Document ID: FDA-2019-D-5743-0026
Agency: fda
Document Type: Notice
Title: Importation of Certain Food and Drug Administration-Approved Human Prescription Drugs, Including Biological Products, and Combination Products Under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability
Posted Date: 2020-10-01T04:00Z

[Federal Register Volume 85, Number 191 (Thursday, October 1, 2020)]
[Notices]
[Pages 61955-61957]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-21521]

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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, and 
Combination Products Under Section 801(d)(1)(B) of the Federal Food, 
Drug, and Cosmetic Act; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, Health and Human Services (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 
``Importation of Certain FDA-Approved Human Prescription Drugs, 
Including Biological Products, and Combination Products under Section 
801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act.'' This 
guidance describes recommended procedures to obtain a National Drug 
Code (NDC) for certain FDA-approved prescription drugs that are 
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 these drugs could be sold at a lower cost in the 
U.S. market. This guidance is intended to address certain challenges in 
the private market faced by manufacturers seeking to sell their drugs 
at lower costs. This guidance finalizes the draft guidance issued on 
December 23, 2019.

DATES: The announcement of the guidance is published in the Federal 
Register on October 1, 2020.

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-2019-D-5743 for ``Importation of Certain FDA-Approved Human 
Prescription Drugs, Including Biological Products, and Combination 
Products under Section 801(d)(1)(B) of the Federal Food, Drug, and 
Cosmetic Act.'' 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. 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

[[Page 61956]]

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, 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 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 guidance document.

FOR FURTHER INFORMATION CONTACT: Lyndsay Hennessey, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6180, Silver Spring, MD 20993-0002, 301-
796-7605; 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; or the Office of 
Regulatory Affairs (ORA), Office of Strategic Planning and Operational 
Policy at ORAPolicyStaffs@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Importation of Certain FDA-Approved Human Prescription 
Drugs, Including Biological Products, and Combination Products under 
Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act.'' 
This guidance represents the Agency's current thinking on the 
importation of certain FDA-approved drugs, including biological 
products, and combination products that are the subject of approved new 
drug applications (NDAs) or biologics license applications (BLAs) and 
that are also authorized for sale in a foreign country in which the 
products were originally intended to be marketed. These are referred to 
in the guidance as ``multi-market approved'' (``MMA'') products. This 
guidance describes procedures to obtain an NDC for an FDA-approved 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 a number of their drugs at 
lower costs and that obtaining NDCs for their drugs may help them to 
address certain challenges in the private market. This guidance is not 
intended to address the applicability of programs administered by the 
Centers for Medicare & Medicaid Services such as the Medicaid drug 
rebate program for manufacturers. The Department of Health and Human 
Services (HHS) may issue further guidance or rulemaking as appropriate. 
HHS guidance, including relevant Medicaid guidance for drugs imported 
following the procedures in this guidance, can be found at https://www.hhs.gov/guidance/.
    This guidance describes: (1) The process for submitting a 
supplement to an approved NDA or BLA 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 (Title II of Pub. L. 
113-54); (5) recommendations related to procedures for importation of 
the MMA product; and (6) other requirements applicable to MMA products.
    This guidance will help ensure manufacturers are aware of 
procedures to facilitate manufacturers' ability to provide access to 
lower-cost drugs in the United States. The guidance details procedures 
that will enable manufacturers to obtain an NDC for the MMA product, 
which could allow manufacturers to offer a drug, biological product, or 
combination product at a lower cost. The NDC for the MMA product also 
will support pharmacovigilance, aid in accurate billing and 
reimbursement, and facilitate clearance of the MMA products through 
FDA's admissibility review.
    This guidance finalizes the draft guidance 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: Draft Guidance for Industry,'' issued on December 23, 
2019 (84 FR 71961). FDA considered comments received on the draft 
guidance as the guidance was finalized. Changes from the draft to the 
final guidance include: Clarifying the description of MMA products, 
including combination products; providing additional recommendations 
for the labeling of MMA products to help ensure that MMA products may 
be readily identified; and providing a template ``Dear Healthcare 
Provider'' letter that manufacturers may use to alert healthcare 
professionals of the availability of an MMA product.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on ``Importation of Certain FDA-Approved Human 
Prescription Drugs, Including Biological Products, and Combination 
Products under Section 801(d)(1)(B) of the Federal Food, Drug, and 
Cosmetic Act.'' 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 no collection of information. Therefore, 
clearance by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not 
required.
    However, this 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 OMB under the PRA. 
The collections of information in 21 CFR part 314 (NDAs)

[[Page 61957]]

have been approved under OMB control number 0910-0001; the collections 
of information in 21 CFR part 601 (BLAs) 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; the collection of 
information pertaining to Dear Health Care Provider Letters has been 
approved under OMB control number 0910-0754; 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.

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/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances; https://www.fda.gov/combination-products/guidance-regulatory-information/combination-products-guidance-documents; or 
https://www.regulations.gov.

    Dated: September 23, 2020.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
[FR Doc. 2020-21521 Filed 9-25-20; 4:15 pm]
 BILLING CODE 4164-01-P