[Federal Register Volume 78, Number 142 (Wednesday, July 24, 2013)]
[Notices]
[Pages 44572-44573]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-17768]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Draft Guidance for Industry on Pre-Launch Activities Importation 
Requests; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Pre-Launch 
Activities Importation Requests (PLAIR).'' This draft guidance 
describes FDA's policy regarding requests for 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 This draft guidance also applies to biologics licensing 
applications (BLAs) regulated by the Center for Drug Evaluation and 
Research. This draft guidance further describes the procedures for 
making these requests and the criteria that FDA will consider in 
granting such requests.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by September 23, 2013. Submit either electronic or written 
comments concerning the proposed collection of information by September 
23, 2013.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 2201, 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access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Marybet Lopez, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 4286, Silver Spring, MD 20993-0002, 301-
796-3110; or Stella Notzon, Office of Regulatory Affairs, Division of 
Import Operations, Food and Drug Administration, 12420 Parklawn Dr., 
Rockville, MD 20857, 301-796-6678.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Pre-Launch Activities Importation Requests (PLAIR).'' 
Historically, when applicants sought to import unapproved finished 
dosage form drug products in preparation for market launch, FDA 
considered such requests, informally referred to as PLAIRs, on a case-
by-case basis. FDA has decided to create a more formal program, and 
this guidance outlines what information should be submitted to FDA in a 
PLAIR, when and how a PLAIR can be submitted, and the circumstances 
under which the Agency intends to grant a PLAIR.
    An applicant who has an NDA, ANDA, or a BLA pending that is nearing 
an FDA application decision can submit a PLAIR request to FDA regarding 
the importation of 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 request, when the product is 
then offered for import, FDA intends to detain the unapproved finished 
dosage form drug product. FDA will, however, regard the PLAIR request 
to mean that the owner or consignee has requested to recondition the 
drug, as specified in the PLAIR request FDA has granted. 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 when and if FDA 
approves the underlying NDA or ANDA within 6 months and the conditions 
of the PLAIR are otherwise met.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the Agency's current thinking on PLAIRs. It 
does not create or confer any rights for or on any person and does not 
operate to bind FDA or the public. An alternative approach may be used 
if such approach satisfies the requirements of the applicable statutes 
and regulations.

II. The Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act (44 U.S.C. 3501-3520) (the PRA), 
Federal Agencies must obtain approval from the Office of Management and 
Budget (OMB) for each collection of information they conduct or 
sponsor. ``Collection of information'' is defined in 44 U.S.C. 3502(3) 
and 5 CFR 1320.3(c) and includes Agency requests or requirements that 
members of the public submit reports, keep records, or provide 
information to a third party. Section 3506(c)(2)(A) of the PRA (44 
U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day 
notice in the Federal Register concerning each proposed collection of 
information before submitting the collection to OMB for approval. To 
comply with this requirement, FDA is publishing notice of the proposed 
collection of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comment on these topics: (1) Whether the proposed collection of 
information is necessary for the proper performance of FDA's functions, 
including whether the information will have practical utility; (2) the 
accuracy of FDA's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection on respondents, including through the use of automated 
collection techniques, when appropriate, and other forms of information 
technology.
    Title: Draft Guidance for Industry on Pre-Launch Activities 
Importation Requests (PLAIR).
    Description: The draft guidance outlines what information should be 
submitted to FDA in a PLAIR, when and how a PLAIR can be submitted, and 
the circumstances under which the Agency intends to grant a PLAIR. 
Section III of the draft guidance requests information collection that 
is subject to the PRA, including the information that should be 
included in a PLAIR, the information to be submitted to the Office of 
Regulatory Affairs (ORA)/Division of Import Operations (DIO) following 
FDA granting a PLAIR, and the notification to ORA/DIO after the 
applicant receives notice from FDA that its drug product is approved. 
Based on FDA's experience with informal requests by applicants to 
import unapproved drug products for purposes described in the draft 
guidance, we estimate that approximately 184 PLAIRs from approximately 
50 applicants will be submitted annually, and that it will take 
applicants approximately 16 hours to prepare and submit each PLAIR. 
This burden estimate also includes the time

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for submitting the information described above to ORA/DIO.
    FDA requests comments on this information collection:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                         Number of
                                                                        Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
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PLAIR..............................................................              50             3.68              184               16            2,944
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    In accordance with the PRA, prior to publication of any final 
guidance document, FDA intends to solicit public comment and obtain OMB 
approval for any additional information collections recommended in this 
guidance that are new or that would represent material modifications to 
those previously approved collections of information found in FDA 
regulations or guidances.

III. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: July 19, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-17768 Filed 7-23-13; 8:45 am]
BILLING CODE 4160-01-P