[Federal Register Volume 87, Number 141 (Monday, July 25, 2022)]
[Notices]
[Pages 44125-44126]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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finalizes the draft guidance of the same title issued on June 1, 2020.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:
     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, 240-402-7500.
     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, 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, [email protected].

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 
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    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


