83 FR 40057 - Patient-Focused Drug Development Guidance: Methods To Identify What Is Important to Patients and Select, Develop, or Modify Fit-for-Purpose Clinical Outcome Assessments; Public Workshop; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 156 (August 13, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 156 (August 13, 2018)
| Page Range | 40057-40059 | |
| FR Document | 2018-17272 |
[Federal Register Volume 83, Number 156 (Monday, August 13, 2018)] [Notices] [Pages 40057-40059] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-17272] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-2455] Patient-Focused Drug Development Guidance: Methods To Identify What Is Important to Patients and Select, Develop, or Modify Fit-for- Purpose Clinical Outcome Assessments; 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) is announcing a 2-day public workshop to convene a discussion on methodological approaches that may be used to identify what is most important to patients and caregivers with respect to burden of disease, burden of treatment, and the benefits and risks in the management of the patient's disease, and best practices for selecting, developing, or modifying fit-for-purpose clinical outcome assessments (COAs) to measure the patient experience in clinical trials. This workshop will inform development of patient- focused drug development guidance as required by the 21st Century Cures Act (Cures Act) and as part of commitments made by FDA under the sixth authorization of the Prescription Drug User Fee Act (PDUFA VI). FDA will publish discussion documents approximately 1 month before the workshop date. FDA is interested in seeking information and comments on the approaches proposed in the discussion documents. FDA is also interested in input on examples, which could be illustrated in the draft guidance, where the approaches proposed in the discussion document have been successfully applied. DATES: The public workshop will be held on October 15 and 16, 2018, from 9 a.m. to 5 p.m. Submit either electronic or written comments on this public workshop by December 14, 2018. 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 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 discussion documents will be made available at: https://www.fda.gov/Drugs/NewsEvents/ucm607276.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 December 14, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of December 14, 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-2455 for ``Patient-Focused Drug Development Guidance: Methods to Identify What is Important to Patients and Select, Develop or Modify Fit-for-Purpose Clinical Outcome Assessments; Public Workshop; Request for Comments.'' Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS [[Page 40058]] 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, [email protected]. 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) and to meet a performance goal included in the sixth authorization of PDUFA VI. Section 3002 of Title III Subtitle A of the Cures Act directs FDA to develop patient-focused drug development guidance to address a number of areas including methodological approaches that may be used to develop and identify what is most important to patients with respect to burden of disease, burden of treatment, and the benefits and risks in the management of the patient's disease; and approaches to identifying and developing methods to measure impacts to patients that will help facilitate collection of patient experience data in clinical trials. In addition, FDA committed to meet certain performance goals under PDUFA VI. This reauthorization, part of the FDA Reauthorization Act of 2017 signed by the President on August 18, 2017, includes a number of performance goals and procedures that are documented in the PDUFA VI Commitment Letter, which is available at https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM511438.pdf. These goal commitments were developed in consultation with patient and consumer advocates, healthcare professionals, and other public stakeholders, as part of negotiations with regulated industry. Section J.1 of the commitment letter, ``Enhancing the Incorporation of the Patient's Voice in Drug Development and Decision-Making,'' (https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM511438.pdf) outlines work, including the development of a series of guidance documents and associated public workshops to facilitate the advancement and use of systematic approaches to collect and utilize robust and meaningful patient and caregiver input that can more consistently inform drug development, and, as appropriate, regulatory decision making. Prior to the issuance of each guidance, as part of the development, FDA will conduct a public workshop to gather input from the wider community of patients, patient advocates, academic researchers, expert practitioners, drug developers, and other stakeholders. II. Purpose and Scope of Meeting FDA is announcing a 2-day public workshop to convene a discussion on: (1) Methodological approaches that may be used to develop and identify what is most important to patients and caregivers with respect to burden of disease, burden of treatment, and the benefits and risks in the management of the patient's disease and (2) best practices for selecting, developing, or modifying fit-for-purpose COAs to measure the patient experience in clinical trials. The purpose of this public workshop is to obtain feedback from stakeholders on: (1) Methods to identify what is important to patients; (2) best practices for eliciting information on which aspects of disease symptoms, signs, impacts, and other issues are important and meaningful to patients; (3) measuring symptoms, signs, impacts and other issues of a disease or condition in a meaningful way; and (4) selecting, developing, or modifying fit-for-purpose COAs to measure the patient experience in clinical trials. FDA 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 discussion documents outlining the topic areas that will be addressed in the draft guidances. These documents will be published approximately 1 month before the workshop date on the website at: https://www.fda.gov/Drugs/NewsEvents/ucm607276.htm. FDA is interested in seeking information and comments on the approaches and considerations proposed in the discussion documents. FDA is also interested in seeking information and comments on additional examples, which could be included in guidance, where the approaches proposed in the discussion document have been successfully applied. After this public workshop, FDA will take into consideration the stakeholder input from the workshop and the public docket and publish draft guidance(s). III. Participating in the Public Workshop Registration: Interested parties are encouraged to register early. To register electronically, please visit: https://pfddmethods.eventbrite.com. Registration for in-person attendance will close on October 10, 2018. Registration for the webcast will remain open until the day of the meeting. Persons without access to the internet can call 240-402-6525 to register. If you are unable to attend the meeting in person, you can register to view a live webcast of the meeting. 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 meeting 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 meeting. Request for Oral Presentations: There will be time allotted during the workshop for open public comment. Sign-up for this session will be on a first-come, first-served basis on the day of the workshop. Individuals and [[Page 40059]] 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, FDA will post it at https://www.fda.gov/Drugs/NewsEvents/ucm607276.htm. Dated: August 8, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-17272 Filed 8-10-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 156 / Monday, August 13, 2018 / Notices 40057
under OMB control number 0910–0733 fit-for-purpose clinical outcome instructions for submitting comments.
is available at https://www.fda.gov/ucm/ assessments (COAs) to measure the Comments submitted electronically,
groups/fdagov-public/@fdagov-drugs- patient experience in clinical trials. This including attachments, to https://
gen/documents/document/ workshop will inform development of www.regulations.gov will be posted to
ucm269919.pdf; 21 CFR parts 50 and 56 patient-focused drug development the docket unchanged. Because your
under OMB control number 0910–0755; guidance as required by the 21st comment will be made public, you are
the guidance for industry entitled Century Cures Act (Cures Act) and as solely responsible for ensuring that your
‘‘Expedited Programs for Serious part of commitments made by FDA comment does not include any
Conditions—Drugs and Biologics’’ under the sixth authorization of the confidential information that you or a
under OMB control number 0910–0765 Prescription Drug User Fee Act (PDUFA third party may not wish to be posted,
is available at https://www.fda.gov/ VI). FDA will publish discussion such as medical information, your or
downloads/Drugs/GuidanceCompliance documents approximately 1 month anyone else’s Social Security number, or
RegulatoryInformation/Guidances/ before the workshop date. FDA is confidential business information, such
UCM358301.pdf; and the ICH guidance interested in seeking information and as a manufacturing process. Please note
for industry entitled ‘‘E6(R2) Good comments on the approaches proposed that if you include your name, contact
Clinical Practice: Integrated Addendum in the discussion documents. FDA is information, or other information that
to ICH E6(R1)’’ under OMB control also interested in input on examples, identifies you in the body of your
number 0910–0843 is available at which could be illustrated in the draft comments, that information will be
https://www.fda.gov/downloads/Drugs/ guidance, where the approaches posted on https://www.regulations.gov.
GuidanceComplianceRegulatory proposed in the discussion document • If you want to submit a comment
Information/Guidances/ have been successfully applied. with confidential information that you
UCM464506.pdf. do not wish to be made available to the
DATES: The public workshop will be
public, submit the comment as a
III. Electronic Access held on October 15 and 16, 2018, from
written/paper submission and in the
Persons with access to the internet 9 a.m. to 5 p.m. Submit either electronic
manner detailed (see ‘‘Written/Paper
may obtain the draft guidance at https:// or written comments on this public
Submissions’’ and ‘‘Instructions’’).
www.fda.gov/Drugs/Guidance workshop by December 14, 2018. See
ComplianceRegulatoryInformation/ the SUPPLEMENTARY INFORMATION section Written/Paper Submissions
Guidances/default.htm, https:// for registration date and information. Submit written/paper submissions as
www.fda.gov/BiologicsBloodVaccines/ ADDRESSES: The public workshop will follows:
GuidanceComplianceRegulatory be held at FDA’s White Oak Campus, • Mail/Hand delivery/Courier (for
Information/default.htm, or https:// 10903 New Hampshire Ave., Bldg. 31 written/paper submissions): Dockets
www.regulations.gov. Conference Center, the Great Room (Rm. Management Staff (HFA–305), Food and
Dated: August 8, 2018.
1503), Silver Spring, MD 20993. Drug Administration, 5630 Fishers
Entrance for the public workshop Lane, Rm. 1061, Rockville, MD 20852.
Leslie Kux,
participants (non-FDA employees) is • For written/paper comments
Associate Commissioner for Policy.
through Building 1 where routine submitted to the Dockets Management
[FR Doc. 2018–17273 Filed 8–10–18; 8:45 am] security check procedures will be Staff, FDA will post your comment, as
BILLING CODE 4164–01–P performed. For parking and security well as any attachments, except for
information, please refer to https:// information submitted, marked and
www.fda.gov/AboutFDA/ identified, as confidential, if submitted
DEPARTMENT OF HEALTH AND WorkingatFDA/BuildingsandFacilities/ as detailed in ‘‘Instructions.’’
HUMAN SERVICES WhiteOakCampusInformation/ Instructions: All submissions received
Food and Drug Administration ucm241740.htm. Workshop updates, must include the Docket No. FDA–
agenda, and discussion documents will 2018–N–2455 for ‘‘Patient-Focused Drug
[Docket No. FDA–2018–N–2455] be made available at: https:// Development Guidance: Methods to
www.fda.gov/Drugs/NewsEvents/ Identify What is Important to Patients
Patient-Focused Drug Development ucm607276.htm prior to the workshop. and Select, Develop or Modify Fit-for-
Guidance: Methods To Identify What Is You may submit comments as Purpose Clinical Outcome Assessments;
Important to Patients and Select, follows. Please note that late, untimely Public Workshop; Request for
Develop, or Modify Fit-for-Purpose filed comments will not be considered. Comments.’’ Received comments, those
Clinical Outcome Assessments; Public Electronic comments must be submitted filed in a timely manner (see
Workshop; Request for Comments on or before December 14, 2018. The ADDRESSES), will be placed in the docket
AGENCY: Food and Drug Administration, https://www.regulations.gov electronic and, except for those submitted as
HHS. filing system will accept comments ‘‘Confidential Submissions,’’ publicly
ACTION: Notice of public workshop; until midnight Eastern Time at the end viewable at https://www.regulations.gov
request for comments. of December 14, 2018. Comments or at the Dockets Management Staff
received by mail/hand delivery/courier between 9 a.m. and 4 p.m., Monday
SUMMARY: The Food and Drug (for written/paper submissions) will be through Friday.
Administration (FDA) is announcing a considered timely if they are • Confidential Submissions—To
2-day public workshop to convene a postmarked or the delivery service submit a comment with confidential
discussion on methodological information that you do not wish to be
sradovich on DSK3GMQ082PROD with NOTICES
acceptance receipt is on or before that
approaches that may be used to identify date. made publicly available, submit your
what is most important to patients and comments only as a written/paper
caregivers with respect to burden of Electronic Submissions submission. You should submit two
disease, burden of treatment, and the Submit electronic comments in the copies total. One copy will include the
benefits and risks in the management of following way: information you claim to be confidential
the patient’s disease, and best practices • Federal eRulemaking Portal: with a heading or cover note that states
for selecting, developing, or modifying https://www.regulations.gov. Follow the ‘‘THIS DOCUMENT CONTAINS
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![Federal Register / Vol. 83, No. 156 / Monday, August 13, 2018 / Notices 40059
organizations with common interests are major and imminently life-threatening used in emergencies to diagnose, treat,
urged to consolidate or coordinate, and combat casualties involving or prevent serious or life-threatening
request time for a joint presentation. No uncontrolled hemorrhage. On the basis diseases or conditions caused by
commercial or promotional material of such determination, the Department biological, chemical, nuclear, or
will be permitted to be presented or of Health and Human Services (HHS) radiological agents and other agents that
distributed at the public workshop. Secretary declared on July 9, 2018, that may cause, or are otherwise associated
Transcripts: As soon as a transcript is circumstances exist justifying the with, an imminently life-threatening
available, FDA will post it at https:// authorization of emergency use of freeze and specific risk to U.S. military forces
www.fda.gov/Drugs/NewsEvents/ dried plasma for the treatment of when there are no adequate, approved,
ucm607276.htm. hemorrhage or coagulopathy during an and available alternatives.
emergency involving agents of military Section 564(b)(1) of the FD&C Act
Dated: August 8, 2018.
combat (e.g., firearms, projectiles, and provides that, before an EUA may be
Leslie Kux,
explosive devices) when plasma is not issued, the Secretary of HHS must
Associate Commissioner for Policy. available for use or when the use of declare that circumstances exist
[FR Doc. 2018–17272 Filed 8–10–18; 8:45 am] plasma is not practical, subject to the justifying the authorization based on
BILLING CODE 4164–01–P terms of any authorization issued under one of the following grounds: (1) A
the FD&C Act. The Authorization, determination by the Secretary of
which includes an explanation of the Homeland Security that there is a
DEPARTMENT OF HEALTH AND reasons for issuance, is reprinted in this domestic emergency, or a significant
HUMAN SERVICES document. potential for a domestic emergency,
DATES: The Authorization is effective as involving a heightened risk of attack
Food and Drug Administration with a biological, chemical, radiological,
of July 9, 2018.
[Docket No. FDA–2018–N–3009] ADDRESSES: Submit written requests for or nuclear agent or agents; (2) a
single copies of the EUA to the Office determination by the Secretary of
Authorization of Emergency Use of a of Counterterrorism and Emerging Defense that there is a military
Freeze Dried Plasma Treatment for Threats, Food and Drug Administration, emergency, or a significant potential for
Hemorrhage or Coagulopathy During 10903 New Hampshire Ave., Bldg. 1, a military emergency, involving a
an Emergency Involving Agents of Rm. 4338, Silver Spring, MD 20993– heightened risk to U.S. military forces,
Military Combat; Availability 0002. Send one self-addressed adhesive including personnel operating under the
label to assist that office in processing authority of title 10 or title 50, United
AGENCY: Food and Drug Administration, States Code, of attack with (i) a
HHS. your request or include a fax number to
which the Authorization may be sent. biological, chemical, radiological, or
ACTION: Notice. nuclear agent or agents; or (ii) an agent
See the SUPPLEMENTARY INFORMATION
section for electronic access to the or agents that may cause, or are
SUMMARY: The Food and Drug otherwise associated with, an
Administration (FDA) is announcing the Authorization.
imminently life-threatening and specific
issuance of an Emergency Use FOR FURTHER INFORMATION CONTACT: risk to U.S. military forces; 1 (3) a
Authorization (EUA) (the Authorization) Michael Mair, Office of determination by the Secretary of HHS
for a freeze dried plasma treatment for Counterterrorism and Emerging Threats, that there is a public health emergency,
hemorrhage or coagulopathy during an Food and Drug Administration, 10903 or a significant potential for a public
emergency involving agents of military New Hampshire Ave., Bldg. 1, Rm. health emergency, that affects, or has a
combat (e.g., firearms, projectiles, and 4340, Silver Spring, MD 20993–0002, significant potential to affect, national
explosive devices) when plasma is not 301–796–8510 (this is not a toll-free security or the health and security of
available for use or when the use of number). U.S. citizens living abroad, and that
plasma is not practical. FDA issued this SUPPLEMENTARY INFORMATION: involves a biological, chemical,
Authorization under the Federal Food, radiological, or nuclear agent or agents,
Drug, and Cosmetic Act (FD&C Act), as I. Background
or a disease or condition that may be
requested by the U.S. Department of Section 564 of the FD&C Act (21 attributable to such agent or agents; or
Defense (DoD). The Authorization U.S.C. 360bbb–3) as amended by the (4) the identification of a material threat
contains, among other things, Project BioShield Act of 2004 (Pub. L. by the Secretary of Homeland Security
conditions on the emergency use of the 108–276), the Pandemic and All- under section 319F–2 of the Public
authorized treatment. The Authorization Hazards Preparedness Reauthorization Health Service (PHS) Act (42 U.S.C.
follows the June 7, 2018, determination Act of 2013 (Pub. L. 113–5), 21st 247d–6b) sufficient to affect national
by the Deputy Secretary of Defense that Century Cures Act (Pub. L. 114–255), security or the health and security of
there is a military emergency or and Public Law 115–92 (2017), allows U.S. citizens living abroad.
significant potential for a military FDA to strengthen the public health Once the Secretary of HHS has
emergency, involving a heightened risk protections against biological, chemical, declared that circumstances exist
to U.S. military forces of an attack with nuclear, and radiological agents and justifying an authorization under
an agent or agents that may cause, or are other agents that may cause, or are section 564 of the FD&C Act, FDA may
otherwise associated with an otherwise associated with, an authorize the emergency use of a drug,
imminently life-threatening and specific imminently life-threatening and specific device, or biological product if the
risk to those forces. The Deputy risk to U.S. military forces. Among other
sradovich on DSK3GMQ082PROD with NOTICES
Agency concludes that the statutory
Secretary of Defense further stated that, things, section 564 of the FD&C Act criteria are satisfied. Under section
more specifically, U.S. forces are now allows FDA to authorize the use of an
deployed in multiple locations where unapproved medical product or an 1 In the case of a determination by the Secretary
they serve at heightened risk of an unapproved use of an approved medical of Defense, the Secretary of HHS shall determine,
within 45 calendar days of such determination,
enemy attack with agents of military product in certain situations. With this whether to make a declaration under section
combat, including firearms, projectiles, EUA authority, FDA can help assure 564(b)(1) of the FD&C Act, and, if appropriate, shall
and explosive devices, that may cause that medical countermeasures may be promptly make such a declaration.
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Document Created: 2018-08-11 00:26:42
Document Modified: 2018-08-11 00:26:42
| 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 15 and 16, 2018, from 9 a.m. to 5 p.m. Submit either electronic or written comments on this public workshop by December 14, 2018. See the SUPPLEMENTARY INFORMATION section for registration date and 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 | 83 FR 40057 |
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