[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, 
leila.hann@fda.hhs.gov; 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, stephen.ripley@fda.hhs.gov.

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]
BILLING CODE 4164-01-P


