine ................... 4 mg ...................................... Tablet; Oral ...................... Do. FDA has reviewed its records and, DEPARTMENT OF HEALTH AND comments by April 30, 2018. Late, under § 314.161, has determined that HUMAN SERVICES untimely filed comments will not be the drug products listed in this considered. Electronic comments must document were not withdrawn from Food and Drug Administration be submitted on or before April 30, sale for reasons of safety or [Docket No. FDA–2016–N–1114] 2018. The https://www.regulations.gov/ effectiveness. Accordingly, the Agency electronic filing system will accept will continue to list the drug products Pharmaceutical Distribution Supply comments until midnight Eastern Time listed in this document in the Chain Pilot Projects; Reopening of at the end of April 30, 2018. Comments ‘‘Discontinued Drug Product List’’ Comment Period; Request for received by mail/hand delivery/courier section of the Orange Book. The Information (for written/paper submissions) will be considered timely if they are ‘‘Discontinued Drug Product List’’ AGENCY: Food and Drug Administration, postmarked or the delivery service identifies, among other items, drug HHS. acceptance receipt is on or before that products that have been discontinued ACTION: Notice; reopening of comment date. from marketing for reasons other than period; request for information. ADDRESSES: You may submit comments safety or effectiveness. as follows: Approved ANDAs that refer to the SUMMARY: The Food and Drug NDAs and ANDAs listed in this Administration (FDA) is reopening the Electronic Submissions document are unaffected by the comment period for the Request for Submit electronic comments in the discontinued marketing of the products Information that appeared in the following way: subject to those NDAs and ANDAs. Federal Register of April 15, 2016. In • Federal eRulemaking Portal: the Request for Information, FDA https://www.regulations.gov/. Follow Additional ANDAs that refer to these requested comments regarding issues the instructions for submitting products may also be approved by the related to utilizing the product identifier comments. Comments submitted Agency if they comply with relevant for product tracing, improving the legal and regulatory requirements. If electronically, including attachments, to technical capabilities of the supply https://www.regulations.gov/ will be FDA determines that labeling for these chain, and identifying system attributes posted to the docket unchanged. drug products should be revised to meet that are necessary to implement the Because your comment will be made current standards, the Agency will requirements established under the public, you are solely responsible for advise ANDA applicants to submit such Drug Supply Chain Security Act ensuring that your comment does not labeling. (DSCSA). The information gathered include any confidential information This is not a significant regulatory from additional public comments will that you or a third party may not wish action subject to Executive Order 12866, further inform the design and to be posted, such as medical and does not impose any additional development of the pilot project(s) that information, your or anyone else’s asabaliauskas on DSK3SPTVN1PROD with NOTICES burden on regulated entities. FDA establishes under the DSCSA. FDA Social Security number, or confidential is reopening the comment period to business information, such as a Dated: April 24, 2017. receive updated comments and any new manufacturing process. Please note that Anna K. Abram, information. if you include your name, contact Deputy Commissioner for Policy, Planning, DATES: FDA is reopening the comment information, or other information that Legislation, and Analysis. period on the Request for Information identifies you in the body of your [FR Doc. 2017–08582 Filed 4–27–17; 8:45 am] published April 15, 2016 (81 FR 22279). comments, that information will be BILLING CODE 4164–01–P Submit either electronic or written posted on https://www.regulations.gov/. VerDate Sep<11>2014 17:38 Apr 27, 2017 Jkt 241001 PO 00000 Frm 00086 Fmt 4703 Sfmt 4703 E:\FR\FM\28APN1.SGM 28APN1

19738 Federal Register / Vol. 82, No. 81 / Friday, April 28, 2017 / Notices • If you want to submit a comment applicable disclosure law. For more Interested persons are requested to with confidential information that you information about FDA’s posting of provide any other relevant information do not wish to be made available to the comments to public dockets, see 80 FR that may inform FDA’s development of public, submit the comment as a 56469, September 18, 2015, or access a pilot project under the DSCSA. written/paper submission and in the the information at: https://www.gpo.gov/ FDA is reopening the comment period manner detailed (see ‘‘Written/Paper fdsys/pkg/FR-2015-09-18/pdf/2015- for the Request for Information for 1 Submissions’’ and ‘‘Instructions’’). 23389.pdf. year, until April 30, 2018. The Agency Docket: For access to the docket to believes that an additional comment Written/Paper Submissions read background documents or the period of 1 year will allow time for Submit written/paper submissions as electronic and written/paper comments interested persons to submit new, follows: received, go to https:// additional, or updated comments on • Mail/Hand delivery/Courier (for www.regulations.gov/ and insert the these important issues. written/paper submissions): Division of docket number, found in brackets in the Dated: April 19, 2017. Dockets Management (HFA–305), Food heading of this document, into the Anna K. Abram, and Drug Administration, 5630 Fishers ‘‘Search’’ box and follow the prompts Deputy Commissioner for Policy, Planning, Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments and/or go to the Division of Dockets Legislation, and Analysis. submitted to the Division of Dockets Management, 5630 Fishers Lane, Rm. [FR Doc. 2017–08583 Filed 4–27–17; 8:45 am] Management, FDA will post your 1061, Rockville, MD 20852. BILLING CODE 4164–01–P comment, as well as any attachments, FOR FURTHER INFORMATION CONTACT: except for information submitted, Daniel Bellingham, Office of marked and identified, as confidential, Compliance, Center for Drug Evaluation DEPARTMENT OF HEALTH AND if submitted as detailed in and Research, Food and Drug HUMAN SERVICES ‘‘Instructions.’’ Administration, 10903 New Hampshire Instructions: All submissions received Ave., Silver Spring, MD 20993–0002, Food and Drug Administration must include the Docket No. FDA– 301–796–3130, DSCSAPilotProjects@ [Docket No. FDA–2017–N–1393] 2016–N–1114 for ’’ Pharmaceutical fda.hhs.gov. Distribution Supply Chain Pilot Government-Owned Inventions; Projects; Reopening of Comment Period; SUPPLEMENTARY INFORMATION: In the Availability for Licensing Request for Information.’’ Received Federal Register of April 15, 2016, FDA comments, those filed in a timely published a Request for Information AGENCY: Food and Drug Administration, manner (see DATES), will be placed in with a 30-day comment period to HHS. the docket and, except for those request comments relating to FDA ACTION: Notice. submitted as ‘‘Confidential implementation of the DSCSA. To permit additional and update SUMMARY: The invention listed in this Submissions,’’ publicly viewable at submissions, we are reopening this document is owned by an agency of the https://www.regulations.gov/ or at the comment period and extending it for U.S. Government and is available for Division of Dockets Management April 30, 2018. We are particularly licensing to achieve expeditious between 9 a.m. and 4 p.m., Monday interested in comments regarding past commercialization of results of federally through Friday. • Confidential Submissions—To or present pilot projects related to funded research and development. submit a comment with confidential enhancing the safety and security of the FOR FURTHER INFORMATION CONTACT: information that you do not wish to be pharmaceutical distribution supply Licensing information and copies of the made publicly available, submit your chain. Stakeholders that may be patent applications listed in this comments only as a written/paper interested in responding to this request document may be obtained by writing to submission. You should submit two for information include manufacturers, the indicated licensing contact at the copies total. One copy will include the repackagers, wholesale distributors, Food and Drug Administration (FDA) information you claim to be confidential dispensers, State and Federal Technology Transfer Program, 10903 with a heading or cover note that states authorities, solution providers, and New Hampshire Ave., Bldg. 1, Rm. ‘‘THIS DOCUMENT CONTAINS standards organizations, and other 4213, Silver Spring, MD 20993, CONFIDENTIAL INFORMATION.’’ The interested persons. FDA is particularly telephone: 240–402–2561, FAX: 301– Agency will review this copy, including interested in learning about the 847–3539. A signed Confidential the claimed confidential information, in practices, processes, and systems that Disclosure Agreement will be required its consideration of comments. The supply chain stakeholders have used or to receive copies of the patent second copy, which will have the considered using in such pilot projects. applications. claimed confidential information This includes, but is not limited to, SUPPLEMENTARY INFORMATION: redacted/blacked out, will be available information about the following: Technology descriptions follow. for public viewing and posted on • Utilizing the product identifier for Title of Abstract: Solid-Phase https://www.regulations.gov/. Submit tracing of a product, which may include Purification of Synthetic DNA both copies to the Division of Dockets verification of the product identifier of Sequences. Management. If you do not wish your a product, including the use of Description of Technology: Scientists name and contact information to be aggregation and inference; at FDA have developed a high- asabaliauskas on DSK3SPTVN1PROD with NOTICES made publicly available, you can • Technical capabilities each sector of throughput method for purifying full- provide this information on the cover the supply chain to comply with length phosphorothioate and native sheet and not in the body of your systems and processes needed to utilize DNA sequences. This method comprises comments and you must identify this the product identifier to enhance the a modified silica gel that enables information as ‘‘confidential.’’ Any tracing of a product; or capture of DNA sequences information marked as ‘‘confidential’’ • System attributes that are necessary functionalized with a novel linker will not be disclosed except in to implement the requirements specifically designed for exclusive accordance with 21 CFR 10.20 and other established under the DSCSA. capture of full-length sequences. This VerDate Sep<11>2014 17:38 Apr 27, 2017 Jkt 241001 PO 00000 Frm 00087 Fmt 4703 Sfmt 4703 E:\FR\FM\28APN1.SGM 28APN1


Document Created: 2017-04-28 03:02:51
Document Modified: 2017-04-28 03:02:51
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice; reopening of comment period; request for information.
DatesFDA is reopening the comment period on the Request for Information published April 15, 2016 (81 FR 22279). Submit either electronic or written comments by April 30, 2018. Late, untimely filed comments will not be considered. Electronic comments must be submitted on or before April 30, 2018. The https://www.regulations.gov/ electronic filing system will accept comments until midnight Eastern Time at the end of April 30, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.
ContactDaniel 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]
FR Citation82 FR 19737 
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR