[Federal Register Volume 85, Number 155 (Tuesday, August 11, 2020)]
[Notices]
[Pages 48541-48542]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-17463]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-4615]


Marketing Status Notifications Under Section 506I of the Federal 
Food, Drug, and Cosmetic Act; Content and Format; 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 ``Marketing 
Status Notifications Under Section 506I of the Federal Food, Drug, and 
Cosmetic Act; Content and Format.'' This guidance is intended to assist 
holders of new drug applications (NDAs) and abbreviated new drug 
applications (ANDAs) approved under the Federal Food, Drug, and 
Cosmetic Act (FD&C Act) with their submission of required marketing 
status notifications. This guidance finalizes the draft guidance of the 
same title issued on January 31, 2019.

DATES: The announcement of the guidance is published in the Federal 
Register on August 11, 2020.

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-2018-D-4615 for ``Marketing Status Notifications Under Section 506I 
of the Federal Food, Drug, and Cosmetic Act; Content and Format.'' 
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.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

[[Page 48542]]

    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 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 multi-center guidances, add 
appropriate addresses. No more than four addresses in this section per 
1998 Document Drafting Handbook.]

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 guidance for industry 
entitled '' Marketing Status Notifications Under Section 506I of the 
Federal Food, Drug, and Cosmetic Act; Content and Format.'' This 
guidance is intended to assist holders of NDAs and ANDAs approved under 
the FD&C Act with their submission of required marketing status 
notifications. The FDA Reauthorization Act of 2017 (Pub. L. 115-52) 
(FDARA) added section 506I to the FD&C Act (21 U.S.C. 356i), which 
imposes additional reporting requirements on NDA and ANDA holders 
regarding the marketing status of approved drug products. This guidance 
identifies the required content for these marketing status 
notifications and the format by which these notifications should be 
submitted to the Agency.
    This guidance finalizes the draft guidance entitled Marketing 
Status Notifications Under Section 506I of the Federal Food, Drug, and 
Cosmetic Act; Content and Format issued on January 31, 2019 (84 FR 
749). FDA considered comments received on the draft guidance as the 
guidance was finalized. Changes from the draft to the final guidance 
were made to address requests for clarity in complying with the 
reporting requirements of section 506I of the FD&C Act.
    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 ``Marketing Status Notifications Under 
Section 506I of the Federal Food, Drug, and Cosmetic Act; Content and 
Format.'' 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

    FDA regulations require NDA and ANDA holders to notify the Agency 
of the marketing status of drug products approved under NDAs and ANDAs. 
FDARA added section 506I to the FD&C Act, which imposes marketing 
status reporting requirements for notification of withdrawal from sale; 
notification of drugs not available for sale, and reports on marketing 
status. This guidance contains no collection 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. However, this guidance refers to previously approved FDA 
collections of information. These collections of information are 
subject to review by OMB under the PRA. The collections of information 
have been approved under OMB control numbers 0910-0001 and 0910-0759.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
either https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs or https://www.regulations.gov.

    Dated: August 4, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-17463 Filed 8-10-20; 8:45 am]
BILLING CODE 4164-01-P