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, 61955-61957 [2020-21521]
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Federal Register / Vol. 85, No. 191 / Thursday, October 1, 2020 / Notices
product quality attributes that affect
drug dissolution and absorption, and
discusses how to capture and present
model assumptions and parameters.
Model validation and refinement are
also discussed.
In addition, the guidance discusses
the major regulatory uses of PBPK
modeling for biopharmaceutics
applications with respect to supporting
product quality. Factors regarding the
development of clinically relevant
dissolution specifications to aid in
biopredictive dissolution method
development and to support clinically
relevant dissolution acceptance criteria
are presented, as well as considerations
for conducting virtual bioequivalence
studies.
PBPK modeling for biopharmaceutics
applications also can be used to
establish clinically relevant drug
product quality specifications other
than dissolution, which can be used to
ensure bioequivalence of batches within
the specification limits, to the pivotal
clinical/bioavailability batches, or to the
reference listed drug for generic drugs.
Finally, the guidance discusses the use
of PBPK analyses for biopharmaceutics
applications as an advanced tool for
quality risk assessment and
management in both the pre- and
postapproval stages.
This draft guidance is being issued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The draft guidance, when finalized, will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 Use of Physiologically Based
Pharmacokinetic Analyses—
Biopharmaceutics Applications for Oral
Drug Product Development,
Manufacturing Changes, and Controls.’’
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.
jbell on DSKJLSW7X2PROD with NOTICES
II. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved FDA collections of
information. 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). The
collections of information in 21 CFR
part 314 have been approved under
OMB control number 0910–0001.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/drugs/guidancecompliance-regulatory-information/
VerDate Sep<11>2014
22:13 Sep 30, 2020
Jkt 253001
guidances-drugs or https://
www.regulations.gov.
Dated: September 23, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020–21652 Filed 9–30–20; 8:45 am]
BILLING CODE 4164–01–P
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
Food and Drug Administration,
Health and Human Services (HHS).
ACTION: Notice of availability.
AGENCY:
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:
SUMMARY:
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://
PO 00000
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61955
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
E:\FR\FM\01OCN1.SGM
01OCN1
61956
Federal Register / Vol. 85, No. 191 / Thursday, October 1, 2020 / Notices
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-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 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.
jbell on DSKJLSW7X2PROD with NOTICES
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
VerDate Sep<11>2014
22:13 Sep 30, 2020
Jkt 253001
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 ‘‘multimarket 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
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Sfmt 4703
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)
E:\FR\FM\01OCN1.SGM
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Federal Register / Vol. 85, No. 191 / Thursday, October 1, 2020 / Notices
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/guidancecompliance-regulatory-information/
guidances-drugs; https://www.fda.gov/
vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances; https://
www.fda.gov/combination-products/
guidance-regulatory-information/
combination-products-guidancedocuments; 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
jbell on DSKJLSW7X2PROD with NOTICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Assistant Secretary for
Planning and Evaluation; Medicaid
Reentry Stakeholder Group
Office of the Assistant
Secretary for Planning and Evaluation,
Department of Health and Human
Services.
AGENCY:
VerDate Sep<11>2014
22:13 Sep 30, 2020
Jkt 253001
Notice of Establishment of the
Medicaid Reentry Stakeholder Group
and Request for Nominations.
ACTION:
The Secretary of HHS has
determined that establishment of the
Medicaid Reentry Stakeholder Group, as
required by the Medicaid Reenty Act, is
desirable to provide advice and
consultation to the Secretary on
innovative strategies to help individuals
who are inmates of public institutions,
and otherwise eligible for Medicaid,
ensure continuity of coverage and
seamless transitions back to the
community. HHS is soliciting
nominations for non-Federal members
of the Stakeholder Group.
DATES: Submit nominations by email
before COB on October 23, 2020.
ADDRESSES: Nominations should be sent
to Jhamirah Howard at
jhamirah.howard@hhs.gov ; Jhamirah
Howard, MPH., Office of the Assistant
Secretary for Planning and Evaluation,
Room 424E Humphrey Building,
Department of Health and Human
Services, 200 Independence Avenue
SW, Washington, DC 20201.
FOR FURTHER INFORMATION CONTACT:
Jhamirah Howard (202) 690–1721,
jhamirah.howard@hhs.gov.
SUPPLEMENTARY INFORMATION: The
Medicaid Reentry Act, Public Law 115–
271, title IV, subtitle D, 132 Stat. 3965
(Oct. 24, 2018) (42 U.S.C. 1396a note)
requires that the Secretary of Health and
Human Services (HHS) establish the
Medicaid Reentry Stakeholder Group.
The Stakeholder Group is governed by
provisions of Public Law 92–463 (5
U.S.C. App), which sets forth standards
for the formation and use of advisory
committees. The Secretary signed the
charter establishing the Stakeholder
Group on July 30, 2020. HHS is
soliciting nominations for non-Federal
members of the Stakeholder Group.
Nominations should include the
nominee’s contact information (current
mailing address, email address, and
telephone number) and a current
curriculum vitae or resume.
The Stakeholder Group will meet
once, to develop best practices (and
submit to the Secretary and Congress a
report on such best practices) for
States—(A) to ease the health carerelated transition of an individual who
is an inmate of a public institution from
the public institution to the community,
including best practices for ensuring
continuity of health insurance coverage
or coverage under the State Medicaid
plan under title XIX of the Social
Security Act, as applicable, and relevant
social services; and (B) to carry out,
with respect to such an individual, such
SUMMARY:
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61957
health care-related transition not later
than 30 days after such individual is
released from the public institution.
The Stakeholder Group shall consist
of at least 24 members: 2 shall be federal
members, appointed by the Secretary or
his designee. The federal members shall
include designees from federal jail and
prison systems, which includes the
Federal Bureau of Prisons. Federal
members will serve as regular
government employees.
The Stakeholder Group shall also
consist of 22 non-federal members who
are representatives of managed care
organizations, Medicaid beneficiaries,
health care providers, the National
Association of Medicaid Directors, state
Medicaid agencies, and representatives
from local and state prison systems, The
Secretary shall appoint one of the
members to serve as the Chair. Nonfederal members will serve as Special
Government Employees.
The Secretary, or his designee, shall
appoint all members of the Stakeholder
Group (both federal and non-federal),
including one of the members to serve
as the Chair. The federal and nonfederal members shall be appointed to
serve for the duration of the time that
the Stakeholder Group is authorized to
operate. Any member appointed to fill
a vacancy for an unexpired term shall be
appointed for the remainder of such
term.
Brenda Destro,
Deputy Assistant Secretary for Planning and
Evaluation (HSP).
[FR Doc. 2020–21591 Filed 9–30–20; 8:45 am]
BILLING CODE 4150–05–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute; Notice of Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the National Heart, Lung,
and Blood Advisory Council.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 [email protected].
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
