[Federal Register Volume 87, Number 41 (Wednesday, March 2, 2022)]
[Notices]
[Pages 11716-11717]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-04155]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0836]


Pre-Launch Activities Importation Requests; 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 ``Pre-Launch 
Activities Importation Requests (PLAIR).'' This guidance finalizes and 
updates the draft guidance of the same title issued on July 24, 2013. 
This guidance finalizes FDA's approach for overseeing requests 
regarding the importation of unapproved finished dosage form drug 
products by applicants preparing products for market launch based on 
anticipated approval of a pending new drug application (NDA) or an 
abbreviated new drug application (ANDA). This guidance also applies to 
biologics licensing applications (BLAs) regulated by the Center for 
Drug Evaluation and Research. This guidance further describes the 
procedures for making these requests and FDA's actions on such 
requests. Finalizing this policy will help increase efficiencies in 
ensuring timely access to drug products upon approval.

DATES: The announcement of the guidance is published in the Federal 
Register on March 2, 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: 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.
    <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-2013-D-0836 for ``Pre-Launch Activities Importation Requests 
(PLAIR).'' 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, 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 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

[[Page 11717]]

``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: Kathleen Joyce, Center for Drug 
Evaluation and Research, Bldg. 51, Rm. 4236, Food and Drug 
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 
301-796-3130, <a href="/cdn-cgi/l/email-protection#92d9f3e6fafef7f7fcbcd8fdebf1f7d2f4f6f3bcfafae1bcf5fde4"><span class="__cf_email__" data-cfemail="d49fb5a0bcb8b1b1bafa9ebbadb7b194b2b0b5fabcbca7fab3bba2">[email protected]</span></a>, or PLAIR Program, Office of 
Drug Security, Integrity and Recalls (ODSIR), <a href="/cdn-cgi/l/email-protection#94d7d0d1c6b9dbd7b9c4d8d5ddc6d4f2f0f5bafcfce7baf3fbe2"><span class="__cf_email__" data-cfemail="82c1c6c7d0afcdc1afd2cec3cbd0c2e4e6e3aceaeaf1ace5edf4">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Pre-Launch Activities Importation Requests (PLAIR).'' 
Historically, when applicants with a pending NDA, ANDA, or CDER-
regulated BLA sought to import unapproved finished dosage form drug 
products into the United States in preparation for market launch, we 
considered such requests, informally referred to as ``PLAIRs,'' on a 
case-by-case basis. In July 2013, FDA issued a draft guidance 
announcing the Agency's approach for overseeing the import of some 
unapproved finished dosage form drug products regulated by CDER prior 
to their approval to facilitate the availability of those products to 
patients upon approval. This guidance largely tracks the July 2013 
draft guidance.
    An applicant with a pending NDA, ANDA, or BLA that is nearing an 
FDA decision may submit a PLAIR to FDA seeking permission to import the 
unapproved finished dosage form drug product that is the subject of the 
application to prepare the product for market launch. If FDA grants the 
PLAIR, FDA intends to detain the unapproved finished dosage form drug 
product when the product covered by the PLAIR is offered for import. 
FDA will, however, consider the PLAIR submission to mean that the owner 
or consignee has requested to recondition the drug, as specified in the 
PLAIR request. FDA will thus detain the drug for up to 6 months pending 
a decision on the underlying application. The Agency will release the 
drug product if, and when, FDA approves the underlying NDA, BLA, or 
ANDA within 6 months and the conditions of the PLAIR are otherwise met. 
If FDA refuses to approve the application or 6 months otherwise elapse 
without FDA approval, FDA may determine that the product is subject to 
refusal.
    FDA's granting of a PLAIR does not represent an implicit or 
explicit statement of the approvability of the application. Rather, 
PLAIR facilitates the process of importing unapproved finished dosage 
form products to prepare for market launch based on the anticipated 
approval by FDA of the pending application. The PLAIR guidance outlines 
which products the PLAIR program covers, what information should be 
submitted to FDA in a PLAIR, when and how we recommend submitting a 
PLAIR, and the process for FDA's action on a PLAIR.
    FDA considered comments received on the draft guidance as the 
guidance was finalized. One change we made in response to comments was 
to include recommended timeframes for earlier submission of certain 
PLAIR-eligible products subject to priority review.
    This guidance finalizes the draft guidance entitled ``Pre-Launch 
Activities Importation Requests (PLAIR)'' issued on July 24, 2013 (78 
FR 44572) and is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on ``Pre-Launch Activities Importation Requests 
(PLAIR).'' 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

    This guidance contains information collection provisions that 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 time 
required to complete this information collection is estimated to 
average 16 hours for the first submission, including the time to review 
instructions. We expect any additional PLAIRs submitted by the same 
firm to take less time. The collections of information pertaining to 
FDA's Pre-Launch Activities Importation Requests have been approved 
under OMB control number 0910-0046. The guidance also refers to other 
previously approved FDA collections of information. The collections of 
information in 21 CFR part 314 relating to new drug applications and 
abbreviated new drug applications have been approved under OMB control 
number 0910-0001; the collections of information in part 601 relating 
to biologics license applications have been approved under OMB control 
number 0910-0338; the collections of information in 21 CFR part 207 
relating to domestic and foreign facility registration, including 
assignment of a national drug code, have been approved under OMB 
control number 0910-0045; and the collections of information in parts 
210 and 211 pertaining to current good manufacturing practice 
requirements have been have been approved under OMB control number 
0910-0139.

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

    Dated: February 23, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-04155 Filed 3-1-22; 8:45 am]
BILLING CODE 4164-01-P


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