Pre-Launch Activities Importation Requests; Guidance for Industry; Availability, 11716-11717 [2022-04155]
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11716
Federal Register / Vol. 87, No. 41 / Wednesday, March 2, 2022 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of
respondents
21 CFR section; activity
Number of
responses per
respondent
Total annual
responses
Average burden
per response
Total hours
Form FDA 356V ..........................................................
VMF submissions ........................................................
187
15
36.5
1
6,825
15
0.75 (45 minutes) ...
20 ...........................
5,118
300
Total ......................................................................
........................
........................
7,628
................................
38,849
1
There are no capital costs or operating and maintenance costs associated with this collection of information.
NADAs and supplements regarding antimicrobial animal drugs that use a recommended approach to assessing antimicrobial concerns as
part of the overall preapproval safety evaluation.
2
Although we have characterized the
information collection activity as a
reporting burden, we include in our
estimate time required for searching
data sources, and preparing and
maintaining necessary and applicable
records. As stated above, although we
receive fewer than one submission
annually when averaged over a 3-year
period, we attribute one response and 1
hour annually to account for CNADA
submissions
We have adjusted our estimate of the
information collection to reflect a
decrease in burden associated with
application submissions in
acknowledgement of respondents’
preference in using FDA’s ‘‘eSubmitter’’
system, which automatically generates
Form FDA 356v and allows respondents
to complete the form and submit
applications and associated information
electronically.
Dated: February 24, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–04373 Filed 3–1–22; 8:45 am]
BILLING CODE 4164–01–P
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.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance for industry entitled ‘‘PreLaunch 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
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
17:34 Mar 01, 2022
Jkt 256001
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:
• 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’’).
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
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–
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.
• 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
E:\FR\FM\02MRN1.SGM
02MRN1
Federal Register / Vol. 87, No. 41 / Wednesday, March 2, 2022 / Notices
lotter on DSK11XQN23PROD with NOTICES1
‘‘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-201509-18/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,
Kathleen.Joyce@fda.hhs.gov, or PLAIR
Program, Office of Drug Security,
Integrity and Recalls (ODSIR), CDEROC-PLAIR@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry entitled ‘‘PreLaunch Activities Importation Requests
(PLAIR).’’ Historically, when applicants
with a pending NDA, ANDA, or CDERregulated 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-bycase 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.
VerDate Sep<11>2014
17:34 Mar 01, 2022
Jkt 256001
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.
PO 00000
Frm 00032
Fmt 4703
Sfmt 9990
11717
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/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
regulatory-information/search-fdaguidance-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
E:\FR\FM\02MRN1.SGM
02MRN1
Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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:
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-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.
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, [email protected], or PLAIR Program, Office of
Drug Security, Integrity and Recalls (ODSIR), [email protected].
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