[Federal Register Volume 85, Number 44 (Thursday, March 5, 2020)]
[Notices]
[Pages 12927-12928]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-04539]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-0437]
Purple Book Enhancement; Establishment of a Public Docket;
Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; establishment of a public docket; request for comments.
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SUMMARY: The Food and Drug Administration (FDA or Agency) announced the
completion of the first phase of the enhanced Purple Book on February
24, 2020. FDA is transitioning the current table format ``Purple Book:
Lists of Licensed Biological Products with Reference Product
Exclusivity and Biosimilarity or Interchangeability Evaluations'' to a
searchable, public-facing online database entitled ``Purple Book:
Database of FDA-Licensed Biological Products.'' FDA is establishing a
docket for public comment to gather stakeholder feedback on the new
database to inform the next phase of development.
DATES: Submit either electronic or written comments by May 4, 2020. FDA
is establishing a docket for public comment. The docket number is FDA-
2020-N-0437. The docket will close on May 4, 2020.
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 May 4, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of May 4, 2020. 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-2020-N-0437 for ``Purple Book Enhancement; Establishment of a
Public Docket; 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 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.govinfo.gov/content/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: Leila Hann, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 22, Rm. 1141, Silver Spring, MD 20993, 301-796-3367,
[email protected]; or Stephen Ripley, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA announced the completion of the first phase of the enhancement
of the ``Purple Book: Database of FDA-Licensed Biological Products''
(Purple Book) on February 24, 2020,
[[Page 12928]]
transitioning the current table format ``Lists of Licensed Biological
Products with Reference Product Exclusivity and Biosimilarity or
Interchangeability Evaluations'' to a searchable, public-facing online
database (available on the FDA website at https://purplebooksearch.fda.gov/).
As part of FDA's commitment to encouraging innovation and
competition among biological products and the development of
biosimilars, and to fulfill goals described in the letter entitled
``Biosimilar Biological Product Reauthorization Performance Goals and
Procedures Fiscal Years 2018 Through 2022,'' (available on the FDA
website at https://www.fda.gov/downloads/ForIndustry/UserFees/BiosimilarUserFeeActBsUFA/UCM521121.pdf) and commitments described in
the Biosimilar Action Plan (available on the FDA website at https://www.fda.gov/media/114574/download), FDA has created the Purple Book
database. The new database provides the public with timely information
about FDA-licensed biological products, including biosimilar and
interchangeable products, through a dynamic, accessible, easy-to-use
online search engine. This expanded Purple Book will offer more
information about approved biological products, including information
about whether a biological product is a reference product for a
licensed biosimilar or interchangeable product, in a user-friendly
format to help users quickly identify FDA-approved biosimilar and
interchangeable products.
The initial Purple Book Version 1.0 announced on February 24, 2020
contains a limited data set that includes all approved biosimilars
products and their related reference products, with simple search and
advanced search functionality. The goal of the initial release is to
gather stakeholder feedback and conduct user testing on the new
database to inform the next phases of development. FDA intends to
release additional phased enhancements to the database. Taking user
testing and stakeholder input into consideration, the enhanced Purple
Book is expected ultimately to include all Center for Biologics
Evaluation and Research (CBER) and Center for Drug Evaluation and
Research (CDER) regulated biological products, including transition
products, in addition to enhanced functionality. A later release of the
enhanced Purple Book will include determinations that have been made
pertaining to exclusivity.
The new Purple Book database is intended to improve transparency
and functionality for stakeholders by providing a complete view of
biological product options, including biosimilar and interchangeable
products, and to advance public awareness about licensed biological
products.
FDA is committed to making the Purple Book database interactive,
user-friendly, and functional for multiple stakeholders with varying
information needs. FDA is publishing this Federal Register notice and
opening a docket to gather public comment on this version of the
database. At the close of the comment period, the Agency will collect
this feedback for consideration as additional functionality and
improvements are developed and implemented.
FDA welcomes any relevant information that stakeholders and other
members of the public wish to share. FDA is particularly interested in
input on how the Agency can improve the Purple Book database in future
releases, including on the questions set forth below.
1. How user-friendly is the information in the new Purple Book
database?
a. Are navigation resources and instructions user-friendly?
b. Do the definitions and hover overs (information available when a
person positions a computer cursor over an image or icon without
selecting it) assist in your understanding?
2. Does the new Purple Book database help improve understanding of
available biological product options among patients, payors,
clinicians, and other parties?
a. What additional information or modifications could improve
understanding about available biological product options?
3. Which functionalities of the new database are most useful to
patients, payors, clinicians, and other parties (e.g., simple search
results, advanced search results, hover over definitions, monthly
historical data change reports, data download capabilities)?
a. Which aspects of the simple search functionality are most useful
for navigating the database and which need improvement?
b. Which aspects of the advanced search functionality are most
useful for navigating the database and which need improvement?
c. What other modifications or enhancements could improve the new
database's functionality or usability?
4. Are there other types of information or functionalities that
would be useful to include in the Purple Book database?
II. Electronic Access
Persons with access to the internet may access the Purple Book at
https://purplebooksearch.fda.gov/.
Dated: March 2, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-04539 Filed 3-4-20; 8:45 am]
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