82 FR 33505 - Enhanced Drug Distribution Security Under the Drug Supply Chain Security Act; Public Meetings; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 138 (July 20, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 138 (July 20, 2017)
| Page Range | 33505-33507 | |
| FR Document | 2017-15204 |
[Federal Register Volume 82, Number 138 (Thursday, July 20, 2017)] [Notices] [Pages 33505-33507] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-15204] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-3857] Enhanced Drug Distribution Security Under the Drug Supply Chain Security Act; Public Meetings; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meetings; request for comments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is announcing three public meetings entitled ``Enhanced Drug Distribution Security Under the Drug Supply Chain Security Act (DSCSA).'' These public meetings are intended to provide members of the pharmaceutical distribution supply chain and other interested stakeholders an opportunity to discuss with FDA, and provide input on, strategies and issues related to the enhanced drug distribution security provisions of the DSCSA. DATES: The public meetings will be held on: August 23, 2017, from 9 a.m. to 4 p.m.; December 5 and 6, 2017, from 9 a.m. to 4 p.m.; and February 28, 2018, from 9 a.m. to 4 p.m. ADDRESSES: The public meetings will be held at FDA's White Oak Campus, 10903 New Hampshire Ave., Bldg. 31, Rm. 1503A, Silver Spring, MD 20993. Entrance for the public meeting participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm. Comments: To permit the widest possible opportunity to obtain public comment, FDA is soliciting either electronic or written comments on all aspects of the public meeting topics. You may submit comments as follows. Please note that the deadlines for submitting either electronic or written comments are 30 days after the meeting to which the comments relate. Comments received by mail/hand delivery/courier (for written/paper [[Page 33506]] submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of the specified date. See the SUPPLEMENTARY INFORMATION section for registration dates and for the deadlines for submitting electronic or written comments related to these public meetings (table 1). 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-2017-N-3857 for ``Enhanced Drug Distribution Security Under the Drug Supply Chain Security Act; Public Meetings; Request for Comments.'' 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.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Daniel Bellingham, Office of Compliance, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301- 796-3130, [email protected]. SUPPLEMENTARY INFORMATION: I. Background On November 27, 2013, the Drug Supply Chain Security Act (DSCSA) (Title II, Pub. L. 113-54) was signed into law. The DSCSA outlines critical steps to build an electronic, interoperable system by 2023 to identify and trace certain prescription drugs as they are distributed within the United States. This system will enhance FDA's ability to protect U.S. consumers from exposure to drugs that may be counterfeit, diverted, stolen, intentionally adulterated, or otherwise harmful by improving the detection and removal of potentially dangerous drugs from the drug supply chain. Section 582(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360eee-1(i)), which was added by the DSCSA, directs FDA to hold public meetings to enhance the safety and security of the pharmaceutical distribution supply chain and provide opportunities for comment from stakeholders. II. Purpose of the Public Meetings FDA will hold public meetings on August 23, 2017, December 5 and 6, 2017, and February 28, 2018, on enhanced drug distribution security. The purpose of these public meetings is to provide members of the pharmaceutical distribution supply chain and other interested stakeholders an opportunity to discuss with FDA, and provide input on, strategies and issues related to the enhanced drug distribution security provisions of the DSCSA. These public meetings will focus on the following topics for discussion: What supply chain security should look like in 2023 What is needed for enhanced drug distribution security What is needed for electronic interoperability Standards for product tracing Data architecture options for an electronic interoperable system The management and maintenance of product tracing data The use of aggregation and inference for enhanced product tracing and verification Building capacity for a unit-level system for product tracing and verification FDA may include additional discussion topics. Materials for each public meeting will be provided on FDA's Web site at https://www.fda.gov/Drugs/NewsEvents/UCM559090.htm 10 days before each public meeting. III. Registration for the Public Meetings To request registration for the public meetings, provide your information including name, company or organization, address, telephone number, and email address to FDA at [[Page 33507]] https://www.fda.gov/Drugs/NewsEvents/UCM559090.htm. Registration requests for each meeting should be received during the time periods specified in table 1. FDA is limiting attendance due to restricted space. In addition, 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 public meeting to represent his/her organization. This will help ensure that the meeting will have broad and varied representation, including across the pharmaceutical distribution supply chain. Registrants will receive confirmation of participation for their chosen meeting from FDA within 14 days of the date of each meeting. There is no registration fee for the public meetings. There will be no onsite registration. If registration reaches maximum capacity, FDA will post a notice closing registration for the meeting on FDA's Web site at https://www.fda.gov/Drugs/NewsEvents/UCM559090.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 meeting. Table 1--Public Meeting Information ---------------------------------------------------------------------------------------------------------------- Relevant section of Public meeting Topics Date/Time this document or electronic address ---------------------------------------------------------------------------------------------------------------- # 1.................................. Supply chain August 23, 2017, 9 a.m. security in 2023. to 4 p.m. Enhanced drug distribution security needs. Advance registration... by July 31, 2017....... Online registration only at https://www.fda.gov/Drugs/NewsEvents/UCM559090.htm. No onsite registration. Comment period closes.. September 22, 2017..... See ``Comments''. Request special by August 16, 2017..... See FOR FURTHER accommodations due to INFORMATION CONTACT. a disability. # 2.................................. Electronic December 5-6, 2017, 9 interoperability. a.m. to 4 p.m. Standards for data exchange. Data architecture. Aggregation and inference. Advance registration... October 2-27, 2017..... Online registration only at https://www.fda.gov/Drugs/NewsEvents/UCM559090.htm. No onsite registration. Comment period closes.. January 5, 2018........ See ``Comments''. Request special by November 28, 2017... See FOR FURTHER accommodations due to INFORMATION CONTACT. a disability. # 3.................................. Further February 28, 2018, 9 refinement of enhanced a.m. to 4 p.m. drug distribution security needs. Building capacity for a unit- level system. Advance registration... January 2-26, 2018..... Online registration only at https://www.fda.gov/Drugs/NewsEvents/UCM559090.htm. No onsite registration. Comment period closes.. March 30, 2018......... See ``Comments''. Request special by February 21, 2018... See FOR FURTHER accommodations due to INFORMATION CONTACT. a disability. ---------------------------------------------------------------------------------------------------------------- IV. Webcasting of the Public Meeting Portions of each public meeting will be recorded and webcast on the day of the meeting. Information for how to access the webcast will be available at https://www.fda.gov/Drugs/NewsEvents/UCM559090.htm within 7 days prior to each public meeting. The webcast will be conducted in listening mode only. Dated: July 14, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-15204 Filed 7-19-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 138 / Thursday, July 20, 2017 / Notices 33505
which can be submitted to the Dockets you look for in an ideal treatment for Dated: July 13, 2017.
Management Staff (see ADDRESSES). For your condition? Anna K. Abram,
context, please indicate if you are (8) If you had the opportunity to Deputy Commissioner for Policy, Planning,
commenting as a patient with HAE or consider participating in a clinical trial Legislation, and Analysis.
on behalf of a child or loved one. studying experimental treatments, what [FR Doc. 2017–15202 Filed 7–19–17; 8:45 am]
things would you consider when BILLING CODE 4164–01–P
Topic 1: Disease Symptoms and Daily deciding whether or not to participate?
Impacts That Matter Most to Patients
III. Meeting Attendance and
(1) Of all of the symptoms that you DEPARTMENT OF HEALTH AND
Participation
experience because of your condition, HUMAN SERVICES
which one of these symptoms has the Registration: If you wish to attend this
most significant impact on your life? meeting, visit https:// Food and Drug Administration
Examples may include nausea, www.eventbrite.com/e/patient-focused-
[Docket No. FDA–2017–N–3857]
vomiting, abdominal pain, swelling of drug-development-for-hereditary-
extremities, facial swelling, tongue angioedema-public-meeting-tickets- Enhanced Drug Distribution Security
swelling, hoarseness or loss of voice, 32300298061. Persons interested in Under the Drug Supply Chain Security
shortness of breath, and difficulty attending this public meeting must Act; Public Meetings; Request for
urinating. register by August 10, 2017. If you are Comments
(2) Are there specific activities that unable to attend the meeting in person,
are important to you that you cannot do you can register to view a live Webcast AGENCY: Food and Drug Administration,
at all or as well as you would like of the meeting. You will be asked to HHS.
because of your condition? Please indicate in your registration if you plan ACTION: Notice of public meetings;
describe, using specific examples. to attend in person or via the Webcast. request for comments.
Examples may include: Participating in Registration is free and based on space
availability, with priority given to early SUMMARY: The Food and Drug
physical activities; and attending work Administration (FDA, the Agency, or
or school and family or social activities, registrants. Early registration is
recommended because seating is we) is announcing three public meetings
during or between attacks. entitled ‘‘Enhanced Drug Distribution
(3) How have your condition and its limited; therefore, FDA may limit the
number of participants from each Security Under the Drug Supply Chain
symptoms changed over time? Security Act (DSCSA).’’ These public
(4) What worries you most about your organization. Registrants will receive
confirmation once they have been meetings are intended to provide
condition? members of the pharmaceutical
accepted. Onsite registration on the day
Topic 2: Patients’ Perspectives on of the meeting will be based on space distribution supply chain and other
Current Approaches to Treatment availability. If you need special interested stakeholders an opportunity
accommodations due to a disability, to discuss with FDA, and provide input
(1) What are you currently doing to on, strategies and issues related to the
treat your condition and its symptoms? please contact Barbara Kass or Loni
enhanced drug distribution security
• What, if anything, are you doing to Warren Henderson (see FOR FURTHER
INFORMATION CONTACT) no later than provisions of the DSCSA.
prevent acute HAE attacks? Examples
September 18, 2017. DATES: The public meetings will be held
may include treatments with
prescription medicines; over-the- Requests for Oral Presentations: on: August 23, 2017, from 9 a.m. to 4
counter products; and other therapies, Patients and patient representatives who p.m.; December 5 and 6, 2017, from 9
including non-drug therapies. are interested in presenting comments a.m. to 4 p.m.; and February 28, 2018,
• What, if anything, do you self- as part of the initial panel discussions from 9 a.m. to 4 p.m.
administer for acute HAE attacks? will be asked to indicate in their ADDRESSES: The public meetings will be
• If you give yourself medication for registration which topic(s) they wish to held at FDA’s White Oak Campus,
acute HAE attacks, which types of address. These patients and patient 10903 New Hampshire Ave., Bldg. 31,
attacks, with respect to body location(s), representatives also must send to Rm. 1503A, Silver Spring, MD 20993.
are you comfortable treating yourself? PatientFocused_CBER@fda.hhs.gov a Entrance for the public meeting
• What treatment has your health brief summary of responses to the topic participants (non-FDA employees) is
professional used for your acute HAE questions by August 3, 2017. Panelists through Building 1 where routine
attacks? Examples may include will be notified of their selection security check procedures will be
prescription medicines; over-the- approximately 7 days before the public performed. For parking and security
counter products; and other therapies, meeting. We will try to accommodate all information, please refer to https://
including non-drug therapies. patients and patient representatives who www.fda.gov/AboutFDA/
(2) How well do these treatments wish to speak, either through the panel WorkingatFDA/BuildingsandFacilities/
work for you? discussion or audience participation; WhiteOakCampusInformation/
(3) What are the most significant however, the duration of comments may ucm241740.htm.
disadvantages or complications of your be limited by time constraints. Comments: To permit the widest
current treatments, and how do they Transcripts: Please be advised that, as possible opportunity to obtain public
affect your daily life? soon as a transcript of the public comment, FDA is soliciting either
asabaliauskas on DSKBBXCHB2PROD with NOTICES
(4) How has your treatment regimen meeting is available, it will be accessible electronic or written comments on all
changed over time and why? at https://www.regulations.gov. It may aspects of the public meeting topics.
(5) What aspects of your condition are be viewed at the Dockets Management You may submit comments as follows.
not improved by your current treatment Staff (see ADDRESSES). A link to the Please note that the deadlines for
regimen? transcript will also be available on the submitting either electronic or written
(6) What treatment has had the most Internet at http://www.fda.gov/ comments are 30 days after the meeting
positive impact on your quality of life? BiologicsBloodVaccines/NewsEvents/ to which the comments relate.
(7) Short of a complete cure for your WorkshopsMeetingsConferences/ Comments received by mail/hand
condition, what specific things would ucm542320.htm. delivery/courier (for written/paper
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![Federal Register / Vol. 82, No. 138 / Thursday, July 20, 2017 / Notices 33507
https://www.fda.gov/Drugs/NewsEvents/ represent his/her organization. This will reaches maximum capacity, FDA will
UCM559090.htm. Registration requests help ensure that the meeting will have post a notice closing registration for the
for each meeting should be received broad and varied representation, meeting on FDA’s Web site at https://
during the time periods specified in including across the pharmaceutical www.fda.gov/Drugs/NewsEvents/
table 1. FDA is limiting attendance due distribution supply chain. Registrants UCM559090.htm. If you need special
to restricted space. In addition, FDA will receive confirmation of accommodations due to a disability,
may limit the number of participants participation for their chosen meeting please contact Daniel Bellingham (see
from each organization based on space from FDA within 14 days of the date of FOR FURTHER INFORMATION CONTACT) at
limitations. FDA recommends that each each meeting. There is no registration least 7 days in advance of the public
organization determine who should fee for the public meetings. There will meeting.
register for the public meeting to be no onsite registration. If registration
TABLE 1—PUBLIC MEETING INFORMATION
Relevant section of this document or
Public meeting Topics Date/Time electronic address
# 1 .......................... • Supply chain security in 2023 ........... August 23, 2017, 9 a.m. to 4 p.m.
• Enhanced drug distribution security
needs.
Advance registration ............................. by July 31, 2017 ................................... Online registration only at https://
www.fda.gov/Drugs/NewsEvents/
UCM559090.htm. No onsite registra-
tion.
Comment period closes ........................ September 22, 2017 ............................. See ‘‘Comments’’.
Request special accommodations due by August 16, 2017 .............................. See FOR FURTHER INFORMATION
to a disability. CONTACT.
# 2 .......................... • Electronic interoperability .................. December 5–6, 2017, 9 a.m. to 4 p.m.
• Standards for data exchange ...........
• Data architecture ...............................
• Aggregation and inference.
Advance registration ............................. October 2–27, 2017 .............................. Online registration only at https://
www.fda.gov/Drugs/NewsEvents/
UCM559090.htm. No onsite registra-
tion.
Comment period closes ........................ January 5, 2018 .................................... See ‘‘Comments’’.
Request special accommodations due by November 28, 2017 ......................... See FOR FURTHER INFORMATION
to a disability. CONTACT.
# 3 .......................... • Further refinement of enhanced drug February 28, 2018, 9 a.m. to 4 p.m.
distribution security needs.
• Building capacity for a unit-level sys-
tem.
Advance registration ............................. January 2–26, 2018 .............................. Online registration only at https://
www.fda.gov/Drugs/NewsEvents/
UCM559090.htm. No onsite registra-
tion.
Comment period closes ........................ March 30, 2018 ..................................... See ‘‘Comments’’.
Request special accommodations due by February 21, 2018 ........................... See FOR FURTHER INFORMATION
to a disability. CONTACT.
IV. Webcasting of the Public Meeting DEPARTMENT OF HEALTH AND Office of Management and Budget
HUMAN SERVICES (OMB) for review and clearance under
Portions of each public meeting will the Paperwork Reduction Act of 1995.
be recorded and webcast on the day of Food and Drug Administration
the meeting. Information for how to DATES: Fax written comments on the
access the webcast will be available at [Docket No. FDA–2010–N–0597] collection of information by August 21,
https://www.fda.gov/Drugs/NewsEvents/ 2017.
Agency Information Collection
UCM559090.htm within 7 days prior to Activities; Submission for Office of ADDRESSES: To ensure that comments on
each public meeting. The webcast will Management and Budget Review; the information collection are received,
be conducted in listening mode only. Comment Request; Index of Legally OMB recommends that written
Dated: July 14, 2017. Marketed Unapproved New Animal comments be faxed to the Office of
Anna K. Abram, Drugs for Minor Species Information and Regulatory Affairs,
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Deputy Commissioner for Policy, Planning, OMB, Attn: FDA Desk Officer, FAX:
AGENCY: Food and Drug Administration,
Legislation, and Analysis. 202–395–7285, or emailed to oira_
HHS.
[FR Doc. 2017–15204 Filed 7–19–17; 8:45 am] submission@omb.eop.gov. All
ACTION: Notice. comments should be identified with the
BILLING CODE 4164–01–P
SUMMARY: The Food and Drug OMB control number 0910–0620. Also
Administration (FDA) is announcing include the FDA docket number found
that a proposed collection of in brackets in the heading of this
information has been submitted to the document.
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Document Created: 2017-07-20 06:57:55
Document Modified: 2017-07-20 06:57:55
| 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 meetings; request for comments. | |
| Dates | The public meetings will be held on: August 23, 2017, from 9 a.m. to 4 p.m.; December 5 and 6, 2017, from 9 a.m. to 4 p.m.; and February 28, 2018, from 9 a.m. to 4 p.m. | |
| Contact | Daniel Bellingham, Office of Compliance, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301- 796-3130, [email protected] | |
| FR Citation | 82 FR 33505 |
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