[Federal Register Volume 84, Number 249 (Monday, December 30, 2019)]
[Notices]
[Pages 71961-71964]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-28141]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-5743]


Importation of Certain Food and Drug Administration-Approved 
Human Prescription Drugs, Including Biological Products, Under Section 
801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act; Draft 
Guidance for Industry; Availability; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; correction.

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SUMMARY: This document corrects the Notice of Availability from the 
Food and Drug Administration (FDA, Agency, or we) announcing the 
availability of a draft guidance for industry entitled ``Importation of 
Certain FDA-Approved Human Prescription Drugs, Including Biological 
Products, under Section 801(d)(1)(B) of the Federal Food, Drug, and 
Cosmetic Act,'' which published in the Federal Register on Monday, 
December 23, 2019. This draft guidance describes procedures to obtain a 
National Drug Code (NDC) for an FDA-approved prescription drug that is 
imported into the United States in compliance with the Federal Food, 
Drug, and Cosmetic Act (FD&C Act), which would provide an additional 
avenue through which drugs could be sold at a lower cost in the U.S. 
market. This draft guidance is intended to address certain challenges 
in the private market faced by manufacturers seeking to sell their 
drugs at lower costs. The Notice was published with two omissions. This 
document corrects those omissions by republishing the Notice in its 
entirety to include the omitted language.

DATES: Submit either electronic or written comments on the draft 
guidance by February 21, 2020, to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as 
follows:

Electronic Submissions

    Submit electronic comments in the following way:

[[Page 71962]]

     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-2019-D-5743 for ``Importation of Certain FDA-Approved Human 
Prescription Drugs, Including Biological Products, under Section 
801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act.'' \1\ 
Received comments 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.
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    \1\ In the Federal Register of December 23, 2019 (84 FR 70557), 
FDA issued a Notice of Availability for this guidance, the subject 
of this correction notice.
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     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 
``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.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    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, 10001 New Hampshire Ave., 
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002 or the 
Office of Communication, Outreach, and Development, Center for 
Biologics Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 71, Rm. 3128, 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.

FOR FURTHER INFORMATION CONTACT: Lyndsay Hennessey, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-7605, or Stephen 
Ripley, Center for Biologics Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver 
Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Importation of Certain FDA-Approved Human Prescription 
Drugs, Including Biological Products, under Section 801(d)(1)(B) of the 
Federal Food, Drug, and Cosmetic Act,'' which, when finalized, will 
represent the Agency's current thinking on the importation of multi-
market approved (MMA) products. This draft guidance describes 
procedures to obtain an NDC for an FDA-approved prescription drug that 
is imported into the United States in compliance with section 801 of 
the FD&C Act (21 U.S.C. 381), which would provide an additional avenue 
through which drugs could be sold at a lower cost in the U.S. market. 
In recent years, FDA has become aware that some drug manufacturers may 
be interested in offering certain of their drugs at lower costs and 
that obtaining additional NDCs for these drugs may help them to address 
certain challenges in the private market. This guidance is not intended 
to address the applicability of the Medicaid drug rebate program for 
manufacturers, which may be addressed in further guidance from other 
components of HHS. This guidance is intended to outline a potential 
pathway by which manufacturers could obtain an additional NDC for an 
FDA-approved drug that was originally intended to be marketed in a 
foreign country. This guidance specifically addresses the importation 
of FDA-approved drugs that were also authorized for sale in a foreign 
country in which the drugs were originally intended to be marketed 
(``MMA product''). This guidance describes: (1) The process for 
submitting a supplement to an approved FDA application for an MMA 
product; (2) the recommended labeling for an MMA product; (3) the 
process for registration and listing and for obtaining an NDC for the 
MMA product; (4) the requirements of section 582 of the FD&C Act (21 
U.S.C. 360eee-1) as added by the Drug Supply Chain Security Act (DSCSA) 
(Title II of Pub. L. 113-54); (5) recommendations related to procedures 
for importation of the MMA product; and (6) other FDA requirements 
applicable to MMA products.
    This guidance, when finalized, will help ensure manufacturers are 
aware of

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procedures to provide access to lower-cost drugs in the United 
States.\2\ The guidance details procedures that will enable 
manufacturers to obtain an additional NDC for the MMA product, which 
could allow greater pricing flexibility for a drug or biological 
product. The additional NDC also will support pharmacovigilance, 
accurate billing and reimbursement, and facilitate clearance of the MMA 
products through customs. This draft guidance is not final nor is it in 
effect at this time.
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    \2\ In the Federal Register of December 23, 2019 (84 FR 70796), 
FDA issued a Notice of Proposed Rulemaking under 21 U.S.C. 384 to 
offer a pathway for importation of drugs from Canada without the 
authorization of the manufacturer.
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    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 current thinking of FDA on the 
importation of MMA products. 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. Issues for Consideration

    As previously noted, FDA is interested in receiving comments on the 
draft guidance. Regarding the approach set forth in the draft guidance, 
in addition to any other issues addressed, FDA requests that commenters 
consider the following issues when submitting comments:
    1. Are there additional considerations for certain types of drug 
products with special handling, such as sterile injectables, drugs with 
boxed warnings, drugs with REMS (Risk Evaluation and Mitigation 
Strategy), controlled substances, or drugs that do not meet the 
definition of ``product'' under the DSCSA (21 U.S.C. 360eee(13))? Are 
there additional considerations for combination products related to the 
content of the guidance (e.g., supplement, labeling, NDC) that would 
warrant additional guidance for use of this approach for those 
products? To the extent that interested parties believe that different 
or additional considerations from those described in the draft guidance 
should apply to such an approach for combination products, we are 
interested in input on that, as well.
    2. The draft guidance uses ``MMA product'' to describe FDA-approved 
drugs that were originally intended to be marketed in a foreign country 
and also authorized for sale in that foreign country. Is this new term 
adequate and understandable? Is there another term that would provide 
more clarity regarding the products discussed in the guidance?
    3. The draft guidance describes how an NDC could be obtained for 
MMA products. What is the effect of a manufacturer using a new labeler 
code as opposed to a new product code to distinguish these products, 
such as for reimbursement?
    4. The draft guidance recommends a labeling statement in the FDA-
approved labeling for the MMA product, including the carton and 
container label, to assist pharmacists and others in accurately 
identifying, dispensing, and billing for these products. FDA seeks 
comment on the specific wording that could be included in the statement 
to differentiate MMA products from other drugs that are not the subject 
of the guidance, if finalized, and to help ensure MMA products are 
easily identifiable to pharmacists and not confusing to patients. FDA 
also seeks comment on other types of distinguishing characteristics on 
the carton and container label that would further enable pharmacists to 
identify an MMA product and distinguish it from other packages of the 
FDA-approved drug, without confusing patients and consistent with other 
applicable requirements relating to carton and container labeling. 
Additionally, would other possible mechanisms, such as a Dear 
Healthcare Provider letter, provide further clarity and reduce 
confusion for pharmacists and other healthcare providers as well as 
patients?
    5. We request comment about how much, on average, the labeling and 
packaging changes described in the draft guidance would cost drug 
manufacturers and repackagers or relabelers. Are there other ways to 
distinguish the appearance of an MMA product? We also request comment 
about alternative labeling approaches that would display the required 
information with equal prominence but may result in lower costs.
    6. The draft guidance describes procedures for manufacturers of 
drug products approved under new drug applications or biologics license 
applications to obtain an additional NDC for an MMA product. FDA is 
interested as to whether manufacturers of generic drugs approved under 
an abbreviated new drug application confront similar pricing issues 
such that it would be appropriate to provide guidance on a similar 
approach for generic drugs. To the extent that interested parties 
believe that different considerations should apply to such an approach 
for generic drugs from those described in the draft guidance, input is 
requested on that as well.
    7. There are complex considerations that impact biosimilar 
development, market entry, and uptake. We are interested in the 
possible impacts of MMA products that are biological products on 
biosimilar development, market entry, and uptake.
    8. Similarly, there are complex considerations impacting generic 
drug market entry. We are interested in the possible impacts of MMA 
products on generic drug development and market entry.
    9. Are there voluntary steps a manufacturer may take in addition to 
the requirements in the DSCSA to ensure the security of the supply 
chain for products imported pursuant to the guidance?
    10. Are there any potential risks associated with the importation 
of products as described in the draft guidance that could be addressed 
by a rulemaking? For example, to what extent, if any, are there 
additional procedures that might better protect against entities 
seeking to introduce counterfeit drugs in the United States? If so, 
please be specific about the potential risk and how it could be 
addressed through rulemaking.
    11. The draft guidance describes a pathway that manufacturers could 
use to offer their products to Americans at a lower price. FDA is 
interested in the factors that could contribute to the decision to use 
this pathway and whether there are reasons to use this pathway other 
than the ability to sell products at a lower price.

III. Paperwork Reduction Act of 1995

    FDA has tentatively concluded that there are no new collections of 
information in this draft guidance. This draft guidance refers to 
previously approved collections of information found in the FD&C Act 
and FDA regulations. These collections of information 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). In accordance with the 
Paperwork Reduction Act, if FDA's tentative conclusion changes, prior 
to publication of any final guidance document FDA intends to solicit 
public comment and obtain OMB approval for any 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.

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    The collections of information in 21 CFR part 314 (new drug 
applications) have been approved under OMB control number 0910-0001; 
the collections of information in 21 CFR part 601 (biologics license 
applications) have been approved under OMB control number 0910-0338; 
the collections of information in 21 CFR part 207 (domestic and foreign 
facility registration, including assignment of an NDC) have been 
approved under OMB control number 0910-0045; the collections of 
information in 21 CFR part 1 (general enforcement regulations) have 
been approved under OMB control number 0910-0046; the collections of 
information in 21 CFR part 201 (labeling) have been approved under OMB 
control number 0910-0572; the collections of information pertaining to 
current good manufacturing practice requirements for finished 
pharmaceuticals and combination products under 21 CFR parts 4, 210, 
211, 610, and 680 have been approved under OMB control numbers 0910-
0139 and 0910-0834; and the collections of information pertaining to 
suspect product identification and notification under section 582 of 
the FD&C Act have been approved under OMB control number 0910-0806.

IV. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, or https://www.regulations.gov.

    Dated: December 23, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-28141 Filed 12-27-19; 8:45 am]
BILLING CODE 4164-01-P


