Orange Book-Questions and Answers; Draft Guidance for Industry; Availability, 33167-33169 [2020-11682]
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jbell on DSKJLSW7X2PROD with NOTICES
Federal Register / Vol. 85, No. 105 / Monday, June 1, 2020 / Notices
505(j)(5)(F), 505A (21 U.S.C. 355a), 505E
(21 U.S.C. 355f), 506H (21 U.S.C. 356h),
and 527 (21 U.S.C. 360cc) of the FD&C
Act; see also 21 CFR 314.108, 316.31,
316.34). The exclusivities identified
above are set forth on a product-specific
basis in the Orange Book. This
information is used by a wide range of
stakeholders, including applicants of
ANDAs and 505(b)(2) applications, in
planning product development.
The Orange Book also plays an
essential administrative role in FDA’s
implementation of recent statutory
provisions related to drug product
regulation. For example, section
505(j)(12) of the FD&C Act, added by the
FDA Reauthorization Act of 2017 (Pub.
L. 115–52) (FDARA), requires FDA to
publish on its website and update at
least every 6 months a list of approved
NDA products that are off-patent and
off-exclusivity, and for which FDA has
not approved an ANDA referencing that
NDA drug product, and FDA uses the
Orange Book to populate this list.
Section 506I of the FD&C Act requires
NDA and ANDA holders to provide a
written notification to FDA 180 days
prior to withdrawing an approved drug
from sale, to provide written
notification to FDA within 180 days of
the date of approval of a drug if that
drug will not be available for sale within
180 days of the date of approval, and to
have reviewed information in the
Orange Book and submitted a one-time
marketing status report. This
information is used by FDA to move
drugs that are not available for sale from
the ‘‘Prescription Drug Product List’’ to
the ‘‘Discontinued Drug Product List’’ in
the Orange Book (see section 506I(e) of
the FD&C Act).
FDA has historically sought to update
and enhance the Orange Book to make
it more accessible and useful to
regulated industry and the public.
Below are examples of updates FDA has
made to the publication:
• In 1985, FDA added to the Orange
Book a list of OTC drug products that
have been approved in NDAs or
ANDAs.
• In 1997, FDA published the Orange
Book on the internet.
• In 2003, FDA started publishing an
indicator as to whether a listed patent
contains drug substance and/or drug
product claims.
• In 2005, FDA made the Orange
Book available for download off the
Agency’s website.
• In 2005, FDA switched from
publishing patent listings in a public
docket to publishing them daily in the
Orange Book.
VerDate Sep<11>2014
19:40 May 29, 2020
Jkt 250001
• In 2005, FDA switched from
publishing generic drug approvals
monthly to publishing them daily.
• In 2015, FDA launched a mobile
application, ‘‘Orange Book Express,’’ to
put timely information in the hands of
those using smartphones and tablets.
• In 2016, FDA redesigned the Orange
Book website to include commonly used
features on the home page and to allow
users to better navigate the Orange Book
and customize their search.
• In 2017, FDA revised the Orange
Book so that drug listings now clarify
which listed drugs are RLDs and which
are reference standards (see § 314.3(b)),
as well as to clarify which products in
the ‘‘Discontinued Drug Product List’’
may be referred to as an RLD.
• In 2017, FDA revised the Orange
Book to include listed patent
submission dates, when available.
• In 2017, FDA added the patent
disputes list to the Orange Book
website, which informs stakeholders
which patents have been disputed by an
outside party to FDA.
• In 2018, FDA updated the Orange
Book to include descriptions indicating
which indication(s) are protected by
orphan drug exclusivity.
As part of FDA’s Drug Competition
Action Plan 1 and our continued effort
to provide more accessible and useful
information in the Orange Book, FDA is
considering whether there are other
opportunities to enhance the
publication. The Drug Competition
Action Plan aims to facilitate more
generic competition, promote patient
access, and improve the economics of
developing generic medicines.
Soliciting public comment on this topic
will help guide the Agency’s priorities
as we consider enhancing the Orange
Book.
II. Establishment of a Public Docket and
Request for Comments
FDA is establishing a public docket to
solicit input from a broad group of
stakeholders, including patients, health
care providers, drug manufacturers,
public policy makers (e.g., Federal and
State health agencies), individuals
involved in patent litigation (e.g., patent
counsel), and any other interested
parties, on whether and how the Orange
Book can be improved. (To note, FDA
intends to publish a separate Federal
Register notice seeking public input
specifically on patent listings in the
Orange Book in the near future, and
thus is not soliciting comment on that
topic now.) In addition to general
1 Available at https://www.fda.gov/drugs/
guidance-compliance-regulatory-information/fdadrug-competition-action-plan.
PO 00000
Frm 00089
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33167
comments, FDA is interested in
responses to the following questions:
• What types of people or entities use
the Orange Book?
• What sections of the Orange Book
do these different types of people or
entities use?
• For what reasons do these people or
entities use the Orange Book? What
additional information or features (e.g.,
additional search functions) could be
incorporated into the Orange Book to
make it more useful?
• Is the information in the Orange
Book regarding therapeutic equivalence
generally useful?
Æ How useful is the second letter of
a therapeutic equivalence evaluation
code?
Æ How could the therapeutic
equivalence information be made more
user-friendly or otherwise be tailored to
meet the needs of people or entities that
use the Orange Book (e.g., the
therapeutic equivalence evaluation
code)?
Æ If you use the information regarding
therapeutic equivalence, how do you
use it?
Æ Does the information regarding
therapeutic equivalence promote drug
competition? And if so, how?
• Is there any other information
regarding the Orange Book that would
be useful for FDA to consider?
Dated: May 26, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–11683 Filed 5–29–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–D–1068]
Orange Book—Questions and
Answers; Draft Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled ‘‘Orange
Book—Questions and Answers.’’ This
guidance is intended to assist interested
parties (including prospective drug
product applicants, drug product
applicants, and approved application
holders) in utilizing the Approved Drug
Products with Therapeutic Equivalence
Evaluations (commonly known as the
SUMMARY:
E:\FR\FM\01JNN1.SGM
01JNN1
33168
Federal Register / Vol. 85, No. 105 / Monday, June 1, 2020 / Notices
Orange Book). This guidance provides
answers to commonly asked questions
FDA has received from interested
parties regarding the Orange Book.
DATES: Submit either electronic or
written comments on the draft guidance
by August 31, 2020 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time 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,
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’’).
jbell on DSKJLSW7X2PROD with NOTICES
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–D–1068 for ‘‘Orange Book—
Questions and Answers.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
VerDate Sep<11>2014
19:40 May 29, 2020
Jkt 250001
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-201509-18/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.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Giaquinto Friedman, Center
for Drug Evaluation and Research, Food
PO 00000
Frm 00090
Fmt 4703
Sfmt 4703
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1670,
Silver Spring, MD 20993–0002, 240–
402–7930, elizabeth.giaquinto@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Orange Book—Questions and
Answers.’’ This guidance is intended to
assist interested parties (including
prospective drug product applicants,
drug product applicants, and approved
application holders) in utilizing the
Orange Book. This guidance provides
answers to commonly asked questions
FDA has received from interested
parties regarding the Orange Book.
The Orange Book identifies drug
products approved by FDA under the
Federal Food, Drug, and Cosmetic Act
and related patent and exclusivity
information. The main criteria for the
inclusion of a drug product in the
Orange Book are that the drug product
is the subject of an approved application
and that FDA has not determined the
drug product to have been withdrawn
from sale for safety or effectiveness
reasons. In addition, the Orange Book
contains therapeutic equivalence
evaluations for approved multisource
prescription drug products. These
evaluations have been prepared to serve
as public information and advice to
state health agencies, prescribers, and
pharmacists to promote public
education on drug product selection and
to foster containment of health care
costs.
This guidance provides answers to
questions that have been received by
FDA staff that manage the Orange Book.
The questions and answers cover the
following topics: General inquiries
about the content and format of the
Orange Book, petitioned abbreviated
new drug applications, the movement of
drug products between different
sections in the Orange Book, and patent
listings.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on ‘‘Orange Book—Questions and
Answers.’’ It does not establish any
rights for any person and is not binding
on FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations.
E:\FR\FM\01JNN1.SGM
01JNN1
Federal Register / Vol. 85, No. 105 / Monday, June 1, 2020 / Notices
II. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved FDA collections of
information. These collections of
information are subject to review by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501–3521). The
collections of information in 21 CFR
314.50(a) through (f), (i), (h), and (k) and
314.94 have been approved under OMB
control number 0910–0001. The
collections of information in 21 CFR
314.50(h), 314.53, Form FDA 3542, and
Form FDA 3542a, have been approved
under OMB control number 0910–0513.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: May 26, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–11682 Filed 5–29–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–1127]
Listing of Patent Information in the
Orange Book; Establishment of a
Public Docket; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of a
public docket; request for comments.
ACTION:
The Food and Drug
Administration (FDA or Agency) is
announcing the establishment of a
docket to solicit comments on the listing
of patent information in the FDA
publication, ‘‘Approved Drug Products
With Therapeutic Equivalence
Evaluations’’ (commonly known as the
‘‘Orange Book’’). We are soliciting
comments on the types of patents
currently listed in the Orange Book and
the impact that any change to current
patent listing practices may have on
drug product development. This notice
is not intended to communicate our
regulatory expectations on these issues
but is instead intended to seek early
input from the public to inform further
regulatory action if determined to be
appropriate.
DATES: Submit either electronic or
written comments by August 31, 2020.
jbell on DSKJLSW7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
19:40 May 29, 2020
Jkt 250001
FDA is establishing a docket
for public comments on this document.
The docket number is Docket No. FDA–
2020–N–1127. The docket will close on
August 31, 2020. Submit either
electronic or written comments by that
date. Please note that late, untimely
filed comments will not be considered.
Electronic comments must be submitted
on or before August 31, 2020. The
https://www.regulations.gov electronic
filing system will accept comments
until 11:59 p.m. Eastern Time at the end
of August 31, 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.
You may submit comments as
follows:
ADDRESSES:
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
PO 00000
Frm 00091
Fmt 4703
Sfmt 4703
33169
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2020–N–1127 for ‘‘Listing of Patent
Information in the Orange Book.’’
Received comments 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-201509-18/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:
Elizabeth Giaquinto Friedman, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1670,
Silver Spring, MD 20993, 240–402–
7930, Elizabeth.Giaquinto@fda.hhs.gov.
E:\FR\FM\01JNN1.SGM
01JNN1
]]>Agencies
[Federal Register Volume 85, Number 105 (Monday, June 1, 2020)]
[Notices]
[Pages 33167-33169]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-11682]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-D-1068]
Orange Book--Questions and Answers; Draft Guidance for Industry;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Orange
Book--Questions and Answers.'' This guidance is intended to assist
interested parties (including prospective drug product applicants, drug
product applicants, and approved application holders) in utilizing the
Approved Drug Products with Therapeutic Equivalence Evaluations
(commonly known as the
[[Page 33168]]
Orange Book). This guidance provides answers to commonly asked
questions FDA has received from interested parties regarding the Orange
Book.
DATES: Submit either electronic or written comments on the draft
guidance by August 31, 2020 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.
ADDRESSES: You may submit comments on any guidance at any time 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, 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-D-1068 for ``Orange Book--Questions and Answers.'' Received
comments 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.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT: Elizabeth Giaquinto Friedman, Center
for Drug Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 75, Rm. 1670, Silver Spring, MD 20993-0002,
240-402-7930, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Orange Book--Questions and Answers.'' This guidance is
intended to assist interested parties (including prospective drug
product applicants, drug product applicants, and approved application
holders) in utilizing the Orange Book. This guidance provides answers
to commonly asked questions FDA has received from interested parties
regarding the Orange Book.
The Orange Book identifies drug products approved by FDA under the
Federal Food, Drug, and Cosmetic Act and related patent and exclusivity
information. The main criteria for the inclusion of a drug product in
the Orange Book are that the drug product is the subject of an approved
application and that FDA has not determined the drug product to have
been withdrawn from sale for safety or effectiveness reasons. In
addition, the Orange Book contains therapeutic equivalence evaluations
for approved multisource prescription drug products. These evaluations
have been prepared to serve as public information and advice to state
health agencies, prescribers, and pharmacists to promote public
education on drug product selection and to foster containment of health
care costs.
This guidance provides answers to questions that have been received
by FDA staff that manage the Orange Book. The questions and answers
cover the following topics: General inquiries about the content and
format of the Orange Book, petitioned abbreviated new drug
applications, the movement of drug products between different sections
in the Orange Book, and patent listings.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Orange
Book--Questions and Answers.'' It does not establish any rights for any
person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.
[[Page 33169]]
II. Paperwork Reduction Act of 1995
This draft guidance refers to previously approved FDA collections
of information. These collections of information are subject to review
by the Office of Management and Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections of
information in 21 CFR 314.50(a) through (f), (i), (h), and (k) and
314.94 have been approved under OMB control number 0910-0001. The
collections of information in 21 CFR 314.50(h), 314.53, Form FDA 3542,
and Form FDA 3542a, have been approved under OMB control number 0910-
0513.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.
Dated: May 26, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-11682 Filed 5-29-20; 8:45 am]
BILLING CODE 4164-01-P
