Notice2022-15831
Orange Book-Questions and Answers; Guidance for Industry; Availability
Primary source
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Published
July 25, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final 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 publication Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book). This guidance finalizes the draft guidance of the same title issued on June 1, 2020.
Full Text
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<title>Federal Register, Volume 87 Issue 141 (Monday, July 25, 2022)</title>
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[Federal Register Volume 87, Number 141 (Monday, July 25, 2022)]
[Notices]
[Pages 44125-44126]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-15831]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-D-1068]
Orange Book--Questions and Answers; Guidance for Industry;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final 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
publication Approved Drug Products with Therapeutic Equivalence
Evaluations (commonly known as the Orange Book). This guidance
finalizes the draft guidance of the same title issued on June 1, 2020.
DATES: The announcement of the guidance is published in the Federal
Register on July 25, 2022.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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, 240-402-7500.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of this 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 guidance document.
FOR FURTHER INFORMATION CONTACT: Susan Levine, Office of Generic Drugs,
Center for Drug Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 75, Rm. 1674, Silver Spring, MD 20993-
0002, 240-402-7936, <a href="/cdn-cgi/l/email-protection#02517771636c2c4e67746b6c67426466632c6a6a712c656d74"><span class="__cf_email__" data-cfemail="0b587e786a6525476e7d62656e4b6d6f6a25636378256c647d">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Orange Book--Questions and Answers.'' This
[[Page 44126]]
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 (FD&C 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 healthcare 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 guidance finalizes the draft guidance entitled ``Orange Book--
Questions and Answers'' issued on June 1, 2020 (85 FR 33167). FDA
considered comments received on the draft guidance as the guidance was
finalized. Changes from the draft to the final guidance include minor
clarifying revisions (including revisions to reflect the Orange Book
Transparency Act of 2020 enacted on January 5, 2021) (Pub. L. 116-290).
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents 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.
II. Paperwork Reduction Act of 1995
While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The following
collections of information have been approved under OMB control number
0910-0001: (1) 21 CFR 314.50(a) through (f), (i), (h), and (k); (2) 21
CFR 314.53 for new drug application (NDA) submissions; (3) amendments
to NDA submissions; (4) supplements to NDA submissions to FDA using
Forms FDA 3542 (Patent Information Submitted Upon and After Approval of
an NDA or Supplement) and 3542a (Patent Information Submitted With the
Filing of an NDA, Amendment, or Supplement); and (5) 21 CFR 314.94.
In addition, the FDA Reauthorization Act of 2017 (Pub. L. 115-52)
added section 506I to the FD&C Act (21 U.S.C. 356i), which imposes
marketing status reporting requirements for notification of withdrawal
from sale, notification of drugs not available for sale, and reports on
marketing status. The collections of information regarding 506I
notifications described in FDA's guidance entitled ``Marketing Status
Notifications Under Section 506I of the Federal Food, Drug, and
Cosmetic Act'' have been approved under OMB control number 0910-0001.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
<a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs">https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Dated: July 19, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-15831 Filed 7-22-22; 8:45 am]
BILLING CODE 4164-01-P
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