Notice2022-20523
How To Obtain a Covered Product Authorization; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request
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Published
September 22, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "How To Obtain a Covered Product Authorization." This guidance describes how eligible product developers can obtain a Covered Product Authorization (CPA) from FDA under the law widely known as the CREATES Act. The CREATES Act provides a pathway for eligible product developers to obtain access to the product samples they need to fulfill testing and other regulatory requirements to support their applications. As described in further detail below, to make use of this pathway, an eligible product developer seeking to develop a product subject to a Risk Evaluation and Mitigation Strategies (REMS) with elements to assure safe use (ETASU) must obtain a CPA from the Agency. This guidance replaces the December 2014 draft guidance for industry "How To Obtain a Letter From FDA Stating That Bioequivalence Study Protocols Contain Safety Protections Comparable to Applicable REMS for RLD," which has been withdrawn. This draft guidance is not final nor is it in effect at this time.
Full Text
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<title>Federal Register, Volume 87 Issue 183 (Thursday, September 22, 2022)</title>
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[Federal Register Volume 87, Number 183 (Thursday, September 22, 2022)]
[Notices]
[Pages 57908-57910]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-20523]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-D-1358]
How To Obtain a Covered Product Authorization; Draft Guidance for
Industry; Availability; Agency Information Collection Activities;
Proposed Collection; Comment Request
AGENCY: Food and Drug Administration, Department of 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the availability of a draft guidance for industry entitled ``How To
Obtain a Covered Product Authorization.'' This guidance describes how
eligible product developers can obtain a Covered Product Authorization
(CPA) from FDA under the law widely known as the CREATES Act. The
CREATES Act provides a pathway for eligible product developers to
obtain access to the product samples they need to fulfill testing and
other regulatory requirements to support their applications. As
described in further detail below, to make use of this pathway, an
eligible product developer seeking to develop a product subject to a
Risk Evaluation and Mitigation Strategies (REMS) with elements to
assure safe use (ETASU) must obtain a CPA from the Agency. This
guidance replaces the December 2014 draft guidance for industry ``How
To Obtain a Letter From FDA Stating That Bioequivalence Study Protocols
Contain Safety Protections Comparable to Applicable REMS for RLD,''
which has been withdrawn. This draft guidance is not final nor is it in
effect at this time.
DATES: Submit either electronic or written comments on the draft
guidance by November 21, 2022 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance. Submit electronic or written comments on the
proposed collection of information in the draft guidance by November
21, 2022.
ADDRESSES: You may submit comments on any guidance at any time as
follows:
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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-2022-D-1358 for ``How To Obtain a Covered Product Authorization.''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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
[[Page 57909]]
for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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:
<a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 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. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for information on
electronic access to the draft guidance.
FOR FURTHER INFORMATION CONTACT: Rana Carroll, Center for Drug
Evaluation and Research, Food and Drug Administration, Building 51, Rm.
6218, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-6135.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``How To Obtain a Covered Product Authorization.'' In December
2019, the law widely known as CREATES (referred to herein as
``CREATES'' or ``the CREATES Act'') was enacted as part of the Further
Consolidated Appropriations Act of 2020.\1\ CREATES makes available a
pathway for developers of potential drug and biological products to
obtain samples of brand products that they need to support their
applications. CREATES establishes a private right of action that allows
eligible developers to sue brand companies that refuse to sell them
product samples needed to support their applications. If the product
developer prevails, the court will order the sale of samples, award
attorneys' fees and litigation costs to the product developer, and may
impose a monetary penalty on the brand company (21 U.S.C. 355-2(b)(4)).
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\1\ See Public Law 116-94 (Further Consolidated Appropriations
Act, 2020, enacting Division N, Title I, Subtitle F, Section 610--
Actions for Delays of Generic Drugs and Biosimilar Biological
Products (Dec. 20, 2019)). The provisions of this law related to
access to product samples were codified at 21 U.S.C. 355-2 and 355-
1(l).
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The product developer must take several specific steps (outlined in
the CREATES Act) before the brand company must sell them product
samples. One of these steps--if the brand product for which samples are
sought is subject to a REMS with ETASU--is that the product developer
must first obtain a CPA from FDA (21 U.S.C. 355-2(b)(2)). CREATES does
not require this step for products that are not subject to REMS with
ETASU. This guidance describes how an eligible product developer can
obtain a CPA from FDA.
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 ``How To
Obtain a Covered Product Authorization.'' 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
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-
3521), Federal Agencies must obtain approval from the Office of
Management and Budget (OMB) for each collection of information they
conduct or sponsor. ``Collection of information'' is defined in 44
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or
requirements that members of the public submit reports, keep records,
or provide information to a third party. Section 3506(c)(2)(A) of the
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a
60-day notice in the Federal Register concerning each proposed
collection of information before submitting the collection to OMB for
approval. To comply with this requirement, FDA is publishing notice of
the proposed collection of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Guidance for Industry: How To Obtain a Covered Product Authorization
OMB Control Number 0910-0014--Revision
The revised information collection described in this guidance
supports FDA Center for Drug Evaluation and Research's implementation
of the law widely known as the CREATES Act, which was enacted as part
of the Further Consolidated Appropriations Act of 2020. As described
above, the CREATES Act establishes a pathway for eligible product
developers to obtain samples of brand products needed to support their
applications.
FDA applications referenced in this guidance include abbreviated
new drug applications (ANDAs) submitted under section 505(j) of the
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)), new
drug applications (NDA) submitted pursuant to section 505(b)(2) of the
FD&C Act (21 U.S.C. 355(b)(2)), and applications for biosimilar
products submitted under section 351(k) of the Public Health Service
Act (42 U.S.C. 262(k)).
Product developers typically need brand product samples to, among
other things, conduct testing comparing their proposed version of a
product to the brand product. For example, an ANDA applicant generally
needs to show that its proposed generic drug product is bioequivalent
to the brand product (see section 505(j)(2)(A) of the FD&C Act).
Bioequivalence is generally demonstrated by conducting studies
comparing the proposed generic drug product to the brand product and
generic applicants are required to retain samples of the brand product
used in testing after a study is complete. Developers of 505(b)(2) and
biosimilar
[[Page 57910]]
products must also typically conduct comparative testing requiring
access to brand product samples.
Under the CREATES Act, the product developer must take several
specific steps (outlined in the CREATES Act) before the brand company
is required to sell them product samples. If the brand product for
which samples are sought is subject to a REMS with ETASU, the product
developer must first obtain a CPA from FDA (21 U.S.C. 355-2(b)(2)).
(CPAs are only available for products that are subject to a REMS with
ETASU. To prevail in the private right of action established by
CREATES, an eligible product developer seeking samples of a product
that is not subject to a REMS with ETASU does not need to obtain a
CPA.)
This information collection enables eligible product developers to
obtain CPAs from FDA so that they can utilize the pathway made
available by the CREATES Act. An ANDA, 505(b)(2), or biosimilar product
developer's use of the CREATES pathway is voluntary, as is the product
developer's request for a CPA. Accordingly, under this information
collection, FDA will collect information voluntarily provided by
eligible product developers in the form of requests for CPAs and
supporting documentation. Requests for CPAs for samples of brand
products used for purposes of development and testing that involve
human clinical trials should be accompanied by study protocols,
informed consent documents, and informational materials for testing
demonstrating that safety protections comparable to those in the REMS
for the brand product will be provided for in the study(ies) for which
the samples are sought.
For generic drug products, a request for a CPA is submitted through
the CDER NextGen collaboration Portal as complex controlled
correspondence to an ANDA. For 505(b)(2) applications and biosimilar
applications, the request for a CPA is submitted to the pre-
investigational new drug application (pIND) or investigational new drug
application (IND) file, and a copy is sent to any existing marketing
application for the product and to <a href="/cdn-cgi/l/email-protection#6f20212b2c0002021a01060c0e1b0600011c2f090b0e4107071c41080019"><span class="__cf_email__" data-cfemail="5c1312181f3331312932353f3d283533322f1c3a383d7234342f723b332a">[email protected]</span></a>.
Respondents for this information collection are drug and biological
product developers that are seeking to use the CREATES pathway to
obtain samples of brand products needed to support their applications.
For ANDA, 505(b)(2), and biosimilar products, the burden of
requesting a CPA is being added to OMB Control No. 0910-0014.
Based on prior experience, FDA estimates the burden of this
collection of information as follows:
Table 1--Estimated Annual Reporting Burden \1\
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Average
Number of Number of Total annual burden per
Guidance Section IV. respondents responses per responses response Total hours
respondent (hours)
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CPA Requests for NDA/Biologics 1 1 1 5 5
License Application products...
CPA Requests for ANDA products.. 11 2 22 5 110
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Total....................... .............. .............. .............. .............. 115
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
III. Electronic Access
Persons with access to the internet may obtain an electronic
version of the draft guidance at <a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs">https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Dated: September 15, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-20523 Filed 9-21-22; 8:45 am]
BILLING CODE 4164-01-P
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