Notice2022-04155
Pre-Launch Activities Importation Requests; Guidance for Industry; Availability
Primary source
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Published
March 2, 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 "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 This guidance finalizes and updates the draft guidance of the same title issued on July 24, 2013.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.
Full Text
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<title>Federal Register, Volume 87 Issue 41 (Wednesday, March 2, 2022)</title>
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[Federal Register Volume 87, Number 41 (Wednesday, March 2, 2022)]
[Notices]
[Pages 11716-11717]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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updates the draft guidance of the same title issued on July 24, 2013.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: <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-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 <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
[[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: <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: 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 <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: 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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