82 FR 45863 - Leveraging Quantitative Methods and Modeling To Modernize Generic Drug Development and Review; Public Workshop; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 189 (October 2, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 189 (October 2, 2017)
| Page Range | 45863-45865 | |
| FR Document | 2017-21017 |
[Federal Register Volume 82, Number 189 (Monday, October 2, 2017)] [Notices] [Pages 45863-45865] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-21017] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-5442] Leveraging Quantitative Methods and Modeling To Modernize Generic Drug Development and Review; 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, the Agency, or we) is announcing the following public workshop entitled ``Leveraging Quantitative Methods and Modeling to Modernize Generic Drug Development and Review.'' The purpose of the public workshop is to engage stakeholders in a discussion of current and emerging scientific approaches and applications for the conduct of quantitative modeling and simulations in generic drug development, especially for complex and locally acting products, and to gain input regarding opportunities and knowledge gaps related to the use of quantitative modeling and simulation to inform regulatory decision making through the product lifecycle. FDA will use the information gained through the workshop to support product-specific guidance development, improve pre-abbreviated new drug applications (ANDA) interactions with applicants, increase the quality and efficiency of regulatory reviews, and identify a next generation modeling and simulation toolset for complex and locally acting products. DATES: The public workshop will be held on October 2 and 3, 2017, from 8:30 a.m. to 4:30 p.m. Submit either electronic or written comments on this public workshop by November 3, 2017. 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, Great Room, Silver Spring, MD 20993. Entrance for the 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 https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm. You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before November 3, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of November 3, 2017. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. 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-5442 for ``Leveraging Quantitative Methods and Modeling to Modernize Generic Drug Development and Review.'' 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 [[Page 45864]] ``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: Lanyan (Lucy) Fang, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4686, Silver Spring, MD 20993, 301-796- 5005, email: [email protected]; or Liang Zhao, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4702, Silver Spring, MD 20993, 240-402- 4468, email: [email protected]. SUPPLEMENTARY INFORMATION: I. Background To enhance dialogue regarding modeling and simulation and communication of recent advances in modeling and simulation, including those supported by the Generic Drug User Fee Amendments regulatory science research program, FDA plans to hold a public workshop to (1) engage stakeholders in a discussion of current and emerging scientific approaches and applications for the conduct of quantitative modeling and simulations in generic drug development, especially for complex and locally acting products, and (2) gain input regarding opportunities and knowledge gaps related to the use of quantitative modeling and simulation to inform regulatory decision making through the product lifecycle. Modeling and simulation has been increasingly used in drug development, providing a framework for synthesizing information and extrapolating beyond what has been studied. Model-informed drug development (MIDD) approaches can be applied to brand drug products approved pursuant to a new drug application (NDA), and generic drug products approved pursuant to an ANDA. MIDD holds particular promise in key opportunity areas including pharmacokinetic/pharmacodynamics (PK/ PD) models, physiologically based pharmacokinetic (PBPK) or absorption models, systems pharmacology, quantitative risk modeling, and emergent machine learning tools. These application areas can leverage the large pharmaceutical data sets (big data) available to FDA and other organizations. Quantitative approaches have been used to address significant scientific and regulatory issues in all phases of the product lifecycle: from pre-investigational new drug applications through NDAs, ANDAs, and post-approval evaluation of new and generic drugs. Given the broad applications of modeling and simulation through the entire lifecycle of a product, there is a need to identify best practices to improve the routine use and acceptance of modeling and simulation for regulatory decision making. The purposes of the workshop are to: (1) Engage global stakeholders and share experience and vision on using quantitative approaches in regulatory decision making for generic drug development and product lifecycle management; (2) Identify and prioritize potential areas for global harmonization for tools to inform regulatory decision making; (3) Share the current state of knowledge and practice in utilizing quantitative methods and modeling for generic drug development and review by case demonstrations and by integrating experience and lessons learned from new drug product development and reviews; (4) Identify opportunities for complex and locally acting product development and discuss approaches and principles in using quantitative methods and modeling to aid product-specific guidance development, pre- ANDA interactions between FDA and prospective applicants, ANDA reviews, and postmarket performance monitoring; and (5) Discuss next generation quantitative method and modeling toolsets, future directions, and application areas beyond currently available tools. There is a paradigm shift to a risk-based product-specific regulatory approach for generic drugs. Examples of this transition include recommendations for partial AUC (area under the concentration- time curve) for some modified release drugs and replicate study bioequivalence (BE) recommendations for narrow therapeutic index (NTI) drugs. These product-specific guidances are driven by the therapeutic significance of either the exposure-response relationships for safety and efficacy (NTI drugs) or the difference in the shape of PK profiles. Modeling and simulation toolsets direct the design and evaluation of PK or comparative clinical endpoint BE studies, help evaluate clinical endpoint sensitivity and feasibility, and enable the assessment of alternative BE approaches. Overall, quantitative methods and modeling support better and faster decisions during the generic drug development and review process because they integrate knowledge accumulated during and after new drug product development, including in vitro in vivo correlation for formulation design, absorption, distribution, metabolism, and excretion properties, population PK, and exposure- response relationships for efficacy and safety. There is also a growing recognition that analysis of large datasets helps organizations and individuals make better decisions. Emerging methodologies that enable the Agency to take advantage of big data will impact how generic drugs are developed, reviewed, and monitored. Knowledge extracted from large datasets can provide FDA the opportunity to improve the focus of regulatory review, modernize BE assessment criteria, and efficiently manage workload by predicting future ANDA applications. Further, such knowledge will support industry's efforts to optimize their generic drug portfolios to meet upcoming patient and market needs. The public workshop will focus on the use and advance of quantitative methods and modeling in modernizing generic drug development, regulatory review, and product lifecycle management. II. Scope of Public Input Requested FDA seeks input on a range of topics related to the conduct of modeling and simulation by pharmaceutical industries and by FDA and on the interpretation and use of simulations for risk-based regulatory assessment. They include: (1) Opportunity areas for model-informed generic drug development and review (2) Risk-based BE standard for complex and locally acting products: a. Under what circumstances would alternative approaches to the product-specific BE guidances be encouraged? b. What can serve as evidentiary data when proposing alternative BE approaches? c. What are the scientific and regulatory challenges in using a model-based BE approach? (3) Emerging quantitative methods and modeling in assisting regulatory decision making for drug development and product life cycle management: a. What are the areas (e.g., excipient selection, molecular target/ mechanism of action-safety profile association, universal exposure response models for drugs with the same target) that can benefit most in the big data era and what will be the regulatory impact and implications? b. What are the potential new methods, including but not limited to, machine learning and their application areas in assisting drug development and review? (4) Post-approval evaluation of the substitutability of generic products for [[Page 45865]] the corresponding reference listed drugs or reference standards: a. How to effectively integrate systems pharmacology, PBPK, and the exposure-clinical response relationship to evaluate product risk and assist BE evaluation? b. What will be the next generation methodologies in postmarket signal detection to evaluate product substitution or compare product performance using the Sentinel database or complementary toolsets? III. Participating in the Public Workshop Registration: Persons interested in attending this public workshop must register online at https://survey.co1.qualtrics.com/jfe/form/SV_3eiJOCsnrPdTZU9. Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone. Registration is free and based on space availability, with priority given to early registrants. Persons interested in attending this public workshop must register by September 25, 2017, midnight, Eastern Standard Time. Early registration is recommended because seating is limited; therefore, FDA may limit the number of participants from each organization. If you need special accommodations due to a disability, please contact Lanyan (Lucy) Fang (see FOR FURTHER INFORMATION CONTACT) no later than 7 days before the workshop. Requests for Oral Presentations: During online registration you may indicate if you wish to present during a public comment session, and which topic(s) you wish to address. We will do our best to accommodate requests to make public comments. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations, and to request time for a joint presentation, or to submit requests for designated representatives to participate in the focused sessions. Following the close of registration, we will determine the amount of time allotted to each presenter and the approximate time each oral presentation is to begin, and will select and notify participants by September 27, 2017. All requests to make oral presentations must be received by the close of registration on September 25, 2017. If selected for presentation, any presentation materials must be emailed to Lanyan (Lucy) Fang (see FOR FURTHER INFORMATION CONTACT) no later than September 28, 2017. No commercial or promotional material will be permitted to be presented or distributed at the public workshop. Streaming Webcast of the Public Workshop: This public workshop will also be webcast. A live webcast of this workshop will be viewable at https://collaboration.fda.gov/dqmm1017/on the day of the workshop. If you have never attended a Connect Pro event before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program, visit https://www.adobe.com/go/connectpro_overview. FDA has verified the Web site addresses in this document, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time. Transcripts: Please be advised that as soon as a transcript of the public workshop is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff (see ADDRESSES). A link to the transcript will also be available on the internet at http://www.fda.gov/Drugs/NewsEvents/ucm554182.htm. Dated: September 26, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-21017 Filed 9-29-17; 8:45 am] BILLING CODE 4164-01-P
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IV. Paperwork Reduction Act of 1995 public workshop by November 3, 2017. • Mail/Hand delivery/Courier (for
This guidance refers to previously See the SUPPLEMENTARY INFORMATION written/paper submissions): Dockets
approved collections of information section for registration date and Management Staff (HFA–305), Food and
found in FDA regulations. These information. Drug Administration, 5630 Fishers
collections of information are subject to ADDRESSES: The public workshop will Lane, Rm. 1061, Rockville, MD 20852.
review by the Office of Management and • For written/paper comments
be held at FDA’s White Oak Campus,
Budget (OMB) under the Paperwork submitted to the Dockets Management
10903 New Hampshire Ave., Bldg. 31,
Reduction Act of 1995 (44 U.S.C. 3501– Staff, FDA will post your comment, as
Great Room, Silver Spring, MD 20993. well as any attachments, except for
3520). The collections of information in Entrance for the public workshop
21 CFR parts 1002, 1010, and 1040 are information submitted, marked and
participants (non-FDA employees) is identified, as confidential, if submitted
approved under OMB control number through Building 1 where routine
0910–0025. as detailed in ‘‘Instructions.’’
security check procedures will be Instructions: All submissions received
Dated: September 22, 2017. performed. For parking and security must include the Docket No. FDA–
Leslie Kux, information, please refer to https://www. 2017–N–5442 for ‘‘Leveraging
Associate Commissioner for Policy. fda.gov/AboutFDA/WorkingatFDA/ Quantitative Methods and Modeling to
[FR Doc. 2017–21079 Filed 9–29–17; 8:45 am]
BuildingsandFacilities/WhiteOak Modernize Generic Drug Development
BILLING CODE 4164–01–P
CampusInformation/ucm241740.htm. and Review.’’ Received comments, those
You may submit comments as filed in a timely manner (see
follows. Please note that late, untimely ADDRESSES), will be placed in the docket
DEPARTMENT OF HEALTH AND filed comments will not be considered. and, except for those submitted as
HUMAN SERVICES Electronic comments must be submitted ‘‘Confidential Submissions,’’ publicly
on or before November 3, 2017. The viewable at https://www.regulations.gov
Food and Drug Administration https://www.regulations.gov electronic or at the Dockets Management Staff
filing system will accept comments between 9 a.m. and 4 p.m., Monday
[Docket No. FDA–2017–N–5442]
until midnight Eastern Time at the end through Friday.
Leveraging Quantitative Methods and of November 3, 2017. Comments • Confidential Submissions—To
Modeling To Modernize Generic Drug received by mail/hand delivery/courier submit a comment with confidential
Development and Review; Public (for written/paper submissions) will be information that you do not wish to be
Workshop; Request for Comments considered timely if they are made publicly available, submit your
postmarked or the delivery service comments only as a written/paper
AGENCY: Food and Drug Administration, acceptance receipt is on or before that submission. You should submit two
HHS. date. copies total. One copy will include the
ACTION: Notice of public workshop; information you claim to be confidential
request for comments. Electronic Submissions
with a heading or cover note that states
Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS
SUMMARY: The Food and Drug following way: CONFIDENTIAL INFORMATION.’’ The
Administration (FDA, the Agency, or • Federal eRulemaking Portal: Agency will review this copy, including
we) is announcing the following public https://www.regulations.gov. Follow the the claimed confidential information, in
workshop entitled ‘‘Leveraging instructions for submitting comments. its consideration of comments. The
Quantitative Methods and Modeling to Comments submitted electronically, second copy, which will have the
Modernize Generic Drug Development including attachments, to https:// claimed confidential information
and Review.’’ The purpose of the public www.regulations.gov will be posted to redacted/blacked out, will be available
workshop is to engage stakeholders in a the docket unchanged. Because your for public viewing and posted on
discussion of current and emerging comment will be made public, you are https://www.regulations.gov. Submit
scientific approaches and applications solely responsible for ensuring that your both copies to the Dockets Management
for the conduct of quantitative modeling comment does not include any Staff. If you do not wish your name and
and simulations in generic drug confidential information that you or a contact information to be made publicly
development, especially for complex third party may not wish to be posted, available, you can provide this
and locally acting products, and to gain such as medical information, your or information on the cover sheet and not
input regarding opportunities and anyone else’s Social Security number, or in the body of your comments and you
knowledge gaps related to the use of confidential business information, such must identify this information as
quantitative modeling and simulation to as a manufacturing process. Please note ‘‘confidential.’’ Any information marked
inform regulatory decision making that if you include your name, contact as ‘‘confidential’’ will not be disclosed
through the product lifecycle. FDA will information, or other information that except in accordance with 21 CFR 10.20
use the information gained through the identifies you in the body of your and other applicable disclosure law. For
workshop to support product-specific comments, that information will be more information about FDA’s posting
guidance development, improve pre- posted on https://www.regulations.gov. of comments to public dockets, see 80
abbreviated new drug applications • If you want to submit a comment FR 56469, September 18, 2015, or access
(ANDA) interactions with applicants, with confidential information that you the information at: https://www.gpo.gov/
increase the quality and efficiency of do not wish to be made available to the fdsys/pkg/FR-2015-09-18/pdf/2015-
regulatory reviews, and identify a next
sradovich on DSK3GMQ082PROD with NOTICES
public, submit the comment as a 23389.pdf.
generation modeling and simulation written/paper submission and in the Docket: For access to the docket to
toolset for complex and locally acting manner detailed (see ‘‘Written/Paper read background documents or the
products. Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments
DATES: The public workshop will be received, go to https://
held on October 2 and 3, 2017, from Written/Paper Submissions www.regulations.gov and insert the
8:30 a.m. to 4:30 p.m. Submit either Submit written/paper submissions as docket number, found in brackets in the
electronic or written comments on this follows: heading of this document, into the
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![Federal Register / Vol. 82, No. 189 / Monday, October 2, 2017 / Notices 45865
the corresponding reference listed drugs Streaming Webcast of the Public ADDRESSES: Requests for copies of the
or reference standards: Workshop: This public workshop will patent application, inquiries, and
a. How to effectively integrate systems also be webcast. A live webcast of this comments relating to the contemplated
pharmacology, PBPK, and the exposure- workshop will be viewable at https:// modification of the Exclusive Patent
clinical response relationship to collaboration.fda.gov/dqmm1017/on the License should be directed to Martha
evaluate product risk and assist BE day of the workshop. Lubet, Ph.D., Technology Transfer
evaluation? If you have never attended a Connect Manager, NCI TTC, 9609 Medical Center
b. What will be the next generation Pro event before, test your connection at Drive, Room IE350, MSC 9702,
methodologies in postmarket signal https://collaboration.fda.gov/common/ Rockville, MD 20850. Telephone: 240
detection to evaluate product help/en/support/meeting_test.htm. To 276–5508. Facsimile: 240 276–5505.
substitution or compare product get a quick overview of the Connect Pro Email: lubetm@mail.nih.gov.
performance using the Sentinel database program, visit https://www.adobe.com/ SUPPLEMENTARY INFORMATION: The
or complementary toolsets? go/connectpro_overview. FDA has following represents the intellectual
III. Participating in the Public verified the Web site addresses in this property to be licensed under the
Workshop document, as of the date this document prospective agreement:
publishes in the Federal Register, but U.S. provisional application 61/
Registration: Persons interested in
attending this public workshop must Web sites are subject to change over 774,878, filed March 8, 2013 entitled
register online at https://survey.co1. time. ‘‘Potent and Selective Inhibitors of
qualtrics.com/jfe/form/SV_3eiJOCsnr Transcripts: Please be advised that as Monamine Transporters; Methods of
PdTZU9. Please provide complete soon as a transcript of the public Making; and Uses Thereof’’ [HHS Ref.
contact information for each attendee, workshop is available, it will be No. E–073–2013/0–US–01];
including name, title, affiliation, accessible at https:// PCT application PCT/US2014/021514,
address, email, and telephone. www.regulations.gov. It may be viewed filed March 7, 2014 entitled ‘‘Potent and
Registration is free and based on at the Dockets Management Staff (see Selective Analogues of: Monamine
space availability, with priority given to ADDRESSES). A link to the transcript will Transporters; Methods of Making; and
early registrants. Persons interested in also be available on the internet at Uses Thereof’’ [HHS Ref. No. E–073–
attending this public workshop must http://www.fda.gov/Drugs/NewsEvents/ 2013/0–PCT–02];
register by September 25, 2017, ucm554182.htm. U.S. application 14/772,486, filed
midnight, Eastern Standard Time. Early Dated: September 26, 2017. September 3, 2015 entitled ‘‘Potent and
registration is recommended because Anna K. Abram, Selective Analogues of Monamine
seating is limited; therefore, FDA may Transporters; Methods of Making; and
Deputy Commissioner for Policy, Planning,
limit the number of participants from Legislation, and Analysis. Uses Thereof’’ [HHS Ref. No. E–073–
each organization. 2013/0–US–06];
[FR Doc. 2017–21017 Filed 9–29–17; 8:45 am]
If you need special accommodations EPO application 14714043.8, filed
BILLING CODE 4164–01–P
due to a disability, please contact September 1, 2015 entitled ‘‘Potent and
Lanyan (Lucy) Fang (see FOR FURTHER Selective Analogues of Monamine
INFORMATION CONTACT) no later than 7 DEPARTMENT OF HEALTH AND Transporters; Methods of Making; and
days before the workshop. HUMAN SERVICES Uses Thereof’’ [HHS Ref. No. E–073–
Requests for Oral Presentations: 2013/0–EP–05];
During online registration you may National Institutes of Health Australian application 2014225550,
indicate if you wish to present during a filed September 8, 2015 entitled ‘‘Potent
public comment session, and which Prospective Modification of Exclusive and Selective Analogues of Monamine
topic(s) you wish to address. We will do Patent License Potent and Selective Transporters; Methods of Making; and
our best to accommodate requests to Analogues of: Monamine Transporters; Uses Thereof’’ [HHS Ref. No. E–073–
make public comments. Individuals and Methods of Making; and Uses Thereof 2013/0–AU–03];
organizations with common interests are Australian application 2017202849,
urged to consolidate or coordinate their AGENCY: National Institutes of Health, filed April 28, 2017 entitled Potent and
presentations, and to request time for a HHS. Selective Analogues of Monamine
joint presentation, or to submit requests ACTION: Notice. Transporters; Methods of Making; and
for designated representatives to Uses Thereof’’ [HHS Ref. No. E–073–
participate in the focused sessions. SUMMARY: The National Institute of Drug 2013/0–AU–07];
Following the close of registration, we Abuse, an institute of the National Canadian application 2903746, filed
will determine the amount of time Institutes of Health, Department of September 2, 2015 entitled ‘‘Potent and
allotted to each presenter and the Health and Human Services is Selective Analogues of Monamine
approximate time each oral presentation contemplating the modification of grant Transporters; Methods of Making; and
is to begin, and will select and notify of an Exclusive Patent License to Uses Thereof’’ [HHS Ref. No. E–073–
participants by September 27, 2017. All EncepHeal Therapeutics, Inc., located in 2013/0–CA–04];
requests to make oral presentations Winston-Salem, North Carolina, to The patent rights to these inventions
must be received by the close of practice the inventions embodied in the have been assigned to and/or
registration on September 25, 2017. If patent applications listed in the exclusively licensed to the Government
selected for presentation, any Supplementary Information section of of the United States of America.
sradovich on DSK3GMQ082PROD with NOTICES
presentation materials must be emailed this notice. The Government previously
to Lanyan (Lucy) Fang (see FOR FURTHER DATES: Only written comments and/or announced its intention to grant an
INFORMATION CONTACT) no later than applications for a license which are exclusive license to EncepHeal at FR
September 28, 2017. No commercial or received by the National Institute on 80:245 (December 22, 2015), pp. 79595–
promotional material will be permitted Drug Abuse’s Technology Transfer 79596.
to be presented or distributed at the Office on or before October 17, 2017 The Notice of Intent to Grant (NOITG)
public workshop. will be considered. specified a Field of Use as ‘‘Use of
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Document Created: 2017-09-30 04:40:57
Document Modified: 2017-09-30 04:40:57
| 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 October 2 and 3, 2017, from 8:30 a.m. to 4:30 p.m. Submit either electronic or written comments on this public workshop by November 3, 2017. See the SUPPLEMENTARY INFORMATION section for registration date and information. | |
| Contact | Lanyan (Lucy) Fang, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4686, Silver Spring, MD 20993, 301-796- 5005, email: [email protected]; or Liang Zhao, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4702, Silver Spring, MD 20993, 240-402- 4468, email: [email protected] | |
| FR Citation | 82 FR 45863 |
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