81 FR 64175 - Progress Toward Implementing the Product Identification Requirements of the Drug Supply Chain Security Act; Public Meeting; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 181 (September 19, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 181 (September 19, 2016)
| Page Range | 64175-64177 | |
| FR Document | 2016-22441 |
[Federal Register Volume 81, Number 181 (Monday, September 19, 2016)] [Notices] [Pages 64175-64177] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-22441] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-2673] Progress Toward Implementing the Product Identification Requirements of the Drug Supply Chain Security Act; Public Meeting; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting; request for comments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing a public meeting entitled ``Progress Toward Implementing the Product Identification Requirements of the Drug Supply Chain Security Act.'' This public meeting is intended to provide members of the pharmaceutical distribution supply chain and other interested stakeholders an opportunity to share information with FDA about the efforts underway to implement the Drug Supply Chain Security Act's (DSCSA's) product identification requirements, including the use of product identifiers to enhance tracing at the product level. DATES: The public meeting will be held on October 14, 2016, from 9 a.m. to 4 p.m. 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. The deadline for submitting comments related to this public meeting is November 14, 2016. ADDRESSES: The public meeting will be held at FDA's White Oak Campus, [[Page 64176]] 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (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 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 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-2673 for ``Progress Toward Implementing the Product Identification Requirements of the Drug Supply Chain Security Act.'' 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., Bldg. 51, Rm. 4285, Silver Spring, MD 20993, 301-796-3130, FAX: 301-847-8722, email: [email protected]. SUPPLEMENTARY INFORMATION: I. Background On November 27, 2013, the 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, stolen, contaminated, 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 (the FD&C Act) (21 U.S.C. 360eee-1), which was added by the DSCSA, directs FDA to hold at least five public meetings to enhance the safety and security of the pharmaceutical distribution supply chain and provide opportunities for comment from stakeholders. In carrying out these public meetings, FDA is required to prioritize topics necessary to inform the guidances described in section 582(h)(3) and (h)(4) related to unit-level tracing and standards for the interoperable data exchanges, respectively, and to take all reasonable and practicable measures to ensure the protection of confidential commercial information and trade secrets. FDA is also required to address each of the eight topics enumerated in section 582(i)(2) in at least one of the five required public meetings. FDA will hold a public meeting on October 14, 2016, to provide members of the pharmaceutical distribution supply chain and other interested stakeholders an opportunity to share information about current practices and industry efforts to implement the DSCSA's product identification requirements, including the use of product identifiers. The format of the meeting involves presentations from the public and followup questions from an FDA panel. FDA will not be inviting specific presenters; rather, with this notice, FDA is soliciting presentations from interested stakeholders. II. Topics for This Public Meeting The main topic FDA is interested in discussing at the public meeting is the supply chain's progress toward implementing the DSCSA's product identification requirements, including best practices in each sector of the pharmaceutical distribution supply chain to conduct product tracing, verification, and product identification. This may include the processes needed to utilize the product identifiers to [[Page 64177]] enhance tracing of product at the package level, including allowing for verification, aggregation, and inference, as necessary. (The product identifier is a standardized graphic that includes, in both human- and machine-readable forms, the National Drug Code, serial number, lot number, and expiration date of the product.) Under section 582(b)(2) and (e)(2) of the FD&C Act, manufacturers and repackagers must affix or imprint a product identifier to each package and homogenous case of a product intended to be introduced in a transaction into commerce, by November 2017 and November 2018, respectively. Other topics of interest to FDA that may be presented at the public meeting include, but are not limited to: An assessment of the steps taken by supply chain members to build capacity for a unit-level system for electronic product tracing, including the impact on (1) the ability of the health care system to maintain patient access to medicines; (2) the scalability of such requirements, including as it relates to product lines; and (3) the capability of different sectors and subsectors, including both large and small businesses, to affix and utilize the product identifier; and information related to the secure, interoperable electronic data exchange among sectors within the pharmaceutical distribution supply chain. FDA will post the agenda of the meeting at http://www.fda.gov/Drugs/NewsEvents/ucm519587.htm. III. Registration Registration to attend is free and will be on a first-come, first- served basis. To register for the meeting either: (1) Email your registration information to [email protected], or (2) mail your registration information to the contact person (see FOR FURTHER INFORMATION CONTACT). Registration information should include: ``Registration for October 14, 2016, DSCSA meeting'' in the subject line, and Registrant name, company or organization, address, phone number, and email address in the body of your email or mailing. Registration requests should be received by October 6, 2016. Onsite registration on the day of the meeting, starting at 8 a.m., will be based on space availability. Seating will be limited; therefore, if registration meets the maximum capacity, FDA will post a notice closing meeting registration for the meeting on FDA's Web site at: http://www.fda.gov/Drugs/NewsEvents/ucm519587.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. IV. Requests for Oral Presentations Any person interested in presenting at the public meeting should include a request to present in a single email with a registration request (see section III. Registration). The request should specify the topic(s) that will be addressed in the presentation. FDA will do its best to accommodate requests for oral presentations. Individuals and organizations with common interests are encouraged to consolidate or coordinate their presentations and can submit a single request to present. All requests to make oral presentations must be received by October 5, 2016. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled public comment session, FDA may conduct a lottery to determine the speakers for the public comment session. The contact person will notify interested persons regarding their request to speak by October 7, 2016. Presenters must email their presentation materials, if any, to [email protected] no later than October 12, 2016. This meeting is not intended to be a venue for circulation of product- specific promotional material, but rather an opportunity to gather information related to stakeholder progress towards implementing the product identification requirements of the DSCSA. V. Webcasting of the Public Meeting Portions of this public meeting will be recorded and Webcast on the day of the meeting. Information for how to access the Webcast will be available at http://www.fda.gov/Drugs/NewsEvents/ucm519587.htm by October 14, 2016. The Webcast will be conducted in listening mode only. Dated: September 13, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-22441 Filed 9-16-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 181 / Monday, September 19, 2016 / Notices 64175
Book.1 The language for enhanced K. Enhancements to User Fee Revenue industry). We will also provide an
capacity is included in section III of the Amounts and Adjustments opportunity for other organizations and
proposed BsUFA II commitment letter. FDA and industry agreed that the individuals to make presentations at the
BsUFA II user fee revenue amounts and meeting or to submit written comments
I. Enhancing Management of User Fee to the docket before the meeting.
Resources fee amounts should be independent of
PDUFA and based on BsUFA program FDA will also hold an open public
FDA is committed to enhancing costs. FDA proposes to establish fees to comment period at the meeting to give
management of BsUFA resources and generate a total of $45 million in user the public an opportunity to present
ensuring BsUFA user fee resources are fee revenue for FY 2018. However, FDA their comments. Registration for open
administered, allocated, and reported in also proposes that it can adjust this public comment will occur at the
an efficient and transparent manner. In amount when setting the user fee registration desk on the day of the
BsUFA II, FDA proposes to establish a amounts published in the FY 2018 meeting and workshop on a first-come,
resource capacity planning function to Federal Register notice to reflect an first-served basis.
Transcripts: As soon as a transcript is
improve its ability to analyze current updated assessment of the BsUFA
available, FDA will post it at http://
resource needs and project future workload, with the limitation that this
www.fda.gov/ForIndustry/UserFees/
resource needs, to modernize its time adjustment cannot increase user fee
BiosimilarUserFeeActBsUFA/
reporting approach, to conduct an revenue by more than $9 million (i.e.
ucm461774.htm.
evaluation of BsUFA program resource relative to the $45 million specified for
management, to publish a 5-year BsUFA FY 2018 user fee revenue). To enhance Dated: September 13, 2016.
financial plan with annual updates, and the predictability of user fee amounts, Leslie Kux,
to convene an annual public meeting, FDA proposes that the amount for each Associate Commissioner for Policy.
beginning in FY 2019, to discuss the BsUFA fee cannot increase more than 25 [FR Doc. 2016–22442 Filed 9–16–16; 8:45 am]
financial plan and progress towards the percent from the respective FY2018 fee BILLING CODE 4164–01–P
financial management enhancements. amount until the capacity planning
FDA also proposes to reduce the adjustment is effective and that FDA can
carryover balance to no greater than 21 otherwise modify the amount of the user DEPARTMENT OF HEALTH AND
weeks of the FY 2022 target revenue by fee revenue generated from each fee HUMAN SERVICES
the end of FY 2022. These type each fiscal year. FDA proposes to
enhancements are described in section adjust the annual user fee revenue Food and Drug Administration
IV of the proposed BsUFA II amount for inflation, to develop a robust [Docket No. FDA–2016–N–2673]
commitment letter. methodology for adjusting fees based on
the capacity needs of the program, and Progress Toward Implementing the
J. Enhancements to Fee Structure and to introduce an annual operating reserve Product Identification Requirements of
Related Mechanisms for Increased adjustment to provide for adequate the Drug Supply Chain Security Act;
Predictability, Stability, and Efficiency carryover resources. Public Meeting; Request for Comments
The current BsUFA fee structure IV. Purpose and Scope of the Meeting AGENCY: Food and Drug Administration,
references PDUFA fees each fiscal year HHS.
If you wish to attend this meeting,
and calculates biosimilar biological
visit http:// ACTION: Notice of public meeting;
product development program (BPD)
bsufapublicmeeting.eventbrite.com. request for comments.
fees based on the PDUFA application
Please register by October 19, 2016. If
fee. FDA and industry agreed that the SUMMARY: The Food and Drug
you are unable to attend the meeting in
BsUFA II fee structure and the fee Administration (FDA) is announcing a
person, you can register to view a live
setting process could be updated to public meeting entitled ‘‘Progress
Webcast of the meeting. You will be
enhance the predictability and stability Toward Implementing the Product
asked to indicate in your registration if
of fee amounts and revenues in a Identification Requirements of the Drug
you plan to attend in person or via the
manner to improve FDA’s ability to Supply Chain Security Act.’’ This
Webcast. Seating will be limited, so
engage in long-term financial planning. public meeting is intended to provide
early registration is recommended.
To address these issues, FDA proposes members of the pharmaceutical
Registration is free and will be on a first-
to discontinue the reduction of the distribution supply chain and other
come, first-served basis. However, FDA
biosimilar biological product interested stakeholders an opportunity
may limit the number of participants
application fee by the cumulative BPD to share information with FDA about the
from each organization based on space
fees paid by sponsors, to discontinue efforts underway to implement the Drug
limitations. Registrants will receive
the establishment and supplement fees, Supply Chain Security Act’s (DSCSA’s)
confirmation once they have been
to rename the product fee as the BsUFA product identification requirements,
accepted. Onsite registration on the day
Program fee, to modify the Program fee including the use of product identifiers
of the meeting will be based on space
billing date to minimize the need for to enhance tracing at the product level.
availability. If you need special
multiple billing cycles, and to add a DATES: The public meeting will be held
accommodations because of a disability,
limitation that a sponsor shall not be on October 14, 2016, from 9 a.m. to 4
please contact Amanda Roache (see FOR
assessed more than five BsUFA Program p.m. To permit the widest possible
FURTHER INFORMATION CONTACT) at least 7
fees for a fiscal year for products opportunity to obtain public comment,
days before the meeting.
mstockstill on DSK3G9T082PROD with NOTICES
identified in each distinct approved FDA is soliciting either electronic or
The meeting will include a
biosimilar biological product written comments on all aspects of the
presentation by FDA and a series of
application held by that sponsor. public meeting topics. The deadline for
invited panels representing different
stakeholder groups identified in the submitting comments related to this
1 The ‘‘Purple Book’’ lists biological products,
statute (such as patient advocacy public meeting is November 14, 2016.
including any interchangeable biological products,
licensed by FDA under the Public Health Service groups, consumer advocacy groups, ADDRESSES: The public meeting will be
Act. health professionals, and regulated held at FDA’s White Oak Campus,
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![Federal Register / Vol. 81, No. 181 / Monday, September 19, 2016 / Notices 64177
enhance tracing of product at the If you need special accommodations DEPARTMENT OF HEALTH AND
package level, including allowing for due to a disability, please contact Daniel HUMAN SERVICES
verification, aggregation, and inference, Bellingham (see FOR FURTHER
as necessary. (The product identifier is INFORMATION CONTACT) at least 7 days in Food and Drug Administration
a standardized graphic that includes, in advance of the public meeting. [Docket No. FDA–2016–N–2610]
both human- and machine-readable
forms, the National Drug Code, serial IV. Requests for Oral Presentations A List of Biomarkers Used as
number, lot number, and expiration date Outcomes in Development of FDA-
Any person interested in presenting at
of the product.) Under section 582(b)(2) Approved New Molecular Entities and
the public meeting should include a
and (e)(2) of the FD&C Act, New Biological Therapeutics (October
manufacturers and repackagers must request to present in a single email with
a registration request (see section III. 2007 to December 2015);
affix or imprint a product identifier to Establishment of a Public Docket
each package and homogenous case of a Registration). The request should
product intended to be introduced in a specify the topic(s) that will be AGENCY: Food and Drug Administration,
transaction into commerce, by addressed in the presentation. FDA will HHS.
November 2017 and November 2018, do its best to accommodate requests for ACTION: Notice; establishment of docket;
respectively. oral presentations. Individuals and request for comments.
Other topics of interest to FDA that organizations with common interests are
may be presented at the public meeting encouraged to consolidate or coordinate SUMMARY: The Food and Drug
include, but are not limited to: their presentations and can submit a Administration (FDA or Agency) is
• An assessment of the steps taken by single request to present. announcing the establishment of a
supply chain members to build capacity docket to receive suggestions,
All requests to make oral recommendations, and comments from
for a unit-level system for electronic
presentations must be received by interested parties (such as academic
product tracing, including the impact on
October 5, 2016. Time allotted for each researchers, regulated industries,
(1) the ability of the health care system
to maintain patient access to medicines; presentation may be limited. If the consortia, and patient groups) on a list
(2) the scalability of such requirements, number of registrants requesting to of biomarkers that were used as
including as it relates to product lines; speak is greater than can be reasonably outcomes to develop FDA-approved
and (3) the capability of different sectors accommodated during the scheduled new molecular entities (NMEs) and New
and subsectors, including both large and public comment session, FDA may Biological Therapeutics from October
small businesses, to affix and utilize the conduct a lottery to determine the 2007 to December 2015. Comments
product identifier; and speakers for the public comment received on this list will help FDA
• information related to the secure, session. The contact person will notify determine the utility of the list and may
interoperable electronic data exchange interested persons regarding their assist FDA in developing databases on
among sectors within the request to speak by October 7, 2016. biomarkers for drug development in the
pharmaceutical distribution supply Presenters must email their presentation future.
chain. materials, if any, to DATES: Submit either electronic or
FDA will post the agenda of the CDERODSIRPublicMeetings@ written comments by November 18,
meeting at http://www.fda.gov/Drugs/ fda.hhs.gov no later than October 12, 2016.
NewsEvents/ucm519587.htm. 2016. This meeting is not intended to be ADDRESSES: You may submit comments
III. Registration a venue for circulation of product- as follows:
Registration to attend is free and will specific promotional material, but rather
an opportunity to gather information Electronic Submissions
be on a first-come, first-served basis. To
register for the meeting either: (1) Email related to stakeholder progress towards Submit electronic comments in the
your registration information to implementing the product identification following way:
CDERODSIRPublicMeetings@ requirements of the DSCSA. • Federal eRulemaking Portal: http://
fda.hhs.gov, or (2) mail your registration www.regulations.gov. Follow the
V. Webcasting of the Public Meeting instructions for submitting comments.
information to the contact person (see
FOR FURTHER INFORMATION CONTACT). Portions of this public meeting will be Comments submitted electronically,
Registration information should recorded and Webcast on the day of the including attachments, to http://
include: meeting. Information for how to access www.regulations.gov will be posted to
• ‘‘Registration for October 14, 2016, the Webcast will be available at http:// the docket unchanged. Because your
DSCSA meeting’’ in the subject line, and www.fda.gov/Drugs/NewsEvents/ comment will be made public, you are
• Registrant name, company or ucm519587.htm by October 14, 2016.
solely responsible for ensuring that your
organization, address, phone number, comment does not include any
The Webcast will be conducted in
and email address in the body of your confidential information that you or a
listening mode only. third party may not wish to be posted,
email or mailing.
Registration requests should be Dated: September 13, 2016. such as medical information, your or
received by October 6, 2016. Onsite Leslie Kux, anyone else’s Social Security number, or
registration on the day of the meeting, Associate Commissioner for Policy. confidential business information, such
starting at 8 a.m., will be based on space as a manufacturing process. Please note
mstockstill on DSK3G9T082PROD with NOTICES
[FR Doc. 2016–22441 Filed 9–16–16; 8:45 am]
availability. Seating will be limited; that if you include your name, contact
BILLING CODE 4164–01–P
therefore, if registration meets the information, or other information that
maximum capacity, FDA will post a identifies you in the body of your
notice closing meeting registration for comments, that information will be
the meeting on FDA’s Web site at: posted on http://www.regulations.gov.
http://www.fda.gov/Drugs/NewsEvents/ • If you want to submit a comment
ucm519587.htm. with confidential information that you
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Document Created: 2016-09-17 02:29:40
Document Modified: 2016-09-17 02:29:40
| 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 meeting; request for comments. | |
| Dates | The public meeting will be held on October 14, 2016, from 9 a.m. to 4 p.m. 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. The deadline for submitting comments related to this public meeting is November 14, 2016. | |
| Contact | Daniel Bellingham, Office of Compliance, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 4285, Silver Spring, MD 20993, 301-796-3130, FAX: 301-847-8722, email: [email protected] | |
| FR Citation | 81 FR 64175 |
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