
[Federal Register Volume 78, Number 118 (Wednesday, June 19, 2013)]
[Proposed Rules]
[Pages 36711-36715]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-14549]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Chapter I

[Docket Nos. FDA-2013-N-0683, FDA-2013-N-0684, and FDA-2013-N-0685]


Food and Drug Administration Safety and Innovation Act Title 
VII--Drug Supply Chain; Standards for Admission of Imported Drugs, 
Registration of Commercial Importers and Good Importer Practices; 
Notification of Public Meeting; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of public meeting; request for comments.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
a public meeting regarding FDA's implementation of Title VII of the 
Food and Drug Administration Safety and Innovation Act (FDASIA), which 
provides FDA with important new authorities to help it better protect 
the integrity of the drug supply chain. In addition to providing a 
general overview of Title VII and FDA's approach to implementing these 
provisions, the meeting will give interested persons an opportunity to 
provide input that will assist FDA in the development of regulations 
implementing two sections of Title VII, which relate to standards for 
admission of imported drugs and commercial drug importers. 
Specifically, FDA is seeking information on the types of information 
that importers should be required to provide under Title VII as a 
condition of admission. FDA is also seeking information regarding 
registration requirements for commercial drug importers and good 
importer practices to be established under Title VII.

DATES: The public meeting will be held on July 12, 2013, from 9 a.m. to 
5 p.m. at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 
Conference Center, the Great Room (rm. 1503), Silver Spring MD 20993. 
Please note that visitors to the White Oak Campus must enter through 
Building 1. The White Oak Campus location is a Federal facility with 
security procedures and limited seating. There is no fee to register 
for the meeting and registration will be on a first come, first serve 
basis. Early registration is recommended because seating is limited. 
Onsite registration will also be permitted if there is available space. 
See section IV of this document, ``How to Participate in

[[Page 36712]]

the Public Meeting,'' for the date and time of the public meeting and 
closing dates for advance registration.

FOR FURTHER INFORMATION CONTACT: Susan DeMars, Office of Global 
Regulatory Operations and Policy, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 32, rm. 3302, Silver Spring, MD 20993, 301-
796-4635, email: susan.demars@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    The globalization of the pharmaceutical market has created 
tremendous challenges for FDA, including dramatic increases in drug 
imports, complex and fragmented global supply chains, and increasing 
threats of fraudulent and substandard drugs. Title VII of FDASIA (Pub. 
L. 112-144) amends the Federal Food, Drug, and Cosmetic Act (the FD&C 
Act) to provide FDA with important new authorities to respond to these 
challenges and better ensure the safety, effectiveness, and quality of 
drugs imported into the United States. These authorities increase FDA's 
ability to collect and analyze data to make risk-informed decisions, 
employ risk-based approaches to facility oversight, partner with 
foreign regulatory authorities to leverage resources through 
information sharing and recognition of foreign inspections, and drive 
safety and quality throughout the supply chain. Implementation of these 
authorities will significantly advance the strategies set forth in the 
Pathway to Global Product Safety and Quality report published by FDA 
(available at http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/GlobalProductPathway/UCM262528.pdf), and accelerate the Agency's adaptation to the rapidly 
changing demands of the global environment. Implementation of these 
authorities will also support and advance FDA's ongoing industry 
oversight of quality related initiatives.
    At the same time, implementation of Title VII of FDASIA is 
difficult and complex, and requires not only the development of new 
regulations, guidances, and reports, but also major changes in FDA 
information systems, processes, and policies. Since the enactment of 
FDASIA in July 2012, FDA has been working diligently to implement the 
provisions of Title VII and has prioritized these efforts based on 
public health impact in order to maximize use of the Agency's limited 
resources.
    Sections 713 and 714 in Title VII of FDASIA relate to drugs 
imported or offered for import and commercial drug importers. Section 
713 allows FDA to require, as a condition of granting admission to a 
drug imported or offered for import into the United States, that an 
importer electronically submit information demonstrating that the drug 
complies with applicable requirements of the FD&C Act. As specified in 
section 713, such information may include: Information demonstrating 
the regulatory status of the drug, such as the new drug application 
number, abbreviated new drug application number, investigational new 
drug number, or drug master file number; facility information, such as 
proof of registration and the unique facility identifier; indication of 
compliance with current good manufacturing practice (CGMP), testing 
results, certifications relating to satisfactory inspections, and 
compliance with the country of export regulations; and any other 
information deemed necessary and appropriate by the Secretary to assess 
compliance. Section 713 also allows FDA to take into account 
differences among importers and types of imported drugs and, based on 
the level of risk posed by the imported drug, provide for expedited 
clearance for those importers that volunteer to participate in 
partnership programs for highly compliant companies and pass a review 
of internal controls, including sourcing of foreign manufacturing 
inputs, and plant inspections. Section 713 requires FDA to adopt 
regulations implementing section 713 not later than 18 months after the 
date of enactment of FDASIA.
    Section 714 requires commercial drug importers to register with FDA 
and submit a unique identifier for the principal place of business at 
the time of registration. FDA is to specify a unique facility 
identifier system to be used by registrants. Section 714 amends section 
502(o) of the FD&C Act (21 U.S.C. 352(o)) to deem misbranded a drug 
imported or offered for import by a commercial importer of drugs not 
duly registered. Section 714 also requires FDA, in consultation with 
the Secretary of the Department of Homeland Security acting through 
U.S. Customs and Border Protection, to issue regulations establishing 
good importer practices that specify the measures an importer shall 
take to ensure that imported drugs are in compliance with the FD&C Act 
and the Public Health Service Act. Section 714 requires FDA to adopt 
regulations implementing section 714 not later than 36 months after the 
date of enactment of FDASIA.
    The public meeting is an opportunity for FDA to share information 
regarding Title VII and the Agency's approach to implementation, and to 
obtain input from stakeholders that will assist FDA in developing 
regulations under sections 713 and 714.

II. Purpose and Format of Meeting

    The first part of the public meeting will consist of introductory 
presentations by FDA that will provide an overview to stakeholders 
regarding Title VII, including the new authorities granted to FDA under 
Title VII and their importance in ensuring drug safety, effectiveness, 
and quality; how Title VII relates to and will help advance FDA's 
larger strategic initiatives; the Agency's approach to implementation; 
and the progress achieved to date.
    The second part of the meeting will be used to obtain input from 
stakeholders on issues relating to standards for admission of imported 
drugs, registration of commercial importers, and good importer 
practices that will assist FDA in the development of the regulations 
described previously. Individuals will have opportunities to express 
their views by making presentations at the meeting and submitting 
written comments to the dockets for these matters (see section V of 
this document).

III. Scope of Public Input Requested

    FDA is particularly interested in obtaining information and public 
comment on the following topics:

A. Section 713: Standards for Admission of Imported Drugs

    1. How should the regulations implementing section 801(r) of the 
FD&C Act (21 U.S.C. 381(r)), as amended by section 713 of FDASIA, 
define ``importer'' as that term is used in 801(r)(l)?
    2. What information should FDA require importers to submit at the 
time of entry that would demonstrate a drug's compliance with 
applicable requirements of the FD&C Act as a condition of granting 
admission of the drug into the United States?
    3. What information could an importer submit to FDA at the time of 
entry to demonstrate compliance with applicable requirements of the 
FD&C Act relating to:
    a. homeopathic drugs intended for human use,
    b. articles intended for human drug compounding,
    c. articles intended for animal drug compounding, and
    d. drugs intended for research?
    4. What facility information should FDA request from importers at 
the time of entry to help assess whether a drug

[[Page 36713]]

complies with applicable requirements of the FD&C Act?
    5. What information could importers submit at the time of entry to 
demonstrate compliance with country of export regulations in accordance 
with section 801(r)(2)(C) of the FD&C Act?
    6. What information could importers submit at the time of entry to 
demonstrate that a drug offered for import complies with U.S. CGMP 
requirements?
    7. What information could importers submit at the time of entry 
that would serve as evidence of satisfactory inspection, such as by a 
foreign government or an agency of a foreign government?
    8. Should FDA require that importers submit certificates of 
analysis (COAs) to the Agency as a condition of admission under section 
801(r) of the FD&C Act? If so, how could an importer demonstrate a 
COA's authenticity?
    9. Section 801(r)(4)(B)(i) of the FD&C Act permits FDA, as 
appropriate, to consider differences among imports and types of drugs 
and ``based on the level of risk posed by the imported drug, provide 
for expedited clearance for those importers that volunteer to 
participate in partnership programs for highly compliant companies and 
pass a review of internal controls, including sourcing of foreign 
manufacturing inputs, and plant inspections.''
    a. What criteria should FDA use to evaluate potential participants 
in ``voluntary partnership programs for highly compliant companies''?
    b. How could FDA take into account differences among importers and 
types of drugs to allow for expedited entry as part of a voluntary 
partnership program?
    c. What risk factors should FDA consider when determining drug 
admissibility under a voluntary partnership program?
    10. What benefits and burdens may be created by requiring drug 
importers to electronically submit information demonstrating that a 
drug complies with applicable requirements of the FD&C Act as a 
condition of admission? How could we minimize any possible burdens? How 
do we strike a reasonable balance between rigor and efficiency in 
requiring information that is both reliable and yet can be submitted 
and reviewed efficiently?

B. Section 714: Registration of Commercial Importers of Drugs

    1. How should the regulations implementing section 714 of FDASIA 
(section 801(s) of the FD&C Act) define ``commercial importer'' to 
ensure that the appropriate entities are required to register with FDA 
and meet requirements regarding good importer practices (GIP)? Should 
these ``commercial importers'' be the same entities as the 
``importers'' required to comply with the standards for admission to be 
adopted under section 801(r) of the FD&C Act?
    2. Under section 801(s)(1) of the FD&C Act, the registration 
regulations will apply to commercial importers of ``drugs.'' A ``drug'' 
is defined in section 201(g)(1) of the FD&C Act (21 U.S.C. 321(g)(1)) 
and includes, but is not limited to, finished dosage form drug 
products, drugs for further processing, active pharmaceutical 
ingredients, and other drug components, including inactive ingredients. 
Should commercial importers of certain types of drugs, such as inactive 
ingredients, be exempt from the commercial importer registration 
requirements? Should the importation of drugs for certain purposes 
(e.g., research use) be exempt from registration?
    3. What information should commercial importers be required to 
submit as part of their registration?
    4. What benefits and burdens might be created by requiring 
commercial drug importers to register with FDA? How can we minimize any 
possible burdens (e.g., through gradual implementation, exemption of 
certain commercial importers, use of other alternatives)?

C. Section 714: Good Importer Practices

    1. How might FDA structure the GIP regulations to avoid imposing 
redundant regulatory requirements on commercial importers that also are 
drug manufacturers and therefore would be subject to both the GIP and 
CGMP requirements?
    2. Should the GIP regulations require commercial importers of drugs 
to establish drug safety management programs to ensure that imported 
drugs meet the requirements of the FD&C Act and the Public Health 
Service Act, as applicable? If so, what matters (e.g., procedures, 
personnel) should the GIP regulations require commercial importers to 
address in such programs?
    3. What drug safety management programs or other measures do 
commercial importers currently have in place to ensure that imported 
drugs are manufactured in compliance with applicable FDA requirements? 
How do these programs and measures differ for different ``types'' of 
drugs?
    4. Should the GIP regulations include qualifications and training 
for personnel who perform GIP activities? If so, what qualifications 
and training should be required?
    5. Should the GIP regulations include a requirement for commercial 
importers to assess whether it is appropriate to import a particular 
drug from a particular foreign supplier? If so, what information on the 
drug and the supplier should the commercial importer be required to 
consider as part of this assessment?
    6. Should commercial importers be required to conduct activities to 
verify that a drug that is offered for import is in compliance with 
applicable U.S. requirements (e.g., the CGMP regulations) and are not 
adulterated under section 501 of the FD&C Act (21 U.S.C. 351) or 
misbranded under section 502 of the FD&C Act? If so, what supplier 
verification activities should commercial importers be required to 
conduct?
    7. Should there be different supplier verification or other GIP 
requirements for different ``types'' of drugs? Should there be 
different requirements for particular types of finished dosage form 
drug products that might be associated with different levels of risk 
(e.g., sterile injectables, drugs that require temperature controls)? 
If so, what should these requirements be?
    8. Should the GIP regulations require commercial importers to 
obtain a COA for each imported drug? Should such a requirement apply 
only to certain types of drugs or commercial importers? If commercial 
importers are required to obtain COAs, should the commercial importer 
also be required to conduct testing to verify the accuracy of the COA?
    9. Should the GIP regulations include specific requirements for 
drugs imported for export in accordance with section 801(d)(3) of the 
FD&C Act? If so, what should these requirements be?
    10. How should the GIP regulations reflect or incorporate the 
requirements concerning the standards for admission of imported drugs 
under section 801(r) of the FD&C Act? For example, should the GIP 
requirements include the adoption of procedures to ensure that the 
commercial importer submits the compliance information required under 
section 801(r) and the regulations implementing that section? If so, 
what procedures should commercial importers be required to follow to 
ensure that these requirements are met?
    11. Should the GIP regulations require commercial importers to take 
corrective actions when the drugs they import or offer for import are 
not in compliance with applicable U.S. requirements? If so, what 
actions should importers be required to take?
    12. Should the GIP regulations include a requirement for commercial 
importers to list the drugs they import or offer for import? If so, 
what

[[Page 36714]]

information should be required with listing?
    13. What records should commercial importers be required to 
maintain under the GIP regulations?
    14. What other matters, if any, should the GIP regulations address?
    15. How should FDA take into account ``differences among importers 
and types of imports, including based on the level of risk posed by the 
imported product,'' in determining reasonable time periods for 
commercial importers to come into compliance with the GIP regulations 
under section 714(d)(3) of FDASIA? In considering such differences, how 
should FDA determine the level of risk posed by an imported drug?
    16. What benefits and burdens might be created by requiring 
commercial importers to comply with GIP regulations? How can we 
minimize any possible burdens (e.g., through gradual implementation, 
exemption of certain commercial importers, use of other alternatives)?

IV. How to Participate in the Public Meeting

    Individuals who wish to present at the public meeting must register 
on or before July 5, 2013, through the FDASIA Web site at http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FDASIA/ucm20027187.htm and provide complete contact information, 
including name, title, affiliation, address, email, and phone number. 
In section III of this document, FDA has included questions for 
comment. You should identify by number each question you wish to 
address in your presentation, provide a brief description of your 
presentation, and indicate the approximate desired length of your 
presentation, so that FDA can consider these in organizing the 
presentations. FDA will do its best to accommodate requests to speak 
and will determine the amount of time allotted to each presenter and 
the approximate time that each oral presentation is scheduled to begin. 
After reviewing the presentation requests, FDA will notify each 
participant before the meeting of the amount of time available and the 
approximate time their presentation is scheduled to begin. If time 
permits, individuals or organizations that did not register in advance 
may be granted the opportunity to make a presentation. An agenda will 
be posted on the FDASIA Web site at http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FDASIA/ucm20027187.htm prior to the 
meeting.
    Table 1 of this document provides information on participating in 
the meeting and on submitting comments to the docket. See table 2 of 
this document for a list of docket numbers and corresponding sections 
of FDASIA and topics.

                 Table 1--Information on Participation in the Meeting and on Submitting Comments
----------------------------------------------------------------------------------------------------------------
                                                                            Address  (non-
                                         Date         Electronic address      electronic)      Other information
----------------------------------------------------------------------------------------------------------------
Date of public meeting..........  July 12, 2013, 9    ..................  FDA White Oak       Onsite
                                   a.m. to 5 p.m.                          Campus, 10903 New   registration
                                                                           Hampshire Ave.,     begins at 7:30
                                                                           Bldg. 31            a.m.
                                                                           Conference
                                                                           Center, the Great
                                                                           Room (rm. 1503),
                                                                           Silver Spring, MD
                                                                           20993.
Advance registration............  By July 5, 2013...  http://www.fda.gov/ ..................  Registration will
                                                       RegulatoryInforma                       also be accepted
                                                       tion/Legislation/                       onsite on the day
                                                       FederalFoodDrugan                       of the meeting,
                                                       dCosmeticActFDCAc                       as space permits.
                                                       t/
                                                       SignificantAmendm
                                                       entstotheFDCAct/
                                                       FDASIA/
                                                       ucm20027187.htm.
Request special accommodations    By July 5, 2013...  ..................  Susan DeMars, 301-  ..................
 due to disability.                                                        796-4635, email:
                                                                           susan.demars@fda.hhs.gov.
Make a request for an oral        By July 5, 2013...  http://www.fda.gov/ ..................  Requests made on
 presentation and provide a                            RegulatoryInforma                       the day of the
 brief description of the oral                         tion/Legislation/                       meeting to make
 presentation.                                         FederalFoodDrugan                       an oral
                                                       dCosmeticActFDCAc                       presentation may
                                                       t/                                      be granted as
                                                       SignificantAmendm                       time permits.
                                                       entstotheFDCAct/                        Information on
                                                       FDASIA/                                 requests to make
                                                       ucm20027187.htm.                        a presentation,
                                                                                               including any
                                                                                               personal
                                                                                               information
                                                                                               provided, may be
                                                                                               posted without
                                                                                               change to http://www.regulations.gov ov.

[[Page 36715]]

 
Submit electronic or written      By August 12, 2013  Federal             FAX: 301-827-6870.  All comments must
 comments.                                             eRulemaking         Mail/Hand-          include the
                                                       Portal: http://     delivery/Courier:   Agency name and
                                                       www.regulations.g   Division of         the docket number
                                                       ov. Follow the      Dockets             corresponding
                                                       instructions for    Management (HFA-    with the section
                                                       submitting          305), Food and      of FDASIA and
                                                       comments.           Drug                topic on which
                                                                           Administration,     you are
                                                                           5630 Fishers        commenting (see
                                                                           Lane, rm. 1061,     table 2 for a
                                                                           Rockville, MD       list of docket
                                                                           20852.              numbers and
                                                                                               corresponding
                                                                                               sections of
                                                                                               FDASIA and
                                                                                               topics). All
                                                                                               received
                                                                                               comments,
                                                                                               including any
                                                                                               personal
                                                                                               information
                                                                                               provided, may be
                                                                                               posted without
                                                                                               change to http://www.regulations.gov ov. FDA
                                                                                               encourages the
                                                                                               submission of
                                                                                               electronic
                                                                                               comments by using
                                                                                               the Federal
                                                                                               eRulemaking
                                                                                               Portal.
----------------------------------------------------------------------------------------------------------------

V. Comments

    Regardless of attendance at the public meeting, interested persons 
may submit either electronic comments regarding this document to the 
Federal eRulemaking Portal at http://www.regulations.gov or written 
comments or the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5600 Fishers Lane, rm. 1061, Rockville, MD 20857. 
Because multiple docket numbers are associated with this document, 
please include with your comments the docket number(s) that corresponds 
with the section of FDASIA and topic on which you are commenting (see 
table 2 of this document for a list of docket numbers and corresponding 
sections and topics). Comments that address more than one docket must 
be filed with each docket to ensure consideration. The deadline for 
submitting comments to the docket is August 12, 2013. 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.

                               Table 2--Docket Numbers for Each Section and Topic
----------------------------------------------------------------------------------------------------------------
           Section of FDASIA                        Topic                             Docket No.
----------------------------------------------------------------------------------------------------------------
713....................................  Standards for admission of  FDA-2013-N-0683
                                          imported drugs.
714....................................  Registration of commercial  FDA-2013-N-0684
                                          importers of drugs.
714....................................  Good importer practice....  FDA-2013-N-0685
----------------------------------------------------------------------------------------------------------------

VI. Transcripts

    Transcripts of the meeting will be available for review at the 
Division of Dockets Management and http://www.regulations.gov 
approximately 30 days after the meeting. A transcript will also be made 
available in either hardcopy or on CD-ROM, upon submission of a Freedom 
of Information request. Written requests are to be sent to Division of 
Freedom of Information (ELEM-1029), Food and Drug Administration, 12420 
Parklawn Dr., Element Bldg., Rockville, MD 20857.

    Dated: June 12, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-14549 Filed 6-18-13; 8:45 am]
BILLING CODE 4160-01-P


