81_FR_22352 81 FR 22279 - Pharmaceutical Distribution Supply Chain Pilot Projects; Request for Information

81 FR 22279 - Pharmaceutical Distribution Supply Chain Pilot Projects; Request for Information

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 73 (April 15, 2016)

Page Range22279-22280
FR Document2016-08681

The Food and Drug Administration (FDA) is soliciting information 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 public comments will assist with the design and development of the pilot project(s) that FDA establishes under the DSCSA.

Federal Register, Volume 81 Issue 73 (Friday, April 15, 2016) 
[Federal Register Volume 81, Number 73 (Friday, April 15, 2016)]
[Notices]
[Pages 22279-22280]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-08681]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Pharmaceutical Distribution Supply Chain Pilot Projects; Request 
for Information

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for information.

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SUMMARY: The Food and Drug Administration (FDA) is soliciting 
information 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 public comments 
will assist with the design and development of the pilot project(s) 
that FDA establishes under the DSCSA.

DATES: Submit written or electronic comments and information by May 16, 
2016.
    You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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): 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; Request for Information.'' Received comments will be placed 
in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at http://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 http://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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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, 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: 

I. Background

    On November 27, 2013, the DSCSA (Title II of Pub. L. 113-54) was 
signed into law. The DSCSA outlines critical steps to build an 
electronic, interoperable system by November 27, 2023, which will 
identify and trace certain prescription drugs as they are distributed 
within the United States. Section 202 of the DSCSA added new sections 
581 and 582 to the Food Drug

[[Page 22280]]

and Cosmetic Act (21 U.S.C. 360eee and 360eee-1). Under section 582(j), 
FDA is required to establish one or more pilot projects, in 
coordination with authorized manufacturers, repackagers, wholesale 
distributors, and dispensers, to explore and evaluate methods to 
enhance the safety and security of the pharmaceutical distribution 
supply chain. The projects established by FDA will take into 
consideration any pilot projects that were conducted prior to enactment 
of the DSCSA.

II. Purpose of the Request for Information

    The request for information is intended to provide interested 
persons an opportunity to submit comments relating to FDA's 
implementation of the DSCSA. 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, 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 assist with FDA's development of a pilot project 
under the DSCSA.

    Dated: April 11, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-08681 Filed 4-14-16; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 73 / Friday, April 15, 2016 / Notices 22279 presentation may be limited. If the project(s) that FDA establishes under • Confidential Submissions—To number of registrants requesting to the DSCSA. submit a comment with confidential speak is greater than can be reasonably DATES: Submit written or electronic information that you do not wish to be accommodated during the scheduled comments and information by May 16, made publicly available, submit your open public hearing session, FDA may 2016. comments only as a written/paper conduct a lottery to determine the You may submit comments as submission. You should submit two speakers for the scheduled open public follows: copies total. One copy will include the hearing session. The contact person will information you claim to be confidential notify interested persons regarding their Electronic Submissions with a heading or cover note that states request to speak by May 18, 2016. Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS Persons attending FDA’s advisory following way: CONFIDENTIAL INFORMATION.’’ The committee meetings are advised that the • Federal eRulemaking Portal: http:// Agency will review this copy, including Agency is not responsible for providing www.regulations.gov. Follow the the claimed confidential information, in access to electrical outlets. instructions for submitting comments. its consideration of comments. The FDA welcomes the attendance of the Comments submitted electronically, second copy, which will have the public at its advisory committee including attachments, to http:// claimed confidential information meetings and will make every effort to www.regulations.gov will be posted to redacted/blacked out, will be available accommodate persons with disabilities. the docket unchanged. Because your for public viewing and posted on If you require accommodations due to a comment will be made public, you are http://www.regulations.gov. Submit disability, please contact Lauren D. Tesh solely responsible for ensuring that your both copies to the Division of Dockets at least 7 days in advance of the comment does not include any Management. If you do not wish your meeting. confidential information that you or a name and contact information to be FDA is committed to the orderly third party may not wish to be posted, made publicly available, you can conduct of its advisory committee such as medical information, your or provide this information on the cover meetings. Please visit our Web site at anyone else’s Social Security number, or sheet and not in the body of your http://www.fda.gov/ confidential business information, such comments and you must identify this AdvisoryCommittees/ as a manufacturing process. Please note information as ‘‘confidential.’’ Any AboutAdvisoryCommittees/ that if you include your name, contact information marked as ‘‘confidential’’ ucm111462.htm for procedures on information, or other information that will not be disclosed except in public conduct during advisory identifies you in the body of your accordance with 21 CFR 10.20 and other committee meetings. comments, that information will be applicable disclosure law. For more Notice of this meeting is given under posted on http://www.regulations.gov. information about FDA’s posting of the Federal Advisory Committee Act (5 • If you want to submit a comment comments to public dockets, see 80 FR U.S.C. app. 2). with confidential information that you 56469, September 18, 2015, or access Dated: April 11, 2016. do not wish to be made available to the the information at: http://www.fda.gov/ Jill Hartzler Warner, public, submit the comment as a regulatoryinformation/dockets/ Associate Commissioner for Special Medical written/paper submission and in the default.htm. Programs. manner detailed (see ‘‘Written/Paper Docket: For access to the docket to [FR Doc. 2016–08637 Filed 4–14–16; 8:45 am] Submissions’’ and ‘‘Instructions’’). read background documents or the BILLING CODE 4164–01–P Written/Paper Submissions electronic and written/paper comments received, go to http:// Submit written/paper submissions as www.regulations.gov and insert the follows: DEPARTMENT OF HEALTH AND • Mail/Hand delivery/Courier (for docket number, found in brackets in the HUMAN SERVICES written/paper submissions): Division of heading of this document, into the Dockets Management (HFA–305), Food ‘‘Search’’ box and follow the prompts Food and Drug Administration and/or go to the Division of Dockets and Drug Administration, 5630 Fishers [Docket No. FDA–2016–N–1114] Lane, Rm. 1061, Rockville, MD 20852. Management, 5630 Fishers Lane, Rm. • For written/paper comments 1061, Rockville, MD 20852. Pharmaceutical Distribution Supply submitted to the Division of Dockets FOR FURTHER INFORMATION CONTACT: Chain Pilot Projects; Request for Management, FDA will post your Daniel Bellingham, Center for Drug Information comment, as well as any attachments, Evaluation and Research, Food and AGENCY: Food and Drug Administration, except for information submitted, Drug Administration, 10903 New HHS. marked and identified, as confidential, Hampshire Ave., Silver Spring, MD ACTION: Notice; request for information. if submitted as detailed in 20993–0002, 301–796–3130, ‘‘Instructions.’’ daniel.bellingham@fda.hhs.gov. SUMMARY: The Food and Drug Instructions: All submissions received SUPPLEMENTARY INFORMATION: Administration (FDA) is soliciting must include the Docket No. FDA– information regarding issues related to 2016–N–1114 for ‘‘Pharmaceutical I. Background utilizing the product identifier for Distribution Supply Chain Pilot On November 27, 2013, the DSCSA product tracing, improving the technical Projects; Request for Information.’’ (Title II of Pub. L. 113–54) was signed asabaliauskas on DSK3SPTVN1PROD with NOTICES capabilities of the supply chain, and Received comments will be placed in into law. The DSCSA outlines critical identifying system attributes that are the docket and, except for those steps to build an electronic, necessary to implement the submitted as ‘‘Confidential interoperable system by November 27, requirements established under the Submissions,’’ publicly viewable at 2023, which will identify and trace Drug Supply Chain Security Act http://www.regulations.gov or at the certain prescription drugs as they are (DSCSA). The information gathered Division of Dockets Management distributed within the United States. from public comments will assist with between 9 a.m. and 4 p.m., Monday Section 202 of the DSCSA added new the design and development of the pilot through Friday. sections 581 and 582 to the Food Drug VerDate Sep<11>2014 17:27 Apr 14, 2016 Jkt 238001 PO 00000 Frm 00072 Fmt 4703 Sfmt 4703 E:\FR\FM\15APN1.SGM 15APN1

22280 Federal Register / Vol. 81, No. 73 / Friday, April 15, 2016 / Notices and Cosmetic Act (21 U.S.C. 360eee and DEPARTMENT OF HEALTH AND comments, that information will be 360eee–1). Under section 582(j), FDA is HUMAN SERVICES posted on http://www.regulations.gov. required to establish one or more pilot • If you want to submit a comment projects, in coordination with Food and Drug Administration with confidential information that you authorized manufacturers, repackagers, do not wish to be made available to the [Docket No. FDA–2016–N–1126] public, submit the comment as a wholesale distributors, and dispensers, to explore and evaluate methods to written/paper submission and in the Circulatory System Devices Panel of enhance the safety and security of the manner detailed (see ‘‘Written/Paper the Medical Devices Advisory Submissions’’ and ‘‘Instructions’’). pharmaceutical distribution supply Committee; Notice of Meeting; chain. The projects established by FDA Establishment of a Public Docket; Written/Paper Submissions will take into consideration any pilot Request for Comments Submit written/paper submissions as projects that were conducted prior to follows: AGENCY: Food and Drug Administration, enactment of the DSCSA. HHS. • Mail/Hand delivery/Courier (for written/paper submissions): Division of II. Purpose of the Request for ACTION: Notice, establishment of a Dockets Management (HFA–305), Food Information public docket; request for comments. and Drug Administration, 5630 Fishers The request for information is SUMMARY: The Food and Drug Lane, Rm. 1061, Rockville, MD 20852. intended to provide interested persons • For written/paper comments Administration (FDA) announces a submitted to the Division of Dockets an opportunity to submit comments forthcoming public advisory committee Management, FDA will post your relating to FDA’s implementation of the meeting of the Circulatory System comment, as well as any attachments, DSCSA. We are particularly interested Devices Panel of the Medical Devices except for information submitted, in comments regarding past or present Advisory Committee. The general marked and identified, as confidential, pilot projects related to enhancing the function of the committee is to provide if submitted as detailed in safety and security of the advice and recommendations to the ‘‘Instructions.’’ pharmaceutical distribution supply Agency on FDA’s regulatory issues. The Instructions: All submissions received chain. Stakeholders that may be meeting will be open to the public. FDA must include the Docket No. FDA– interested in responding to this request is establishing a docket for public 2016–N–1126 for ‘‘Circulatory System for information include: Manufacturers, comment on this document. Devices Panel of the Medical Devices repackagers, wholesale distributors, DATES: The meeting will be held on June Advisory Committee; Notice of Meeting; dispensers, State and Federal 2 and 3, 2016, from 8 a.m. to 6 p.m. Establishment of a Public Docket; authorities, solution providers, ADDRESSES: Hilton Washington DC Request for Comments.’’ Received standards organizations, and other North/Gaithersburg, Grand Ballroom, comments will be placed in the docket interested persons. FDA is particularly 620 Perry Pkwy., Gaithersburg, MD and, except for those submitted as interested in learning about the 20877. The hotel telephone number is ‘‘Confidential Submissions,’’ publicly practices, processes, and systems that 301–977–8900. Answers to commonly viewable at http://www.regulations.gov supply chain stakeholders have used or asked questions including information or at the Division of Dockets considered using in such pilot projects. regarding special accommodations due Management between 9 a.m. and 4 p.m., This includes, but is not limited to, to a disability, visitor parking, and Monday through Friday. transportation may be accessed at: • Confidential Submissions—To information about the following: http://www.fda.gov/ submit a comment with confidential • Utilizing the product identifier for AdvisoryCommittees/ information that you do not wish to be tracing of a product, which may include AboutAdvisoryCommittees/ made publicly available, submit your verification of the product identifier of ucm408555.htm. You may submit comments only as a written/paper a product, including the use of comments as follows: submission. You should submit two aggregation and inference; copies total. One copy will include the Electronic Submissions information you claim to be confidential • Technical capabilities each sector of the supply chain to comply with Submit electronic comments in the with a heading or cover note that states systems and processes needed to utilize following way: ‘‘THIS DOCUMENT CONTAINS the product identifier to enhance the • Federal eRulemaking Portal: http:// CONFIDENTIAL INFORMATION.’’ The www.regulations.gov. Follow the Agency will review this copy, including tracing of a product; or instructions for submitting comments. the claimed confidential information, in • System attributes that are necessary Comments submitted electronically, its consideration of comments. The to implement the requirements including attachments, to http:// second copy, which will have the established under the DSCSA. www.regulations.gov will be posted to claimed confidential information Interested persons are requested to the docket unchanged. Because your redacted/blacked out, will be available provide any other relevant information comment will be made public, you are for public viewing and posted on http:// that may assist with FDA’s development solely responsible for ensuring that your www.regulations.gov. Submit both of a pilot project under the DSCSA. comment does not include any copies to the Division of Dockets confidential information that you or a Management. If you do not wish your asabaliauskas on DSK3SPTVN1PROD with NOTICES Dated: April 11, 2016. third party may not wish to be posted, name and contact information to be Leslie Kux, such as medical information, your or made publicly available, you can Associate Commissioner for Policy. anyone else’s Social Security number, or provide this information on the cover [FR Doc. 2016–08681 Filed 4–14–16; 8:45 am] confidential business information, such sheet and not in the body of your BILLING CODE 4164–01–P as a manufacturing process. Please note comments and you must identify this that if you include your name, contact information as ‘‘confidential.’’ Any information, or other information that information marked as ‘‘confidential’’ identifies you in the body of your will not be disclosed except in VerDate Sep<11>2014 17:27 Apr 14, 2016 Jkt 238001 PO 00000 Frm 00073 Fmt 4703 Sfmt 4703 E:\FR\FM\15APN1.SGM 15APN1


Document Created: 2016-04-15 00:55:02
Document Modified: 2016-04-15 00:55:02
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; request for information.
DatesSubmit written or electronic comments and information by May 16, 2016.
ContactDaniel Bellingham, 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 Citation81 FR 22279 
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