83 FR 46170 - Evidence-Based Treatment Decision in Transplantation: Patient Individualized Treatment; Choosing the Right Regimen for the Right Patient; Public Workshop; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 177 (September 12, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 177 (September 12, 2018)
| Page Range | 46170-46172 | |
| FR Document | 2018-19816 |
[Federal Register Volume 83, Number 177 (Wednesday, September 12, 2018)] [Notices] [Pages 46170-46172] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-19816] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-3010] Evidence-Based Treatment Decision in Transplantation: Patient Individualized Treatment; Choosing the Right Regimen for the Right Patient; 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 ``Evidence-Based Treatment Decision in Transplantation: Patient Individualized Treatment; Choosing the Right Regimen for the Right Patient.'' This public workshop is intended to discuss potential candidate biomarkers to determine organ transplant patients' immunologic risk for organ rejection or tolerance. The public workshop will include discussion of the biomarker qualification process and how it could be used to develop biomarkers for use in clinical trials in transplantation, to develop new drugs to address unmet needs, and in clinical practice to guide patient treatment selection. Speakers will be patients who will provide perspective on the challenges of living with a transplant, managing immunosuppression and perspectives on tolerability, adherence, and risk that may inform patient-reported outcome (PRO) and patient-focused drug development. DATES: The public workshop will be held on September 27, 2018, from 8:30 a.m. to 6 p.m. and September 28, 2018, from 8 a.m. to 12:30 p.m. Submit either electronic or written comments on this public workshop by November 19, 2018. See the SUPPLEMENTARY INFORMATION section for registration date and information. ADDRESSES: The public workshop will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503, sections B and C), 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 19, 2018. The [[Page 46171]] https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of November 19, 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-2018-N-3010 for ``Evidence-Based Treatment Decision in Transplantation: Patient Individualized Treatment; Choosing the Right Regimen for the Right Patient.'' 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: Derek Alberding or Ramou Pratt, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 240-402-0963, derek.alberding@fda.hhs.gov, or 301-796-3928, ramou.pratt@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing a public workshop entitled ``Evidence-Based Treatment Decision in Transplantation: Patient Individualized Treatment; Choosing the Right Regimen for the Right Patient.'' This public workshop is intended for academic experts, industry, healthcare providers, patients, other U.S. Government Agencies, and other stakeholders. II. Topics for Discussion at the Public Workshop Presentations and discussions will cover identifying potential candidate biomarkers that could: Be considered for the biomarker qualification process be used in identifying patients at high immunologic risk or low immunologic risk be used in clinical trials to develop drugs to address unmet individual needs in transplantation be used to make appropriate immunosuppressive regimen treatment decisions In addition, patient speakers will provide perspectives on: Challenges of living with a transplant, managing immunosuppression, and tolerability, adherence, and risk of therapy. The goal of these presentations is to inform PRO and patient- focused drug development. III. Participating in the Public Workshop Registration: 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 14, 2018, midnight Eastern Time. To register, please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone to TransplantationWorkshop2018@fda.hhs.gov. Early registration is recommended because seating is limited; therefore, FDA may limit the number of participants from each organization. Registrants will receive confirmation when they have been accepted. If time and space permit, onsite registration on the day of the public workshop will be provided beginning at 7:30 a.m. We will let registrants know if registration closes before the day of the public workshop. If you need special accommodations due to a disability, please contact Derek Alberding or Ramou Pratt (see FOR FURTHER INFORMATION CONTACT) no later than September 13, 2018. 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 [[Page 46172]] organizations with common interests are urged to consolidate or coordinate their presentations, and request time for a joint presentation, or 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 14, 2018. All requests to make oral presentations must be received by September 10, 2018. If selected for presentation, any presentation materials must be emailed to TransplantationWorkshop2018@fda.hhs.gov (see FOR FURTHER INFORMATION CONTACT) no later than September 19, 2018. 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 at https://collaboration.fda.gov/ebtd092018/. 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 website addresses in this document, as of the date this document publishes in the Federal Register, but websites 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 https://www.fda.gov/Drugs/NewsEvents/ucm605761.htm. Dated: September 6, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-19816 Filed 9-11-18; 8:45 am] BILLING CODE 4164-01-P
![46170 Federal Register / Vol. 83, No. 177 / Wednesday, September 12, 2018 / Notices
suggestion and will implement the While we are especially appreciative temporary waiver from the electronic
revision. of the comments received in response to reporting requirements associated with
We also received comment that some our notice, we continue to welcome postmarket adverse drug events under
users have experienced ‘‘timing out’’ feedback at all times regarding ways we section 760 of the FD&C Act. While we
while completing Form FDA 3500B might improve the MedWatch Program expect few such waiver requests, we
online and requested that any time limit and the associated forms. In addition to retain a placeholder for one respondent
for completing online forms be the revisions discussed previously, on annually, and we estimate it takes 1
extended. We were not aware of this our own initiative we are now including hour to complete the request.
issue and will investigate to see whether
burden associated with written We therefore estimate the burden for
it relates to the online functionality of
submissions under § 329.100(c)(2) (21 the information collection as follows.
the form. If so, we will make the
CFR 329.100(c)(2)) that request a
necessary adjustments.
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
FDA center or 21 CFR section and/or FDA form responses per burden per Total hours
respondents responses
respondent response
Center for Biologics Evaluation and Research/Center
for Drug Evaluation and Research:
Form 3500 ............................................................ 14,727 1 14,727 0.66 (40 minutes) .. 9,720
Form 3500A (§§ 310.305, 314.80, 314.98, 599 98 58,702 1.21 ........................ 71,029
600.80, and 1271.350).
Form 3500A (§ 310.305 outsourcing facilities) ..... 50 2 100 1.21 ........................ 121
Center for Devices and Radiological Health:
Form 3500 ............................................................ 5,233 1 5,233 0.66 (40 minutes) ... 3,454
Form 3500A (part 803) ......................................... 2,277 296 673,992 1.21 ........................ 815,530
Center for Food Safety and Applied Nutrition:
Form 3500 ............................................................ 1,793 1 1,793 0.66 (40 minutes) ... 1,183
Form 3500A .......................................................... 1,659 1 1,659 1.21 ........................ 2,007
Center for Tobacco Products:
Form 3500 ............................................................ 39 1 39 0.66 (40 minutes) ... 26
All Centers:
Form 3500B .......................................................... 13,750 1 13, 750 0.46 (28 minutes) .. 6,325
Written requests for temporary waiver under 1 1 1 1 ............................. 1
§ 329.100(c)(2):
Total ...................................................................... ........................ ........................ ........................ ................................ 909,396
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
While we retain the currently SUMMARY: The Food and Drug DATES: The public workshop will be
approved estimate for the information Administration (FDA, the Agency, or held on September 27, 2018, from 8:30
collection, as noted previously we have we) is announcing the following public a.m. to 6 p.m. and September 28, 2018,
added burden associated with written workshop entitled ‘‘Evidence-Based from 8 a.m. to 12:30 p.m. Submit either
submissions under § 329.100. Treatment Decision in Transplantation: electronic or written comments on this
Dated: September 4, 2018. Patient Individualized Treatment; public workshop by November 19, 2018.
Choosing the Right Regimen for the See the SUPPLEMENTARY INFORMATION
Leslie Kux,
Right Patient.’’ This public workshop is section for registration date and
Associate Commissioner for Policy.
intended to discuss potential candidate information.
[FR Doc. 2018–19742 Filed 9–11–18; 8:45 am]
biomarkers to determine organ ADDRESSES: The public workshop will
BILLING CODE 4164–01–P
transplant patients’ immunologic risk be held at the FDA White Oak Campus,
for organ rejection or tolerance. The 10903 New Hampshire Ave., Bldg. 31
DEPARTMENT OF HEALTH AND public workshop will include Conference Center, the Great Room (Rm.
HUMAN SERVICES discussion of the biomarker 1503, sections B and C), Silver Spring,
qualification process and how it could MD 20993. Entrance for the public
Food and Drug Administration be used to develop biomarkers for use workshop participants (non-FDA
employees) is through Building 1 where
[Docket No. FDA–2018–N–3010] in clinical trials in transplantation, to
routine security check procedures will
develop new drugs to address unmet
be performed. For parking and security
Evidence-Based Treatment Decision in needs, and in clinical practice to guide information, please refer to https://
Transplantation: Patient Individualized patient treatment selection. Speakers www.fda.gov/AboutFDA/
Treatment; Choosing the Right will be patients who will provide WorkingatFDA/BuildingsandFacilities/
daltland on DSKBBV9HB2PROD with NOTICES
Regimen for the Right Patient; Public perspective on the challenges of living WhiteOakCampusInformation/
Workshop; Request for Comments with a transplant, managing ucm241740.htm.
AGENCY: Food and Drug Administration, immunosuppression and perspectives You may submit comments as
HHS. on tolerability, adherence, and risk that follows. Please note that late, untimely
may inform patient-reported outcome filed comments will not be considered.
ACTION: Notice of public workshop;
(PRO) and patient-focused drug Electronic comments must be submitted
request for comments.
development. on or before November 19, 2018. The
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![46172 Federal Register / Vol. 83, No. 177 / Wednesday, September 12, 2018 / Notices
organizations with common interests are ACTION: Notice; establishment of a confidential information that you or a
urged to consolidate or coordinate their public docket; request for comments. third party may not wish to be posted,
presentations, and request time for a such as medical information, your or
joint presentation, or submit requests for SUMMARY: The Food and Drug anyone else’s Social Security number, or
designated representatives to participate Administration (FDA) announces a confidential business information, such
in the focused sessions. Following the forthcoming public advisory committee as a manufacturing process. Please note
close of registration, we will determine meeting of the Oncologic Drugs that if you include your name, contact
the amount of time allotted to each Advisory Committee. The general information, or other information that
presenter and the approximate time function of the committee is to provide identifies you in the body of your
each oral presentation is to begin, and advice and recommendations to FDA on comments, that information will be
will select and notify participants by regulatory issues. The meeting will be posted on https://www.regulations.gov.
September 14, 2018. All requests to open to the public. FDA is establishing • If you want to submit a comment
make oral presentations must be a docket for public comment on this with confidential information that you
received by September 10, 2018. If document. do not wish to be made available to the
selected for presentation, any DATES: The meeting will be held on public, submit the comment as a
presentation materials must be emailed October 10, 2018, from 8 a.m. to 1 p.m. written/paper submission and in the
to TransplantationWorkshop2018@ manner detailed (see ‘‘Written/Paper
ADDRESSES: FDA White Oak Campus,
fda.hhs.gov (see FOR FURTHER Submissions’’ and ‘‘Instructions’’).
10903 New Hampshire Ave., Bldg. 31
INFORMATION CONTACT) no later than Conference Center, the Great Room (Rm. Written/Paper Submissions
September 19, 2018. No commercial or 1503), Silver Spring, MD 20993–0002.
promotional material will be permitted Submit written/paper submissions as
Answers to commonly asked questions follows:
to be presented or distributed at the including information regarding special • Mail/Hand delivery/Courier (for
public workshop. accommodations due to a disability, written/paper submissions): Dockets
Streaming Webcast of the Public visitor parking, and transportation may Management Staff (HFA–305), Food and
Workshop: This public workshop will be accessed at: https://www.fda.gov/ Drug Administration, 5630 Fishers
also be webcast at https:// AdvisoryCommittees/AboutAdvisory Lane, Rm. 1061, Rockville, MD 20852.
collaboration.fda.gov/ebtd092018/. Committees/ucm408555.htm. • For written/paper comments
If you have never attended a Connect FDA is establishing a docket for submitted to the Dockets Management
Pro event before, test your connection at public comment on this meeting. The Staff, FDA will post your comment, as
https://collaboration.fda.gov/common/ docket number is FDA–2018–N–3308. well as any attachments, except for
help/en/support/meeting_test.htm. To The docket will close on October 9, information submitted, marked and
get a quick overview of the Connect Pro 2018. Submit either electronic or identified, as confidential, if submitted
program, visit https://www.adobe.com/ written comments on this public as detailed in ‘‘Instructions.’’
go/connectpro_overview. FDA has meeting by October 9, 2018. Please note Instructions: All submissions received
verified the website addresses in this that late, untimely filed comments will must include the Docket No. FDA–
document, as of the date this document not be considered. Electronic comments 2018–N–3308 for ‘‘Oncologic Drugs
publishes in the Federal Register, but must be submitted on or before October Advisory Committee; Notice of Meeting;
websites are subject to change over time. 9, 2018. The https://www.regulations. Establishment of a Public Docket;
Transcripts: Please be advised that as gov electronic filing system will accept Request for Comments.’’ Received
soon as a transcript of the public comments until midnight Eastern Time comments, those filed in a timely
workshop is available, it will be at the end of October 9, 2018. Comments manner (see ADDRESSES), will be placed
accessible at https:// received by mail/hand delivery/courier in the docket and, except for those
www.regulations.gov. It may be viewed (for written/paper submissions) will be submitted as ‘‘Confidential
at the Dockets Management Staff (see considered timely if they are Submissions,’’ publicly viewable at
ADDRESSES). A link to the transcript will postmarked or the delivery service https://www.regulations.gov or at the
also be available on the internet at acceptance receipt is on or before that Dockets Management Staff between 9
https://www.fda.gov/Drugs/NewsEvents/ date. a.m. and 4 p.m., Monday through
ucm605761.htm. Comments received on or before Friday.
Dated: September 6, 2018. October 1, 2018, will be provided to the • Confidential Submissions—To
Leslie Kux, committee. Comments received after submit a comment with confidential
that date will be taken into information that you do not wish to be
Associate Commissioner for Policy.
consideration by FDA. made publicly available, submit your
[FR Doc. 2018–19816 Filed 9–11–18; 8:45 am]
You may submit comments as comments only as a written/paper
BILLING CODE 4164–01–P
follows: submission. You should submit two
copies total. One copy will include the
Electronic Submissions information you claim to be confidential
DEPARTMENT OF HEALTH AND
Submit electronic comments in the with a heading or cover note that states
HUMAN SERVICES
following way: ‘‘THIS DOCUMENT CONTAINS
Food and Drug Administration • Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ FDA
https://www.regulations.gov. Follow the will review this copy, including the
instructions for submitting comments. claimed confidential information, in its
daltland on DSKBBV9HB2PROD with NOTICES
[Docket No. FDA–2018–N–3308]
Comments submitted electronically, consideration of comments. The second
Oncologic Drugs Advisory Committee; including attachments, to https:// copy, which will have the claimed
Notice of Meeting; Establishment of a www.regulations.gov will be posted to confidential information redacted/
Public Docket; Request for Comments the docket unchanged. Because your blacked out, will be available for public
comment will be made public, you are viewing and posted on https://
AGENCY: Food and Drug Administration, solely responsible for ensuring that your www.regulations.gov. Submit both
HHS. comment does not include any copies to the Dockets Management Staff.
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Document Created: 2018-09-12 02:06:36
Document Modified: 2018-09-12 02:06:36
| 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 September 27, 2018, from 8:30 a.m. to 6 p.m. and September 28, 2018, from 8 a.m. to 12:30 p.m. Submit either electronic or written comments on this public workshop by November 19, 2018. See the SUPPLEMENTARY INFORMATION section for registration date and information. | |
| Contact | Derek Alberding or Ramou Pratt, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 240-402-0963, [email protected], or 301-796-3928, [email protected] | |
| FR Citation | 83 FR 46170 |
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