82 FR 57990 - Prescription Drug User Fee Act VI Commitment To Assess Current Practices of the Food and Drug Administration and Sponsors in Communicating During Investigational New Drug Development; Establishment of a Public Docket; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 235 (December 8, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 235 (December 8, 2017)
| Page Range | 57990-57991 | |
| FR Document | 2017-26437 |
[Federal Register Volume 82, Number 235 (Friday, December 8, 2017)] [Notices] [Pages 57990-57991] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-26437] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-6313] Prescription Drug User Fee Act VI Commitment To Assess Current Practices of the Food and Drug Administration and Sponsors in Communicating During Investigational New Drug Development; Establishment of a Public Docket; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice; establishment of a public docket; request for comments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the statement of work to assess current practices of FDA and sponsors in communicating during investigational new drug (IND) development and identify best practices and areas of improvement. The independent assessment is part of FDA performance commitments under the recent reauthorization of the Prescription Drug User Fee Act (PDUFA). The independent assessment of current practices of FDA and sponsors in communicating during drug development is described in detail in the document entitled ``PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2018 Through 2022'' available at https://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm511438.pdf. As part of FDA performance commitments described in this document, the assessment will be conducted by an independent contractor. FDA is providing for public comment on the statement of work before revising and requesting contractor proposals. DATES: Submit either electronic or written comments by January 22, 2018. ADDRESSES: 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 January 22, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of January 22, 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. You may submit comments as follows: 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, [[Page 57991]] 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-6313 for ``Prescription Drug User Fee Act VI Commitment to Assess Current Practices of the Food and Drug Administration and Sponsors in Communicating During Investigational New Drug Development.'' 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: Yoni Tyberg, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1151, Silver Spring, MD 20993, 301-348- 1718, Fax: 301-847-8443, [email protected]. SUPPLEMENTARY INFORMATION: I. Background The IND phase of drug development is the time during which human trials of investigational drugs are conducted. During the IND phase, sponsors and FDA engage in many types of communications. To ensure the effectiveness of human drug review programs, it is critical that these communications be conducted in a timely and efficient manner. The timely review of the safety and effectiveness of new drugs and biologics is central to FDA's mission to protect and promote the public health. Prior to enactment of PDUFA in 1992, FDA's drug review process was relatively slow and not very predictable compared to that of other countries. Due to concerns expressed by both industry and patients at the time, Congress enacted PDUFA, which provided the added funds through user fees that enabled FDA to hire additional reviewers and support staff and upgrade its information technology systems. In return for additional resources, FDA agreed to certain review performance goals, such as completing reviews of new drug applications and biologics license applications and taking regulatory actions on them in predictable timeframes. These changes revolutionized the drug approval process in the United States and enabled FDA to speed the application review process for new drugs and biologics without compromising the Agency's high standards for demonstration of safety, efficacy, and quality of new drugs and biologics prior to approval. PDUFA provides FDA with a source of stable, consistent funding that has made it possible for it to focus on promoting innovative therapies and help bring to market critical products for patients. When PDUFA was originally authorized in 1992, it had a 5-year term. The program has been subsequently reauthorized every 5 years with the most recent reauthorization occurring in 2017 for fiscal years (FYs) 2018-2022. To prepare for the 2017 reauthorization of PDUFA, FDA conducted negotiations with the regulated industry and held regular consultations with public stakeholders including patient advocates, consumer advocates, and health care professionals between September 2015 and February 2016. Following these discussions, related public meetings, and Agency requests for public comment, FDA published proposed recommendations for PDUFA VI for FYs 2018-2022. FDA committed under PDUFA VI to contract with an independent third party to assess current practices of FDA and sponsors in communicating during IND development and to identify best practices and areas of improvement. The statement of work can be accessed at https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM577087.pdf. Dated: December 4, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-26437 Filed 12-7-17; 8:45 am] BILLING CODE 4164-01-P
![57990 Federal Register / Vol. 82, No. 235 / Friday, December 8, 2017 / Notices
Registration is free and based on requested to register all participants, but ACTION: Notice; establishment of a
space availability, with priority given to to view using one connection per public docket; request for comments.
early registrants. Persons interested in location.
attending this public workshop must SUMMARY: The Food and Drug
If you have never attended a Connect
register by January 18, 2018, 4 p.m. Administration (FDA) is announcing an
Pro event before, test your connection at
Eastern Time. Early registration is opportunity for public comment on the
https://collaboration.fda.gov/common/
recommended because seating is statement of work to assess current
help/en/support/meeting_test.htm. To
limited; therefore, FDA may limit the practices of FDA and sponsors in
get a quick overview of the Connect Pro
number of participants from each communicating during investigational
program, visit http://www.adobe.com/
organization. Registrants will receive new drug (IND) development and
go/connectpro_overview. FDA has
confirmation when they have been identify best practices and areas of
verified the Web site addresses in this
accepted. If time and space permit, improvement. The independent
document, as of the date this document assessment is part of FDA performance
onsite registration on the day of the publishes in the Federal Register, but
public workshop will be provided commitments under the recent
Web sites are subject to change over reauthorization of the Prescription Drug
beginning at 7:30 a.m. We will let time.
registrants know if registration closes User Fee Act (PDUFA). The
Transcripts: Please be advised that as independent assessment of current
before the day of the public workshop. soon as a transcript of the public
If you need special accommodations practices of FDA and sponsors in
workshop is available, it will be communicating during drug
due to a disability, please contact Susan accessible at https://
Monahan, Center for Devices and development is described in detail in
www.regulations.gov. It may be viewed the document entitled ‘‘PDUFA
Radiological Health, Food and Drug at the Dockets Management Staff (see
Administration, 10903 New Hampshire Reauthorization Performance Goals and
ADDRESSES). A link to the transcript will Procedures Fiscal Years 2018 Through
Ave., Bldg. 32, Rm. 5231, Silver Spring,
also be available on the Internet at 2022’’ available at https://www.fda.gov/
MD 20993–0002, 301–796–5661 or
https://www.fda.gov/MedicalDevices/ downloads/forindustry/userfees/
email: Susan.Monahan@fda.hhs.gov, no
NewsEvents/WorkshopsConferences/ prescriptiondruguserfee/
later than January 16, 2018.
Requests for Oral Presentations: default.htm. ucm511438.pdf. As part of FDA
During online registration, you may IV. Reference performance commitments described in
indicate if you wish to present during a this document, the assessment will be
public comment session and which The following reference is on display conducted by an independent
topic(s) you wish to address. We will do at the Dockets Management Staff (see contractor. FDA is providing for public
ADDRESSES), and is available for viewing comment on the statement of work
our best to accommodate requests to
make public comments and requests to by interested persons between 9 a.m. before revising and requesting
participate in the focused sessions. and 4 p.m., Monday through Friday; it contractor proposals.
Individuals and organizations with is also available electronically at https:// DATES: Submit either electronic or
common interests are urged to www.regulations.gov. FDA has verified written comments by January 22, 2018.
consolidate or coordinate their the Web site addresses, as of the date ADDRESSES: You may submit comments
presentations, and request time for a this document publishes in the Federal as follows. Please note that late,
joint presentation, or submit requests for Register, but Web sites are subject to untimely filed comments will not be
designated representatives to participate change over time. considered. Electronic comments must
in the focused sessions. Following the 1. FDA’s Digital Health Innovation Action be submitted on or before January 22,
close of registration, we will determine Plan issued on July 27, 2017 available at: 2018. The https://www.regulations.gov
the amount of time allotted to each https://www.fda.gov/MedicalDevices/ electronic filing system will accept
presenter and the approximate time DigitalHealth/UCM567265.
comments until midnight Eastern Time
each oral presentation is to begin, and Dated: December 4, 2017. at the end of January 22, 2018.
will select and notify participants by Leslie Kux, Comments received by mail/hand
January 19, 2018. All requests to make Associate Commissioner for Policy. delivery/courier (for written/paper
oral presentations must be received by [FR Doc. 2017–26457 Filed 12–7–17; 8:45 am] submissions) will be considered timely
the close of registration on January 18, if they are postmarked or the delivery
BILLING CODE 4164–01–P
2018, 4 p.m. If selected for presentation, service acceptance receipt is on or
any presentation materials must be before that date.
emailed to Maggie Fu at maggie.fu@ DEPARTMENT OF HEALTH AND You may submit comments as
fda.hhs.gov no later than January 25, HUMAN SERVICES follows:
2018. No commercial or promotional
material will be permitted to be Electronic Submissions
Food and Drug Administration
presented or distributed at the public Submit electronic comments in the
workshop. [Docket No. FDA–2017–N–6313]
following way:
Streaming Webcast of the Public • Federal eRulemaking Portal:
Workshop: This public workshop will Prescription Drug User Fee Act VI https://www.regulations.gov. Follow the
also be webcast. The webcast link will Commitment To Assess Current instructions for submitting comments.
be available on the registration Web Practices of the Food and Drug Comments submitted electronically,
page after January 23, 2018. Please visit including attachments, to https://
sradovich on DSK3GMQ082PROD with NOTICES
Administration and Sponsors in
FDA’s Medical Devices News & Communicating During Investigational www.regulations.gov will be posted to
Events—Workshops & Conferences New Drug Development; Establishment the docket unchanged. Because your
calendar (https://www.fda.gov/ of a Public Docket; Request for comment will be made public, you are
MedicalDevices/NewsEvents/ Comments solely responsible for ensuring that your
WorkshopsConferences/default.htm) comment does not include any
and select this event from the list of AGENCY: Food and Drug Administration, confidential information that you or a
items provided. Organizations are HHS. third party may not wish to be posted,
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![Federal Register / Vol. 82, No. 235 / Friday, December 8, 2017 / Notices 57991
such as medical information, your or Staff. If you do not wish your name and actions on them in predictable
anyone else’s Social Security number, or contact information to be made publicly timeframes. These changes
confidential business information, such available, you can provide this revolutionized the drug approval
as a manufacturing process. Please note information on the cover sheet and not process in the United States and
that if you include your name, contact in the body of your comments and you enabled FDA to speed the application
information, or other information that must identify this information as review process for new drugs and
identifies you in the body of your ‘‘confidential.’’ Any information marked biologics without compromising the
comments, that information will be as ‘‘confidential’’ will not be disclosed Agency’s high standards for
posted on https://www.regulations.gov. except in accordance with 21 CFR 10.20 demonstration of safety, efficacy, and
• If you want to submit a comment and other applicable disclosure law. For quality of new drugs and biologics prior
with confidential information that you more information about FDA’s posting to approval.
do not wish to be made available to the of comments to public dockets, see 80 PDUFA provides FDA with a source
public, submit the comment as a FR 56469, September 18, 2015, or access of stable, consistent funding that has
written/paper submission and in the the information at: https://www.gpo.gov/ made it possible for it to focus on
manner detailed (see ‘‘Written/Paper fdsys/pkg/FR-2015-09-18/pdf/2015- promoting innovative therapies and
Submissions’’ and ‘‘Instructions’’). 23389.pdf. help bring to market critical products
Docket: For access to the docket to for patients. When PDUFA was
Written/Paper Submissions
read background documents or the originally authorized in 1992, it had a
Submit written/paper submissions as electronic and written/paper comments 5-year term. The program has been
follows: received, go to https:// subsequently reauthorized every 5 years
• Mail/Hand delivery/Courier (for www.regulations.gov and insert the with the most recent reauthorization
written/paper submissions): Dockets occurring in 2017 for fiscal years (FYs)
docket number, found in brackets in the
Management Staff (HFA–305), Food and 2018–2022. To prepare for the 2017
heading of this document, into the
Drug Administration, 5630 Fishers reauthorization of PDUFA, FDA
‘‘Search’’ box and follow the prompts
Lane, Rm. 1061, Rockville, MD 20852. conducted negotiations with the
• For written/paper comments and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061, regulated industry and held regular
submitted to the Dockets Management consultations with public stakeholders
Staff, FDA will post your comment, as Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
including patient advocates, consumer
well as any attachments, except for advocates, and health care professionals
information submitted, marked and Yoni Tyberg, Center for Drug Evaluation
and Research, Food and Drug between September 2015 and February
identified, as confidential, if submitted 2016. Following these discussions,
as detailed in ‘‘Instructions.’’ Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 1151, Silver Spring, related public meetings, and Agency
Instructions: All submissions received requests for public comment, FDA
must include the Docket No. FDA– MD 20993, 301–348–1718, Fax: 301–
847–8443, Yonatan.Tyberg@ published proposed recommendations
2017–N–6313 for ‘‘Prescription Drug for PDUFA VI for FYs 2018–2022. FDA
User Fee Act VI Commitment to Assess fda.hhs.gov.
committed under PDUFA VI to contract
Current Practices of the Food and Drug SUPPLEMENTARY INFORMATION: with an independent third party to
Administration and Sponsors in assess current practices of FDA and
Communicating During Investigational I. Background
sponsors in communicating during IND
New Drug Development.’’ Received The IND phase of drug development development and to identify best
comments, those filed in a timely is the time during which human trials practices and areas of improvement.
manner (see ADDRESSES), will be placed of investigational drugs are conducted. The statement of work can be
in the docket and, except for those During the IND phase, sponsors and accessed at https://www.fda.gov/
submitted as ‘‘Confidential FDA engage in many types of downloads/ForIndustry/UserFees/
Submissions,’’ publicly viewable at communications. To ensure the PrescriptionDrugUserFee/
https://www.regulations.gov or at the effectiveness of human drug review UCM577087.pdf.
Dockets Management Staff between 9 programs, it is critical that these
a.m. and 4 p.m., Monday through communications be conducted in a Dated: December 4, 2017.
Friday. timely and efficient manner. Leslie Kux,
• Confidential Submissions—To The timely review of the safety and Associate Commissioner for Policy.
submit a comment with confidential effectiveness of new drugs and biologics [FR Doc. 2017–26437 Filed 12–7–17; 8:45 am]
information that you do not wish to be is central to FDA’s mission to protect BILLING CODE 4164–01–P
made publicly available, submit your and promote the public health. Prior to
comments only as a written/paper enactment of PDUFA in 1992, FDA’s
submission. You should submit two drug review process was relatively slow DEPARTMENT OF HEALTH AND
copies total. One copy will include the and not very predictable compared to HUMAN SERVICES
information you claim to be confidential that of other countries. Due to concerns
with a heading or cover note that states expressed by both industry and patients Food and Drug Administration
‘‘THIS DOCUMENT CONTAINS at the time, Congress enacted PDUFA, [Docket No. FDA–2017–D–6294]
CONFIDENTIAL INFORMATION.’’ The which provided the added funds
Agency will review this copy, including through user fees that enabled FDA to Changes to Existing Medical Software
the claimed confidential information, in hire additional reviewers and support Policies Resulting From Section 3060
sradovich on DSK3GMQ082PROD with NOTICES
its consideration of comments. The staff and upgrade its information of the 21st Century Cures Act; Draft
second copy, which will have the technology systems. In return for Guidance for Industry and Food and
claimed confidential information additional resources, FDA agreed to Drug Administration Staff; Availability
redacted/blacked out, will be available certain review performance goals, such AGENCY: Food and Drug Administration,
for public viewing and posted on as completing reviews of new drug HHS.
https://www.regulations.gov. Submit applications and biologics license
ACTION: Notice of availability.
both copies to the Dockets Management applications and taking regulatory
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Document Created: 2017-12-08 01:43:38
Document Modified: 2017-12-08 01:43:38
| 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; establishment of a public docket; request for comments. | |
| Dates | Submit either electronic or written comments by January 22, 2018. | |
| Contact | Yoni Tyberg, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1151, Silver Spring, MD 20993, 301-348- 1718, Fax: 301-847-8443, [email protected] | |
| FR Citation | 82 FR 57990 |
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