82 FR 58816 - Patient-Focused Drug Development: Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data; Public Workshop; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 239 (December 14, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 239 (December 14, 2017)
| Page Range | 58816-58817 | |
| FR Document | 2017-26978 |
[Federal Register Volume 82, Number 239 (Thursday, December 14, 2017)] [Notices] [Pages 58816-58817] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-26978] [[Page 58816]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-6312] Patient-Focused Drug Development: Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data; Public Workshop; Request for Comments AGENCY: Food and Drug Administration, HHS.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 or Agency) is announcing the following public workshop entitled ``Patient-Focused Drug Development: Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data.'' The purpose of the public workshop is to convene a discussion on how a person seeking to develop and submit proposed draft guidance relating to patient experience data for consideration by FDA may submit such proposed draft guidance to the Agency. This workshop will inform development of patient-focused drug development guidance as required by the 21st Century Cures Act (Cures Act). FDA plans to publish a background document approximately 2 weeks before the workshop date. DATES: The public workshop will be held on March 19, 2018, from 1 p.m. to 5 p.m. Submit either electronic or written comments on this public workshop by May 18, 2018. See the SUPPLEMENTARY INFORMATION section for additional registration 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. 1503), 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. Workshop updates, agenda, and background document will be made available at https://www.fda.gov/Drugs/NewsEvents/ucm582081.htm prior to the workshop. 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 May 18, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of May 18, 2018. 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-6312 for ``Patient-Focused Drug Development: Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data.'' 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: Meghana Chalasani, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1146, Silver Spring, MD 20993-0002, 240- 402-6525, Fax: 301-847-8443, Meghana.Chalasani@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background This public workshop is intended to support FDA implementation of requirements for guidance development under section 3002 of the Cures Act (Pub. L. 114-255). Section 3002 of Title III, Subtitle A, of the Cures Act directs [[Page 58817]] FDA to develop patient-focused drug development guidance to address a number of areas, including how a person seeking to develop and submit a proposed draft guidance relating to patient experience data for consideration by FDA may submit such proposed draft guidances. In FDA's ``Plan for Issuance of Patient-Focused Drug Development Guidance,'' (the Plan) available at https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM563618.pdf, the Agency proposed issuing a guidance addressing this topic described in section 3002 during the second quarter of 2018. FDA recognizes that, like the other patient-focused drug development guidances described in the Plan, developing this draft guidance will also benefit from public input from the wider community of patients, patient advocates, academic researchers, expert practitioners, drug developers, and other stakeholders prior to FDA's drafting of the guidance. Accordingly, the Agency is scheduling this public workshop. After this public workshop, FDA will take into consideration the stakeholder input from the workshop and the public docket, and publish a draft guidance by the end of fiscal year 2018. II. Purpose and Scope of Meeting FDA is announcing a public workshop to convene a discussion on topics related to developing and submitting proposed draft guidance relating to patient experience data by an external stakeholder. The purpose of this public workshop is to obtain input from stakeholders on considerations for development and submission of proposed draft guidance relating to patient experience data submitted by an external stakeholder, including: (1) Defining the scope of the proposed draft guidance, (2) developing the proposed draft guidance, and (3) submitting the proposed draft guidance to FDA, including the process and format. The Agency is seeking information and comments from a broad range of stakeholders, including patients, patient advocates, academic and medical researchers, expert practitioners, drug developers, and other interested persons. FDA will publish a background document outlining the topic areas that will be addressed in the draft guidance approximately 2 weeks before the workshop date at the following website: https://www.fda.gov/Drugs/NewsEvents/ucm582081.htm. After this public workshop, FDA will take into consideration the stakeholder input from the workshop and the public docket, and publish a draft guidance by the end of fiscal year 2018. III. Participating in the Public Workshop Registration: Interested parties are encouraged to register early. To register electronically, please visit https://pfdd-proposeddraftguidance.eventbrite.com. Persons without access to the internet can call 240-402-6525 to register. If you are unable to attend the public workshop in person, you can register to view a live webcast. You will be asked to indicate in your registration if you plan to attend in person or via the webcast. Seating will be limited, so early registration is recommended. Registration is free and will be on a first-come, first-served basis. However, FDA may limit the number of participants from each organization based on space limitations. Registrants will receive confirmation once they have been accepted. Onsite registration on the day of the public workshop will be based on space availability. If you need special accommodations because of a disability, please contact Meghana Chalasani (see FOR FURTHER INFORMATION CONTACT) at least 7 days before the public workshop. Open Public Comment: There will be time allotted during the public workshop for open public comment. Sign-up for this session will be on a first-come, first-serve basis on the day of the public workshop. Individuals and organizations with common interests are urged to consolidate or coordinate, and request time for a joint presentation. No commercial or promotional material will be permitted to be presented or distributed at the public workshop. Transcripts: As soon as a transcript is available of the public workshop, FDA will post it at https://www.fda.gov/Drugs/NewsEvents/ucm582081.htm. Dated: December 11, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-26978 Filed 12-13-17; 8:45 am] BILLING CODE 4164-01-P
![58816 Federal Register / Vol. 82, No. 239 / Thursday, December 14, 2017 / Notices
DEPARTMENT OF HEALTH AND on or before May 18, 2018. The https:// https://www.regulations.gov or at the
HUMAN SERVICES www.regulations.gov electronic filing Dockets Management Staff between 9
system will accept comments until a.m. and 4 p.m., Monday through
Food and Drug Administration midnight Eastern Time at the end of Friday.
May 18, 2018. Comments received by • Confidential Submissions—To
[Docket No. FDA–2017–N–6312]
mail/hand delivery/courier (for written/ submit a comment with confidential
Patient-Focused Drug Development: paper submissions) will be considered information that you do not wish to be
Developing and Submitting Proposed timely if they are postmarked or the made publicly available, submit your
Draft Guidance Relating to Patient delivery service acceptance receipt is on comments only as a written/paper
Experience Data; Public Workshop; or before that date. submission. You should submit two
Request for Comments copies total. One copy will include the
Electronic Submissions
information you claim to be confidential
AGENCY: Food and Drug Administration, Submit electronic comments in the with a heading or cover note that states
HHS. following way: ‘‘THIS DOCUMENT CONTAINS
ACTION: Notice of public workshop; • Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The
request for comments. https://www.regulations.gov. Follow the Agency will review this copy, including
instructions for submitting comments. the claimed confidential information, in
SUMMARY: The Food and Drug Comments submitted electronically, its consideration of comments. The
Administration (FDA or Agency) is including attachments, to https:// second copy, which will have the
announcing the following public www.regulations.gov will be posted to claimed confidential information
workshop entitled ‘‘Patient-Focused the docket unchanged. Because your redacted/blacked out, will be available
Drug Development: Developing and comment will be made public, you are for public viewing and posted on
Submitting Proposed Draft Guidance solely responsible for ensuring that your https://www.regulations.gov. Submit
Relating to Patient Experience Data.’’ comment does not include any both copies to the Dockets Management
The purpose of the public workshop is confidential information that you or a Staff. If you do not wish your name and
to convene a discussion on how a third party may not wish to be posted, contact information to be made publicly
person seeking to develop and submit such as medical information, your or available, you can provide this
proposed draft guidance relating to anyone else’s Social Security number, or information on the cover sheet and not
patient experience data for confidential business information, such in the body of your comments and you
consideration by FDA may submit such as a manufacturing process. Please note must identify this information as
proposed draft guidance to the Agency. that if you include your name, contact ‘‘confidential.’’ Any information marked
This workshop will inform development information, or other information that as ‘‘confidential’’ will not be disclosed
of patient-focused drug development identifies you in the body of your except in accordance with 21 CFR 10.20
guidance as required by the 21st comments, that information will be and other applicable disclosure law. For
Century Cures Act (Cures Act). FDA posted on https://www.regulations.gov. more information about FDA’s posting
plans to publish a background • If you want to submit a comment of comments to public dockets, see 80
document approximately 2 weeks before with confidential information that you FR 56469, September 18, 2015, or access
the workshop date. do not wish to be made available to the the information at: https://www.gpo.gov/
DATES: The public workshop will be public, submit the comment as a fdsys/pkg/FR-2015-09-18/pdf/2015-
held on March 19, 2018, from 1 p.m. to written/paper submission and in the 23389.pdf.
5 p.m. Submit either electronic or manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
written comments on this public Submissions’’ and ‘‘Instructions’’). read background documents or the
workshop by May 18, 2018. See the Written/Paper Submissions electronic and written/paper comments
SUPPLEMENTARY INFORMATION section for received, go to https://
Submit written/paper submissions as
additional registration information. www.regulations.gov and insert the
follows:
ADDRESSES: The public workshop will • Mail/Hand delivery/Courier (for docket number, found in brackets in the
be held at FDA’s White Oak Campus, written/paper submissions): Dockets heading of this document, into the
10903 New Hampshire Ave., Bldg. 31 Management Staff (HFA–305), Food and ‘‘Search’’ box and follow the prompts
Conference Center, the Great Room (Rm. Drug Administration, 5630 Fishers and/or go to the Dockets Management
1503), Silver Spring, MD 20993. Lane, Rm. 1061, Rockville, MD 20852. Staff, 5630 Fishers Lane, Rm. 1061,
Entrance for the public workshop • For written/paper comments Rockville, MD 20852.
participants (non-FDA employees) is submitted to the Dockets Management FOR FURTHER INFORMATION CONTACT:
through Building 1 where routine Staff, FDA will post your comment, as Meghana Chalasani, Center for Drug
security check procedures will be well as any attachments, except for Evaluation and Research, Food and
performed. For parking and security information submitted, marked and Drug Administration, 10903 New
information, please refer to https:// identified, as confidential, if submitted Hampshire Ave., Bldg. 51, Rm. 1146,
www.fda.gov/AboutFDA/ as detailed in ‘‘Instructions.’’ Silver Spring, MD 20993–0002, 240–
WorkingatFDA/BuildingsandFacilities/ Instructions: All submissions received 402–6525, Fax: 301–847–8443,
WhiteOakCampusInformation/ must include the Docket No. FDA– Meghana.Chalasani@fda.hhs.gov.
ucm241740.htm. Workshop updates, 2017–N–6312 for ‘‘Patient-Focused Drug SUPPLEMENTARY INFORMATION:
agenda, and background document will Development: Developing and
sradovich on DSK3GMQ082PROD with NOTICES
be made available at https:// Submitting Proposed Draft Guidance I. Background
www.fda.gov/Drugs/NewsEvents/ Relating to Patient Experience Data.’’ This public workshop is intended to
ucm582081.htm prior to the workshop. Received comments, those filed in a support FDA implementation of
You may submit comments as timely manner (see ADDRESSES), will be requirements for guidance development
follows. Please note that late, untimely placed in the docket and, except for under section 3002 of the Cures Act
filed comments will not be considered. those submitted as ‘‘Confidential (Pub. L. 114–255). Section 3002 of Title
Electronic comments must be submitted Submissions,’’ publicly viewable at III, Subtitle A, of the Cures Act directs
VerDate Sep<11>2014 21:28 Dec 13, 2017 Jkt 244001 PO 00000 Frm 00025 Fmt 4703 Sfmt 4703 E:\FR\FM\14DEN1.SGM 14DEN1](https://thefederalregister.org/doc/82_FR_59055/page/1.svg)
![Federal Register / Vol. 82, No. 239 / Thursday, December 14, 2017 / Notices 58817
FDA to develop patient-focused drug docket, and publish a draft guidance by licensing to achieve expeditious
development guidance to address a the end of fiscal year 2018. commercialization of results of
number of areas, including how a federally-funded research and
III. Participating in the Public
person seeking to develop and submit a development. Foreign patent
Workshop
proposed draft guidance relating to applications are filed on selected
patient experience data for Registration: Interested parties are inventions to extend market coverage
consideration by FDA may submit such encouraged to register early. To register for companies and may also be available
proposed draft guidances. electronically, please visit https://pfdd- for licensing.
In FDA’s ‘‘Plan for Issuance of proposeddraftguidance.eventbrite.com. FOR FURTHER INFORMATION CONTACT: Dr.
Patient-Focused Drug Development Persons without access to the internet Natalie Greco, 301–761–7898;
Guidance,’’ (the Plan) available at can call 240–402–6525 to register. If you Natalie.Greco@nih.gov. Licensing
https://www.fda.gov/downloads/ are unable to attend the public information and copies of the patent
ForIndustry/UserFees/ workshop in person, you can register to applications listed below may be
PrescriptionDrugUserFee/ view a live webcast. You will be asked obtained by communicating with the
UCM563618.pdf, the Agency proposed to indicate in your registration if you indicated licensing contact at the
issuing a guidance addressing this topic plan to attend in person or via the Technology Transfer and Intellectual
described in section 3002 during the webcast. Seating will be limited, so Property Office, National Institute of
second quarter of 2018. FDA recognizes early registration is recommended. Allergy and Infectious Diseases, 5601
that, like the other patient-focused drug Registration is free and will be on a first- Fishers Lane, Rockville, MD 20852; tel.
development guidances described in the come, first-served basis. However, FDA 301–496–2644. A signed Confidential
Plan, developing this draft guidance may limit the number of participants Disclosure Agreement will be required
will also benefit from public input from from each organization based on space to receive copies of unpublished patent
the wider community of patients, limitations. Registrants will receive applications.
patient advocates, academic researchers, confirmation once they have been SUPPLEMENTARY INFORMATION:
expert practitioners, drug developers, accepted. Onsite registration on the day Technology description follows.
and other stakeholders prior to FDA’s of the public workshop will be based on
drafting of the guidance. Accordingly, space availability. If you need special Monoclonal Antibody Specific for DNA/
the Agency is scheduling this public accommodations because of a disability, RNA Hybrid Molecules
workshop. After this public workshop, please contact Meghana Chalasani (see Description of Technology
FDA will take into consideration the FOR FURTHER INFORMATION CONTACT) at
stakeholder input from the workshop NIAID has a hybridoma available for
least 7 days before the public workshop.
and the public docket, and publish a Open Public Comment: There will be non-exclusive licensing that produces a
draft guidance by the end of fiscal year time allotted during the public monoclonal antibody specific for DNA/
2018. workshop for open public comment. RNA hybrids. This antibody, which has
Sign-up for this session will be on a been extensively characterized by NIH
II. Purpose and Scope of Meeting researchers, is already a widely-used
first-come, first-serve basis on the day of
FDA is announcing a public the public workshop. Individuals and research tool. It is currently the only
workshop to convene a discussion on organizations with common interests are monoclonal antibody available that is
topics related to developing and urged to consolidate or coordinate, and specific for DNA/RNA hybrids, making
submitting proposed draft guidance request time for a joint presentation. No it a unique reagent. It is used in
relating to patient experience data by an commercial or promotional material immuno-fluorescence (IF) microscopy,
external stakeholder. The purpose of will be permitted to be presented or where it can be used to detect sites of
this public workshop is to obtain input distributed at the public workshop. transcriptional activity and potentially
from stakeholders on considerations for Transcripts: As soon as a transcript is sites of viral replication. It has also been
development and submission of available of the public workshop, FDA used in DNA/RNA immunoprecipitation
proposed draft guidance relating to will post it at https://www.fda.gov/ (DRIP) experiments by a variety of
patient experience data submitted by an Drugs/NewsEvents/ucm582081.htm. researchers.
external stakeholder, including: (1) Aside from its use as a research tool,
Defining the scope of the proposed draft Dated: December 11, 2017. this antibody has potential to be used in
guidance, (2) developing the proposed Leslie Kux, diagnostic kits for viral/bacterial
draft guidance, and (3) submitting the Associate Commissioner for Policy. infections, cancers, and a variety of
proposed draft guidance to FDA, [FR Doc. 2017–26978 Filed 12–13–17; 8:45 am] other human diseases. DNA/RNA
including the process and format. The BILLING CODE 4164–01–P hybrids arise during normal cellular
Agency is seeking information and function, but they are typically present
comments from a broad range of in cells at low levels. When DNA/RNA
stakeholders, including patients, patient DEPARTMENT OF HEALTH AND hybrids are found at high levels in a
advocates, academic and medical HUMAN SERVICES cell, it indicates that the cell is
researchers, expert practitioners, drug ‘‘abnormal’’. For example, the cell may
developers, and other interested National Institutes of Health be cancerous or infected with a virus.
persons. FDA will publish a background NIH researchers have also incorporated
document outlining the topic areas that Government-Owned Inventions; the antibody into a micro-array
Availability for Licensing
sradovich on DSK3GMQ082PROD with NOTICES
will be addressed in the draft guidance platform, expanding its potential for use
approximately 2 weeks before the AGENCY: National Institutes of Health, in diagnostic devices.
workshop date at the following website: HHS. This technology is available for
https://www.fda.gov/Drugs/NewsEvents/ ACTION: Notice. licensing for commercial development
ucm582081.htm. in accordance with 35 U.S.C. 209 and 37
After this public workshop, FDA will SUMMARY: The invention listed below is CFR part 404, as well as for further
take into consideration the stakeholder owned by an agency of the U.S. development and evaluation under a
input from the workshop and the public Government and is available for research collaboration.
VerDate Sep<11>2014 21:28 Dec 13, 2017 Jkt 244001 PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 E:\FR\FM\14DEN1.SGM 14DEN1](https://thefederalregister.org/doc/82_FR_59055/page/2.svg)
Document Created: 2018-10-25 10:51:05
Document Modified: 2018-10-25 10:51:05
| 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 March 19, 2018, from 1 p.m. to 5 p.m. Submit either electronic or written comments on this public workshop by May 18, 2018. See the SUPPLEMENTARY INFORMATION section for additional registration information. | |
| Contact | Meghana Chalasani, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1146, Silver Spring, MD 20993-0002, 240- 402-6525, Fax: 301-847-8443, [email protected] | |
| FR Citation | 82 FR 58816 |
2024 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR