81 FR 7807 - Proposed Pilot Project(s) Under the Drug Supply Chain Security Act; Public Workshop; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 30 (February 16, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 30 (February 16, 2016)
| Page Range | 7807-7809 | |
| FR Document | 2016-02977 |
[Federal Register Volume 81, Number 30 (Tuesday, February 16, 2016)] [Notices] [Pages 7807-7809] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-02977] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-0407] Proposed Pilot Project(s) Under the Drug Supply Chain Security Act; Public Workshop; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop; request for comments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing a public workshop entitled ``Proposed Pilot Project(s) under the Drug Supply Chain Security Act (DSCSA).'' This public workshop will provide a forum for discussing proposed design objectives of pilot projects that will explore and evaluate methods to enhance the safety and security of the pharmaceutical distribution supply chain. FDA would like to obtain information and input from interested pharmaceutical distribution supply chain members about issues related to utilizing the product identifier for product tracing, improving the technical capabilities of the supply chain, and identifying the system attributes that are necessary to implement the requirements established under the DSCSA. The information gathered from the workshop and the public comments submitted to the docket will further inform FDA's development of its pilot project program. DATES: The public workshop will be held on April 5, 2016, from 9 a.m. to 5 p.m. and April 6, 2016, from 9 a.m. to 12:15 p.m. The deadline for submitting either electronic or written comments on this workshop is April 21, 2016. See the SUPPLEMENTARY INFORMATION section for registration date and information. ADDRESSES: The public workshop will be held at FDA's White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503A), Silver Spring, MD 20993-0002. Entrance for the confirmed public workshop participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm. 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 [[Page 7808]] 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-0407 for ``Proposed Pilot Project(s) under the Drug Supply Chain Security Act; Public Workshop; Request for Comments.'' 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, 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] (include ``DSCSA pilot projects'' in the subject line). SUPPLEMENTARY INFORMATION: I. Background On November 27, 2013, the Drug Supply Chain Security Act (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 the new sections 581 and 582 to the Food, Drug, and Cosmetic Act (FD&C 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. FDA intends to establish a pilot project program to implement section 582(j) of the FD&C Act. The overarching goals of this program include assessing the ability of supply chain members to satisfy the requirements of section 582 and to identify, manage, and prevent the distribution of suspect and illegitimate drugs; identifying the system attributes needed to implement the requirements of section 582, particularly the requirement to utilize a product identifier for product tracing purposes; and demonstrating the electronic, interoperable exchange of product tracing information across the pharmaceutical distribution supply chain. FDA intends to coordinate its pilot project program efforts with stakeholders that reflect the diversity of the pharmaceutical distribution supply chain, including large and small entities from all industry sectors. II. Purpose of the Public Workshop This public workshop is intended to provide an opportunity for interested persons to provide comments on and discuss the proposed design objectives of pilot projects that will explore and evaluate methods to enhance the safety and security of the pharmaceutical distribution supply chain. FDA would like to obtain information and input from interested pharmaceutical distribution supply chain members about issues related to utilizing the product identifier for product tracing, improving the technical capabilities of the pharmaceutical distribution supply chain, and identifying the system attributes that are necessary to implement the requirements under section 582. FDA would also like to learn more about the practices, processes, and systems that supply chain stakeholders currently use or plan to use to meet the requirements under section 582, particularly the product tracing and verification requirements. These practices, processes, and systems may include those that supply chain stakeholders would consider using in pilot projects or those that supply chain stakeholders have already used in other previous pilot projects. By March 29, 2016, FDA will post the workshop agenda and other relevant materials under the DSCSA section of its Web site at http://www.fda.gov/Drugs/NewsEvents/ucm481767.htm. Supply chain stakeholders that might be interested in attending the public workshop include manufacturers, repackagers, wholesale distributors, dispensers, State and Federal authorities, solution providers, and standards organizations. Participants at the workshop will not be asked to develop consensus opinions during the discussion, but rather to provide their individual perspectives. Regardless of attendance at the public workshop, interested stakeholders may submit comments to the public docket related to any of the public workshop materials, including the agenda and other posted materials on FDA's Web site, in addition to comments specific to the design of pilot projects that will explore and evaluate methods to [[Page 7809]] enhance the safety and security of the pharmaceutical distribution supply chain. Stakeholders may comment on utilizing the product identifier for product tracing and the technical capabilities of the pharmaceutical distribution supply chain and the system attributes that are necessary to implement the requirements under section 582. The information gathered from the workshop participants and from the comments submitted to the docket for the public workshop will further inform FDA's development of its pilot project program under section 582(j) of the FD&C Act. III. Registration for the Public Workshop To request registration for the public workshop, provide your information including name, company or organization, address, telephone number, and email address to FDA at http://www.fda.gov/Drugs/NewsEvents/ucm481767.htm. Registration requests should be received by March 11, 2016. FDA is limiting workshop attendance due to limited space. FDA may limit the number of participants from each organization based on space limitations. FDA recommends that each organization determine who should register for the workshop to represent his/her organization. This will help ensure that the workshop will have broad and varied representation across the pharmaceutical distribution supply chain. Registrants will receive confirmation of participation for the workshop from FDA by March 18, 2016. There is no registration fee for the public workshop. There will be no onsite registration. If registration reaches maximum capacity, FDA will post a notice closing registration for the workshop on FDA's Web site at http://www.fda.gov/Drugs/NewsEvents/ucm481767.htm. If you need special accommodations due to a disability, please contact Daniel Bellingham (see FOR FURTHER INFORMATION CONTACT) at least 7 days in advance of the public workshop. IV. Webcasting of the Public Workshop Portions of this public workshop will be recorded and Webcasted on the day of the workshop. Information for how to access the Webcast will be available at http://www.fda.gov/Drugs/NewsEvents/ucm481767.htm by March 29, 2016. The Webcast will be conducted in listening-mode only. Dated: February 9, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-02977 Filed 2-12-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 30 / Tuesday, February 16, 2016 / Notices 7807
MD 20993–0002, Audrey.Thomas@ epidemiology, biostatistics, and Pilot Project(s) under the Drug Supply
fda.hhs.gov. healthcare data systems integration. Chain Security Act (DSCSA).’’ This
SUPPLEMENTARY INFORMATION: The This workshop will provide public workshop will provide a forum
purpose of this public workshop is to clinicians, researchers, and others from for discussing proposed design
discuss the scientific progress being the medical device industry, objectives of pilot projects that will
made in harnessing evidence generated professional societies, health care explore and evaluate methods to
from the real-world use of medical delivery systems groups, patient enhance the safety and security of the
devices to improve device safety and advocacy groups, and FDA the pharmaceutical distribution supply
effectiveness. The role that unique opportunity to discuss this important chain. FDA would like to obtain
device identification plays in improving topic. information and input from interested
device evaluation, to support more Agenda: The agenda is located at pharmaceutical distribution supply
informed clinical and patient decision- www.pharmacy.umaryland.edu/ chain members about issues related to
making, and device innovation will also DeviceEval. utilizing the product identifier for
be discussed. Registration: There is a registration fee product tracing, improving the technical
The foundation (strategy and steps) to attend this public workshop. The capabilities of the supply chain, and
for the development of a national registration fee is charged to help defray identifying the system attributes that are
evaluation system for medical devices the costs for facilities, materials, and necessary to implement the
has been developed by FDA’s Center for food. Seats are limited and registration requirements established under the
Devices and Radiological Health will be on a first-come, first-served DSCSA. The information gathered from
(available at basis. the workshop and the public comments
www.pharmacy.umaryland.edu/ To register, please complete submitted to the docket will further
DeviceEval). In 2015, two registration online at: inform FDA’s development of its pilot
multistakeholder groups issued reports www.pharmacy.umaryland.edu/ project program.
that develop the science and provide DeviceEval. The costs of registration for DATES: The public workshop will be
recommendations that further the the different categories of attendees are held on April 5, 2016, from 9 a.m. to 5
establishment of this system: ‘‘Building as follows: p.m. and April 6, 2016, from 9 a.m. to
an Effective National Medical Device 12:15 p.m. The deadline for submitting
Surveillance System’’ and Category Cost either electronic or written comments
‘‘Recommendations for a National Industry Representative ........ $50
on this workshop is April 21, 2016. See
Medical Device Evaluation System: Charitable Nonprofit and the SUPPLEMENTARY INFORMATION section
Strategically Coordinated Registry Academic Other Than Uni- for registration date and information.
Networks to Bridge the Clinical Care versity of Maryland ............ 50 ADDRESSES: The public workshop will
and Research’’ (available at University of Maryland, Col- be held at FDA’s White Oak Campus,
www.pharmacy.umaryland.edu/ lege Park and Baltimore ... 0 10903 New Hampshire Ave., Bldg. 31
DeviceEval). Government .......................... 0 Conference Center, the Great Room (Rm.
To successfully harness relevant 1503A), Silver Spring, MD 20993–0002.
information from the diverse set of real- Accommodations: Attendees are Entrance for the confirmed public
world evidence, the United States must responsible for their own hotel workshop participants (non-FDA
develop the necessary infrastructure accommodations. If you need special employees) is through Building 1 where
which is not yet in place today. We accommodations due to a disability, routine security check procedures will
continue to explore ways to improve the please contact Ann Anonsen (see FOR be performed. For parking and security
efficiency and cost-effectiveness of data FURTHER INFORMATION CONTACT).
information, please refer to http://
generation in traditional medical device Dated: February 9, 2016. www.fda.gov/AboutFDA/
clinical trials while maintaining data Leslie Kux, WorkingatFDA/BuildingsandFacilities/
quality. The goal is to streamline the Associate Commissioner for Policy. WhiteOakCampusInformation/
process and restore the United States to [FR Doc. 2016–02966 Filed 2–12–16; 8:45 am] ucm241740.htm.
the country of first choice to conduct You may submit comments as
BILLING CODE 4164–01–P
clinical research for medical technology follows:
innovation and ultimately bring their
products first to U.S. patients. Electronic Submissions
DEPARTMENT OF HEALTH AND
Limitations of current postmarket HUMAN SERVICES Submit electronic comments in the
surveillance tools, such as passive following way:
reporting, also constrain ability to Food and Drug Administration • Federal eRulemaking Portal: http://
rapidly address safety concerns. A www.regulations.gov. Follow the
national evaluation system for medical [Docket No. FDA–2016–N–0407] instructions for submitting comments.
devices, which leverages real-world Proposed Pilot Project(s) Under the Comments submitted electronically,
evidence, can help FDA more efficiently Drug Supply Chain Security Act; including attachments, to http://
strike the right balance between Public Workshop; Request for www.regulations.gov will be posted to
premarket and postmarket data Comments the docket unchanged. Because your
collection, facilitate access to medical comment will be made public, you are
mstockstill on DSK4VPTVN1PROD with NOTICES
devices, and more quickly and robustly AGENCY: Food and Drug Administration, solely responsible for ensuring that your
identify safety signals that may arise in HHS. comment does not include any
the postmarket period. The promise of ACTION: Notice of public workshop; confidential information that you or a
using real-world evidence to promote request for comments. third party may not wish to be posted,
the safety and effectiveness of medical such as medical information, your or
devices can only be achieved through SUMMARY: The Food and Drug anyone else’s Social Security number, or
robust public-private partnerships and Administration (FDA) is announcing a confidential business information, such
new approaches to informatics, public workshop entitled ‘‘Proposed as a manufacturing process. Please note
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![Federal Register / Vol. 81, No. 30 / Tuesday, February 16, 2016 / Notices 7809
enhance the safety and security of the Dated: February 9, 2016. You may submit comments as
pharmaceutical distribution supply Leslie Kux, follows:
chain. Stakeholders may comment on Associate Commissioner for Policy.
Electronic Submissions
utilizing the product identifier for [FR Doc. 2016–02977 Filed 2–12–16; 8:45 am]
product tracing and the technical BILLING CODE 4164–01–P
Submit electronic comments in the
capabilities of the pharmaceutical following way:
• Federal eRulemaking Portal: http://
distribution supply chain and the
DEPARTMENT OF HEALTH AND www.regulations.gov. Follow the
system attributes that are necessary to
HUMAN SERVICES instructions for submitting comments.
implement the requirements under Comments submitted electronically,
section 582. The information gathered including attachments, to http://
Food and Drug Administration
from the workshop participants and www.regulations.gov will be posted to
from the comments submitted to the [Docket No. FDA–2016–N–0437]
the docket unchanged. Because your
docket for the public workshop will comment will be made public, you are
Evaluation of the Safety of Drugs and
further inform FDA’s development of its solely responsible for ensuring that your
Biological Products Used During
pilot project program under section comment does not include any
Lactation; Public Workshop; Request
582(j) of the FD&C Act. for Comments confidential information that you or a
III. Registration for the Public third party may not wish to be posted,
AGENCY: Food and Drug Administration, such as medical information, your or
Workshop HHS. anyone else’s Social Security number, or
To request registration for the public ACTION: Notice of public workshop; confidential business information, such
workshop, provide your information request for comments. as a manufacturing process. Please note
including name, company or that if you include your name, contact
SUMMARY: The Food and Drug
organization, address, telephone information, or other information that
Administration (FDA) is announcing a
number, and email address to FDA at identifies you in the body of your
public workshop entitled ‘‘Evaluation of
http://www.fda.gov/Drugs/NewsEvents/ comments, that information will be
the Safety of Drugs and Biological
posted on http://www.regulations.gov.
ucm481767.htm. Registration requests Products used during Lactation.’’ The • If you want to submit a comment
should be received by March 11, 2016. purpose of this workshop is to provide with confidential information that you
FDA is limiting workshop attendance a forum to discuss the current state and
do not wish to be made available to the
due to limited space. FDA may limit the future directions of the collection of
public submit the comment as a written/
number of participants from each data on the potential risks to breastfed
paper submission and in the manner
organization based on space limitations. infants with maternal use of
detailed (see ‘‘Written/Paper
FDA recommends that each medications during lactation. The
Submissions’’ and ‘‘Instructions’’).
organization determine who should workshop will review current
register for the workshop to represent approaches to the collection of data Written/Paper Submissions
his/her organization. This will help when drugs are used or expected to be Submit written/paper submissions as
used during lactation. The workshop follows:
ensure that the workshop will have
will also discuss and consider novel • Mail/Hand delivery/Courier (for
broad and varied representation across
approaches to improve the quality and written/paper submissions): Division of
the pharmaceutical distribution supply quantity of data, to inform of the
chain. Registrants will receive Dockets Management (HFA–305), Food
potential risks of medication use during and Drug Administration, 5630 Fishers
confirmation of participation for the lactation, and to raise awareness and
workshop from FDA by March 18, 2016. Lane, Rm. 1061, Rockville, MD 20852.
engage stakeholders about • For written/paper comments
There is no registration fee for the communication of safety information submitted to the Division of Dockets
public workshop. There will be no related to maternal use of medications Management, FDA will post your
onsite registration. If registration during lactation. comment, as well as any attachments,
reaches maximum capacity, FDA will DATES: The public workshop will be except for information submitted,
post a notice closing registration for the held on April 27, 2016, from 8 a.m. to marked and identified, as confidential,
workshop on FDA’s Web site at http:// 5 p.m.; and April 28, 2016, from 8 a.m. if submitted as detailed in
www.fda.gov/Drugs/NewsEvents/ to 1 p.m. Registration closes on April 8, ‘‘Instructions.’’
ucm481767.htm. If you need special 2016. Submit electronic or written Instructions: All submissions received
accommodations due to a disability, comments to the public docket by May must include the Docket No. FDA–
please contact Daniel Bellingham (see 28, 2016. 2016–N–0437 for ‘‘Evaluation of the
FOR FURTHER INFORMATION CONTACT) at ADDRESSES: The public workshop will Safety of Drugs and Biological Products
least 7 days in advance of the public be held at FDA’s White Oak Campus, used during Lactation; Public
workshop. 10903 New Hampshire Ave., Bldg. 31 Workshop; Request for Comments.’’
Conference Center, the Great Room (Rm. Received comments will be placed in
IV. Webcasting of the Public Workshop 1503A), Silver Spring, MD 20993–0002. the docket and, except for those
Portions of this public workshop will Entrance for the public workshop submitted as ‘‘Confidential
be recorded and Webcasted on the day participants (non-FDA employees) is Submissions,’’ publicly viewable at
mstockstill on DSK4VPTVN1PROD with NOTICES
through Building 1 where routine http://www.regulations.gov or at the
of the workshop. Information for how to
security check procedures will be Division of Dockets Management
access the Webcast will be available at
performed. For parking and security between 9 a.m. and 4 p.m., Monday
http://www.fda.gov/Drugs/NewsEvents/ information, please refer to http:// through Friday.
ucm481767.htm by March 29, 2016. The www.fda.gov/AboutFDA/ • Confidential Submissions—To
Webcast will be conducted in listening- WorkingatFDA/BuildingsandFacilities/ submit a comment with confidential
mode only. WhiteOakCampusInformation/ information that you do not wish to be
ucm241740.htm. made publicly available submit your
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Document Created: 2016-02-13 03:13:29
Document Modified: 2016-02-13 03:13:29
| 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 of public workshop; request for comments. | |
| Dates | The public workshop will be held on April 5, 2016, from 9 a.m. to 5 p.m. and April 6, 2016, from 9 a.m. to 12:15 p.m. The deadline for submitting either electronic or written comments on this workshop is April 21, 2016. See the SUPPLEMENTARY INFORMATION section for registration date and 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] (include ``DSCSA pilot projects'' in the subject line). | |
| FR Citation | 81 FR 7807 |
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