82 FR 29569 - Program for Enhanced Review Transparency and Communication for Original 351(k) Biologics License Applications in Biosimilar User Fee Act II
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 124 (June 29, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 124 (June 29, 2017)
| Page Range | 29569-29570 | |
| FR Document | 2017-13609 |
[Federal Register Volume 82, Number 124 (Thursday, June 29, 2017)] [Notices] [Pages 29569-29570] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-13609] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-3199] Program for Enhanced Review Transparency and Communication for Original 351(k) Biologics License Applications in Biosimilar User Fee Act II AGENCY: Food and Drug Administration, HHS. ACTION: Notice; establishment of docket; request for comments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the statement of work for an assessment of the Program for Enhanced Review Transparency and Communication for original biologics license applications (BLAs) (351(k)s) submitted under the Public Health Service Act (hereafter referred to as 351(k) applications) (hereafter referred to as the Program). The Program is part of the FDA performance commitments under the proposed reauthorization of the Biosimilar User Fee Act (BsUFA), which, if enacted into law, will allow FDA to collect user fees for the review of 351(k) applications for fiscal years (FYs) 2018-2022. As part of the FDA performance commitments described in this document, the Program will be evaluated by an independent contractor in an interim and final assessment. DATES: FDA is providing a period of 30 days for public comment on the statement of work before beginning the assessment. The statement of work can be accessed at https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM559341.pdf. Public comments will be accepted through July 31, 2017. See ADDRESSES section below for information about submitting comments to the public docket. 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 July 31, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of July 31, 2017. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' [[Page 29570]] Instructions: All submissions received must include the Docket No. FDA-2017-N-3199 for ``Program for Enhanced Review Transparency and Communication for Original 351(k) Biologics License Applications in BsUFA II.'' 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: Azada Hafiz, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1148, Silver Spring, MD 20993, 240-402- 6073, Fax: 301-847-8443, Azada.Hafiz@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background The timely review of 351(k) applications is central to FDA's mission to protect and promote the public health. The BsUFA was first enacted by Congress in 2012 and authorizes FDA to collect user fees for 351(k) applications. FDA dedicates BsUFA user fees to the efficient review of 351(k) applications and to facilitate the development of safe and effective biosimilar biological products for the American public. FDA dedicates the additional fee resources to hire reviewers and support staff and upgrade its information technology systems. With the availability of these additional fee resources, FDA was able to agree to certain review performance goals, including a complete review of 351(k) applications and taking regulatory action within specified timeframes. The current authorization of the program (BsUFA I) expires in September 2017. As directed by statute, FDA prepared recommendations for the reauthorization of BsUFA for a new 5-year period by conducting negotiations with the regulated industry and holding regular consultations with public stakeholders including patient advocates, consumer advocates, and healthcare professionals. Following these discussions, related public meetings, and Agency requests for public comment, FDA transmitted proposed recommendations for BsUFA II for fiscal years 2018-2022. FDA's BsUFA II recommendations include an FDA commitment to implement a new review program for 351(k) applications to promote the efficiency and effectiveness of the first-cycle review process and minimize the number of review cycles necessary for approval of these complex applications. The Program is described in detail in section I.B of the document entitled ``Biosimilar Biological Product Reauthorization Performance Goals and Procedures Fiscal Years 2018 Through 2022'' available at https://www.fda.gov/downloads/forindustry/userfees/biosimilaruserfeeactbsufa/ucm521121.pdf. II. BsUFA II Program for Enhanced Review Transparency and Communication for Original 351(k) BLAs FDA recognizes that increasing communication between the Agency and applicants during FDA's review has the potential to increase efficiency in the review process. To enhance review transparency and improve communication between the FDA review team and the applicant, FDA has proposed for BsUFA II a new review model (the Program), for the review of all 351(k) applications. The Program will allow for additional communication between FDA review teams and the applicants of biosimilar biological products in the form of a Biological Product Development Type 4 (pre-351(k) BLA) meetings, mid-cycle communications, and late- cycle meetings. To accommodate this increased interaction during regulatory review and to address the need for additional time to review these complex applications, FDA's review clock will begin after the 60- day administrative filing review period for applications reviewed under the Program. The goal of the Program is to improve the efficiency and effectiveness of the first-cycle review process by increasing communications during application review. This will provide sponsors with the opportunity to clarify previous submissions and provide additional data and analyses that are readily available, potentially avoiding the need for an additional review cycle when concerns can be promptly resolved without compromising FDA's standards for approval. Dated: June 23, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-13609 Filed 6-28-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 124 / Thursday, June 29, 2017 / Notices 29569
limited; therefore, FDA may limit the Transcripts: Please be advised that as PrescriptionDrugUserFee/
number of participants from each soon as a transcript of the public UCM559341.pdf. Public comments will
organization. Registrants will receive workshop is available, it will be be accepted through July 31, 2017. See
confirmation when they have been accessible at https:// ADDRESSES section below for
accepted. If time and space permit, www.regulations.gov. It may be viewed information about submitting comments
onsite registration on the day of the at the Dockets Management Staff (see to the public docket.
public meeting/public workshop will be ADDRESSES). A link to the transcript will ADDRESSES: You may submit comments
provided beginning at 8 a.m. We will let also be available approximately 45 days as follows. Please note that late,
registrants know if registration closes after the public workshop on the untimely filed comments will not be
before the day of the public workshop. Internet at http://www.fda.gov/ considered. Electronic comments must
If you need special accommodations MedicalDevices/NewsEvents/ be submitted on or before July 31, 2017.
due to a disability, please contact Susan WorkshopsConferences/default.htm. The https://www.regulations.gov
Monahan, Center for Devices and (Select this public workshop from the electronic filing system will accept
Radiological Health, Food and Drug posted events list). comments until midnight Eastern Time
Administration, 10903 New Hampshire at the end of July 31, 2017. Comments
Dated: June 23, 2017.
Ave., Bldg. 66, Rm. 4321, Silver Spring, received by mail/hand delivery/courier
MD 20993–0002, 301–796–5661, email: Anna K. Abram,
(for written/paper submissions) will be
susan.monahan@fda.hhs.gov no later Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
considered timely if they are
than August 30, 2017. postmarked or the delivery service
Requests for Oral Presentations: [FR Doc. 2017–13611 Filed 6–28–17; 8:45 am]
acceptance receipt is on or before that
During online registration you may BILLING CODE 4164–01–P
date.
indicate if you wish to present during
the public comment session, and which Electronic Submissions
topic you wish to present. We will do DEPARTMENT OF HEALTH AND Submit electronic comments in the
our best to accommodate requests to HUMAN SERVICES following way:
make public comments. Individuals and • Federal eRulemaking Portal:
organizations with common interests are Food and Drug Administration https://www.regulations.gov. Follow the
urged to consolidate or coordinate their [Docket No. FDA–2017–N–3199] instructions for submitting comments.
presentations, and request time for a Comments submitted electronically,
joint presentation. Following the close Program for Enhanced Review including attachments, to https://
of registration, we will determine the Transparency and Communication for www.regulations.gov will be posted to
amount of time allotted to each Original 351(k) Biologics License the docket unchanged. Because your
presenter and the approximate time Applications in Biosimilar User Fee Act comment will be made public, you are
each oral presentation is to begin, and II solely responsible for ensuring that your
will select and begin notifying comment does not include any
participants by September 5, 2017. All AGENCY: Food and Drug Administration,
HHS. confidential information that you or a
requests to make oral presentations third party may not wish to be posted,
must be received by the close of ACTION: Notice; establishment of docket; such as medical information, your or
registration on September 1, 2017. If request for comments. anyone else’s Social Security number, or
selected for presentation, any confidential business information, such
SUMMARY: The Food and Drug
presentation materials must be emailed as a manufacturing process. Please note
to Natasha Townsend (see FOR FURTHER Administration (FDA) is announcing an
opportunity for public comment on the that if you include your name, contact
INFORMATION CONTACT) no later than information, or other information that
September 8, 2017, 5 p.m. No statement of work for an assessment of
the Program for Enhanced Review identifies you in the body of your
commercial or promotional material comments, that information will be
will be permitted to be presented or Transparency and Communication for
original biologics license applications posted on https://www.regulations.gov.
distributed at the public workshop.
(BLAs) (351(k)s) submitted under the • If you want to submit a comment
Streaming Webcast of the Public with confidential information that you
Workshop: This public workshop will Public Health Service Act (hereafter
referred to as 351(k) applications) do not wish to be made available to the
also be Webcast. Persons interested in public, submit the comment as a
viewing the Webcast must register (hereafter referred to as the Program).
The Program is part of the FDA written/paper submission and in the
online by September 8, 2017, 4 p.m. The manner detailed (see ‘‘Written/Paper
Webcast link will be available on the performance commitments under the
proposed reauthorization of the Submissions’’ and ‘‘Instructions’’).
registration Web page after September 8,
2017. Organizations are requested to Biosimilar User Fee Act (BsUFA), Written/Paper Submissions
register all participants, but to view which, if enacted into law, will allow Submit written/paper submissions as
using one connection per location. FDA to collect user fees for the review follows:
If you have never attended a Connect of 351(k) applications for fiscal years • Mail/Hand delivery/Courier (for
Pro event before, test your connection at (FYs) 2018–2022. As part of the FDA written/paper submissions): Dockets
https://collaboration.fda.gov/common/ performance commitments described in Management Staff (HFA–305), Food and
help/en/support/meeting_test.htm. To this document, the Program will be Drug Administration, 5630 Fishers
get a quick overview of the Connect Pro evaluated by an independent contractor
sradovich on DSK3GMQ082PROD with NOTICES
Lane, Rm. 1061, Rockville, MD 20852.
program, visit: http://www.adobe.com/ in an interim and final assessment. • For written/paper comments
go/connectpro_overview. FDA has DATES: FDA is providing a period of 30 submitted to the Dockets Management
verified the Web site addresses in this days for public comment on the Staff, FDA will post your comment, as
document, as of the date this document statement of work before beginning the well as any attachments, except for
publishes in the Federal Register, but assessment. The statement of work can information submitted, marked and
Web sites are subject to change over be accessed at https://www.fda.gov/ identified, as confidential, if submitted
time. downloads/ForIndustry/UserFees/ as detailed in ‘‘Instructions.’’
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![29570 Federal Register / Vol. 82, No. 124 / Thursday, June 29, 2017 / Notices
Instructions: All submissions received MD 20993, 240–402–6073, Fax: 301– transparency and improve
must include the Docket No. FDA– 847–8443, Azada.Hafiz@fda.hhs.gov. communication between the FDA
2017–N–3199 for ‘‘Program for SUPPLEMENTARY INFORMATION: review team and the applicant, FDA has
Enhanced Review Transparency and proposed for BsUFA II a new review
Communication for Original 351(k) I. Background model (the Program), for the review of
Biologics License Applications in The timely review of 351(k) all 351(k) applications. The Program
BsUFA II.’’ Received comments, those applications is central to FDA’s mission will allow for additional
filed in a timely manner (see to protect and promote the public communication between FDA review
ADDRESSES), will be placed in the docket health. The BsUFA was first enacted by teams and the applicants of biosimilar
and, except for those submitted as Congress in 2012 and authorizes FDA to biological products in the form of a
‘‘Confidential Submissions,’’ publicly collect user fees for 351(k) applications. Biological Product Development Type 4
viewable at https://www.regulations.gov FDA dedicates BsUFA user fees to the (pre-351(k) BLA) meetings, mid-cycle
or at the Dockets Management Staff efficient review of 351(k) applications communications, and late-cycle
between 9 a.m. and 4 p.m., Monday and to facilitate the development of safe meetings. To accommodate this
through Friday. and effective biosimilar biological increased interaction during regulatory
products for the American public. FDA review and to address the need for
• Confidential Submissions—To dedicates the additional fee resources to additional time to review these complex
submit a comment with confidential hire reviewers and support staff and applications, FDA’s review clock will
information that you do not wish to be upgrade its information technology begin after the 60-day administrative
made publicly available, submit your systems. With the availability of these filing review period for applications
comments only as a written/paper additional fee resources, FDA was able reviewed under the Program.
submission. You should submit two to agree to certain review performance The goal of the Program is to improve
copies total. One copy will include the goals, including a complete review of the efficiency and effectiveness of the
information you claim to be confidential 351(k) applications and taking first-cycle review process by increasing
with a heading or cover note that states regulatory action within specified communications during application
‘‘THIS DOCUMENT CONTAINS timeframes. The current authorization of review. This will provide sponsors with
CONFIDENTIAL INFORMATION.’’ The the program (BsUFA I) expires in the opportunity to clarify previous
Agency will review this copy, including September 2017. submissions and provide additional
the claimed confidential information, in As directed by statute, FDA prepared data and analyses that are readily
its consideration of comments. The recommendations for the available, potentially avoiding the need
second copy, which will have the reauthorization of BsUFA for a new 5- for an additional review cycle when
claimed confidential information year period by conducting negotiations concerns can be promptly resolved
redacted/blacked out, will be available with the regulated industry and holding without compromising FDA’s standards
for public viewing and posted on regular consultations with public for approval.
https://www.regulations.gov. Submit stakeholders including patient
both copies to the Dockets Management Dated: June 23, 2017.
advocates, consumer advocates, and
Staff. If you do not wish your name and Anna K. Abram,
healthcare professionals. Following
contact information to be made publicly these discussions, related public Deputy Commissioner for Policy, Planning,
available, you can provide this Legislation, and Analysis.
meetings, and Agency requests for
information on the cover sheet and not public comment, FDA transmitted [FR Doc. 2017–13609 Filed 6–28–17; 8:45 am]
in the body of your comments and you proposed recommendations for BsUFA BILLING CODE 4164–01–P
must identify this information as II for fiscal years 2018–2022. FDA’s
‘‘confidential.’’ Any information marked BsUFA II recommendations include an
as ‘‘confidential’’ will not be disclosed FDA commitment to implement a new DEPARTMENT OF HEALTH AND
except in accordance with 21 CFR 10.20 review program for 351(k) applications HUMAN SERVICES
and other applicable disclosure law. For to promote the efficiency and National Institutes of Health
more information about FDA’s posting effectiveness of the first-cycle review
of comments to public dockets, see 80 process and minimize the number of Center for Scientific Review; Notice of
FR 56469, September 18, 2015, or access review cycles necessary for approval of Closed Meetings
the information at: https://www.gpo.gov/ these complex applications. The
fdsys/pkg/FR-2015-09-18/pdf/2015- Program is described in detail in section Pursuant to section 10(d) of the
23389.pdf. I.B of the document entitled ‘‘Biosimilar Federal Advisory Committee Act, as
Biological Product Reauthorization amended (5 U.S.C. App.), notice is
Docket: For access to the docket to hereby given of the following meetings.
read background documents or the Performance Goals and Procedures
Fiscal Years 2018 Through 2022’’ The meetings will be closed to the
electronic and written/paper comments public in accordance with the
received, go to https:// available at https://www.fda.gov/
downloads/forindustry/userfees/ provisions set forth in sections
www.regulations.gov and insert the 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
docket number, found in brackets in the biosimilaruserfeeactbsufa/
ucm521121.pdf. as amended. The grant applications and
heading of this document, into the the discussions could disclose
‘‘Search’’ box and follow the prompts II. BsUFA II Program for Enhanced confidential trade secrets or commercial
and/or go to the Dockets Management Review Transparency and property such as patentable material,
sradovich on DSK3GMQ082PROD with NOTICES
Staff, 5630 Fishers Lane, Rm. 1061, Communication for Original 351(k) and personal information concerning
Rockville, MD 20852. BLAs individuals associated with the grant
FOR FURTHER INFORMATION CONTACT: FDA recognizes that increasing applications, the disclosure of which
Azada Hafiz, Center for Drug Evaluation communication between the Agency would constitute a clearly unwarranted
and Research, Food and Drug and applicants during FDA’s review has invasion of personal privacy.
Administration, 10903 New Hampshire the potential to increase efficiency in Name of Committee: Center for Scientific
Ave., Bldg. 51, Rm. 1148, Silver Spring, the review process. To enhance review Review Special Emphasis Panel; PAR16–274:
VerDate Sep<11>2014 18:29 Jun 28, 2017 Jkt 241001 PO 00000 Frm 00097 Fmt 4703 Sfmt 4703 E:\FR\FM\29JNN1.SGM 29JNN1](https://thefederalregister.org/doc/82_FR_29693/page/2.svg)
Document Created: 2018-11-14 10:17:04
Document Modified: 2018-11-14 10:17:04
| 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 docket; request for comments. | |
| Dates | FDA is providing a period of 30 days for public comment on the statement of work before beginning the assessment. The statement of work can be accessed at https://www.fda.gov/downloads/ForIndustry/ UserFees/PrescriptionDrugUserFee/UCM559341.pdf. Public comments will be | |
| Contact | Azada Hafiz, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1148, Silver Spring, MD 20993, 240-402- 6073, Fax: 301-847-8443, Aza[email protected] | |
| FR Citation | 82 FR 29569 |
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