[Federal Register Volume 87, Number 183 (Thursday, September 22, 2022)]
[Notices]
[Pages 57908-57910]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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How To Obtain a Covered Product Authorization; Draft Guidance for 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the availability of a draft guidance for industry entitled ``How To 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guidance replaces the December 2014 draft guidance for industry ``How 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which has been withdrawn. This draft guidance is not final nor is it in 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DATES: Submit either electronic or written comments on the draft 
guidance by November 21, 2022 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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proposed collection of information in the draft guidance by November 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:
     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-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 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 second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available

[[Page 57909]]

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 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 [email protected].
    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 https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    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